The Role of Pharmacovigilance in Psychiatry

Volume 4 Issue 5 May, 2014

Consultation Liaison Psychiatry Focus: ‘Pharmacology’

A 37 year old female patient was diagnosed as a case of partial epilepsy based on history, examination, investigations
and clinical judgment. She was then prescribed the antiepileptic drug, Tablet Levetiracetam, 500 mg per day. Her seizure was well controlled with the drug. After 4 months of therapy, she failed to report for her monthly visit. As she was part of a clinical study, she was contacted over phone for follow up. It was found out that she started showing less interest in household chores, was socially withdrawn and felt like committing suicide. A diagnosis of Levetiracetam induced suicidal tendency was attained based on literature review and causality assessment. The drug was stopped; the patient was prescribed Tablet Carbamazepine and was referred to psychiatry department for assessment and further monitoring.

The above is a case of adverse drug reaction (ADR). This rare reaction was reported due to the vigilant attitude of the
concerned practitioner. To collate, process, and analyze such pharmacovigilance data, the pharmacovigilance program
of India (PvPI) was started in the year 1986. The mission of PvPI is to safeguard the health of the population by ensuring that the benefits of use of medicines outweigh the risks associated with their use. PvPI is coordinated by the Indian Pharmacopoeia Commission and conducted by the Central Drugs Standard Control Organization (CDSCO). The purpose of PvPI is to collate data, process and analyze it and use the inferences to recommend regulatory interventions, besides communicating risks to healthcare professionals and the public.

In psychiatry practice, it is very important to be aware of and report ADRs as 1.5% of severe ADRs in hospital settings are due to psychotropic drugs. Also, like the above case, many other drugs are known to produce psychiatric adverse
reactions. This has a huge impact due to challenge in diagnosis as the patients may not recollect about their medication history. The other impacts are due to extended hospitalization and increase in health care cost. A physician has to remember a few points before arriving at diagnosis of ADR. These are absence of other causes, temporal relationship, pharmacological mechanism of the drug, response to de-challenge, re-challenge and likelihood of reaction. Sometimes physicians fail to detect and report ADRs due to lack of awareness about ADR, failure to follow up with patients, busy practice schedule, and a negative attitude due to fear of medico-legal implications.

Recently PvPI has started a pharmacovigilance helpline. The number is: 1800-180-3024.
For more information and reporting ADR, one should visit the website:

http://www.cdsco.nic.in/writereaddata/ADR%20form%20PvPI.pdf

0 0