Today, many medicines are in high demand in the world, and citizens often buy them on the recommendation of friends or by their own decision, forgetting that medicines should be taken only as prescribed by a doctor. It is important to remember that a product such as a medicine requires special attention, which should not be sold uncontrollably given its specificity.
The state takes measures to ensure the quality, safety and effectiveness of medicines, regulating their circulation on the market. To avoid uncontrolled sales, some drugs are dispensed strictly by prescription.
In this publication, we will analyze how the prescription status of a drug is determined in our country.
In Kazakhstan, drugs are classified as prescription based on the Rules approved by the order of the Minister of Health of the Republic of Kazakhstan dated January 6, 2021 No. КР ДСМ-4.
According to the Rules, in order to classify a drug as a prescription drug, a state expert organization conducts a study of:
- pharmacological compatibility of components;
- source of origin and specific activity;
- methods of administration and side effect profile;
- pharmacological properties (pharmacokinetics, pharmacodynamics);
- adequacy of doses according to pharmacokinetic parameters;
- degree of risk of abuse and dependence, as well as the maximum permissible content of narcotic drugs, psychotropic substances and precursors in drugs;
- results of studies of toxicity, impact on reproductive function, embryotoxicity, teratogenicity, mutagenicity, carcinogenicity;
- safety and efficacy of the drug;
- expected benefit-risk ratio.
Prescription drugs include:
- containing narcotic drugs, psychotropic substances and precursors subject to control in the Republic of Kazakhstan in accordance with the legislation;
- for parenteral administration;
- used exclusively in a hospital;
- the prescription and further use of which must be carried out under constant supervision of a physician;
- intended for the treatment of diseases, the diagnosis of which is established in a hospital or in institutions with the necessary diagnostic equipment, and the use of the drug and subsequent monitoring is carried out on an outpatient basis;
- containing a medicinal substance, the activity and (or) adverse reactions of which require further study: newly registered drugs with a new active substance; drugs with limited experience of use; new dosage, new dosage regimen, new route of administration, new indication for use, new age groups;
- posing a danger to human health when used in accordance with the instructions for medical use of the drug without medical supervision;
- posing a danger to human health when used by the population without complying with the requirements of the instructions for medical use of the drug;
- subject to prescription dispensing by clinical and pharmacological groups in accordance with the established appendix.
A full list of drugs subject to prescription dispensing by clinical and pharmacological groups can be found in the appendix to the Rules at the link:
https://adilet.zan.kz/rus/docs/V2100022042
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