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CODE OF ETHICS

Preamble

The Code deals with the ethics rather than the laws governing pharmacy practice. Laws and ethics
of health care necessarily overlap considerably, since both share the concern that the conduct of
health care professionals reflects respect for the well-being, dignity and self determination of
patients. The two domains of law and ethics remain distinct, and the Code, while prepared with
awareness of the law, is addressed to ethical obligations.

The pharmacist, by entering the profession, is committed to moral norms of conduct and assumes a
professional commitment to the health and well-being of patients. As citizens, pharmacists continue
to be bound by the moral and legal norms shared by all other participants in society. As individuals,
pharmacists have a right to choose to live by their own values as long as those values do not
compromise pharmacy care.

Adoption of the Code represents a conscious undertaking on the part of the members of the College
of Pharmacists of British Columbia to be responsible for practising in accordance with the expressed
principles (values and obligations). The Code defines and seeks to clarify the obligations of
pharmacists to use their knowledge and skills for the benefit of others, to minimize harm, to respect
patient autonomy and to provide fair and just pharmacy care for their patients.

! For those entering the profession, the Code identifies the basic moral commitments of
pharmacy care and serves as a source for education and reflection.

! For those within the profession, the Code serves as a basis for self-evaluation and peer review.

! For those outside the profession, the Code provides public identification of the professional
ethical expectation of its members.

Therefore the Code of Ethics is educational, guides behaviour, and expresses to the larger
community the values and ideals that we espouse by reason of trust and commitment.

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Elements of the Code

The Code contains different elements designed to help the pharmacist in its interpretation. The
values and obligations are presented by topic and not in order of importance.

! Values express broad ideals of pharmacy practice. They establish correct directions for
pharmacy practice. In the absence of a conflict of ethics, the fact that a particular action
promotes a value of pharmacy practice may be decisive in some specific instances. Pharmacist
behaviour can always be appraised in terms of values; How closely did the behaviour approach
the value? How widely did it deviate from the value? The values expressed in the Code must be
adhered to by all pharmacists in their practice. Because they are so broad, however, values
may not give specific guidance in difficult instances.

! Obligations provide more specific direction for conduct than do values; obligations spell out
what a value requires under particular circumstances.

It is also important to emphasize that even when a value or obligation must be limited, it nonetheless
carries moral weight. For example, a pharmacist who is compelled to testify in a court of law on
confidential matters is still subject to the values and obligations of confidentiality. While the
requirement to testify is a justified limitation upon confidentiality, in other respects confidentiality
must be observed. The pharmacist must only reveal that confidential information that is pertinent to
the case at hand, and such revelation must take place within the appropriate context.
Value 1 - Pharmacists respect the professional relationship with the patient and acts with
honesty, integrity and compassion.

Obligations
1. The patient-pharmacist relationship is a covenant, meaning that a pharmacist has moral
obligations in response to the trust received from society. In return for this, a pharmacist
promises to help patients achieve optimum benefit from their medications, to be committed to
their welfare, and to maintain their trust.
2. A pharmacist has a duty to tell the truth, to act with conviction of conscience, and to avoid
discriminatory practices and behaviour.

Value 2 - Pharmacists honour the individual needs, values and dignity of the patient.

Obligations
1. A pharmacist assists patients to make informed choices about their own best interests.
2. A pharmacist aids patients in their expression of needs and values, and recognizes their right to
live at risk.
3. A pharmacist's commitment to the patient's care must be sensitive to, but not prejudiced by,
factors such as the patient's race, religion, ethnic origin, social or marital status, gender, sexual
orientation, age, or health status.
4. A pharmacist recognizes the patient's membership in a family of choice, and, with the patient's
consent, attempts to facilitate, where appropriate, the participation of significant others in the
care of the patient.
5. A pharmacist's conduct at all times acknowledges the patient as a person. Discussion of care in
the presence of the patient should, whenever possible, actively include the patient.

Value 3 - Pharmacists support the right of the patient to make personal choices about
pharmacy care.

Obligations
1. A pharmacist has the primary responsibility to inform the patient about available pharmacy care.
Consent is an essential precondition to the provision of care.
2. A pharmacist owes a duty to disclose material risks associated with medication therapy.
Adequate disclosure is normally achieved by highlighting the more frequent and serious side
effects, as well the probability of their occurrence.
3. Valid consent, usually verbal, represents the free and informed choice of the competent patient
to undergo pharmacy care.
4. A pharmacist should aid patients in becoming an active participant in their care to the maximum
extent that circumstances permit.
5. A pharmacist provides information to the patient in an understandable and sensitive way.
6. A pharmacist does not withhold pertinent medication information or use deceptive tactics in
obtaining consent. When the patient's questions require information beyond that available to a
pharmacist, the patient will be referred to an appropriate health care professional.
Value 4 - Pharmacists provide competent care to the patient and actively supports the
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Obligations
1. A pharmacist places concern for the well-being of the patient at the centre of professional
practice, providing the best care that circumstances, experience and education permit.
2. A pharmacist who suspects incompetence or unethical conduct by a health care professional
will first consider the welfare of the patient. Subject to that principle, the following will apply:
A pharmacist should engage in direct discussion with the health care professional involved, if
a situation can be resolved without peril to the patient.
A pharmacist shall not participate in efforts to deceive or mislead patients about the cause of
alleged harm or injury resulting from unethical or incompetent conduct.
3. A pharmacist commits to lifelong learning designed to maintain relevant knowledge and skills.

Value 5 - Pharmacist protect the patient's right of confidentiality.

Obligations
1. A pharmacist provides pharmacy care with consideration for the personal privacy of patients.
2. An affirmative duty exists to institute and maintain practices that protect patient confidentiality.
3. A pharmacist, where appropriate, reveals to the patient the boundaries of professional
confidentiality. Pharmacy care may require that other health care personnel have access to or
be provided with the relevant information. Whenever possible, the patient should be informed,
and generally, it is up to the patient to determine who should be informed and what personal
information should be released.
4. When a pharmacist is confronted with the necessity to disclose, confidentiality should be
preserved as much as possible. Both the amount of information disclosed and those to whom
disclosure is made should be restricted to that which is necessary.
5. A pharmacist may breach confidentiality when the failure to disclose information will place other
persons or the patient in serious danger. A pharmacist will, whenever possible, consult with
other health professionals involved with the patient before breaching confidentiality.

Value 6 - Pharmacist respect the values and abilities of colleagues and other health
professionals.

Obligations
1. A pharmacist accepts responsibility to work with colleagues and other health care professionals
and with public interest pharmacy organizations and patient advocacy groups, to promote safe
and effective pharmacy care.
2. A pharmacist, when appropriate, asks for the consultation of colleagues or other health
professionals or refers the patient.
Value 7 - Pharmacists endeavour to ensure that the practice environment contributes to safe
and effective pharmacy care.

Obligations
1. A pharmacist manager has a responsibility to foster an optimal practice environment and to
ensure the provision of required resources.
2. If there is a conflict between professional activities and management policies, professional
responsibilities will take precedence.
3. A pharmacist will challenge employment conditions that are inconsistent with professional
practice as described in this code.

Value 8 - Pharmacists ensure continuity of care in the event of job action, pharmacy closure
or conflict with moral beliefs.

Obligations
1. A pharmacist has a duty through coordination and communication to ensure the provision of
essential pharmacy care throughout the duration of any job action or pharmacy closure.
Patients who require ongoing or emergency pharmacy care are entitled to have those needs
satisfied.
2. A pharmacist is not ethically obliged to provide requested pharmacy care when compliance
would involve a violation of his or her moral beliefs. When that request falls within recognized
forms of pharmacy care, however, there is a professional obligation to refer the patient to a
pharmacist who is willing to provide the service. The pharmacist shall provide the requested
pharmacy care if there is no other pharmacist within a reasonable distance or available within a
reasonable time willing to provide the service.
Commentary
Ethical Problems

Situations often arise that present ethical problems for pharmacists in their practice. These situations
tend to fall into three categories:

(a) Ethical violations involve the neglect of moral obligation; for example, a pharmacist who
neglects to provide competent pharmacy care to a patient because of personal inconvenience
has ethically failed the patient.

(b) Ethical dilemmas arise where ethical reasons both for and against a particular course of action
are present and one option must be selected. A patient who is likely to refuse some appropriate
form of pharmacy care presents the pharmacist with an ethical dilemma. For example, a patient
might refuse to take medication to treat their cancer if there is a likelihood of hair loss. In this
case, substantial moral reasons may be offered on behalf of several opposing options.

(c) Ethical distress occurs when pharmacists experience the imposition of practices that provoke
feelings of guilt, concern or distaste. Such feelings may occur when pharmacists are ethically
obliged to provide particular types of pharmacy care despite their personal disagreement or
discomfort with the course of treatment prescribed. For example, the sale of injection devices
for nonmedical use has been shown to reduce the HIV infection rate, but a pharmacist may hold
a personal belief against facilitating the use of illicit drugs.

The Code provide clear direction for avoiding ethical violations. When a course of action is
mandated by the Code, and there exists no opposing ethical principle, ethical conduct requires that
course of action.

The Code cannot serve the same function for all ethical dilemmas or for ethical distress. There is
room within the profession of pharmacy for conscientious disagreement among pharmacists. The
resolution of any dilemma often depends upon the specific circumstances of the case in question,
and no particular resolution may be definitive of good pharmacy practice. Resolution may also
depend upon the relative weight of the opposing principles, a matter about which reasonable people
may disagree.

The Code cannot relieve ethical distress but it may serve as a guide for pharmacists to weigh and
consider their responsibilities in the particular situation, Inevitably, pharmacists must reconcile their
actions with their consciences in providing pharmacy care to patients.

The Code tries to provide guidance for those pharmacists who face ethical problems. Proper
consideration of the Code should lead to better decision-making when ethical problems are
encountered.

It should be noted that many problems or situations seen as ethical in nature are problems of
miscommunication, failure of trust or management dilemmas in disguise. There is, therefore, a
distinct need to clarify whether the problem is an ethical one or one of another sort.
The revised Code of Ethics for Pharmacists and Pharmacy Technicians:
Questions & Answers

Q Why was the Code reviewed?

A In 2005 the Society committed to undertake a fundamental review of the


existing Code of Ethics and Standards for pharmacists and Code of Ethics for
pharmacy technicians in response to the changing roles, responsibilities, and
working practice of the pharmacy profession. The new Code has been
designed to promote and support the use of professional judgement and
reflects the professional considerations facing modern pharmacy.

Q What was the review process?

A A working group was formed to oversee the review process. This group
contained representatives from each sector of pharmacy as well as patient
and public interest representatives.

Council stated from the outset that it wished to engage the profession and
public throughout the review process and a series of consultations were held.
Responses to these consultations were vital in shaping the revised Code.

Q What has changed?

A The structure of the revised Code of Ethics is very different from the existing
Codes. The fundamental changes include:

• The revised Code of Ethics is based on a set of principles that will inform the
conduct, practice and performance of pharmacists and pharmacy technicians
• The principles are intended to be applicable to all sectors of the profession,
irrespective of whether an individual is involved in direct patient care
• The revised Code applies to both pharmacists and pharmacy technicians.
This is based on the fact that the same ethical principles should be applicable
to all sectors of the profession, even though how they are applied will depend
on an individual’s role and circumstances
• The revised Code is designed to promote and support a culture of
accountability and professional judgement
• The revised Code does not contain detailed technical guidance, but acts as
the core document from which further standards and guidance can be
developed

The requirements of the revised code reflect key issues for modern pharmacy
practice, such as encouraging patients to be involved in decisions about their
care, respecting patient choice and working in partnership with other
healthcare professionals.

Q What are the principles that the Code is based on?

A The revised Code of Ethics is based on seven principles. Each principle is


supported by requirements that explain the types of actions and behaviours
expected of pharmacists and pharmacy technicians when applying the
principles in practice. The seven principles are:

Page 1 27/06/2007
1. Make the care of patients your first concern
2. Exercise your professional judgement in the interests of patients and the
public
3. Show respect for others
4. Encourage patients to participate in decisions about their care
5. Develop your professional knowledge and competence
6. Be honest and trustworthy
7. Take responsibility for your working practices

Q If the revised Code does not include detailed technical guidance, where
can I obtain this information?

A Unlike previous versions, detailed standards and guidance will be produced


separately from the Code.

Seven professional standards and guidance documents have been developed


to support and expand on the principles of the new Code of Ethics in the
following areas:

• Patient consent
• Patient confidentiality
• Sale and supply of medicines
• Pharmacist prescribers
• Pharmacists and pharmacy technicians in positions of authority
• Advertising
• Internet pharmacy

Q When does the revised Code come in to effect?

A The revised Code comes in to force on 1 August 2007. The supporting


professional standards and guidance documents will also come into effect on
this date. The requirements of the existing Code will still apply until 1 August.
You can get a preview of the revised Code and its supporting documents on
the Society’s website www.rpsgb.org.

Q When will I receive my revised copy of the Code?

A Printed copies of the new Code and its supporting documents will be
distributed to all registrants with The Pharmaceutical Journal on 21 July 2007.

Q Who should I contact if I have any questions?

A Further information about the revised Code of Ethics and the review process
can be obtained by contacting Lynsey Cleland, Head of Professional Ethics
on tel: 020 7572 2519, email: lynsey.cleland@rpsgb.org.

Advice on the Code and other professional or legal obligations can be


obtained by contacting the Society’s Legal and Ethical Advisory Service on
tel: 020 7572 2308, email: ftp@rpsgb.org.

