Perspectives in Clinical Research

LETTER TO EDITOR
Year
: 2015  |  Volume : 6  |  Issue : 3  |  Page : 171--172

Good pharmacovigilance practice: Need of the hour from pharmaceutical companies


Neha Bhati, Sridharan Kannan, Prem P Khosla 
 Department of Pharmacology, Subharti Medical College and Hospital, Meerut, Uttar Pradesh, India

Correspondence Address:
Prem P Khosla
Department of Pharmacology, Subharti Medical College and Hospital, Delhi-Haridwar Bypass Road, Meerut - 250 005, Uttar Pradesh
India




How to cite this article:
Bhati N, Kannan S, Khosla PP. Good pharmacovigilance practice: Need of the hour from pharmaceutical companies.Perspect Clin Res 2015;6:171-172


How to cite this URL:
Bhati N, Kannan S, Khosla PP. Good pharmacovigilance practice: Need of the hour from pharmaceutical companies. Perspect Clin Res [serial online] 2015 [cited 2020 Oct 30 ];6:171-172
Available from: https://www.picronline.org/text.asp?2015/6/3/171/159944


Full Text

Sir,

For a successful pharmacovigilance program, all the stake holders viz. physicians, nurses, pharmacists and patients need to be sensitized towards reporting adverse drug reactions (ADRs). This is especially of a concern in India, where the awareness of reporting ADR has been found to be poor [1] and lack of time, training have been accounted for underreporting of ADRs amongst physicians. [2] Moreover, when a new drug is prescribed, physicians have a vital role of being more vigilant in reporting ADRs. Marketing representatives (MRs) from pharmaceutical companies approach physicians for the promotion of their drugs. While a new drug is promoted to physicians, it is important to discuss the reporting of ADRs. But, there is no data on whether such information is disseminated by MRs. Hence, to explore this, we undertook a questionnaire (validated and consisted of four items) based survey amongst 500 doctors of various streams working in a private medical college after obtaining institutional ethics committee approval and written informed consent. All the physicians reported that they have been approached by MRs for promotion of new drugs at least once. Only 51/500 (10.2%) physicians opined that they were given details regarding the need to report ADRs for a new drug. A total of 25/500 (5%) physicians opined that they were informed by MRs that they should be more vigilant in reporting ADRs for new drugs especially when used in vulnerable population (children, pregnant and lactating women, elderly) that has not undergone licensing trials. Additionally, 458/500 (91.6%) participants opined that the MRs told them that the new drug is completely safe as it has been thoroughly evaluated and only 14/500 (2.8%) reported that they were given ADR reporting form by the MRs.

Our study found a poor intimation of ADR reporting by MRs to prescribing physicians reflecting a poor pharmacovigilance practice. Studies suggest that information provided by MRs is often biased towards the promoted product. [3],[4] Due to differences in the indications and healthcare systems, use of new drugs following marketing approval reveals the complete picture of ADRs. It is the responsibility of marketing authorization holder for continuous monitoring of safety of new drugs in human beings, to report regulatory agencies and to keep up-to-date the product insert. MRs on behalf of the pharmaceutical companies gets in touch with the prescribers and provide good information about drug indication but weak information about drug contraindication. [5] In the Indian context, as indeed the case in many developing countries, the MR is still the main source of information, especially regarding new drugs. [6] Studies show that sales representatives failed to provide any information about common or serious side effects and the type of patients (vulnerable population) who should not use the medicine in 59% of the promotions. [6]

 CONCLUSION



We found that majority of the prescribing doctors in our research population were not informed about the ADRs of new drugs by MRs from pharmaceutical companies. This highlights the lacunae of pharmaceutical companies towards pharmacovigilance. The MRs should be trained and emphasized the importance of pharmacovigilance and the need to convey the same to the prescribers when a new drug is being prescribed.

References

1Yadav S. Status of adverse drug reaction monitoring and pharmacovigilance in selected countries. Indian J Pharmacol 2008;40:S4-9.
2Radhakrishnan R, Vidyasagar S, Verma MD. An educational intervention to assess knowledge, attitude, practices of pharmacovigilance among health care professionals in an Indian tertiary care teaching hospital . Int J Pharm Tech Res 2011;6:78-92.
3Ziegler MG, Lew P, Singer BC. The accuracy of drug information from pharmaceutical sales representatives. JAMA 1995;273:1296-8.
4Tuffs A. Only 6% of drug advertising material is supported by evidence. BMJ 2004;328:485.
5Mikhael EM. The reliability and accuracy of medical and pharmaceutical information that were given by drug companies through medical representatives to Iraqi physicians. Int J Pharm Sci 2014 ;6:627-30.
6Doctors not informed of harmful effects of medicines during sales visits. Available from: http://www.news.ubc.ca. [Last accessed on 2014 Oct 09].