Will the move the tighten guidelines for complementary medicine make things safer or further muddy the waters?

A recent move by the Medical Board of Australia (MBA) to tighten guidelines for complementary medicine practitioners could cause more confusion and uncertainty for patients if taken too far, according to leaders in the compounding pharmacy sector.

Experienced pharmacist Matthew Bellgrove from National Custom Compounding said many in the compounding sector had been asking for clarity and greater definition in the guidelines for years, however it was important to ensure evidence-based medicine did not become the innocent victim of a well-intentioned clean-up of the industry.

“For example vitamins and nutritional supplements have been mentioned in the consultation paper, however it’s been well-established for many years that vitamins and diet management are crucial in the treatment of many common conditions. Diabetes, anemia, cardiovascular disease, obesity and rickets are just a few that come to mind.”

“Compounding pharmacists have also been mentioned – the same compounding pharmacists who are swamped with orders from hospitals and doctors desperate to get their patients the medication they need every time the manufacturer can’t keep up with demand,” Matthew continued, “This is something that’s happening far too often of late.”

“Greater detail in the definitions is what will be needed to ensure the public can continue to access quality, proven treatments while being protected from unsafe practices.”

The MBA’s public consultation paper is currently seeking feedback from industry on new guidelines for medical practitioners working in the fields of  ‘complementary and unconventional medicine’, including integrative doctors. The paper also aims to clear up some of the uncertainty around what the MBA terms ‘emerging treatments’.

According to the MBA the move to tighten guidelines was instigated after it received complaints about “…insufficient information being provided to patients, inappropriate tests being ordered, inappropriate prescribing and inappropriate treatments being provided to vulnerable consumers.”

Matthew said he, and other reputable compounding pharmacists welcomed the move to provide greater clarity on what the Board expected and to weed out unscrupulous and unethical operators.

“Greater definition would give the public far greater confidence in responsible complementary medicine practitioners and in particular integrative doctors,” Matthew said, “The integrative doctors we work with are highly professional, highly principled practitioners, and I know they welcome every opportunity to prevent the snake-oil peddlers from taking advantage of vulnerable patients.”

“There’s a place for both complementary and integrative medicine in our health care system. According to the MBA themselves over two-thirds or consumers use complementary medicine, which shows the demand, and acceptance, is there.”

“And there’s many compelling examples of complementary and conventional medicine practitioners working together and achieving exceptional results for the patient.”

“Tighter guidelines will make more of these kinds of collaborations possible and will give patients greater confidence, and choice, when seeking treatment, However it’s important that the new guidelines make things clearer, not muddy the waters even further.”

Submissions to the MBA’s ‘Consultation on complementary and unconventional medicine and emerging treatments’ close on 12 April 2019.

For anyone unsure how to make a submission a new website is available to help – go to https://integrativemedicinefreedomofchoice.com/

Government recognises potential of personalised medicine through $65 million grant program

The Australian government has recognised the potential of personalised medicine in a very public way by today announcing $65 million in competitive grants for genomic research into cures for cancer, childhood diseases and diseases with low survival rates.

The compounding pharmacy sector is applauding the announcement, viewing it as a step in the right direction towards a health care culture that treats the unique health care needs of the individual on a case-by-case basis. Custom medication, made specifically for the individual, is an area the compounding pharmacy sector has been specialising in for many years.

Matthew Bellgrove, Head Pharmacist at one of Australia’s biggest compounding pharmacies, National Custom Compounding, says if the grant program proves successful it could save countless lives as well as significantly cut health care costs in this country.

“Currently there are a lot of unknowns with many diseases and a lot of time and money is spent on medications and treatments where the outcome is very uncertain,” Matthew said, “People with serious disease like cancer cannot afford the time needed for a trial-and-error approach, and the expense to themselves and the public purse is significant.”

Matthew says he is excited about what the grant program might unearth. He hopes new information and  techniques will come to light that will help health care professionals identify exactly what’s going on in an individual’s body.

“For the first time we may have solid, valuable information – hard data at a cellular level. We could commence treatment with a much greater degree of certainty and develop custom-made medications and treatment plans created specifically for that individual.”

“The compounding pharmacy sector can play an important role in this – we can make up medication, from scratch, with precisely the right ratio of medicinal ingredients to target a disease as it presents in the individual,” Matthew said, “Commercially manufactured drugs do a great job, but they are ‘one-size-fits-all’, which may not bring about the best result in all cases.”

“No two people are alike, and neither is the way their immune systems deal with disease. Custom medicine, designed for the individual, is the way of the future.”

In the field of diagnostic medicine, genomics refers to the mapping and analysis of an individual’s DNA, to better understand their unique individual cellular make-up, and potentially develop a treatment for any diseases or health conditions they may be suffering.