Page 2 27/06/2007
COVER STORY

Professionalism is a lifelong commitment


APhA–ASP seeks to increase awareness
By Andrew P. Traynor and Heather R. Ferguson

Pharmacy has experienced many The white paper defines “professional socialization” as “the
changes in the 150 years since a group of process of inculcating a profession’s attitudes, values, and
creative, innovative, and proud pharma- behaviors in a professional.” It goes on to state that the “goal of
cists first gathered in Philadelphia to cre- professional socialization is to develop professionalism.”
ate a national professional society of Professional socialization begins when students first apply to
pharmacists. It was the goal of these phar- one of the nation’s 84 colleges of pharmacy. It is at this time that
macists to maintain the viability of, and they make the decision to become a professional. Students reaf-
address the issues facing, the profession. firm their commitment on the first day of orientation when they
Since that time, the profession has Traynor dedicate themselves to acquiring the knowledge and skills neces-
changed from one focused on managing sary to practice pharmacy. Throughout their education, students
the production of drugs to one primarily concerned with the commit to constantly improving their knowledge for the benefit
safe, effective, and appropriate use of medications and the pro- of their patients.
vision of enhanced pharmacy services to patients. Although the Pharmacists devote themselves to providing service to their
practice of pharmacy has changed, the fact that pharmacists are communities. When providing these ser-
professionals has remained the same. vices, they are expected to make consci-
Pharmacy, like many other professions, is continuously evolv- entious, ethical decisions and to be
ing to meet the needs of the public it serves. Pharmacists are and responsible for their work. Students must
will always remain professionals and they must work to instill take the initiative to learn and understand
the profession’s attitudes and values in students who, as pharma- the characteristics that make pharmacy a
cists, will be responsible for maintaining the continuity of phar- profession and not merely an occupation.
macy as a profession. Professionalism is a lifelong commitment
that pharmacists must continually practice
A profession, not just an occupation Ferguson and develop.
The importance of pharmacy students’ professional develop-
ment has been long recognized as a key issue in pharmacy edu- Has the pharmacist shortage weakened
cation. A 5-year commitment by the Task Force on Professional- professionalism?
ism resulted in publication of the White Paper on Pharmacy Throughout the country, print and television media have
Student Professionalism, in the January/February 2000 issue of drawn attention to the pharmacist shortage. When students apply
Journal of the American Pharmaceutical Association. Drafted by to pharmacy school, what are their intentions? Today, most stu-
APhA–ASP and the American Association of Colleges of Phar- dents enter pharmacy school hoping to serve the public and
macy Council of Deans, the white paper focuses on raising improve health care outcomes, but each student has at least one
awareness and leading action on developing professionalism classmate who entered pharmacy school with the intention to
among pharmacy students. This paper looks at the definitions of strike it rich. A pharmacist shortage means big money, but this
professionalism and challenges in professional development and money has the potential to distract students from their true rea-
makes recommendations for students, educators, and practition- son for choosing pharmacy as a profession.
ers. The white paper calls for the profession to recommit itself to The pharmacist shortage has also increased the workload of
enhancing the professional development of students. practicing pharmacists. Increased workloads for pharmacists

12 Pharmacy Student September/October 2002


serving as preceptors and men-
tors have the potential to reduce
the time they can give and
lower the quality of the guid-
ance they offer. So, students,
excited about the opportunity to
implement innovative services
as they begin rotations, often
encounter resistance from these
overburdened pharmacists.
Some of these pharmacists have
developed a jaded perception of

PHOTO BY MITCH ROTHHOLZ


professionalism due to the cur-
rent stresses in their practice
environment.
This is something pharmacy
students may encounter as they
make the transition from the Graduates of the 2002 APhA Summer Leadership Institute pose in white labcoats.
classroom to practice. Only
through the continuous development of professional attitudes will The Executive Committee encourages activities such as the
students acquire the skills necessary to overcome these challenges. formation of professionalism committees consisting of pharmacy
students and faculty members devoted solely to the professional-
Professionalism activities encouraged ization of pharmacy students. The Executive Committee also
Keeping in mind the white paper’s assertion that the goal of encourages the planning and organizing of white coat cere-
professional socialization is to develop professionalism, the monies, pinning ceremonies, and mentoring opportunities, as
2002–2003 APhA–ASP Executive Committee renewed its well as promoting classroom civility, honor codes, and conduct
efforts to increase the awareness of professionalism in phar- that fosters professionalism in schools and colleges of pharmacy.
macy and actively promote professional development for It is our hope that the results of these professionalism initiatives
Academy members. will spread to both students and practitioners.

Defining ‘professional’ Examples of professionalism


Professional: A member of a profession who displays the At the University of Georgia College of Pharmacy, the
following 10 traits: incoming class participates in a white coat ceremony that
excites and encourages them as they begin their professional
1. Knowledge and skills of a profession.
journey in pharmacy. Before they begin their fourth profes-
2. Commitment to self-improvement of skills and
sional year and embark on rotations, students attend a pinning
knowledge.
ceremony that signifies the last step that they must take before
3. Service orientation. they become practitioners.
4. Pride in the profession. Recently, the University of Washington School of Pharmacy
5. Covenantal relationship with the client. implemented a new program in which the incoming class is
6. Creativity and innovation. required to develop its own oath of professionalism. This oath
7. Conscience and trustworthiness. will inform and guide their activities throughout their years of
pharmacy school. As a reminder of their commitment, this oath
8. Accountability for his or her work.
of professionalism will be read at their graduation.
9. Ethically sound decision making. Students and faculty members at University of Minnesota
10. Leadership. College of Pharmacy have banded together to address profes-
Professionalism: The active demonstration of the traits of sionalism issues. The group applied to the University Central
a professional. Council to form an Ad Hoc Committee on Professionalism.
Professional socialization (professionalization): The pro- The committee consists of four faculty members and four
cess of inculcating a profession’s attitudes, values, and pharmacy students, one student representative from each class.
behaviors in a professional. The goal of professional social- The committee has held luncheons with a random selection of
ization is to develop professionalism, as defined by the 10
character traits above. Professionalism continued on page 14

September/October 2002 Pharmacy Student 13


Professionalism continued from page 13 The Pledge of Professionalism
As a student of pharmacy, I believe there is a need to build
students to talk about issues and discuss proposed courses of
and reinforce a professional identity founded on integrity, ethi-
action. One proposal being seriously considered is holding
cal behavior, and honor. This development, a vital process in
professional development colloquia in combination with the
my education, will help to ensure that I am true to the profes-
curriculum. Recognizing that the development of professional-
sional relationship I establish between myself and society as I
ism as an evolutionary process, these colloquia will address
become a member of the pharmacy community. Integrity will
specific areas of professionalism, such as civility, professional
be an essential part of my everyday life, and I will pursue all
organizations, the recognition of colleagues, professional
academic and professional endeavors with honesty and com-
responsibilities, professional awareness, contemporary issues
mitment to service.
in pharmacy literature, expectations during externships and
To accomplish this goal of professional development, as a
rotations, maintaining professionalism, and mentoring, for
student of pharmacy I will:
each class. This committee will explore other options for addi-
A. DEVELOP a sense of loyalty and duty to the profes-
tional programming in the near future.
sion by contributing to the well-being of others and by enthu-
University of Minnesota Associate Dean Ron Hadsall stated:
siastically accepting responsibility and accountability for
“As pharmacy educators, we should focus on knowledge, prac-
membership in the profession.
tices, and attitudes in pharmacy. Right now, we place the major-
B. FOSTER professional competency through lifelong
ity of our efforts on knowledge and practice. We need to place
learning. I will strive for high ideals, teamwork, and unity
emphasis on attitudes toward pharmacy.”
within the profession in order to provide optimal patient care.
C. SUPPORT my colleagues by actively encouraging per-
Active role required
sonal commitment to the Oath of a Pharmacist and the Code
Pharmacy professionals are people who take the initiative to
of Ethics for Pharmacists as set forth by the profession.
develop their skills and dedicate themselves to learning from
D. DEDICATE my life and practice to excellence. This
and communicating with their peers. They join professional
will require an ongoing reassessment of personal and profes-
associations and actively participate in advocacy for their pro-
sional values.
fession. Professionals strive to be creative and innovative in
E. MAINTAIN the highest ideals and professional
their profession. They take on leadership roles in both the pro-
attributes to ensure and facilitate the covenantal relationship
fession of pharmacy and the provision of care to patients.
required of the pharmaceutical caregiver.
Above all, professionals take pride in their profession. It is the
The profession of pharmacy is one that demands adherence
obligation of pharmacy educators and pharmacy students to
to a set of ethical principles. These high ideals are necessary to
develop the characteristics and values necessary to become
ensure the quality of care extended to the patients I serve. As a
professionals and help instill them into others.
student of pharmacy, I believe this does not start with gradua-
APhA–ASP has always worked to supplement these obliga-
tion; rather, it begins with my membership in this professional
tions and foster student development and will continue to do so
college community. Therefore, I will strive to uphold this
in the years to come. Together, pharmacy students must take an
pledge as I advance toward full membership in the profession.
active role in changing the attitudes of their peers who have yet
I voluntarily make this pledge of professionalism.
to embrace professionalism.
Adapted from the University of Illinois College of Pharmacy’s
Andrew P. Traynor is a third-year PharmD candidate at the
Pledge of Professionalism, 1993. Developed and adopted by
University of Minnesota College of Pharmacy and 2002–2003
APhA–ASP and the American Association of Colleges of Pharmacy
APhA–ASP president-elect. Heather R. Ferguson, is a fourth-year
Council of Deans Task Force on Professionalism on June 26, 1994.
PharmD candidate at the University of Georgia College of Pharmacy
and 2002–2003 APhA–ASP Speaker of the House.

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14 Pharmacy Student September/October 2002


Professional Standards and
Guidance for Responsible Pharmacists

About this document


The Code of Ethics sets out seven principles of ethical practice that you
must follow as a pharmacist. It is your responsibility to apply the
principles to your daily work, using your judgement in light of the
principles.
The Code of Ethics says that you must ‘Make the care of patients your
first concern’. In meeting this principle you are expected to:
• Provide a proper standard of practice and care to those for whom you
provide professional services.
• Be satisfied as to the integrity and quality of products to be supplied
to patients.
• Maintain timely, accurate and adequate records and include all
relevant information in a clear and legible form.
• Undertake regular reviews, audits and risk assessments to improve
the quality of services and minimise risks to patient and public safety.
As the responsible pharmacist for a registered pharmacy, you have both
a professional and a legal duty to comply with the requirements of the
Medicines Act 1968 and the regulations made under the Act, The
Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008.
This document expands on the principles of the Code of Ethics to
explain your professional responsibilities when acting in your capacity
as the responsible pharmacist. It is designed to meet the Society’s
obligations under the Pharmacists and Pharmacy Technicians Order
2007 and other relevant legislation.

1
Professional Standards and Guidance for Responsible Pharmacists

From 2010 the current regulatory responsibilities of the Royal


Pharmaceutical Society will, be transferred to the General
Pharmaceutical Council, the arrangements for which are currently
under discussion at the time of writing. The regulatory role of the
Pharmaceutical Society of Northern Ireland is similarly under
discussion.
This document does not give detailed guidance on the legal
requirements, but you must ensure you comply with relevant legislative
requirements. The UK Health Departments have produced factual
guidance on the Health Act 2006 amendments to the Medicines Act
1968, and the responsible pharmacist regulations made under section
72A of the 1968 Act.
Where this document refers to ‘the Act’ this is the Medicines Act 1968 as
amended by the Health Act 2006. Where this document refers to ‘the
regulations’ these are The Medicines (Pharmacies) (Responsible
Pharmacist) Regulations 2008. This document does not detail all the
requirements of the Act or the regulations, but will reference these
where appropriate.
Status of this document
Principle 6.6 of the Code of Ethics states that you must comply with
legal requirements, mandatory professional standards and accepted
best practice guidance.
This document contains:
• Mandatory professional standards (indicated by the word ‘must’) for
all registered pharmacists; and
• Guidance on good practice (indicated by the word ‘should’) which you
should follow in all normal circumstances.
If a complaint is made against you the Society’s fitness to practise
committees will take account of the requirements of the Code of Ethics
and underpinning documents, including this one. You will be expected
to justify any decision to act outside its terms.

2
Professional Standards and Guidance for Responsible Pharmacists

1. THE RESPONSIBLE PHARMACIST


The responsible pharmacist is the pharmacist appointed to secure the
safe and effective running of the pharmacy in relation to the sale and
supply of medicines. At any one time there can only be one responsible
pharmacist for a registered pharmacy premises.
STANDARDS
The Act requires each registered pharmacy premises to have a
responsible pharmacist in order to operate lawfully. As the responsible
pharmacist, the Act requires you to secure the safe and effective running
of the pharmacy. In complying with this legal duty and exercising your
professional judgement, you must:
1.1 establish the scope of your role and responsibilities and take
all reasonable steps to clarify any ambiguities or uncertainties
with the pharmacist in a position of authority or other
delegated person.
1.2 not undertake work that is outside of your competency.
2. PHARMACY PROCEDURES
To comply with the Act, the responsible pharmacist is required to
establish, if not already established, maintain and review pharmacy
procedures. Appendix A lists the minimum information to be included in
pharmacy procedures that must be in place, as required in the
regulations.
Where this document refers to pharmacy procedures, these are
currently known as standard operating procedures. The standards in
this section apply to those procedures detailed in Appendix A.
In this section, reference to an amendment to a procedure is intended to
mean a temporary change to the procedure due to a change in the
pharmacy’s circumstances, for example a member of staff is off sick or a
power failure. Where amended, the procedure must revert to its original
content once the change in circumstance is resolved.
In this section, a review is where you revaluate the content of the
current procedure to ensure that it is still applicable and workable.
Review must be in accordance with the standards below, or following an
incident in the pharmacy which indicates that it may no longer be
operating safely and effectively, for example a near miss.
3
Professional Standards and Guidance for Responsible Pharmacists

STANDARDS
The pharmacy procedures form part of the quality framework for the
safe and effective running of the pharmacy. Pharmacy procedures must
be fit for purpose, and reflect the day to day running of the specific
pharmacy premises. The regulations set out the minimum areas
information required in the pharmacy procedures that must be in place.
In addition, you ensure that:
2.1 the procedures are being operated in the pharmacy and the
requirement for amendment or review is assessed by you.
2.2 it is clear to staff on duty which procedures are in operation on
the day.
2.3 adequate back ups of the content of pharmacy procedures are
maintained.
2.4 pharmacy procedures must be applicable at all times under
normal circumstances;
Establishing the pharmacy procedures
2.5 if you are the responsible pharmacist who is responsible for
establishing the pharmacy procedure(s), these are:
2.5.1 marked with the date of preparation.
2.5.2 marked with the date it is due for review.
The amendment of pharmacy procedures
2.6 in the event that you make a temporary amendment to the
pharmacy procedure, an audit trail is maintained to identify:
2.6.1 what procedures are currently in place;
2.6.2 what procedures were previously in place;
2.6.3 the responsible pharmacist who amended or reviewed the
procedures and date on which any changes were made.

4
Professional Standards and Guidance for Responsible Pharmacists

The review of pharmacy procedures


2.7 the procedures are reviewed at least once every two years, and
at any time that an incident or event occurs which indicates that
the pharmacy is not running safely and effectively
2.8 any changes to the procedures, following their review, are
notified to the person in position of authority as soon as it is
reasonably practicable.
2.9 an audit trail is maintained to identify:
2.9.1 what procedures are currently in place;
2.9.2 what procedures were previously in place;
2.9.3 the responsible pharmacist who reviewed the procedures
and date on which any changes were made.

Good practice
• All members of staff involved in the sale and supply of medicines
should read and comply with the pharmacy procedures
• Pharmacy procedures should not be dependant on the presence
and ways of working of the responsible pharmacist under whose
authority they were established
• You should record the reason for the review or amendment

3. PHARMACY RECORD
STANDARDS
Failure to complete the pharmacy record, as required in the Act, is a
criminal offence that could result in prosecution. Appendix B sets out
the minimum information to be included in the pharmacy record, as
required by the regulations. In addition, you must:
3.1 ensure the record is accurate and contemporaneous
3.2 make appropriate back-ups of an electronic record to ensure
the record is available at the premises
3.3 safeguard a paper based record by initialling and dating any
amendments to an entry made in the record
3.4 ensure that any alterations to the electronic record identify
when and by whom the alteration was made.
5
Professional Standards and Guidance for Responsible Pharmacists

4. ABSENCE FROM THE PHARMACY


The regulations enable the pharmacy to continue to operate for the sale
and supply of medicines for a maximum of two hours during the
operational hours of the pharmacy between midnight and midnight
without the presence of a responsible pharmacist, subject to specified
conditions. The regulations require you to remain contactable with
pharmacy staff where this is practical. You must also be able to return
with reasonable promptness. You must return with reasonable
promptness, where in your opinion this is necessary to secure the safe
and effective running of the pharmacy. If you cannot remain contactable,
you must arrange for another pharmacist to provide advice throughout
the period of absence or for any time during that period that you are out
of contact. You must exercise your professional judgment in deciding
whether to be absent from the pharmacy.

Good practice
• You should record your reason for absence.
• You should wherever possible, plan your absence in advance of
leaving the pharmacy.
• You should consider the length of time it will take for you to travel
to and from the pharmacy to the alternative destination, in
considering your ability to return with reasonable promptness.
• You should consider what would be the most appropriate means to
remain contactable with the pharmacy, for example a pager or
mobile telephone and any risks in being able to remain contactable,
for example where travelling through areas with poor mobile phone
reception.

