Determining and managing the delivery and supply of medicines is the duty of the state. Within the framework of this obligation, the state determines the system that – if necessary – provides the citizens with access to safe, effective and good quality medications that comply with regulations.
Every substance or mixture of substances used to prevent or treat human diseases is regarded as medication, if they elucidate favorable effects enabling to restore, repair or alter physiological functions and help to establish diagnoses.
Extemporaneous or magistral preparations form a special group of medicines. These medications are prepared by pharmacists at the pharmacy based on the guidelines of the Hungarian (Pharmacopoeia Hungarica, in Hungarian: Magyar Gyógyszerkönyv) and the European Pharmacopoeia (in Hungarian: Európai Gyógyszerkönyv) or the Formulae Normalaes (FoNo, Compilation of Standardized Prescription Formulas, in Hungarian: Szabványos Vényminta Gyűjtemény) by the doctor’s prescription or on their own initiative.
Homeopathic medications form another group of drugs; however, it has to be highlighted that no scientific studies could prove any favorable effect by them on any human diseases.
Authorization of medicines
In order to become authorized and distributed on the market, drugs need marketing authorization which is issued by the authorities on the request of the pharmaceutical company if the product is safe.
During the authorization process they determine and record the classification of the drug in the marketing authorization - or in the Pharmacopoeia or in the Compilation of Standardized Prescription Formulas in case of magistral preparations-, according to which the drug is classified as prescription only or over the counter drug.
Prescription-only vs. over-the-counter medications
Doctors prescribe medications on prescriptions for patients listed on their registry (rules of registration are determined by legislation).
All doctors and dentists are entitled to prescribe medications. For doctors, veterinarians and pharmacists – if they can authentically verify their profession-, prescription-only medications can be sold without a prescription in the quantity sufficient for a maximum of 30 days, except for medications in the following categories: narcotic (K1, K2) and psychotropic (P2, P4) drugs.
Medications can be qualified as prescription-only drugs, if -even when appropriately administered- they may threaten the patient’s health without medical supervision.
For example, they might induce addiction or -if administered concomitantly with other drugs- extra caution must be taken. The mode of application and the disease type can also pose a threat – e.g., in the case of medications used in infectious diseases or in the case of injections. These support the importance of having access to these drugs only with prescriptions.
Most of the medicines are prescription-only medications. Prescriptions are practical tools for medical supervision. Beside prescription-only medications, over-the-counter drugs (OTC) are also available.
Medications can be qualified as over-the-counter drugs (OTC), if they can be purchased at pharmacies without a prescription. Before administration, self-diagnosis can be established with unlikely errors or if self-diagnosis is mistaken, there are no severe health consequences, and the danger of administration (side-effects, drug interactions) is low even in case of overdosing the drug. However, caution must be taken when administering OTC drugs, too.
The same medicine might be available in prescription only and in OTC form as well. Usually, OTC drugs contain smaller doses of the medicines, they contain fewer tablets or lower doses of the active agents, therefore, their administration does not require medical surveillance or prescriptions.
Prescription-only drugs are accessible only in pharmacies, while the out-of-pharmacy distribution of OTC medications is regulated by the National Institute of Pharmacy and Nutrition (in Hungarian: Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet, OGYÉI).
Those drugs can be distributed in out-of-pharmacy, small-scale distributor facilities, which are accessible in pharmacies as OTC drugs, and before their administration, self-diagnosis can be established with unlikely errors or if self-diagnosis is mistaken, there are no severe health consequences, and the danger of administration (side-effects, drug interactions) is low even in case of overdosing the drug.
Out-of-pharmacy, small-scale distributors must also ensure the appropriate storage conditions and regulations for the medication.
Though certain OTC drugs are accessible at out-of-pharmacy distributor facilities, too, it is advised to inform the treating physician and the pharmacist about the administration of OTC drugs – especially, if they prescribe prescription-only medications while you are taking an OTC drug.
In conclusion, all medications belong to the prescription-only category, where medical surveillance is necessary for safe administration. Hence, everybody has access to the appropriate medications, thereby helping to preserve their own health.