08 May 2018

Homeopathy in Australian Pharmacies

The national Government has released its response to last year's Final Report of the Review of Pharmacy Remuneration and Regulation.

The response is of particular interest for disengagement regarding the sale and promotion of homeopathic products, which - as noted in a range of authoritative studies highlighted in this blog (eg here and here) - have no therapeutic efficacy apart from the placebo effect. It is disquieting that pharmacists continue to sell 'medications' in which it is impossible to detect a pharmacologically active agent. That practice, and the Commonwealth's response (an embodiment of regulatory capture), tells us something useful about health policy and about regulation, which we can contextualise through reference to the failures of ASIC, TGA, APRA and the OAIC evident in current reporting of for example the Hayne Royal Commission.

The response states
The Government responds to the Report in accordance with meeting its obligations under the Sixth Community Pharmacy Agreement (6CPA). The independent Review upholds a commitment made between the Australian Government and the Pharmacy Guild of Australia (the Guild), during negotiations of the 6CPA in 2015, to conduct a comprehensive review of pharmacy remuneration and regulation.
The Terms of Reference for the Review provided that it would make recommendations on the future remuneration, regulation including pharmacy location rules and other arrangements that apply to pharmacy and wholesalers for the dispensing of medicines and other services, including preparation of infusions or injections for chemotherapy, provided under the Pharmaceutical Benefits Scheme (PBS), to ensure consumers have reliable and affordable access to medicines.
In November 2015, the then Minister for Health, the Hon Sussan Ley MP, appointed Professor Stephen King to chair a panel of three eminent independent reviewers to undertake the Review. Other members appointed to the Review Panel were Ms Jo Watson and Mr Bill Scott. The Government acknowledges the comprehensive consultation, analysis and strategic thinking undertaken by the Review Panel in delivering the Report.
The Government notes that the Report has been informed by an extensive public consultation process and gratefully acknowledges the input of all individuals and organisations who contributed their knowledge, expertise and vision to the Review.
The Report notes that Australia’s pharmacy sector is evolving and adapting to change – it is in the midst of transition from a product supply focus to one which is more patient-centred and adaptive to an outcomes-based approach to the optimal use of medicines – and that this trend is also occurring internationally.
The Government notes that a number of recommendations of the Review complement work that has already been undertaken, or is in progress by Government and/or other organisations, agencies or jurisdictions to progress issues that support community pharmacy with this transition. Other recommendations of the Review will require further investigation by Government. The Government recognises the pivotal role of the community pharmacy sector in delivering medicines to Australian patients. The Government is committed to working closely with community pharmacies and other stakeholders to address the significant pressures being placed on the health system, including a growing burden of chronic disease, an ageing population, and growing demand for high-cost, high-tech services and breakthrough medicines.
xxx The 6CPA between the Government and the Guild provides approximately $18.9 billion to more than 5,700 community pharmacies for dispensing PBS medicines, providing pharmacy programs and services and for the Community Service Obligation (CSO) arrangements with pharmaceutical wholesalers.
The 6CPA, which operates until 30 June 2020, supports Australia’s National Medicines Policy and the sustainability of the PBS, contributes to the Government’s investment in new medicine listings (since coming into Government in September 2013, the Coalition has added around $8.2 billion worth of medicines to the PBS) and provides greater certainty of Government revenue to community pharmacies, in an environment of ongoing medicine price reductions associated with price disclosure.
In May 2017, the Government entered into a compact with the Guild to strengthen the PBS. As part of the 2017-18 Budget measure Improving Access to Medicines – support for community pharmacies, the Government is providing $825 million over three years from 2017–18 to support and improve Australians’ access to medicines.
