13081-Regulationsc_self-medication_Bled-

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

Aims of the presentation : 

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

Health status - Self-care : 

3 Health status - Self-care 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

Self-medication : 

4 Self-medication “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

Common cold : 

5 Common cold 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...

Physical items : 

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!

Regular food : 

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/

EU : 

8 EU

Slide 9: 

9 WHO

Food supplements... : 

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!

“Healing” food : 

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 ...

Regulations for “healing” food : 

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

Drugs : 

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

European Medicines Agency (EMEA)http://www.emea.europa.eu/home.htm : 

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

Human Medicines : 

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

Herbal Medicines : 

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

European Medicines Agency (EMEA) : 

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

Zdravila rastlinskega izvora - kakovost : 

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

Misconceptions regarding Herbal Medicines : 

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.

Traditional Herbal Medicines : 

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!

Slide 21: 

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

Level of evidence : indications : 

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

Herbal “ingredients” : 

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

Risk in use of herbal medicines : 

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)

National medicines database – C-OTC drugs : 

25 National medicines database – C-OTC drugs

Homeopathic remedies : 

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!

Traditional drugs : 

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

The role of a doctor : 

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 drugs we 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.

Ethical dilemmas : 

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”.

Conclusions : 

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.

Thank you for your attention! : 

31 Thank you for your attention! rose-berry