Trans Tasman Proposal

Submission to the Trans Tasman Regulatory Agency proposals on behalf of the Pharmacy Guild of Australia

THE PHARMACIST’S ROLE

The Pharmacy Guild of Australia (“The Guild”)represents proprietor pharmacists in Australia who are members of the Guild. The Guild is considered to be the major representative body of pharmacists by the Australian Government The Guild’s current membership is circa 4,500 of the circa 5,000 community pharmacies in Australia.

  • Pharmacists’ training includes pharmacology and toxicology. These two elements are necessary when advising members of the public on the correct use and potential side-effects and interactions of their medication. This is the pharmacists’ traditional role in the community. It is our belief that it is in the public interest that a pharmacist be available to provide this type of information to purchasers of goods with medicinal potential whenever they may require it. It has been the community expectation that this function saves it from being given incorrect medication and from making incorrect choices when self-medicating.
  • The abiding principle of pharmacists is the determination to ensure that their patient receives only efficacious medicine, the taking of which is in the patient’s best interests. The profession of pharmacy universally traditionally pledges to refuse to sell to a client a medicine which would do him or her harm.
  • The pharmacist is also a marketing professional. The Pharmacy Guild of Australia has in recent times initiated a challenge to members to comply with “Quality Care” parameters.
  • These ensure that a uniform minimum standard of dual professionality is applied to each and every customer who walks through its door.
  • So far, an astonishing 60% plus pharmacies have voluntarily applied for accreditation to these requirements.
  • This – simply put – is world’s best practice.
  • Australian Pharmacies are open all hours and provide shop front professional accessibility. This feature is the envy of consumers, medical practitioners and Health Ministers alike all over the planet.
  • Australian pharmacy also enjoys a valuable, co-operative relationship with prescribing practitioners, who respect our skill, dedication to integrity in dispensing – which sees Australia with the lowest iatrogenic mortality rate in the developed world.
  • Successive Australian Governments respect Australian pharmacy as having been a major player in delivering the least costly health delivery system – enjoying relatively lower health costs than any other Western Government. (eg the American Health expenditure is something in the order of 50% more that Australia’s, expressed as a percentage of gross domestic product).
  • The present Government has a policy on pharmacy which reads as follows: “This (Party) recognises pharmacy as a cost-effective and caring means of delivering health care to the community”. (The opposition shares similar views).
  • The relative cost differential on national health system expenditures is largely attributed to:
  • the skill of Australian pharmacists at the point of dispensing medication prescribed by doctors (as patients increasingly wander to medical centres and choose GPs randomly).
  • Pharmacists’ expertise in toxicology (their traditional strength) – and their ability to communicate this effectively – is the single most important feature in maximising patient compliance and minimising accidental drug-to-drug interaction.
  • In developed countries, over thirty percent of hospital admissions are caused by these factors. Needless to say, Australia has the world’s lowest hospital admission rate due to iatrogenic disease.
  • So, it is imperative that – in the emerging allied profession of complementary medicine – that pharmacy’s traditional role in the giving of advice in toxicology is utilised to the maximum so that Australia’s proud record of maximum access to helpful medication with minimum toxic side-effects is maintained end enhanced.
  • That’s why many pharmacies now enjoy such a strong relationship with naturopaths and herbalists.
  • Their expertise – alongside that of pharmacists – ensures that pharmacy outlets retain their traditional expertise.
  • That means that the consumer retains a most cost-effective, caring and READY ACCESS to information.
  • This is the relationship between pharmacy and consumer which has kept Australia’ population the healthiest in the world

OPEN SELLERS

  • It is a matter of some regret that we have recently witnessed the move of several toxic substances to the list of “open sellers” – including lignocaine and acyclovir.
  • It is our belief that – without adequate counselling availability – unnecessary and possibly irreparable harm may fall to those individuals who use such substances incorrectly.
  • These have been joined by highly concentrated herbal complexes with names such as “Ease a Cold” (Pharmacare Labs).
  • It is imperative that the same mistakes are not made with complementary medicine. This issue should be redressed before it is too late.
  • Otherwise, Australia’s proud record of relatively low iatrogenic hospital admissions may be under threat.

