Compounding conundrum


Cautions issued to compounders who broke guidelines over replicating commercial products  

The Pharmacy Board of Australia has expressed concerns about pharmacists’ breaching compounding guidelines by preparing products that are identical to available commercial products.

In its latest quarterly newsletter, the Board says it has identified examples of medicines that were compounded by pharmacists without “proper regard” to existing guidelines.

The Board says in the cases it identified, pharmacists had compounded medicines when an appropriate commercial product or was available, and/or the compounded formulation was similar to an available commercial product that was “not likely to produce a different therapeutic outcome….”

“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,” the Board says.

“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.”

The Board said in the cases in question that involved a prescription, the pharmacists had not contacted prescribers.

Several pharmacists were cautioned in relation to their practice, the Board said, and they were advised to ensure that they comply with the Board’s compounding guidelines at all times when compounding medicines.

It reminds pharmacists that its ‘Guidelines on compounding of medicines’ state that 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.

 

 

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8 Comments

  1. Philip Smith
    08/07/2017

    There are a few out there compounding Phentermine, because it can be done for half the price of commercially available.

    • Jarrod McMaugh
      09/07/2017

      Depends on the formula.

      You can compound phentermine at strengths that are not commercially available, or in combination with other supportive weight-loss ingredients.

      But you can’t compound Phentermine 15mg, 30mg or 40mg doses. This is a breach as stated in the article.

      • Andrew
        10/07/2017

        Chuck a bit of chromium in there and you’re good to go.

        • Michael Buckley
          10/07/2017

          Not so Andrew. I suggest you read the Guideline number 2 more closely. To add chromium you are breaching the guidelines if chromium doesn’t make any clinically significant impact relative to the commercial product. If it does then you need to contact the Dr and provide evidence based justification in your compounding records. You are using the same flawed rationale as compounders who dispense testosterone cream plus zinc or T cream plus chrysin –

          • Andrew
            10/07/2017

            You forgot to declare your conflict of interest Michael Buckley of Lawley Pharmaceuticals.

            It’s not my job to literature search for a prescribing doctor – who’s paying for that? As long as the script is valid and for a legal substance it’s fine by me.

          • Michael Buckley
            12/07/2017

            That’s where you are wrong Andrew because it is your professional responsibility as a pharmacist to refer to the literature. It’s part of you job description!

            I have previously declared my interest in this forum and happily do so again.
            I refer you to part of my public submission to the King Review (number 126) and the section entitled Professional Obligations.

            “As the custodians of pharmaceutical knowledge including drug activity, drug efficacy, drug combinations, drug toxicity and drug adverse effects pharmacists are a critical link in Australia’s healthcare system. Pharmacists consistently rank highly in the most-respected and trusted of health professionals. This is a position of privilege and with privilege comes responsibility.
            The practice of pharmacy, including the activities of all pharmacists, is bound by legislated Acts of state and federal parliaments and by professional ethics, Guidelines and Codes of practice.
            The exponential growth of the compounding industry since 2002 has been self-regulated until introduction of the Board’s Guidelines in March 2015. The TGA’s June 2013 Options for reform of the regulatory framework for pharmacy compounding statement identified many of the concerns and risks associated with the existing regulatory framework for the compounding of medicines. The Board’s back-ground information statement released with the Guidelines provides supporting information on the legislative and professional standards expected of compounders to comply with the Guidelines. As I have outlined there are many compounding pharmacies who have actively evaded, wilfully misinterpreted or simply ignored the requirements of the Guidelines.
            The reason is simply financial gain. ​​​​
            For compounders to change past business practices and comply with the Guidelines means a reduction in turnover and profitability. Compounding is extremely lucrative when there is no requirement to comply with the standards compared with the highly regulated and vigorously policed pharmaceutical manufacturing industry. While the various state/territory pharmacy premises regulatory authorities or responsible bodies have the power to conduct audit/inspections of approved and/or registered premises and their associated facilities these audits appear not to be undertaken in a systematic nor widespread manner. Auditing a manufacturing facility requires a totally different and unique set of skills compared to that of auditing a retail pharmacy. It is well known that the TGA struggles to find skilled and experienced staff to undertake industry audits. To find qualified auditors and then audit over 500 compounding pharmacies currently operating in Australia is undeniably a challenge.
            I fully understand both sides of the compounded vs TGA approved products equation as I have a foot in both camps. As Australia’s first compounder of bioidentical hormones back in the early 1990’s and then my transition to manufacturing at a TGA approved facility I have an in-depth understanding of the obligations and regulatory oversight for both. I am the nominated pharmacist of a retail pharmacy, Lawley Direct, which specialises in the dispensing of prescription hormones.
            The Board expects and trusts compounding pharmacists to do the right thing, self-regulate and comply with the Guidelines and professional standards. Unfortunately this expectation and trust is being betrayed. Not a week goes by when I don’t have at least three discussions with either a patient or physician who has encountered a “problem compounding experience”. It is my opinion that many compounding pharmacists are happy to continue with a “business as usual” approach because they know there is no active surveillance and hence minimal likelihood of consequences. The financial rewards are significant compared to the low risk of detection for non-compliance and hence the Guidelines and professional obligations are cast aside.”

            I feel this adequately expresses my stance and declares my vested (not conflicted) interest in this matter.

            For the on-going health and safety of the patients you serve I suggest in future you refer to the literature and the Guidelines on Compounding. The message from the Board’s latest Newsletter to compounding pharmacists and the profession is clear.

            The script you have may be valid, however your suggestion to ‘chuck in’ another ‘active’ substance without consulting the doctor is not. Additionally, if you do include that substance with no evidence based reference to the clinical justification for doing so your suggestion is neither valid nor compliant with the Guidelines.

            I suggest you read the section in my submission entitled ‘Evasion’.

          • Andaroo
            16/07/2017

            Yep, I’m definitely going to send all compounded scripts I receive to a different retail pharmacy to be made up. Sounds like a solid business practice sure to keep me out of receivership. I’ll make sure to choose one with a history of strong arming, anticompetitive behavior like Lawley too.

  2. Tamer Ahmed
    10/07/2017

    I have never heard of this rule before ? What difference would it make to the baord if I make Salicylic Acid 5% in Aqueous Cream cause I have the ingredients on the same day ?.Compared to me having to order the Salicylic Acid 5% in Sorbolene Cream (David Craig) for the next day ?What kind of nany board regulates these guidelines ?

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