LABORATORY FOR COMPOUNDING MEDICINES
A compounded medicine is a drug prepared in a pharmacy according to a prescription (formula) for a specific patient or user (Article 24, paragraph 1 of the Law on Medicines and Medical Devices, Official Gazette of RS 30/10, 107/12, 113/17, 105/17).
The preparation of each compounded medicine in the laboratory of the Galena Specija pharmacy is approached by adhering to professional regulations regarding the prescribed medicinal substance, appropriate selection of excipients, pharmaceutical form, preparation procedure, concluding with packaging and labeling.
Before the very beginning of the preparation of a compounded medicine, possible incompatibilities among the drug's ingredients are assessed and excluded, and compatibility with the internal packaging is taken into account. After preparation and until dispensing, compounded medicines are stored under adequate conditions.
Their preparation is of great importance for certain groups of patients (children and the elderly), for whom industrial medicines are not available in pharmacies.
Since compounded medicines are prescribed by a doctor and prepared exclusively by a pharmacist, it is necessary for these healthcare professionals to cooperate closely. It is necessary for the pharmacist, when dispensing a compounded medicine, to talk with the patient or the person picking up the medicine and to give clear instructions on the method of application and storage of the drug.
Pharmacists are the only healthcare professionals who possess the knowledge and skills necessary for the preparation and method of application of these drugs.
The most commonly prepared pharmaceutical/medicinal forms are: oral solutions, cutaneous solutions, cutaneous emulsions, cutaneous suspensions, syrups, oral powders, cutaneous powders, hard capsules, suppositories, pessaries, ointments, creams, gels, lotions, pastes, eye drops and lotions, eye ointments, eye gels…
Compounded medicines prepared by pharmacists in the laboratory of the Galena Specija pharmacy are intended for ophthalmological, gynecological, dermal, oral, dental, and veterinary use, as well as for use in pediatrics, gastroenterology, physiatry, and radiology. Special parts of the laboratory are areas (cabinets) for the preparation of sterile compounded medicines and drugs with so-called highly active substances that are classified as biohazards.
In cooperation with pharmaceutical companies and doctors conducting clinical trials of drugs, pharmacists in the laboratory of the Galena Specija pharmacy prepare medicines in the appropriate pharmaceutical form and required strength.
Frequently asked questions
What is a compounded medicine under the law?
Under the Law on Medicines and Medical Devices, a compounded (magistral) medicine is a medicine prepared in the pharmacy according to a prescription (formula) for a specific patient or user. It is prepared by a pharmacist in accordance with professional regulations regarding the active substance, the choice of excipients, the pharmaceutical form, and the preparation procedure.
Which pharmaceutical forms are most often prepared in the compounding laboratory?
Most often oral solutions, cutaneous solutions and emulsions, suspensions, syrups, powders, hard capsules, suppositories and pessaries, ointments, creams, gels, lotions, and pastes, as well as eye drops, lotions, ointments, and gels.
For which areas of medicine are compounded medicines intended?
They are intended for ophthalmic, gynecological, dermal, oral, dental, and veterinary use, as well as for pediatrics, gastroenterology, physiatry, and radiology. Dedicated parts of the laboratory are used to prepare sterile medicines and medicines containing highly active (biohazard) substances.
Why are compounded medicines important for children and the elderly?
For certain groups of patients, particularly children and the elderly, suitable industrial medicines are often not available in the required dose or form. Compounding makes it possible to tailor the therapy precisely to those patients.
Who prepares compounded medicines and how is safety ensured?
Compounded medicines are prepared exclusively by pharmacists, the only health professionals with the knowledge and skills to do so. Before preparation, possible incompatibilities among the ingredients are ruled out and compatibility with the packaging is checked, and the medicines are kept under appropriate conditions until they are dispensed.