Two-thirds of patients stopped using Uprima, a drug commonly prescribed for erection problems, because they felt it wasn't effective, according to a large-scale study published in the July issue of the urology journal BJU International.
And 70 per cent of family doctors who expressed an opinion using an official National Health Service (NHS) drug feedback form felt the drug wasn't effective.
Researchers at the UK's Drug Safety Research Unit and University of Portsmouth analysed prescribing data for 11,185 patients seen by NHS family doctors.
The data was gathered from official Green Form Questionnaires that ask doctors to record any significant events recorded in a patient's notes after prescribing newly marketed medicines.
Key findings included:
The 11,185 forms covered patients who were first prescribed Uprima between October 2001 - three months after the drug was launched in the UK - and December 2002. Just over 21,000 Questionnaires were issued and 57 per cent of GPs responded.
At least six months after the first prescription for Uprima was issued for each patient, their family doctor was sent a Green Form Questionnaire that requested details about the patient's age and sex and their use of Uprima.
They were also asked to record any significant events that had occurred since the patient was prescribed Uprima, such as suspected drug reactions, unexpected deterioration or improvement in the patient's condition, referral to a specialist or any clinically important changes in laboratory tests.
The form also included questions on diseases commonly associated with erectile dysfunction - such as diabetes and heart disease – together with previous use of similar drugs and co-prescribing of medication for angina.
"Prescription-Event Monitoring provides surveillance on a national scale after new drugs are launched" explains lead researcher Professor Saad Shakir.
"Because family doctors are not approached before the decision to treat a patient has been made, they are not subject to detailed inclusion or exclusion criteria. The decision to prescribe is made purely as a result of their clinical knowledge of the patient and the drug involved.
"The result is real world clinical data that provides information of illness and death in patients treated with newly marketed drugs – a valuable tool in drug safety assessment."
The Drug Safety Research Unit is an independent charity that works in association with the University of Portsmouth. It receives unconditional grants from pharmaceutical companies who have no control over the conduct or publication of studies carried out by the Unit. The manufacturers of Uprima have made donations to the Unit.
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Notes to editors
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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