“PROMOTING HEALTH, PREVENTING ILLNESS AND MANAGING DISEASE: CURRENT ISSUES FOR PHARMACY MANAGEMENT”
QUEENSLAND 2009

I like to have a good working relationship with my local pharmacists.

I like to know that if one of my patients has questions or problems with medications then I can trust that they will get expert and considered advice from them.
I like to know that if I prescribe or recommend a product for a patient, that it will be in stock or that the pharmacist will be able to source it for them in quick time, and that any warnings or potential interactions will be highlighted and discussed.
I know my colleagues in general practice feel the same.

My brief for the keynote address to you today was to give you something to think about.
So today I am going to talk you about some of the big issues in the business and politics of pharmacy, and what the future might hold. The presentation has the title:

“PROMOTING HEALTH, PREVENTING ILLNESS AND MANAGING DISEASE: 

CURRENT ISSUES FOR PHARMACY MANAGEMENT”

Now while that might sound fairly benign, I will be concentrating more on the socio-political issues surrounding the effective delivery of prevention, health promotion and disease management in the community setting and who is best placed to deliver it, rather than the theory. And in my experience these issues can tend towards the less benign.

I should also add at the outset that the reason we all do the work that we do is
• Firstly to contribute to the general wellbeing of our patients and customers…and
• Secondly to maintain successful and viable businesses.

These two aims can never be mutually exclusive. It is not possible to continue to provide services unless the business is viable. So I trust we are on the same page.
That said, as professionals in the business of managing pharmacies, you cannot afford to ignore the political landscape which will affect your businesses in the years to come.
DEMOGRAPHIC CHANGE
First…the demographic reality. We have a growing aging population. Loosely translated, this means more old people. Old people are more likely to get sick. That means more potential for chronic disease and disability. The baby-boomers are in their fifties and sixties, and the importance of health promotion and planning for the health system for the next twenty years, is that the baby-boomers will be turning seventy or eighty by then. The only solution to the exponentially expanding costs of health care of an aging population is to find ways of preventing chronic illness and disability.
This will have implications for pharmaceutical research, development, marketing and service delivery. Both in prevention and treatment of chronic disease, the roles of GP and pharmacist can only get busier.
Another major shift in the healthcare landscape which I will talk about today is the evolution of primary care practice to an integrative and multidisciplinary model with resultant changes to the relationships in primary care, particularly the relationships between GPs and pharmacists.

GOVERNMENT POLICY
Much as we hate to admit it, government health policy is a major player in the healthcare field, particularly in a system that is at least partly (and in the case of Australia substantially) Government funded.
PBS pricing reform means that co-payments have the potential to increase. There is no doubt that such a move tends to inevitably impact the most on lower socioeconomic groups…. It seems that the pharmaceuticals most likely to be targeted are those which improve quality of life rather than increase longevity.
Take hormone replacement therapy as an example. Just recently, when most forms of HRT were removed from the PBS, I had a number of patients who decided to stop HRT …NOT because of the risk of adverse effects, but because of the added cost, and they told me they were prepared to see how long they could tolerate the symptoms of menopause before they decide what they were going to do.
Recent research from Western Australia showed that as cost pressures rise, patients in the lower socioeconomic groups reduce dosages or eliminate medications such as proton pump inhibitors, statins and asthma medications to save money.

THE “GFC”
We cannot ignore broader economic influences. With the global financial crisis, people are looking at all sorts of ways to reduce their living costs, including the costs of healthcare. Many of my colleagues are concerned that financial stress will prompt our patients to access prescription medications from dubious unregulated online retailers, or not fill prescriptions at all. There is also likely to also be a greater shift over to generics.

PREVENTIVE HEALTH
This movement that is well and truly on the march.
“The Preventative Health Taskforce” was established by the current government in April 2008 to provide advice to governments and health providers on preventative health programs and strategies, focusing on the burden of chronic disease currently caused by
• obesity,
• tobacco and
• the excessive consumption of alcohol.
Now while they are not the only preventable health issues, they make a good start. Coming out of the recent budget, funding has been made available for a new Preventative Health Agency within the Federal Department of Health. It remains to be seen how this agency will do business, but it does flag the intentions of the current government to focus on prevention.
Community pharmacy is no stranger to preventative health education, and the Pharmaceutical Society has already expressed a willingness to be involved in delivering some of the objectives of the Taskforce. The Pharmaceutical Society of Australia has said, "Pharmacists are the most accessible of all health professionals and consumers concerned about their weight, or their drinking or smoking, can walk into a pharmacy and get professional advice immediately. "The pharmacist also can help them with programs specifically designed to deal with the issues they may be facing."
Now we may have come from a different planet, but while I can understand a customer asking about a weight loss program or a smoking cessation kit…in my experience it can be a big ask to get patients to admit to excessive alcohol consumption even once they have known you well over many visits, let alone divulge it in the environment of their local pharmacy where they could easily be overheard by neighbours or acquaintances.
Honestly…does pharmacy training equip pharmacists to assess alcohol-related organ damage and counseling techniques to reduce alcohol abuse? Is it actually something that pharmacists would even WANT to do? These sorts of statements just make the representative organizations look naïve and ignorant of the nuances of these sometimes difficult areas of clinical practice.

