Adverse reactions postmarketing surveillance

Jones JK, Idanpaan-HeikkUa, JE. Adverse Reactions, Postmarketing Surveillance and Pharmacoepidemiology. In Burley DM, Qarke JM, Lasagna L, Edward Arnold, eds. Pharmaceutical Medicine. A Division of Hodder Stoughton Publishers, 1993 145-80. 

Noah, B.A. and D.B. Brushwood, "Adverse Drug Reactions in Elderly Patients Alternative Approaches to Postmarket Surveillance," /. Hlth. Law, 33, 383-454 (2000). 

Brewer, T. and Colditz, G.A. (1999). Postmarketing surveillance and adverse drug reactions Current perspectives and future needs. JAMA 281 824-829. 

Phase IV. Studies or trials conducted after a medicine is marketed to provide additional details about the medicine s efficacy or safety profile. Different formulations, dosages, durations of treatment, medicine interactions, and other medicine comparisons may be evaluated. New age groups, races, and other types of patients can be studied. Detection and definition of previously unknown or inadequately quantified adverse reactions and related risk factors are an important aspect of many Phase IV studies. If a marketed medicine is to be evaluated for another (i.e., new) indication, then those clinical trials are considered Phase II clinical trials. The term postmarketing surveillance is frequently used to describe those clinical studies in Phase IV (i.e., the period following marketing) that are primarily observational or nonexperimental in nature, to distinguish them from well-controlled Phase IV clinical trials or marketing studies. 

Therefore, postmarketing surveillance is conducted to examine safety and effectiveness. The terms pharmacovigilance and pharmacosurveillance studies are also used in this context. Pharmacosurveillance monitors all reports of adverse reactions and thus compiles extended safety data. Pharmacosurveillance is therefore a critical component of the overall process of ensuring all members of a target disease population receive the greatest protection from adverse reactions. 

Fratmfelder FW, Fraunfelder FT. Scientific challenges in postmarketing surveillance of ocular adverse drug reactions. Am ) Ophthalmol 2007 143 145-149. 

Lortie EM. Postmarketing surveillance of adverse drug reactions Problems and solutions. Can Med Assoc J 1986 135 27-32. 

Etodolac, a pyranocarboxylic acid, was first marketed in the UK in 1986. By 1988, etodolac had been reported 27 times to the UK Committee on Safety of Medicines as being suspected of causing serious adverse reactions (1). In a French postmarketing safety study in 51 355 patients taking 200-600 mg/day, 10% of patients reported a total of 6236 adverse reactions and 9% dropped out because of adverse reactions, 21 of which were judged severe (2). In another four postmarketing surveillance studies in 8334 patients with rheumatic conditions who took 200-600 mg/day of etodolac for periods ranging from 4 weeks to 1 year, 23% reported adverse events and 9%... 

Postmarketing surveillance data of adverse events after Japanese encephalitis immunization in Japan and the USA have been compared (7). The rates of total reported adverse events were 2.8 per 100 000 doses in Japan and 15.0 per 100 000 doses in the USA. In Japan, 17 neurological disorders were reported from April 1996 to October 1998 (0.2 per 100 000 doses), whereas in the USA there were no serious neurological adverse events temporally associated with Japanese encephalitis vaccine from January 1993 to June 1999. Rates for systemic hypersensitivity reactions were 0.8 and 6.3 per 100 000 doses in Japan and the USA respectively. 

Pharmaceutical companies must report suspected adverse drug reactions noted during postmarketing surveillance studies. 

Grahame-Smith DG. Report of the adverse reactions working party to the Committee on Safety of Medicines. London Department of Health and Social Security, 1983. Joint Committee of ABPI, BMA, CSM, and RCGP. Guidelines on postmarketing surveillance. BMJ 1988 296 399-400. 

Reporting during postmarketing surveillance of a drug is usually the method by which the incidence of rare adverse drug reactions is established. 

Pharmacovigilance Postmarketing Surveillance and Adverse Drug Reactions Reporting... 

Observational studies In a hospital-based postmarketing surveillance study 80% of 799 patients with schizophrenia from 122 psychiatric hospitals were treated for 4 weeks with aripiprazole 10-30 mg/day (mean modal dose 15 mg/day) [57 ]. There were significant improvements in clinical current scales and the most frequent adverse reactions were insomnia, irritability, restlessness, nausea, and vomiting. 

Concerns have been raised about the use of adjuvanted pandemic vaccines in patients with immune disorders, such as immunodeficiency, autoimmune disorders, and solid organ transplants. To date, postmarketing surveillance has not found evidence for causality of any adverse reactions in such patients. Viral infections, such as influenza, can lead to severe complications in immunocompromised patients. 

Systematic reviews There has been a systematic review of adverse reactions to black cohosh as reported in 13 clinical trials, three postmarketing surveillance studies, four case series, and eight single case reports [25 ]. Three studies reported no serious adverse events. In one trial one of 21 patients had joint pain in the hands. Another trial reported... 

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