6
Professional Standards and Guidance for Responsible Pharmacists

APPENDIX A
The regulations require that the pharmacy procedures must provide
information on the following:
• Arrangements to ensure that medicinal products are:-
- ordered
- stored
- prepared
- sold by retail
- supplied in circumstances corresponding to retail sale
- delivered outside the pharmacy and
- disposed of
in a safe and effective manner.
• The circumstances in which a member of pharmacy staff who is not a
pharmacist may give advice about medicinal products
• The identification of members of pharmacy staff who are, in the view
of the responsible pharmacist, competent to perform specified tasks
relating to the pharmacy business;
• The keeping of records about the matters mentioned above
• Arrangements which are to apply during the absence of the
responsible pharmacist from the premises
• Steps to be taken when there is a change of responsible pharmacist at
the premises
• The procedure which is followed if a complaint is made about the
pharmacy business
• The procedure which is to be followed if an incident occurs which may
indicate that the pharmacy business is not running in a safe and
effective manner and
• The manner in which changes to the pharmacy procedures are to be
notified to the staff

7
Professional Standards and Guidance for Responsible Pharmacists

APPENDIX B
The regulations require the following details to be included in the
pharmacy record:
• The responsible pharmacist’s name
• Their registration number
• The date and time at which the responsib]le pharmacist became the
responsible pharmacist
• The date and time at which the responsible pharmacist ceased to be the
responsible pharmacist
• In relation to absence from the premises by the responsible pharmacist:
- The date of absence
- The time at which the absence commenced
- The time at which they returned
- If they have been responsible pharmacist for more than one premises,
this fact1
1
At this time a responsible pharmacist cannot be responsible for more
than one pharmacy premises.
Guidance that supports this document
We have produced documents or guidance bulletins on the following
which should be considered in conjunction with these standards:
• Code of ethics for pharmacists and pharmacy technicians
• Professional standards and guidance for pharmacists and pharmacy
technicians in positions of authority
You can download these documents and more copies of this document
from our website (www.rpsgb.org) or you can telephone us on
020 7735 9141.
Other sources of Society advice
Further information or advice on the professional or legal obligations of
the pharmacy profession can be obtained by contacting the Society’s legal
and ethical advisory service on 020 7572 2308, or email
leadvice@rpsgb.org.
8 1st October 2009
Professional Standards and Guidance for the Sale and
Supply of Medicines

About this document


The Code of Ethics sets out seven principles of ethical practice that you
must follow as a pharmacist or pharmacy technician. It is your
responsibility to apply the principles to your daily work, using your
judgement in light of the principles.
The Code of Ethics says that you must ‘Make the care of patients your
first concern’.
In meeting this principle you are expected to:
• Provide a proper standard of practice and care to those for whom you
provide professional services.
• Seek all relevant information required to assess an individual’s needs
and provide appropriate treatment and care. Where necessary, refer
patients to other health or social care professionals or other relevant
organisations.
• Seek to ensure safe and timely access to medicines and take steps to
be satisfied of the clinical appropriateness of medicines supplied to
individual patients.
• Encourage the effective use of medicines and be satisfied that
patients, or those who care for them, know how to use their
medicines.
• Be satisfied as to the integrity and quality of products to be supplied
to patients.
• Ensure that you have access to the facilities, equipment and materials
necessary to provide services to professionally accepted standards.
This document expands on the principles of the Code of Ethics to set out
your professional responsibilities if you are involved in the sale and
supply of medicines. It is designed to meet Society’s obligations under
the Pharmacists and Pharmacy Technicians Order 2007 and other
relevant legislation.
This document does not detail legislative requirements, but when
selling or supplying medicines you must comply with relevant legislative
and contractual requirements, including NHS terms of service.
41
Professional Standards and Guidance for the Sale and Supply of Medicines

Status of this document


Principle 6.6 of the Code of Ethics states that you must comply with
legal requirements, mandatory professional standards and accepted
best practice guidance.
This document contains:
• Mandatory professional standards (indicated by the word ‘must’) for
all registered pharmacists and pharmacy technicians; and
• Guidance on good practice (indicated by the word ‘should’) which you
should follow in all normal circumstances.
If a complaint is made against you the Society’s fitness to practise
committees will take account of the requirements of the Code of Ethics
and underpinning documents, including this one. You will be expected
to justify any decision to act outside its terms.

1. PHARMACEUTICAL STOCK
STANDARDS
Patients, members of the public and other healthcare professionals are
entitled to expect that medicines sold or supplied within the course of
professional pharmacy practice are obtained from a reputable source
and fit for the intended purpose. You must ensure that:
1.1 if you suspect you have been offered or supplied a counterfeit or
defective medicine, this is reported to the Medicines and
Healthcare products Regulatory Agency, the Royal
Pharmaceutical Society, the Veterinary Medicines Directorate or
the marketing authorisation holder as appropriate to the
individual situation. Any such stock must be segregated from
other pharmacy stock and must not be sold or supplied for the
treatment of any person(s).
1.2 pharmaceutical stock is stored under suitable conditions, taking
into consideration the stability of the drug.
1.3 particular attention is paid to protection of pharmaceutical stock
from contamination, sunlight, atmospheric moisture and adverse
temperatures. You must ensure that where you have concerns

42
about the stability of a medicine, it is segregated from the rest of
the stock and not sold or supplied for patient use.
1.4 refrigerators used for pharmaceutical stock are capable of storing
products between 2C and 8C. They must be equipped with a
maximum/minimum thermometer, or other suitable alternative,
which is checked on each day the pharmacy is open and the
maximum and minimum temperatures recorded. Steps must be
taken to rectify discrepancies in temperatures.
1.5 all stocks of medicines in the pharmacy have batch and expiry
details. Medicines must be removed from blister or foil packs
only at the time of dispensing to assist an individual patient.
1.6 date expired stock is segregated from the rest of the pharmacy
stock and appropriately disposed of. Procedures must be in place
to reduce the risk of short dated or out-of-date stock being
accidentally supplied to a patient or member of the public. In the
event of a pandemic flu, Level 6, date expired medicines may be
supplied to patients, where this is in line with guidance issued by
the Government and/or the RPSGB.’
1.7 products that may be injurious to a person’s health, for example
tobacco products, alcoholic beverages and products intended to
mask the signs of alcohol or drug consumption are not sold or
supplied from registered pharmacy premises.
1.8 medicines returned to the pharmacy from a patient’s home, a
care home or a similar institution are not supplied to another
patient. While awaiting disposal, these medicines must be clearly
marked and segregated from other stock.1 In the event of a
pandemic flu, Level 6, patient returned medicines may be
supplied to patients, where this is in line with guidance issued by
the Government and/or the RPSGB.’
1.9 within the hospital setting, all medicines returned to the
pharmacy department from a ward or other hospital department
are examined under the direction of a pharmacist to assess their
suitability for being returned to stock. Patients’ own drugs
brought into hospital with them must not be returned to
pharmacy stock or be supplied to another patient.1
1 The Society is currently considering its policy on the re-use of patient returned medicines. Until such
time that this has been given full consideration 1.8 and 1.9 must be complied with. Any change in policy
will be notified via the pharmacy press.
43
Professional Standards and Guidance for the Sale and Supply of Medicines

2. SUPPLY OF OVER THE COUNTER (OTC) MEDICINES


STANDARDS
When purchasing medicines from pharmacies patients expect to be
provided with high quality, relevant information in a manner they can
easily understand. You must ensure that:
2.1 procedures for sales of OTC medicines enable intervention and
professional advice to be given whenever this can assist the safe
and effective use of medicines. Pharmacy medicines must not be
accessible to the public by self-selection.
2.2 when a patient or their carer requests advice on treatment,
sufficient information is obtained to enable an assessment to be
made of whether self-care is appropriate, and to enable a
suitable product(s) to be recommended.
2.3 if a sale is not considered suitable, the reasons for this are
explained to the patient and they are referred to another
healthcare professional where appropriate.
2.4 when an OTC medicine is supplied, sufficient advice to ensure the
safe and effective use of the medicine is provided. You must take
into account any other specific information such as safe storage, or
short expiry dates that the patient may need to be counselled on.
2.5 all staff involved in the sale or supply of an OTC medicine are
trained, or are undertaking the training required for their duties,
and are aware of situations where referral to the pharmacist or
other registered healthcare professional may be necessary.
Consideration must be given to the types of OTC medicines that
may require the personal intervention of a pharmacist e.g. those
that have recently become available without prescription, those
that may be subject to abuse or misuse, or where the marketing
authorisation for non-prescription use is restricted to certain
conditions and circumstances.

44
2.6 all persons involved in the sale of OTC products are aware of the
abuse potential of certain OTC medicines and other products. You
must be alert to requests for large quantities and abnormally
frequent requests and refuse to make a supply where there are
reasonable grounds for suspecting misuse.
2.7 particular care is exercised when supplying products for children,
the elderly and other special groups or individuals, or where the
product is for animal use.
2.8 requests for certain medicines such as emergency hormonal
contraception are handled sensitively and the patient’s right to
privacy and confidentiality is respected.
2.9 any information provided about OTC medicines is up to date,
accurate and reliable.
2.10 you keep up to date with developments regarding new products
and policies for health promotion and are aware of local and
major national and topical health promotion initiatives.

3. SUPPLY OF PRESCRIBED MEDICINES


STANDARDS
Patients are entitled to expect the dispensing service provided to be
accurate, accessible and reasonably prompt. Appropriate standard
operating procedures must be in place for the dispensing services you
provide, or are responsible for and you must ensure that:
3.1 you seek to maintain adequate stock holdings.
3.2 every prescription is clinically assessed by a pharmacist to
determine its suitability for the patient.
3.3 the patient receives sufficient information and advice to enable
the safe and effective use of the prescribed medicine.
3.4 appropriate records of clinical interventions are maintained.
3.5 patients or their carers are informed if you are unable to dispense
their prescription in its entirety and given the opportunity to take
their prescription to another pharmacy.

45
Professional Standards and Guidance for the Sale and Supply of Medicines

3.6 when medication is outstanding, the patient, carer or their


representative is provided with a legible note detailing the name
and quantity of medicine outstanding and, where possible,
informed when the balance will be available for collection. A
record of the medicine owed must be kept in the pharmacy.
3.7 a product with a marketing authorisation is supplied where such
a product exists in a suitable formulation and is available, in
preference to an unlicensed product or food supplement.2
3.8 except in an emergency, a specifically named product is not
substituted for any other product without the approval of the
patient or carer and the prescriber, a hospital drug and
therapeutics committee, or other similar locally agreed protocols.
3.9 when providing services for drug misusers you do not deviate
from the instructions given on the prescription. Sugar and/or
colour-free products have a greater potential for abuse than
syrup based and coloured products and must not be dispensed
unless specifically prescribed.
3.10 all solid dose and all oral and external liquid preparations are
dispensed in suitable reclosable child resistant containers
unless:
• the medicine is in an original pack or patient pack such as to
make this inadvisable;
• the patient has difficulty in opening a child resistant container;
• a specific request is made by the patient, their carer or
representative that the product is not dispensed in a child
resistant container;
• no suitable child resistant container exists for a particular
liquid preparation, or
• the patient has been assessed as requiring a compliance aid.
3.11 labelling of dispensed products is clear and legible and where
appropriate includes any cautionary and advisory labelling
recommended by the current British National Formulary.
3.12 appropriate systems and procedures are in place if you prepare
monitored dosage systems.
2 except where methadone mixture is prepared extemporaneously in accordance with Appendix 1
46
3.13 reimbursement claims for NHS or other professional services are
honest and accurate.
3.14 procedures are in place to minimise the risk of dispensing errors
or contamination of medicines. A record of errors or near miss
incidents must be made and practices reviewed in light of such
incidents.

GOOD PRACTICE GUIDANCE


• Where verbal information is provided about a prescribed medicine
necessary records of this should be maintained, when clinically
appropriate.

4. EXTEMPORANEOUS PREPARATION OR COMPOUNDING


STANDARDS
This standard is not intended to cover the reconstitution of dry powders
with water or other diluents.
Patients are entitled to expect that products extemporaneously
prepared in a pharmacy are prepared accurately and are suitable for
use. If you wish to be involved in extemporaneous preparation you must
ensure that:
4.1 a product is extemporaneously prepared only when there is no
product with a marketing authorisation available3 and where you
are able to prepare the product in compliance with accepted
standards.
4.2 you and any other staff involved are competent to undertake the
tasks to be performed.
4.3 the requisite facilities and equipment are available. Equipment
must be maintained in good order to ensure that performance is
unimpaired, and must be fit for the intended purpose.
4.4 you are satisfied as to the safety and appropriateness of the
formula of the product.

3 except where methadone mixture is prepared extemporaneously in accordance with Appendix 1


47
Professional Standards and Guidance for the Sale and Supply of Medicines

4.5 ingredients are sourced from recognised pharmaceutical


manufacturers and are of a quality accepted for use in the
preparation and manufacture of pharmaceutical products.
Where appropriate, relevant legislation must be complied with.
4.6 particular attention and care is paid to substances which may be
hazardous and require special handling techniques.
4.7 the product is labelled with the necessary particulars, including
an expiry date and any special requirements for the safe handling
or storage of the product.
4.8 if you are undertaking large scale preparation of medicinal
products, all relevant standards and guidance are adhered to.
4.9 records are kept for a minimum of two years. The records must
include:
• the formula,
• the ingredients,
• the quantities used,
• their source,
• the batch number,
• the expiry date,
• where the preparation is dispensed in response to a
prescription, the patient's and prescription details and the date
of dispensing,
• the personnel involved, including the identity of the pharmacist
taking overall responsibility.

GOOD PRACTICE GUIDANCE


• Where possible, all calculations and measurements should be
double checked by a second appropriately trained member of
staff.

48
5. REPEAT MEDICATION SERVICES
STANDARDS
A repeat medication service is a service operated in co-operation with
local prescribers, in which pharmacists will provide professional support
to assist in the rational, safe, effective and economic use of medicines.
In order to provide a repeat medication service, you must:
5.1 ensure the pharmacy operates a patient medication record
system notified to the Information Commissioner’s Office.
5.2 ensure that an audit trail exists to identify each request and supply.
5.3 establish, at the time of each request, which items the patient or
carer considers are required and ensure that unnecessary
supplies are not made. At this stage pharmacists must also use
their professional judgement to decide whether concordance or
other problems encountered by the patient may require early
reference to the prescriber.
5.4 not request a repeat prescription from a surgery before obtaining
the patient’s or carer’s consent. You may however institute a
patient reminder system.
5.5 record all interventions in order to be able to deal with any
queries that may arise.

6. DELIVERY SERVICES
STANDARDS
A delivery service is where the medicine is handed to the patient, their
carer or other designated person other than on registered pharmacy
premises. When providing medicines via a delivery service you still have
a professional responsibility to ensure that patients or their carers know
how to use the medication safely, effectively and appropriately and
check that they are not experiencing adverse effects or compliance
difficulties. You must ensure that:
6.1 on each occasion a delivery service is provided you use your
professional judgement to determine whether direct face-to-face
contact with the patient or their carer is necessary.

49
Professional Standards and Guidance for the Sale and Supply of Medicines

6.2 you obtain consent from the patient or their carer to provide the
delivery service on a single occasion or for a set period of time.
6.3 delivery to a person other than the patient or carer is undertaken
only where they have been specifically designated by the patient
or their carer.
6.4 you maintain appropriate records of requests for the service.
6.5 the delivery mechanism used:
• enables the medicine to be delivered securely and promptly to
the intended recipient with any necessary information to
enable safe and effective use of their medicine;
• caters for any special security/storage requirements of the
medicine;
• incorporates a verifiable audit trail for the medicine from the
point at which it leaves the pharmacy to the point at which it is
handed to the patient, their carer or other designated person,
or returned to the pharmacy in the event of a delivery failure;
• safeguards confidential information about the medication that
a patient is taking.

