23 June 2017

Medications and Marketing

Quarantining the quack medicines? The interim report of the Review of Pharmacy Remuneration and Regulation features the following summary
This Interim Report presents the Panel’s key findings and a series of options – or possible reform paths – for stakeholders to consider.
In essence, this Interim Report continues the conversation flowing from the release of the Review of Pharmacy Remuneration and Regulation Discussion Paper in July 2016, which resulted in more than 500 submissions to the Review.
The options for reform presented throughout this report have consolidated issues raised within the submissions and other feedback as well as primary evidence gathered from work specifically commissioned by the Review.
The report and its options capture a broad range of thoughts and ideas surrounding reform but do not discuss specific issues of implementation. Although this review has not been concerned with the specifics of implementation, the Panel welcomes and encourages further submissions that provide additional insight into such matters where considered appropriate.
This Review is primarily consumer focused and, while the viability and sustainability of an effective community pharmacy network is a key consideration, the Panel has also sought to identify services and programs that are of benefit and the consumer ultimately values.
It is important that consumers can easily access information about the services offered by community pharmacies. The Panel presents options to improve consumers’ access to information. This is an important step toward improving services and the equity of medicine access.
Consumers self-select the pharmacy model that best suits their needs. This should continue to ensure a viable and vibrant pharmacy network. However, consumers also need, and expect, consistent minimum levels of service from all community pharmacies.
This includes community pharmacy providing consumers with professional advice on complementary medicines. To avoid potential harm, or the confusion between the efficacies of different types of medicines, pharmacists need to be easily accessible to give needed advice when consumers choose a complementary or pharmacy-only medicine.
The Panel considers that the implementation of technology and mechanisms to support the use of electronic prescriptions and electronic medical records is overdue. While recognising that governments and industry are working to implement technology enablers, the first step needs to be about timely recognition of an electronic script as a valid prescription record for legislative and Pharmaceutical Benefits Scheme (PBS) purposes.
The Panel has noted some good practices and initiatives across the broader health sector in this regard, including improved communication and synergies between hospital and community pharmacies. Nevertheless, there still remain significant opportunities to improve services and reduce medicine-related risks for patients moving between healthcare settings.
The Panel’s strategic vision is the continued development of an innovative, sustainable community pharmacy network that is adaptive to the inevitable changes occurring in health care.
Emphasis must therefore be on remuneration which rewards efficient pharmacy operations while enabling appropriate payment for providing all consumers with equitable access to PBS medicines, consistent with the National Medicines Policy. Remuneration based on the efficient costs of dispensing within a best-practice pharmacy is appropriate and ensures a fair and equitable use of government funds while safeguarding the variety of business models that exist today.
These efficient costs are tied to the delivery of core services by the pharmacist for the supply of PBS medicines and related services as needed by the consumer. In order to establish an appropriate level of remuneration for community pharmacy, government needs information about the costs of these core services. At present, these costs and their associated value are difficult to determine, as the accounting information required to inform decision-making at this level is not being made available to government. Increased transparency in the use of these public funds is therefore strongly supported by the Panel.
Few, if any, submissions to the Review approved of all aspects of the current location rules. The Review notes the 2014 National Commission of Audit and the Competition Policy Review (the Harper Review) in 2015, which recommended the removal of these rules. Options for the removal and/or replacement of the location rules are presented in this Interim Report.
In a federation like Australia, there will often be variation in rules across the country. However, the variations in relevant legislation between states and territories are causing undue administrative burden for pharmacists and confusion for some consumers, especially those travelling between jurisdictions. Improving regulatory arrangements will help to ensure nationally consistent services for all consumers, better align services with consumer access, and increase innovation in community pharmacy while reducing barriers to entry.
While advances in medicines are always welcomed, the escalating cost of their listing on the PBS could serve to compromise current supply arrangements. For example, the increasing prevalence of high-cost medicines listed on the PBS, and their associated terms of trade, has challenged the ability of many community pharmacies to supply these medicines. The Panel considers that the risks to pharmacies in supplying high-cost medicines may be better managed by placing an upper limit on wholesale payments made by community pharmacists.