TEAMWORK IN MEDICINE

We also see pharmacy extending its relationship role (with medical practitioners) to natural therapy clinicians and look forward to working closely with them for the betterment of community health.

Professional Research Resources

  • Finally, the emergence of The Herbal Medicine Research & Education Centre (HMREC) at Sydney University’s Department of Pharmacy (under Prof. Basil Roufegalis) will help maintains pharmacy’s presence at the forefront of knowledge and training in toxicology and therapeutic use of complementary medicine.
  • However, the funding for this support can only come to pharmacy through its traditional channels of sales, as it does not possess a fee-for-service feature.
  • This all adds up to a great benefit to public health – as a health issue – and also a huge saving to the community in minimising health cost blowouts from
  • Increased doctor and hospital visits directly resulting from adverse effects of self medication.
  • Succession prescribing of PBS drugs (to counter ADRs)

TGA LOBBY PRESSURE

  • Finally, it is our belief that the TGA is under great temptation to simply buckle to the manufacturers’ lobby and to allow open selling in this area and disregard true health concerns.
  • That’s why it is imperative to hold firm and consider that there is not a health educational tool in existence to guide people to the correct health purchase choice other than the information that a trained health professional can provide.

Submission of the Pharmacy Guild of Australia to the Trans Tasman agency to regulate therapeutic products.

(Following stakeholders’ Consultation meeting on july 18’th 2002).

DEFINITION

complementary medicine (CM)

Rationale

  • The actual name is irrelevant as long as the act is worded to include the description of the various modalities: ie herbal medicine, homoeopathic medicine, nutritional medicine, flower remedies, etc (see list below) – plus the classifications of illnesses they purport to treat.

We believe that the word “medicines” should be in The Act. Further, it is the consensus (Guild, HMREC, ATMS and NHAA representatives) that the phrase “Complementary Medicine” is generally accepted by the community as defining the medicines including those mentioned below..

DEFINITION OF CONSTITUENT ITEMS to be embraced under the act.

Introduction

  • We agree that the information and product explosion of recent years means that – for the public interest to be best served – this whole area needs to be re-defined. Eg Many active constituents of plants have been isolated and identified in the last twenty years.
  • “New” herbs have been introduced to our public- principally from India, Japan, China, the Pacific region and South America.
  • Research has also unearthed different actions of known whole herbs and nutrients. Eg Olea europea (and its immune activity), Trigonella foenum-graecum (and its effect on cholesterol) and alpha lipoic acid (and its sparing action on biological auto-antixodants) to name but a few.
  • Some nutrients exhibit quite unexpectedly beneficial actions which have been known for some time – eg the chelating properties of orotic acid – but which have seen new implications evolve . eg .
  • Beneficial properties can have a pharmacological contra-indication eg Calcium Orotate and tetany as well as nutrient-to-drug interactions (eg Orotates with calcium channel blockers).
  • Further, there is an increasing need – and growing acceptance of – specific dietary intervention aimed at a medical outcome – such as low cholesterol diets etc.
  • Some studies have recently revealed that the original herb has more potency and beneficial outcomes on medical conditions than synthetic hormonal analogues eg Cimicifuga and menopausal syndrome.
  • For that reason, the name chosen to describe the medicines brought into this net should be appended with the full gamut of classes of substances, modalities, desired health outcomes and conditions treated which the act describes or seeks to describe. Not only that, but also it needs to include the purposes of such products and indeed other modalities – for the definition to be complete. The following is a – probably not exhaustive – list of such products, conditions, health outcomes and modalities.

Apologia:

Bear in mind that complementary medicines delve into preventative areas not presently explored by synthetic medicine. Such areas include:

Adaptogens

Tropho-restorative

Tonic

Nervine

Antioxidant

Demulcent

Alterative

Lymphatic

Then, the Ayuvedic medical system sees a herb as having such actions as:

Rasa-tikta (bitter), Katu (pungent), Guna-laghu (light), Verya-ushna (hot), Vipak-katu (pungent);

Yet, in the traditional Chinese medicine system, the same herb may have actions such as: bitter, sweet and cold; entering the Liver and Stomach meridians. Clears heat and detoxifies poisons.