GOOD PRACTICE GUIDANCE


• Wherever possible a signature should be obtained to indicate safe
receipt of the medicines.
• Systems should be in place to inform a patient who is not at home
that delivery was attempted.

50
7. PRESCRIPTION COLLECTION SERVICE
STANDARDS
A prescription collection service encompasses any scheme where a
pharmacy receives prescriptions other than directly from the patient,
their carer or their representative. When providing such a service you
must:
7.1 obtain consent to receive patients’ prescriptions. The request for
the ongoing service must be from the patient or their carer and
procedures must exist for maintaining records of the initial
request for the service.
7.2 explain fully to patients, or their carers, what the service involves,
including the time period required to collect/receive and
dispense their prescription.
7.3 ensure that any members of staff who collect prescriptions are
acting in accordance with your directions.
7.4 take all reasonable steps to ensure patient confidentiality and
the security of prescriptions.
7.5 make sure that requests for repeat prescriptions are initiated by
the patient or their carer. A reminder system may be instituted
but a prescription must not be requested from a surgery before
obtaining the patient’s or their carer’s consent.
7.6 on receipt of prescriptions, including electronic prescriptions, be
satisfied that you are authorised to receive and dispense them.
Any prescription received for which you do not have the authority,
must be returned to the surgery for collection by the patient or
carer, or be directed to the pharmacy authorised to receive it.

51
Professional Standards and Guidance for the Sale and Supply of Medicines

8. COMPLEMENTARY THERAPIES AND MEDICINES


STANDARDS
You must ensure that you are competent in any area in which you offer
advice on treatment or medicines. If you sell or supply homoeopathic or
herbal medicines, or other complementary therapies, you must:
8.1 assist patients in making informed decisions by providing them
with necessary and relevant information.
8.2 ensure any stock is obtained from a reputable source.
8.3 recommend a remedy only where you can be satisfied of its
safety and quality, taking into account the Medicines and
Healthcare products Regulatory Agency registration schemes for
homoeopathic and herbal remedies.

9. EMERGENCIES
STANDARDS
There may be occasions when you are required to assist members of the
public or patients in an emergency. In such situations you must:
9.1 where appropriate, consider using the exemption in legislation
that allows pharmacists to make an emergency supply of
medicines if a patient has an urgent need for them. You must
consider the medical consequences, if any, of not making the
supply and be satisfied that your decision will not lead to patient
care being compromised.
9.2 advise the patient on how to obtain essential medical care where
you do not consider an emergency supply to be appropriate.
9.3 assist persons in need of emergency first aid or medical
treatment whether by administering first aid within your
competence or by summoning assistance.

52
10. PATIENT GROUP DIRECTIONS
STANDARDS
If you are involved in the supply and/or administration of a medicine
under a patient group direction (PGD) you must:
10.1 be satisfied that the PGD is legally valid and that it has been
approved by the relevant authorising body.
10.2 ensure that when supplies are made the agreed protocol is
followed and the information specified in the PGD is recorded.
These records must include the identity of the pharmacist
assuming responsibility for each supply.
10.3 ensure you have up-to-date knowledge relating to the clinical
situation covered by the PGD, the medicine and its use for the
indications specified.
10.4 ensure that you have undertaken any training required for
operation of the PGD.
If you are involved in writing and/or approving patient group directions
(PGD) you are accountable for their content and must ensure that:
10.5 you are familiar with your role and responsibilities and the
government advice set out in relevant guidance.
10.6 only PGDs which comply with legal requirements are approved.
10.7 the staff training specified will enable safe operation of the PGD.
10.8 the appropriate people have been involved in the drafting,
approval and signing of the PGD.
10.9 you have up-to-date knowledge relating to the clinical situation
being covered by the PGD, the medicine and its use for
indications specified in the PGD.

53
Professional Standards and Guidance for the Sale and Supply of Medicines

Guidance that supports this document


We have produced documents or guidance bulletins on the following which
should be considered in conjunction with these standards:
• Code of ethics for pharmacists and pharmacy technicians
• Professional standards and guidance for patient consent
• Professional standards and guidance for patient confidentiality
• Emergency first aid; guidance for pharmacists
• Patient group directions: a resource pack for pharmacists
• The safe and secure handling of medicines: a team approach (The Duthie
Report)
• Emergency supplies guidance (Law and Ethics Bulletin)
• Safe storage of medicines in patient’s homes (Law and Ethics Bulletin)

You can download these documents and more copies of this document from our
website (www.rpsgb.org) or you can telephone us on 020 7735 9141.

Other sources of Society advice


Further information or advice on the professional or legal obligations of the
pharmacy profession can be obtained by contacting the Society’s legal and
ethical advisory service on 020 7572 2308 or e-mail leadvice@rpsgb.org.

April 2009
54
Appendix 1

EXTEMPORANEOUS PREPARATION OF METHADONE MIXTURE


You must supply a product with a marketing authorisation, where such a
product exists in a suitable formulation and is available, in preference to
an unlicensed product or food supplement. You must only prepare a
product extemporaneously if there is no product with a marketing
authorisation available and where you are able to prepare the product in
compliance with accepted standards.
An exception to these requirements, to permit the extemporaneous
preparation of methadone mixture in circumstances where a licensed
product is available, will be granted provided the following
requirements are adhered to:
STANDARDS
(a) If a licensed product is available, methadone mixture may only be
prepared extemporaneously if the quantity of methadone dispensed on
a regular basis is large enough to preclude storage of sufficient
quantities of the licensed product within the pharmacy, in accordance
with the safe custody requirements of the Misuse of Drugs legislation.
(b) In addition to the standard operating procedures (SOPs) required for
dispensing, a SOP must be in place for the extemporaneous preparation
of methadone. The SOP must ensure safe systems and provide a
verifiable audit trail. Adherence to the SOP must be ensured.
(c) Extemporaneous preparation must only be carried out by persons
who are appropriately trained and competent to do so.
(d) All quantities of methadone powder and diluent, and any colourings,
flavourings and stabilisers, must be accurately measured. You must not
rely on the accuracy of the quantities of powder, diluent etc stated on
the manufacturer’s packs.
(e) The equipment used to measure and prepare extemporaneous
methadone products must be appropriate and be maintained in good
order to ensure that performance is unimpaired.
(f ) Equipment must be properly cleaned between each batch of
extemporaneously prepared product to ensure that no residue from
previous batches remains.
(g) Visual checks must be made to ensure the methadone powder has
fully dissolved in the diluent.
55
Professional Standards and Guidance for the Sale and Supply of Medicines

(h) Stock bottles must not be reused.


(i) The product must be labelled with the necessary particulars,
including:
• The name and strength of the product
• The quantity of medicinal product in the container
• Any special handling and storage requirements (eg, store in safe
custody)
• The batch expiry date
• A batch reference number
(j) For each batch of extemporaneous methadone mixture prepared a
record must be maintained for a minimum of two years of:
• The formula
• The ingredients and quantities used
• The source, batch number and expiry date of the ingredients
• The batch number and expiry date of the extemporaneously prepared
mixture
• The persons involved in preparing the product, including the identity
of the pharmacist assuming overall responsibility
(k) Extemporaneously prepared methadone mixture must be stored in a
cabinet, cupboard or room that meets the requirements of the Misuse of
Drugs (Safe Custody) Regulations 1973.
(l) Extemporaneous preparation of methadone mixture, when a licensed
product is available, carries increased liability and must be covered by
indemnity insurance arrangements.

GOOD PRACTICE GUIDANCE


• Running balances of methadone powder and the resulting
extemporaneously prepared methadone mixture should be
maintained.
• The prescriber and the patient should be informed that the
methadone product being supplied does not have a marketing
authorisation.
• Wherever possible all measurements should be checked by a
second person.
56
Professional Standards and Guidance for the Sale and
Supply of Medicines

About this document


The Code of Ethics sets out seven principles of ethical practice that you
must follow as a pharmacist or pharmacy technician. It is your
responsibility to apply the principles to your daily work, using your
judgement in light of the principles.
The Code of Ethics says that you must ‘Make the care of patients your
first concern’.
In meeting this principle you are expected to:
• Provide a proper standard of practice and care to those for whom you
provide professional services.
• Seek all relevant information required to assess an individual’s needs
and provide appropriate treatment and care. Where necessary, refer
patients to other health or social care professionals or other relevant
organisations.
• Seek to ensure safe and timely access to medicines and take steps to
be satisfied of the clinical appropriateness of medicines supplied to
individual patients.
• Encourage the effective use of medicines and be satisfied that
patients, or those who care for them, know how to use their
medicines.
• Be satisfied as to the integrity and quality of products to be supplied
to patients.
• Ensure that you have access to the facilities, equipment and materials
necessary to provide services to professionally accepted standards.
This document expands on the principles of the Code of Ethics to set out
your professional responsibilities if you are involved in the sale and
supply of medicines. It is designed to meet Society’s obligations under
the Pharmacists and Pharmacy Technicians Order 2007 and other
relevant legislation.
This document does not detail legislative requirements, but when
selling or supplying medicines you must comply with relevant legislative
and contractual requirements, including NHS terms of service.
41
Professional Standards and Guidance for the Sale and Supply of Medicines

Status of this document


Principle 6.6 of the Code of Ethics states that you must comply with
legal requirements, mandatory professional standards and accepted
best practice guidance.
This document contains:
• Mandatory professional standards (indicated by the word ‘must’) for
all registered pharmacists and pharmacy technicians; and
• Guidance on good practice (indicated by the word ‘should’) which you
should follow in all normal circumstances.
If a complaint is made against you the Society’s fitness to practise
committees will take account of the requirements of the Code of Ethics
and underpinning documents, including this one. You will be expected
to justify any decision to act outside its terms.

1. PHARMACEUTICAL STOCK
STANDARDS
Patients, members of the public and other healthcare professionals are
entitled to expect that medicines sold or supplied within the course of
professional pharmacy practice are obtained from a reputable source
and fit for the intended purpose. You must ensure that:
1.1 if you suspect you have been offered or supplied a counterfeit or
defective medicine, this is reported to the Medicines and
Healthcare products Regulatory Agency, the Royal
Pharmaceutical Society, the Veterinary Medicines Directorate or
the marketing authorisation holder as appropriate to the
individual situation. Any such stock must be segregated from
other pharmacy stock and must not be sold or supplied for the
treatment of any person(s).
1.2 pharmaceutical stock is stored under suitable conditions, taking
into consideration the stability of the drug.
1.3 particular attention is paid to protection of pharmaceutical stock
from contamination, sunlight, atmospheric moisture and adverse
temperatures. You must ensure that where you have concerns

42
about the stability of a medicine, it is segregated from the rest of
the stock and not sold or supplied for patient use.
1.4 refrigerators used for pharmaceutical stock are capable of storing
products between 2C and 8C. They must be equipped with a
maximum/minimum thermometer, or other suitable alternative,
which is checked on each day the pharmacy is open and the
maximum and minimum temperatures recorded. Steps must be
taken to rectify discrepancies in temperatures.
1.5 all stocks of medicines in the pharmacy have batch and expiry
details. Medicines must be removed from blister or foil packs
only at the time of dispensing to assist an individual patient.
1.6 date expired stock is segregated from the rest of the pharmacy
stock and appropriately disposed of. Procedures must be in place
to reduce the risk of short dated or out-of-date stock being
accidentally supplied to a patient or member of the public. In the
event of a pandemic flu, Level 6, date expired medicines may be
supplied to patients, where this is in line with guidance issued by
the Government and/or the RPSGB.’
1.7 products that may be injurious to a person’s health, for example
tobacco products, alcoholic beverages and products intended to
mask the signs of alcohol or drug consumption are not sold or
supplied from registered pharmacy premises.
1.8 medicines returned to the pharmacy from a patient’s home, a
care home or a similar institution are not supplied to another
patient. While awaiting disposal, these medicines must be clearly
marked and segregated from other stock.1 In the event of a
pandemic flu, Level 6, patient returned medicines may be
supplied to patients, where this is in line with guidance issued by
the Government and/or the RPSGB.’
1.9 within the hospital setting, all medicines returned to the
pharmacy department from a ward or other hospital department
are examined under the direction of a pharmacist to assess their
suitability for being returned to stock. Patients’ own drugs
brought into hospital with them must not be returned to
pharmacy stock or be supplied to another patient.1
1 The Society is currently considering its policy on the re-use of patient returned medicines. Until such
time that this has been given full consideration 1.8 and 1.9 must be complied with. Any change in policy
will be notified via the pharmacy press.
43
Professional Standards and Guidance for the Sale and Supply of Medicines

2. SUPPLY OF OVER THE COUNTER (OTC) MEDICINES


STANDARDS
When purchasing medicines from pharmacies patients expect to be
provided with high quality, relevant information in a manner they can
easily understand. You must ensure that:
2.1 procedures for sales of OTC medicines enable intervention and
professional advice to be given whenever this can assist the safe
and effective use of medicines. Pharmacy medicines must not be
accessible to the public by self-selection.
2.2 when a patient or their carer requests advice on treatment,
sufficient information is obtained to enable an assessment to be
made of whether self-care is appropriate, and to enable a
suitable product(s) to be recommended.
2.3 if a sale is not considered suitable, the reasons for this are
explained to the patient and they are referred to another
healthcare professional where appropriate.
2.4 when an OTC medicine is supplied, sufficient advice to ensure the
safe and effective use of the medicine is provided. You must take
into account any other specific information such as safe storage, or
short expiry dates that the patient may need to be counselled on.
2.5 all staff involved in the sale or supply of an OTC medicine are
trained, or are undertaking the training required for their duties,
and are aware of situations where referral to the pharmacist or
other registered healthcare professional may be necessary.
Consideration must be given to the types of OTC medicines that
may require the personal intervention of a pharmacist e.g. those
that have recently become available without prescription, those
that may be subject to abuse or misuse, or where the marketing
authorisation for non-prescription use is restricted to certain
conditions and circumstances.

44
2.6 all persons involved in the sale of OTC products are aware of the
abuse potential of certain OTC medicines and other products. You
must be alert to requests for large quantities and abnormally
frequent requests and refuse to make a supply where there are
reasonable grounds for suspecting misuse.
2.7 particular care is exercised when supplying products for children,
the elderly and other special groups or individuals, or where the
product is for animal use.
2.8 requests for certain medicines such as emergency hormonal
contraception are handled sensitively and the patient’s right to
privacy and confidentiality is respected.
2.9 any information provided about OTC medicines is up to date,
accurate and reliable.
2.10 you keep up to date with developments regarding new products
and policies for health promotion and are aware of local and
major national and topical health promotion initiatives.

3. SUPPLY OF PRESCRIBED MEDICINES


STANDARDS
Patients are entitled to expect the dispensing service provided to be
accurate, accessible and reasonably prompt. Appropriate standard
operating procedures must be in place for the dispensing services you
provide, or are responsible for and you must ensure that:
3.1 you seek to maintain adequate stock holdings.
3.2 every prescription is clinically assessed by a pharmacist to
determine its suitability for the patient.
3.3 the patient receives sufficient information and advice to enable
the safe and effective use of the prescribed medicine.
3.4 appropriate records of clinical interventions are maintained.
3.5 patients or their carers are informed if you are unable to dispense
their prescription in its entirety and given the opportunity to take
their prescription to another pharmacy.

