PHARMACOVIGILANCE:

Pharmacovigilance is the science and activities relating to the detection, Assessment, understanding and prevention of adverse effects or any other Medicine related problems

AIMS OF PHARMACOVIGILANCE
Patient care and safety Keeps tracks of any drastic effects of drug Assessment of benefits, harm, effectiveness Effective communication to the public Encourage safe, rational, and more effective use of various medicine

MEDICINE

ADVERSE REACTIONS

Aminophenazone (amidopyrine) Agranulocytosis

Chloramphenicol
Clioquinol Erythromycin estolate

Aplastic anaemia
Myelooptic neuropathy (SMON) Cholestatic hepatitis

Fluothane
Methyldopa Oral contraceptives Practolol Reserpine Statins Thalidomide

Hepatocellular hepatitis
Hemolytic anaemia Thromboembolism Sclerosing peritonitis Depression Rhabdomyolysis Congenital malformations

Importance of pharmacovigilance
Drug monitoring Pharmaceutical preparations Adverse drug reaction reporting Product surveillance Post marketing legislation

Post Marketing Surveillance

Monitoring of drug safety after introducing into the market through various systems Need 1.To assess risk benefit ratio 2.To confirm safety and efficacy 3.To detect less common adverse effects

Methods of Surveillance
Anecdotal reporting Voluntary reporting Intensive event reporting Cohort studies (prospective) Case control studies (retrospective) Population statistics Meta-analysis

Partners in Pharmacovigilance
The WHO quality assurance and safety : medicines team The uppasala monitoring centre National pharmacovigilance centers The pharmaceutical industry Hospitals and academia Health professionals Patients Others partners

Ethics in Pharmacovigilance
The Erice declaration provides framework of values and practice for collection, analysis and subsequent communication of drug safety issues. It asserts scientific and clinical issues on the one hand and right of the public to be openly and fully informed on the other. It requires the active commitment of all involved regulators, policy makers, health personnel, journalists and (not last) pharmaceutical manufacturers. Information about drug safety programmes should be easily available to the public so that the central role of patient in safe and rational use of drugs is understood. Available information is not always reliable and scientifically valid. Direct advertising to the consumer resulting self medication, illicit sale of medicines over internet and over prescribing by doctor on demand.

ADR Monitoring
Systemically collecting information about adverse drug experiences with the aim of, through feed back to the parties involved, contribute to continuously improving drug therapy.

Who reports ?
Doctors-hospital level, MO from PHC,GPs Dentists Drug manufacturers Pharmacists and nurses

What to report ?
New drugs all suspected adverse reaction Established drugs - All serious reactions-well recognized
- All reactions to vaccines - Unexpected high frequency of a known adverse reaction - All reactions to pregnant & lactating women including new born

Where to report ?
Nearest ADR monitoring centers Peripheral centers Regional centers national center at new Delhi Directly on internet www.fda.gov/MedWatch

Reasons not to report

Uncertain association Too trivial to report Too well known to report Unaware- existence of national center Unaware- of the need of to report of ADRs Not enough time Non availability of ADR forms Too bureaucratic Legal issues Lack of feed back

Functions of Pharmacovigilance
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. Identifying new information about hazards associated with medicines. Preventing harm to the patients.

Regulatory Bodies

Europe

India

Germany

US

MHLW, Japan

Conclusion
Current progress in pharmacovigilance is marked by increasing use of databases and by attempts to make the process more proactive and organized. Attempts are being made to augment the spontaneous, random nature of the generation of pharmacovigilance data and to make the process more systematic and structured. There has been a coming together of academic, regulatory and industrial interests across many countries to produce the guidance documents mentioned above as well as good practice guidelines for the conduct of pharmacoepidemiology studies. Health ministries, health professionals and the public can all be reassured by knowing that there is a competent and functional system in place that focuses on the safety of medicines used in the prevention and treatment of disease, including vaccines and pharmaceuticals for family planning.