Herbal Medicines and GPhC Inspection

Complementary and Alternative Medicines - Any medicial system that doesn't belong to our definition of mainstream or conventional mecidince license. Herbal and Homeopathic Medicines are the only 2 CAMs covered in the Human Medicines Regulations 2012. Herbal Medicines is included in HMRs Part 7 sch. 29
Herbal product is not registered as a medicinal product, it could be sold in the UK as a food or cosmetic, in which case it does not have to comply with medicines legislations. If it is a medicinal product it can either be reigstered as a traditional herbal medicine or be licensed with a MA. Diffrence between the two are, tranditional does not have to make efficacy claim however, product with MA have to do so.
1. The use of products in which all the active ingredients are of herbal origin to treat the sick. They are usually plant derived materials - may be raw or processed and from one or more plants.
  1. Advantages: Ready available, can be highly effective, allow self-treatment where no OTC medicine is available and 'natural' products (often, considered safe) - e.g. Senakot
Difference to Orthodox:?
1. Herbal Medicines: They are whole plant or parts such as roots, leaves etc. Herbal Med are used in combinations - holitic, they are naturally occuring and often not standarised. Diagnosis is aimed at symptoms rather than the disease i.e. they are mainly used to relief a symptom rather than cure disease
2. Orthodox medicines: Isolated or synthesised chemical entities, specific activity and individual ingredients, they are often synthethic or manufactured, purified and standarised and used to treat a specific condition.
Unlicensed herbal medicines were permitted to be supplied by pharmacies under Schedule 12(1) of the Medicines Act, now not available for retailers to purchase from 2011.
Registration of Traditional Herbal Medicines
1. Traditional herbal medicines making therapeutics claims had 2 options for registrations. 1) Register as a conventional medicines - meet certain conditions and through clinical trials. 2) Under the Traditional Herbal Registration Scheme (THR). Unregistered products cannot make any therapeutic claim but can be sold as a dietary supplement eg. cosmetics and most herbal teas not covered by the legislation.
2. Traditonal Herbal Registration Scheme: To quantify the product, it msut have been in use in EU for 30 years or, have been in use in EU for 15 years plus 15 years elsewhere. It must demonstrate qualtiy and safety plus meet required manufacturing standards and finally it product must provide certain patient information, such as side-effects, contraindications etc and the health claims based on traditonal use. The THR logo should only be used on products that are registered under this scheme.
Human Medicines Regulations Part 7 - Traditonal Herbal Registrations
1. 5 Sets of conditions that are required to be met in order to meet the basic definition for inclusion in the THR scheme. These include:
  1. 1. If by virtue of its compositions and indications product is appropriate for use without the need of of a practitioner to diagnose the condition needed to treat, prescribe the product or monitor product's use.
  2. 2. Product is needed to be administered at a particular strength and in accordance with a particular posology.
  3. 3. If product is intended to be administered externally, orally or by inhalation
  4. 4. The product is not harmful and that the pharmacological effects and claimed efficacy are plausible
2. They are regulated by the MHRA. Applicant must be established in EU and application in English and state whether the product is to be sold as a pharmacy or GSL item. Registration is for 5 years initally but indefinite if renewed. Lapses if product not marketted ithin 3 years or if not available for more than 3 years post marketting. Registration is subject to pharmacovigilance. It can be evoked if there is concern for harm; that the effects are no longer plausible, or that the quality is not as per the application. There are procedures for withdrawal from the market or suspencion and manufacture are required to maintain records. Penalties can include the max statutory fine and or imprisonment for upto 2 years.
Herbal Medicines and Pharmacy
1. Mainly involved in OTC sale or pre-packaged and labelled registered products eg Senna or Senokot tablets. They are often used for shorrt self-limiting conditions eg. echinacea for cold or flu. Professional responsibility not to recommend if there is a doubt about the suitablity for the patient. Should sell a registered product where possible.
2. St John's Wort: Report suspected ADRs. Watch for interactions and side effects for misuse e.g St John's Wort CI during pregnancy and lactation. Adverse effects: GI symptoms and allergic reactions. Interaction: reduce the effect of warfarin, hormonal contraceptives, Digoxin, Statins etc.
GPhC -Inspectors and Inspections
1. Enforce Standards for Registered pharmacies: issued in 2012. They are grouped under 5 principles - which are used by the GPhC as regulatory approach.
  1. 1. The governance arragements safeguard the health, safety and wellbeing of patients and the public.
  2. 2.Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public.
  3. 3.The environment and condition of the premises from which pharmacy services are provided, and any associated premises, safeguard the health, safety and wellbeing of patients and the public.
  4. 4.The way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public.
  5. 5.The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public.
GPhC Inspections:
1. Carried out approximately every 3 years but moving to risk-based approach so a pharmacy posing concerns will be inspected more frequenlty. Usually (not always) a notification of impending visit without stating the time or date is sent to the pharmacy. However, in current views, the GPhC are trying to move this towards un-announced visit to ensure that pharmacy premises and services should always be upto standard - not when a notification of inspection are sent. Inspection usually takes upto 2 hours and in those time, a pharmacy needs to demonstrate how they meet the standards across all 5 principles to show that they are keeping patients safe.
2. How are they assessed? Usually its through show, tell me approach - which includes managers, locums and other staff although it is the owner and superintendent pharmacist who will be called to account. They need to provide, a written or documentary evidence, observing interaction with patients, questioning and posing scenarios to staff and testing systems, processes and procedures. SOP alone are not enough, need to show how it works in practice.

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