Compounding pharmacies act with impunity

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Compounding pharmacies act with impunity

 

Over the past year Lawley has received dozens of complaints from patients who have been prescribed AndroFeme or AndroForte testosterone creams yet have been provided with a compounded product instead. In some cases this had severely compromised existing treatment.

Some compounding pharmacies act with impunity when it comes to the compounding of hormones.

The Pharmacy Board of Australia’s compounding guidelines state:

’A compounded medicine should be prepared only in circumstances where:

  • an appropriate commercial product is unavailable
  • a commercial product is unsuitable (e.g. if a patient experienced an allergy to an excipient in the commercial product), or
  • when undertaking research sanctioned by a recognised human research ethics committee.

The compounding of a medicine (whether prescribed or not) that would be a close formulation to an available and suitable commercial product, and would not be likely to produce a different therapeutic outcome to the commercial product, should not take place. In the case that such a medicine has been prescribed, the pharmacist should notify the prescriber that this medicine cannot be compounded under these circumstances.’

In simple terms, compounding pharmacists who repeatedly dispense compounded products in preference to commercial products do so because of financial gain and appear to have little regard for the guidelines governing dispensing, professional ethics, the prescribers intent nor the patients health.

Many doctors have no idea that their patients are dispensed compounded products despite them prescribing branded items.

Legality: It is the doctor who writes the prescription who is legally responsible for any adverse events or legal claims from a patient who has been affected by the use of a compounded product containing bioidentical hormones. For that reason it is important that the doctor must be fully aware of the benefits as well as the adverse events related to the use of pharmacological products that have not been approved by the Australian Therapeutic Goods Administration.

There is inadequate scientific evidence to show that:

  • Compounded bioidentical hormones are effective.
  • Compounded hormones are safe and free of adverse side-effects.
  • These compounds are pure and free from contamination.
  • There are no studies comparing the effect of doses of compounded bioidentical hormones to conventional HRT or ART.
  • There is inadequate scientific evidence documenting interactions between the compounded hormones, or between these hormones and other drugs which may be taken at the same time.

To minimise the chance of compounders misrepresenting the prescribed Lawley product please tick the No Substitution box on the prescription or write No Substitution. Legally the pharmacy MUST supply the branded commercial product.

To reinforce this message Lawley has available self-inking stamps which we are happy to provide to doctors to stamp on their patients prescriptions.

To receive a NOT TO BE COMPOUNDED. DO NOT SUBSTITUTE stamp please email michaelb@lawleypharm.com.au or call 1800 627 506.

Compounding pharmacy has a rightful place the healthcare system where there are definite gaps in commercially available products, however in the area of transdermal hormones all the key “bio-identical” hormones (testosterone, oestradiol, oestriol and progesterone) are available commercially in Australia for both men and women.

 

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