45
Professional Standards and Guidance for the Sale and Supply of Medicines

3.6 when medication is outstanding, the patient, carer or their


representative is provided with a legible note detailing the name
and quantity of medicine outstanding and, where possible,
informed when the balance will be available for collection. A
record of the medicine owed must be kept in the pharmacy.
3.7 a product with a marketing authorisation is supplied where such
a product exists in a suitable formulation and is available, in
preference to an unlicensed product or food supplement.2
3.8 except in an emergency, a specifically named product is not
substituted for any other product without the approval of the
patient or carer and the prescriber, a hospital drug and
therapeutics committee, or other similar locally agreed protocols.
3.9 when providing services for drug misusers you do not deviate
from the instructions given on the prescription. Sugar and/or
colour-free products have a greater potential for abuse than
syrup based and coloured products and must not be dispensed
unless specifically prescribed.
3.10 all solid dose and all oral and external liquid preparations are
dispensed in suitable reclosable child resistant containers
unless:
• the medicine is in an original pack or patient pack such as to
make this inadvisable;
• the patient has difficulty in opening a child resistant container;
• a specific request is made by the patient, their carer or
representative that the product is not dispensed in a child
resistant container;
• no suitable child resistant container exists for a particular
liquid preparation, or
• the patient has been assessed as requiring a compliance aid.
3.11 labelling of dispensed products is clear and legible and where
appropriate includes any cautionary and advisory labelling
recommended by the current British National Formulary.
3.12 appropriate systems and procedures are in place if you prepare
monitored dosage systems.
2 except where methadone mixture is prepared extemporaneously in accordance with Appendix 1
46
3.13 reimbursement claims for NHS or other professional services are
honest and accurate.
3.14 procedures are in place to minimise the risk of dispensing errors
or contamination of medicines. A record of errors or near miss
incidents must be made and practices reviewed in light of such
incidents.

GOOD PRACTICE GUIDANCE


• Where verbal information is provided about a prescribed medicine
necessary records of this should be maintained, when clinically
appropriate.

4. EXTEMPORANEOUS PREPARATION OR COMPOUNDING


STANDARDS
This standard is not intended to cover the reconstitution of dry powders
with water or other diluents.
Patients are entitled to expect that products extemporaneously
prepared in a pharmacy are prepared accurately and are suitable for
use. If you wish to be involved in extemporaneous preparation you must
ensure that:
4.1 a product is extemporaneously prepared only when there is no
product with a marketing authorisation available3 and where you
are able to prepare the product in compliance with accepted
standards.
4.2 you and any other staff involved are competent to undertake the
tasks to be performed.
4.3 the requisite facilities and equipment are available. Equipment
must be maintained in good order to ensure that performance is
unimpaired, and must be fit for the intended purpose.
4.4 you are satisfied as to the safety and appropriateness of the
formula of the product.

3 except where methadone mixture is prepared extemporaneously in accordance with Appendix 1


47
Professional Standards and Guidance for the Sale and Supply of Medicines

4.5 ingredients are sourced from recognised pharmaceutical


manufacturers and are of a quality accepted for use in the
preparation and manufacture of pharmaceutical products.
Where appropriate, relevant legislation must be complied with.
4.6 particular attention and care is paid to substances which may be
hazardous and require special handling techniques.
4.7 the product is labelled with the necessary particulars, including
an expiry date and any special requirements for the safe handling
or storage of the product.
4.8 if you are undertaking large scale preparation of medicinal
products, all relevant standards and guidance are adhered to.
4.9 records are kept for a minimum of two years. The records must
include:
• the formula,
• the ingredients,
• the quantities used,
• their source,
• the batch number,
• the expiry date,
• where the preparation is dispensed in response to a
prescription, the patient's and prescription details and the date
of dispensing,
• the personnel involved, including the identity of the pharmacist
taking overall responsibility.

GOOD PRACTICE GUIDANCE


• Where possible, all calculations and measurements should be
double checked by a second appropriately trained member of
staff.

48
5. REPEAT MEDICATION SERVICES
STANDARDS
A repeat medication service is a service operated in co-operation with
local prescribers, in which pharmacists will provide professional support
to assist in the rational, safe, effective and economic use of medicines.
In order to provide a repeat medication service, you must:
5.1 ensure the pharmacy operates a patient medication record
system notified to the Information Commissioner’s Office.
5.2 ensure that an audit trail exists to identify each request and supply.
5.3 establish, at the time of each request, which items the patient or
carer considers are required and ensure that unnecessary
supplies are not made. At this stage pharmacists must also use
their professional judgement to decide whether concordance or
other problems encountered by the patient may require early
reference to the prescriber.
5.4 not request a repeat prescription from a surgery before obtaining
the patient’s or carer’s consent. You may however institute a
patient reminder system.
5.5 record all interventions in order to be able to deal with any
queries that may arise.

6. DELIVERY SERVICES
STANDARDS
A delivery service is where the medicine is handed to the patient, their
carer or other designated person other than on registered pharmacy
premises. When providing medicines via a delivery service you still have
a professional responsibility to ensure that patients or their carers know
how to use the medication safely, effectively and appropriately and
check that they are not experiencing adverse effects or compliance
difficulties. You must ensure that:
6.1 on each occasion a delivery service is provided you use your
professional judgement to determine whether direct face-to-face
contact with the patient or their carer is necessary.

49
Professional Standards and Guidance for the Sale and Supply of Medicines

6.2 you obtain consent from the patient or their carer to provide the
delivery service on a single occasion or for a set period of time.
6.3 delivery to a person other than the patient or carer is undertaken
only where they have been specifically designated by the patient
or their carer.
6.4 you maintain appropriate records of requests for the service.
6.5 the delivery mechanism used:
• enables the medicine to be delivered securely and promptly to
the intended recipient with any necessary information to
enable safe and effective use of their medicine;
• caters for any special security/storage requirements of the
medicine;
• incorporates a verifiable audit trail for the medicine from the
point at which it leaves the pharmacy to the point at which it is
handed to the patient, their carer or other designated person,
or returned to the pharmacy in the event of a delivery failure;
• safeguards confidential information about the medication that
a patient is taking.

GOOD PRACTICE GUIDANCE


• Wherever possible a signature should be obtained to indicate safe
receipt of the medicines.
• Systems should be in place to inform a patient who is not at home
that delivery was attempted.

50
7. PRESCRIPTION COLLECTION SERVICE
STANDARDS
A prescription collection service encompasses any scheme where a
pharmacy receives prescriptions other than directly from the patient,
their carer or their representative. When providing such a service you
must:
7.1 obtain consent to receive patients’ prescriptions. The request for
the ongoing service must be from the patient or their carer and
procedures must exist for maintaining records of the initial
request for the service.
7.2 explain fully to patients, or their carers, what the service involves,
including the time period required to collect/receive and
dispense their prescription.
7.3 ensure that any members of staff who collect prescriptions are
acting in accordance with your directions.
7.4 take all reasonable steps to ensure patient confidentiality and
the security of prescriptions.
7.5 make sure that requests for repeat prescriptions are initiated by
the patient or their carer. A reminder system may be instituted
but a prescription must not be requested from a surgery before
obtaining the patient’s or their carer’s consent.
7.6 on receipt of prescriptions, including electronic prescriptions, be
satisfied that you are authorised to receive and dispense them.
Any prescription received for which you do not have the authority,
must be returned to the surgery for collection by the patient or
carer, or be directed to the pharmacy authorised to receive it.

51
Professional Standards and Guidance for the Sale and Supply of Medicines

8. COMPLEMENTARY THERAPIES AND MEDICINES


STANDARDS
You must ensure that you are competent in any area in which you offer
advice on treatment or medicines. If you sell or supply homoeopathic or
herbal medicines, or other complementary therapies, you must:
8.1 assist patients in making informed decisions by providing them
with necessary and relevant information.
8.2 ensure any stock is obtained from a reputable source.
8.3 recommend a remedy only where you can be satisfied of its
safety and quality, taking into account the Medicines and
Healthcare products Regulatory Agency registration schemes for
homoeopathic and herbal remedies.

9. EMERGENCIES
STANDARDS
There may be occasions when you are required to assist members of the
public or patients in an emergency. In such situations you must:
9.1 where appropriate, consider using the exemption in legislation
that allows pharmacists to make an emergency supply of
medicines if a patient has an urgent need for them. You must
consider the medical consequences, if any, of not making the
supply and be satisfied that your decision will not lead to patient
care being compromised.
9.2 advise the patient on how to obtain essential medical care where
you do not consider an emergency supply to be appropriate.
9.3 assist persons in need of emergency first aid or medical
treatment whether by administering first aid within your
competence or by summoning assistance.

52
10. PATIENT GROUP DIRECTIONS
STANDARDS
If you are involved in the supply and/or administration of a medicine
under a patient group direction (PGD) you must:
10.1 be satisfied that the PGD is legally valid and that it has been
approved by the relevant authorising body.
10.2 ensure that when supplies are made the agreed protocol is
followed and the information specified in the PGD is recorded.
These records must include the identity of the pharmacist
assuming responsibility for each supply.
10.3 ensure you have up-to-date knowledge relating to the clinical
situation covered by the PGD, the medicine and its use for the
indications specified.
10.4 ensure that you have undertaken any training required for
operation of the PGD.
If you are involved in writing and/or approving patient group directions
(PGD) you are accountable for their content and must ensure that:
10.5 you are familiar with your role and responsibilities and the
government advice set out in relevant guidance.
10.6 only PGDs which comply with legal requirements are approved.
10.7 the staff training specified will enable safe operation of the PGD.
10.8 the appropriate people have been involved in the drafting,
approval and signing of the PGD.
10.9 you have up-to-date knowledge relating to the clinical situation
being covered by the PGD, the medicine and its use for
indications specified in the PGD.

53
Professional Standards and Guidance for the Sale and Supply of Medicines

Guidance that supports this document


We have produced documents or guidance bulletins on the following which
should be considered in conjunction with these standards:
• Code of ethics for pharmacists and pharmacy technicians
• Professional standards and guidance for patient consent
• Professional standards and guidance for patient confidentiality
• Emergency first aid; guidance for pharmacists
• Patient group directions: a resource pack for pharmacists
• The safe and secure handling of medicines: a team approach (The Duthie
Report)
• Emergency supplies guidance (Law and Ethics Bulletin)
• Safe storage of medicines in patient’s homes (Law and Ethics Bulletin)

You can download these documents and more copies of this document from our
website (www.rpsgb.org) or you can telephone us on 020 7735 9141.

Other sources of Society advice


Further information or advice on the professional or legal obligations of the
pharmacy profession can be obtained by contacting the Society’s legal and
ethical advisory service on 020 7572 2308 or e-mail leadvice@rpsgb.org.

April 2009
54
Appendix 1

EXTEMPORANEOUS PREPARATION OF METHADONE MIXTURE


You must supply a product with a marketing authorisation, where such a
product exists in a suitable formulation and is available, in preference to
an unlicensed product or food supplement. You must only prepare a
product extemporaneously if there is no product with a marketing
authorisation available and where you are able to prepare the product in
compliance with accepted standards.
An exception to these requirements, to permit the extemporaneous
preparation of methadone mixture in circumstances where a licensed
product is available, will be granted provided the following
requirements are adhered to:
STANDARDS
(a) If a licensed product is available, methadone mixture may only be
prepared extemporaneously if the quantity of methadone dispensed on
a regular basis is large enough to preclude storage of sufficient
quantities of the licensed product within the pharmacy, in accordance
with the safe custody requirements of the Misuse of Drugs legislation.
(b) In addition to the standard operating procedures (SOPs) required for
dispensing, a SOP must be in place for the extemporaneous preparation
of methadone. The SOP must ensure safe systems and provide a
verifiable audit trail. Adherence to the SOP must be ensured.
(c) Extemporaneous preparation must only be carried out by persons
who are appropriately trained and competent to do so.
(d) All quantities of methadone powder and diluent, and any colourings,
flavourings and stabilisers, must be accurately measured. You must not
rely on the accuracy of the quantities of powder, diluent etc stated on
the manufacturer’s packs.
(e) The equipment used to measure and prepare extemporaneous
methadone products must be appropriate and be maintained in good
order to ensure that performance is unimpaired.
(f ) Equipment must be properly cleaned between each batch of
extemporaneously prepared product to ensure that no residue from
previous batches remains.
(g) Visual checks must be made to ensure the methadone powder has
fully dissolved in the diluent.
55
Professional Standards and Guidance for the Sale and Supply of Medicines

(h) Stock bottles must not be reused.


(i) The product must be labelled with the necessary particulars,
including:
• The name and strength of the product
• The quantity of medicinal product in the container
• Any special handling and storage requirements (eg, store in safe
custody)
• The batch expiry date
• A batch reference number
(j) For each batch of extemporaneous methadone mixture prepared a
record must be maintained for a minimum of two years of:
• The formula
• The ingredients and quantities used
• The source, batch number and expiry date of the ingredients
• The batch number and expiry date of the extemporaneously prepared
mixture
• The persons involved in preparing the product, including the identity
of the pharmacist assuming overall responsibility
(k) Extemporaneously prepared methadone mixture must be stored in a
cabinet, cupboard or room that meets the requirements of the Misuse of
Drugs (Safe Custody) Regulations 1973.
(l) Extemporaneous preparation of methadone mixture, when a licensed
product is available, carries increased liability and must be covered by
indemnity insurance arrangements.

GOOD PRACTICE GUIDANCE


• Running balances of methadone powder and the resulting
extemporaneously prepared methadone mixture should be
maintained.
• The prescriber and the patient should be informed that the
methadone product being supplied does not have a marketing
authorisation.
• Wherever possible all measurements should be checked by a
second person.
56
Professional Standards for Pharmacists and Pharmacy Technicians in Positions of Authority

Professional Standards for Pharmacists and Pharmacy


Technicians in Positions of Authority

About this document


The Code of Ethics sets out seven principles of ethical practice that you
must follow as a pharmacist or pharmacy technician. It is your
responsibility to apply the principles to your daily work, using your
judgement in the light of the principles.
The Code of Ethics says that you must ‘Take responsibility for your
working practices’ and sets out what you are expected to do when
applying this principle in practice.
This document expands on the principles of the Code of Ethics to set out
your professional responsibilities if you are in a position of authority. It
is designed to meet the Society’s obligations under the Pharmacists and
Pharmacy Technicians Order 2007 and other relevant legislation.
The term ‘position of authority’ encompasses the wide range of
managerial responsibilities pharmacists and pharmacy technicians
undertake, including managing a pharmacy, pharmacy team or
department, being a superintendent pharmacist or pharmacy owner, or
managing services in a hospital, trust or other field of practice such as
industry or academia. The standards in this document are intended to
apply to all practice settings. As pharmacists and pharmacy technicians
take on management responsibilities to varying degrees, the ability to
put into effect parts of this document will depend on the authority your
position gives you and the area of practice in which you work.
If you have overall responsibility for the provision of pharmacy services
within your organisation (for example, if you own a registered pharmacy
premises, are a superintendent pharmacist, or are a chief pharmacist),
you must ensure that all the standards set out in this document are met.
Where you have delegated the day-to-day implementation of any of the
standards you retain overall responsibility for ensuring that the
standards are met.

