Compounding pharmacist to pay $73,000 in damages

Compounding pharmacist

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.

An excerpt of the Pharmacy Board's guidelines.
Pharmacy Board guidelines.

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.”

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  1. Jarrod McMaugh

    When I read the headline of this article, my intent was to read the details and outcome, then make a comment in support of adhering to the guidelines, since they are clearly there for a reason.

    As a proprietor of a compounding pharmacy I have seen practices that aren’t appropriate – usually when patients or pharmacies ring me to make enquiries. These may include:
    • batch making for another pharmacy to dispense when they receive a script
    • making to order for another pharmacy, but not including the compounding-pharmacy’s dispense label.
    • filling multiple repeats at once without clarifying with the prescriber

    that being said, these practices aren’t widespread – certainly not “common” amongst the 600 compounding pharmacies in Australia, and I think Mr Buckley should be very careful not to imply that it is common for compounding pharmacists to breach guidelines without a very reliable evidence base.

    I fill prescriptions for Lawley products, and I also fill scripts for compounded products that are similar to these products, but in strengths that are not commercially available. If Lawley or another manufacturer bring new strengths to market, then I will compound fewer items. That’s pretty straight forward.

    I can understand Mr Buckley’s frustration that a small number of pharmacies would compound when a commercial product is available & involves considerable investment, but one of the realities of compounding is the flexibility of dosing is valued by prescribers. Most of the compounded items my pharmacy dispenses are for strengths that are not available commercially – prescribers & patients have access to extremely flexible dosing options. For hormone compounding, it’s almost a rarity to dispense the same strength/combination to multiple patients.

    So, while guidelines are being breached, I applaud Mr Buckley for addressing the issue and raising awareness of poor practices, I think it’s inapropriate to imply widespread practices that breach guidelines amongst all – or even the majority – of compounding pharmacies.

    • Ronky

      How do you know “these practices aren’t widespread”? I’m sure the vast majority of crooked operators don’t ring you up to tell you they’re breaking the law. That’s right, these practices are illegal, not merely “aren’t appropriate”.

      • Jarrod McMaugh

        For the same reason that I know that many other illegal practices aren’t widespread.

        Clearly it’s a philosophical discussion – but the default view when we are discussing illegal practices among professionals who are registered with a national registration body is that these illegal practices are not widespread.

        In addition, in Victoria we have the Pharmacy Authority, who monitors/investigates the practice of compounding pharmacies. They’ve been pretty effective at dealing with the small number of illegal practices in Victoria.

        • Ronky

          Has the monitoring authority said that only a small minority of the compounding pharmacies in Victoria are compounding illegally? Or do you mean it’s only prosecuted a few of them? Probably because it has limited resources and focusses on the biggest and most outrageous and harmful breaches.

          It’s easy for a highly conscientious pharmacist to imagine “the vast majority of my peers must be like me”. But I don’t share your confidence in the fact that these people are registered. Out of the tens of thousands of registered pharmacists, only 600 (probably fewer) own a compounding pharmacy. Some no doubt because they conscientiously want to help patients get better treatment. others would have other motivations mixed in.

  2. Philip Smith

    Duromine manufacturers could have a field day, not saying all 600 do a Phentermine 20mg or 32mg, but it’s half the price of Duromine.

    How do you prove one is allergic to preservatives or excipients?
    If a doctor states as such do we need documented evidence?

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