Editorial

Adverse Drug Reaction Reporting and Pharmacovigilance of New Therapeutic Agents

Authors: Steven Joseph Haas, B PHARM, B PHARM SCI (HONS), MSHPA, MAEA

Abstract

Much media attention and public interest has been recently expressed with respect to major recalls of popular medications worldwide, the most pertinent being the rofecoxib withdrawal in 2004.1,2 Situations such as this have heightened both academic and clinical interest in the areas of medication safety and pharmacovigilance. Fortunately, not all adverse reactions warrant the removal of medications from the arsenal of therapeutic agents at our disposal – however, our increased awareness of adverse reactions allows for the identification of unique and potentially devastating effects that have not been identified in clinical trials before the medication's availability on the general market. Reports of this nature are essential to ensuring the health and wellbeing of patients, not just with respect to adverse reactions implicated with particular medications, but also for the potential of drug-drug interactions and the possible influence of pre-existing comorbidities (two very important factors with respect to complicated medical fields such as neurology). The potential impact of alcohol consumption and complimentary medicines such as St John's Wort also add new dimensions to the situation at hand.3 Unfortunately, these complicating factors may not be incredibly evident at that particular time and may only become significant as the number of case reports increases and a pattern emerges.

This content is limited to qualifying members.

Existing members, please login first

If you have an existing account please login now to access this article or view purchase options.

Purchase only this article ($25)

Create a free account, then purchase this article to download or access it online for 24 hours.

Purchase an SMJ online subscription ($75)

Create a free account, then purchase a subscription to get complete access to all articles for a full year.

Purchase a membership plan (fees vary)

Premium members can access all articles plus recieve many more benefits. View all membership plans and benefit packages.

References

1. Singh D. Merck withdraws arthritis drug worldwide. BMJ 2004;329:816.
 
2. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis: VIGOR Study Group. N Engl J Med 2000;343:1520–1528.
 
3. Williams ER, Taylor RE. Adverse drug reactions as cause of admission to hospital: alcohol and other non-prescribed drugs may have impact on adverse drug reactions. BMJ 2004;329:459.
 
4. Tebb Z, Tobias JD. New anticonvulsants: new adverse effects. South Med J 2006;99:375–379.
 
5. McDonnell PJ, Jacobs MR. Hospital admissions resulting from preventable adverse drug reactions.Ann Pharmacother 2002;36:1331–1336.
 
6. Dormann H, Criegee-Rieck M, Neubert A, et al. Lack of awareness of community-acquired adverse drug reactions upon hospital admission: dimensions and consequences of a dilemma. Drug Saf2003;26:353–362.
 
7. Vallano A, Cereza G, Pedros C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol 2005;60:653–658.
 
8. Herdeiro MT, Figueiras A, Polonia J, et al. Physicians' attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2005;28:825–833.
 
9. Bannwarth B. Do selective cyclo-oxygenase-2 inhibitors have a future? Drug Saf 2005;28:183–189.