Herbal Drug Regulation

What are herbal medicines? • Medicines with active ingredients made from plant parts such as leaves, roots or flowers • Just because they are natural does not mean that they are safe to be taken • Herbal medicines can be - THR products - PL products - Food supplements, including nutraceuticals What are homeopathic medicines? • Alternative medicines based on the use of highly diluted substances, which practitioners claim can cause the body to heal itself • They are very old, much older than most prescribed drugs, hence they are sometimes marked as being for 'traditional use only' • In 2017, NHS England said it would no longer fund homeopathy on the NHS as the lack of evidence for its effectiveness beyond a placebo effect did not justify the cost, and this was backed by a High Court judgement in 2018 • Pharmacists cannot advise or sell homeopathic medicines, and they should ensure wherever possible that people do not stop taking their prescribed medicines if they are taking or considering taking a homeopathic product What is the role of pharmacists in selling • Pharmacists must be aware that people requesting homeopathic products may homeopathic medicines? have serious underlying undiagnosed medical conditions, which may require referral to another healthcare professional. • Pharmacists must advise people considering a homeopathic product about 1 / 10 their lack of efficacy beyond that of a placebo. • When giving a THR medicine, even though it is a trusted product and is regulated for safety and quality, advice must be given and if the condition is serious, the prescribed medication should not be stopped and replaced by a herbal medicine What is THR? • Traditional Herbal Remedy • It is a legislation from the EU that was created in 2004 and amended in 2005 (remember the dates!) • The Traditional Herbal Medicines Registration Scheme (THMRS) is the scheme for when the THR regulation first came out • Any herbal product in the UK market that makes a medical claim must be under the THR regulation • The WHO Traditional Medicine Strategy was developed and launched in 2014 with the goal of documenting and understanding traditional medicines practice and exploring ways to integrate them into modern healthcare systems • For a product to be regulated in the UK or EU, it must have been used as the product, not the plant, for 30 years, and 15 of those years must have been within the EU rule. This helps to ensure that the product is safe as any side effects are likely to have been reported in that time. • THR products relieve symptoms, rather than curing eg products can be indicated for diabetes but instead they relieve water retention to ease symptoms • All THR products can be trusted by pharmacists 2 / 10 • All drugs under the THR are protected through the Yellow Card scheme for reporting adverse effects What traditions do herbal drugs come from? • Western herbal medicine • African herbal medicine • Unani (yunani) medicine • Ayurvedic medicine • Traditional Chinese medicine (TCM) What is western herbal medicine? • Utilises a mixture of herbal products based upon the diagnosis • Can be practiced during one-to-one consultations • Herbal preparations can be tinctures (alcoholic/ water extracts of a plant) or dried herb What is African herbal medicine? • The practice of medicinal plants arising from Southern Africa What is unani (yunani) medicine? • An ancient system based upon Greek philosophers • It is predominantly practiced in the Middle East and South Asia • It is believed that four key elements of air, earth, fire and water all constitute health in the human body • The presence of 4 humors in the body in a state of equilibrium preserves health. These 4 humors are blood (dam), phlegm (balgham), yellow bile (safra), and black bile (sauda) • It utilises herbs to treat/ maintain the 4 humors What is Ayurvedic medicine? • An ancient system based upon Indian Hindu traditions • It is based on the Indian belief that health is affected by all aspects of life, specifically these 5 elements: air, water, fire, earth and ether. An imbalance in 3 / 10 these elements cause an imbalance in the human body which gives rise to diseases • It utilises medicinal herbs and other elements such as animal parts/ heavy metals What is Traditional Chinese Medicine (TCM)? • The ancient practice of medicine utilising predominantly plant parts • In China, there are hospitals which fully treat by TCM, or there are TCM dispensaries within normal hospitals • People want to buy more natural products as they believe this is better and safer for them • They are taken as an alternative when other prescribed medicines do not seem Why is the global herbal medicines marto be effective, and some of these herbal ket growing in value? medicines do appear to have an effect • They can potentially be cheaper and easier to access • They are likely to be tailored to a persons specific diagnosis What is THMPD? • The European Directive on Traditional Herbal Medicinal Products • Between 2000 and 2005, the UK and EU were concerned at the free availability of unregulated and possible dangerous herbal drug products. Authorities did not know what was in these products and the quality of them. Thus, an EU directive THMPD was first constituted in 2004 and amended in 2005. • It is governed and enforced by the MHRA in the UK • Herbal products have multiple compounds in them so is difficult to test clinically. Therefore there is no assurance of quality, efficacy and safety for consumers 4 / 10 and healthcare professionals. Thus the THMPD decided that only certain products should be produced and sold, and so most herbal products were not allowed to be sold • It first came into force in 2011. This allowed companies a time period of 7 years to align their production to the requirements of the THR regulations. Many companies already had the GAP (good agricultural practice) and the GMP (good manufacturing practice) in place for this • By 2014, the sell through period had ended and all herbal drug products with a medicinal claim should now have been THR registered. • On the packaging, there must be a statement that is clear and evident of its intended purpose/indications for use with the wording "A traditional herbal medicinal product used for the relief of the symptoms of..., based on traditional use only" • The packaging must include the 9 digit THR number that is specific to the product • Inside the packaging, there