In Western terms, the purpose for prescribing the same CM include conditions such as:

  • Chronic fatigue.
  • Free radical-induced conditions
  • Immune insufficiency
  • Obesity
  • Anorexia
  • Lipid peroxidationàInflammatory disorders, tumours from
  • Atmospheric pollution
  • Electromagnetic radiation
  • Lipid peroxides
  • Pesticides and
  • Other contaminants
  • General drug-replacement maintenance therapy- eg Synthetic HRT, cholesterol balance etc.
  • Eliminating impurities – animal, metallic, synthetic in water supply
  • Spiritual balance
  • Fitness and exercise therapy
  • Most major medical conditions

UNDERLYING CAUSE

  • Traditional medicine treats underlying cause of illness. Its components do not possess a pharmacological action in the traditional sense.
  • That’s because herbs can possess up to a hundred or so active constituents – which must all possess synergistic activity with each other and other herbs used in combination – to have the desired effect.

* This means two things ;

  • The regime must be altered as the condition changes and
  • No herbal combination can be prescribed legitimately to treat the same illness in any two individuals, as each set of underlying causes may be different.

(Remember, six numbers win lotto and we are talking about hundreds of herbs with a potentially infinite number of combinations of thousands of active constituents).

That’s why, just letting these loose on the general public will be contrary to the interest of the health of the individual concerned and the public at large.

Definition of classes of medicines and modalities –
INDUSTRY AND REGULATOR’S PERSPECTIVE

Fundamentally, Pharmacy has a view that the regulator’s perspective and Pharmacy practitioners’ perspective is not dissimilar. We need to:

• use or combine the best of the natural medicinal modalities available, • use an easily understandable classification system and • ensure adequate professional advice is available on demand to the consumer to ensure optimum health outcomes.

We reject totally the notion that the free market should be the determinant in wellness benefits attributed to a complementary or pharmaceutical medical product. *; **

* [Inasmuch as the whole idea of complementary and pharmaceutical medication is to attain or maintain the health of an individual, it is farcical to consider jeopardizing any person’s health by allowing “trial and error” market philosophy** to apply to health issues.

** The United States has a more liberal policy than us – more akin to New Zealand’s. The outcome there is that the percentage of money spent on health is 13.5% of the GDP. Australia’ health expenditure is under 10% of GDP. That means that the “suck it and see” market philosophy on medicine and complementary medicine results in a disastrous blowout of 50% of the current annual expenditure].

The bottom line is that the Australian system – of maximising interaction between consumer and practitioner – allows for an overall reduction in spending by the consumer. Not only that, but it also means that the health of the consumer – and therefore quality of life – is immeasurably improved.

The best part is that the billions of dollars spent annually by taxpayers on the training of Pharmacists, Herbalists, Naturopaths and Medical Practitioners is not wasted but utilised to assist that taxpayer.

CLASSIFICATION of medicines and devices

herbal medicine ( Western, Sub-continental, Eastern (Chinese, Japanese, Malaysian), Australasian, Pacific, North- and South American)

targeted nutritional medicine (vitamins, minerals, fatty acids, essential and occasionally non-essential amino acid, glycoproteins, proteoglycans, hydrolysates, dairy concentrates, (with or without additives), chemically-treated concentrates, Bio Pectin)

Homoeopathic medicine

Other energetic medicines , including

– Bach Flower and

  • Australian Bush Flower remedies.
  • Aromatherapy

Electrical amperage including:

  • Tens therapy
  • Precision™ microcurrent therapy
  • Relaxation therapies
  • Bodywork therapies
Definition of concentrated extracts from natural sources.

The above modalities include the use of products including whole herbs as well as :

(The following list is not exhaustive)

  • extracted plant biochemical constituents(including mono-, sesqui-, di-, and tri-terpenes, beta-polysaccharides, lactones, flavonoids, isoflavones, waxes, gums, resins, sterols, steroidal saponins, coumarins, tannins, lignans, volatile oils, mucilages, polyacetylenes, polyphenols, purines, puranols, saponins, alkaloids, organic acids, chlorophyls, anthraquinones, anthocyanidins and various glycosides);
  • Animal secretory products:
  • Antibody concentrates
  • Animal extract products including:
  • hydroxyappetites
  • trachea and fin cartilage
  • glandular products
  • Whole bacteria
  • Fungi
  • Microbial isolates
  • Fungus isolates
  • Algae whole herbs and extracts
  • Whole Grass extracts (eg Rye, wheat, barley)
  • Insect products (eg bee products)
  • Marine products (eg fish oils & offal extracts and concentrates; oceanic plant products eg kelp, spirulina)

It is a fact that – in many cases – such products do not merely complement existing medical treatments but are treatments in their own right. Further, they are able to cover all classes of conditions and illnesses – acute chronic and terminal in certain instances.

