Reporting systems, adverse drug reactions

Few drugs are more controversial. More adverse reactions to the drug have been reported to the FDA than any other drug in the 24-year history of the FDA s adverse drug reaction reporting system. Thomas G. Whitde and Richard Wieland (The Story Behind Prozac. the Killer Drug) write, Based on documents recently obtained by under the Freedom of Information Act, as of September 16,1993,28,623 reports of adverse reactions to Prozac had been received by the FDA. ... 

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

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 ... 

Establishing and maintaining a pharmacovigilance system to capture and evaluate all reports of suspected adverse drug reactions. 

American Society of Hospital Pharmacy (1995). ASHP Guidelines on adverse drug reaction monitoring and reporting. Am. J. Health Systems Pharm. 52 417—419. 

Chen MC, Huang S-M, Mozersky R, Beitz J, Honig P. Drug interactions involving St. John s Wort-data from FDA s adverse reaction reporting system. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, Denver CO, October 2001. 

As emphasized in chapter 13, the data once again confirm the importance of the spontaneous reporting system compared to controlled clinical trials in revealing dangerous adverse drug reactions, in this case violence and aggression. 

Adverse drug reactions are of significant concern in the pharmaceutical technology arena. Various drug and patient factors that predispose to ADRs have been identified. Reporting systems used to screen and assess ADRs facilitate the understanding of risk factors and contribute to the development of systematic improvement in the prevention of ADRs. 

Rossi, A. Knapp, D. Discovery of new adverse drug reactions. A review of the food and drug administration s spontaneous reporting system. JAMA 1984,252,1030-1033. 

In a review of definite or probable drug-associated pancreatitis spontaneously reported to the Dutch adverse drug reactions system during 1977-98, azathioprine was the suspected drug in four of 34 patients, two of whom had positive rechallenge (37). Although most of the carefully described reports of azathioprine-induced pancreatitis were found in patients with inflammatory bowel disease, transplant recipients can also suffer this complication. 

A definite case of pancreatitis proven by positive rechallenge was also briefly cited in a review of drug-associated pancreatitis spontaneously reported to the Dutch adverse drug reactions system (261). 

Includes, when necessary, notes on nomenclature, information about the results of observational studies, comparative studies, and placebo-controlled studies in relation to reports of adverse drug reactions, and a general summary of the major adverse effects. ORGANS AND SYSTEMS Cardiovascular (includes heart and blood vessels) Respiratory Ear, nose, throat... 

---