The remuneration and regulation for the wholesale supply of PBS medicines can also be improved. The options presented by the Panel remove unnecessary regulation and focus medicine distribution on the suppliers, who have the strongest incentives to ensure that consumers can access their medicines. The options will improve the effectiveness and accountability for the public funds used to support wholesaling and establish clear base-level terms of trade for community pharmacy. The Panel notes that successive Community Pharmacy Agreements (CPA) have led to important improvements in the engagement of community pharmacy. But they have also limited improvement in some areas. The CPA remains an appropriate mechanism to discuss and agree on the delivery of PBS medicines through community pharmacy. However, all the parties responsible for the major components of that delivery need to be represented as signatories to the agreement.
This is currently not the case, and the Panel considers that future agreements should be extended to include broader sector and consumer health representation. The Panel notes the many bodies which have claimed to be representative of pharmacy and/or pharmacists across the country. These bodies have challenged the notion that community pharmacy models currently operating in Australia are all represented appropriately, in CPA negotiations to date, to ensure integration and coordination across the pharmacy profession.
National policy includes the integration and financing of community pharmacy as a primary health focus on patient outcomes delivered through safe and effective pharmaceutical care.
Across the broader health policy and systems management, there is a need for wider presence of community pharmacy input and, conversely, a wider representation of pharmacy and consumer leadership is required.
The Panel notes that community pharmacy in the longer term will necessarily be led across various private and professional bodies with various agendas, and the challenge for government will be to coordinate agreements with a number of representatives to ensure that public access and health priorities are managed effectively. The Panel also considers that the CPA is not the right mechanism to negotiate and agree on programs and services that are not directly related to the delivery of PBS medicines. Such services are more appropriately agreed separately between the government and the relevant key stakeholders and funded on their own merits and evidence base. For example, the Panel has noted that pharmacies provide many valuable programs and services that are either not funded or underfunded, and the Panel considers these merit separate negotiation and agreement outside the CPA.
Ensuring that Aboriginal and Torres Strait Islander people have timely and affordable access to PBS medicines and medication management support services remains a priority that underpins the desire to improve access and affordability in remote locations.
The Panel recognises the benefits of programs such as the Closing the Gap PBS Co-Payment Measure. However, such programs need to be properly integrated to ensure that the program benefits follow the individual, regardless of where their prescription is written or dispensed. The Panel also considers that the ability for an Aboriginal Health Service to employ pharmacists and operate a pharmacy should be trialled to see if it improves services and outcomes for Indigenous Australians.
This Interim Report further presents options for consideration in relation to:
  • current complexities and administrative inefficiencies with the section 100 Highly Specialised Medicines program 
  • fees paid by the government for the compounding of chemotherapy medicines which meet minimum safety and quality standards 
  • use of mechanisms such as machine dispensing to improve access to medicines and related advice in remote communities.
The Panel re-emphasises that the options and alternatives presented in this Interim Report are not designed to address potential implementation issues. They are options for reform.The Panel notes that the Australian Government’s 2017–18 Budget contained a range of decisions that affect elements of this Review. These decisions impact upon a number of community pharmacy programs and the pharmacy location rules.
The Interim Report presents options to replace or modify the pharmacy location rules. However, given the Government’s recent commitment to continue the current location rules, the Panel considers that its options to replace the current location rules are no longer immediately relevant to this Review. While they are included in the Interim Report for the sake of transparency around the Panel’s consideration of the issue, they will not be presented in the Final Report.
However, the Panel will continue to consider the options presented to modify the location rules that have been put forward on the assumption that the current location rules will be retained.
The Panel therefore welcomes further discussion through the submission of new evidence and additional insights in relation to what community pharmacy should look like in the future. This will be important for informing the Panel’s recommendations to be presented in the Review’s final report.