That being the case, the use of the word “complementary” does not cover the totality of client expectation but suffices as a legal term if accompanied by a definition similar to the above, but completed in detail.

Scheduling and self-certification proposals:

3a) Self-certification for low risk products – Industry’s perspective

The proposed complementary medicines need to be handled in a way which guarantees consumers’ safety. Therefore they need to be sold in an environment where expert advice is always available.

That means they are better handled by people trained in their therapeutic action and toxicology.

Eg

Definition of “Low Risk

A “low risk” product is one which – when taken in good faith by a reasonable person – it can DO NO HARM.

PREPARED PRODUCTS WHICH CAN BE SAFELY INCLUDED ON “LOW RISK” LIST”

SCHEDULE 1P

  • Culinary herbs (with suitable toxicity warnings eg garlicàdamage to mucous membrane is applied topically or taken in concentrated form; or gingeràanaphylactic reaction in salicylate-sensitive people etc)
  • Herbs suitable for regular ingestion and traditionally used to maintain health (eg Ispaghala, Sterculia, Psyllium)
  • Suitably low-dosed vitamins [(probably maximum of ½ MDR. Eg taking 2 x MDR of zinc over time can produce birth deformities in offspring; Vitamin A toxicity is well-documented; calcium in 2 x MDR over time can cause arthropathy, nephropathy, constipation, tetany; other examples include zinc, selenium, thiamine etc (in fact any vitamin will exhibit toxic effects in overdosage similar to efficiency effects and so a potential purchaser should have access to a toxicology-trained health professional)]
  • Powdered milk foods

(MDR = “Minimum Daily Requirement” = RDI = RDA))

CERTIFICATION:

  • Child dose to be as little as 1/5 of adult dose
  • Dose strictly in accordance with instructions or as directed by practitioner
  • Prolonged use of any one herb or set of herbs/ vitamins/ food supplements may be harmful. Check regularly with health practitioner for advice.

NEXT HIGHEST RISK

SCHEDULE (S2P)

  • “Medicinal” herbs with low toxicity rating [eg Althea officinalis – Anthemis nobilis, Matricaria recutita]
  • Herbs where indicated for low risk illness eg constipation, common cold, other minor ailments.
  • Homoeopathic medicines eg constipation, common cold, other minor ailments.
  • Floral remedies ” ” ” “
  • Essential oils of concentration up to 10% in carrier oil.
  • Vitamins where indicated for minor ailments
  • MDR of Vitamins
  • ¼ MDR of minerals (including electrolytes)
  • All amino acids
  • Electrolyte replacements
  • Breast feeding substitutes
  • Amino Acid treatments
CERTIFICATION
  • Above plus:
  • For sale in Pharmacy or Practitioner store* only

* A Practitioner Store is a store in which a practitioner is employed for the purpose of purchasing CM.

SCHEDULE 3P

  • Medicinal Herbs with known cautions or indications of toxicity in high doss mentioned in the literature (eg Chionanthus virginicus – frontal headaches, sore eyes, flatulence and vomiting)
  • Greater than MDR of vitamins
  • Greater than ¼ MDR of minerals (including electrolytes)
  • Any nutritional or other remedy where indicated for more serious acute ailments or mild chronic ill health
  • Essential oils in carrier in concentrations up to 50%

CERTIFICATION

  • Above, but change to For sale by pharmacist or practitioner* only

NEXT HIGHEST RISK (S4P)