As the government’s statement says, “The result (of genomic research) is a tailored treatment based on the individual and it means we can find out what medicine might work for a particular disease and then get it to the patient.”

Grant funding will be available for three years and will be awarded to genomic research projects focussed on:

  • Cancers and diseases where survival rates are currently very low
  • Serious childhood diseases
  • Ethical, legal and social issues associated with genomics in health care.

The grant program will also be encouraging applications from multidisciplinary teams working together to answer complex genomics research questions.

A National Health and Medical Research Office will be created to oversee the genomic research grant program and will sit under the government’s Medical Research Future Fund (MRFF). Professor Kathryn North AC has been appointed to lead a new genomics scientific sub-committee that will manage the project.

Grant applications will open 28 March 2019 and the Flagships: Pathogen Genomics Grants opportunity will open 14 May 2019. The Guidelines are available on the GrantConnect website

Should we be worried about parabens in medicine?

Parabens are used in many medications as a preservative. They’re also used in many cosmetics, skin care products and processed foods for the same reason. And they do a top notch job. They’re tasteless, odourless, colourless, they don’t react to chemicals they come in contact with, and they’re cheap. Without them, medicines, foods and other products – products that sit in storage and on shelves for a long time – would start to grow mould and bacteria and become unsafe to use and consume.

However we know a small number of the population are allergic to parabens, around 2 per cent, and recently there has been increasing concern over the possible health consequences of long-term accumulation of parabens in the body.

Health authorities around the world mandate that parabens used in food products should be at concentrations of no more than 0.1{648ff2b140dd79f8b10f01740237e66061b7c0f8b396ba52d99047c684c8722c}, except for Europe which has banned their use in food altogether. Similarly, most pharmaceuticals are manufactured with no more than 0.1{648ff2b140dd79f8b10f01740237e66061b7c0f8b396ba52d99047c684c8722c} parabens, however some liquid medicines can have paraben concentrations up to 5{648ff2b140dd79f8b10f01740237e66061b7c0f8b396ba52d99047c684c8722c}.

With parabens being used in more and more everyday products, could their levels build up in the body to toxic levels? Proponents of parabens say they have ‘minimal toxicity’, however that doesn’t mean they have ‘no’ toxicity. Could toxins accumulate in the body over time if multiple paraben-containing products are used every day?

There’s no clear answer. No long-term studies have been conducted to test this theory of paraben accumulation however one controversial study has found parabens in human urine, serum, milk, placental tissue and breast tumour tissue. One Japanese study in 2002 found that parabens interfered with the male reproductive functioning of rats however no similar studies have been conducted for humans.

If you have a known allergy to parabens or have concerns about their use, a reputable compounding pharmacy like National Custom Compounding can, with a script from your doctor, make up your medication from scratch without parabens or other preservatives. We can do this safely as the medicine is being made locally, not in a facility overseas, and does not need to be stored for long periods of time.

Call us on 1300 731 755 or email [email protected] for more information.

Could garlic oil be a cure for Lyme disease?

Is there nothing garlic can’t do? The unassuming, yet over-achieving little white bulb is now being touted as a possible treatment for a condition known for being hard to beat – Lyme disease.

According to a paper penned by researchers from John Hopkins University, in clinical trials garlic oil as well as cinnamaldehyde oil, a component of cinnamon bark, completely sterilised the stationary phase culture of the B.burgdorferi species of bacteria. B.burgdorferi is believed to be the pathogen responsible for Lyme disease.

The paper published in the journal, Antibiotics, also claims that, at concentrations of 0.05{648ff2b140dd79f8b10f01740237e66061b7c0f8b396ba52d99047c684c8722c} garlic and cinnamaldehyde completely eradicated regrowth of the B.burgdorferi species. This is important to note as regrowth of the bacteria is a major impediment to full recovery for Lyme disease sufferers.

Lyme disease is commonly treated with a course of antibiotics for up to a month, however many sufferers – up to 20{648ff2b140dd79f8b10f01740237e66061b7c0f8b396ba52d99047c684c8722c} – report their symptoms persisting long after their course has finished. Recent studies have shown that B.burgdorferi can develop ‘dormant persisters’ that are not affected by the kind of antibiotics currently prescribed for Lyme disease.

These ‘dormant persisters’ may explain why some sufferers of Lyme disease do not respond to the usual treatment, however firm evidence for this has yet to be found.

The study also found that, at higher concentrations of 0.1{648ff2b140dd79f8b10f01740237e66061b7c0f8b396ba52d99047c684c8722c}, pimento oil, myrrh oil, hydacheim oil, and Litsea cubeba oil achieved similar results to garlic and cinnamaldehyde.

