Category: News

ACP Response MBA Public Consultation

Dear Members

My name is Daryll Knowles, I am the owner of Australian Custom Pharmaceuticals, one of Australia’s largest compounding pharmacies. I have been practising compounding for over 30 years and my facility is a recognized education site for University students and Compounding pharmacist training.

It is only through thorough dialogue and understanding of all stake-holders’ positions that informed and objective decisions can be made.

To make clear the MBA’s expectations, there needs to be clarification of definitions to ultimately increase positive medical outcomes for patients and give guidance to practitioners. Further clear guidance will also, as it has done in the compounding pharmacy industry, provide comfort to appropriately trained medical practitioners.

As a compounding pharmacist I have been involved in various public consultations with  Pharmacy Board of Australia (PBA) and Pharmacy Council of NSW (PCNSW), via submissions,   investigating the Guidance for Compounding Pharmacies and Pharmacists.  Like the MBA, the PBA and PCNSW’s primary objective is public safety.

The PBA and PCNSW has set about achieving this by clarifying vagaries of definitions and updating their guidance with regard to existing Australian and global standards.  This gave compounding pharmacists a clarity of their expectations.

By the PBA mandating compounding pharmacies use recognized global standards for sterile (USP 797) and regarding Non-sterile compounding (USP 795, APF) it has given compounding pharmacists a clear path to compliance which has the ultimate result in increased patient safety. If a medical practitioner providing complementary, unconventional medicine and emerging treatments uses a compounding pharmacist who complies with PBA Guidelines, Pharmaceutical Society of Australia (PSA) Professional Practice Standards and are accredited in USP 797 and USP 795 they can rest assured that the quality and conduct of these pharmacists is of a standard to maximize positive patient safety and positive medical outcomes.

I note and refer to the MBA /PBA Joint statement of 24th November 2017 which in summary states that the two regulatory bodies have a similar belief in what defines “Good Practice” and where the individual scope of responsibility lies for both medical practitioners and pharmacists with regard to the current guidance.

It is from experience in the compounding industry and the requirement for clarification of the expectations from the current hazy guidance that leads me to support Option 2.

In stating my preference for Option 2 I also acknowledge the MBA’s intentions on page 18 of the Discussion paper that:

Guidelines that define good practice for complementary and unconventional medicine and emerging treatment:

  • would not reduce consumer choice
  • would not restrict medical practitioners’ practice
  • would not result in significant cost increases for consumers or medical practitioners
  • would not restrict existing, accepted practice that may fall within the definition of complementary and unconventional medicine and emerging treatments
  • would not stifle innovation or clinical research and trials.
  • would not reduce consumer choice
  • would not restrict medical practitioners’ practice
  • would not result in significant cost increases for consumers or medical practitioners
  • would not restrict existing, accepted practice that may fall within the definition of complementary and unconventional medicine and emerging treatments
  • would not stifle innovation or clinical research and trials.

It is my opinion that integrative, complimentary and functional medicine as some of the oldest disciplines are absolutely essential fields of medicine.

I also find the rolling of integrative, complimentary and functional medicine into the same category as other unproven or experimental and emerging therapies such as stem cell therapies, unregistered diagnostic techniques or procedures, whether used in addition to (complimentary), or instead of conventional medicine (Alternative) as over complicating the argument. This includes unconventional use of approved medical devices and therapies (Off label Use). NSW Ministry of Health actually has policy regarding the widespread prescribing of alternative use of Conventional medicines.

Is very confusing and just plain wrong in terms of the level of evidence for each of these different disciplines.

We currently have over 3500 integrative medical practitioners on our database and over the last 15 years dispensed over one million socially valuable evidence-based medicines to hundreds of thousands of patients. There are over 600 (estimate only) compounding pharmacies in Australia of all different sizes. The fact that this industry has flourished over the past three decades indicates that patients want this industry to be both available, and above all safe for them to access medicines. The patient outcomes from this complimentary and integrative industry in terms of patient’s safety is over whelmingly positive.  TGA is unable to identify one death from the use of complimentary or integrative medicines as opposed to the over 650,000 deaths from Iatrogenic mishaps from “conventional medicines” (Pharmaceutical Society of Australia 2019. Medicine Safety)

The alternative to appropriately trained medical doctors and accredited compounding pharmacists is – perhaps unsurprisingly – Dr Google and Online stores that dispense these medicines with no prescription or supervision. People will still seek these treatments. It is therefore essential that this industry is regulated in a reasonable fashion to allow it to flourish in a safe and cost-effective fashion, rather than driving it and patients underground and to the internet for their medicines. It is correct for the MBA to have concerns about the conduct of some medical practitioners or compounding pharmacists as explained in the examples of illegal behaviour which negatively impacts on patient safety. Unfortunately, individuals who choose to act illegally will not be affected by a stricter guidance. Stricter guidance however will benefit legitimate, appropriately trained practitioners who already conduct their practice within the expectations of the MBA and remove the stresses of vague definitions and interpretation of less specific guidance. Ultimately helping remove the ever-growing fear of being investigated on the say so of non-practicing, vindictive complainants who use these vagaries to promote their own agendas.

