Hot weather no risk to medicine stocks
Fans might make dispensary staff feel better but only air-conditioning
units can reduce the temperature |
The recent spell of unusually hot weather in the United Kingdom poses no significant risk to medicines stored at ambient temperatures, say pharmaceutics experts.
Most medicines are tested to meet the requirements of the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH) which demand stability in more
challenging conditions than seen in the UK.
In general, products that meet the international requirements must remain
within their specifications after storage for six months at 40C. Products
which have to be stored in a refrigerator are expected to be stable for
six months at 25C. More detailed stability testing is only needed if
these conditions are not met. Products are also expected to tolerate “short
term excursions outside the label storage conditions, such as might occur
during shipping.”
One academic expert commented: “There’s nothing to worry
about. Most medicines are tested up to 40C. Most dosage forms are formulated
for a worldwide market and may sit on airport tarmacs for a few days
at up to 50C.”
He added that short-term high temperatures were not a problem for solid
dosage forms, provided they were not also exposed to high humidity. But
semi-solids, such as ointments, could be expected to soften.
An Association of the British Pharmaceutical Industry spokeswoman said
that manufacturers printed storage guidance on medicine labels and everyone
should adhere to that guidance. Pharmacists who were concerned about
individual products should contact their manufacturers for advice.
Boots The Chemists has hired air-conditioning units for some of its stores
that are not air-conditioned. In addition, stores have been told to take
appropriate action, including using cool boxes to protect more vulnerable
lines.
A Royal Pharmaceutical Society spokesman said that the Society’s
guidance to pharmacists was set out in the section on stock in the Code
of Ethics and Standards. This says that pharmacists must exercise their
knowledge of stability of materials to segregate for disposal any substances
that are likely to have deteriorated.
Society warning The Royal Pharmaceutical Society issued a press
release on 11 August warning members of the public that the summer
heat could damage their medicines. People should keep medicines
out of direct sunlight and away from heat, light and moisture,
it said.
The Society’s science secretary, Dr John Clements, said: “Gelatin
capsules can stick together and soften, ointments and creams can change in consistency
and become runny, making them less easy to apply, and suppositories can melt.” The
Society advised people who were unsure about the condition of their medicines
to speak to their pharmacists.
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