It’s important to note that the findings outlined in the paper came from a trial conducted on cells in a controlled laboratory environment. Much larger studies on animal subjects, followed by human subjects would be needed to ascertain if similar results could be achieved within the human body.

Until recently Lyme disease was believed to be a condition confined to the United States, however a growing number of cases have been reported in Australia in recent years.

In 2012, the Lyme Disease Association of Australia reported over 200 known cases of Lyme disease in Australia, with over half the people affected claiming they had not recently travelled overseas.

In the United States, B.burgdoferi is usually transmitted by a tick bite with a distinctive ‘bulls-eye’ red rash appearing a few days later.

Other less specific symptoms include neck stiffness, headaches, nausea, general weakness, fevers, chills and muscle and joint aches and pains.

 

Citation:

Feng, J.; Shi, W.; Miklossy, J.; Tauxe, G.M.; McMeniman, C.J.; Zhang, Y. Identification of Essential Oils with Strong Activity against Stationary Phase Borrelia burgdorferi. Antibiotics 2018, 7, 89.

High dose Vitamin C found to suppress tumour growth

High doses of intravenous Vitamin C can help to significantly suppress the growth of cancerous tumours, according to a team of researchers from Poland and the U.S.

In a review published in the journal Molecules last month, lead author Blazej Rubis from the Poznan University of Medical Sciences claimed that data showed Vitamin C could be effective in prohibiting the growth of tumours in the pancreas, liver, prostate and ovaries and may also have benefit in the treatment of sarcoma and malignant mesothelioma.

“The addition of high doses of AA (ascorbic acid – Vitamin C) alone or in combination with standard cancer drugs significantly enhances suppression of tumour growth,” Rubis claims based on the findings of the review.

The method of administration was key to Vitamin C’s effectiveness according to the research team. Intravenous administration was found to deliver significantly better results than oral administration.

“When ascorbate (Vitamin C) is administered orally, only moderate increase in its plasma concentration is achieved. In contrast, when ascorbate is administered intravenously, concentrations in the millimolar levels are easily achieved although for a short period only,” the review states.

While the antioxidant-effects of Vitamin C were found to help in suppressing the growth of tumours, the review also found that the vitamin enhanced and promoted the effects of specific medications used to treat the tumours.

“…simultaneous administration of ascorbate (Vitamin C) with oxaliplatin or irinotecan (cancer drugs) inhibited tumour growth in vivo, and the effect was significantly higher compared to that of these compounds alone.”

The implications for future study into potential cancer treatment is promising as Vitamin C is well tolerated by almost all patients, even those with compromised immune systems.

The review was authored by scientists and researchers from The Greater Poland Cancer Centre, Poznan University of Medical Sciences and Brown University in the U.S.

New report finds high rate of medication errors in hospital discharge summaries

A new report released in January by the Pharmaceutical Society of Australia (PSA) has found that at least one medication error occurs in 3 out of 5 Australian hospital discharge summaries prepared without consultation with a pharmacist.

The report titled Medicine Safety: Take Care, also found that over 90 per cent of patients have at least one medication-related error after they’ve been discharged from hospital.

Matthew Bellgrove, Head Pharmacist at National Custom Compounding, said the findings were cause for concern and illustrated the vital role pharmacists play in a patient’s overall health care management program.

“Despite very strict controls, human errors in medication do occur from time to time, however the high percentages mentioned in this report came as an unpleasant surprise to me,” Matthew said

“The same report found that 250,000 Australians are admitted to hospitals annually due to medication-related problems, at an annual cost of 1.4 billion. You have to wonder how many of these admissions could be avoided if our health care system placed greater emphasis on the role of the pharmacist.”

Of equal concern to the pharmacy community is the statistic that when changes to a patient’s medication were made during their hospital stay, these changes were not recorded on the discharge summary in 80 per cent of cases.

“This easily explains why 90 per cent of patients have problems with their medication after they leave the hospital,” Matthew said, “Medication is by far the most common intervention we make in health care, however something as simple as documentation seems to be tripping us up.”

Too little, too much, or the wrong kind of medication can potentially be just as serious as a poorly performed operation. This is why consultation with a pharmacist is so important.”

“Pharmacists have highly specialised knowledge and training in pharmaceuticals – this report suggests that these skills are being underutilised currently, presenting a real opportunity for the health care community to work towards improvement.”

 

Health of the elderly at risk from pill-crushing culture in aged care facilities

As many as one in five older patients has difficulty swallowing tablets and capsules (a condition called dysphagia), however the most obvious solution – liquid medicine – is rarely available for the kinds of drugs commonly prescribed for the elderly.