In creating clearer guidance, I would like to draw the MBA attention to the definitions that have been suggested.

Conventional medicine:

It appears that the MBA and other industry group members consider the economic decision of a Pharmaceutical manufacturing company to engage in the process of registering a drug on the ARTG (Australian Register of Therapeutic Goods) as the primary qualifier for it to be regarded as conventional medicine.  This disregards the fact that this same drug may have been tested and trialled but not registered for other uses or is registered in another country for a different purpose. A well-known example is Sildenafil. Pfizer trialled this drug for pulmonary hypertension in neonates and subsequently for erectile dysfunction. It then made the purely economic decision to register sildenafil for erectile dysfunction thus creating a conventional on-label use and relegating the pulmonary hypertension use to a controversial off label or unconventional use even though it was the primary indication for which sildenafil was originally investigated. Under this definition it is the economic decision of a pharmaceutical company that decides whether a drug is conventional or not.

This leads to confusion especially when drugs are registered with Drug Regulatory authorities overseas for uses that are not registered in Australia. Are these conventionally used overseas drugs then conventional medicine in Australia? By this definition, no. Take for example ketamine and its use in treatment resistant depression (TRD). There is a product registered by the FDA for TRD but in Australia we still consider this an experimental and unconventional use.

My opinion on this is to disregard the confusing terms of conventional and unconventional altogether and keep the terms:

1)Off-label – non registered indication for a registered drug on the TGA ARTG,

2) On-label – Registered indication for a registered drug on the TGA ARTG,

3) Complimentary use – prescribed in combination with a main stream medicine to augment a positive medical outcome and

4) Alternative medicine – which is used instead of a mainstream medical protocol after failure of a positive outcome from main stream medicine.

All of these different types  and uses of medicines regardless of whether the use of these are off-label, on-label (conventional) or registered with TGA or other global medicines authority, alternative to the registered medicines or treatment should simply be judged on whether they are safe evidence-based medicine. This cuts through the red tape and conflicts of interests.

The term Evidence based medicine also needs to be clarified and re-defined in modern terms.

“Prior to a firm definition of EBM health practitioners and Regulators relied on the clinical expertise of more experienced colleagues and text books to provide them with information they needed to inform patient care.” (Dr M Bushell MPS Aust Pharm Vol38 No. 3 4.19)

The problem with this was with disciplines like integrative, complimentary and functional medicines the right expert was not always called on. We had experienced mainstream medicine practitioners who never prescribed these types of medicines giving biased personal opinions.

The term “evidence-based medicine” was first described in modern times as “the conscious, explicit and judicious use of current best evidence about the care of the individual patient. It means integrating individual clinical expertise with best available external clinical evidence from systematic research” (Sachet et al 1996)

What one practitioner believes is strong evidence another and often a Board member or mainstream expert does not. Using a tool as simple as the NHMRC Hierarchy of Evidence Decision making table (see attached) or the PICOS Framework would give a simple guidance to all involved in prescribing or investigating the prescribing of medicines or treatment. It may very well reduce the need to engage other  practitioners to provide their opinions (the opinion of one person) who are not actually experts in the specific field they are ask to comment on. For example, asking an endocrinologist to comment on the use of integrative medicine for an off-label use may not be appropriate for their training.  The expert need not be a professor to simply apply the PICOS Framework or the NHMRC Decision table for evidence based on research already carried out.

The only task left to do is determine exactly what level of evidence deems a medical protocol or medicine as evidence based so that practitioners can be clear on what constitutes evidence base in the eyes of the Regulator.

Public Hospitals more often than not when  paediatric treatment, will prescribe off label medications.  Australia – due to its small economic size and population – will never, and could never, be expected to have the same variety of drug registrations as the US or Europe. Australia therefore delegates many drugs to the off-label category. But as our paediatricians demonstrate on a daily basis they are prescribing off-label medications safely for their patients.