  • Herbs with known toxic effects in therapeutic dose (eg Tussilago farfara, Symphytum officinale – Pyrollizidine alkaloidsàveno-occlusive disease if misused; Ephedra sinicaàhabit-forming in high doses; Loboelia inflataàanticholinergic properties in high doses; Urginia maritima – contains weak cardicac glycoside constituency; Hypericum perforatum (Photosensitisation in susceptible individuals, possible rebound depression; Echinacea sppàhypertension in susceptible individuals)
  • Herbs with known contraindication (eg pregnancy, epilepsy etc)
  • Herbs with known herb-to-drug interaction (eg Hypericum perforatum and SSRI and MAOI antidepressants, possibly certain cheeses and chianti wines. See current list in The Journal of Complementary Medicine*)

CERTIFICATION:

  • Sale by prescription of practitioner* only
  • It should be noted that this list of drug/herb interactions has only accumulated by REPORTAGE. in other words, these are the most popularly prescribed herbs. It is almost certain that there are many others which will produce similar reactions.
  • The agency must ask itself if it is willing to discover by chance an adverse REACTION or sponsor significant research in this area by university institutions accepted as researchers in this area?
  • In the meantime, it is imperative that most herbs be handled through the established practitioner system until each herb is given a “clean bill of health”.
  • For the purposes of the act, a “Practitioner” is described as an ATMS or NHAA- approved prescriber of herbal medicine

3b) Self certification system for low risk products – regulator’s perspective

  • We suggest Schedule 1P, 2P, 3P and 4P
  • Basic details don’t differ from our industry perspective above.
  • This mirrors the pharmaceutical equivalent of lower risk drugs.

– The “P” indicates the fact that qualified practitioners can prescribe them [ie recognised – ie duly qualified – practitioners (Herbalists, Naturopaths or Homoeopaths who are accepted as members by their relevant association*) who prescribe such complementary medicines within their specialty].

– The grades represent the ramifications of various degrees of risk associated with individual items or products of complementary medicine and/or the purpose for which the medicines are prescribed/promoted. **

* Relevant bodies include ATMS, NHAA and others as formal recognition of standards of education of their member CM practitioners is accomplished.

** Seemingly harmless substances can alter disease states or healthy — states -eg The Orotates mentioned can cause acute muscle cramping if taken in an imbalanced way – even heart muscle

– They can also interact with calcium-channel blocking drugs, nullifying their effect and causing hypertension.

– St John’s Wort (Hypericum perforatum) is capable of eliciting acute photosensitivity reactions even in normal doses and cause rebound depression in susceptible individuals. It can also interact with prescribed MAOI and SSRI antidepressants.

(See appendix below)

  • Options for handling New Zealand substances that are not currently listable.
  • Complementary medicines on Australian schedules which are imported from New Zealand need to be labelled according to Australian conditions and vice versa.
  • Uniformity of regulations would therefore be desirable.
  • Certifications on the basis of safety and unity should favour the consumer.
  • If both countries agree to this principle then certification standards (listable or registerable) will not be an issue as they will finish up identical.
  • Substances meeting GMP standards only to be included.

Other issues

1) Practitioners are increasingly being approached by clients to restrict their prescribing to “natural” products (CMs).

Not only that, but also:

  • Naturopaths are now trained on a scientific footing in their diploma studies.
  • Further, it has been mooted at peak-body level that future Naturopathic physicians will require a Degree in Pharmacy, Medicine or Health Science.
  • Nutriceutical products themselves are becoming more targeted in their activity.
  • A natural division is occurring between specifically formulated, targeted herbal/nutritional blends and non-specific food supplements.
  • Of these, many “Grandfathered” products would today fall into a category requiring trained practitioner intervention.
  • It is becoming obvious that the grace period of “grandfathered” products will need to end at the commencement of this new legislation.
  • So, for this review to be effective, it is obvious that all products – existing and new – will need to be brought under an umbrella of clean skin uniform legislation.
  • These restrictions include recording name and address of client and supplier and the purpose for which they are being administered.
  • DISPENSING COMPLEMENTARY MEDICINES
  • Pharmacists and registered practitioners will guarantee optimum public access to complementary medicines.
  • Prescriptions from practitioners suitably qualified in complementary medicine can only be dispensed by a pharmacist or registered natural therapist qualified in the field involved.
  • Phytomedicines and high doses of vitamins have consequences and the public needs access to a qualified practitioner when making a purchase decision.
  • Spectacular growth in the field in the future will make this proviso even more imperative.
  • Sponsors’ requirements regarding relative risk may be satisfied by approved literature studies of the substance alone.
  • Evaluation of such a substance in combination may be made by a panel of independent suitably qualified judges.
  • Such decisions may be appealed provided reasonable grounds are shown.
  • GMP only medicines may be approved.
  • RISKS ASSOCIATED WITH INADEQUATE INFORMATION may be overcome if suitably qualified people can be easily accessed by the purchaser.
  • RISKS ASSOCIATED WITH PARTICULAR CLAIMS– may be overcome if
  • Therapeutic claims cannot be made or
  • A suitably qualified practitioner is available for advice at the place of purchase and the sale recorded or
  • Irrefutable clinical trial data is available and all toxicology warnings are clearly displayed on the pack and in all cases
  • Graded according to severity of complaint for which the cure is claimed (ie S2P, S3P or S4P)
  • Class 1 products would encompass items, constituents or products in standard culinary or food-requirment doses or quantities.