1
If you are a pharmacist or pharmacy technician with other management
responsibilities, for example, if you have management responsibilities
for a group of pharmacies or staff within your organisation, you must
ensure that the standards in this document are met wherever it is your
responsibility and within your power to do so. Where it is not, you must
raise awareness of any problems with those who are in a position to
make change.
If you are the responsible pharmacist, as defined in the Medicines Act,
you must ensure that you also comply with the professional standards
and guidance for responsible pharmacists. The extent to which the
standards in this document apply to you will be dependant upon the
specific role and responsibilities that you have been employed to
undertake.
This document does not detail legislative requirements, but when in a
position of authority you must comply with the legislative and
contractual requirements, such as NHS terms of service, relevant to your
management responsibilities.

Status of this document


Principle 6.6 of the Code of Ethics states that you must comply with
legal requirements, mandatory professional standards and accepted
best practice guidance.
This document contains:
• Mandatory professional standards (indicated by the word ‘must’) for
all registered pharmacists and pharmacy technicians in positions of
authority.
You must follow the standards where it is your responsibility and within
your power to do so.
If a complaint is made against you the Society’s fitness to practise
committees will take account of the requirements of the Code of Ethics
and underpinning documents, including this one. You will be expected
to justify any decision to act outside its terms.
Sections 1-9 of this document are applicable to all practice settings.
Sections 10 and 11 outline requirements specific to registered retail
pharmacies.
2
Professional Standards for Pharmacists and Pharmacy Technicians in Positions of Authority

1. ACCEPTING POSITIONS OF AUTHORITY


STANDARDS
You must accept work only where you have the skills and competence for
the tasks to be performed. When taking on any position of authority you
must:
1.1 establish the scope of your role and responsibilities and clarify
any ambiguities or uncertainties about where your responsibilities
lie.
1.2 have the necessary knowledge, skills and experience, including
sufficient language competence, to undertake the role.
1.3 be able to comply with your legal and professional obligations and
manage effectively the activities you are responsible for.
1.4 keep up to date with and observe the laws, statutory codes and
professional obligations relevant to your particular
responsibilities.
1.5 declare to the relevant person or authority any interests that could
be perceived to influence your judgement in financial or
commercial dealings which impact on patient care or public safety.

2. POLICIES AND PROCEDURES


STANDARDS
You must ensure that all legal and professional requirements are
observed in relation to the pharmaceutical aspects of the business or
professional services you manage. It is essential that appropriate
policies and procedures are established, maintained and reviewed.
Policies and procedures must be made readily available to relevant staff.
There must be clarity on areas of responsibility and clear lines of
accountability must exist.

3
If you are a pharmacy owner, superintendent pharmacist or pharmacy
manager in a hospital, trust, or other field of practice you have overall
responsibility for setting out the standards and policies for the provision
of pharmacy services by your organisation. If you are a pharmacist or
pharmacy technician with management responsibilities for the day-to-
day running of one or more departments or pharmacy premises, you
must ensure that policies and procedures are appropriate for the
particular department or premises you are responsible for.
You must, as appropriate to your particular management
responsibilities, ensure that:
2.1 policies and standard operating procedures to ensure the safe
and effective provision of pharmacy services in accordance with
relevant legal and professional requirements are in place,
maintained and regularly reviewed.
2.2 clear lines of accountability exist and a retrievable audit trail of
the health professional taking responsibility for the provision of
each pharmacy service is maintained.
2.3 appropriate policies for the number and required experience
levels of staff for the business or department(s) you manage are
in place and are made known to relevant staff.
2.4 suitable arrangements are in place when members of staff are off
duty and effective handover procedures are followed.
2.5 there are systems to identify and manage risks to patients, the
public and those you employ. There must be procedures to deal
with incidents that pose a threat to patient, public or employee
safety and to review practices in light of such incidents.
2.6 procedures are in place to record errors or near miss incidents,
notify the person responsible, and review procedures as
appropriate.
2.7 procedures respect and protect confidential information about
patients and employees in accordance with current legislation,
relevant codes of practice and professional guidelines.
2.8 systems are in place to ensure that the supplier and the quality of
any medicines, devices and pharmaceutical ingredients obtained
are reputable.

4
Professional Standards for Pharmacists and Pharmacy Technicians in Positions of Authority

2.9 appropriate security measures are in place to protect stocks of


medicinal products, devices, and pharmaceutical ingredients,
especially those which may be at particular risk of theft or abuse.
2.10 any advertising and promotional activity you authorise for
professional services or medicinal products complies with
appropriate advertising codes of practice, professional guidance
and the law.

3. PHARMACY PREMISES AND FACILITIES


STANDARDS
The pharmacy premises, department or facilities you manage must
enable safe systems of work and be appropriate to the professional
services being provided. You must ensure that:
3.1 the pharmacy premises, department or facilities you are
responsible for do not bring the pharmacy profession into
disrepute.
3.2 all relevant statutory requirements and regulations are complied
with.
3.3 any part of the premises from which professional services are
provided is readily identifiable and well maintained.
3.4 medicines, pharmaceutical ingredients, devices and other stock
at the pharmacy premises or facilities are stored under
conditions appropriate to the nature and stability of the product
concerned.

4. RESPONSIBILITIES TO THOSE YOU EMPLOY, MANAGE OR LEAD


STANDARDS
You must make sure that those you employ, manage or lead, including
temporary staff and locums, are not prevented or hindered from
performing their professional and legal duties. You must ensure that:
4.1 the views, beliefs and rights of those you employ, manage or lead
are respected and protected.
4.2 financial or other targets do not compromise the professional
5 services you and your staff provide.
4.3 those you employ, manage or lead:
• are aware of and are able to comply with their professional and
legal responsibilities, and that systems are in place to facilitate
this.
• are able to exercise their professional judgement in the best
interest of patients and the public;
• understand their individual roles and responsibilities, including
the activities and decisions which have and have not been
delegated to them;
• are provided with the information necessary to enable them to
perform their duties safely and effectively;
• are not required to undertake tasks that they are not competent
and trained, or being trained, to do;
• have appropriate supervision, either through close personal
supervision (trainee staff, for example) or, where legislation
permits and the staff are appropriately trained and qualified,
through a managed system with clear reporting structures.
4.4 working conditions and practices are lawful and resources,
facilities and equipment enable staff to provide services to
professionally accepted standards.
4.5 staff are able and encouraged to take appropriate rest breaks.
When agreeing working hours and rest breaks with employees
you must take into account legislative requirements, individual
requirements for breaks and the needs of patients.

5. EMPLOYING OTHERS
STANDARDS
Individuals who are employed or engaged to provide pharmacy services,
including temporary staff and locums, must be suitable for the role
given to them. If you employ or engage pharmacists, pharmacy
technicians or other pharmacy staff (including trainees and students), or
if you have overall responsibility for their employment within your
organisation, you must be satisfied that:

6
Professional Standards for Pharmacists and Pharmacy Technicians in Positions of Authority

5.1 appropriate checks are carried out before employment commences


and that adverse findings do not make employing or engaging the
individual untenable. Depending on the remit and responsibilities
of the role this may include inquiries about previous criminal
convictions, verification of professional registration status and
checks on any conditions or limitations on practice.
5.2 the individual to be employed has or will undertake appropriate
training to attain the skills, knowledge and competency, including
sufficient language competence for their role.
5.3 reliable references are sought and provided.
5.4 the requirements of the Code of Ethics are taken into account
when making decisions relating to the conduct of pharmacists,
pharmacy technicians, pre-registration trainees or student
pharmacy technicians.
5.5 the Society is informed if there is concern that the professional
competence or fitness to practise of a pharmacist, pharmacy
technician, pre-registration trainee or student pharmacy technician
may compromise patient care or public safety.
5.6 there is co-operation with investigations or inquiries into the
fitness to practise of anyone you employ and the impact of any
findings and decisions on the employee’s role and responsibilities
are taken into account.

6. TRAINING AND DEVELOPMENT


STANDARDS
Pharmacists, pharmacy technicians and other staff must have the
appropriate knowledge, skills and competence for the roles they
undertake and must be provided with training and development
opportunities to strengthen and improve these. Where you employ,
manage or lead others you must ensure that:
6.1 individuals have access to the training they need and undertake
any accredited training requirements relevant to their duties in a
timely manner.

7
6.2 you take steps to satisfy yourself that the pharmacists and pharmacy
technicians you employ, manage or lead are aware of their obligation to
undertake continuing professional development relevant to their
professional duties, and are supported to meet this requirement.
6.3 staff who seek assistance because they do not feel able to carry out their
professional work are reasonably and effectively supported.
6.4 the progress and performance of staff, particularly trainees, is regularly
reviewed with honest and constructive feedback.
6.5 when training pre-registration trainees or student pharmacy technicians:
• the trainee is fit to practise throughout their training contract,
• the training meets the development needs of the trainee and provides
the necessary range of experiences of professional practice,
• the trainee is appropriately supervised and monitored by their pre-
registration tutor or supervisor and their performance is honestly and
impartially evaluated,
• pre-registration training is provided in approved premises and the
Society is notified when such training is being provided.

7. ENABLING OTHERS TO RAISE CONCERNS


STANDARDS
It is important that those you employ, manage or lead, including temporary staff
and locums, are able to raise concerns about risks to patients or the public.
Appropriate systems need to be in place to deal with these concerns. You must
make sure that:
7.1 there is an appropriate and effective mechanism for staff to raise
concerns about risks to patients or the public, including concerns about
inadequate resources, policies and procedures, or problems with the
health, behaviour or professional performance of others.
7.2 staff have ready access to information on how to raise concerns, and who
they should be raised with.
7.3 staff who raise genuine concerns are appropriately supported and
protected.

8
Professional Standards for Pharmacists and Pharmacy Technicians in Positions of Authority

7.4 systems are in place to investigate concerns promptly, fully and


fairly, and appropriate records are maintained of any
investigations and action taken.
7.5 concerns which cannot be addressed at a local level are referred
to senior management and/or the appropriate authority, such as
a regulatory body.
Further information and advice on raising concerns can be found in the
Society’s guidance document ‘Raising concerns- guidance for
pharmacists and registered pharmacy technicians’ (www.rpsgb.org).

8. HANDLING COMPLAINTS
STANDARDS
All complaints about individuals, activities or services under your
managerial control must be dealt with in an appropriate and
professional manner. Where applicable, NHS complaints procedures
must be followed. If you are in a position of authority you must be
satisfied that:
8.1 systems are in place to enable complaints to be dealt with
promptly, constructively and honestly.
8.2 those you employ, manage or lead, including temporary staff and
locums, are familiar with the complaints procedure.
8.3 complainants receive a timely and constructive response and are
informed about the way in which the complaints process will
proceed.
8.4 anyone being investigated is treated fairly and individuals who
are being asked to account for their conduct are made fully aware
of the allegations made against them.
8.5 appropriate records are maintained of any complaints received
and the action taken.

9
9. INDEMNITY ARRANGEMENTS
STANDARDS
All pharmacists and pharmacy technicians have a responsibility to ensure
that their professional activities are covered by adequate professional
indemnity arrangements. Where you employ or engage pharmacists,
pharmacy technicians or other staff you must ensure that:
9.1 all professional activities undertaken by you or under your control are
covered by adequate professional indemnity cover.
9.2 those you employ or engage are aware of the extent of the
professional indemnity cover provided to them.

10. SUPERINTENDENT PHARMACISTS AND RESPONSIBLE PHARMACISTS


FOR A REGISTERED PHARMACY PREMISES
Superintendent pharmacists and responsible pharmacists have statutory
functions detailed in the Medicines Act 1968. The specific professional
requirements for pharmacists undertaking these statutory roles and the
relationship between the two roles are explained below.

Superintendent pharmacists
STANDARDS
As a superintendent pharmacist you are required to manage the keeping,
preparing, dispensing and sale or supply of medicinal products by a
registered retail pharmacy business owned by a body corporate. You have a
responsibility to set the overarching standards and policies for the
pharmaceutical aspects of the business. You must ensure that all legal and
professional requirements are adhered to and must respond appropriately to
any systems failures or concerns that may arise. The role of superintendent
pharmacist is a key position carrying full time responsibility and
accountability within a company.

10
Professional Standards for Pharmacists and Pharmacy Technicians in Positions of Authority

You must be satisfied that you have sufficient resources, authority and
influence within your organisation to comply with your legal and professional
responsibilities. You must also make sure that the members of the board of
the body corporate are aware of and understand your responsibilities. As
superintendent pharmacist, you retain overall professional accountability for
the pharmaceutical aspects of the business even if you are employed for
fewer hours than the pharmacy business operates. If you are employed as a
superintendent pharmacist on a part time basis, or are not resident in the UK
it is very unlikely that you will be able to comply adequately with the legal
and professional responsibilities of this role.
You must ensure that the responsible pharmacist is supported to fulfil their
legal and professional responsibilities and appropriate systems need to be in
place to deal with concerns raised by the responsible pharmacist.

Responsible Pharmacist
STANDARDS
Where a pharmacy premises is owned by a body corporate, the
superintendent pharmacist is required to set the overarching standards and
policies for the pharmacy business. As the responsible pharmacist of a
particular pharmacy at any given time, you must secure the safe and effective
running of that pharmacy for the sale and supply of medicinal products, as
required by the Medicines Act 1968. You are responsible for ensuring
appropriate procedures for the pharmacy while you are the responsible
pharmacist . Where model procedures have been agreed by the pharmacy
owner or superintendent pharmacist you must ensure that they are
implemented and amended or reviewed where necessary within the
pharmacy you are assuming responsibility for. You must ensure that you
exercise your professional judgment in complying with your statutory duty to
secure the safe and effective running of the pharmacy and that you comply
with the standards detailed in the professional standards and regulatory
guidance for responsible pharmacists.

11
11. BODIES CORPORATE
STANDARDS
Where a body corporate owns a pharmacy business, a superintendent
pharmacist must be appointed to manage the pharmaceutical aspects of the
business. The Society expects members of the board of a body corporate to
consider and act on the advice of the superintendent pharmacist when dealing
with the requirements of the pharmaceutical parts of the business. The
superintendent pharmacist needs to be provided with the necessary support
and resources to carry out his or her legal and professional obligations as
detailed in this document.
The Society must be notified in writing of any changes to the address or
ownership of a registered pharmacy premises, or superintendent pharmacist of
a body corporate.

Guidance that supports this document


We have produced documents or guidance bulletins on the following which
should be considered in conjunction with these standards:
• Code of ethics for pharmacists and pharmacy technicians
• Professional standards and guidance for responsible pharmacists
• Professional standards and guidance for the sale and supply of
medicines
• Professional standards and guidance for patient confidentiality
• Raising concerns- guidance for pharmacists and registered pharmacy
technicians
• Rest breaks (Law and Ethics Bulletin)
You can download these documents and more copies of this document from
our website (www.rpsgb.org) or you can telephone us on 020 7735 9141.

Other sources of Society advice


Further information or advice on the professional or legal obligations of the
pharmacy profession can be obtained by contacting the Society’s legal and
ethical advisory service on 020 7572 2308, or email ftp@rpsgb.org.
1 Oct 2009 12
FOR IMMEDIATE RELEASE CONTACT: Gail Street
June 23, 2005 Public Relations Director
202-429-7558

Statement by John A. Gans, Executive Vice President and CEO


American Pharmacists Association (APhA)

Pharmacists & Physicians: Not Just a Matter of Conscience


Despite the alarming headlines, pharmacists and physicians agree. Patients should
receive their medications without harassment and interference. The American Pharmacists
Association’s (APhA) two-part policy statement supports the ability of the pharmacist to step
away from participating in activity to which they have personal objections—but not step in the
way. The Association supports the pharmacists’ ability to choose not to fill a prescription based
on moral or ethical values. But recognizing the pharmacist’s important role in the health care
system, APhA supports the establishment of systems to ensure that the patient’s health care
needs are served.

