Prescription-event monitoring and reporting of adverse drug reactions

Heeley, Emma; Riley, Jane; Layton, Deborah; Wilton, Lynda V.; Shakir, Saad

doi:10.1016/s0140-6736(01)06898-2

Cited by 120 publications

(77 citation statements)

References 3 publications

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“…Although rash is not listed in the SmPC for valsartan, 19 reports of rash have been sent to the CSM by 6/12/1999 (Drug Analysis Print from the MCA). 18 Insomnia was reported in 0.4% of the cohort with 54 reports during the treatment period with valsartan, of which 14 (27.7%) were reported in the first month of treatment. Again, there is no mention of insomnia as an adverse event in the SmPC for valsartan.…”

Section: Discussionmentioning

confidence: 95%

The safety of valsartan: results of a postmarketing surveillance study on 12 881 patients in England

2002

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Section: Discussionmentioning

confidence: 95%

The safety of valsartan: results of a postmarketing surveillance study on 12 881 patients in England

2002

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“…This response rate is still substantial compared with the proportion of suspected ADRs which are reported in spontaneous ADR reporting schemes. 16,17 For data collection systems that are dependent on a third party, such as PEM, response bias is likely. 7 Under-reporting, including of serious or fatal events is possible in PEM.…”

Section: Discussionmentioning

confidence: 99%

Safety profile of orlistat: results of a prescription-event monitoring study

2006

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Introduction: Orlistat, the first of a new class of drugs for the treatment of obesity, was launched in the UK in December 1998. The prescribing information recommends that treatment with orlistat should be discontinued after 12 weeks if the patient has not achieved a specified loss of weight. Objective: To monitor the safety of orlistat prescribed in the primary care setting in England using prescription-event monitoring (PEM). Methods: A postmarketing surveillance study using the observational cohort technique of PEM. Patients were identified from dispensed prescriptions issued by primary care physicians for orlistat between December 1998 and November 1999. The outcome data were event reports obtained by sending questionnaires (green forms) to the prescribing doctor at least 6 months after the first prescription for an individual patient. Incidence densities, expressed as number of first reports of an event/1000 patient-months of exposure, were calculated. Significant differences between incidence densities (IDs) for events reported in the 1st month (ID 1 ) and months 2 and 3 (ID 2-3 ) of exposure were regarded as potential signals. Reasons for stopping orlistat were analysed. Follow-up information was requested for selected events and used to assess the causal association with orlistat. Results: Green forms containing clinically useful information on 16 021 patients (median age 45 years (interquartile range 35-54); 80.1% females) were received. The events reported most frequently during the 1st month of treatment were 'not effective' (639; 4.0% of cohort), diarrhoea (371; 2.3%) and weight loss (230; 1.4%). Twelve clinical adverse events were identified for which ID 1 was significantly greater than ID 2-3 . These included non-specific events (e.g. intolerance, malaise/ lassitude, unspecified side effects), weight loss and vaginitis/vulvitis. The remaining events were gastrointestinal in nature and included diarrhoea, pain abdomen, flatulence, nausea/vomiting, rectal discharge, faecal incontinence and 'gastrointestinal unspecified' events. A similar pattern of predominately gastrointestinal events was seen for reasons for stopping and suspected adverse drug reactions. Review of selected events for causality revealed 45 events which were assessed as possibly or probably related to orlistat. Conclusions: This study shows that orlistat is fairly well tolerated. The safety profile of orlistat was similar to the prescribing information and experience reported in the literature.

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“…However, this level of response is similar to other postal surveys 30 and reporting using PEM remains higher than reporting using the Yellow Card Scheme. 31,32 Furthermore, the study was unable to capture prescriptions dispensed within the secondary care setting, such as hospitals. The lack of information concerning secondary care prescription might have led to survivor bias within the study.…”

Section: Study Limitationsmentioning

confidence: 99%

Utilisation and Tolerability of Aliskiren in the Primary Care Setting in England

Coughtrie

Doe

Layton

et al. 2016

J of Clinical Hypertension

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2Aliskiren (Rasilez), a direct renin inhibitor, is indicated for the treatment of essential hypertension. A postmarketing prescription-event monitoring (PEM) study was conducted in England to monitor the safety and utilization of aliskiren. Summary statistics and event incidence densities were calculated. The cohort consisted of 6385 individuals with a median age of 68 years (interquartile range, 59-76). Aliskiren was largely prescribed for its licensed indication of hypertension (93.3%) and was reported as "effective" by the prescriber in 77.4% of individuals. Frequently reported clinical events during treatment were diarrhea (3.1% of on-treatment events), malaise/lassitude (3.0%), and nausea/ vomiting (1.2%), which were also common reasons for treatment cessation. Renal events were rare, with 24 cases probably or possibly related to aliskiren use, and four of which were classified as acute renal failure using RIFLE (Risk Injury Failure Loss End-Stage Kidney Disease) criteria. These results should be used in conjunction with other clinical and pharmacoepidemiologic studies to optimize the safe prescribing of aliskiren. J Clin Hypertens (Greenwich).

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Prescription-event monitoring and reporting of adverse drug reactions

Cited by 120 publications

References 3 publications

The safety of valsartan: results of a postmarketing surveillance study on 12 881 patients in England

The safety of valsartan: results of a postmarketing surveillance study on 12 881 patients in England

Safety profile of orlistat: results of a prescription-event monitoring study

Utilisation and Tolerability of Aliskiren in the Primary Care Setting in England

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