At the risk of a gratuitous self-plug, the use of these medicines in young children was one of the issues of concern that Ray Moynihan and I highlighted in our book, Ten Questions You Must Ask Your Doctor (Allen & Unwin, 2008). We came across several references raising concerns about these products’ use in children when researching the book back in 2007.

So the TGA is certainly not rushing the jump.

Nonetheless, the move will be such a challenge to accepted practices that it will need to be backed by a long-term educational campaign. So argues Ron Batagol, a Pharmacy and Drug Information Consultant.

He writes:

“In a move that is likely to provoke much spirited debate amongst doctors, pharmacists and, most importantly, the parents and carers who look after the day-to-day health issues of  young children in their care, the Therapeutic Goods Administration (TGA) has given notice that it is intending to  “upschedule” over-the-counter cold and cough products to Prescription Only for children under six years and Pharmacist Only for children aged between six and 12 years.

As part of the upscheduling exercise, the TGA has also recommended cough and cold medicines should not carry dosage instructions for children under six years old. The TGA says that this approach would bring the regulation of cough and cold preparations in Australia into line with measures in place in the UK and Canada.

After extensive  internal and external reviews of the evidence surrounding both  efficacy and safety in use, the proposed changes are stated by TGA to have been made ” in light of the current lack of evidence of efficacy and the historical profile of adverse drug reactions (ADRs) in Australia and overseas”.

It is certainly true, that the  consensus of informed opinion amongst paediatricians about the usefulness and propensity of side-effects of these products is in concurrence with the TGA assessment.

Now I must say that there is a whole fascinating social phenomenon associated with parents and carers buying cough ands cold products for children in their care.

This has, in fact,  been noted in the TGA External Review, where they raise the concept of  “social medication” which researchers have found is, in part, aimed at modifying child behaviour to more acceptable patterns, and in part a ‘coping strategy, and that cough and cold medicines were a common “social medication” in this respect’. Pharmacists at the “coal face” will be very familiar with this belief amongst their clients and the associated behaviour patterns.

Presumably, in recognition of  the social behavioural re-scheduling moves would certainly make them feel to some extent disenfranchised, turning on its head as it does, a long-held, even if erroneous, understanding that recommending a suitable cough and cold product for use by children served both a therapeutic and, as discussed, also a “social” function.

It seems to me that there will need to be long-term educational campaign on this issue, if the  proposed changes are adopted.

Indeed, TGA has said that the changes recommended would need to be widely promoted and explained to medical practitioners, pharmacists, parents and caregivers, and that particular efforts be directed towards educating consumers, medical practitioners and pharmacists that OTC cough and cold medicines have not been shown to be effective, and are potentially harmful in children under 6 years of age.

From recent discussions of this issue, when I raised it on our major pharmacy internet discussion website Auspharmlist, I have no doubt that at all that education and explanation will certainly be needed for many of my pharmacist colleagues, and their professional organizations!  This is, of course, quite understandable.

After all, on the face of it, the proposed issue is somewhat analogous to the lengthy but ultimately quite successful campaign over the past 5-10 years, to “educate” doctors and inform the broader community that antibiotics are not required to treat a whole range of common infections, and may ultimately promote bacterial resistance.

Five to ten years ago, of course, patients virtually demanded an antibiotic from their doctors in such situations.  These days, most patients are aware of this or, at least, do understand the situation when it is explained to them.

But, with TGA inviting responses from  stakeholder organisations, it is going to  require a huge effort to achieve the aims of broader community understanding of the rationale for the move by TGA to restrict availability of this group of widely-used, and generally well-regarded  infant and childrens’ medicines.”

She writes:

“Last week the 2009 annual report from the National Committee for Quality Assurance  (NCQA) was released.

The NCQA is a private, not-for-profit organization that was founded in 1990. The State of Health Care Quality report monitors and reports annually on performance trends over time, tracks variations in patterns of care, and provides recommendations for future quality improvement.

This report highlights how valuable an independent analysis of quality measures for private health insurance plans and the two government-funded plans, Medicare and Medicaid, is for everyone involved – policy makers, budget managers, health care services and professionals and patients.  The analysis is based on data that the health plans report voluntarily.

