Patients may be denied access to essential drugs under a plan to clamp down on compounding chemists.
The Professional Compounding Chemists of Australia (PCCA) have voiced concerns about a discussion paper on the regulation of extemporaneously prepared medicines. The paper was prepared by the National Co-ordinating Committee on Therapeutic Goods to address claims that compounding could not be effectively regulated by state pharmacy boards.
Under the proposed changes, pharmacists would only be allowed to compound products listed on the Australian Register of Therapeutic Goods (ARTG).
Jenny Giam, technical and training manager at PCCA, said this could lead to serious consequences for patients who could benefit from treatments prepared by compounding pharmacists.
"Since doctors often request compounded products because they are not available in Australia, this restriction will result in patients having to do without a medicine that may be best suited to their condition, or have to pay more and wait longer to import it from overseas," she said.
"The implications are also that PBS subsidised compounds and Australian Pharmaceutical Formulary formulas will be prohibited."
Ms Giam said that just because a product did not appear on the ARTG did not mean it was found to be unsafe.
"Very often it is because there are insufficient commercial returns to warrant registration. The organisation responsible for assessing safety is the National Drugs and Poisons Schedule Committee, and the Standard for the Uniform Scheduling of Drugs and Poisons should be the reference used to determine whether a drug can be compounded," Ms Giam said.
The TGA will also regulate larger commercial compounders, responding to claims that they operate more like drug manufacturers than pharmacists. However, self-regulation of moderate levels of compounding will continue. Other proposals include restricted dosage forms and advertising of compounded products.
The National Co-ordinating Committee on Therapeutic Goods invites responses to the discussion paper by 23 May, 2008. Email comments to
standards@tga.gov.au.