Essential to APhA’s policy is establishing systems to assure patient access before the
prescription ever reaches the pharmacist. Well-constructed systems are seamless; and often the
patient is unaware of the pharmacist’s action. On this point, we agree with the AMA and
welcome dialogue that will ensure this continued recognition of the need to serve patients and
recognize the individual beliefs of pharmacists and physicians. Just as physicians are not
required to provide all medical services, pharmacists should not be required to provide all
pharmacy services.

It is unfortunate that the conversation between the AMA and APhA did not take place
before their House of Delegates action. But physicians and pharmacists collaborate every day to
improve medication use and advance patient care—including navigating issues of conscience.
We look forward to working with the AMA on this issue, much as our individual members are
working together with physicians today.

Just like doctors, pharmacists abide by a Code of Ethics for the delivery of health care.
And yes, just like doctors, pharmacists make sure that patients are getting the prescriptions they
need without interruption at the pharmacy.

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-S1
Pharmacy Professionalism Toolkit
for Students and Faculty

Provided by the
American Pharmacists Association Academy of Student Pharmacists
American Association of Colleges of Pharmacy
Committee on Student Professionalism

Version 1.0
2004

2003-04 Committee Members

AACP Representatives APhA-ASP Representatives

Thomas Reinders, Co-chair Amit Patel, Co-chair


(Virginia Commonwealth University) (University of Cincinnati)
Robert Beardsley Gail Caballes
(University of Maryland) (University of Washington)
Nanci Murphy James Hobbs
(University of Washington) (University of Kentucky)
Amy Schwartz Brea Olson
(Nevada College of Pharmacy) (University of Tennessee)
Andrew Traynor,
(University of Minnesota)
John Vinson
(University of Arkansas for Medical Sciences)
TABLE OF CONTENTS

PREAMBLE.................................................................................................................................. 4
TEN TRAITS THAT DISTINGUISH A PROFESSIONAL.................................................................... 4
DESCRIPTION OF THE PROFESSIONALISM TOOLKIT .................................................................. 7
STUDENT RECRUITMENT ...................................................................................................... 8
I. INTRODUCTION ................................................................................................................................. 8
II. POSSIBLE ACTIVITIES................................................................................................................... 10
A. Pre-Pharmacy Organizations................................................................................................... 10
B. Outreach Programs-Career Fairs............................................................................................. 11
C. Outreach Programs—Mentoring and Shadowing ................................................................... 12
D. Educating the Public on the Pharmacist’s Role in Health Care .............................................. 13
E. Professionalism Prerequisite................................................................................................... 14
ADMISSIONS ............................................................................................................................. 15
I. INTRODUCTION ............................................................................................................................... 15
II. POSSIBLE ACTIVITIES................................................................................................................... 16
A. Application Process................................................................................................................. 16
B. Interview Process .................................................................................................................... 17
C. Staff Participation in the Admissions Process ........................................................................ 18
NEW STUDENTS....................................................................................................................... 19
I. INTRODUCTION ............................................................................................................................... 19
II. POSSIBLE ACTIVITIES................................................................................................................... 21
A. Student Orientation ................................................................................................................. 21
B. Professionalism Orientation Booklet ...................................................................................... 23
C. Peer Mentoring Programs ....................................................................................................... 24
D. Introduction to Student Pharmacy Organizations ................................................................... 26
E. White Coat Ceremonies .......................................................................................................... 28
F. Public Affirmation of Professionalism.................................................................................... 30
G. Service Projects in Community............................................................................................... 32
H. Charity Fundraisers ................................................................................................................. 34
I. Outside Speakers to Reinforce Messages ............................................................................... 35
J. Introductory Pharmacy Courses ............................................................................................. 37
K. Student Portfolio Process ........................................................................................................ 39
L. Integration into Residence Life Programs (if relevant)........................................................... 40
M. Issues for 0 – 6 Programs (if relevant) .................................................................................... 41
N. Issues for Distance Learning Programs (if relevant)............................................................... 42
O. Issues for Religious-Affiliated Programs (if relevant) ............................................................ 43
PROFESSIONAL YEARS 01, 02, 03 (DIDACTIC) ................................................................ 44
I. INTRODUCTION ............................................................................................................................... 44
II. POSSIBLE ACTIVITIES................................................................................................................... 45
A. Honor System.......................................................................................................................... 45
B. Dress Code .............................................................................................................................. 46
C. Course Content and Structure ................................................................................................. 47
D. Classroom Demeanor.............................................................................................................. 49
E. Student Membership on School and College Committees...................................................... 50
F. Professional Demeanor: Faculty, Teaching Assistants, Preceptors, Staff & Administrators.. 51
G. Ethics Course Offering............................................................................................................ 52
H. Leadership and Political Advocacy Course Offering.............................................................. 53
I. Recognition and Awards......................................................................................................... 54
J. Cultivating Student and Faculty Relationships....................................................................... 55

2
K. Professional Pharmacy Organizations..................................................................................... 56
L. Student Leadership Council .................................................................................................... 57
M. Community Service Requirements (Service Learning) .......................................................... 58
N. Pinning / Professional Commitment Ceremony (End of P3) .................................................. 59
O. Faculty Retreat ........................................................................................................................ 60
P. Student Professionalism Assessment ...................................................................................... 61
EXPERIENTIAL EDUCATION............................................................................................... 62
I. INTRODUCTION ............................................................................................................................... 62
II. POSSIBLE ACTIVITIES................................................................................................................... 65
A. Student Orientation ................................................................................................................. 65
B. Faculty / Preceptor Orientation and Training Programs ......................................................... 67
C. Professional Portfolios ............................................................................................................ 70
D. Mentor Programs .................................................................................................................... 71
E. Service Learning..................................................................................................................... 72
F. Community and Hospital Practicums (Introductory Experiences) ......................................... 73
G. Classroom Workshops and/or Reflections.............................................................................. 74
I. Advanced Practicums ............................................................................................................. 77
EXTRACURRICULAR ACTIVITIES..................................................................................... 78
I. INTRODUCTION ............................................................................................................................... 78
II. POSSIBLE ACTIVITIES................................................................................................................... 80
A. Professionalism Scholarships and Awards.............................................................................. 80
B. Professionalism Committees................................................................................................... 81
C. Patient-care Projects................................................................................................................ 83
D. Poster Presentations ................................................................................................................ 84
E. Patient Counseling Activities/Competitions ........................................................................... 85
F. Developing a Portfolio ............................................................................................................ 86
G. Honor Codes ........................................................................................................................... 87
H. Broadening the Scope of Practice ........................................................................................... 88
I. Leadership Conferences.......................................................................................................... 89
J. Mentor Programs .................................................................................................................... 90
K. Interprofessional Activities ..................................................................................................... 91
L. Etiquette Dinner ...................................................................................................................... 92
M. Monthly Column on Professionalism ..................................................................................... 93
APPENDIXES ............................................................................................................................. 94
Appendix A - Experiential Rotation Timeline (P1 - P3)......................................................................... 94
Appendix B - Experiential Rotation Timeline: P4.................................................................................. 95
Appendix C – Professionalism Competency in the Curriculum ............................................................. 96

3
Preamble
Pharmaceutical care has been described as the “direct, responsible provision of medication-related care
for the purpose of achieving definite outcomes that improve a patient’s quality of life.” Pharmaceutical
care responsibilities include obtaining and reviewing the patient’s medication history, screening for
potential adverse side effects or allergies, providing recommendations for appropriate therapy, educating
patients on the proper use of their medications, monitoring the patient’s ability to take the medication
correctly, monitoring the patient’s drug therapy over time, and collaborating with other health
professionals and the patient to ensure that optimal health outcomes are achieved. Pharmaceutical care
also involves the provision of services (e.g., administering immunizations) that improve access to health
care and promote public health. At the core of patient-pharmacist relationships is a pledge to the patient
(or covenant) that the pharmacist will exercise competent judgment and place the patient’s safety and
welfare above all other considerations. It is a privilege to practice as a pharmacist and, as such, requires
not only competence in the specialized knowledge and skills unique to our profession, but a continuing
commitment to excellence, a respect and compassion for others, and adherence to high standards of
ethical conduct. 1

In order to enhance pharmaceutical care, students, faculty and practitioners must enhance professionalism
with pharmacy education and practice. To define professionalism, the committee looked to the material
developed by the APhA-ASP/AACP Task Force on Professionalism. The following summarizes its
important findings.

TEN TRAITS THAT DISTINGUISH A PROFESSIONAL


As defined in the 1999 APhA-ASP/AACP White Paper on Student Professionalism2, pharmacists and
pharmacy students act professionally when they display the following behaviors as categorized into 10
broad traits 3 :

1. Knowledge and skills of a profession


2. Commitment to self-improvement of skills and knowledge
3. Service orientation
4. Pride in the profession
5. Covenantal relationship with client
6. Creativity and innovation
7. Conscience and trustworthiness
8. Accountability for his/her work
9. Ethically sound decision-making
10. Leadership

1
ASHP Statement on Pharmaceutical Care
2
APhA-ASP/AACP-COD Task Force on Professionalism. White paper on pharmacy student professionalism. J.
Am. Pharm. Assoc. 2000; 40:96-102.
3
Ten Marks of a Professional Working Smart. New York, NY: National Institute of Business Management, March
11, 1991; 17(5)

4
Professional Knowledge, Skills and Behaviors
! Performs responsibilities in a manner consistent with the school’s or college’s educational
outcomes statement, the CAPE outcomes, NABP and ACPE competencies, professional
associations’ competency statements and other professionalism documents
! Interacts effectively with faculty, staff, other students, patients and their families, pharmacy
colleagues and other health professionals

Commitment to Self-Improvement and Life-Long Learning


! Reflects critically on his or her actions and seeks to improve proficiency in all facets of his/her
responsibilities
! Accepts and responds to constructive feedback
! Provides constructive feedback to others
! Recognizes limitations and seeks help when necessary
! Takes responsibility for learning; an active and self-directed learner
! Does not participate in activities that compromise learning (disruptive behavior, cheating)
! Maintains personal health and well-being

Service Orientation/Altruism
! Demonstrates concern for the welfare of others; uses skills and knowledge to improve their
quality of life
! Recognizes and avoids conflicts of interest
! Provides service to the community and society-at-large
! Offers to help others when they are busy or in need of assistance
! Shares opportunities for recognition with others
! Does not seek to profit unfairly from others
! Puts patient needs above their own, e.g., staying as long as necessary to ensure appropriate care

Continuing Commitment to Excellence and Pride in the Profession


! Demonstrates dedication to his/her patients and the profession supported by a strong work ethic
! Upholds the competent delivery of health care services; addresses lack of knowledge or skill in
self and others
! Conscientious; well-prepared for class and clinical rotations
! Displays a consistent effort to exceed minimum requirements; demonstrates quality work

Covenantal Relationship with the Patient and Respect for Others


! Empathetic and responsive to the needs of the patient, the patient’s family and other members of
the health care team
! Respects a patient’s autonomy, privacy, and dignity
! Involves the patient as a partner in his/her health care decisions; honors the patient’s values and
belief systems
! Respects and appreciates the diversity of his/her patients
! Listens and communicates effectively
! Maintains appropriate boundaries
! Advocates for others
! Non-judgmental; displays compassion and empathy
! Skillful in establishing a rapport with patients and other health care team members
! Contributes to team building
! Maintains composure and adapts well to changing or stressful situations
! Resolves conflicts fairly

5
Creativity and Innovation
! Contributes to quality improvement in all professional endeavors
! Applies creative and innovative approaches to challenges
! Contributes to the development of new knowledge and practices that advance pharmaceutical care

Conscience and Trustworthiness


! Demonstrates a high degree of integrity, truthfulness, and fairness
! Uses time and resources appropriately
! Truthful about facts or events
! Does not hide errors

Accountability
! Demonstrates initiative, reliability and follow-through in fulfilling commitments
! Promptly completes responsibilities in a timely manner (notifies appropriate individual of
unexpected emergencies)
! Responsible for, and accountable to others (e.g., patients their families, to society and the
profession)
! Accepts responsibility for one’s errors and explores ways to prevent errors from occurring in the
future
! Confronts individuals who demonstrate unprofessional behavior
! Does not participate in activities that impair judgment or compromise patient care responsibilities
! Accountable for his/her academic and professional performance

Ethically Sound Decision-Making


! Demonstrates an awareness of professional norms, laws, and behavior; knowledgeable of theories
and principles underlying ethical conduct
! Adheres to high ethical and moral standards
! Able to cope with a high degree of complexity and uncertainty
! Controls emotions appropriately even under stressful conditions; maintains personal boundaries
! Prioritizes responsibilities properly

Leadership
! Contributes to the profession; actively involved in professional organizations or other venues
! Proactive in solving social and professional challenges
! Helps promote a culture of professionalism
! Embraces and advocates for change that improves patient care
! Encourages current and future pharmacists in their professional development

6
DESCRIPTION OF THE PROFESSIONALISM TOOLKIT
The primary goal of the APhA-ASP/AACP Committee on Student Professionalism is to promote the
professionalization of pharmacy students and faculty. To achieve this goal, the committee developed a
resource of specific activities and strategies that students and administrators can utilize to effectively
promote and assess professionalism on their own campuses.

This document provides professionalism activities in six broad areas:


! Recruitment
! Admissions
! New Students
! Professional Years: P1, P2, P3 (Didactic)
! Experiential Education
! Extra-curricular Activities

For each area, the committee has attempted to identify the “successful practices” used in the nation’s
colleges and schools of pharmacy. Each section reviews what has worked well in the past and provides
insights into possible problems that may occur when trying to implement these activities. Examples of
pharmacy institutions that have experience with the program or policy are provided as reference points.
The committee recognizes that other AACP member institutions may also implement similar tools,
events, or programs, but committee members were not aware of these activities and apologize for any
glaring oversights. The toolkit also references activities described in the abstracts submitted for the 2004
AACP School Poster Session. Although an abstract may include information about numerous
professionalism activities within the institution, the toolkit may only highlight one of these activities. The
activities and references in each area are not listed in any particular order.

In developing this toolkit, the committee considered four key stages to addressing professionalism within
colleges and schools of pharmacy:

1. Define attributes related to professionalism


2. Identify relevant behaviors that correspond to those attributes
3. Create a culture of professionalism in pharmacy schools and practice settings
4. Develop valid and reliable means of assessment and feedback.

AACP and APhA-ASP committee members would like to see the Pharmacy Professionalism Toolkit
serve as a living document and continue to evolve over time. Please contact Libby Ross, AACP Director
of PharmCAS and Student Affairs, at Lross@aacp.org, if you would like to make a contribution to an
existing activity in the list or suggest new ways to promote professionalism in pharmacy education.

“Knowledge is derived from the scientific method; wisdom is gained from human interactions.”
AAMC Council of Academic Societies

7
STUDENT RECRUITMENT
Best Practice Guidelines

Gail D. Caballes, University of Washington


Nanci L. Murphy, University of Washington

I. INTRODUCTION

Background
Pharmaceutical care as described by Hepler and Strand, promotes a “covenantal and caring relationship
with patients.” To establish and foster successful patient relationships, a pharmacist must not only
exercise sound professional judgment, but also demonstrate personal attributes such as integrity,
accountability, and compassion. Prospective pharmacy students should become familiar with the unique
roles and responsibilities of a pharmacist as early as possible. It is important to recruit students who
embrace the pharmaceutical care philosophy and are willing to uphold the profession’s high standards of
moral and ethical conduct. Students must also realize that professional development is an ongoing process
and willingly engage in activities that will enhance their practice skills throughout their career.
Practitioners, faculty members, current students and mentors may influence an applicant’s initial
perception of the profession. It is therefore important that all contribute to enhancing (rather than
undermining) an applicant’s understanding of professionalism and the core values fundamental to our
profession.