Part 3.5 regarding Homeopathic Products states
There are unacceptable risks where community pharmacies are allowed to sell homeopathic products.
While most stakeholders supported the continued sale of complementary medicines in community pharmacy, the practice of homeopathy and sale of homeopathic products did not receive such support. In 2015 the National Health and Medical Research Council (NHMRC) conducted an assessment of the evidence of efficacy of homeopathy and concluded:
“Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective. Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.”
The general consensus as demonstrated by submissions to the Review and the Panel’s face-to-face consultations is that homeopathy and homeopathic products do not belong in community pharmacies. The majority of pharmacists and other stakeholders argued that these products lack any evidence base and have sufficient evidence of non-efficacy to preclude their ethical sale in community pharmacies.
This is supported by the public positions of professional pharmacy bodies – for example, the PSA, whose Position Statement on Complementary Medicine states: “PSA does not support the sale of homeopathy products in pharmacy.”
The only defence put to the Panel regarding homeopathy was that it was harmless and able to be used as a placebo in certain circumstances. The Panel does not believe that this argument is sufficient to justify the continued sale of these products in pharmacies that supply PBS medicines.
In particular, the Panel notes that the supply of homeopathic products through pharmacies is not benign but, rather, risks creating a perception of reliability and efficacy in the mind of the consumer based on the status of the pharmacy as a healthcare provider. This may encourage patients to choose a homeopathic product over a conventional medicine with robust evidence of efficacy, which creates a risk of harm to the patient’s health.
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.
In considering complementary products the interim report states
Consumers value access to complementary medicines in the community pharmacy setting, where they can receive advice on their selection and use that is backed by an appropriate level of evidence.
The Review’s consultation process has clearly demonstrated that consumers expect access to complementary medicines in their local pharmacy.
It is also clear that consumers value pharmacist advice to support their selection and use of complementary medicines. Research undertaken by Hall and Partners concluded:
“The inclusion of complementary medicines and treatments (primarily thought of as vitamin and mineral supplements) in pharmacies attracts majority support among Australian consumers, most of whom want to access these products in pharmacy. This result is unsurprising given the current Australian health climate that reflects a widespread belief in complementary medicines or treatments as a part of managing one’s health, based on the influence of doctors, health experts, spokespeople, media and word of mouth. Consumers rely on pharmacists to help them understand whether certain complementary medicines are safe to take with their pharmaceutical medicine.”
Community pharmacy owners expressed similar views in the submissions to the Review. They were overwhelmingly supportive of complementary medicines continuing to be sold in community pharmacy, as patients have the opportunity to seek advice from, or be referred to, a pharmacist.
This includes advice on the evidence base relating to the product, advice on whether the product is appropriate for that patient, advice on potential adverse reactions with other medications and referral to a general practitioner where appropriate.
There was also a strong focus on the importance of quality advice being available for consumers, as demonstrated by the following submission:
“Complementary medicines will continue to be sold whether or not they are ranged in pharmacy. However the pharmacy is a controlled environment where advice can be easily obtained.
While most complementary medicines are safe there are some that can have adverse consequences if taken with the wrong prescription medicines. The pharmacy is the right place for consumers to determine how to best use complementary medicines from trained healthcare professionals.”
Many pharmacy owners and pharmacists emphasised their support for the consumer’s right to choose when it comes to managing their health needs. This includes the use of complementary medicines alongside traditional pharmacy medicines.
A submission from Move Muscle, Bone and Joint Health explained that many consumers expect their pharmacist to play a supporting role in when obtaining complementary medicines:
“the use of complementary medicines in conjunction with pharmaceutical compounds is very common for muscle, bone and joint conditions. Further, many people using complementary medicines do not discuss this with their doctors. Sabanovic et al found that people with chronic pain often used a combination of prescribed, off the shelf and complementary medications to manage their pain.