This year the results are disappointing, as they show that for the third year in a row, the quality of US health care has not improved across many key measures of clinical quality.

There are probably multiple reasons for the flat results of 2009, but a key factor is the lagging US economy which has led purchasers to focus more on cost than on quality.  Insurance plans have naturally followed suit and paid more attention to negotiating discounts and less to improving performance. And the most effective tool — tying payments to performance — is not being well utilised enough, especially by the Medicare program.

A related issue is that a many Americans lose their jobs, there is greater demand on Medicaid programs at a time when stets budgets are under maximum pressure.

But the report also shows that quality care is not necessarily expensive care, which does mean that in difficult financial times, improvements in quality should still be possible

Failure to jump-start quality improvement carries a significant price. This report estimates that improvements made in years past have saved between 165,000 and 272,000 lives, and there is much more progress possible. If all health plans performed at the same level as the top 10 percent of plans (the 90th percentile), between 49,400 and 115,300 deaths could be prevented each year, along with billions saved in health care spending.

The NCQA goes further with the data which is reported to them  – they rank the plans and publish the results every year in USA Today and on their website.

This transparency is not without its downside, and the private health insurance funds, under pressure from promised health care reforms, have been doing their best to airbrush their failing results.

As the NCQA President states in the preface, “This report provides ample evidence of the need for reform. ……These warning lights cannot be ignored.”

Will we ever get to such openness in Australia?  And would we feel that health care reform was a little more urgent if we had some longitudinal data to highlight where quality could be improved, and lives and dollars saved?”

Lesley Russell is the Menzies Foundation Fellow at the Menzies Centre for Health Policy at the University of Sydney and the Australian National University, and a Research Associate at the US Studies Centre, University of Sydney. She is currently a Visiting Fellow at the Center for American Progress in Washington DC.

Regular readers may remember that earlier this year Michele Kosky, executive director of the Health Consumers’ Council in WA, asked the TGA and Medicines Australia to investigate whether the consumer advertisement breaches the ban on direct-to-consumer advertising of prescription medicines.

In June, Croakey reported back that Kosky had not had any response from the TGA. Now it is October and, when I checked recently, she still had not had a response. Perhaps someone from the TGA might like to enlighten us about why the long delay?

Meanwhile, in case you missed her story in the Crikey bulletin last week, Dr Agnes Vitry, from the University of South Australia, has been examining some of the broader issues around direct-to-consumer advertising.

“Pfizer is running a big marketing campaign for its combination heart pill, Caduet. Medical magazines have been carrying full-page advertisements, advising doctors that “patients will soon be asking about their suitability for combination heart medications”.

The advertisement includes a sample from a consumer advertising campaign, which advises readers to talk to their doctor about a combination heart pill if they’re taking multiple medicines for their heart. The consumer ad incudes a rip-out section to take to the doctor, which carries a Pfizer logo and says “I’d like to discuss my treatment for high blood pressure or high cholesterol. Please advise me if a combination heart pill is suitable.”

This is occurring despite a Medicines Australia Code of Conduct, which complements the Australian legislation that prohibits direct-to-consumer advertising of prescription medicines. However, the code has several loopholes that allow pharmaceutical companies to subvert the ban on DTCA.

Unfortunately, direct-to-consumer advertising of Caduet is not an isolated case.

De facto direct-to-consumer advertising increasingly occurs in the form of “unbranded” advertisements or campaigns about specific diseases and conditions, which do not mention of the name of a specific medicine, but may include the company name or their logo.

Famous examples of unbranded marketing campaigns include the Viagra “Welcome Back Tiger” campaign. Pfizer, the maker of Viagra, simultaneously advertised to GPs and to consumers in popular magazines. The only difference between advertisements was the “omission” of the product name and product information in the consumer version. The tiger character became prominent in subsequent campaigns, making it synonymous with the product.

There are multiple examples of ongoing de facto DTCA campaigns in Australia. For example, Pfizer is currently running the “Master” marketing campaign for Champix (varenicline), a new drug marketed for smoking cessation.

