Community pharmacies in polypill trial

05 July 2010

Several community pharmacies are participating in a new polypill trial being launched through the University of Auckland.

It is the first time pharmacy has been involved in a trial of its kind.

The polypill, or Red Heart Pill, is designed for patients at high risk of heart attack or stroke and comprises four components in one capsule.

The randomised control trial will involve 600 people including 300 Maori, to be recruited through their usual GPs, study co-leader Raina Elley says.

Participants in the open-label study will either be prescribed one of two versions of the Red Heart Pill (75mg of aspirin, 40mg of simbastatin and 10mg of lisinopril, plus either  50mg of atenolol  or 12.5mg of hydrochlorothiazide ), or continue with their usual medication.

The study will assess whether the use of a single pill results in better adherence to medication and subsequently improves health outcomes, she says. It will also compare results between Maori and non-Maori.
“But to be able to do that you have to really mimic usual practice,” Dr Elley says. Therefore patients will collect their prescriptions from a pharmacist. “We supply the community pharmacies and they dispense it just as though they were dispensing a usual medication,” she says, adding previous polypill trials have been for medium risk patients and conducted within a hospital setting.

Pharmacists involved will have more contact than usual with patients because they will need to keep a log of  participants and view their trial cards, given the Red Heart Pill is only licensed for trial use, Dr Elley says. They will be paid a dispensing and management fee.

The study is targeting areas with large Maori populations, and practices in Otara, Panmure, Mount Wellington and Glen Innes are among the first to be involved.
 “We know that there are inherent problems in those populations,” she says.

So far, seven pharmacists in these areas are participating, including Pharmacy Guild chair Ian Johnson’s.

Mr Johnson says he agreed to participate in the study because of the involvement of his local GP, and because as guild chair it is important for him to know what’s going on.
However, Mr Johnson says he is sceptical about the benefits of a polypill.

“Intuitively as a pharmacist I believe medication needs to be tailored to an individual and I struggle with the one size fits all dynamic that a polypill has,” he says.
Mr Johnson points out that cutting down medications from four to one poses financial risk to pharmacists.

“My focus would be on patient outcome first as opposed to pharmacy specific matters but if everything changed overnight it would severely rock the business model under which pharmacy operated.”
The trial, which began early last month, will have a recruitment phase of 18 months and a follow-up time of at least 12 months, she says.

The Red Heart pill will be available to all participants in the intervention arm of the study until the end of the whole trial which is expected to be the end of 2012.

The results of the New Zealand trial will be combined with trials in Australia, England, Ireland, India and the Netherlands to see if, overall, the number of heart attacks and strokes are reduced.

Dr Elley hopes more Auckland GPs and pharmacists will participate in the study.

 

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