E-drug: Re: Classification of medicines in OTC/PO etc.
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The current Norwegian requirements for transfer of products from
Prescription Only to Over The Counter
The SLK (the drug regulatory agency) evaluates applications for transfer
from POM to OTC, but may also take the initiative to the transfer. In the
assessment, the SLK weighs the advantages of self-care against the risks of
the condition to be treated, the possibilities for and risks associated with
wrong diagnosis, and the risks associated with the medication.
The patient must be able to assess whether there is indication for
self-treatment. The condition to be treated, should be non-dangerous and
preferably self-limiting. The dangers assiciated with wrong or delayed
diagnosis should be minimal. Typical examples are headache, nasal
stuffiness, menstrual pain, constipation, mild acne, small wounds, lice, dry
cough, motion sickness, pollen allergy, acid reflux. The aim of treatment is
enhanced comfort. The indication for treatments should be so simple that
the patient without special qualifications can commence treatment based on
symptoms or signss that are easily evaluable. Treatment should result in
rapid onset of evaluable and discernible effect. Lack of effect should be
easily detectable. Treatments with slow response, low responder rates or
responses that are difficult to evaluate, are not suitable for OTC.
Aspirin 300-500 mg is OTC in packs of 20 as an analgesic. In 70 mg strength
for platelet inhibition it is POM, as prophylaxis of thrombosis is not
suitable for
self-treatment.
The OTC medicines should carry minimal risk at the recommended dose and
duration of treatment of masking conditions that require medical attention.
This may in some cases mean that strength of the OTC preparations are lower
than the POM.
Only the treatment of first choice should be OTC. This is to avoid time
consuming experimentation before the patient seeks medical treatment. In
case of therapeutic failure the patient is advised to seek medical attention.
Only the safest effective substances.
New substances with insufficiently known margin of safety are only in
exceptional cases granted OTC status. Agents that are considered, must as a
rule have been so long on the market that safety and efficacy are known.
Only drugs for non-dangerous conditions will be recommended for OTC status.
For this reason, the drug must have high margin of safety to give a net
positive effect on health. If a number of substances are on the market, OTC
status will only be given to the safest and most efficaceous ones. These
agents will have to be those with the highest margin of safety both at
correct and incorrect usage, for example wrong indication or overdose.
Contraindications, interactions and precautions must be absent or so simple
that only few or simple absolute warnings need be given. Agents with abuse
potential will not be given OTC status.
Safety and safety margins will always be assessed in relation to the
proposed indication and presumed target group for the drug. Age limitations,
pregnancy and lactation are always assessed specially. Package size,
strength and
formulation are also given consideration. Dosage must be simple.
Interindividual pharmacokinetic variability must be of little importance.
User instructions including dosage recommendations will be printed on the
package. OTC status
is only granted to medicines that are so simple in use that complete user
information can be printed on the package. The package insert and other
information must be brief, simple, complete, and understandable for anybody,
regardless of background.
Gadeholt G. Kriterier for � gj�re legemidler reseptfrie (Criterias for
making drugs available OTC). Nytt om legemidler (Bulletin of the Norwegian
medicines Control Authority) 1996; 19 (4); 75. Translation by the author.
Regards
Gaut Gadeholt
Rikshospitalet (The National Hospital)�
gaut@online.no (private)
gaut.gadeholt@labmed.uio.no (work)
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