The consumer campaign includes TV, radio, outdoor and online advertising. The “Master” is featured by a pack of cigarettes, “representing the manipulative inner voice of nicotine addiction”. This campaign encourages smokers to seek healthcare professional advice and visit outsmartcigarettes.com, a commercial website listing websites for smoking cessation products such as nicotine replacement product. At the same time, Pfizer is promoting Champix towards doctors and pharmacists and give them promotional leaflets to distribute to their patients.

Wide-scale advertising to the public of new medicines, whose long-term health effects are still unknown, is a threat to public health as two-thirds of the medicines that are withdrawn from the market due to safety concerns have been on that market for less than three years.

While advertising a medicine for smoking cessation such as Champix may seem a laudable objective, Champix is a new drug and as such, may cause severe adverse effects that may only be discovered post-marketing. No surprise, it is actually what happened with Champix.

Since the initial marketing of Champix, medicine agencies around the world have issued stronger and stronger safety alerts. In the United Kingdom, 1241 reports of suspected adverse reactions were received during the first year of marketing, mainly psychiatric adverse effects with headaches, abnormal dreams and nightmares, depressions and depressed moods and suicidal ideations.

In December 2008, the Australian Adverse Drug Reactions Advisory Committee (ADRAC) bulletin stated that they had received 339 adverse reaction reports with varenicline up to October 2008, more than 72% being psychiatric symptoms including depression, aggression, agitation, abnormal dreams, insomnia, hallucination and anger. There have also been reports of suicidal/self-injurious ideation or behaviour.

In July 2009, the US Food and Drug Administration required Champix to carry the agency’s strongest safety warning over side-effects including depression and suicidal thoughts. Despite the new, stricter warnings, the FDA said consumers and doctors still have to weigh the benefit versus the risks when taking the drug. “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, the director of the FDA’s Centre for Drug Evaluation and Research.

Another ongoing DTCA campaign is the Bayer’s campaign on how “low testosterone can take the life out of you” (for example, full-page advertisement in the  August 22-23 Weekend Australian Magazine). This campaign encourages men to see their doctors if they have any symptoms such as “lack of vitality, reduced sex drive, mood swings, poor concentration and reduced strength”.

Bayer’s low testosterone campaign is typical of a disease awareness campaign that is used as a strategy to extend the boundaries of illness and to expand markets for new products. In the case of Bayer’s campaign, men are told to view non-specific and common symptoms that may occur in ageing as a treatable disease that could be cured. It is similar to the promotion of hormone replacement therapy (HRT) for menopausal women.

And when you have the “disease”, look out for the drug! A single internet search showed that Bayer was marketing in Australia a range of testosterone products, such as Reandron 1000 and Testogel. The use of testosterone products (androgens) in men outside very limited indications is not a harmless measure.

Severe adverse effects from inappropriate use of androgens include sodium and water retention, oedema, acne, gynaecomastia, impotence, testicular atrophy, priapism, inhibition of spermatogenesis, degenerative changes in seminiferous tubules, impaired glucose tolerance, hypercalcemia, polycythaemia, decreased clotting factors, increased LDL cholesterol, aggressive behaviour, psychotic symptoms, physical and psychological dependence, withdrawal symptoms etc.

The ban on DTCA is related to the ban on direct sales of prescription medicines. It a health protection measure to prevent unsafe and unnecessary medication use. The ban on DTCA is consistent with regulatory aims to protect health and with the National Strategy for Quality Use of Medicines to encourage appropriate medicine use. DTCA may pretend to be information, but its primary objective is to increase sales of one particular medicine without any consideration for the public health issues.

Unbranded product advertising and disease-awareness campaigns are two of the most common forms of DTCA that should not be allowed in Australia if the current regulatory ban was properly enforced.

Over the past 20 years, several complaints have been sent to Medicines Australia about unbranded product advertising and disease-awareness campaigns. To our knowledge, they have never been upheld if the name of the advertised product was not explicitly mentioned in the advertising campaign. Any further complaint to the TGA would just remain ignored because of their absolute “trust” in the efficacy of the self-regulatory system for the control of drug promotion.