PRIMARY CARE
When we think of primary care, it has tended to be synonymous with “general practice”.
However, the face of primary care is rapidly evolving. In my early days as a practitioner, general practice was largely a cottage industry. GPs worked solo or in small group practices. We usually managed the business elements of the practices ourselves.
Since the late 1990s, government incentives for practices to amalgamate, and big business interested in general practice and the potential for vertical integration of pathology and radiology services led to bigger group practices often under a corporate banner.
When it comes to delivery of health care, while GPs are the main frontline and the most common coordinators or “integrators” of community-based health care (and in my view rightly so), there are some moves in the medico-political sphere that are signaling that we may see a significant shift in the professional dynamics...for better or worse.
Government policy is certainly signaling a shift to multidisciplinary health care with funding available for the establishment of 31 so-called “GP super clinics” at locations around the country. At this stage there is no data to show whether these clinics are either financially viable or whether they deliver improved health outcomes compared with the current model.

I can illustrate the differences between group GP practice and multi-discipilinary or integrative practice to you with personal experience. I own and operate two primary care clinics which demonstrate the differences emerging in the primary care landscape.
The first is a clinic consisting of about a dozen general practitioners. We are the first port of call for patients with acute medical problems and with chronic medical conditions, and when patients require treatment or advice from other types of practitioners, be they medical specialists, surgeons, dieticians, podiatrists, physiotherapists, pharmacists and so forth, we organize these… and the other health professionals report back to us on their findings.
GPs arrange investigations, hospital admissions and the vast majority of their prescriptions.

Definition of Integrative Medicine
“Integrative Medicine is the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines to achieve optimal health and healing.”
Developed and Adopted by The Consortium of Academic Health Centers for Integrative Medicine, May 2005

At uclinic, we have a multidisciplinary team consisting of GPs, psychologists, naturopaths, a chiropractor, dietitian, Shiatzu practitioner and an acupuncturist. Patients may see a GP first and be referred to other practitioners, but similarly patients may book into one of the other health professionals first. We may request one of our naturopaths to recommend or assess a herbal treatment or supplement combination in addition to or instead of a pharmaceutical. Our dietitian may recommend nutritional changes.
Of course GPs are at this stage the only health professionals able to recommend prescription products. However, other practitioners have and will continue to recommend OTC products themselves. The government has already moved to allow medical certificates for work absence to be issued by non-medical health workers.
With increasing numbers of products being removed from prescription-only and being able to be purchased OTC, the numbers of products able to be recommended by allied health professionals will grow.
Patients, whether we know it or not, are accessing many different types of therapies and practitioners often do not know who else their patient might be seeing or what advice they are following.
Clearly, pharmacists providing services to multidisciplinary clinics or to customers accessing a variety of therapeutic modalities will need to have a strong working knowledge of herb-drug interactions. Many customers are looking to their own preventive health prescription and self-medicate with OTC supplements and look to pharmacy for advice.
A major role in prevention will be to anticipate and avert any possible side effects or adverse interactions.

Good public health policy demands greater integration, not fragmentation.

THE RISE OF CAM
• Each year between 50-75% of the Australian adult population use at least one complementary medicine product and one in four Australians use complementary medicine services.
• There are in excess of fifteen million consultations nationwide each year in herbal medicine, naturopathy, acupuncture, chiropractic and osteopathy alone.[i]
• It is estimated that up to 80% of cancer patients use CM alongside their conventional treatment.[ii]
• The international trend is to increasing usage.
• ½ to 2/3 of CM users have consulted a medical practitioner or specialist for the same condition. However, communication between practitioners occurred in only 27% of cases.
• This rise is affecting the practice of pharmacy at community and tertiary level whether pharmacists are aware of the extent or not.

