Post ANAO Report – the way ahead.

In his State of the Union address on 20 January, 2015, President Barrack Obama said:
“I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time.”
And crucial to achieving that reality, said experts who addressed the 2014 Mid-year Clinical Meeting of the American Society of Health-System Pharmacists (ASHP) a month earlier, is continued development and implementation of testing and decision support technologies, greater educational opportunities and the leadership of pharmacists.

And because it is a drug-related role it is natural that pharmacists lead the way.
The fact that it comes as new technologies associated with Pharmacogenomics may be both fortuitous and coincidental for Australia’s pharmacists, who have the potential of facing a professional vacuum in their clinical role development, post the ANAO report recently published.
The Australian National Audit Office reported in February that the agreement has failed to deliver any tangible improvement in the quality use of medicines  – which is its reason for being.”

The Professional Pharmacists Australia union, in a recent media release stated:
“It is extremely concerning that 20,000 employed pharmacists and millions of Australian consumers were completely shut out of a process that determines the shape and form of pharmacy services for the next five years.

“Without Government leadership on this, we face the very real possibility that the Sixth CPA will be negotiated by pharmacy owners, for pharmacy owners.

“We believe that the Government has within its power, an opportunity to strengthen community health outcomes by bringing together the knowledge and experience of community pharmacists, and the interests of consumers, to create a future for pharmacy that serves everyone, not just owners.

“The current policy settings have failed on several fronts. The community is not getting best value for money, consumers are not getting the best healthcare and employee pharmacists are entangled in retail sales, rather than using their professional knowledge and skills.

“More innovative rules have been adopted to great effect in places such as Scotland and New Zealand, where community pharmacy has shifted away from simply being a storefront, to becoming an integrated part of healthcare provision.

“Now is the time to find solutions to the challenges facing the sector and improve outcomes for more Australians. To be successful, this requires the input of many groups, and the exclusion of none.

So the stage is set for Australian Clinical Services Pharmacists to take control of their direction and opportunity (with government assistance) to drive new roles that are already being proven in the US.
It will also need Australian pharmacy schools to update their offerings and be able to deliver virtually, suitable education in a decentralised fashion to pharmacists “on the job”.
Evidence continues to underscore how variations in human genetic makeup may help explain differences in individual responses to treatments for cancer, HIV/AIDS and depression, among other health conditions.
To date, 138 drugs including codeine, proton pump inhibitors, abacavir (Ziagen, ViiV) and irinotecan now have genetic data in their FDA-approved product labeling.

In the case of irinotecan, labeling states that dosage adjustments should be considered in patients who test positive for the UGT1A1×28 allele and who are thus poor metabolizers of the colorectal cancer medication. This genetic variant can lead to severe and potentially life-threatening side effects, especially when irinotecan is given at higher dose levels. If a patient tests positive for UGT1A1×28, prescribers can order lower doses, often with no loss of efficacy (J Clin Oncol 2006;24[28]:4534-4538).

Similarly, data suggest that genetic polymorphisms can influence how patients respond to paclitaxel.
In one study, investigators reported a near doubling of the risk for paclitaxel-induced neuropathy in patients with CYP2C8×3 status (Breast Cancer Res Treat2012;134[1]:401-410).

Fully utilizing this type of genetic information could have profound implications for health care, experts said. In 2013, U.S. pharmacies dispensed 738 million prescriptions whose uses may have been improved with pharmacogenomics (Annu Rev Pharmacol Toxicol 2015;55:89-106). Total prescription drug expenditures that same year, according to the Centers for Medicare & Medicaid Services, reached $271 billion.

“There’s been a dramatic increase in not only the cost of health care but also the availability of data that helps us select the best therapies for patients,” said Philip Empey, PharmD, an assistant professor of pharmacy at the University of Pittsburgh’s School of Pharmacy. “The completion of the Human Genome Project, and the plummeting costs of getting genetic information on patients, creates an opportunity.”

And in the “black hole” surrounding 5CPA methodology, something ought to be salvaged by including all the voices of pharmacy and creating lead roles for clinical services in matching patients to drugs, and also including the social basis for health by pointing and assisting patients in the health drivers for freshly prepared and nutritionally dense foods.
This latter area of activity makes more sense in reconnecting with a local community rather than running a range of packaged grocery specials.
At last I can be personally involved with a patient with skills, that when delivered by me, will make a real difference.

At the University of Florida, a clinical decision support program is now available and fires an alert if a drug is not optimal for a patient given his or her genotype—much like a drug interaction warning.
And the list of supported drugs continues to expand.
Next up are a variety of pain medications, including codeine and oxycodone.
The presence of CYP2D6 genetic polymorphisms can predict how well a patient will metabolize these drugs.
Pharmacists are “front and centre” in this program—surrounded by a multidisciplinary team of pathologists, physicians, nurses, phlebotomists and information technology experts.
With an in-house pharmacogenomics lab, they’ve achieved 24-hour turnaround times. Outside labs can take days, even weeks.