In the past few years, the successive waves of international scandals have revealed to a wide public that misleading drug promotion and unethical behaviour of top international drug companies were systemic problems and not isolated cases. The passive attitude of regulatory agencies will have to change if they want to keep the trust of the Australian public.

Parliamentary Secretary for Health Mark Butler recently declared that the government has begun to conduct a complete review of how the relationship between pharma companies and doctors is regulated. We hope that the Australian government will take vigorous steps to enforce the ban of DTCA in Australia including unbranded product advertising and disease-awareness campaigns. We hope that we will regain confidence in the Australian regulatory agencies to achieve what they are meant to achieve: preventing unsafe and unnecessary medication use and protecting the Australian public from the harm of misleading drug promotion.”

• Dr Agnes Vitry is a member of Healthy Skepticism and Health Action International

But at least we now have some idea of what sort of questions we should be asking, thanks to a report released this week by the Australian Institute of Health and Welfare, called Towards national indicators of safety and quality in health care (and available here).

The Australian Commission on Safety and Quality in Health Care funded the Institute to develop safety and quality indicators for various health settings, including primary care and community health care services, hospitals, specialised health services (such as palliative care, defence health services etc), and residential aged care.

Now that we at least know the questions to ask, we’re somewhat further down the path towards open public reporting of health service performance.

The report notes, however, that the issue remains extremely contentious and that “Australia has yet to follow the lead of countries such as the United States of America and United Kingdom which have adopted detailed regular public reporting at the provider level”.

While there are many concerns about the impact and usefulness of open public reporting, the report says it could have two purposes: to provide transparency and to inform decision-making about overall priorities and system-level strategies for safety and quality improvement; and to inform quality improvement activities of service providers.

It cites one study comparing the degree to which performance information stimulated quality improvement activity in hospitals if it was publicly reported or if hospitals received private reports.

The authors reported finding strong evidence that “….making performance information public stimulates quality improvement in the areas where performance is reported to be low. Since quality improvement efforts among the public-report hospitals appear to be significantly greater than in hospitals given only private reports, there is added value to making performance information public.”

To give you an idea of the indicators suggested by the report, they include:

For primary care and community health services:

• General practices with a register and recall system for patients with chronic disease
• People with moderate to severe asthma who have a written asthma action plan
• Mental health care plans in general practice
• Annual cycle of care for people with diabetes mellitus

For hospitals:

• Assessment for risk of venous thromboembolism in hospitals
• Pain assessment in the emergency department
• Stroke patients treated in a stroke unit
• Complications of transfusion
• Health care associated infections acquired in hospital
• Adverse drug events in hospitals
• Malnutrition in hospitals and residential aged care facilities
• Pressure ulcers in hospitals and residential aged care facilities

For specialised health services:

• Post-discharge community care for mental health patients
• Functional gain achieved in rehabilitation
• Multi-disciplinary care plans in sub-acute care

For residential aged care:

• Oral health in residential aged care
• People receiving a medication review
• Falls resulting in patient harm in hospitals and residential aged care facilities

The report note that indicators already exist for specific types of services, including Key Performance Indicators for Public Sector Mental Health Services, Australian Council on Healthcare Standards clinical indicator sets, for specific population groups such as the Aboriginal and Torres Strait Islander Health Performance Framework, and the COAG National Healthcare Agreement Performance Indicators.

Now that we have all these questions to ask, when will the answers be made available to the public? And will we make best use of them? So many questions searching for answers…

Carol Bennett, executive director of the Consumers Health Forum, is encouraging the public to discuss the pros and cons of vaccination with their health provider, rather than relying on media coverage to inform their decisions.

Here is what she has to say:

“While I do not claim to be an expert on the H1N1 vaccine and the specific risks associated with the vaccination, I think we will need to rely on individual health service providers to be aware of, and inform, consumers about the risks rather than expecting consumers to rely on a broad media discussion of potential risk factors.

I know that the risks of any vaccination vary considerably according to individual characteristics – a preschool child has different risks to a teenager who has different risks to an obese middle aged nurse or an older businessman with pre existing asthma and diabetes.

Knowing there are some risks does not inform individuals about how the risk relates to them personally.

