E-drug: Re: Wall Street Journal on expired drug (cont'd)
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Scott Hillstrom writes regarding expired drugs (contibution to debate
on 'Wall Street Journal on expired drug donations'). Many in the
pharmaceutical profession may agree that 'expiry date' of a product
is a safe guard against administration of products that are no longer
fit for intended purpose. Simply put, all drugs are given an expiry
in view of the fact that being chemicals, they do deteriorate at some
point in time. This deterioration can be an easily recognised event,
such as a change in colour of the total formulation (eg, tablet,
liquid product, etc), change in smell (eg, as happens with
acetylsalicyclic acid), etc. So, we can know that a product is no
longer fit for intended use. So, we may learn to 'know' when a
product has 'expired' or is no longer fit for use.
For some pharmaceutical products, the changes which occur to show that
the product is no longer fit are not that physically evident. To
observe that change, one needs to undertake physical/ chemical
analytical test to validate whether any ingredient making up that
particular formulation is in fact still at standard level. That is,
we're not only concerned with the active ingredient.
The question of 'knowing' when a product has expired is one of many
important points to be considered in this debate. To this must be
added factors such as effect of product handling, storage conditions,
etc. As others have pointed out, pharmacist (specially those
pharmacists and chemists with long experience in quality control,
product quality assurance and process validation) know that some
products may still be viable after the expiry date. But this is on the
basis of certain factors being in place. For example, how the product
has been stored (storage conditions), how it has been handled (eg, has
the container been opened, is dispensing conducted from the large pack
container), etc. If these basic, and in some settings, almost ideal
handling conditions are not present, then one would not be advised in
those circumstances to take ones professional knowledge or experience
for granted, and use products past their expiry date.
In many developing countries resources that may be required to
institute considered checks and balances of pharmaceutical products,
specially those that are exired, are absent. Refer to the fact that in
many of these countries, even the institution authorised to conduct
routine quality control checks on pharmaceutical products do not have
the resources to carry out that task. Therefore, what health facility
in these countries can afford to transfer funds to resource this
activity?
I don't need to point out that many people have had their health
damaged through administration of, or self- medication with, expired
products. In this, I agree with James Russo (Parternship for Quality
Medical Donations), in that adherence to WHO Guidelines on Drug
Donations is of utmost importance. Any promotion of the idea that it
is safe to use pharmaceutical products after expiry date ought not to
be promoted. Proper safe guards which must go hand in hand with that
view have to be in place.
My question is: Is this the sort of information we need to share with
the public? Should not this information remain within the domain of
the informed healthcare worker and his or her QC/QA expert? Do we
appreciate the consequence of informing the public that expiry drugs
are 'ok' to use? Are we being responsible or merely arrogant?
Regards,
Bonnie
Bonnie Fundafunda Ph.D, MBA, B.Pharm.
Marketing Manager
ECHO International Health Services Limited
Ullswater Crescent, Coulsdon, Surrey CR5 2HR, UK
Tel: +44 (0)20 8660 2220
Fax: +44 (0)20 8668 0751
email: bfunda@echohealth.org.uk
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