Items or products with a therapeutic action should be class II or III, being S2P, S3P or S4P.

JUSTIFICATION OF OUR PROPOSAL

Our Position

  • The Guild wishes to see that the wider community interest is served ahead of sectional interests.
  • We must be careful not to be seduced by the wishes of those who would attempt to mass market herbo-nutriceutical medicines for the sake of merely achieving extra sales.
  • Disasters such as allowing paracetamol and aspirin on the open selling lists must NEVER be repeated – let alone repeated with complementary medicine.
  • It has become apparent (from the comments made in the meeting of July 18’th) that many industry representatives – who would seek to give advice to the industry and to the Agency – do not actually have a good understanding of the products that their clients manufacture.
  • Not only that but also they are charged by their clients with the job of “selling” as many products as possible to an unregulated or non-scheduled category.
  • Our suggestions are offered in the spirit of community experience and expectations because that is our professional commitment.
  • So, our scheduling proposals for herbo-nutriceutical (complementary) medicines are predicated with an understanding of their potential for toxicity in concentrated form, or even in single use form in many cases.
  • The fact is that many herbs were not intended for single use in traditional herbal medicine but for combination use.
  • Larger doses of single herbs can therefore exert toxicology not noted in current literature (e.g. lymphatic herbs such as Echinacea can increase blood pressure in single, high doses).
  • The Guild would see a toxicology lexicon listed and differentiated into 3 or 4 classifications – as broadly suggested by the TGA.

TRAINING:

  • The training – of General Physicians, Pharmacists, Naturopathic Physicians and Medical Herbalists – in the materia medica of herbs, homoeopathics and potent nutritional supplements is both expensive and time-consuming.
  • Such people have a passion and intimate knowledge of the above-mentioned lexicon.
  • This training is too expensive to society to be by-passed by favouring grocery shops in any proposed scheduling.

PROFESSIONAL STANDARDS

Educational backgrounds of holders of diplomas and degrees must be assured. For that reason, colleges and institutions should:

  • Use only teachers qualified to lecture and examine who are approved by a relevant Authority.
  • Exhibit a core curriculum approved by that Authority.
  • Show membership of approved practitioner associations
  • Show adherence to an association-regulated Continuing Education system

MARKETING:

  • Crass commercialism would have us introduce little or no legislation to regulate sales and indeed have reinforced this notion at today’s meeting.
  • It is interested in only gross sales and profit
  • Pharmacists and trained natural practitioners have a good history of obeying their professional ethics in the face of mass marketing where medication is concerned.
  • That means that a pharmacist will opt to advise against a purchase where a better alternative is indicated for the client’s health.
  • Not only that, but also pharmacists are trained in counseling techniques to ensure that the client extracts optimum use of a health-care product.
  • Supermarkets at present – tragically – mass market many potent pharmaceuticals at present which pharmacy still sells responsibly in the main. [E.g. analgesics (paracetamol – which is lethal in a dose of twelve tablets – and aspirin – which is capable of causing gastric bleeding, renal failure and stroke with prolonged use of even recommended dosages) and cough mixtures containing addictive substances- such as Nyal’s Bronchitis mixture).
  • Pharmacy in particular is very good at competing with supermarkets in ordinary consumer markets and has everything to gain in a less restricted market place.
  • So, our argument is being developed in the public interest, as it is our belief that – in the long term – that is also in our interest as a responsible profession.

