Part and parcel of change
Community pharmacists should be smiling soon. According to this week's Agenda for 2004 (p508) the one product that they would most like to be available as a pharmacy medicine is chloramphenicol eye-drops and, next week, their dreams will start to come true. The Journal understands an
application for switching the status of chloramphenicol eye-drops from
prescription-only medicine to pharmacy medicine is to be made to the
Medicines and Healthcare products Regulatory Agency. This will set the
wheels in motion that will end, probably early next year, with pharmacists
being able to sell the product over the counter.
Switching the status of medicines from POM to P has changed over the
past 12 months or so with the introduction of a new process in 2002 to
make more medicines available to patients more quickly. Before that,
switching involved a legislative change, whereas now, in simple terms,
once the Committee on Safety of Medicines has recommended that a change
can be made, it is done on the order of the Secretary of State for Health.
Omeprazole is the latest prescription-only medicine to follow this path.
After the application was made, the MHRA opened a consultation period
on 16 May 2003, closing it on 27 June. Nothing then happened in public,
although marketeers at GlaxoSmithKline Consumer Healthcare were beavering
away behind closed doors preparing for launching OTC omeprazole as Zanprol.
The switched licence authorisation was formally made on 19 January this
year, and the process completed with the launch of Zanprol on 16 March.
Just before Easter, The Journal understood that the switch of simvastatin
was to be formally announced this week following the completion of the
MHRA consultation in mid-January: at the very least, the Secretary of
State was going to make the announcement in a north London pharmacy.
The Daily Mail had the same understanding over the timing, and ran a
negative story about it on Monday. The expected announcement was not
made. Rumours started: the Government had been frightened off by the
Daily Mail, whose readers include the wives of precisely the group the
Government and manufacturers hope will buy simvastatin OTC.
The Journal understands that the CSM has recommended that the switch
from Zocor (POM) to Zocor Heart-Pro (P) can be made. When the Secretary
of State applies the rubber stamp (if he has not already done so), and
MSD/Johnson & Johnson decide to launch it, could be at any time.
Pharmacists will be divided over whether this is a good or a bad thing,
but The Journal believes it is going to happen. This week’s
Agenda for 2004 points out that switches are all part and parcel of the changes
facing pharmacists and they should be welcomed as a tool for ensuring
that pharmacists’ skills are used to the full.
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