Prescription-event monitoring

Heeley, E., et al., "Prescription-Event Monitoring and Reporting of Adverse Drug Reactions," Lancet, 358, 1872-1873 (2001). 

Rawson NSB, Pearce GL, Inman WHW. Prescription event monitoring methodology and recent progress. / Clin Epidemiol 1990 43 509-22. 

Layton D, Riley J, Wilton LV, et al. Safety profile of rofecoxib as used in general practice in England results of a prescription-event monitoring study. Br J Clin Pharmacol 20(B 55 166-74. 

Layton D, Heeley E, Hughes K, et al. Comparison of the incidence rates of thromboem-boUc events reported for patients prescribed rofecoxib and meloxicam in practice in England using prescription event monitoring. Rheumatology 2003 42 1342-53. 

Inman WHW, Rawson NSB, Wilton LV. Prescription event monitoring. In Inman WHW, editor. Monitoring for drug safety. 2nd ed. Lancaster (UK) MTP Press/Kluwer Academic Publishers Group 1986. p. 213-36. 

Mann RD, Pearce GL, Dunn N, Shakir S. Sedation with non-sedating antihistamines four prescription-event monitoring studies in general practice. BMl 2000,320 1184-1187. 

A number of antidepressant drugs, particularly SSRIs, can increase plasma prolactin concentrations, although galactorrhea is uncommon. In a prescription event monitoring survey of about 65 000 patients, compared with SSRIs, moclobemide was associated with a relative risk of galactorrhea of 6.7 (95% Cl = 2.7, 15) (727). However, this was substantially less than the risk associated with the dopamine receptor antagonist risperidone (relative risk compared with SSRIs 32 95% Cl = 14, 70). 

The frequency of sedation due to acrivastine, cetirizine, fexofenadine, and loratadine has been investigated in four prescription-event monitoring studies in 43 363 patients in general practice in the UK (53). Prescriptions were obtained for each cohort in the immediate postmarketing period. Sedation and drowsiness were the main outcome measures. The odds ratios (adjusted for age and sex) for the incidences of sedation compared with loratadine were 0.63 (95% Cl = 0.36, 1.11) for fexofenadine, 2.79 (1.69, 4.58) for acrivastine, and 3.53 (2.07, 5.42) for cetirizine. There was no increased risk of accident or injury with any of the four drugs. 

A comparison of data from prescription event monitoring in over 13 000 recipients of cisapride and from a further 9726 recipients involved in a controlled study showed that diarrhea, in about 2-4% of patients, was the commonest adverse effect reported. Other relatively common adverse effects are headache, abdominal pain, nausea and vomiting, and constipation, all in about 1-1.5% of patients. 

Wager E, Tooley PJ, Pearce GL, Wilton LV, Mann RD. A comparison of two cohort studies evaluating the safety of cisapride Prescription-Event Monitoring and a large phase PV study. Eur J Chn Pharmacol 1997 52(2) 87-94. 

In 1986, the UK Drug Safety Research Unit at Southampton published a report on its prescription event monitoring study of etodolac (SEDA-13, 80). Etodolac was rated effective in only 56% of 9109 patients, and the Unit concluded that the average dosage used... 

If analysis of the frequency of adverse events is based on prescription event monitoring (PEM), the rates of adverse events are usually substantially lower. In one study, over 11 000 patients taking each antibiotic were monitored (19). Among the fluoroquinolones, ciprofloxacin, norfloxacin, and ofloxacin were used. Adverse events resulted in withdrawal of norfloxacin or ofloxacin in under 1% of patients (19). 

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