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Medicines Management
Issue no 2, p3
March/April 2002

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Local ethics committees approve majority of PSNC-led pilots

Eight of the nine pilot sites taking part in the Community Pharmacy Medicines Management Project have received approval from their local research ethics committees (LREC) and will soon be recruiting their first patients.

John Dixon, manager for the project, which is being led by the five national bodies in community pharmacy headed by the Pharmaceutical Services Negoti-ating Committee, said that the pilot based in North Tyneside PCT had just received approval, leaving North Southwark PCG as the only scheme now awaiting LREC approval.

"We don't think we're very far away from the first group of patients being invited for their first appointment — researchers have been looking at coronary heart disease registers in the GP practices and validating them," said Mr Dixon. He said the first phase of the project would involve inviting sufficient patients from each practice to produce five patients per community pharmacy to take part in a test run to evaluate the study processes and documentation before the larger trial began.

After looking at the acceptibility of the methodology, researchers will then make any amendments to the study documentation before enrolling patients in the larger study.

The process of inviting patients is likely to take several weeks, and a second letter will be sent by the practices to invited patients who do not respond first time around. Once patients have given their consent to the study, the researchers at Aberdeen will send them a baseline questionnaire, and the practice will begin the process of extracting their relevant details from their medical record and recording them on the form used by the community pharmacists to review patients.

Mr Dixon said that service improvements for CHD patients being planned by individual PCTs would not affect the study, as all the patients would benefit, whether in the control or intervention groups. "We will be looking to show a benefit in the intervention group of patients above whatever developments take place locally," he said.

He said that the remuneration arrangements that had been agreed with the DoH were for pharmacists taking part in the pilot only, and should not be seen as a basis for future negotiations. "We're interested in finding out how long the process takes for each patient, including the time taken to prepare for and write up the intervention. We hope to show an economic benefit as well as a health gain for the individual patient from their use of this community pharmacy-based service," Mr Dixon explained.

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