Medication

Safety
 Introduction
Medication safety has been a priority of health system pharmacy practice in the
recent years. Driven by landmark publications, pharmacists have been attempting to
reduce medication risks in institutions. The report To Err Is Human: Building a
Safer Health System includes the nature of injuries associated with both
appropriate and inappropriate use of medications. Some of the followings were
revealed in the report.
Medical errors are common
Medical errors are tragic
Medical errors are expensive
Medical errors are preventable
Medical errors are not fully appreciated
In a follow up report, the Institute of Medicine committee published Crossing The
Quality Chasm: A New Health System for the Twenty first Century
highlights the causes of medical error and calls for fundamental changes to improve
health care.
 Definitions

Drug related problems (DRPs) events associated with drug therapies that
can slow down the optimal patient outcome.
Medication misadventures iatrogenic hazards associated with indicated drug
therapy resulting in patient harm that can be attributable to error, immunologic
response or idiosyncratic response.
Medication errors mistakes in the medication use process that may result in
negative outcomes.
Administration errors occur when patients are administered something other
than that prescribed for the patient.
Dispensing errors mistakes made during the dispensing process.
Prescribing errors when prescriptions have an incorrect drug selection, dose,
dosage form, quantity, route, concentration, rate of administration or instructions
for use of drug.
 Monitoring errors failure to review a prescribed regimen for appropriateness
or the failure to use appropriate clinical or laboratory data for adequate
assessment of patient response to drug therapy.
Transcription and interpretation errors made during the transcribing or
interpreting of prescriptions caused by the misinterpretation of abbreviations,
illegible hand written prescriptions, and misinterpretation of spoken
prescriptions.
Adverse Drug Reactions DRPs that are unexpected, unintended and
undesired. May or may not be the result of a medication error.
Allergic reactions immunologic hypersensitivities to drugs.
Idiosyncratic reactions abnormal responses to drug that are peculiar to
individuals.
Side effects not ADRs. Well known drug reactions that are expected and does
not require change in patient management.
 Adverse drug events ADR. Due to the use or lack of intended use of a
drug.
Drug Related Morbidity failure of a drug to achieve its intended health
outcome due to unresolved DRPs.
Sentinel Events unexpected incidents resulting in death or the potential
for serious physical or psychological injury.
Latent Injuries propensity, for harm during the process of care that
actually does not result in patient injury.
Potential injuries mistakes in prescribing, dispensing, or medication
administration that have the potential to cause an injury but did not.
Errors of commission can occur when the patient receives either a correct
drug or an incorrect drug.
Errors of omission result in the patient failing to receive drugs that can be
beneficial.
Preventing Medication Errors

Reasons why medication errors occur:

Look-alike and sound-alike drugs
Sloppy communication
Illegible handwriting, incorrect transcription,
and verbal miscommunications
Distractions and overwork
Poorly designed medication labels
Poor personnel management
General recommendations to prevent
medication errors

Involve patient in the medication use process

Consumer-oriented medication resources
should be available
Health care providers should have access to
patient information and decision-support
tools and technologies
Medication labeling needs to be improved
Health information technology must be
improved
General recommendations to prevent
medication errors

Congressional funding should be increased

Health Care payers and oversight
organizations should be more active in
promoting good medication use practices
Recommendations specific to pharmacies and
pharmacists

Pharmacists must keep up with the medication

literature
Pharmacists should verify the accuracy of the
prescription
Patient identities should be verified using bar codes
Patients should be educated about ways to prevent
errors
Patients should be engaged in managing their own
medication decision-support systems
Prescription filling technology needs to be assessed
and improved
Recommendations specific to pharmacies and
pharmacists

Pharmacists should monitor patients for high

risk side effects
Pharmacists should routinely review the
patient medication records
Culture of Safety

It exists where safety is a key element of

everyones job
Leaders encourage workers to seek out and
implement new ways of ensuring safety of
patients
Culture of safety avoids blaming individuals,
an instead focusing on identifying errors in
the system that lead occurs
MODELS OF QUALITY
IMPROVEMENT

