An Overview

ByPougang Golmei

M.Pharm (Pharmacology)RIPANS,Aizawl

What is pharmacovigilance?

Who runs the pharmacovigilance?

Why do we need vigilance?

Contents

Pharmacovigilance in India?

PHARMACO (GREEK) = medical substance

• Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. PV collects, records, codes ADEs/ADRs analyses and assesses the reports, promotes the safe use of drugs, creates appropriate structures and means of communication needed to perform its tasks.

VIGILIA (LATIN) = to keep watch

AIM & SCOPE

TO IMPROVE PATIENT CARE & SAFETY IN RELATION TO MEDICINES & ALL MEDICAL & PARAMEDICAL INTERVENTIONS

To improve public health & safety in relation to the use of medicines

To contribute to the assessment of benefit, harm, effectiveness and risk of medicines

To promote understanding, clinical training & effective communication to health professionals & the public

•Data gathering related to the detection, assessment, understanding, and prevention of adverse events•Identifying new information about hazards associated with medicines, preventing harm to patients•Post-marketing surveillance (?)•Medical errors are broader category which includes adverse reactions but also other factors (diagnostic errors, equipment failure, nosocomial infections ... )

PHARMACOVIGILANCE

Adverse Event (AE) – any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a casual relationship with this treatmentAdverse Drug Reaction (ADR) – a response to a drug which is noxious and unintended, and which occurs at doses normally used in man.Serious Adverse Event (SAE) – AE that is either life-threatening, fatal, cause of prolong hospital admission, cause persistent disability or concern misuse or dependence

COMMON TERMS USED IN VIGILANCE

Serious Adverse Drug Reaction (SADR) – ADR where SAE conditions of severity applies

Unexpected Adverse Drug Reaction (UADR) – an adverse reaction, the nature or severity of which is not consistent with market authorization, or expected from the characteristics of the drug.

Signal – reported information on a possible relationship between an adverse event and a drug, unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information

Expected and Unexpected Events

•Expected are those adverse events that were observed during clinical trials or post-approval observations and are mentioned in Summary of Product Characteristics (SPC)•Unexpected are those adverse events that were not previously observed and are not documented (in SPC)•Based on frequency of occurrence there are following categories of adverse events:

Category FrequencyVery commonCommonUncommonRareVery rare < 1/10,000

≥ 1/10 ≥1/100 and <1/10≥ 1/1,000 and <1/100≥ 1/10,000 and <1/1,000

Pharmacovigilance applies to life cycle of a medicine

Who runs the vigilance programme?

WHO Programme for International Drug Monitoring

WHO Programme for International Drug Monitoring

WHO Collaborat

ing centre,

UPPSALA

WHOHead

quarters

What information should be reported?

What to report? WHO Recommendation

•Every single problem related to the use of a drug, because probably nobody else is collecting such information•All suspected adverse reactions•ADRs associated with radiology contrast media, vaccines, diagnostics, drugs used in traditional medicine, herbal remedies, cosmetics, medical devices and equipment•Lack of efficacy and suspected pharmaceutical defects•Counterfeit pharmaceuticals•Development of resistance

What to Report (at least)• Requirements for reporting differ from country to country. However, in

each developed country healthcare professionals are legally obligated to report adverse reactions (although it is not always clearly stated which)

• It is important to report serious unexpected ADRs – those that are not described in SPC. Unexpected include also side effects mentioned in SPC when these occur in higher frequencies then described.

• Most cases of unexpected ADRs are associated with medicines newly introduced on the market

• It has no sense to report expected adverse• In clinical praxis it is usually not easy to evaluate causality – report also

in cases you are not sure about causal relationship• Heathcare professionals may report adverse events also to marketing

authorization holder for a medicine but are not obligated to

Who report?

PhysiciansPharmacistsPharmaceutical companies qualified persons(Pharmacovigilance/Regulatory manager)

Investigational products (clinical trials)Post-approval reporting – Individual Case Safety Report (ICSR), Periodic Safety Update Report (PSUR)

In many countries patients are encouraged (but not obligated) to report side effects

Who Regulates Drug Safety?

• Slovakia – State Institute for Drug Control, Section of Drug Safety and Clinical TrialsCzech Republic - State Institute for Drug Control, Pharmacovigilence departmentUK – Medicines and Healthcare Products Regulatory Agency, Vigilence Risk Management of MedicinesUSA – Food and Drug Administration, Center for Drug Evaluation and ResearchIndia- Central Drugs Standard Control Organization

Why do we need pharmacovigilance?

Humanitarian concern

Promoting rational use of medicines and

adherence

ADR may cause sudden

death

Ethics to know of something that is

harmful to another person who does not

know, and not telling, is unethical

Basic steps in setting up a Pharmacovigilance CentrePrepare a plan according to the points below for the establishment of the pharmacovigilance system.1. Make contacts with the health authorities and with local, regional or national institutions and groups, working in clinical medicine, pharmacology and toxicology outlining the importance of the project and its purposes.2. Design a reporting form and start collecting data by distributing it to hospital departments, family practitioners, etc.3. Produce printed material to inform health professionals about definitions, aims and methods of the pharmacovigilance system.4. Create the centre: staff, accommodation, phone, word processor, database management capability, bibliography etc.5. Take care of the education of pharmacovigilance staff with regard, for example, to:

• data collection and verification• interpreting and coding of adverse reaction descriptions• coding of drugs• case causality assessment• signal detection• risk management.

6. Establish a database (administrative system for the storage and retrieval of data7. Organize meetings in hospitals, academia and professional associations, explaining the principles and demands of pharmacovigilance and the importance of reporting.8. Promote the importance of reporting adverse drug reactions through medical journals, other professional publications, and communications activities.9. Maintain contacts with international institutions working in pharmacovigilance, e.g. the WHO Department of Essential Drugs and Medicines Policy (Geneva) and the Uppsala Monitoring Centre, Sweden