PROFESSIONAL EDUCATION
 This increasing interest in, use of and evidence for CM compels the pharmacy profession to incorporate herbal and nutritional supplement familiarisation into undergraduate teaching, Continuing Professional Education programs, staff up-skilling programs and postgraduate offerings as a public health priority.
 Funding is required for curriculum development
 Given that Australian universities have not yet universally embraced the integrative approach to patient care and until such time as they do, a lot of effort needs to be invested at postgraduate level to increase the numbers of practitioners, including pharmacists, with the skills to adopt an integrative model of health care.
Current marketing of pharmaceuticals in my experience is very “drug first” orientated.
In future I think there needs to be more of a focus on acknowledging where drug treatment is not first-line, but rather reflect an ideology of “where drug therapy is indicated”.
This might apply to hypertension for example, where weight loss, diet and exercise are first line treatment with the possible addition of supplements such as fish oil, magnesium or coQ10.
The integrative model will lead to a fundamental change in therapeutic guidelines with a repositioning of many pharmaceuticals and the increasing use of herbal and nutritional supplements… and this will need to be reflected in the continuing education of pharmacists and their staff.

PUBLIC EDUCATION AND INFORMATION
Many patients self-prescribe or rely on minimal information and guidance. An important traditional and ongoing role in prevention for community pharmacy is in the dissemination of reliable evidence-based advice on prescribed and OTC medication.

The rise in use of herbal medicines and nutritional supplements has not been matched by community education about responsible use of these products, including advice on correct combinations and doses of supplements and herbal treatments, as well as identifying potential herb-drug interactions.

Development and implementation of a practical communication strategy for professional and community education needs to be a priority for the industry and government. 

INTERPROFESSIONAL RELATIONSHIPS
The ongoing close professional relationship between GPs and pharmacists has depended to a large extent on a form of détente. You do your thing and we do our thing and we communicate when patient care requires it.

This is the reason that for so long, the medical profession has collectively tolerated the elephant in the living room…the illogical continuation of protectionist policies which could be perceived as favouring pharmacy over other parts of the health sector, including the medical sector, with dubious logic to back it up.

PROTECTIONISM
 “Governmental policy aimed at shielding a fragile economy, or a weak or critical sector, from cheaper or better imports or potential competitors through imposition of trade barriers, quotas, and/or inordinately stringent or time consuming inspection or quality regulations.”

For years we have shrugged off the irritation that anyone can own and operate a medical practice while a pharmacy must be owned by a pharmacist…even if it would make perfect sense for all concerned…patients, GPs and employed pharmacists.
It can’t be about ensuring that pharmacy graduates can own and operate their own businesses. There are about 18000 pharmacists in Australia and only 3000 pharmacies. The obvious mathematical conclusion is that many of these pharmacist-owners own more than one outlet, and the majority of pharmacists are employed. The obvious question to ask is why pharmacists can only be employed by pharmacists.
In fact, if you are not a registered pharmacist you can’t even hold a key to a pharmacy…not even a pharmacy manager without a pharmacy degree and registration can enter a pharmacy without the presence of a pharmacist.

Moreover, why is it that a new pharmacy can’t open within 1.5km of an existing one, but a new general practice (which could be owned by a pharmacist) can open up next door to an existing general practice without any restrictions?
The strange anti-competitive rules applying to pharmacy seem to be completely out of step with the strict policy governing every other type of business structure in Australia and you would have to wonder how long this can last.
As a pharmacy management exercise, it would be worthwhile to model the impact of a change of policy to see what impact this would have on pharmacy as a profession and the future of community pharmacy itself.

The pharmacy ownership landscape has largely flown under the radar. That is until recently when headlines in the daily press have shone a spotlight on the different treatment of pharmacy businesses compared to virtually every other type of business.
Questions are starting to be asked about why this is so and why it should remain so.
There is a growing perception that maybe there is something not quite right or in the public interest about the back room deals done by the political arm of the pharmacy lobby.

Perhaps the fundamental question to ask is this: would pharmacy even survive without the oxygen of protectionist policies, or is it being kept alive on the artificial life support generated by its powerful lobbyists? Can it go on forever?

However, there are far bigger issues about the current and future role of community pharmacy and its relevance in the health care spectrum in this era of role-substitution and task re-definition, particularly where medications come packaged and labeled and prescribing information is available on every GP’s desktop. Not to mention the widespread availability of drugs on the internet.

“SLEEPING BEAST”
Pharmacy ownership, operation and practice are fundamental issues for general practice and the activities of the pharmacy lobby have been causing quiet consternation in medical circles for some time. You could say this has been the “sleeping beast”.

