E-DRUG: Two drug systems in the U.S.
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