It is at this point I would like to raise the prospect of Option 3

That an appropriately trained practitioner be able to prescribe unconventional medicines when able to present adequate evidence to demonstrate safety and efficacy for the patient.

This could include integrative, compounded, complimentary and alternative off label or on-label uses of main stream medicines.

In summary:

  1. Encourage medical practitioners as an extra layer of public safety to only engage compounding pharmacies that comply with PBA and PSA Guidance and practice at a minimum accreditation level of USP 797 and USP 795 and APF 24. Compounding Pharmacies are able to under go accreditation to obtain these standards.
  2. Delete the terms Conventional and unconventional as the definitions are confusing and at best based on the economic decisions of drug companies and potentially leave the door open to biased opinions by those who may have pecuniary interests.
  3. Every drug and protocol used by doctors or compounded by pharmacists should be evidence based. A useful tool is the NHMRC Hierarchy of Evidence Decision table or the PICOS Framework.
  4. Consider an Option 3, if we must choose to do something, and like the vast majority of the leading western countries in Europe and the United states allow appropriately trained specialist practice their chosen field of practice and use evidence-based medicines to safely bring more positive patient outcomes.

I applaud the Medical Board of Australia for creating the public consultation paper aiming for clearer regulation for medical practitioners providing complementary, unconventional medicine and emerging treatments.

 

Yours Sincerely

Daryll Knowles

Urological Society of Australia and New Zealand Conference 2018

This weekend – 24th of February – we are departing for the annual Urological Society of Australia and New Zealand Conference.

This will be our third year of attendance to a show we like very much.

However, this year will be a little different.

Whilst many urologists utilise the services of a compounding pharmacy, few compounders can actually prepare and dispense the medicines they prescribe.  ACPHARM is definitely the largest of them all, and this year – 2018 – we will get even bigger.

The recent regulation changes mean that compounders are scrambling to comply. Changes include supplying evidence for potency (ie product stability) and sterility.

What has become evident over the last 3 weeks is that many compounders did not anticipate the February 1st deadline actually going through.

But it did.

So, why is ACPHARM happy about this?

Because we have always complied – even before it was regulation.

To us, it just made sense to be able to prove that we were providing a sterile product that contained exactly what it said on the label. It’s just good compounding practice.

So, over the years we invested heavily in these tests across our whole range of sterile products.

As a result, ACPHARM can ensure uninterrupted supply with zero price increases as a result of these new regulations.

Free webinar

If you want to hear more about these changes and are reading this before March 5th, 2018, we are running a webinar that will detail all of the new guidelines and how they affect prescribers and patients.

Why is Compounding Pharmacy growing in Australia?

Matt Chalmers

When I started in this industry in 2002, there were just 12 compounding pharmacies in Australia.

Today, there are over 500 compounding pharmacies that will make and dispense medicines by doctor’s prescription and patient order.

There are a number of reasons for this rise, however there are two major contributors that, above all others, influence this growth:

  1. Retail pharmacy profits are ever-diminishing.
  2. Personalised medicine is in the rise.

Why are retail pharmacy profits down?

The rise of the “big box” pharmacy (think, Chemist Warehouse) mean that local pharmacies have trouble competing. When your local competition can sell their stock for lower than you can buy it, based on volume of purchases, business is tough.

Along with increased competition, the Australian government has steadily been reducing pharmacy profits from controlled PBS prices

The rise of personalised medicine

Personalised medicine is a growing market sector. Routinely, when the subject is brought up in conversation, the comment made – no matter the location – is always, “It’s the future.”

And it is the future. As big pharma deteriorates, the era of smaller, bespoke manufacturers draws nearer. And who better to provide these services in Australia than Compounding pharmacies, such as ACP?

Big Pharma as an industry has been on the decline since the early 2000’s. A 2016 article in Forbes Magazine states:

“For decades, the pharmaceutical industry has been highly profitable. The recipe for such profits has been pretty simple for most of the last half-century–discover a chemical or molecule that treats a common problem, like hypertension or diabetes or erectile dysfunction, and make billions of dollars while that product is still under patent protection. But of course, profits were never so simple. It takes billions of dollars to develop one new drug suitable for testing in humans and even then, the drug might turn out to be too toxic or to have too little benefit to make it on to the market. It might take a handful of such drugs before a company finally finds one that works, a single blockbuster that can hopefully make up for all that investment. But the cost of new drug development is rising, and the number of big wins is declining–with the number of common illnesses in need of interventions dwindling–so it is getting increasingly difficult to bring enough blockbusters to market to make up for all those drugs that go bust.”

https://www.forbes.com/sites/peterubel/2016/07/29/is-the- golden-era- of-pharmaceutical- profits-over/#ea6a3207207b

Pharmaceutical compounding has long been the bastion of personalised medicine. The use of compounding pharmacy by health practitioners and professionals has increased exponentially since 2000. But its roots of course are much earlier, and indeed every pharmacy before the establishment of Big Pharma engaged in some form of compounding.