ETHICS

  • In that endeavour, our ethical approach is to place the health of the client first and consideration of sales/profit second. I must say that the ethics of qualified natural therapists in the main also closely follow this line.
  • There are around 5,000 retail pharmacies in this country and most feel bound by these ethics of professional propriety.

AVAILABILITY/accessibility

  • The proponents of unrestricted marketing of physiologically-acting nutriceutical medicines (CMs) would have us believe that they are concerned that the consumer has ready access to such products at all times.
  • We would agree with that by pointing out that there are over 5 pharmacy outlets for every Colesworth store.and pharmacy and natural therapists offer ultimate accessibility to the public because:
  • They are more convenient to drive to and walk into
  • They are easier to exit from (no checkout queues)
  • Many are open at late hours and on weekends
  • It is easier to find products in them
  • It is possible to seek professional advice while purchasing products in them
  • They experience intense competition and must keep their profit margin down to stay in business
  • So the public is the winner at every turn

We note that a manufacturer’s consultant mentioned the word “supermarket” in the same sentence as “accessibility”.

  • We therefore dispute that this is the case for the above reasons.
  • It is our belief that pharmacy is accessible, convenient to access and highly competitive
  • That means that accessibility is not a unique feature of supermarkets.

Appendix:

HERBS WITH TOXIC EFFECTS

There is a short list of 150-plus herbs that have some significant toxic effect if taken OR USED incorrectly. It is certain that many more herbs will be added to this list.

That means that any form of concentration of a herb could well take it from the Schedule 2P category to the “potentially toxic” S3P or S4P category

We submit that – in the interests of public safety – these herbs be allowed only as schedule 3P or 4P items.

We can supply the names of these herbs and their toxic effects if requested by the Agency.

HERBS WHICH INTERACT WITH PHARMACEUTICAL DRUGS

The above-mentioned list of herbs with actions now known to interact with commonly prescribed pharmaceutical drugs has been widely circulated and is reproduced in The Journal of Complementary Medicine.

This list names 23 herbs with potential to alter the effect of drugs on humans.

The herbs are:

Bilberry, Celery seed extract, Cranberry, Echinacea, Garlic, Ginger, Ginkgo biloba, Grape seed extract, Green tea, Guarana, Kava kava, Kelp, Korean ginseng, Liquorice, Pau d’arco, Saw palmetto Schizandra, Slippery elm bark, St John’s wort, St Mary’s thistle, Tribulis terrestris & Valerian.

Herbs contraindicated in pregnancy

We have so far prepared a list of some 66 herbs that are contraindicated in pregnancy. This list is by no means exhaustive. As it is beyond the scope of this preliminary meeting to actually name names of herbs – and as our literature scan is continuing – we are happy to supply our list to date upon your request.

MINERALS OFFERING TOXICITY POTENTIAL (and some examples) include:

Calcium, Magnesium, Chromium, Copper, Sodium, Potassium

Zinc– Birth defects (up to third generational); competitive inhibition of absorption of other minerals.

Electrolytes(Na, K, Ca, Mg) can cause dehydration and death (especially in dehydrated athletes and infants, young children, sufferers of BP or cardiac illness and the elderly,) if wrongly used.

Vitamins & amino acids offering toxic potential and some examples:

B1, B3, B6, E, B15, B17,

Vitamin K – warfarin interaction

Vitamin A: Liver toxicity, alopoecia, birth defects (up to third generational) and death.

(Effects mainly revolve around the compromise of enzyme activity in cases of mineral and vitamin toxicity)

Amino Acids:

Most essential amino acids are potentially toxic in individual doses.

(Toxic effects involve competitive inhibition of active transport absorption sites).

OTHER POTENTIAL DRUG INTERACTIONS

Some examples are:

Amino Acids such as:

Eg: dl-Phenylalanine; tyrosine, tryptophan;

Fatty acid extracts such as:

Omega-3 – enhance seizure activity eg temporal lobe epilepsy

Omega-3 & -6 inhibit absorption of Vitamins A, D, E, K

Calcium: Interacts with isotretinoin and analogues; calcium channel-blocking drugs;

An exhaustive list is being compiled and can be provided on request.

End of report to first T.T.Agency meeting.