E-drug: Pharmacy Compounding in Australia
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Dear E-Drug Colleagues:
The Therapeutic Goods Administration of Australia has posted an analysis
regarding the expanding practice of extemporaneous compounding.
"Review of the need for further regulation of extemporaneous compounding"
can be accessed here:
http://www.tga.gov.au/meds/extempcomp.htm
The report highlights sentinel events associated with pharmacy compounded
drugs in the US stating "These events highlight the danger of ill-informed
and ill-judged medical and pharmacy practices being allowed to continue
without proper checks and balances".
Excerpts from the Report:
"The practice of extemporaneous compounding on a large scale developed first
in the US. Pharmacies in the US were being taken over by chains, and
independent pharmacists were finding it particularly hard to compete.
Compounding offered them a profitable niche. Medicines were compounded that
were "personalized" for the client. A franchised arrangement evolved, based
on the legislative exemptions that were made for quite different purposes".
"A small number of Australian pharmacists have become franchisees of the US
compounding groups. There is a wide range of preparations made in a number
of sectors, e.g. women's health, sports medicine, pain management and
veterinary medicines".
"The system of operation utilises email, fax and post to cover a wide
population, much wider than the local population around the pharmacy, and
sometimes interstate or internationally..."
"...the scale of operation in some of the pharmacies was very large, with
filing cabinets full of incomplete and completed prescriptions on hand, and
large stocks of raw materials, including some highly active substances such
as progesterone and testosterone. Concern was expressed as to the source of
these raw materials and the apparent lack of evidence of quality of some of
them. Often facilities were reported to be very modern, but not invariably
so."
"..Pharmacy Boards usually do not have staff that have backgrounds in GMP
and so they may not find it easy to critically assess these activities".
"Searching the UK Medicines and the National Health Service websites did
not find any reference to the practice of compounding. It is known that the
MCA used to issue special licenses to NHS hospitals in relation to certain
aspects of manufacture in the past, but this appears to have ceased. No
further effort was made in this regard as all the evidence points to the
centre of practice as being the US".
Policy recommendations discussed in the paper include:
Warnings to prescribers
Warnings to patients
Advertising restrictions
Risk-based regulation
Conditional exemptions
Quantity limits
Disclosure to patients and prescribers that compounded drugs are not
approved for safety and efficacy and not manufactured in compliance with GMP
is the subject of a Citizens' Petition filed with the US FDA. The petition,
Citizen Petition re Labeling and Advertisements for Compounded,
Aqueous-Based Drugs for Inhalation, exhibits and submitted comments can be
accessed here:
http://www.fda.gov/ohrms/dockets/dockets/05p0116/05p0116.htm
If you are unable to access any of the above documents, please contact me
directly.
Respectfully,
Sarah Sellers PharmD MPH
ssellers@jhsph.edu