Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
48
Ophthalmology ethics
Alex V Levin
CHAPTER CONTENTS
Introduction 767
Informed consent 768
Confidentiality 769
Truth telling 769
Boundary issues 770
Multiculturalism 770
Vulnerable populations 770
Pediatric ethics 770
Futility 771
Medical error 771
Impaired physicians and ophthalmic
professionals 772
Resource allocation 772
Research ethics 772
Innovation 773
Genetics ethics 773
Advertising 774
Fee splitting 774
Medical industry 775
Cosmetic surgery 775
Financial issues 776
Trainees in patient care 776
Resolution of ethical dilemmas 776
INTRODUCTION
Issues that challenge our ethical and moral value systems
have been part of medicine throughout recorded history.
2013 Elsevier Inc
767
Section | 8 |
Ethics
Law
Policy
Ethics
Law
Moral
Foundations
Philosophy
Policy
Fig. 48-2 A more complex model for ethical consideration
that is perhaps more applicable to a person with a deeper
interest in bioethics.
768
INFORMED CONSENT
Gone are the days when physicians simply told their
patients what must be done to their bodies to treat their
disease. Rather, we have developed a healthy recognition
of the importance of autonomy: the right of persons to
make their own decisions about what they will and will
not allow. Informed consent represents a partnership
between medical professionals and their patients. Doctors
have a fiduciary duty to ensure that each patient under
stands the treatment recommendations. Admittedly, this
is not always entirely possible as patients rarely can achieve
the same level of understanding as the doctor. In some
cases, the patient may have such strong feelings of trust
towards their physician that they make little effort to attain
the knowledge level of truly informed consent and instead
wish for the doctor to do whats best for me. Yet the obli
gation of the physician remains to at least attempt to
demonstrate that the patient does indeed have some com
prehension of the medical plan.
Informed consent is more than the signed piece of paper
entitled consent form. Informed consent is a process,
documented in the patients health record, wherein the
physician or a trained delegate (e.g., the ophthalmic assis
tant) educates the patient and asks for his or her participa
tion in the decision-making process. When the physician
delegates this process, there should be an opportunity for
the patient to ask questions of the physician and speak
directly to the physician if desired. Some situations require
little more than the patients action. When a patient sits
at the slit lamp and puts their head forward, it is an
implied consent to be examined. But when the medical
encounter is to involve aspects of risk, in particular risks
of bodily harm as in surgery or laser treatment, then more
formal informed consent, preferably documented by the
patients signature, is required. Performing a procedure
Ophthalmology ethics
without consent may be considered as battery. Clearly
there will be situations usually those surrounding emer
gency medical issues when the informed consent process
must be either abbreviated or abandoned, assuming rea
sonable effort has been made.
The eye doctor must inform the patient of all common
risks, no matter how small (including those that might
result not only in changes in function but also appear
ance), and also all serious risks, no matter how uncom
mon. The disclosure of risk should be considered in the
context of what a reasonable patient would want to know.
Although the risks are very small, reasonable people
would likely want to know about the risk of death from
general anesthesia or the risk of blindness from cataract
surgery.
Comprehension is another foundation of informed
consent. Patients may refuse treatment, even if their deci
sion will result in death or blindness, if they are deemed
to have the capacity to do so. If the decision-making capac
ity of the patient is in question (e.g., in Alzheimer disease),
then a substitute decision maker must be found. In some
jurisdictions this is a legal designation by power of
attorney, whereas in other cultures it may be a family
designation by virtue of marriage, age, or sibship. Informed
consent for children is discussed below.
Even when the patient is deemed capable, the ophthal
mologist must ensure that the necessary information for
decision making is presented in an understandable way.
