A recent Federal Court case highlights the risk and cost to compounding pharmacies that do not adhere to guidelines
The Melbourne compounding pharmacist in question had supplied their own compounded testosterone cream to a patient who presented with a script for the Lawley Pharmaceuticals product, AndroForte® 5.
Lawley Pharmaceuticals took legal action against that compounding pharmacy for passing off and misrepresentation in trade and commerce.
The action was settled last week in the Federal Court, with the compounding pharmacy agreeing to pay $73,000 in damages and costs.
Lawley Pharmaceuticals Medical Director and pharmacist Michael Buckley says the outcome sends a “strong message” about the importance of following guidelines.
“The Pharmacy Board of Australia rules state that if there’s a commercial product available, the pharmacy needs to provide that product. If it’s not suitable, the pharmacy needs to advise the patient and speak to the doctor first,” Mr Buckley tells AJP.
Unsuitability includes whether a patient has experienced an allergy to an excipient in the commercial product, according to the Pharmacy Board of Australia’s guidelines.
“Many don’t follow the guidelines and to put it simply, it’s mainly because of profit,” says Mr Buckley.
“There’s roughly 600 compounding pharmacies in Australia and we know a lot of them are doing this.
“It puts patient safety at risk – they may have the best intentions but when compounding the safety standards are not there, there’s no trials data… it’s not the same. The Board is very specific about how medicines should be compounded,” he says.
The Endocrine Society of Australia also does not endorse compounded bioidentical hormones, as they believe it leads to “unnecessary risks with treatment”.
In addition to paying damages and costs, the compounding pharmacy has also agreed to take reasonable steps to comply with Pharmacy Board guidelines.
“This outcome sends a strong message to the more than six hundred compounding pharmacies across Australia to comply with the Guidelines – particularly in relation to our commercially available testosterone products,” says Mr Buckley.
“We will continue to monitor the market.”