E-DRUG: Quality, postmarketing control of medicines
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dear E-druggers,
Although not directly related to bioequivalence of generics to original
brands, this is of critical importance. Ensuring that medicines in use in a
country are of acceptable quality involves more than prequalifying
manufacturers/suppliers. Post marketing surveillance of quality of
medicines is equally important, in addition to other measures.
But for the post marketing surveillance of quality of medicines to be
useful�which in my opinion will ultimately yield indications for further
action�we shall need meaningful pharmaceutical records.
Do meaningful pharmaceutical records exist in most health facilities in
developing countries? So if you suspect a product is substandard, and you
therefore seek to have it tested, how will you track the distribution of a
batch from a particular manufacturer/supplier? How will you execute
arrangements for recall? Without sound pharmaceutical records, how do you
expect to ensure quality by only pre-qualifying suppliers? What if they put
up a show during the pre-qualification process, when in reality they can�t
measure-up in the long-term?
Because after you have spent a fortune on investigating your illness�may be
involving taking expensive X-rays, delivering some of your body fluids for
examination�and your doctor diagnoses an infection, you want to take quality
medicine in order to clear the problem. You certainly wouldn�t like
counterfeits or substandard drug. You certainly wouldn�t want to jeopardize
the terminal stage of your care�by taking unwholesome medicines.
And we must recognize that surveillance of quality of medicines must be an
ongoing activity, not something you do once in a while. Yes, the cost
involved may be beyond the reach of many developing countries. But when
research based pharmaceutical companies in Germany recognized the problem of
fake or counterfeit medicines, they developed a simple, field laboratory
technique used to identify and quantify medicines in capsules and tablets
and syrups commonly used in developing countries. The cost of a kit of Thin
Layer Chromatography with 1,000 runs of tests is $3,000, which takes the
cost per run to $3.
Despite the availability of the above option, most drug regulatory
authorities in developing countries are understaffed and the employees are
overworked and they may even lack infrastructure to enable them to execute
equitable services at district level!
Therefore it seems sound to propose that a portion of the global fund to
fight tuberculosis, HIV/AIDS, and malaria be channeled to strengthening the
regulatory framework of pharmaceutical markets so that part of the terminal
stage of fighting the epidemics isn�t jeopardized as a result of accessing
substandard / counterfeit medicines. How do you justify spending billions of
dollars on diagnosing diseases for which you administer medicines of
suspicious quality? Doesn�t it make health sense to channel some funding to
such a worth cause as postmaketing surveillance of quality of medicines
involving use of meaningful pharmaceutical records?
George Kibumba, MPS.,
Teaching Assistant,
Clinical Pharmacy,
Department of Pharmacy,
Makerere University, Kampala, Uganda.
Mobile: 256-78-430 080
E-mail: kibumba@yahoo.com.
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