Every sleeping beast has its wake up call, and general practice has roused to the stimulus of the prospect of pharmacists providing primary care diagnosis and treatment advice which we feel should be the professional province of general practice, and then dispensing and profiting.

There are several heads to this beast.
• under-qualified people providing medical advice.
• anti-competitive nature of restricting doctors’ ability to recommend or prescribe and dispense, given that the pharmacy lobby seems to see no problem with pharmacy staff both recommending and dispensing.
• Impact on GP-pharmacist relationship

Let’s examine this issue of recommending and dispensing a little more closely:
At first we were only talking about fairly simple over the counter preparations, but as more medications like asthma relievers and non steroidal anti-inflammatory drugs came off prescription and became available over the counter, the range of riskier medications for potentially sicker customers available to be recommended by variably trained pharmacy assistants widened.

As one example, back some years ago, elements in the Pharmacy lobby started to try to take over management of asthma…without training in broader aspects of respiratory medicine and without the ability to disrobe a customer in the shop to listen to their chest for signs of pneumonia or pleurisy, or to recognise an impending crisis. For those of us with specialist training and experience in general practice, it was a shake your head moment. What were they thinking?
You can’t just hive off the “wheeze”, call it “asthma” and treat it by a simple predetermined protocol.

That was followed by an effort to take on the management of obesity…without the advantage of physical examination or investigations to exclude possible causative factors like hypothyroidism or Cushing’s disease. Or the broader issues like monitoring for complications of obesity.

Just this week, there are reports of doctors condemning a study suggesting pharmacists should replace doctors for treatment of minor ailments, and the argument goes that such a move would further fragment care and lead to unacceptable conflicts of interest for the pharmacy industry.
The study conducted for the Australian Self Medication Industry (ASMI) are proposing a model where pharmacists would treat conditions such as headache, joint pain, acute upper respiratory tract infection, viral infection and diarrhoea, and refer “more complex cases” to GPs.

SUBSTITUTE DOCTORS
What has really got doctors’ attention, and not in a good way, is the recent controversy over plans by nurse practitioner-led clinic group Revive to roll out a national chain of clinics in pharmacies across Australia, and ongoing debate over new laws that would grant nurse practitioners MBS, PBS and referral rights.
Now for those of you here who are pharmacists, just how confident would you be to work out which headaches are tension headaches, migraine, a brain tumour or an early presentation of meningitis? How many of you could confidently tell the difference between diarrhoea caused by rotavirus, a bacterial food poisoning or an attack of ulcerative colitis?
Medicolegal experts are already reeling about the ramifications of misdiagnosis by pharmacists and the lack of a comprehensive patient history, diagnostic skill or ongoing relationship with patients. I hope you are ready for the cost of your professional indemnity insurance to go through the roof.
My colleagues are genuinely worried about the pharmacy lobby’s efforts to take over these areas of clinical practice which should, for the sake of patient safety, be the province of general practice. It is just not possible to comprehensively manage conditions like asthma or diabetes or obesity in the environs of a retail store and without medical training in the nuances of chronic disease management.
That move seemed has now reappeared in what many of us consider to be a far more sinister form. ..nurse practitioners in pharmacies.

This has really got the medical profession offside… the prospect of pharmacy chains employing practice nurses as “substitute doctors”.
I don’t like to think I have to be watching over my shoulder for my local pharmacist to be setting up a quasi-general practice with a surrogate doctor in the form of a nurse practitioner or a pharmacist who thinks they can diagnose a medical problem without the benefit of a detailed physical examination involving removing all or some of a patient’s clothing, AND having an awareness and skills to deal with all of the possible complicating factors.

About ten minutes standing in your average pharmacy leaves the average GP breathless as variably trained pharmacy assistants listen to customers’ brief list of symptoms or self-diagnoses and then without the benefit of a full history or even a cursory physical examination, then recommend a variety of variably useful products which they then dispense.

One of my GP colleagues was recently waiting at the counter of a pharmacy while a mother described her baby’s nappy rash. My colleague had alarm bells going off at the description which sounded a lot like a staph infection, while the young pharmacy assistant recommended a range of lotions without even considering taking a look at the nappy rash itself, which would have been a pointless exercise in any case as they would have had no paediatric dermatology training and had probably never looked inside a nappy in any case.
There is a need for a mandatory minimum qualification and up-skilling of pharmacy assistants who have direct customer contact.

LEVEL PLAYING FIELD?
The pharmacy agreement is set to be renegotiated soon. This includes government funding of fees for dispensing, fees for providing medicines information (even though a survey found that only 15% of pharmacies actually provide this information), incentive payments for dispensing generics, and so on.

