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Pharmacy groups back moves to make Viagra available over the counter, but AMA questions checklist approach to treatment

Leading pharmacy groups have backed a proposal to allow pharmacists to supply sildenafil (Viagra) over-the-counter, subject to a range of protocols and conditions.

However, the AMA says allowing the move would hamper patient care as pharmacists working with a “simple checklist” would not properly examine or treat erectile dysfunction. 

Both the PSA and Pharmacy Guild have sent detailed submissions endorsing the submission, as regulators sought public feedback before announcing their decision.

The submissions follow a request, currently under consideration by the Advisory Committee on Medicines Scheduling (ACMS) to:

  • Create a new Schedule 3 entry for sildenafil in oral preparations containing 50 mg of sildenafil per dosage unit in packs containing not more than 8 dosage units;
  • Include sildenafil in Appendix H to permit advertising; and
  • To include sildenafil in Appendix M to provide additional controls or supply requirements to allow sildenafil to be supplied by a pharmacist.

The Pharmacy Guild reiterated its support, put forward in a submission to a previous, rejected, rescheduling proposal in 2018. It did, however, reject allowing advertising under Appendix H.

“We believe that with the additional controls included in Appendix M sildenafil would meet the
requirements for a Schedule 3 medicine,” the Guild submission said.

“We would be happy to work with the profession to agree on a professional standard for the supply of this medicine that would include:

  • Protocol and guidance for supply
  • Inclusion criteria for supply
  • Recording processes
  • Training requirements
  • Education standard
  • Advice on an appropriate professional consultation fee

The Guild said supply should be recorded against a professional standard and this information should be accessible for audit and reporting.

“Allowing controlled access to sildenafil without a prescription has led to an increase in discussions
between men and healthcare providers in New Zealand, where erectile dysfunction medicines are already available for supply by pharmacists under certain conditions”.

In its submission, the PSA also said it supported the proposal for an S3 entry for sildenafil. 

Noting the range of controls and restrictions for supply and referral, including education and
consultation documentation, PSA said it supported the Appendix M entry requiring the supply of S3 sildenafil “to be contingent on pharmacists supplying sildenafil in accordance with professional standards and guidelines for supply of medicines for erectile dysfunction issued by the PSA”.

“Should the proposed rescheduling of sildenafil be recommended by the delegate, PSA would
develop a practice standard and guideline to incorporate any patient-characteristics or clinical
criteria that may be defined to restrict supply within the pharmacist scope of practice”. 

Guidelines would consider regulatory and professional practice obligations, assessment of patient need based on applicable signs/symptoms, comprehensive history and/or limited investigations (eg. blood pressure), determining appropriateness of supply through consideration of contraindications and precautions, medicine interactions, other more appropriate treatment options (including non-pharmacological), provision of counselling information including treatment expectations, adverse effects, lifestyle factors, follow-up advice and proactive recommendation to see their GP if they have not had a recent cardiovascular or diabetes check.

The move was opposed by the AMA who said they “lodged a submission last year opposing an application to down-schedule sildenafil. No new, publicly available, information appears to have been provided to substantiate or justify another application, following the TGA’s rejection of the previous application”.

The AMA submission questioned the ability of pharmacists to properly examine and treat erectile dysfunction through a “checklist”.  

“ED is a marker of the state of the blood vessels in other parts of the cardiovascular system and
should be thoroughly investigated before phosphodiesterase inhibitors are prescribed. This is
best investigated by the patient’s usual medical practitioner in a consultation where this issue
can be teased out and, if appropriate, alternatives discussed.

“ED may also be caused by many other prescription medicines,” the submission added. “It is also crucially important to explore whether there are psychological causes of ED which can be a very significant reason for presentation”.

“The above issues cannot be addressed by answering a simple check list of questions posed by a
pharmacist”.

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12 Comments

  1. Michael Post
    25/01/2019

    I am all for S3 sildenafil where evidence of established ED diagnosis treated with PDIs by a medical professional is produced.
    ED psychology is outside pharmacist scope of practice . Popping a pill is not the first line solution.
    Rare irreversible hearing loss complicates pharmacist initiated supply.

  2. fiquet
    25/01/2019

    I think the current lack of privacy areas are a large barrier to this drug being S3 in pharmacy.

    • Jarrod McMaugh
      25/01/2019

      Faulty logic

      1) how is this supposed lack of privacy OK or S4 but not S3?
      2) every pharmacy has private counselling areas.
      3) most (if not all) have private consultation rooms
      4) some states (like Vic) have requirements for private consulting areas that are strictly enforced.

      • fiquet
        25/01/2019

        Hi Jarrod,
        While this may be the ideal, in reality the private consultation areas are not used for routine discussions (which this one would be).

        I am sad to say a lot of pharmacies still don’t have a consult room that they actually use (this is from my locum pharmacist experience across Vic).

        Case in point: I recently visited a newly refurbished pharmacy that focuses on health services and care.
        Unfortunately I had to discuss my mouth thrush and other health issues in the middle of the pharmacy isles and then at the register. The experience was further enhanced by a large man breathing on my neck impatient for me to end my discussion so he could buy some sunglasses at the said register. I’m not sure how comfortable a typical patient would be to discuss their ED in a similar situation.

        As a patient, I have not yet had the experience if the said private discussion areas used in other pharmacies either.

        • Jarrod McMaugh
          25/01/2019

          I can provide you with an anecdote that has the opposite outcome if you like.

          I have so many of them that I’m sure there would be one for each anecdote you provide that suggests that there is no privacy……..

        • Gavin Mingay
          25/01/2019

          Were you visiting a discount pharmacy for your thrush treatment??
          Why were you discussing oral thrush in an aisle and not in the S3 area??

          • fiquet
            29/01/2019

            I was visiting a brand-new pharmacy in an affluent inner-eastern suburb. The pharmacy belongs to a banner borne of two large chains that have recently merged together .
            At the local discount pharmacy I am typically offered the counselling at the scripts out counter within earshot of several other people hovering ( because there are no chairs ).
            If I was aiming to get sildenafil and wanted to discuss my problems, neither of these settings would be suitable.
            I am glad some pharmacies have privacy areas for their patients (as they should) ,and as for me , I am yet to experience one .

  3. chris
    25/01/2019

    The AMA submission questioned the ability of pharmacists to properly examine and treat erectile dysfunction through a “checklist”.
    As far as examinations go and considering comments by fiquet, maybe we can take them out the back in a private, professional consulting area and conduct a thorough examination. Some patients may say no thankyou with no hard feelings. Others may quickly want to get to the point. It is a serious matter and patients are very keen to get to the end of it. I would also add that professional shop thieves may see this as a lucrative venture so definitely it should be not be stored near the durex and Ky. Nevertheless if such a widespread professional organization was interested as ..allegedly… the baby powder folks in Sydney, police should certainly be on the lookout for hardened criminals. If you also interested in a greater population for this great land of yours, it cannot do any harm and like Peter Costello mentioned here’s one for the country.

  4. Andrew
    25/01/2019

    That’s an lot of requirements for a fairly benign drug. Thinking of the likely margins on OTC sildenafil the economics of a pharmacist spending much more than 30-45 seconds on screening and sale don’t stack up.

  5. Gavin Mingay
    26/01/2019

    I feel sorry for this old bloke in the photo – he seems to get dragged out for every story on ED the AJP publishes…

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