Risks may be described in relative terms rather than with
incidence data. For example, one might say that the risk
of an entirely well young adult dying from general anes
thesia is less than the risk of dying in a road traffic acci
dent. Although written information is helpful, it must be
readable, preferably on a grade 68 level. Consent forms
with many pages have become common, yet one can ques
tion whether they are likely to be read and understood by
an average patient. No document can fully replace the
conversation between physician and patient. The patient
must be given the opportunity to ask questions and receive
answers before making a voluntary decision without influ
ence or coercion.
CONFIDENTIALITY
The ophthalmic health care team, like all medical profes
sionals, has a duty to protect the confidentiality of the
patient. The fulfillment of this duty enhances the trust
relationship with and respects the autonomy of the
patient.
Sharing of health records with other medical profession
als is just one aspect of the confidentiality issue. One
should remember that, although the chart itself belongs
to the physician or the health care institution, the informa
tion in the chart belongs to the patient. Information
Chapter | 48 |
TRUTH TELLING
Truth telling is another fundamental tenet that underlies
the ethical practice of medicine. It is a foundation to the
769
Section | 8 |
BOUNDARY ISSUES
Respect for persons also entails that their bodies not be
violated in nonconsensual ways such as sexual advances
or touching. This principle applies not only between
co-workers in an ophthalmology office or clinic but also
between health care professionals and their patients. Vio
lation of boundaries may also come in the form of
personal affronts without actual physical touching. Exam
ples might include comments with inappropriate sexual
content, or aggressive and condescending behavior. The
field of organizational ethics addresses many of these sce
narios and the relationships between co-workers in various
roles. In general, it is advisable for health care profes
sionals to similarly avoid such behaviors, gestures, and
advances towards their patients, including activities such
as dating or sexual liaison.
MULTICULTURALISM
Many societies represent a rich blend of ethnicity, religion,
and culture. With this variety in the patient population,
ophthalmic professionals will likely encounter behaviors
that seem foreign, if not objectionable. One must respect
that there are a wide variety of behaviors to which the
terms right and wrong do not apply. Rather, tolerance
and understanding, often reached simply through dia
logue, become the basis of therapeutic success and patient
compliance. For example, there are ways for a patients
appointment to be altered to a time that does not conflict
770
VULNERABLE POPULATIONS
One must be particularly careful when addressing ethical
dilemmas where the patient is part of a vulnerable popula
tion such as children (see below), prisoners, minorities,
and other groups who may, by virtue of their position
in society, prejudice, and prior unjust treatment, have
impaired decision-making capacity or a lack of proper
empowerment. Illness and infirmity may in themselves
make the patient more vulnerable and less able to engage
in capable decision making. The ophthalmic team must
guard against bias and parentalism in these cases and
maintain a healthy respect for the autonomy of these indi
viduals. It is easy to become blinded by our beneficent
parentalistic desires to benefit the patient and in so doing
ignore the importance of autonomy for all patients. One
might argue that extra care is required in order to ensure
the rights, boundaries, privileges, and autonomy of such
patients.
PEDIATRIC ETHICS
The ethical issues surrounding the care of children have
enormous scope that extends well beyond the reaches of
this chapter. Children are indeed a vulnerable population
yet they do have a right to respect for their autonomy,
which, even if they are not currently able to express it, will
eventually blossom.
It is recommended that children be involved in their
health care as much as possible, including discussions
about their disease and proposed treatment. Infants and
young children may not have the ability to participate
meaningfully in the informed consent process so their
parents/guardians become substitute decision makers,
although the physician must ascertain that the decisions
of these individuals are indeed in the best interest of
Ophthalmology ethics
the child. Although adults have the right to refuse treat
ment for themselves, even though such refusal could
lead to death or blindness, they do not have the right to
make such decisions for their children in most jurisdic
tions in North America. In such cases, if the health care
team is unable to form a partnership with the family that
would lead to a satisfactory resolution of the conflict,
then the physician may be obligated to approach the
child protection or legal system for intervention on behalf
of the child. Before resorting to these means, attempts to
resolve conflicts with the use of social workers, clergy,
mental health professionals, and other mediators can be
helpful.
