Regulations regarding safety and quality control of products in self-medication

1. Regulations regarding safety and quality control of products in self-medication Janko Kersnik, Slovenia

2. Aims of the presentation • Regulation of medicines • Regulation of herbal products • Regulation of food supplements • Quality control • Role of a doctor • Ethical dilemmas

3. Good health Better performance Preventive awareness Minor problems Acute problems Chronic conditions Doing nothing Self-care Own experience Family tradition Neighbour’s advice Healer advice Professional advice Self-medication From above Health status - Self-care

4. “Healing” food Drugs Human Medicines Herbal Medicinal Products Homeopathic, traditional, “booster”... drugs Physical items Heat, cold, water, TENS… Regular food Proteins, fruits, vegetables, grains... Food supplements Vitamins and Minerals Self-medication

5. Physical items Regular food Food supplements “Healing” food Drugs Warm clothes, avoiding exercise, bed rest, sauna, cooling with alcohol or vinegar or water bandages... Lemons, warm beverages... Vitamin C... Linden tea, rose-berry tea... Aspirin, paracetamol, nasal drops, combination drugs, antibiotics, homeopathy products... Common cold

6. Physical items • Regulations only as part of technical safety standards for technical equipment used in self-care • Neglected area, little evidence, widely used... • A lot of misconceptions, inappropriate use, overuse, underuse... • Use logic and be cautious!

7. Regular food • Proteins, fruits, vegetables, grains... • Pesticides, microbes, heavy metals... • http://ec.europa.eu/food/index_en.htm • http://www.who.int/foodsafety/en/

8. EU

9. WHO

10. Food supplements... ...means any food the purpose of which is to supplement the normal diet and which - (a) is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; and (b) is sold in dose form. • Strict regulations – Food Safety Authority – NOTIFICATION http://www.opsi.gov.uk/si/si2003/20031387.htm • Use logic and be cautious!

11. “Healing” food • Olive oil for gallstones, cholesterol • “Betacel” margarine • Apple vinegar for cholesterol • Goat milk for cancer • Garlic for wait loss • Ham for tuberculosis • Alcohol for physical strength • Starving for cancer treatment • ...

12. Regulations for “healing” food • Same as normal food regulations • NOTIFICATION to Agency for drugs • Many productsare home made or of unknown origin – threat due to misconception for the use and due to possible contamination • Use logic and be cautious!

13. Drugs • Human Medicines • Herbal Medicinal Products • Herbal Medicines • Traditional Herbal Medicines • Herbal “ingredients” in drugs • Homeopathic, traditional, “booster”... drugs

14. European Medicines Agency (EMEA)http://www.emea.europa.eu/home.htm Regulation (EC) No 726/2004

15. Human Medicines • Good safety control • Scientific Guidelines for Human Medicinal Products • Rigorous registration procedures • Use logic and be cautious! Assess ability of a patient for self-medication. • Don’t change each “old” drug for a “new” one – some side effects are visible only after years of use

16. Herbal Medicines • Same regulations as synthesised drugs • Active drug is extracted from a plant • The drug is defined by the name of a plant and part of the plant from which the extraction takes part - Valeriana officinalis L., radix • The data on efficacy and safety can be taken from the literature, if the drug is in use over 10 years. – Publication and consultation of Community monographs

17. European Medicines Agency (EMEA) of Regulation (EC) No 726/2004.) of Regulation (EC) No 726/2004.) of Regulation (EC) No 726/2004.)

18. Semen Stable form Geographic origin validation Drug Packing r - , - c , Quality of herbal medicines Zdravila rastlinskega izvora - kakovost Dosage of active compund Farm production End product control General conformity for medicinal products Agricultural production Pesticides... Drying, storing... Substance entry control Production Appropriate processes Drug extract Testing during production Additives

19. Misconceptions regarding Herbal Medicines • Herbal medicines are not “real” medicines. – Not true. • If they do not help, they can not harm. – They are potent drugs. • Herbal medicines are regarded as food supplements, aids in self-care, etc. – They have their role according to their indication list – same as synthesised drugs.

20. Traditional Herbal Medicines • The registration process is “easier” • Inadequate information on safety, interactions... • Level of evidence according to WHO grading for traditional herbal medicines is usually lower – also the indications should be less rigorous – self-mediaction • Use logic and be cautious!

21. Serious indications A Mild indications B Traditional use C Misleading indications/use X

22. Level of evidence : indications • white thorn: • white thorn extract: Heart Failure II NYHA - A level of evidence • white thorn tea: supports heart - C level or evidence – on the basis of many years of experience = traditional herbal medicine

23. Herbal “ingredients” • Cosmetics • “Drugs” (ointments) • Food • Beverages • NOTIFICATION to Agency for drugs • Use logic and be cautious!

24. Risk in use of herbal medicines • Unwanted side effects • Dose related, idiosyncratic, teratogen • Interactions • St Johns worth, ginko, garlic, ginseng, camomile... • Poor quality • Wrong plant • Contamination (Pb, As, aflatoxins) • Synthesised drugs added (Chinese medicines)

25. National medicines database – C-OTC drugs

26. Homeopathic remedies • From medical science different concepts • The effect of drugs is not related to the dosage • Little scientific evidence • Production of drugs outside EMEA • Unknown effectiveness and safety • Use logic and be cautious!

27. Traditionaldrugs • Should not be mixed up for homeopathic remedies • They use different concepts (i.e. Chinese traditional drugs) • Little scientific evidence • Production of drugs outside EMEAregulation • False sense of safety due to traditional use or/and natural origin of remedies • Unknown effectiveness and safety • Use logic and be cautious!

28. The role of a doctor • Health education of our patients is one of permanent tasks during each consultation. • We have high responsibility in guiding patients in eventual use of prescription medicines in self-medication. • With sensible advice on self-care practices and use of OTC drugswe can lower office visits and contribute to safe self-medication. • We have to take full medication and self-care history to avoid interactions. • Pharmcovigilance is mandatory for all drugs.

29. Ethical dilemmas • Serving two or even more “lords” – a doctor has to follow medical science • Advices unproven medication • Advertises or sell non-medical remedies • Avoids communication on self-care • Acknowledges use of unnecessary, ineffective or potentially unsafe self-medication practices in order to be “in”.

30. Conclusions • Doctors have to take careful medication and self-care history as part of medical history. • Human medicines and herbal medicines undergo rigorous control and are safe, if used in justified cases. • Doctors have a duty to teach patients how to use prescription and OTC drugs for self-care, when appropriate and to warn them to avoid them, if potentially dangerous or can be misused. • Doctors have to present their clear attitude against unsolicited use of no proven remedies or other substances in self-medication. • Doctors should not act judgementally.

31. Thank you for your attention! rose-berry