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TGA presentation: Scheduling working group meeting one, 9 February 2018
Medicines scheduling and scheduling policy ad hoc working group meeting
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.
- Presented by: Adj. Prof John Skerritt
- Presented at: Scheduling Working Group meeting
- Presentation date: 9 February 2018
- Presentation summary:The role and key priorities of the Working Group
Medicines scheduling and scheduling policy ad hoc working group meeting
Adj. Prof John Skerritt
Deputy Secretary, Health Products Regulation Department of Health
Scheduling Working Group meeting 9 February 2018
Slide 1 - Role of the working Group (over several meetings!)
- Input on potential regulatory controls for inclusion in legislation around advertising of Schedule 3 (Pharmacist-only) medicines – today's focus
- Propose criteria for a new appendix in the Poisons Standard would be established to enable additional controls or requirements for Schedule 3 substances to be specified, in particular those recently down-scheduled from Schedule 4 – start discussion today
- Develop a framework and guidelines for proactively identifying particular S4 human medicinal substances for consideration for down-scheduling – start discussion today
Slide 2 - A common challenge for each of these roles is to get the balance right !
- Balance benefits and harms
- Encourage awareness and informed decision-making by patients
- Encourage self-care where appropriate
- Enable improved health literacy
- Use of a medicine to be based on genuine need not marketing push
- Enable patients to know that they don’t have to make a doctors appointment to obtain particular medicines
Slide 3 - The new Scheduling Policy Framework (SPF) and Scheduling Handbook
- Applicant must submit a summary for publication outlining the proposal
- Public consultation of up to 4 weeks on the interim delegates decision and open to any interested party
- Scheduling delegate now has greater discretion for whether to refer a matter to an Advisory Committee or to make a decision themselves
- Applicants can use a risk-benefit model when preparing their submissions
- A limited trial to assess the value of applicants presenting to the advisory committees
Slide 4 - The new Scheduling Policy Framework (SPF) and Scheduling Handbook (continued)
- The structure and the content of the Committee's advice, and the delegate's reasons for scheduling decision will be revised for clarity
- Applications for chemicals scheduling consideration to be submitted directly to the Secretariat (after refinement of requirements and processes)
- Scheduling Secretariat will enhance communication processes
Slide 5 - Reforms to the advertising of S3 pharmacist only medicines
Slide 6 - Therapeutic Goods advertising reforms
Schedule 3 meds advertising
- Two public consultations in 2017
- Government supported an increase in the number of S3 substances that can be advertised, but noted a diversity of views
- Recognition that this requires safeguards:
- mandatory requirements for advertisements
- specific factors to consider when adding a substance to the list of those that can be advertised (Appendix H)
- types of substances/ presentations that shouldn't be advertised
Therapeutic Goods Advertising Code
- Is currently being rewritten and will be subject to further consultation commencing March
- Outlines the legal requirements for advertisements of therapeutic goods
- Details the restricted representations that apply to therapeutic goods advertisements
Slide 7 - Range of stakeholder views around S3 pharmacist only medicine advertising
- "Australia is the only country in the world that does not routinely allow pharmacist OTC medicines to be advertised"
- "if its safe enough to be OTC, in most cases it should be safe enough to advertise"
- "consumers will not know that they don’t need to see a doctor to get many important OTC medicines… responsible self-care should be encouraged"
Opponents or those with concerns:
- "May encourage inappropriate use, pressure on pharmacists to provide"
- "Pharmacist should propose use rather than have the medicine requested"
- "Need legally binding-safeguards e.g. Statement of risks, see your pharmacist, not just in the fine print"
Slide 8 - But the Government has made its decision
- So the discussion now needs to be about what specific controls or safeguards are appropriate, rather than re-litigating the decision
- Need to emphasise the Advertising Code is legally binding
- Even though its called a code
- Being recast – current code is principles-based so compliance and enforcement is harder where there is ambiguity
- TGAs previous enforcement powers were limited
- Requirements in the Code apply to all advertisements, including S3 advertisements
- So the discussion is about what additional controls are needed for S3
Slide 9 - What are the basic requirements in the code? (currently, and in the proposed update)
- Advertisements for therapeutic goods directed to consumers (but not health professionals) must comply with the Code.