This reality has led to many staff at Australian aged-care facilities crushing a patient’s prescribed tablets or pills and adding it to food and drink. This makes administration more comfortable for the resident and lessens the risk of medication being skipped. It seems the most obvious solution and it’s easy to understand why aged-care staff would employ this method.

However the ‘pill-crushing’ approach has been proven to be at best problematic, and at worst, dangerous to a patient’s long term health.

Is pill-crushing dangerous?

According to the government’s NPS MedicineWise agency, “The stability and bioavailability of drugs can be significantly changed by the simple act of crushing a tablet, preparing an oral liquid from a tablet or capsule, or mixing a crushed tablet or capsule powder with food or other thickening agents.”

“Manipulating solid dosage forms remains a significant source of medication error and harm to patients.”

And this assertion is backed by research.

A study conducted by the University of South Australia found that 17 per cent of the medications that were altered for ease of administration in South Australian aged care homes had the potential to subsequently cause, “…increased toxicity, decreased efficacy, unpalatability, safety or stability concerns.”

The authors of the study also noted, “In all occasions where more than one medicine was altered, they were crushed together within the same vessel. In 59{648ff2b140dd79f8b10f01740237e66061b7c0f8b396ba52d99047c684c8722c} of occasions where the same vessel was shared amongst residents, the vessel was not cleaned between residents and in 70{648ff2b140dd79f8b10f01740237e66061b7c0f8b396ba52d99047c684c8722c} of cases where medicines were altered, spillage, and thus potential loss of dosage, was observed.”

Last year researchers from the University of Queensland found that up to 24 per cent of a medication’s mass could be lost when a pill was crushed, depending on the method employed. The US Food and Drug Administration recommends less than 3{648ff2b140dd79f8b10f01740237e66061b7c0f8b396ba52d99047c684c8722c} mass loss should occur when a medication is altered by a method such as crushing.

Alternatives to pill-crushing

NPS MedicineWise recommends that in cases of dysphagia, if a commercially available liquid version of a drug, or a suitable drug alternative cannot be found, then health care workers should consider, “extemporaneously compounded medicine – this remains off-label use but is produced using an evidence-based approach.”

Compounded medication refers to medication that is made by hand, to order, by a fully qualified compounding pharmacist.

Few aged care facilities or community pharmacies have the specially trained staff and purpose-built facilities to compound medication, however a reputable compounding pharmacy can help.

With a script from the patient’s doctor, a compounding pharmacy like National Custom Compounding can make up, as a liquid or trouche, many of the medications commonly prescribed to older Australians.

To find out more about how compounded medication can help patients who have trouble swallowing medication, contact one of the friendly team at National Custom Compounding on 1300 731 755 or email [email protected].

New study finds Vitamin D can prevent potentially fatal lung attacks

Topping up the Vitamin D levels of patients with certain respiratory conditions leads to a 45{648ff2b140dd79f8b10f01740237e66061b7c0f8b396ba52d99047c684c8722c} reduction in lung attacks according to researchers from Queen Mary University of London.

The researchers recently reviewed the results of three clinical trials involving 469 people with chronic obstructive pulmonary disease (COPD) and found that those who started out with low levels of Vitamin D could significantly reduce their risk of lung attack by increasing their Vitamin D to optimal levels.

Increasing Vitamin D was shown to have significant benefit only in those study participants who started out with low levels of Vitamin D. No benefit was observed for those whose Vitamin D levels were already adequate.

COPD is an umbrella term that includes a number of lung conditions including emphysema, chronic bronchitis and chronic asthma. Most COPD-related deaths occur due to lung attacks which have a tendency to escalate rapidly, inflaming the airways and making it very difficult to breath.

In the study, recently published in the British Medical Journal’s Thorax, an approach known as “individual participant data meta-analysis” was used to extrapolate data from the three trials and compile it into one database for greater statistical analysis.

According to the authors of the study, “Around one-fifth of COPD patients in the UK – about 240,000 people – have low levels of vitamin D. Reducing risk of attacks in such a large group would have major benefits for patients and for health services, since many attacks require costly hospital admission.”

The implications of the research are many – Vitamin D has a very good safety profile, can be safely taken in conjunction with many other medications and comes at very low cost.

However the researchers caution that their review included a statistically small number of participants and that a much larger clinical trial  needed to be conducted to verify the significance of their findings. The authors report that a much larger trail is currently underway in the Netherlands and is due to conclude in 2020.

National Custom Compounding can make up once-weekly and once-monthly doses of Vitamin D. We can prepare 10000IU doses which is a stronger preparation than the typical dose of 1000IU produced by most vitamin companies.

For more information contact one of the friendly team from National Custom Compounding on 1300 731 755 or [email protected]