Doesn’t this sound a better blueprint for a patient-centred home that has the potential for community pharmacies to provide the “home”?
Doesn’t it answer some of the medical criticisms of the 5CPA in that adverse reactions were not improved under that program segment (but could be dramatically improved with pharmacogenomics services), and does it not point to a prescribing role as a non-pharmacy owner with the ability to further match a patient with a 3D printer prescription, written as software code and delivered electronically to a pharmacy computer?
Wouldn’t an outreach to patients being discharged from hospitals make better sense with appropriate “handover” protocols to a clinical service pharmacist with a base in a community pharmacy?
And with all the relevant skills would it not make most sense to have an alliance between the clinical service pharmacist and a community pharmacy to deliver health in this type of a patient-centred home?

This is the future of pharmacy, and I mourn for all the wasted years created by a dysfunctional PGA leadership supported by a problematic government department.

In the US, the ASHP, helps run the Clinical Pharmacogenetics Implementation Consortium (CPIC). The CPIC aims to address some of the barriers to the use of Pharmacogenomics in clinical practice, by offering providers anywhere with evidence-based guidelines for translating test results into prescribing decisions.
Behind the guidelines are peer-reviewed studies, like recent research that found a patient’s genotype can predict response to mercaptopurine, an essential leukemia drug (Am J Med Genet C Semin Med Genet 2014;166C:45-55).

The CPIC also has created informatics tools to further aid clinicians. These tools include passive and active clinical decision support (CDS) programs that are vendor-agnostic and can be applied to any electronic health record.

The Centre for Health-System Pharmacy Leadership, in their “Pharmacy Forecast 2015-2019,” reported that 79% of experts surveyed predicted “at least one academic medical centre in their region will have a formal pharmacy-based pharmacogenetic information/consultation service for health professionals and patients within the next five years.”

“Health care is becoming increasingly integrated.
 Pharmacogenomics is going to be part of programs led by health systems.”
“That’s where the future of health care overall lies, and that’s how pharmacogenomics is going to be more broadly implemented—with pharmacists taking broad leadership roles.”

And in a week where pharmacists collectively have had reason to be a bit “down” we can all take heart at the above positive direction.

But we do need a new crop of imaginative and qualified leaders to move the profession in this direction – and as quickly as possible!

But there’s more!
Technology has existed for the past five years where pharmacists, using near infrared spectral analysis equipment, can immediately verify the ingredients of any dose of any medication.
As a QUM process would it not be a great claim to be able to say that in Australian pharmacy, we have eradicated counterfeit drugs?
Spectral analysis develops images of “footprints” in any drug mixture and can measure the actual molecule, the dose present and whatever else it has been compounded with. The technology is cheap and it’s available now.

And as a last QUM suggestion I reprint an extract of a media release by the Victorian State Coroner:

“According to the coroner’s office, 384 deaths were attributed to drugs and alcohol in 2014, up from 342 in 2010. The state’s total overdose death toll has risen for the fifth consecutive year, and compares with the 2014 Victorian road toll of 248 people killed.

Coroner Audrey Jamieson presented the newly released figures around the drug death toll at the International Medicine in Addiction Conference in Melbourne on Saturday.

The findings also highlight how prescription drugs in general, and benzodiazepines in particular, consistently contribute to more deaths than either illicit drugs or alcohol.

Prescription drugs were found to have contributed to the deaths in more than 82 per cent of the 384 cases investigated by forensic pathologists. Illicit drugs were found to have contributed to 42 per cent of all fatal overdoses, and alcohol was found to have contributed to nearly one in four deaths, although many overdose deaths involved more than one substance.

Benzodiazepines – including commonly prescribed sedatives for treating anxiety and sleeping pills – are now involved in more than half of all overdoses.

Diazepam contributed to 168 deaths in Victoria last year, making it the largest contributor to overdoses. By contrast, heroin contributed to 135 deaths, alcohol contributed to 93 deaths and methamphetamine contributed to 52 deaths.

Coroner Jamieson told the conference the findings revealed how benzodiazepines were ubiquitous in overdoses involving other drugs, widely misused and highly addictive.

The findings highlight continuing calls from medical professionals and the State Coroner to introduce a real-time register for doctors and pharmacists to monitor prescriptions and to tighten prescription practices around benzodiazepines.”

We have had the technology for years to create such a register and it is not inexpensive to produce.
Pharmacists should note the Victorian Coroner’s findings and get on with the job.
And here we find the disconnect – there is likely to be a conflict of interest because the inventor of the best system may not be favoured by the PGA.

This should never be the case.
And the inventor would probably not get a grant to develop and build the project in the first place, because “you know who” control all the grant applications.

While this glaring situation persists pharmacy will continue to attract more negative comment from mainstream media.
I’m over it!

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