- All advertisements are also subject to the Therapeutic Goods Act and Regulations and the Australian Consumer Law
- Advertisements are assessed in terms of its probable impact upon the reasonable person to whom the advertisement is directed.
- Points of comparison with other products should reflect the body of scientific evidence.
Slide 10 - Currently the code says adverts cannot /or be likely to:
- Arouse unwarranted and unrealistic expectations of effectiveness
- Lead to consumers self-diagnosing or inappropriately treating potentially serious diseases
- Mislead, abuse trust or exploit lack of knowledge of consumers
- Lead people to believe they are suffering from a serious ailment
- Suggest that harm may result from the product not being used
- Encourage inappropriate or excessive use
- Claim that it is effective in all cases, safe or have no side-effects
- Be directed to minors
- Be endorsed by government, hospitals or individual healthcare professionals
Slide 11 - Current code requirements for S3 OTC medicines in Appendix H (some exceptions for radio advertisements under 15 seconds)
Advertisements must contain:
- the trade name and reference to the approved indications
- a list of ingredients or state "ALWAYS READ THE LABEL"
- direct and internet marketing adverts which must contain a full list of the active ingredients and mandatory warning statements
Advertisements must state:
- "USE ONLY AS DIRECTED" for claims relating to symptoms of diseases or conditions
- "YOUR PHARMACIST’S ADVICE IS REQUIRED"
Slide 12 - Current additional requirements (for unscheduled, S2 or S3 products)
Analgesic advertisements must
- say "Use only as directed. Incorrect use could be harmful. Consult your healthcare professional if symptoms persist"
- not imply that analgesic consumption is safe; or will relax, relieve tension, sedate or stimulate
Vitamin advertisements shall not imply they
- substitute for good nutrition or a balanced diet; or
- are superior to dietary nutrients or that normal health may be affected by not taking vitamins
Weight management medicine advertisements
- must balance product claims with references to healthy energy-controlled diet and physical activity
Slide 13 - This advertisement from the 1950-1960s would not align with the current Code on several grounds
Slide 14 - What additional mandatory requirements should apply for advertisements of S3 substances?
Two additional requirements were proposed in the consultation paper:
"Your pharmacist must decide if this product is suitable for you"
- to be included prominently in the advertisement
- for print advertisement this statement should appear at the top of the advertisement, for broadcast media this should be the leading statement
"Ask your pharmacist about side effects relevant to you"
- to be included prominently in the advertisement (print advertisements - at the bottom of the advertisement, for broadcast media - the ending statement)
- a single standard phrase to be included at the top/beginning and bottom/end of an advertisement
Slide 15 - Some submissions felt that these statements were not specific enough - or that more statements were needed
- But few specific suggestions were made in consultation responses
- In the consultation paper we did say "More specific requirements around statements will be consulted upon at the time of public consultation on the draft advertising code"
- Our job is to discuss this today to help draft the code for public consultation
- We will develop a specific guidance document for potential advertisers of S3 substance to have all the rules in one place
Slide 16 - What else could be specified?
FDA requires prescription medicine advertisements to be "clear, conspicuous and neutral"
- Easily understandable language
- Audio volume, articulation, pacing of talking
- Avoid distracting representations/ images
- Text placement, contrasting background, size and style of font
- These considerations are equally relevant for OTC medicine advertisements?
Information on benefits of the medicines
- Do all of the approved indications need to be covered?
- Require signposting to the CMI/ additional information (e.g. website)?
- How do we avoid discouraging the use of non-medicine options?
Slide 17 - Appropriate context for talking about adverse events?
Slide 18 - What else could be specified? Side effects or risks of adverse events
- Avoid pleasant backgrounds that downplay potential risks
- Avoid distracting music or images in broadcast/internet advertisements
- Require simultaneous presentation of adverse events in audio and visual formats?
- How should warning statements in print adverts be presented?
- Do we mandate font sizes / prominence
- Do we mandate proportion of broadcast advert that adverse events are mentioned
But too much detail on adverse events may reduce the impact of warnings!
Slide 19 - Should the requirements be more specific? Or are very specific requirements not feasible?
- At present specific wording is mandated and statements "must be included prominently"
- What does prominent mean?
- May be unworkable to specify particular font sizes across print media, internet, billboards
- Leading and ending statements are specified in broadcasts
- Should there be extra requirements for what is and isn't permitted in visuals?