Likewise, parents may not harm their children and there
is a firm legal obligation to report a suspicion of child
abuse or neglect to child protection authorities. This is a
legal as well as a moral obligation. Some physicians fail
to report because of a lack of confidence in the system, a
fear that parent and child will be separated unjustly, uncer
tainty over the diagnosis, a feeling that a well-known good
family could never abuse or neglect their child, a fear of
lost patient referrals, or a disinclination to have to take
time to go to court to testify. In reality, the facts suggest
that these fears and concerns are largely unjustified and
inaccurate. In all cases, the health professionals legal obli
gation to report is the primary responsibility.
Older children may have some ability to participate in
their own care decisions even if they are not mature
enough to give full consent. In these situations, one should
try to obtain the childs assent, or agreement, to proceed
with the medical plan. This can be done by involving
the child in the decision-making process with the
parents/guardians, asking the child directly about their
questions or concerns and even documenting in the chart
that this process occurred, with or without the childs
signature. Ascertaining when a child is able to give consent,
separate from that of the parents, may be defined by law
(and varies by jurisdiction) or simply by the assessment of
the ophthalmic team. In Ontario, there is no legal age of
consent. Older children and adolescents may have wishes
that differ from those of their parents. Taking a familycentered approach to care, which attempts to find thera
peutic alliance, will require time, patience, and perhaps
the support of other professionals in the field. The health
care team is advised to maintain a manifest respect for the
childs autonomy, confidentiality, and right to know the
truth about their care.
FUTILITY
Just as the adult patient may decide against treatments
proposed by the physician, the physician may refuse to
give a treatment requested by the patient if, in the best
judgment of the physician, the treatment is unlikely to
Chapter | 48 |
MEDICAL ERROR
Error is part of medicine. Much attention has been paid to
error in medicine, with large studies confirming its high
incidence and prevalence. Every ophthalmic team member
will at some time make an error that may or may not lead
to patient harm. Of course, we must always strive to reduce
error and many strategies have evolved to encourage this,
including the systems approach, which attempts to prevent
error by adapting the environment in which we work. For
example, if two eye drop bottles are so similar that they
could easily be mistaken for each other, it may be desirable
to place colored tape around one bottle or move the two
different medications to different locations in the office.
Marking the eye to be operated before surgery and preop
erative time outs are system interventions to avoid per
forming surgery on the wrong eye or patient.
Another approach to error, which has been unfortu
nately all too prevalent in medicine, is that of individual
blame, punishment, and secrecy. The aviation industry
has been a leader in the recognition that a nonpunitive
approach and the encouragement of error reporting with
team problem solving is the most productive path towards
error reduction. Likewise, disclosure to patients is a fun
damental part of an ethical response. Research studies
continue to show that patients do want to know when
errors are made.
Disclosure of error leads to a reduction in malpractice
claims and judgments as well as an increase in the trusting
partnership between doctor and patient. Disclosure may
present difficult challenges. Is a rupture of the posterior
capsule during cataract surgery by a skilled surgeon a com
plication (i.e., a known adverse event with a known fre
quency that accompanies any procedure) or an error? If
the outcome of surgery is not influenced (i.e., intraocular
lens in the bag, no vitreous loss, quiet eye), does the
patient need to know? Some would argue that disclosure
of such an event would be too complicated for the patient
to understand even though this same patient was pre
sumed to understand enough to give consent for surgery.
771
Section | 8 |
772
RESOURCE ALLOCATION
The allocation of scarce resources has become an increas
ingly frequent ethical challenge as the cost of ophthalmic
care continues to rise as a result of remarkable technologic
advances. Should only those with the means to afford
it have access to multifocal intraocular lenses? Should
limited operating theater time be allocated to the surgeons
who do the most expensive operations with remarkable
powers to restore vision on patients with uncommon
diseases or to the surgeons who do much less expensive
operations on larger numbers of patients with less pro
found impacts on vision? Should we use the most expen
sive suture in keeping with the surgeons preference even
if there is no demonstrable benefit to the patient? Should
the donor cornea go to the 1-month-old infant with uni
lateral Peters anomaly or to the 70-year-old person with
bilateral pseudophakic bullous keratopathy?