Total quality management, continuous quality

improvement, six-sigma, LEAN
Safety is enhanced by improving the core processes of
the medication use system
Must be patient-centered
Quality must be measured and monitored properly
Poorly designed systems set up individuals to fail
Solutions to safety problems should address the system
not individuals
PDSA CYCLE OF SAFETY IMPROVEMENT
PLAN- attempts to clarify the purpose of the quality improvement
effort
Bottom-up approach- everyone is involved in the process, frontline
health care workers
- To clarify the expected actions- analysis is done

DO- Once a plan is established, it needs to be implemented usually

done on a small scale to allow adjustments

STUDY- check studies the effect of the change on the safety

measure

ACT- small scale change is implemented on a larger level

Once a desired safety goal is achieved, a new goal is established
improves safety of patients
MEASURES OF HEALTH CARE QUALITY

By Donabedian

STRUCTURES-measures of the presence of

something that is reasonably associated
with quality
-their relationship with quality and patient
safety is not always clear or established
 Structures that should be present for ensuring
safe medication use

Formulary system Access to electronic health rescords

Effective human resources Computerized prescriber order entry
management Medication references
Adequate staffing Standard drug administration
Suitable work environments Use of standard abbreviations
Lines of authority and areas of Review mechanism for reviews of
responsibility drug related problems
Systematic program of quality Educational programs
improvement
Clinical information about patients
Patient medication profiles
Pharmacy department
Unit dose systems
 PROCESS- actions reasonably associated
with quality such as checking of patient
medication profiles

OUTCOMES- quality of safety systems needs

to be assessed by their impact on patient
health outcomes
 Processes Associated with Safe Medication
Use
Dispensing only in pharmacy department
Storage
Routine inspections should be conducted
Use of home medications are
discouraged
Storage of discontinued or unused drugs
Discharge counseling of patients
Pharmacists should clarify prescription
Manual transcription of physician orders
Collaborate with other healthcare
professional
Participate in drug theraphy monitoring
Provide information on the correct use of
medications
Use of technology and support
personnel
Checks should be conducted on all
work
Monitoring high risk drug products
Use of ready to administer medication
dosage forms
Manipulation of drugs by nurses should
be minimized
Time delivery of medications
Monitoring of actual administration to
ensure safety
Medications returned to the pharmacy
is reviewed for potential system
breakdowns
Monitoring, Reporting, and
Communicating
ADR-Monitoring and Reporting Programs
necessary to detect, evaluate, and develop mechanisms to
prevent ADRs and their associated morbidity, mortality, and
increased costs.

Alerting Orders- prescriptions which alert pharmacists that an

ADR may have occurred and an investigation should be
conducted.
Types:
Tracer drugs used to treat ADRs
Abrupt discontinuation or decrease in dosage
Stat orders for laboratory assessments
 Who are Most At Risk for
ADRs?

Those with most trouble adjusting

to the negative consequences
Pediatric patients less predictable
drug responses
Elderly patients - taking multiple
medications and greater sensitivity
to medications
Oncology patients exposed to
highly toxic therapeutic
regimens/immunocompromised
How Do We Report an ADR?

1. Report the adverse reaction immediately

after it occurs.
2. Prescribers, Nurses and Pharmacists should
be notified
3. Think about any other factors which may
contribute in causing the Event.
4. Serious or unexpected ADR should be
reported to the FDA or the drugs
manufacturer
Why Arent ADRs Reported?

Lack of knowledge about the reporting

systems or perceived difficulty
Uncertainty about whether or not a
drug is the cause of an adverse event
Lack of time or high workload
Lack of understanding about why it is
important to report
Complacency
Medication Reconciliation

Attempts to correct problems such as

Omissions in therapy
Medication duplication
Errors in dosing
Potential drug interactions
Conducted each time a patient transitions across
departments or location.
Medication Reconciliation
Process

1. Verification
2. Clarification
3. Reconciliation
4. Transmission
National Quality Organizations
-Promote Health Care Quality and Patient Safety

The Institute of Medicine

Institute for Healthcare Improvement

Improve health care throughout the world

National Quality
Organizations

National Quality Forum

The Leapfrog Group

National Quality
Organizations

Joint Commission

Centers for Medicare and Medicaid Service

National Quality
Organizations

Agency for Healthcare

Research and Quality

National Committee for Quality Assurance

National Quality
Organizations

American Society of
Health-System
Pharmacists

Pharmacy Quality Alliance