Organizational and legal study of the circulation of the combined medicines containing dextropropoxyphene

Abstract

Introduction.Scientific studies in recent years in the field of pharmaceutical law and forensic pharmacy indicate the existence of cause-effect relationships of various kinds of addictive dependence and illegal circulation of certain groups of combined medicines containing controlled active pharmaceutical ingredients. Illegal production of narcotic drugs and psychotropic substances from the combined drugs containing controlled active pharmaceutical ingredients is of particular concern because these medicines are in legal trade in the pharmaceutical sector of Ukraine and used by patients in the treatment of pain of various etiologies, with colds, dry cough and others. Purpose of the work is to carry out organizational and legal studies of the legal circulation of combined medicines containing controlled active pharmaceutical ingredient – dextropropoxyphene. Materials and methods.Research material were legal documents, instructions for medical use of combined medicines, forensic and pharmaceutical practice, scientific literature sources and Internet sites. In carrying out organizational and legal studies were used conventional regulatory, documentary, retrospective, forensic and pharmaceutical comparative graphical analysis methods.Results and discussion.In the course of the organizational and legal research on the characteristics of the legal handling controlled drugs that contain controlled active pharmaceutical ingredient - dekstropropoksyfen found that to date its circulation is regulated by the Order of the Ministry of healthcare of Ukraine from 19.07.2005. №360 «On approval of the rules of writing prescriptions and requirements, orders for drugs and medical products, the Procedure for sale of drugs and medical supplies from pharmacies and their structural subdivisions and Instruction on storage, accounting and disposal of prescription forms and claims-orders» According to the requirements of this order all combined dekstropropoksyfen-containing medicines should be discharged on a single prescription form F-1. To streamline the rules trafficking controlled drugs, which include controlled narcotic, have restrictions on their circulation stages of prescribing and dispensing, which is associated with quantitative content of psychoactive substances. Thus, for controlled medicines containing in its composition dekstropropoksyfen amount set for delivery in one recipe is not more than 0.6 grams of narcotic drug (p. 1.22.2 Order). In order to control the traffic of controlled medicines containing in its composition dekstropropoksyfen, regardless of its quantity and dosage form, all dekstropropoksyfen-containing medicines be subject-quantifiable in health care institutions that adopted Annex 3 of this order.Conclusions.During the organizational and legal studies analyzed the current pharmaceutical legislation-governing circulation of combined dextropropoxyphene-containing medicines. The particularities of the prescription of dextropropoxyphene-containing medicines were shown. On the example of the medicine of "Spazmoleks" showed the change in the regulatory framework of the combined circulation of the medicines and changing availability dextropropoxyphene-containing medicines for forensic and pharmaceutical criteria of "control mode". During the organizational and legal research conducted a retrospective analysis of prescription turnover dextropropoxyphene-containing medicines. According to the analysis revealed that these drugs are sold from pharmacies and structural units by the prescription F-1. Furthermore, according to existing pharmaceutical legislation it is possible to write and dispense recipe of the F-1 in combined dextropropoxyphene medicaments in an amount of more than 0.6 g in the case when packing products contains not more than 50 tablets. It was fixed that today dextropropoxyphene-containing medicines are subject-quantifiable. In the format of organizational and legal studies analyzed the circulation of the prescription forms of F-1 in health care.