Resolution of these issues is often difficult, complex
and far removed from the patient, yet still impacting
their care. A full discussion of these issues is beyond the
scope of this chapter, but perhaps the starting point
is recognition of the best interest of the patient (beneficence), if not all patients, in the resource allocation
decision-making process. There is also an ethical duty
to best represent the interests of society which can at times
compete with the interests of an individual patient. Clearly
we cannot provide every possible aspect of medical care
to every patient but we can use a utilitarian approach to
achieve the greatest good. For an excellent discussion
of this and other ethical issues in a practical format,
the reader is referred to Bioethics at the Bedside provided
by the Canadian Medical Association Journal (http://
www.collectionscanada.gc.ca/eppp-archive/100/201/300/
cdn_medical_association/cmaj/series/bioethic.htm).
RESEARCH ETHICS
In academic health science centers, and sometimes in
community ophthalmic practice as well, there is a desire
to achieve advancement in ophthalmic care through
research. The researcher has certain ethical responsibilities
towards the research subject, which include informed
consent, confidentiality, disclosure, and respect for persons.
There is also a duty to ensure that the patient is not
Ophthalmology ethics
enrolled in a frivolous project unlikely to yield meaningful
results, a project where the potential benefits are out
weighed by potential harm, or a project that enhances
discrimination toward the patient or the group they rep
resent. Refusal to participate must not influence the care
or the access to care that a patient receives.
Recognizing the difficulties in honoring these obliga
tions, all research should be evaluated in advance and
approved by a research ethics board (REB, also known as
institutional review board, IRB) the membership of
which should be multidisciplinary, with representation of
the lay public as well. REBs are available both inside and
outside academic institutions. Research done in the com
munity is not an excuse for avoidance of REB review. Most
jurisdictions are now requiring even retrospective chart
reviews to obtain such approval. REBs may try to stream
line these processes. Although the process of REB approval
may seem arduous, its objective is to facilitate good
research rather than impede progress, while protecting
both the researcher and the patient.
INNOVATION
Ophthalmology is a highly technologic field. It is not
uncommon for ophthalmologists to find themselves
trying something new. Such presumed advances may
come as the result of publications in the peer-reviewed
literature, a throw-away publication, a presentation at a
meeting, conversations with colleagues, or de novo from
the creative mind of a thoughtful practitioner. The innova
tion may be as simple as a new way of tying a knot during
surgery or as complex as a piggyback intraocular lens
implanted into a neonate to deal with aphakic high
hyperopia with a predicted removal of the second lens at
a later date. Other examples include new intraocular
lenses, new techniques for refractive surgery, and smaller
instrumentation for retinal surgery. Some innovations are
applications of technology and experience from one
patient population to another (e.g., intraocular lenses in
children) and others are new only to that physician (e.g.,
switching to smaller gauge phacoemulsification). Should
innovation be allowed to proceed outside that purview of
the research paradigm with involvement of an REB?
Research is designed to answer questions and improve
the care of patients. Research studies are constructed to
follow the scientific method, which allows these questions
to be answered in a fashion that minimizes bias and the
influence of chance. Research is also distinguished by the
informed consent, which allows a patient to understand
the level of evidence base for the intervention in the
context of their care, and the REB-mandated monitoring,
which protects participants from unintended harm as early
as possible. Unfortunately, there are many examples of
innovation that proceeded without a research protocol
Chapter | 48 |
GENETICS ETHICS
Genetics has become an increasingly prominent part of
virtually every aspect of medicine. Ophthalmic profession
als must have a working knowledge of genetics in almost
every aspect of the field, from age-related macular degen
eration and cataract to steroid-induced glaucoma and con
genital malformations. Advances in genetics are already
bringing to ophthalmology the possibility of gene-based
therapy for a variety of diseases.
