Drug reaction reporting

Bukowski, J.A. and Wartenberg, D. (1996). Comparison of adverse drug reaction reporting in veterinary and human medicine. JAVMA 209 40 15. 

WHO (1975). Requirements for Adverse Drug Reaction Reporting. WHO, Geneva. 

Faich GA. National adverse drug reaction reporting. Arch Int Med 1991 151 1645-7. 

Griffin JP. Survey of adverse drug reaction reporting schemes in fifteen countries. Br ] Clin Pharmacol 1985 22 83S-100S. 

Fletcher AP. Spontaneous adverse drug reaction reporting vs eventmonitoring a comparison./Roy Soc Med 1991 84 341-4. 

McEwen J. Improving adverse drug reaction reporting. Med Toxicol 1987 2 398-404. 

Griffin JP Survey of the spontaneous adverse drug reactions reporting schemes in 15 countries. Br / Clin Pharmacol 1986 22 Suppl 1 83S-100S. 

CIOMS. International reporting of adverse drug reactions (Report of CIOMS Working Group I). Geneva Counsil for International Organizations of Medical Sciences 1990. 

Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group. Eur J Clin Pharmacol 1997 52(6) 423-7. 

Belton KJ, Lewis SC, Payne S, Rawlins M. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol 1995 39 223-6. 

Diplopia may be an early sign of generalized drug-induced muscle dysfunction. Altogether, 71 cases of diplopia, possibly related to various HMG-CoA inhibitors, have been collected from adverse drug reactions-report-ing databases. The information was mostly too scanty to judge a causal relation, but improvement occurred in 33 on withdrawal, and two patients had positive rechallenge data (52). 

The Food and Drug Administration (FDA) maintains a computerized human teratogen Information system as part of Its adverse drug reaction reporting... 

An important issue in the Lacuzong case was the capacity of one, two, or three daily doses of Paxil 10 to cause severe mental disturbances. During my site visit to the offices of GSK, I combed through adverse drug reaction reports to determine how early in treatment they began. I discovered that the first few days were the greatest time of risk. 

Medwar, C., Herxheimer, A. (2003-2004). A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxetine. International Journal of Risk and Safety in Medicine, 16, 5-19. 

Before moving from discipline-specific standards to a review process that focuses on a multidisciplinary and systems-based approach to care, medication standards were in department-specific chapters, such as pharmacy, nursing, and medical staff, with the latter centered arormd the Pharmacy and Therapeutics committee, the formulary and adverse drug reaction reporting. Over time, the pharmacy standard disappeared and was integrated into the overall patient care chapters. For the 2004 standards, the JCAHO has published a new chapter entitled Medication Management, which reflects increased focus on medication systems and safety. This chapter divides the medication process into six segments ... 

Primary reports describing adverse reactions and drug-induced diseases include spontaneous reports and other unpublished data available from the manufacturer or the FDA. All reports of adverse reactions reported to the FDA can be retrieved (without identifiers) under the legal authority of the Freedom of Information Act. Anecdotal and descriptive reports of ADRs (including case reports and case series) are occasionally reported in the literature but are often incomplete and inconclusive. Guidelines for evaluating adverse drug reaction reports have been described (56). 

Cl5me KE, German MR. Adverse drug reaction reporting. Focus on cost and prevention. Pharm and Ther 1992 17 1145-56. 

In a 5-year toxicological study of traditional remedies and food supplements carried out by the Medical Toxicology Unit at Guy s and St. Thomas Hospital, London, 1297 symptomatic enquiries by medical professionals were evaluated (28). Of these, an association was considered to have been confirmed, probable, or possible in 12, 35, and 738 cases respectively. Ten of the confirmed cases were related to Chinese or Indian herbal remedies. As a result of these findings, in October 1996 the UK Committee on Safety of Medicines extended its yellow card scheme for adverse drug reaction reporting to include unhcensed herbal remedies, which are marketed mostly as food supplements in the UK (the scheme had always apphed to hcensed herbal medicines) (29,30). This was an important milestone in herbal pharmacovigilance. 

In cases when the medicinal product has been registered in other countries, it is desirable to present information on the adverse drug reaction reports collected during the post-registration survey of the medicinal product. If possible, these data shall be discussed in respect to the data for consumption of the medicinal product. It is necessary to attach the publications made on the safety of the medicinal product under registration and the safety of other medicinal products containing the same active substance(s). 

Clinical Pharmacology Unit Adverse drug reaction reports will be submitted to this unit. The unit maintains contact with international bodies regarding adverse drug reactions. 

The National Pharmaceutical Administration is staffed by pharmacists who evaluate all applications for product licence, conduct GMP audits in the case of a local manufacturer, conduct post-marketing surveillance and also actively monitor adverse drug reaction reports. 

Food and Drug Administration. Adverse Drug Reaction Reporting. Washington, D.C. FDA, 1969. 

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