Prescription‐event monitoring (PEM) in 1996—a method of non‐interventional observational cohort pharmacovigilance

Mann, Ronald D.; Wilton, Lynda V.; Pearce, Gillian; Mackay, F. J.; Dunn, Nick

doi:10.1002/(sici)1099-1557(199710)6:3+<s5::aid-pds272>3.3.co;2-6

Cited by 23 publications

(24 citation statements)

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“…The crude asthma death rate was 19.1 per 10 000 years of observation (95% CL 9.9 to 33.4). There were 73 asthma deaths in the salmeterol cohort after follow up,10 giving a crude death rate of 35.6 per 10 000 years of observation (95% CL 28.5 to 46.3). These results could have resulted from differences in indication, disease severity, asthma management, or drug effectiveness.…”

Section: Discussionmentioning

confidence: 99%

Risk of non-fatal cardiac failure and ischaemic heart disease with long acting beta 2 agonists

Martin

Dunn

Freemantle

et al. 1998

Thorax

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Background-The long term safety of agonists, particularly in patients with heart disease, has not been fully established. Rates and relative risks of non-fatal cardiac failure and ischaemic heart disease were calculated, comparing bambuterol and salmeterol with the reference drug nedocromil. Results-The age and sex adjusted relative risk of non-fatal cardiac failure associated with bambuterol was 3.41 (95% confidence limits (CL) 1.99 to 5.86) when compared with nedocromil. When salmeterol was compared with nedocromil the adjusted relative risk of non-fatal cardiac failure was 1.10 (95% CL 0.63 to 1.91). The adjusted relative risk of non-fatal ischaemic heart disease was 1.23 (95% CL 0.73 to 2.08) and 1.07 (95% CL 0.69 to 1.66) for bambuterol and salmeterol, compared with nedocromil, respectively. However, in the first month of exposure the adjusted relative risk of non-fatal ischaemic heart disease was 3.95 (95% CL 1.38 to 11.31) when bambuterol was compared with nedocromil. Conclusions-Caution should be exercised when prescribing long acting oral agonists to patients at risk of cardiac failure. More definitive evidence would come from prospective randomised trials. (Thorax 1998;53:558-562) Methods-This

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Section: Discussionmentioning

confidence: 99%

Risk of non-fatal cardiac failure and ischaemic heart disease with long acting beta 2 agonists

Martin

Dunn

Freemantle

et al. 1998

Thorax

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“…As previously mentioned, one of the drawbacks of spontaneous reporting is under reporting and as a counter to this in human medicine, other mechanisms have been introduced. Of these, perhaps the most successful is prescription‐event monitoring (Mann et al. , 1997; Mann, 1998, 2000).…”

Section: Violation Of Maximum Residue Limitsmentioning

confidence: 99%

“…For example, and as discussed earlier, in human medicine, prescription event monitoring is an important tool in post marketing surveillance of pharmaceuticals. Prescription information is collected centrally and can be used to support investigations of specific adverse drug reactions in groups of patients (Mann, 1997, 1998, 2000). It is reliant on the central (or semi‐central) collection of prescription data.…”

Section: Pharmacoepidemiologymentioning

confidence: 99%

Veterinary pharmacovigilance. Part 2. Veterinary pharmacovigilance in practice – the operation of a spontaneous reporting scheme in a European Union country – the UK, and schemes in other countries

Woodward¹

2005

Vet Pharm & Therapeutics

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Veterinary pharmacovigilance, as it operates in the European Union (EU), covers a very broad remit, including adverse effects in treated animals, exposed humans and the environment, and in addition, it extends to cover the violation of maximum residue limits. The mainstay of veterinary pharmacovigilance is the spontaneous reporting scheme working along side other systems such as those reporting on residues surveillance. One of the most well established schemes in the EU is that operating in the UK and this paper examines the evolution of that scheme and some of its findings, data from other countries, and information available from the literature. It also tentatively examines the ways that pharmacovigilance can be used for regulatory purposes, and the contribution from pharmacoepidemiology.

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“…Population based pharmacy databases could be used for modified prescription event monitoring11 studies. Pharmacy prescription event monitoring surveillance of selected pharmacy status drugs could be undertaken by sending questionnaires to pharmacists and asking them to fill in details from their database.…”

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confidence: 99%

Monitoring the safety of over the counter drugs

Clark

Layton

Shakir

2001

BMJ

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Prescription‐event monitoring (PEM) in 1996—a method of non‐interventional observational cohort pharmacovigilance

Cited by 23 publications

References 0 publications

Risk of non-fatal cardiac failure and ischaemic heart disease with long acting beta 2 agonists

Risk of non-fatal cardiac failure and ischaemic heart disease with long acting beta 2 agonists

Veterinary pharmacovigilance. Part 2. Veterinary pharmacovigilance in practice – the operation of a spontaneous reporting scheme in a European Union country – the UK, and schemes in other countries

Monitoring the safety of over the counter drugs

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