On the positive side, the pharmacy policy may serve to keep the huge corporate entities from taking over and squashing smaller, independently operated competition as has happened in petrol stations, liquor outlets and grocery stores, so preserving the public service provided by community pharmacy. But given that pharmacists can own a chain of pharmacies, they are able to form valuable oligopolies of their own.

However, the current environment opens up the whole question of pharmacy policy, free trade and the relative immunity of pharmacy from competition policy.
Why shouldn’t general practices have our own co-located dispensary with an employed pharmacist? It would certainly be more convenient for patients.
One of the arguments that has been put by the pharmacy lobby, and often perpetuated by elements of the medical profession itself, is that prescribing and dispensing should be economically at arm’s length to avoid so-called “perverse incentives”. What’s that about?

Pharmacists or pharmacist-employed nurse practitioners can be trusted not to over-recommend OTC products they are selling at a profit but GPs can’t be trusted with the same?
What about the financial compensation to substitute generics for prescribed brands? Why is that not a “perverse incentive”?

It certainly can’t be an argument about patient safety. Our cupboards are full of pharma-supplied starter packs and samples which we dispense liberally at our sole discretion.

INTERNET PHARMACY
When it comes to potential threats to the viability of community pharmacy, they don’t come much bigger than the word wide web.
In fact, it is an irony that in the face of protectionist policy, there has been the exponential growth in internet pharmacy sales
Once of my patients recently told me, “You have no idea how many people are ordering whatever drugs they want over the internet…antidepressants, sleeping pills, impotence drugs…things they know their doctors don’t want to prescribe them. The drugs just arrive in the mail”.

Pretty much any drug can be ordered over the internet without any contact with a doctor OR a pharmacist, without basic prescribing suitability checks, and regardless of whether the drug is approved by regulatory authorities.
There are apparently three motivations for ordering drugs online…cost saving, convenience and avoiding doctors.
The upside of a virtual pharmacy may be accessibility for elderly or disabled people who have trouble getting to the real pharmacy. There is also the possibility of cost savings for drugs not subsidised by the PBS.
However, any advantages would at least in theory have to be outweighed by the potential dangers, especially for the elderly. How do we know that drugs bought over the internet are from a reputable source, or produced by a “copycat” foreign manufacturer, without the quality controls of drugs sold through regulated routes? Just last week I saw a patient who had bought a supplement over the internet. He had taken this same type of supplement from a reputable manufacturer in the past with no problems. This time he had ordered it from a supplier over the net and his face and eyes inflated with a serious allergic reaction.

People purchasing these products, even if they appear to be the same as they would purchase from their pharmacy, do not know whether the products contain the correct, or indeed any active ingredients? There was a case in the US of counterfeit hormone patches with no active ingredients. They do not know if these products contain contaminants or toxic ingredients? Often the packaging is not secure and labeling incorrect or ilegible?
Without a doctor’s assessment and prescription or the double checking of a pharmacist, there can be no way of knowing about individual suitability and dosing, or for contraindications, precautions or interactions.
According to reports from the USA, drugs sold on the internet include clopidogrel, thyroxine and warfarin. The perils in unregulated supply of these drugs is obvious.

This issue has been around for almost a decade, but clearly the authorities have not been able to do much about it.
The truth is, our regulators have no control over this market, Customs are unable to capture the international traffic in small quantities of pharmaceuticals and customers looking for cheaper or “no questions asked” access to drugs they want or at lower prices are overlooking or unaware of the potential dangers.
We can have no idea how big the market is for internet sales. We do not know where the drugs are manufactured, whether they have been appropriately tested for quality, which patients are taking which drugs and what the individual or public health impact is. We can only guess. Our best hope is through public awareness.

CONCLUSION
Community pharmacy in Australia has a long and proud history. There are many major shifts in the business and political landscape occupied by pharmacies, and more change to come.
It is essential for general practice and pharmacy to maintain a co-operative and mutually supportive relationship.
At the moment it appears to me that the two professions are drifting further apart rather than increasing co-operation. Where is the dialogue?

The future of pharmacy will depend largely on the relationship of trust between pharmacist and customer and pharmacist and GPs all working towards to common goal of optimizing health for all Australians
The world of healthcare generally is evolving all the time. The challenge for pharmacy management is to anticipate these changes adapt its activities and objectives to be able to continue to provide benefits to the community in the context of the community’s needs and preferences.

Prof Kerryn Phelps
Queensland 2009