Asian Journal of Management

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Study on Role of Postmarketing Surveillance in New Drug Development


Affiliations
1 Department of Pharmacology, Teegala Ram Reddy College of Pharmacy, Saroor Nagar, Meerpet, Hyderabad – 97, India
2 Department of Management Studies Thiyagaraja College of Arts and Science, Madurai, India
3 Periyar College of Pharmaceutical Sciences, Tiruchirappalli-21, India
     

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Post marketing surveillance aims to monitor and evaluate both the beneficial and adverse effects of drugs after approval for general use. The Health Council in the Netherlands has defined post marketing surveillance (PMS) as 'The systematic surveillance and scientific study of all intended and unintended effects of medicines on human health, after their release for marketing'. Spontaneous reports should be supplemented by analytical studies, monitoring of cohorts of users of new drugs, using record-linkage to track their subsequent outcomes and to interpret the results of such analyses in the context of variability of drug exposure. Furthermore, the introduction of drugs with a new pharmacological profile especially requires post marketing surveillance of adverse events, as illustrated by the case of ibopamine. Programs for collecting and reporting safety information on drugs such as adverse drug reactions include an adverse drug reaction reporting system undertaken by pharmaceutical companies, the drug safety information reporting system undertaken by medical personnel, and the WHO International Drug Monitoring Program whereby drug safety information is exchanged among various countries. The present work has been designed to create awareness and knowledge about the post-marketing surveillance research and its emerging role in the new drug development.

Keywords

Post Marketing Surveillance, Pharmaceutical, Drug Monitoring
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  • Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA 1999; 281:824-9.

  • Strom BE (ed). Pharmacoepidemiology. Chichester: John Wiley & Sons, third edition, 2000.

  • Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 1999; 281:1728-34.

  • Meyboom RHB, Egberts ACG, Gribnau FWJ Hekster YA. Pharmacovigilance in perspective. Drug Saf 1999; 21:429-47.

  • Temple R. Meta-analysis and epidemiologic studies in drug development and postmarketing surveillance. JAMA 1999; 281:841-4.

  • Bemt MLA van den, Egberts TCG, de Jong-van den Berg LTW, Brouwers JRBJ. Drug related problems in hospitalised patiensts. Drug Safe 2000; 22:321-33.

  • Hawker, P, C., et al., “Gastric Cancer After Cimetidine in Patient With Two Negative Pretreatment Biopsies,” Lancet 1:709, 1980.

  • Finkel, M. J., “FDA’s Criteria for Safety and Effectiveness of Drugs” presented at the First Workshop on Drug Control in the Region of the Americas, Pan American Health Organization, Washington, D. C., May 1, 1979.

  • Beta-Blocker Heart Attack Study Group, “The Beta-Blocker Heart Attack Trial,” A.h4. A. 246:2073, 1981.

  • Waller PC, Wood SM, Breckenridge AM, Rawlins MD. Why the Safety Assessment of Marketed Medicines (SAMM) guidelines are needed. Br J Clin Pharmacol 1994; 38:93.

  • Leufkens HG, Urquhart J. Variability in patterns of drug usage. J Pharm Pharmacol 1994; 46 Suppl 1:433-37.


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  • Study on Role of Postmarketing Surveillance in New Drug Development

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Authors

A. Tamil Selvan
Department of Pharmacology, Teegala Ram Reddy College of Pharmacy, Saroor Nagar, Meerpet, Hyderabad – 97, India
C. Jothibaskara Mohan
Department of Management Studies Thiyagaraja College of Arts and Science, Madurai, India
S. Karpagam Kumara Sundari
Periyar College of Pharmaceutical Sciences, Tiruchirappalli-21, India
R. Suthakaran
Department of Pharmacology, Teegala Ram Reddy College of Pharmacy, Saroor Nagar, Meerpet, Hyderabad – 97, India

Abstract


Post marketing surveillance aims to monitor and evaluate both the beneficial and adverse effects of drugs after approval for general use. The Health Council in the Netherlands has defined post marketing surveillance (PMS) as 'The systematic surveillance and scientific study of all intended and unintended effects of medicines on human health, after their release for marketing'. Spontaneous reports should be supplemented by analytical studies, monitoring of cohorts of users of new drugs, using record-linkage to track their subsequent outcomes and to interpret the results of such analyses in the context of variability of drug exposure. Furthermore, the introduction of drugs with a new pharmacological profile especially requires post marketing surveillance of adverse events, as illustrated by the case of ibopamine. Programs for collecting and reporting safety information on drugs such as adverse drug reactions include an adverse drug reaction reporting system undertaken by pharmaceutical companies, the drug safety information reporting system undertaken by medical personnel, and the WHO International Drug Monitoring Program whereby drug safety information is exchanged among various countries. The present work has been designed to create awareness and knowledge about the post-marketing surveillance research and its emerging role in the new drug development.

Keywords


Post Marketing Surveillance, Pharmaceutical, Drug Monitoring

References