This funding includes an additional $210 million over three years to community pharmacies and $15 million to pharmaceutical wholesalers in response to lower than forecast prescription volumes and in recognition of the impact of the package of price reduction policies outlined in the Budget measure. As part of the 2017-18 Budget measure, the Government is also providing $600 million in funding to community pharmacy for new and expanded community pharmacy programs delivered under the 6CPA. This funding will enable pharmacies to offer new or expanded services to consumers, including home visits by pharmacists, helping patients with their medication, and supporting Health Care Homes (HCH) with medicine management. The Government undertakes to work collaboratively with the Guild and other key stakeholders to maintain the community pharmacy model and to secure a viable community pharmacy sector that continues to meet the needs of consumers into the future.
The recommendations in the report cover
 2-1: PBS Pricing Variations. 
2-2: The $1 Discount. 
2-3: PBS Safety Net 
2-4: Pharmacy Atlas 
2-5: Consumer Medicines Information. 
2-6: Electronic Prescriptions . 
2-7: Electronic Medications Record 
2-8: Electronic Prescriptions — Consumer Choice 
3-1: Access to Medicines Programs for Indigenous Australians 
3-2: Pharmacy Ownership and Operation by an Aboriginal Health Service 
3-3: Patient Labelling of Medicines under Bulk Supply Arrangements 
3-4: Machine Dispensing 
4-1: Community Pharmacy — Minimum Services 
4-2: Complementary Medicines in Community Pharmacy 
4-3: Placement of Scheduled Medicines within a Community Pharmacy 
4-4: Sale of Homeopathic Products in PBS Approved Pharmacies 
5-1: Community Pharmacy Accounting Information (King  and Watson) and Alternative Recommendation 5-1 (Scott) 
5-2: Remuneration to be based on the Cost of Dispensing Services Associated with a Best Practice Pharmacy Model (King and Watson)  and Alternative Recommendation (Scott) 
5-3: Remuneration for Dispensing – Methodology (King and Watson) and Alternative Recommendation  (Scott) 
5-4: Remuneration Limits 
5-5: Remuneration for Other Services 
6-1: Reforms to Pharmacy Location Rules 
6-2: Pharmacy Location Rules — Concentration of Ownership 
6-3: Transparency in Government Programs . 
6-4: Rural Pharmacy Maintenance Allowance 
6-5: Harmonising Pharmacy Legislation 
6-6: Evaluation Mechanisms 
7-1: Community Service Obligation 
7-2: A Comprehensive Supply Chain Analysis 
7-3: Supporting Access to High-Cost Medicines 
7-4: Supporting Access to Highly Specialised Medicines 
7-5: Tightening the Listing of Generic Medicine 
8-1: Scope of Community Pharmacy Agreements — Dispensing 
8-2: Scope of Community Pharmacy Agreements — Wholesaling 
8-3: Scope of Community Pharmacy Agreements — Programs and Services 
8-4: Community Pharmacy Agreement Participants. 
9-1: Community Pharmacy Programs — Key Principles . 
9-2: Dose Administration Aids — Standards . 
9-3: Home Medicines Review — Removal of Caps 
9-4: Pharmacy Support for Residential Aged Care Facilities 
9-5: Support for Expanded Pharmacy Services Identified by Pharmacy Trial Program 
10-1: Chemotherapy Compounding — Uniform Minimum Standards 
10-2: Chemotherapy Compounding — Payments. 
10-3: Chemotherapy Compounding — Practice Models 
11-1: Managing Patient Medicine Risks on Discharge from Hospitals
In relation to Recommendation 4-4: 'Sale of Homeopathic Products in PBS Approved Pharmacies' the report noted
 Homeopathy and homeopathic products should not be sold in PBS-approved pharmacies. This requirement should be referenced and enforced through relevant policies, standards and guidelines issued by professional pharmacy bodies. 
The Government response is
The Government notes this recommendation. 
The Government notes the importance of the provision of information to consumers for all medicines and health related products available through community pharmacy. 
Professional standards have been designed for use by individual pharmacists to assess their own professional practice. They are intended to serve as guidance for desired standards of practice. However, it is the sole responsibility of the individual pharmacist to determine, in all circumstances, whether a higher standard is required. It is equally their  responsibility to meet that standard and ensure that consumers are provided with the best available information about the current evidence for, or lack-of efficacy in, offered treatments and therapies. 
As in relation to Recommendation 4-2, the Government has accepted the recommendations of the independent RMMDR reforming the regulation of complementary medicines in Australia.
The report's recommendation regarding 4-2 was
Community pharmacists are encouraged to:
a. display complementary medicines for sale in a separate area where customers can easily access a pharmacist for appropriate advice on their selection and use; and 
b. provide appropriate information to consumers on the extent of, or limitations to, the evidence of efficacy of complementary medicines. This could be achieved through the provision of appropriate signage within the pharmacy (in the area in which these products are sold), directing consumers to ‘ask the pharmacist for advice’ if required.
The Government has endorsed a regime where pharmacies - increasingly owned by chains - are free to sell what would be acerbically characterised as snake oil on the basis that a pharmacist is on the premises and thus available to answer any question about whether the pills, potion or salve will work.