I am not one to support health consumers being treated as mugs, but I am confident most health consumers would prefer to discuss their specific circumstances with their health service provider rather than base their risk assessment on generalised advice provided by media summaries of a Health Minister’s statement about potential side effects.

My reading of the media is that the Health Minister has been transparent in both the advice she has received (including potential risk factors) and the policy that she is adopting.”

Below is a document that the Medical Indemnity Protection Society has sent members, making it clear that they will be covered only if they obtain informed consent from patients. This means discussing the potential benefits and risks of vaccination versus no vaccination.

It is interesting to contrast what the Government is telling the public with what doctors are expected to tell their patients. Quite a contrast.

Now, don’t get me wrong. I am not opposed to vaccination per se, and I am certainly not seeking to inflame anti-vaccination campaigns generally.

What I do want, however, is for those in positions of authority to be upfront and honest with the public – in the way that the health professionals charged with delivering the vaccination program are expected to be.

I’ve been thinking about what Minister Roxon could feasibly say when asked about the pros and cons of vaccination and issues such as the infection control concerns around multidose vials.

Of course she doesn’t want to say anything that will lead to alarmist tabloid headlines. But that doesn’t mean she can’t acknowledge that there are legitimate concerns, and to explain how these are being addressed.

Apart from anything, this discussion might help members of the public play a more active role in their care. I was struck by a comment on the earlier Croakey post, where a reader asked: “Is there anything ‘mug consumers’ of swine flu vaccination can do to minimise their risk of contamination with multidose vials?”

It’s not such a silly question. Ensuring consumers are informed about potential risks is well acknowledged within the broader safety and quality field of being one way to minimise the risk of adverse events or to ensure they are effectively managed if they do arise.

If the Government insists on treating the general public like mugs who are incapable of engaging with these issues in a sensible way, it is missing an opportunity. And so are the health professionals who would prefer all these debates stay firmly behind closed doors.

Anyway, enough ranting from me. Here is the advice from the Medical Indemnity Protection Society to doctors:

SWINE FLU VACCINATION – MEMBER INFORMATION
The Australian Government plans to distribute the swine flu (H1N1) vaccine in the near future. This information from MIPS clarifies the indemnity issues surrounding this vaccination program for members and their employees.

Indemnity for members
MIPS will indemnify its members for administering the H1N1 vaccine however, members are required to:
•    provide patients with adequate informed consent including a succinct summary of the current information needed to make an informed decision about H1N1 vaccination.  This should include information about the risks of the vaccine, the general risks of an injection and risks of electing not to have the vaccine;
•    follow the current draft RACGP Guidelines for the use of multi-dose vials (MDV’s) available at http://www.racgp.org.au/h1n1/33545; and
•    meet MIPS general requirements of appropriate qualifications, training and experience.

Informed consent
Members need to appropriately advise patients of the risks of H1N1 and the risks of having or not having a H1N1 vaccination based on their individual circumstances so that patients can make an informed decision (and therefore provide informed consent to undergo vaccination).
For example this should include:
•    information regarding risks associated with H1N1 compared with seasonal flu;
•    information comparing risks from catching H1N1 compared with risks associated with vaccination;
•    advising that the vaccine is currently undergoing clinical trials; and
•    that it is currently not clear whether one or two doses will be required to achieve immunity.

Although presumed, it is not yet confirmed that the risks of H1N1 are in general much higher than normal seasonal flu and/or the extent that the risks of H1N1 are more serious and/or more likely than the risks associated with vaccination.

According to the Australian Government there have been no concerns raised from early vaccination trial data, however it is possible concerns might be subsequently identified.  Members should also set patient expectations that a second vaccination dose may be required and ensure appropriate recall systems are in place to achieve that.

Ultimately, it is the patient after having been appropriately informed, that must make a decision as to whether they wish to proceed with vaccination or not.

Information material
The Australian Government has advised it will provide health professionals and patients with Pandemic H1N1 Influenza Vaccine Information material and also a “consent” form. These should be used.  Refer www.healthemergency.gov.au.  As for any health service the patient’s medical record must also reflect advice given and the patient decision.

