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Pharmacovigilence

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Aifa Afzal
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70 views28 pages

Pharmacovigilence

Uploaded by

Aifa Afzal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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“PHARMACOVIGILENCE”

ITS ABOUT “TO BE VIGILANT ABOUT THE DRUG RELATED HAZARDS”

Especially;
•THE MONITORING & REPORTING OF ADRs
GENERAL
• There should be a basic and clear idea between side-
effects and the adverse drug reactions.
• SIDE EFFECTS
• Expected, well known reaction resulting in little or no
change in patient management e.g drowsiness or dry
mouth due to administration of certain
antihistamines, or nausea associated with certain
anticancer drugs.
• Further side effect can be defined as an effect with a predictable frequency and an effect
whose intensity and occurrence are related to the size of the dose
ADVERSE DRUG REACTIONS
• WHO—defines ADRs as;
• “Any response to a drug which is noxious, unintended and
occurs at doses used for prophylaxis, diagnosis or therapy of
disease, or for the modification of physiological function.”
• FDA—defines,
• “A serious drug event (events relating to drugs and devices)
as one in which, the patient outcome is death, life
threatening, hospitalization, disability, or congenital anomaly,
or required intervention to prevent permanent impairment or
damage.”
WHO / FDA CLASSIFICATION OF ADRS

• TYPE-A REACTIONS

• TYPE-B REACTIONS
TYPE-A REACTIONS
• Qualitatively normal but augmented
• Unrelated to the primary therapeutic effects.
• Predictable from pharmacology of a drug
• Dose dependent
• Do not usually cause serious illness
• Identified before a drug is marketed.
• Some have latency e.g. teratogenicity.
TYPE-B REACTIONS
• Usually due to “Hypersensitivity” & “Idiosyncratic”,
mechanism
• Bizarre effects that are unpredictable on the basis of
drug’s known pharmacology
• Unrelated to dose
• Although rare, but cause serious illness and death
• Account for many drug withdrawals from the market e.g.
Lipobay, has recently been withdrawn
CONT…
• Thin line between side effects & ADRs
• The clinical trials evaluate most common ADRs i.e.Type-A Reactions
• Many type-B reactions are evaluated after a drug is available for widespread use
• Continuous post marketing surveillance is often required before many type-B reactions can be
identified
DETECTION & MONITORING OF ADRS

• Methods most commonly adopted in post marketing surveillance


1. Case Reports
2. Cohort Studies
3. Case-control Studies
4. Spontaneous Reporting Schemes
CASE REPORTS
Detection of new and serious reactions, particularly Type-
B reactions
• This involves publication of single case reports, or case
series of ADRs in medical literature.
• Case reports, in the past have been vital in alerting the
professionals to several adverse reactions, such as,
“Halothane induced Hepatitis”.
COHORT STUDIES
• Study the fate of a large group of patients taking a particular
drug
• Compare adverse event rates in group of patients taking
drug of intent, with a comparative group
• Cohort studies include:
1. Ad hoc investigations to investigate specific problems
2. Sponsorship by pharmaceutical companies
3. Prescription Event Monitoring (PEM)
4. Variety of record linkage schemes
CASE- CONTROL STUDIES
Valuable information on the incidence of Type B reactions
& association between drug & disease
• Comparison of drug usage between a group of patients
with a particular disease and control group who are
similar in confounding factors but don’t have the disease
• Confirms whether or not a drug causes a given reaction
once suspicion has been raised.
SPONTANEOUS REPORTING SCHEMES
• Many countries have established a scheme for adverse drug reaction reporting called as,
“Committee on Safety of Medicines,” (CSM)
• The physicians are asked to report all suspected serious reactions to newer products
• CSM reporting scheme provides valuable early warnings & enables the study of factors
associated with them
• CSM has introduced a “Yellow Card Scheme,”

•
• Yellow card scheme is capable of detecting both rare and
common reactions
• Inexpensive to operate
• It should be available to all the physicians in every health
care facility
• It is unfortunate that in Pakistan there is considerable
under reporting of such reactions
• Less than 5% of serious adverse reactions are notified
IDENTIFICATION OF ADRS

• Causal relationship between a specific drug and a clinical


event
• Recognition of ADR features
• Patient should be informed about possible ADRs and how to
recognize them
• Patient should be asked to report any unexpected symptoms,
which may develop while taking that drug or within a month or
so of its discontinuation
• Assessment whether ADRs are definite, probable or possible
due to the drug
ASSESSMENT OF LIKELIHOOD OF ADRS
When an ADR is suspected following factors should be
taken into account
• Full history of patient
• Past drug history (OTC, herbal, homeopathic or any
other drugs )
• Nature of the reaction
• Timing of symptoms or events
It is relatively easy to recognize an ADR that occurs soon
after drug administration
ROLE OF PHARMACIST IN ADR MONITORING
• Leadership in the development, maintenance and ongoing evaluation of ADR programs

• Approval of such programs through appropriate committees as, P&TC and organization's
administration
PHARMACIST SHOULD FACILITATE
• Analysis of each reported ADRs
• Identification of drugs and patients at risk
• Development of policies & procedures for ADR monitoring
• Interaction between physicians, nurses and paramedics
• Educational purposes
• Publication of reports
MOH INITIATIVE
ADR- REPORTING
• In October 2000, Ministry of Health Pakistan, developed & distributed a comprehensive ADR
reporting form to all the health care institutions
• MAIN AIM
• To Centralize
• Regularize the mechanism of reporting ADRs
EXPECTATIONS
• Valuable Database

• Resource for implementation of corrective actions

• With “Yellow Card System”, in place staff can be regularly updated on compliance.
CONCLUSION
• ADRs are inevitable risk associated with use of modern medicines
• Careful attention to dosage & factors like age, sex, renal and hepatic functions will minimize
the risk of type A reactions
• The Pharmacist is well placed to assist in prevention, detection and monitoring of ADRs
CONT…
• It remains the responsibility of every health professional
to evaluate the appropriateness of a particular opinion or
therapy in the context of the actual clinical situation &
with due consideration for any new development in the
field.

• Strengthening the professional interaction between


Physicians, Pharmacists, Nurses & other allied health
professionals.
PHARMACIST’S OBLIGATION
• Its Pharmacist’s responsibility and professional obligation to report any suspected ADR.
• Pharmacist in an organized health care system should develop a comprehensive, ongoing
programs for reporting & monitoring of ADRs.
ADR MONITORING & REPORTING PROGRAM
This program should encourage:
• ADR surveillance
• Facilitate ADR documentation
• Promote reporting of ADRs.
• Monitor the safety of drug use in high risk patients
• Stimulate the education of health professionals.
ADR programs should focus on:

• Identifying problems leading to ADRs.


• Planning for positive changes.
• Measuring the results of these changes.
MEDICATION ERRORS
Medication error is a mistake in prescribing, dispensing and administration of drugs.
• Types of Medication
• Prescribing errors
• Omission errors
• Wrong time errors
• Unauthorized drug errors
• Improper dose errors
• Wrong dosage form errors
• Improper dose errors
• Wrong drug preparation errors
• Wrong administration technique errors
• Compliance errors
• Self medication.

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