Recruitment activities offer a wide variety of opportunities to introduce professionalism. Many schools
have hired individuals whose primary responsibility is to plan and oversee recruitment initiatives.
Application materials, including information on school websites, should contain information on
pharmacy’s evolving role in health care and the professional attributes that support patient-centered care.
The Oath of the Pharmacist, the Pledge to Professionalism, the Pharmacist’s Code of Ethics, and the
school’s internal documents on professional behavior, are examples of references that ought to be made
available to prospective students. High school counselors and pre-pharmacy advisers should be
knowledgeable on the academic and personal qualities that enhance future success. Presentations at career
fairs, pre-pharmacy club meetings and other similar forums could include discussions on pharmaceutical
care and the pharmacist’s integral role on the health care team.

Planning Elements
Each school must identify the best individuals to work on these initiatives. Since professionalism issues
can arise in many ways and in different situations, appropriate steps must be taken to ensure the overall
message is consistent with the college or school’s program expectations. Although the main introduction
to professionalism is typically given prior to the start of the first professional year, it is important to
discuss professionalism earlier to increase awareness of this issue.

Students, faculty, staff, and practitioners are often invited to speak at area high schools, community
colleges, and universities. Practitioners and pharmacy students delivering presentations at their former
high schools and pre-pharmacy institutions, have been particularly well-received. Creating written
materials, such as PowerPoint presentations, brochures and poster boards should involve collaboration
with faculty, staff, students and practitioners. Presenters should be familiar with opportunities in the
different areas of pharmacy (community pharmacy, hospital pharmacy, academia, etc.) to ensure student
interest areas area addressed. Discussion of the Code of Ethics, the Oath of the Pharmacist, and the Pledge
to Professionalism, as well as a discussion of ethical issues, will help reinforce the high value the school
places on professionalism.

8
A PowerPoint template could be created for presentations or discussions with prospective students. This
would ensure that an accurate and consistent message is delivered regardless of the presenter.
Documenting what went well and what needs improvement will help subsequent presenters improve this
activity in the future.

Timelines
Recruitment opportunities present themselves throughout the year. Students may request applications or
visit the advising office at any time during the year. Scheduling visits with other schools and groups is
not always feasible unless dates are set well in advance. For this reason, individual programs should
create timelines that best fits their schedules. However, since the topic of professionalism is quite broad,
adequate preparation is necessary. Pharmacy programs should enlist current students to participate in
recruitment activities before they leave campus at the end of the school year. This will allow sufficient
time to plan in the summer months when students may have more free time.

Promotion
In order for recruitment materials to be available by the start of the school year, promotion for committee
chairs and members should occur towards the end of the preceding school year. Faculty participation
should also be sought before the summer session begins.

Evaluation
Documentation of applicant responses regarding their understanding of professionalism will help in the
evaluation of these initiatives.

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II. POSSIBLE ACTIVITIES

A. Pre-Pharmacy Organizations

Description of activity
Pre-pharmacy organizations are typically composed of students interested in applying to pharmacy
school. These organizations provide an excellent forum to explore career opportunities, learn about the
school or college’s program of studies, and prepare for the admission process. Students can inquire about
classes, internship opportunities, and receive advice on admissions. They may also participate in journal
clubs or extracurricular activities planned by current pharmacy students.

Rationale
Before applying to a program, students often seek the advice of a college counselor or program advisor to
answer technical questions on the admissions process and Pharm.D. degree requirements. Current student
pharmacists, however, can provide other kinds of information. This would be a great opportunity to
discuss the topic of professionalism, as well as involve pre-pharmacy students in activities that foster
leadership, altruism and pride in the profession.

Areas of professionalism addressed


Activities promoting the importance of professionalism will raise awareness of this topic and create a
baseline of expectations students may refer back to as they progress through the application process.

Special issues involving planning / promotion / implementation


Pharmacy students who lead these discussions must be well-versed in professionalism issues and able to
apply these tenets to different work environments and situations. Faculty advisors should also either be
present and/or consulted before information is presented to pre-pharmacy students.

Examples of programs and resources


! Duquesne University
! Western University of Health Sciences
! University of Kentucky

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B. Outreach Programs-Career Fairs

Description of activity
Career fairs provide a forum for high school and college students to explore different career options. This
is an opportune time to discuss the evolving role of pharmacists and key attributes essential to the
provision of pharmaceutical care.

Rationale
Although it is not uncommon for students to have identified a career goal while still in high school, many
may be still trying to decide among the various choices in the health professions. Career fairs allow
prospective students to explore current opportunities in the pharmacy profession.

Areas of professionalism addressed


This type of program helps increase awareness of the pharmacist’s role in health care and acquaints a
prospective student on the profession’s expectations regarding professional behavior.

Special issues involving planning / promotion / implementation


The issue of finding representatives to attend high school career fairs may be problematic since they are
often scheduled on a weekday. If the fair spans the course of a day, finding students, faculty and
practitioners to remain at a booth for this length of time presents a significant challenge.

Examples of programs and resources


! Rutgers University
! South Dakota State University
! University of Florida
! University of Tennessee
! “Keep your Options Open,” Iowa Pharmacists Association (Provides resources for those involved in
recruitment activities): www.iarx.org/Resources?putlications/Options.aspx

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C. Outreach Programs—Mentoring and Shadowing

Description of activity
Mentoring allows the prospective student to learn about the pharmacy program and the profession from a
current student or a practitioner. Introducing middle and high school students to the pharmacy profession
via job shadowing programs allows them to see first-hand the skills, attitudes and education necessary for
a successful career as a pharmacist. Strong role models and mentors can help students overcome
challenges to professionalism they may face in the future.

Rationale
Prospective students can experience for themselves the day-to day activities of the pharmacist and the
challenges/opportunities this career presents. The mentor can share work experiences that require
professional behavior and also discuss scenarios where unprofessional behavior was observed.

Areas of professionalism addressed


The mentor can explain expectations of professional behavior as it applies to different settings and
situations.

Special issues involving planning / promotion / implementation


Finding students and practitioners willing to donate time to take a prospective student “under their wing”
presents the biggest challenge. If the plan is to create a structured mentor program, recruiting mentors
needs to begin well in advance of the projected start date.

Examples of programs and resources


At Purdue University, for example, “freshmen are matched with an upper class pharmacy student who
provides support, encouragement, and guidance. All freshmen are eligible to participate. First, second,
and third professional year pharmacy students serve as mentors.”

! Ohio State University - Early Admissions Pathway (EAP) Mentoring Program


! Auburn University
! University of Florida
! University of Pittsburgh
! Western University of Health Sciences
! University of Washington
! St. John’s University
! University of Wisconsin-Madison
! NACDS Pharmacies of Promise. www.pharmaciesofpromise.org

2004 AACP School Poster:


“Professionalism Is More Than a White Coat: Beyond Rules and Rituals.” Cynthia J. Boyle, Jill
A. Morgan, Robert S. Beardsley, University of Maryland.

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D. Educating the Public on the Pharmacist’s Role in Health Care

Description of activity
There are a number of different ways pharmacy students and faculty can promote the role of pharmacists
in health care, including use of the media, health fairs, career days, presentations, printed materials,
videos, web sites, organized events, etc. Schools are encouraged to promote these public education
activities to prospective pharmacy students.

Rationale
The public’s perception of the pharmacist needs to reflect current roles in patient care. Efforts should be
made to emphasize the pharmacist’s role in improving health outcomes as well as the professional tenets
central to pharmaceutical care.

Schools should include language on professionalism in recruitment brochures, web pages and application
materials. It is important that applicants are aware of the school’s expectations, in both academic
performance and professional behaviors.

Areas of professionalism addressed


Pride in the profession, service orientation, raising the general public’s awareness on the requisite
knowledge, skills and abilities required of a practicing pharmacist.

Examples of programs and resources


! Auburn University:
http://pharmacy.auburn.edu/prospective_student professional_degree/expected-attributes.htm
! University of Washington’s Admission, Graduation and Academic Standards Document
http://depts.washington.edu/pha/students/applciation/2004packet.pdf pg. 10-11
! AACP website
http://www.aacp.org
! St. John’s University- “Good Morning America”
! Long Island University “Today Show” http://www.brooklyn.liunet.edu/wn/2003/55.html
! University of Washington - “Northwest Afternoon”
! National Pharmacy Week activities – http://www.aphanet.org
! Canadian Pharmacists Association: Pharmacy Week site -
http://www.pharmacists.ca/content/hcp/resource_centre/pharmacist_awareness/resource_manual.cfm

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E. Professionalism Prerequisite

Description of activity
Schools and colleges identify selected courses, i.e., biology, chemistry, calculus, etc. as prerequisites for
admission to their programs. Students could also be asked to submit information on their professionalism
traits as a required component of their application.

Professional attributes could include:


! Demonstrates a spirit of inquiry and curiosity (desire to learn beyond course expectations)
! Demonstrates creativity (projects, extracurricular or work activities)
! Demonstrates a capacity to achieve with an awareness of strengths and weaknesses
! Demonstrates compassion and empathy
! Works well on a team
! Builds a good rapport with others
! Strong problem-solving ability
! Accountable and responsible
! Good oral and written communication skills
! Demonstrates an ability to cope with life’s situations
! Decisive and resourceful
! Displays strong ethics
! Maintains composure in stressful or unfamiliar situations

A portfolio could include a letter of recommendation from a supervisor, co-worker, faculty member, or
patient, and a description of projects or volunteer experiences where these traits were demonstrated.

Rationale
It is hoped that students who demonstrate professional attributes prior to entering a pharmacy degree
program will continue to value these behaviors as practitioners.

Areas of professionalism
Service orientation, creativity and innovation, trustworthiness, accountability for his/her work, leadership,
compassion, etc.

Special issues involving promotion/planning and implementation


! Faculty approval
! Identifying what activities will count toward the prerequisite
! Evaluation of whether this prerequisite impacts success as a pharmacy student

Examples of programs and resources


! See also topics under Admissions
! University of Washington

2004 AACP School Poster:


“Achieving Professionalism in the Pharmacy Program at the University of Montana.” Lori J.
Morin, Jean T. Carter, Gayle A. Cochran, University of Montana.

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ADMISSIONS
Best Practice Guidelines

James Hobbs, University of Kentucky


Thomas Reinders, Virginia Commonwealth University
John Vinson, University of Arkansas for Medical Sciences

I. INTRODUCTION
Background
The admissions process is tantamount to licensure as a pharmacist since the majority of students entering
colleges and schools of pharmacy complete their degree. Thus, professionalism is an important element of
the admissions process. In addition to academic preparedness, admission committees should evaluate an
applicant’s potential to demonstrate and embrace the professional behaviors and attitudes necessary to
provide quality patient care.

Planning Elements
Written documentation about the admissions process for pharmacy degree programs must be available to
prospective applicants. The same information should be available to all prospective applicants regardless
of the communication channel (e.g., written, verbal, electronic). An admissions committee should be
formed to objectively assess an applicant’s credentials provided in a standardized format (e.g.,
PharmCAS, supplemental application forms).

Timelines
All information about the admissions process should be reviewed by administrators and faculty prior to
the start of each admissions cycle, generally in the late summer or early fall. Updates or revisions should
be provided as needed.

Promotion
Prospective applicants to colleges and schools of pharmacy are likely to receive general information about
the profession and specific information about the admissions process from a variety of sources. Usual
sources include websites (e.g., AACP, PharmCAS, or specific schools or colleges), academic advisors at
colleges or universities and alumni.

Evaluation
The adequacy of the admissions process can be measured against standardized measures of achievement
as students progress through the academic program and upon graduation. Standardized measures include
grade point averages, grades within specific disciplines, participation in student organizations, and
performance in advanced pharmacy practice experiences, post-graduate study, and the type of
employment upon graduation.

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II. POSSIBLE ACTIVITIES

A. Application Process

Description of activity
The application process is initiated by the completion of a formal application which can be centralized
(e.g., PharmCAS) or decentralized with the submission of an application directly to the college or school.
Many pharmacy institutions that utilize PharmCAS also require a supplemental application to capture
school-specific information not captured on the standardized form.

Rationale
The formal application process serves as an appropriate and consistent means of obtaining information
from prospective applicants.

Areas of professionalism addressed


Accountability and respect are the major components of professionalism addressed with the application
process.

Special issues involving planning/promotion/implementation


Traditional assessment measures (e.g., grades, PCAT scores) are identified to determine an applicant’s
suitability to pursue pharmacy as a career option. Since health professionals are called upon to provide a
variety of health-related and civic services in their community, the application process should provide
applicants with an opportunity to identify their participation in extracurricular activities. Additionally,
these may be enhanced through the submission of reference letters from individuals who have known the
applicant over a period of time and generally have observed the application of their knowledge, skills and
attitudes. Admission offices may require letters from faculty, employers, advisors, and health
professionals.

Examples of programs and resources


See also “Professionalism Prerequisite” under “Student Recruitment” header.

2004 AACP School Poster:


“Professionalization as a Continuum: From Prepharmacy Student to Alumni.” Kenneth M. Hale,
Robert W. Brueggemeier, Gerald L. Cable, Sylvan G. Frank, Milap C. Nahata, The Ohio State
University.

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B. Interview Process

Description of activity
An admissions interview is an organized event that facilitates a dialog between representatives from the
School (e.g., faculty, students, alumni) with prospective applicants. These sessions can be arranged as
part of the admissions process.

Rationale
Applicants should understand the need for evaluation by representatives from the school concerning their
knowledge, skills and attitudes. Likewise, applicants should be able to interview school or college
representatives about the suitability of their program for their particular needs.

Areas of professionalism addressed


Accountability, integrity, service, leadership, respect, and a personal commitment to life-long learning are
the major components of professionalism addressed with the interview process.

Special issues involving planning/promotion/implementation


The interview process should be organized with a specific itinerary for each prospective applicant. Some
colleges and schools begin with a presentation by the Dean or their representative that offers an overview
of the program and incorporates the expectations of professionalism from students enrolled in the
pharmacy degree program. The overview is generally followed by an assessment of the applicant through
formal interviews, the preparation of an extemporaneous on-site essay, and the possible completion of one
or more standardized assessment tools. The session may conclude with a tour of the college or school and
the campus.

Representatives serving as interviewers should participate in a formal orientation session to achieve a


measure of uniformity among interviewers. Colleges and schools must consider the investment of time
and resources that are required to conduct a formal training program for those participating as
interviewers (e.g., faculty, alumni and students). Likewise, the institution should consider the investment
of time and resources necessary to conduct interview sessions for prospective applicants. Strategies for
the recruitment, reward and recognition of participating faculty, students and alumni must be considered.

The admissions committee may develop a set of standardized interview questions to achieve a fair and
consistent assessment of all applicants. The interview process should incorporate behavioral interviewing
techniques that assess competencies determined to be key in pharmacy student success. Since pharmacists
must be able to solve a variety of problems in their daily practice of the profession, special attention
should be given to developing scenarios that involve common problem solving skills.

Examples of programs and resources


2004 AACP School Poster:
“A Strategic Approach to Student Professional Development at the University of Missouri-
Kansas City School of Pharmacy.” Maureen Knell, Mary L. Euler, Patricia A. Marken, University
of Missouri- Kansas City.

Reference
Latif DA. Using the Structured Interview for a More Reliable Assessment of Pharmacy Student
Applicants. Am J Pharm Educ. 2004; 68(1):21.

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C. Staff P