Multi-dose vials
For adults the H1N1 vaccine will be presented in multi-dose vials. Practitioners and patients need to be aware of the steps taken to remove potential risks associated with use of multi-dose vials particularly in relation to vertical transmission of blood borne diseases. Strict adherence to the RACGP Draft “Guidelines for the use of multi-dose vials” is required by MIPS because it will remove that risk and thereby provide confidence to patients when making a decision about H1N1 vaccination.

Other matters
The normal issues associated with seasonal influenza vaccines for e.g. egg allergies/potential issues with preservative, risk of bruising, infection, sterile abscess, nerve damage etc. remain for consideration in respect of H1N1 vaccination.

In addition, strict attention to maintaining the cold chain (especially in view of the huge volume of vaccine and potential vaccinations) provides a greater challenge than for other vaccination programmes.

Indemnity for members, those under members direct supervision and practice staff
For those members whose practices are considering arranging for employed staff such as practice nurses to administer the vaccine, in addition to compliance with the above requirements (e.g. for advice and use of multi-dose vials) it is important to remember under the individual MIPS Insurance medical indemnity policy a MIPS member is covered for vicarious liability claims that arise from the provision of healthcare by others under the member’s direction in accordance with clause 12.1.7 of the member’s medical indemnity policy. The relevance of the clause is the requirement for the member’s appropriate and adequate direct supervision and also for the supervised individual to act within practice protocols. The MIPS Insurance Policy can respond if the member’s practice staff seeks indemnity from the member on the basis that the claim against them is as a result of the member’s actions or inactions but only if all requirements are met.

MIPS Members’ Practice staff and the practice entity are also indemnified in accordance with the terms and conditions of the MIPS Member Practice Entity Policy. (A practice entity is defined as a practice in which a member has a financial interest and the majority of shares are owned by medical practitioners working in the practice). In general terms this policy provides cover for health care errors made by practice nurses, receptionists and other administrative staff who act independently and which may financially implicate the practice and/or the member.

It is important to remember that MIPS requirements (as listed above including consent and use of RACGP guidance for the use of multi-dose vials) will be a pre-requisite in relation to indemnity for any H1N1 vaccination matters that arise.

There are many potential downsides to such simplistic messages.

You can read more about some of them in this article, published today in the SMH and online at the National Times, by Simon Chapman and Alexandra Barratt, from the School of Public Health at the University of Sydney.

Asked about infection control concerns surrounding the use of multidose vials(as outlined in this Crikey story recently), Minister Roxon said these are “very minimal”.

Does she realise what dangerous territory she’s entering here?

Our national infection control guidelines (you can read them here) state that the use of multidose vials is a “high risk” procedure (p49).

The guidelines cite the Australian Drug Evaluation Committee’s advice that “injectable products packaged in multidose vials should not be used except where products such as insulin are intended solely for the exclusive use of an individual patient”.

The guidelines also state: “When single-dose vials or ampoules are not available, the risk of cross-contamination is high if injectable products are used on multiple patients.” They recommend several measures for controlling this risk.

If the Government and its advisors have decided the potential benefits of a mass vaccination program outweigh the costs, including potential harms, then fair enough. Not everyone agrees with them, but that’s their call.

It’s another matter entirely to mislead the public in an effort to sell their program.

This will come back to bite them on the bum, pardon the language, if history is any guide. You don’t have to look too far back to find an example of the perils of health ministers spruiking pharmaceuticals.

Below follows is an extract from Ten Questions You Must Ask Your Doctor, which I wrote with another health journalist Ray Moynihan. This particular section comes from a chapter urging readers to be more alert to the possibility of side effects from medications and notes that these are often downplayed.

“In June 2000, the then Australian Minister for Health, Dr Michael Wooldridge, issued a most extraordinary media statement. In it, he announced that the first of a new class of arthritis drugs called COX 2 inhibitors would be funded by the Australian Government. He said the drug, celecoxib (sold under the brand name Celebrex), was significantly safer than older types of drugs used to treat arthritis and called it a ‘major breakthrough in arthritis therapy’.