must be a What characterises a THR product to the detailed patient information leaflet that public and healthcare professionals? derives from the summary of product characteristics. This is NOT the same as an advertising leaflet, like those in a food supplement product • There would also be a certification mark (leaf symbol), that is owned by the MHRA, on the product if it is THR Herbal products mirror their packaging of products that the public would recognise, to create a greater likelihood of purchas5 / 10 ing Two products can look very similar but one may have a THR registration and the other may not What are PL products? • Private label products • These are products which are created by one company to be sold and branded by another company • For example, Kaloba has a Schwabe logo which is a group of companies in the pharmaceutical and health industry, focusing on plants. The largest percentage of the group is in Germany. Licenses for products can be shared from other countries for use in the UK. • The MHRA are trying to bring herbal PL products into line with the THR regulation. • Two products can look very similar but one may be a THR product and the other may be a PL product What are food supplements? • In the UK, food supplements are regulated by the Food Standards Agency • Herbal remedies can fall into this category, ONLY if they are not making a medical claim. • If they make a medical claim, they are either illegal or need to be regulated under the THR EU directive. • For example, food supplements include - Korean ginseng root extract - ultra turmeric/ turmeric root extract containing curcumin - menopace supplements 6 / 10 What is cannabis? • Cannabis is a class B drug • There are three PIL products that contain cannabis for specific indications, which doctors can prescribe and pharmacists can dispense • Cannabis based medicinal products are listed in schedule 2 to the 2001 regulations to be used legally since 2018 but it can only be given by a healthcare professional • The dose of CBD (cannabidiol) has changed in 2020 from a daily dose of 70mg to 10mg, under the Food Standards Agency What are examples of herbal medicines? • Devils Claw • St John's Wart • Arnica • Gingko • Echinacea • Black Cohosh • Kaloba • Valerian • Horse chestnut What is St John's Wort? Plant name: Hypericum perforatum Active constituents: hyperforin and hypericin, but hypericin is what primarily helps to lift low mood Indications for use: To lift low mood and for mild anxiety (there is good clinical evidence to suggest that it is effective) Brands: KarmaMood, Hyperiforce What is Devils Claw? Plant name: Harpagophytum procumbens Active constituents: Iridoid glycosides ie harpagoside Indications for use: Backache, muscle ache, joint ache, and rheumatic pain Brand names: FlexiHerb 7 / 10 What is Arnica? Plant name: Arnica montana Active constituents: Sesquiterpene lactones (i.e. helenalin and dihydro-helenalin) Indications for use: gel for muscles, aches and pains Brand names: Atrogel What is Gingko? Plant name: Gingko biloba Active constituents: terpene lactones (ginkgolides and diterpenes) and ginkgo flavone glycosides (ginkgetin, bilobetin, and sciadopitysin) Indications for use: memory and thought problems, anxiety, vision problems What is Echinacea? Plant name: Echinacea purperea Active constituents: Alkamides, caffeic acid derivatives, cyclodextrin. Indications for use: effervescent tablets for cold and flu relief Brand names: Echinaforce What is Black cohosh? Plant name: Cimicifuga racemosa Active constituents: Triterpene glycosides, including actein, 27 deoxyactein and cimifugoside Indications for use: menopause relief for hot flushes, night sweats and mood swings Brand names: MenoHerb What is Kaloba? Plant name: Pelargonium sidoides Active constituents: highly oxygenated coumarins, gallic acid-derivatives, flavonoids, phenolic and hydroxycinnamic acid-derivatives Indications for use: upper respiratory tract infections eg common cold, sore throat, runny or blocked nose, coughs. It can come as a syrup or tablets 8 / 10 What is Valerian? Plant name: Valeriana officinalis Active constituents: valerenic acids, such as monoterpenes and sesquiterpenes, and iridoid glycosides Indications for use: for temporary relief of sleep disturbances Brand names: Kalms, Nytol or Dormeasan What is Horse chestnut? Plant name: Aesculus hippocastanum Active constituents: Aescin Indications for use: to relieve symptoms of varicose veins, can be given as tablets or as drops Brand name: Venaforce • Black cohosh has been linked to rare cases of hepatic reactions Patients must stop taking the product immediately and consult their doctor if they develop signs and symptoms that suggest liver dysfunction eg fatigue, anorexia, yellowing or the skin and eyes, severe upper stomach pain, nausea, vomiting, dark urine. Oestrogens may only be taken simultaneously with this product under medical supervision as their effect What are examples of harmful interac- may be intensified by black cohosh. tions in herbal drugs? • Echinacea has been linked to possible allergic reactions in patients prone to such events. Symptoms in some of these cases can be severe. The MHRA advises that it should not be used at the same time as immunosuppressants, specifically ciclosporin and methotrexate • Valerian has few known interactions but should not be used with hypnotics or sedatives, as valerian can enhance the effects of these. There are also possible interactions with other herbal drugs eg 9 / 10 ginkgo and st johns wort. • St John's wort has many interactions because hyperforin is metabolised at the same CYP p450 enzyme site as many prescribed drugs What is contamination? • Contamination is when a substance contains another unwanted or dangerous substance • Examples of contamination are - aristolochic acids from Aristolochia species can accumulate in soil and vegetables, and these aristolochic acids can be poisonous to the human liver - chemicals, metals or other plants found in herbal teas, present during harvesting - heavy metals found in Hershey's chocolate, present from the manufacturing process or from the cocoa plant material • It is important to make sure the plant in the product is the plant that is named so that the plant can be identified for interactions What is adulteration? • Adulteration is secretly mixing a substance with another • Examples of adulteration are - dietary supplements - slimming aids 10 / 10