Pharmacy has an opportunity to bring together patients’ experiences and preferences, to discuss possible interactions and to provide advice. As there are significant poly-pharmacy risks between prescribed, off the shelf and complementary medications, prohibiting businesses from providing the range of options is counterintuitive.”
In general, stakeholders put forward the view that pharmacists perform a valuable role in advising consumers on complementary medicines. However, there is some concern relating to the sale of products with a limited evidence base, or none at all, alongside prescription and other scheduled medicines.
The Hall and Partners’ consumer research noted:
“The presence of these products within the pharmacy environment does, to some extent, allow complementary medicines to borrow some of the clinical trust placed in the pharmacy. However, this research finds no evidence to support the view that their presence in turn negatively impacts clinical trust in the pharmacist. If pharmacies are to supply complementary medicines, this brings with it a consumer expectation these products have been selected for their health benefits and that staff will be able to provide related product advice – especially about possible interactions or side effects.”
However, Dieticians Association Australia contradicted these assertions, suggesting: “it is confusing for patients if non-evidence based therapies are sold alongside prescription medicines. It is reasonable to expect that pharmacists manage any conflicts of interest and provide evidence based advice to consumers, but it is difficult to see how this can be realised in a retail environment in which evidence based and non-evidence based products are collocated.”
The Panel agrees with the above comments and remains concerned that the sale of complementary medicines alongside other medicines may mislead consumers. It therefore concludes that complementary medicines should be held in a separate area within community pharmacies, where customers can easily access a pharmacist for appropriate advice.
The Panel notes that complementary medicines encompass a wide range of products generally considered useful for health maintenance and enhancement. This extends to a range of products with a history of use based on cultural and traditional values.
The Panel also noted that the current Therapeutic Goods Administration (TGA) pre-market approval process for the listing of complementary medicines on the Australian Register of Therapeutic Goods (ARTG) is based on assessment of a lower level of evidence than that for registered medicines.
Complementary medicines listed on the ARTG are subject to specific requirements relating to the level of therapeutic claim made for each product, the ingredients which it may contain and the facilities and standard to which the product is manufactured. The Panel also notes that no assessment of efficacy is made as part of the TGA listing process.
Although the sponsor (or manufacturer) of a complementary medicine is required to hold evidence of the efficacy of that product for its approved indication, this evidence is not assessed by the TGA prior to listing on the ARTG.
The Panel considers that limited consumer understanding of the TGA approval process for complementary medicines coupled with the availability of these products through community pharmacy can give rise to unsubstantiated expectations of the efficacy or medical benefits offered by these products.
The Panel notes that the recent Review of medicines and medical devices regulation (2015) made a range of recommendations relating to the regulation of complementary medicines. It was suggested that two further reviews be undertaken to potentially streamline the regulatory framework for low-risk products and increase consumer access to the products. Significantly, the TGA’s February 2017 public consultation paper, Reforms to the regulatory framework for complementary medicines: Assessment pathways, notes that:
“A critical issue in the use of listed complementary medicines is to ensure that they are suitable for self-selection by consumers and that the information provided with the medicine supports consumer health decisions.”
Clearly, community pharmacists can play a valuable role in advising consumers on the potential health benefits or dangers of using complementary medicines. The Panel remains concerned that consumers may be misled about the value of complementary medicines in the absence of appropriate evidence-based advice at the point of sale. In this context, the TGA’s actual role in the approval process for complementary medicines may be misunderstood by consumers, who may be likely to believe that that role is much broader than what occurs.
The Panel therefore considers that community pharmacies should provide consumers with information on any limitations noted by the TGA over the medical efficacy of these products. This could be achieved through the provision of appropriate signage near the sale of these products which clearly informs on the relevant TGA limitation.
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 b. provide appropriate information to consumers on the extent of, or limitations to, the Therapeutic Goods Administration (TGA) role in the approval of complementary medicines. This could be achieved through the provision of appropriate signage (in the area in which these products are sold) that clearly references any limitations on the medical efficacy of these products noted by the TGA.