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Storage temperature
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Storage temperatures
Guidance was issued in 2001
From Mr J. Taylor, CChem, FRSC
The news item concerning the risk of hot weather to medicines stocks
(PJ, 16 August, p195) was at best misleading, at worst it could result
in the supply of sub-standard medicines. The article appears to have
misinterpreted the ICH guideline on stability testing and has not considered
the potential effect of exposure to major excursions of temperature outside
the labelled storage requirements on chemical stability and, consequently,
on product shelf lives. The academic expert mentions that semi-solids
could be expected to soften, but neglects to mention that high temperatures
may also lead to irreversible physical changes in emulsion and suspension
systems. Sedimentation of active ingredients may result in non-uniformity
of dosage in multidose systems, leading to the likelihood of under- and
over-dosage. Sedimentation in suppositories with a high level of active
ingredient may result in a product that falls apart during insertion.
Pharmaceutical manufacturers and distributors take great care to ensure
that medicines are stored and transported under conditions compatible
with good practices and in accordance with the specified storage temperatures.
There have been extensive discussions between the industry and its service
providers concerning transportation. Hauliers and airlines are aware
of the risks to medicines that can be caused by extremes of temperature.
The impression given by the expert that medicines “may sit on airport
tarmacs for a few days at up to 50C” is not supported in practice
in our experience of medicines supplied to or from the United Kingdom.
Our recommendations on the control and monitoring of storage and transportation
temperatures of medicinal products (PDF
65K) were published in The Journal in 2001
(PJ, 28 July 2001, p128). The foreword to the article states: “Although
these recommendations have been produced by the Medicines Control Agency
in response to interest from the pharmaceutical industry and wholesalers,
they are relevant to the storage of medicines in community pharmacies,
hospitals and clinics.” The recommendations are as relevant now
as they were when the article was published. It is vital that the quality
of medicines is maintained throughout the distribution chain from manufacturer
to patient, including adherence to the labelled storage requirements.
The Royal Pharmaceutical Society and its members have an important role
to play in this regard.
The Society provides guidance to its members concerning segregation and
disposal of materials that are likely to have deteriorated. It is not
always straightforward to assess whether exposure to extremes of temperature
could have resulted in significant deterioration, unless this is associated
with visible physical changes. It is difficult to assess the possible
effect on chemical stability and we suggest that, where there is reason
to suspect that deterioration may have occurred, the pharmacist uses
his or her professional judgement coupled with a risk assessment based
on a number of criteria. Such a risk assessment should include review
of the labelled storage requirements and associated warnings, the nature
of the product (eg, solid dose forms are likely to be less affected than
aqueous solutions) the time of exposure to temperatures above the labelled
recommendations and the maximum temperature that might have been reached,
coupled with the pharmacist’s knowledge of the product.
However, if the pharmacist remains unsure about the disposition of the
product, we suggest that he or she consults the marketing authorisation
holder or the manufacturer and, if necessary, seeks confirmation in writing
that the stability of the product will not have been adversely affected.
John Taylor
Medicines and Healthcare products Regulatory Agency |
* PDF files on PJ Online require Acrobat
Reader 4 or later.