[e-drug] Two drug systems in the U.S.

e-drug
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E-DRUG: Two drug systems in the U.S.
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dear E-druggers,

Many do not realize that a two drug system already exists in the US.

Drugs provided to seniors under Medicare Part B are increasing manufactured in massive quantities outside federal oversight under the guise of pharmacy compounding. In the US Government Accountability Office's report issued last week (Appropriate dispensing fee needed for suppliers of inhalation therapy drugs GAO-05-72), the U.S. government represented that an alternative to Astra Zeneca's Pulmicort Respules is available as a powder, and that 10 out of 12 suppliers included in their investigation regularly "compound" the medications they dispense. The report actually includes non-compliant, compounded drugs in their acquisition cost estimates. There are no generic equivalents for Pulmicort Respules, and, the budesonide bulk active marketed to pharmacies for compounding is not a pharmaceutical grade chemical (see 2004 Red Book--a sourcing reference for pharmacies).

Considering this, it may be inappropriate for the US to push for developing and least developing countries' drug supplies to meet strict US standards when they are not demanding the same for drugs supplied to U.S. Medicare beneficiaries.

Sarah Sellers, PharmD MPH
ssellers@jhsph.edu

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E-DRUG: [e-drug] Two drug systems in the U.S. (2)
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Dear E-Druggers

I find Sarah's comments really Interesting.

Compromising standards in any setting is reprehensible
and it probably suggest a failure of process of
quality assurance. But are these suppliers of
compounded medication pharmacists? Because if they
are, then their activities is a serious breach of
professional ethics and the professional regulatory
body for US pharmacists ought to be concerned. But I
doubt very much if these suppliers involved are indeed
pharmacists.

Be that as it may, extemporaneous compounding of
various dosage forms is an important responsibility
and even specialty in Pharmacy practice. And it is one
that demand strict adherence to pharmacoepial
standards. For example, pharmacists in Nigeria are
currently providing paediatric compounding services
for medications that do not have available in Nigeria
paediatric dosage forms. This is especially true for
the Anti-Retrovirals used in management of HIV/AIDS.

Finally, I hope rather than accuse the US governement
of pontificating on adherence with standards in
developing setting while condoning non-adherence in
their backyard, we should sensitise regulatory bodies
in all countries irrespective to be alive to their
responsibilities of ensuring quality assurance.

Sincerely

K.B Yusuff
Dept. of Clinical Pharmacy
Faculty of Pharmacy
University of Ibadan, Nigeria.
yusuffkby@yahoo.co.uk