Drug and Therapeutics Committee: Session 4. Assessing and Managing Medicine Safety
Drug and Therapeutics Committee: Session 4. Assessing and Managing Medicine Safety
Drug and Therapeutics Committee: Session 4. Assessing and Managing Medicine Safety
Committee
Session 4. Assessing and Managing
Medicine Safety
1
Objectives
Describe the significance of—
Adverse drug reactions (ADRs)
Medication and prescribing errors
Understand—
Principles of medicine safety evaluation
Management of spontaneous case reports of
ADRs and medication and prescribing errors
The process of monitoring, evaluating, and
preventing ADRs and adverse drug events
Outline
Key Definitions
Introduction
ADRs—Pre- and postmarketing surveillance
Causality
Implications for the DTC
Adverse Drug Events and Medication Errors
Activities
Summary
Key Definitions (1)
Adverse drug reaction (ADR)
A noxious and unintended response to a medicine that occurs at
normal therapeutic doses used in humans for prophylaxis, diagnosis,
or therapy of disease, or for the modification of physiologic function
The word “effect” is used interchangeably with “reaction.”
Side effect
Any unintended effect of a pharmaceutical product occurring at normal
therapeutic doses and is related to its pharmacological properties.
Such effects may be well-known and even expected and require little
or no change in patient management.
Serious adverse effect
Any untoward medical occurrence that occurs at any dose and results
in death, requires hospital admission or prolonged hospital stay,
results in persistent or significant disability, or is life threatening
Key Definitions (2)
Adverse drug event
Any untoward medical occurrence that may be present during
treatment with a medicine but does not necessarily have a causal
relationship with this treatment. Adverse drug events include
medication errors and overdoses.
Causality
The probability that a particular medicine is responsible for an
isolated effect or ADR.
Signal
Reported information on a possible causal relationship between and
adverse event and a medicine, the relationship being previously
unknown or incompletely documented. Usually more than one signal
report is required to generate a signal, depending on the
seriousness of the event and the quality of the information.
Key Definitions (3)
Prescribing error
Incorrect medicine ordering by a prescriber
Medication error
Administration of a medicine or dose that differs from the
written order
Negligence
Medical decision making or care below the accepted
standards of practice
Introduction
ADRs and events constitute a serious problem increasing
morbidity and mortality and health care costs worldwide.
Overall incidence of ADRs in hospitalized patients in the
United States in 1998 was 6.7%, and fatalities were 0.32%.
Lazarou, J., B. H. Pomeranz, and P.N. Corey. 1998. Incidence of Adverse Drug
Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies.
JAMA 279 (15):120–25.
Postmarketing surveillance
Spontaneous reporting
Postmarketing clinical trials—Phase IV
Other methods—observational studies, meta-analysis, case
reports
Determining causality
Actions taken to manage new ADRs
Postmarketing Surveillance of ADRs:
Spontaneous Reports
Best method for detecting new ADRs
Local level
Managing ADRs
Step 1. Evaluate the nature of the event.
Severe ADRs
Educate and monitor prescribers.
Change the formulary or standard treatment guideline if
necessary to substitute a medicine that is safer or that is easier to
use by staff.
Modify patient monitoring procedures.
Notify drug regulatory authorities and manufacturers.
All ADRs
Educate and warn patients.
Prevention of ADRs
Schematic of preventable and unavoidable
adverse events
Unavoidable Avoidable
Preventable
Adverse
Events
Remaining
Uncertainties:
· Unexpected
ADRs and side
Injury or Death effects
· Unstudied uses
· Unstudied
populations
DTC's Role in Preventing ADRs
Review ADR reports regularly and inform professional staff of the
incidence and impact of ADRs in the region.
Discuss changes in the formulary or standard treatment guidelines for
significant or recurring problems with ADRs.
Educate staff, especially providers, concerning ADRs.
Identify medicines on the formulary that are “high risk” and should be
monitored closely by physicians and pharmacists.
Identify “high-risk” patient populations, including pregnant women,
breast-feeding women, the elderly, children, and patients with renal or
liver dysfunction; close monitoring of these patient populations by
physicians and pharmacists will help prevent serious adverse
reactions.
Review medication errors and product quality complaints to ensure
they are not contributing to the incidence of ADR at the hospital.
Adverse Drug Events (1)
An adverse drug event is any untoward
medical occurrence that may be present
during treatment with a medicine but does
not necessarily have a causal relationship
with this treatment.
Workplace factors
Poor lighting, noise, interruptions, excessive workload
Pharmaceutical factors
Excessive prescribing
Confusing medicine nomenclature, packaging, or labeling
Increased number or quantity of medicines per patient
Frequency and complexity of calculations needed to prescribe,
dispense, or administer a medicine
Lack of effective policies and procedures
When Medication Errors Occur (1)
Medicine Ordering or Prescribing
Transcribing
Dispensing
MEDICATION
Administering
ERROR
Monitoring
When Medication Errors Occur (2)
Medicine Ordering or Prescribing 77.8%
Transcribing 5.8%
Dispensing 1.0%
MEDICATION
ERROR
Administering 12.8%
Fortescue E.B., et al. 2003. Prioritizing Strategies for Preventing Medication Errors Monitoring 0.5%
and Adverse Drug Events in Pediatric Inpatients. Pediatrics 111:722–29.
Preventing Medication Errors (1)
Establish consensus group of physicians, nurses,
and pharmacists to select best practices
Massachusetts, USA**
Pharmacists assigned to make rounds with the intensive care
unit team
Made 366 recommendations on medicines; 362 accepted
Reduction in preventable adverse drug events due to
prescribing errors from 10.4 to 3.5 per 1,000 patient-days
*Dean, B., M. Schachter, C. Vincent, et al. 1998. Causes of Prescribing Errors in Hospital Inpatients:
a Prospective Study. Lancet 359 (9315):1373–78.
**Leape, L.L., D.J. Cullen, M.D. Clapp, et al. Pharmacist Participation on Physician Rounds and
Adverse Drug Events in the Intensive Care Unit. JAMA 282(3):267–70.
Activities
Activity 1
Case history: Penicillin Anaphylaxis Reported
Activity 2
Case history: Acute Respiratory Infection in a Two-
Year Old
Activity 3
Serious ADRs with Phen-Fen Combination
Medicine
Summary (1)
DTCs can contribute significantly to improved
medicine safety by—