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Letters to the Editor
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Adverse events
Reporting problems with medical devices
From Dr S. Ludgate
Pharmacists will be aware of increasing numbers of medical devices now
being sold over the counter directly to the public. These cover a wide
range of products but include such items as contact lenses and contact
lens care products, blood pressure monitors, blood glucose meters, bandages
and dressings, along with self-test kits such as cholesterol and pregnancy
tests. This growth has occurred not simply because of the availability
of more products but because patients with chronic illnesses are increasingly
wanting to manage their own care and treatment regimens. The public is
also becoming increasingly knowledgeable about their health needs and
treatment options.
Although all devices must carry a CE mark, denoting safety and fitness
for purpose, problems can occur during manufacture or in subsequent use,
leading to adverse events. These events may involve the performance of
the device itself (eg false negative or false positive results), a lack
of understanding by the user, problems with the instructions for use,
or defects in the packaging.
If a device purchaser reports an adverse event, or if a pharmacist becomes
aware of an adverse event or a potential issue, this should be reported
to to the Medicines and Healthcare
products Regulatory Agency (MHRA),
the UK regulatory authority for devices, as well as for drugs. We operate
an adverse incident reporting system, similar to the yellow card system
for drugs. Under this system, all reported adverse events are investigated
and further action taken as appropriate. This may involve issuing advice
to the health service through means of a device alert, asking pharmacists
to take immediate action to prevent further problems occurring, or by
production of a simple guidance leaflet. In a small number of cases,
the device in question may be removed from the market.
Such reporting really does work. Last year, as a result of investigations
made, 58 safety warnings were issued, 443 product recalls or field corrections
were undertaken, and 739 improvements in designs, manufacturing processes
or quality systems were undertaken by manufacturers.
To report an adverse event pharmacists can use our on-line reporting
system via our website at www.mhra.gov.uk. There they can also download
a form and e-mail it to aic@mhra.gsi.gov.uk, or fax it to 020 7084 3109.
Another option is to telephone the incident hotline on 020 7084 3080
or the clinical team for advice on 020 7084 3123.
Susanne Ludgate
Clinical Director (Devices)
MHRA
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The
Pharmaceutical Journal