It was highly unusual that a Health Minister would feel the need to single out any one drug for such an enthusiastic plug. It was even more remarkable considering that a careful reading of the scientific literature would have shown there were already rumblings of concern about the safety of COX 2 inhibitors. Over the next few years, these rumblings turned into a roar of alarm and an international scandal damaging public trust in drug regulatory agencies, medical journals and drug companies alike.

We now know that tens of thousands of people around the world paid a very high price – suffering heart attacks and strokes – for following advice to take drugs that they had been assured, wrongly as it turned out, were safer than older types of arthritis drugs.

Taxpayers and patients also paid a very high price for the overly enthusiastic promotion of these drugs, which reaped huge profits for their manufacturers. While safety concerns surround many of the COX 2 inhibitors, including the one so warmly endorsed by Dr Wooldridge, the most alarming case is that of rofecoxib, which was sold under the brand name Vioxx by the drug giant Merck.

The history of rofecoxib reveals how so many different groups failed to protect the public’s safety…”

I am not suggesting that swine flu vaccination will turn into this scale of disaster. I sincerely hope not.

But the point is that there are enough lessons from recent history for Health Ministers to be extremely cautious about how they pitch pharmaceuticals and other health interventions to the public.

We need to be able to have an open and frank discussion about the costs and potential harms of any interventions – including vaccines – as well as their potential benefits.

It’s not surprising, of course, that magazines like Australian Doctor, Medical Observer or the latter’s new Practice Nurse tend to slant their coverage towards the perceived interests of their readers. Any sensible media organisation selects stories, writes them and displays them with the audience firmly in mind.

But one downside of silo-based publishing is that it leads to silo-based coverage of health issues, whose limitations become more apparent as we move towards an era of team-based, multidisciplinary care.

The dream of my colleague and I was that our new magazine would have a multi-disciplinary readership, and thus would cover stories in a way that didn’t give any particular weight to any particular professional perspective. That way, the stories might really be about health, rather than health professionals.

In this day and age, our magazine will probably remain a pipe dream; you don’t hear of too many new publications starting up. But I’d like to think that Croakey offers a forum for discussion across disciplines and sectors.

So I was most interested to receive a note on the “thorny issue of interprofessional practice” from Associate Professor Ann Larson, Director of the Combined Universities Centre for Rural Health, in Geraldton.

She was responding to a new study, led by researchers with a long interest in the potential of medicine reviews to reduce adverse events and improve care (including Libby Roughead from the Sansom Institute at the University of South Australia).

The study found that when GPs and pharmacists collaborated on home medication reviews for heart failure patients, the patients were less likely to end up in hospital than those who had no such review. The study was testing what happens in the real world – being based on retrospective analysis of patient records – rather than as part of a randomised controlled trial.

But for Ann Larson, the study has raised at least as many questions as providing answers.  She writes:

“Roughead’s retrospective study of the medical records of veterans with heart failure found that that a formal pharmacist intervention, in the form of home medication reviews and other consultations between the pharmacist and GP, was associated with reductions in hospitalizations.  This is consistent with other studies that have found pharmacist collaborative care to be effective.

What interests me the most is that the study also contributes to a larger debate of the value of inter-professional practice and its role in health care reform, but as such raises many questions.

How far can we generalize the experience of patients with GPs who have elected to seek pharmacist input?  In a small study I was involved in, a committed GP made at least some change in almost all patients’ (84%) medications following a home medication review (Quirke et al 2006).

However, are all GPs as receptive to pharmacists’ input?  And are patients who could benefit from a home medication review equally or more likely to see a GP who initiates collaborative care as those who do not?  If home medication reviews were mandated for certain conditions, would there be the same impact on prescribing patterns?

Another question is what causes the association between collaborative care and reduced hospitalizations?  Is it improved prescribing habits or more informed and motivated patients?  The answer will influence how these observed benefits could be extended to all Australians.

If GP’s prescribing habits are affected, then it may be that pharmacists need only conduct home medication reviews on a small of patients, but have more detailed feedback which will promote best practice prescribing.  On the other hand, if home medication reviews are effective because the pharmacist and patient communicate better than the patient does with his or her GP, then other health professionals or even trained lay people may be able to give medication education to patients with equal results.

