Quality, Safety and Efficacy of Herbal Products: the role of the pharmacist

What are reasons for increased use of HMPs? (8 points)

Q: What are reasons for increased use of HMPs? (8 points)

1. Perception that HMPs are natural and therefore 'safe'

2. Philosophical and religious beliefs

3. Family traditions

4. Lack of need for professional advice

5. No requirement to disclose use to healthcare professionals

6. Desire for autonomy in healthcare

7. Influence of friends, social media, celebrity endorsements

8. Lower pricing compared to conventional medicines

What are the main issues related to HMPs? (3 points)

1. Evidence of effectiveness of herbal medicines

2. Risks to patient safety from herbal medicines and practices

3. Educational standards and public understanding

What are the risks associated with HMPs? (6 points)

1. Presence of toxic substances

2. Accidental or deliberate supply of harmful herbs

3. Misidentification due to appearance or common names

4. Use of dangerous herbs in Traditional Chinese and Ayurvedic medicine

5. Examples: Aristolochia fangchi (Aristolochic acid), Aconitum kusnezoffii/japonicum (Aconitine)

6. Need for guidance and safety testing protocols (EMA & EFSA)

What are the regulatory categories for herbal products? (3 points)

1. Registered medicinal products (PL or THR)

2. Food or cosmetic products - not guaranteed for safety or quality

3. Unlicensed herbal remedies - obtained via consultation with herbal practitioners

What is the Traditional Herbal Medicines Registration Scheme (THMRS)? (3 points)

1. THR assures safety and quality but not efficacy

2. Requires traditional use for at least 30 years (15 years in EU)

3. Licensed products (PL) require demonstration of safety, quality, and efficacy

How can HMPs be safely produced? (5 points)

1. Follow GMP at all stages

2. Use GAP and GCP practices

3. Address chemical complexity of plant materials

4. Recognize factors influencing content/concentration of plant constituents

5. Prevent substitution and processing error

What issues affect the processing of botanical material? (5 points)

1. Must adhere to GMP standards

2. Human error and fraudulent practices

3. Accidental or intentional substitution of botanicals

4. Need for stringent manufacturing and QC under THMRS

5. Use British/European Pharmacopoeia methods to standardize quality

What is the importance of extract composition in HMPs? (3 points)

. Determines dose per unit and total daily dose

2. Influences product efficacy and consistency

3. Needs careful processing and quantification

What is QA standardisation and how is it achieved? (5 points)

. Possible only if active constituents are known

2. Quantifies key pharmacologically active compounds or groups

3. Ensures minimum content levels

4. Supports reproducibility across batches

5. Uses characterisation of marker compounds

What role do pharmacists play in HMP safety and use? (6 points)

1. Advise patients/consumers on safe use

2. Clarify whether product is food, cosmetic, or registered HMP

3. Check if the product is licensed, registered, or a food supplement

4. Assess the product-s quality

5. Exercise caution with unlicensed/unregistered products

6. Refer to MHRA/RPS resources for verification

Q: What are the key conclusions about HMPs? (5 points)

1. Ensure safe production practices

2. Ongoing safety monitoring is crucial

3. Implement strict QC during manufacturing

4. Use Patient Information Leaflets and MHRA/RPS guidance

5. Report adverse effects via the Yellow Card Scheme