- Do we need to keep adverts at Year 8 reading level and avoid over-use of technical terms?
Slide 20 - Reviewing what current S3 substances should be advertised
Slide 21 - What S3 substances should be advertised?
The consultation paper proposed that the delegate should consider:
- Potential public health benefit
- Likelihood that advertising may lead to inappropriate patterns of use
- The provisions of the Code and any prohibited and restricted representations relevant to the substance
- Whether advertising could be of goods for an indication other than those included in the ARTG
- Responsibility of pharmacists to be actively involved in medicine supply
- Available Consumer Medicine Information
- Available Risk Management Plan for an S3 environment
- Level of patient education necessary to ensure safe and effective use
- Desire of consumers to manage their own medication
Slide 22 - Substances unsuitable for inclusion in Appendix H
With Appendix H the default position, need to consider what criteria could make a substance inappropriate for DTC advertising:
- Injectables – but what about e.g. naloxone
- Use in emergency situations? ditto
- Where safer analogues/ equivalent medicines are available
- Where there is potential for inappropriate use, abuse or diversion
- Where the substances form part of surgical procedure
- Medicines for a chronic condition that requires medical advice?
Are any additional criteria appropriate?
Are some of the above unnecessary? other countries either do not mandate exclusions or have fewer exclusions e.g. psychotropics, narcotics or abortifacients (UK)
Slide 23 - Proposed Administrative processes for moving certain S3 substances into Appendix H
- With the current S3 substances would not be dependent on receipt of a submission, but submissions are welcome
- The working group would assist in screening current S3 substances
- Public consultation undertaken after development of a substance list
- For substances proposed for re-scheduling this would be in parallel with the scheduling consideration
- Referral to the ACMS would be at the Delegate's discretion
- Consistent with scheduling decisions, implementation dates for any moves to Appendix H will be set to allow pharmacists and industry enough time to undertake education and preparedness activities
Slide 24 - Proactively identifying S4 medicine substances for consideration for down-scheduling
Slide 25 - "Develop a framework and guidelines for proactively identifying particular S4 human medicinal substances for consideration for down-scheduling"
What can we learn from overseas processes?
- E.g. UK, Ireland, Singapore, Denmark have done this
- Most involved stakeholder group advisory groups to identify lists
- Some countries (e.g. UK) implemented streamlined down-scheduling processes for substances in the same class
Any models will need to be adapted for Australia as some overseas countries schedule products rather than, or as well as, substances
Slide 26 - Learnings from the UK stakeholder platform for reclassification of medicines
- Critical to involve a wide range of stakeholders – consumers, doctors, pharmacists, nurses, industry….
- Need to agree on fundamentals "the safety of the substance is well established"…. or "that it first needs to be better established"
- UK Stakeholder group didn’t just come up with a list of substances but
- Focused on management of risks of supply and acceptability to patients and health professionals
- Reviewed impact of pharmacy controls over down-scheduled medicines
- Looked at switch case histories – confusion when there was significantly different conditions of use for OTC vs prescription forms of a medicine
- Existing public workshop for down scheduling proposals have benefit but purpose and processes needed to be refined
Slide 27 - Common types of products seen as suitable for OTC provision internationally
- Smoking Cessation
- Weight Management
- Analgesia (oral and topical), Cough/Cold
- Topical Antifungal, Dermatological, Acne Preparations
- Eye and ear drops
- Oral care (e.g. topical cold sore preparations and antiseptic mouthwash)
- Gastrointestinal (including antacids, laxatives, anti-emetics)
- Anti-dandruff shampoo
- Hair loss treatments
Slide 28 - Some recent down-schedulings to OTC internationally
- Triptans for migraine – UK and several EU countries
- Simvastatin for cholesterol – UK (discontinued 2010)
- Tamsulosin for benign prostate hypertrophy – UK
- Sildenafil – UK, Poland and NZ
- Ulipristal - Emergency hormonal contraception – UK, NZ, Australia
- Transdermal oxybutynin for overactive bladder – US
- Topical adapalene for acne – US, Singapore and NZ
- Clindamycin and erthromycin for acne – Singapore
- Calcipotriol for mild psoriasis – NZ, UK
- Oseltamvir for influenza – NZ
- Trimethoprim for urinary tract infections – NZ
- Proguanil for malaria prophylaxis – UK
- Combined oral contraceptives - with only one doctor's prescription required every three years - NZ, Netherlands, some US states
Slide 29 - Adding a new appendix to the poison standard to provide additional safeguards when down-scheduling
Slide 30 - Adding a new appendix to the poisons standard
Propose criteria for a new appendix in the Poisons Standard to enable additional controls or requirements for Schedule 3 substances to be specified, in particular those recently down-scheduled from Schedule 4
- What could this entail? Evidence that risk of down scheduling could be adequately managed
- Inclusion in the SUSMP as an Appendix would give consistent national controls and make them legally binding
- Not proposed that the detailed criteria e.g. of required training are described in the appendix – instead these would be developed by the relevant society and included for CPD points
- Once we have some specific proposals, we would need to get legal advice that they are within the overarching powers provided for by the Therapeutic Goods Act 1989
- Should down-schedulings be audited and the medicines returned to prescription only if pharmacist compliance is poor?