Recognition of the role of genetics in eye disease brings
with it some special ethical challenges. There may be con
fidentiality issues with the sharing of information within
families and the need to obtain such information to give
appropriate genetic counseling. Insurance companies may
have a desire to obtain information about patient risk for
773
Section | 8 |
ADVERTISING
Physician advertising is now legal in many jurisdictions.
Some ophthalmologists have rejected this as an affront to
the profession that degrades our field to a business no
different from auto sales. Others have embraced advertis
ing as a means of public education at a time when
informed consent has received so much attention.
The main ethical principle that applies to this and the
financially related issues that follow below is that of con
flict of interest. Rarely do physicians advertise solely for
the altruistic benefit of disseminating information to
774
FEE SPLITTING
There are several forms of fee splitting. In the most typical
arrangement, one caretaker (e.g., an ophthalmologist)
pays back the referring professional (e.g., an optometrist)
as a demonstration of gratitude for a referral and presum
ably to provide an incentive for further referral. This
reward is referred to as a kick back or profit sharing and
may take the form of cash or other benefits such as tickets
to a sporting event, free meals, gift certificates, or even
cash. Another arrangement might involve a shared practice
wherein members of the group all benefit from the aggre
gate activity of the group and therefore encourage referrals
to each other. An example might be the multispecialty
ophthalmology group where all cataract patients are sent
to the retina specialist within the group for preoperative
examination. Lastly, fee splitting may take the form of
co-management. The ophthalmologist delegates the post
operative care of patients to another provider, often an
optometrist, and provides a payment in cash or in kind
for that service. Alternatively, the optometrist may bill the
patient directly for services that would otherwise fall under
the care of the surgeons postoperative care and as such
may not have been billable.
Although some may perceive these arrangements as
beneficial to the patient, providing continuity of care and
improved access to care, others have identified the conflict
of interest that may be inherent, particularly if the patient
is unaware of the arrangement. Research has shown that
patients are, in general, unhappy with these relationships.
Some jurisdictions have policy or law which proscribes
against these arrangements. Health care providers should
Ophthalmology ethics
initiate and sustain referral practices based on the best
interest of the patient rather than their own financial gain.
The American Academy of Ophthalmologys stance has
been to encourage ophthalmologists to provide postop
erative care for their own patients unless there are com
pelling reasons why this cannot be accomplished (e.g.,
surgeon leaving town for holiday) and only if the patient
is informed in advance. In situations where the conflict of
interest persists, physicians are encouraged to disclose
these relationships to the patient in a further attempt to
avoid any illusion of impropriety.
One must recognize that disclosure of a conflict of
interest does not remove the conflict. Patients may not
be empowered, especially when made vulnerable by
status, illness, or age to act in response to such disclosures
as they may feel that to do so would deny them access
to the provider they want and to whom they were
referred. This may leave the patient uncomfortable, suspi
cious, and more likely to be a dissatisfied participant in
their care.
MEDICAL INDUSTRY
Medical industry provides us with our therapeutic agents,
diagnostic agents, medical technology, and surgical equip
ment. It is a necessary and integral part of medicine. In
addition to the use of these products, physicians will
have direct interaction with representatives of medical
industry in the form of sales representatives wanting to
give information about new products, opportunities to try
new products, invitations to participate or lead industrysponsored educational events with or without social
components, invitations to become a spokesperson for
industry products, invitations to write papers/conduct
research/write monographs sponsored by industry, offers
of grants to support research activities or program devel
opment, gifts of free samples of medications or gifts
ranging from items of nominal value for medical use
(e.g., note pads with the drug company name on each
page), to more significant gifts such as sporting event
tickets, free meals, and even all-expenses-paid trips to
lovely locations with or without a sometimes nominal
educational component.