Our own CEO and founder, Daryll Knowles has long roots in preparing formulas to specification – as early as the 80’s – when he made timed-release capsules for children needing a sustained dose of medicine to see them through their school day. These were produced in his compounding pharmacy in Sydney.

However, there is a more recent development that heralds exciting times for compounding pharmacies in Australia.

Pharmacogenomics is the study of the role of genes in drug response. That is, how an individual will metabolise a particular drug. Put simply,  pharmacogenomics tells us that patients don’t belong in the pigeon-holes that current regulations think we do.

Let’s illustrate with an example.

Michelle has a condition which requires a specific drug to alleviate her symptoms. This drug is available in 2 strengths, 50mg and 100mg. However, when Michelle takes the 50mg strength, she does not get resolution of her symptoms. When she takes the 100mg strength, her symptoms go away, but she gets side-effects.

A simple test of Michelle’s pharmacogenomics illustrates that indeed, those two strengths are not suitable for her, and that she requires a dose in the middle – 75mg. However, to make a drug commercially available in Australia is very expensive – up to $2million – for one dose form (eg capsules, tablets, creams etc) and one strength. Big Pharma is not in a position to register a dose specifically designed for Michelle as they would never recoup their investment.

This is where pharmaceutical compounding can help.

Compounding pharmacies in Australia are able to produce a customised medicine, specific to Michelle’s needs. A compounding pharmacy can make the right dose and even change the dose form, to help our patients achieve the best clinical outcomes.

Of course, we use simple numbers in this example, but this is what our pharmacists at Australian Custom Pharmaceuticals, the largest compounding pharmacy in Australia, are doing every day.

The future of compounding

So where is all of this going?

There is a push by regulators to change compounding. Changes have been proposed to regulations regarding sterile – that is, compounding of products that are to be injected – to improve the basic requirements of training and facilities of compounders providing these services. It is a step in the right direction, and will ensure that only those compounding pharmacies in Australia with intent to produce high-quality materials are able to operate.

More and more researchers are pointing to customised medicine being the future. More and more doctors are engaging in the education required to provide this level of medicine to their patients.

More and more organisations and continuing medical education providers are delivering the training necessary to tailor medicines and medical offerings to the individual patient’s needs.

Certainly, personalised medicines, taking into account simple considerations such as patient age, weight, BMI and sex, or more complex factors such as individual genomics, are an ever-increasing medical sector – one which compounding pharmacies in Australia are poised to service with their offering of tailor-made and bespoke medicines.

Attention: Medical Weightloss Institute patients

ACPHARM in conjunction with Dr Jackie Forrester is working toward a satisfactory end for our patients, the former clients of the Medical Weightloss Institute.

You may have received some correspondence recently from us which can be viewed here.

We would like your assistance in helping us discover the category in which you may fall.

Our observations conclude that you may fall into one of these three categories:

  1. Patients currently undergoing the program and paid in advance, in full. For those patients paid in full in advance, ACPHARM will undertake to provide you with the medicines for no additional charge for the term of your existing MWI contract.*
  1. Patients currently undergoing the program and paying month-to-month. For patients paying month to month and wish to continue, arrangements will be made with you to continue treatment via consultations directly with Dr Forrester and medicine provided from ACPHARM.
  1. Patients wanting to reinstate the program as provided by Dr Jackie Forrester. For patient’s wanting to take advantage of savings afforded by dealing with the doctor and pharmacy directly,

Please fill in all the details below, and we will be in contact with you shortly with the proposed method of moving forward and helping you attain your weight-loss goals.

 

  • Preferred method of contact
  • As an MWI client I am a:

 

Hello Gold Coast

acpharm-gold-coast

We are pleased to announce the latest addition to our family — ACPHARM Gold Coast, owned and managed by Jack Hammond.

It will incorporate all of the global systems we have developed on a local scale.

Download the Gold Coast – 6page DL flyer

Contact details:

PHONE-  1300 MY MEDS ( 1300 696 337 )

Fax: 07 5676 6371

ACPHARM Queensland

24 Surfers ave, Mermaid Waters QLD 4218

http://acpharmqld.com.au/