- AHMAC would also have to approve the new Appendix
Slide 31 - A S3 version of appendix D for pharmacists? What does Appendix D say for doctors for S4/8 medicines?
Appendix D - Additional controls on possession or supply of poisons included in Schedule 4 or 8 - List of poisons included in Schedule 4 or 8 where additional specified controls apply on possession or supply
Examples of Appendix D controls. Product can only be prescribed by:
- Particularly authorised medical practitioners – particular training (e.g. specialty), or specifically authorised by CTH health department
- Must provide advice to women of childbearing age
- Must exclude possibility of pregnancy
- Possession without authority illegal
Slide 32 - Examples of additional controls in UK and NZ for newly down-scheduled substances
- Requirement for detailed patient interviews and questionnaires, e.g.
- In NZ for sildenafil or trimethoprim
- In UK prior to dispensing OTC triptans for migraine – but now replaced with a simpler verbal interview protocol
- In Netherlands - verbal interview / questionnaire before naproxen supply
- NZ also permits supply without prescription of otherwise prescription only medicines
- Short-courses of trimethoprim
- Dispensing if there is evidence of a doctors prescription in the last three years (e.g. certain Combined Oral Contraceptives)
- This approach is out of scope of the AHMAC/ Minister’s Decision
Slide 33 - NZ model for newly down-scheduled medicines
- Like Australia, NZ has a pharmacist-only medicine classification
- Controlled pharmacist-supply model for newly rescheduled medicines can involve
- pharmacist training being mandated before supply
- strict criteria for supply, screening tools
- comprehensive documentation about supply
- Monitoring of risks and benefits is critical e.g. for sildenafil
- Risks – inappropriate use, cardiac safety, failure to refer for physical or psychological causes of erectile dysfunction
- Possible benefits - Earlier treatment for erectile dysfunction, detecting other conditions during the consultation, avoidance of internet or nightclub sales
Slide 34 - UK model for OTC Sumatriptan (Imigran recovery®)
Specific criteria for who should see a doctor before being provided the product
"Your pharmacist will need to ask you various questions about your health and other medicines you may be using before they can sell you this medicine"
Imigran recovery ® - You will need to see a doctor if:
- You had your first ever migraine attack in the last twelve months
- You've had fewer than five migraines in the past
- You're aged 50 years or over and are having migraine attacks for the first time
- The pattern of your migraines has changed, or your attacks have become more frequent/ persistent/ severe, or you don't recover completely between attacks
- You have four or more migraine a month or migraines last for longer than 24 hours
- You are pregnant or breastfeeding
- You have three or more risk factors for heart disease
- You are taking a combined oral contraceptive and your migraine attacks started within the last three months, your migraines have got worse, or you get migraines with aura
Slide 35 - Next steps... after this (and the next) meeting
- Finish drafting S3 medicine advertising guidelines using the feedback from this group and other targeted consultations
- The guidelines will be consulted on at the same time as the revised Therapeutic Goods Advertising Code, which will contain the mandatory requirements for advertisements of S3 substances
- Based on advice, the delegate will consider the substances currently in S3 for inclusion in Appendix H
- these will also be subject to public consultation
- By the end of 2018, Appendix H could be updated with all the substances that are currently in Schedule 3 and are considered to be are appropriate for advertising
- During 2018 the working group would explore possible future additions to Schedule 3
- these would still be required to go through the full process
- submission, consultation, ACMS processes and delegate decisions
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