Transcript Ragulations self-medication

Regulations regarding
safety and quality control
of products in selfmedication
Janko Kersnik, Slovenia
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Aims of the presentation
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Regulation of medicines
Regulation of herbal products
Regulation of food supplements
Quality control
Role of a doctor
Ethical dilemmas
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Health status - Self-care
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Good health
Better performance
Preventive
awareness
Minor problems
Acute problems
Chronic conditions
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Doing nothing
Self-care
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Own experience
Family tradition
Neighbour’s advice
Healer advice
Professional advice
Self-medication
– From above
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Self-medication
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Physical items
– Heat, cold, water,
TENS…
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Regular food
– Proteins, fruits,
vegetables, grains...
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Food supplements
– Vitamins and Minerals
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“Healing” food
Drugs
– Human Medicines
– Herbal Medicinal
Products
– Homeopathic,
traditional,
“booster”... drugs
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Common cold
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Physical
items
Regular food
Food
supplements
“Healing”
food
Drugs
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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...
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Physical items
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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!
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Regular food
Proteins, fruits, vegetables,
grains...
 Pesticides, microbes, heavy
metals...
 http://ec.europa.eu/food/index_en.
htm
 http://www.who.int/foodsafety/en/
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EU
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WHO
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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
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Use logic and be cautious!
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“Healing” food
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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
...
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Regulations for
“healing” food
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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!
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Drugs
Human Medicines
 Herbal Medicinal Products
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– Herbal Medicines
– Traditional Herbal Medicines
– Herbal “ingredients” in drugs
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Homeopathic, traditional,
“booster”... drugs
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European Medicines Agency
(EMEA)
http://www.emea.europa.eu/home.htm
Regulation (EC) No 726/2004
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Human Medicines
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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
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Herbal Medicines
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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
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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
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of Regulation (EC) No 726/2004.)
European Medicines
Agency (EMEA)
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Quality
of herbal
medicines
Zdravila
rastlinskega
izvora Stable
- kakovost
Semen
form
Dosage of
active compund
General conformity
for medicinal products
Appropriate
processes
Testing during
production
Geographic origin
End
product Agricultural
control production
Production
Substance
entry
control
Farm production
Pesticides...
Drying, storing...
Drug
Drug extract
Additives
Packing
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r
-c
,
Misconceptions regarding
Herbal Medicines
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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.
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Traditional Herbal
Medicines
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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!
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Serious indications
A
Mild indications
B
C
Traditional use
Misleading
indications/use
X
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Level of evidence :
indications
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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
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Herbal “ingredients”
Cosmetics
 “Drugs” (ointments)
 Food
 Beverages
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NOTIFICATION to Agency for drugs
Use logic and be cautious!
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Risk in use of herbal
medicines
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Unwanted side effects
– Dose related, idiosyncratic, teratogen
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Interactions
– St Johns worth, ginko, garlic, ginseng,
camomile...
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Poor quality
– Wrong plant
– Contamination (Pb, As, aflatoxins)
– Synthesised drugs added (Chinese medicines)
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National medicines
database – C-OTC drugs
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Homeopathic remedies
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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
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Use logic and be cautious!
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Traditional drugs
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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!
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The role of a doctor
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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 selfcare history to avoid interactions.
Pharmcovigilance is mandatory for all drugs.
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Ethical dilemmas
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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”.
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Conclusions
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Doctors have to take careful medication and selfcare 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.
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Thank you for your attention!
rose-berry
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