Medication errors & pharmacovigilance

The goal of medication therapy is achieving defined therapeutic outcomes to improve a

patient's quality of life while minimizing risk. There are both known and unknown risks
associated with the therapeutic use of prescription and nonprescription drugs and drug
administration devices. These risks and their associated hazards have been defined as drug
misadventures. These include both adverse drug events (ADEs) & Medication errors (MEs)
The National Coordinating Council for Medication Error Reporting and Prevention
(NCCMERP) defines an ME as: "Any preventable event that may cause or lead to inappropriate
medication use or patient harm while the medication is in the control of the healthcare
professional, patient, or consumer. Bates et.al has defined ME as - Any error occurring in the
medication use process

Fig 1. Medication- Use process

1999 report- To Err is Human by the Institute of Medicine (IOM) stated that medical
mistakes kill 44,000 to 98,000 patients annually in the United States, causing more deaths than
breast cancer, motor vehicle accidents, and infections of human immunodeficiency virus
The causes of MEs are multifactorial and span healthcare disciplines. MEs compromise
patients' confidence in the healthcare system and increase healthcare costs.
First, Do No Harm- "5 Rights" of safe medication administration
Right drug, right patient, right dose, right route and right time

Swiss cheese" model of medication error:

Classification of medication errors based on a psychological approach:

NCCMERP Index for Categorizing Medication Errors:

Managing Errors:
Just Culture" of Patient Safety: It focuses on the sequence of events that led to the error,
rather than the person who made the error. It is a proactive approach in which risks are reviewed
and outcomes of events are evaluated. This encourages all employees to be stakeholders in the
prevention of MEs and ADEs.
An ounce of prevention is worth a pound of cure

Pharmacovigilance:
Adverse drug reaction (ADR): WHO defines an ADR as a response to a drug that is noxious
and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or
therapy of disease, or for modification of physiological function. The terms ADR and adverse
drug effect can be used interchangeably. Adverse effects are not rare; an incidence of 1025%
has been documented in different clinical settings. It is important also to avoid confusion with
the term adverse drug event (ADE).
An ADR in a patient is an adverse outcome that is attributed to a suspected action of a drug,
whereas an ADE is an adverse outcome that occurs after the use of a drug, but which may or may
not be linked to use of the drug. All ADRs are ADEs, but not all ADEs will be ADRs.

Severity of adverse drug reactions: has been graded as

Minor: No therapy, antidote or prolongation of hospitalization is required
Moderate: Requires change in drug therapy, specific treatment or prolongs
hospital stay by atleast one day.
Severe: Potentially life-threatening, causes permanent damage or requires
intensive medical treatment.
Lethal: Directly or indirectly contributes to death of the patient
Pharmacovigilance has been defined by the WHO (2002) as the science and
activities relating to the detection, assessment, understanding and prevention of
adverse effects or any other drug related problems
The Pharmacovigilance Programme of India was initiated by the Government of
India in July 2010 in AIIMS, New Delhi as NCC for monitoring ADRs in the
country for safe-guarding public health.
Reporting of Adverse Drug Reactions:
i.
ii.
iii.
iv.
v.

Spontaneous reporting
Post-marketing surveillance
Prescription event monitoring
Computerized medical record linkage
Other sources- Direct patient reporting, Published case reports,
Pharmacoepidemiological studies

Who can Report: Clinicians, dentists pharmacists, nurses and others

What to Report: All types of suspected ADRs (Known or unknown, serious &
non-serious, frequent or rare)

Although pharmacovigilance is primarily concerned with pharmaceutical

medicines, adverse reactions associated with drugs used in traditional medicine
(e.g. herbal remedies) should also be considered. Special fields of interest are drug
use in pregnancy, lactation, paediatric and geriatric patients
In addition, the reporting of lack of efficacy and suspected pharmaceutical
defects is recommended, especially when there is the possibility of manufacturing
problems, counterfeit pharmaceuticals or of the development of resistance e.g.
antibiotics.
How and Whom to Report- Use the Suspected Adverse Drug Reaction
Reporting Form report any ADR.
Whom- to the nearest AMC or directly to the NCC.
NCC-PvPI also created a helpline number 1800-180-3024 to report adverse
reactions associated with medicines