Home medication reviews are still fairly rare in Australia.  Only 5% of this study of veterans had one.  If they were to be expanded, a number of other issues would become important.  Again, in our little study we found that while the GP was very satisfied with the program, local pharmacists felt that it was of limited financial or professional value, especially in circumstances where there is only one or two pharmacists and a requirement for constant presence at the business.

If the demand increased to the point that some pharmacists would derive most of their income from conducting HMRs, would the independent relationship between the pharmacist and GP be compromised?  Would their need to be a code of conduct to resolve situations where there was a difference of opinion or an error by either party?  Nor should we forget the patient?  What is the appropriate role for a patient and should HMRs be promoted to patients rather than to the GPs?

And finally I cannot help but speculate on the impact in rural and remote areas.  I have already mentioned the problems for the solo pharmacist.

But many small towns and remote communities lack a resident pharmacist altogether.  If HMRs are to be encouraged as an effective model of inter-professional care then it will be necessary to explore HMRs by telephone or with the assistance of another type of health worker being the eyes (and even ears) for the distant pharmacist.  If provision in the fee structure is not made for HMRs by distance, rural and remote residents will lose out again from benefiting from health care reform.

It is axiomatic that two professionals from complementary but distinct disciplines will provide better care than one professional.  The fact is that doubling the number of health professionals will be a more expensive service.  Understanding what features of collaborative care result in health gains are critical if we are to afford the better health care that we all want.”

(Quirke J, Wheatland B, Gilles M, Howden A and LARSON A. 2006. Home Medicines Review: do they change prescribing, and patient and pharmacist acceptance? Australian Family Physician. 35(4):266-267.)

The PM cited Australian research, recently published in the New England Journal of Medicine and reported in Crikey,  which found, he said, “that a commonly available treatment for fractures of the bones of the spinal cord was in fact no better than doing nothing at all”.

The PM said the Government was “keen to explore in conjunction with private health insurers and our research community” an NHMRC suggestion that treatments, therapies and devices which are not backed by evidence should be evaluated.

In the light of the PM’s enthusiasm for ensuring that health funding is well spent, I wonder whether he and his office are familiar with the work that was being done along these lines by the Royal Australasian College of Surgeons in evaluating surgical techniques.

Professor Guy Maddern, a surgeon who has been a driving force behind this work, writes of his great frustration at the Government’s apparent lack of support for the work:

“The recent publications in the New England Journal of Medicine describing the results of vertebroplasty highlight the problem of introduction of new surgical technologies.

Whenever a new procedure is assessed, particularly in its early stages, it is often difficult to prove that it is a superior step forward than existing technologies. This is in part because it is difficult to conduct the trials necessary to prove benefit.

Rather than rejecting a procedure because the evidence fails to be compelling, these two recent publications in the New England Journal of Medicine highlight the need for careful and assessed introduction of new technologies and procedures into surgical practice.

It is a great shame that the Australian Commonwealth Government does not greatly value assessment of procedures, particularly if they are not associated with a new Medicare item. While great efforts are put into assessing introduction of new drugs, substantial efforts are put into assessing new devices, much less effort and energy is put into the assessment of new procedures which often represent an alteration, which may be significant, of existing procedures.

It has been a great disappointment to the Royal Australasian College of Surgeons that the Commonwealth Government has not felt the need to continue to support the Australian Safety and Efficacy Register of New Interventional Procedures in Surgery.

This organisation, run by the College of Surgeons, attempts to look at new procedures that are introduced without the necessity for new Medicare item numbers. It may be that the alteration of a length of bowel, an angle of suturing or the use of existing devices in new and novel ways can bring enormous benefits but also potentially enormous harm to patients.

This desperately needs to be assessed and reported on, but explaining this to the Government at this time is a difficult and frustrating experience.

The reporting of this recent study highlights the difficulties in assessing new technologies but does not excuse the process from occurring. Hopefully it will provide further evidence to the health authorities that such activities are desperately needed within our health system.”

More info about the scheme is available in this British Medical Journal article.