Warning for doctors prescribing compounded peptides

Mar 13, 2017

One of your patients asks about compounded peptides that he has seen advertised on the internet as a miracle treatment for obesity, injury rehabilitation and ageing. The patient tells you a few of his friends have accessed these compounded peptides by prescription over the internet, but he would prefer you, as his family GP, to prescribe them for him. He claims that his friends are already seeing great benefits.

Your patient has probably accessed one of several websites that allow injectable compounded peptides to be purchased online. Both the prescriptions and the peptides can be sourced online.

NSW Health’s Pharmaceutical Regulatory Unit (PRU) has notified Avant about the risks for doctors who are prescribing these compounds, whether online or in the surgery.

It is important to remember that every prescription you write comes with clinical, ethical and legal responsibilities. Prescribing compounded medicines and prescribing online involve additional issues for practitioners.

Clinical, ethical and legal responsibilities in prescribing

You have a responsibility to make sure that any medication you prescribe is safe, appropriate, and prescribed in accordance with an accepted therapeutic standard. You should never write a prescription for any substance that you are not familiar with, nor for something that you feel is not in the best interests of the patient. If your patient is seeking treatment or information on the use of peptide hormones, and if you are not familiar with widely accepted and proven use of these hormones, you should refer the patient to an endocrinologist.

Compounded medicines and the law

All medicines and therapeutic goods in Australia must be registered for use by the Therapeutic Goods Administration (TGA), unless certain exemptions apply. One such exemption allows the use of compounded medicines. Traditionally, the intent of the compounding exemption1 has been to enable the provision of medications and creams that are customised to the individual, especially creams, for children, and in strengths not available in Australia. Recently, however, there has been concern over an increase in the production of the compounded medicines and potential exploiting of the compounding exception. However, be aware that compounding pharmacies (unless licenced by the TGA) are not manufacturers and do not necessarily meet safety and infection control standards.

The compounding of injectable peptides that have been used for performance enhancement has raised special concerns. These concerns, including limited available information about ‘the risks and benefits of the substances as there has been minimal use under appropriate medical supervision’ and the potential of misuse and harms, led the TGA to include these peptides under Schedule 4 of the Medicines Schedule. When prescribing peptides you need to comply with the relevant poisons regulations, including ensuring that prescriptions meet all prescription requirements (eg, strength, name, etc) and that compounded prescriptions comply with an accepted therapeutic standard.2

Prescribing online

The PRU has referred a number of doctors and pharmacists, particularly those working with online sites, for investigation by regulatory bodies. The online nature of this type of prescribing has implications for doctors (and patients) all over the country.

Doctors who prescribe these substances without seeing a patient are at particular risk of additional scrutiny by the regulators.

Prescribing over the internet, to patients whom you have never seen or met brings its own challenges and risks. These include identifying the patient, making sure you are able to take an adequate history and/or physical examination in order to ensure patient safety, the absence of any contraindications, ensuring the indications for treatment are satisfied, and organising appropriate follow up. All of these risks are amplified when the prescribing is performed in the context of large scale commercial relationships.

Key tips


  • Remember that every prescription that you write comes with clinical, ethical and legal responsibilities.
  • You need to satisfy yourself that your prescription complies with your obligations under the Code of Conduct for Doctors in Australia to provide good patient care.
  • Be aware of your responsibilities under the poisons legislation in your state for prescribing scheduled medications.
  • If you are prescribing via telehealth, ensure that you comply with the Medical Board of Australia’s Guidelines on technology-based patient consultations.

In case you missed it, Dr Jammal was quoted in the Australian Doctor news article on this issue late last year.

References

https://www.tga.gov.au/australian-register-therapeutic-goods
2 For example in NSW under Part 3 of the Poisons and Therapeutic Goods Regulation 2008 http://www.legislation.nsw.gov.au/inforce/59740cf7-67c1-42cd-b129-e4d76a127716/2008-392.pdf

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