As the reasonable patient would likely expect that the
medical decisions of their ophthalmologist are free from
influence and conflict of interest, it is not difficult to see
why multiple studies have shown that patients generally
object to such relationships between physicians and
medical industry. Research also indicates that, despite the
often-heard claims of physicians to the contrary, these
practices do affect our prescribing patterns. It is then not
surprising to learn that medical industry spends billions
of dollars on advertising and such contacts with physi
cians, presumably not out of purely altruistic motives but
Chapter | 48 |
COSMETIC SURGERY
As discussed above, patients have the autonomous right to
choose what they will and will not allow to be done to
their bodies (with the exception of futile interventions; see
above). Cosmetic surgery acts on a patients wish to have
something normal about their body changed to another
normal variant, often at large cost. Proponents of cosmetic
surgery would argue that the patient does not perceive the
condition as normal and therefore making the change, so
that the patient feels more normal, is well within the
helping nature of the medical profession. Analyzing the
philosophical differences on this topic is beyond the scope
of chapter, but the ethical issue of conflict of interest is
again worthy of consideration.
Laser refractive surgery has proliferated worldwide. In
many communities, as a procedure not covered by insur
ance plans, surgeons may charge sizeable fees and perform
the surgery exclusively in private clinics. People have
flocked to have this surgery, allowing enormous numbers
of patients to abandon their contact lenses and glasses. But
interviews of the lay public suggest that many go for the
procedure because they believe that the surgery will fix
775
Section | 8 |
FINANCIAL ISSUES
In addition to the ethical issues discussed above, many
of which have financial implications for the physician
(e.g., fee splitting, advertising, medical industry, cosmetic
surgery), all medical practitioners are also faced with
moral challenges related to charging and collecting fees for
services rendered. Although altruism is an ethical principle
that should pervade much of medicine, there will in
almost every setting be a business component: expenses
must be covered, employees must be paid, and the physi
cian deserves an income commensurate with their skill,
training and success. Opportunities abound for making
minor, or even major, manipulations in billing practices
that will further increase income while staying within the
law and out of detection by the patient.
This potential conflict of interest and the ethical issues
that such practices raise, have long been troubling to the
ophthalmic profession and served as the basis over the last
century for the emergence of the American Academy
of Ophthalmologys increasing interest in ethics with
the establishment of a Code and an Ethics Committee.
The potential conflict of interest was also recognized
in the United States in the form of safe harbor legislation
that put restrictions on potentially unethical arrange
ments. More subtle billing practices may also raise similar
concerns that profit motives conflict with the best interest
of the patient. In the past, in some Canadian provinces,
ophthalmologists got paid more if the patient was referred
from a physician as opposed to an optometrist even
though the same service is performed. Some ophthalmol
ogists were very creative in getting around this rule by
writing consultation letters back to the patients family
776
Ophthalmology ethics
consider the relevant key ethical principles, institutional
policies and societal law. Multidisciplinary conversations
with peers and colleagues can be particularly helpful. Dif
ficult situations arise when an employee (e.g., ophthalmic
assistant) has a different viewpoint on an ethical issue
from the supervisor or employer. Open conversation
can often resolve these conflicts. Consultation may be
sought from bioethicists or other professionals who have
had formal training in the field. Many written resources
are now available; ethical issues have found their way
into hundreds of journal articles on virtually every topic
as well as the resources mentioned above, books,
and internet-based courses and case discussions. The
University of Toronto Joint Centre for Bioethics website
(www.jointcentreforbiothics.ca/) is another useful resource
that can link readers to a wide variety of information on
bioethics and case management.
Each reader of this chapter and every professional in the
field of ophthalmic care will be faced with the task of
resolving ethical dilemmas. The word ethics is indeed a
Chapter | 48 |
777