PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “DRUG LEGISLATION, CONTROL AND DISTRIBUTION”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 109 records · Page 6Linked to original sources
PubMed2001

Monitoring of national drug policies--regional comparison between Bulgaria, Romania, Macedonia, Bosnia Herzegovina.

After the profound economic and political changes most of the East European countries started market-oriented reforms. During the last 10 years rapid development of the private pharmaceutical sector and a slow privatisation process was observed. The balance between the private and public sector became very important for achieving NDP goals. The goal of this study is to evaluate the availability and development of the NDP structures in East European countries--Bulgaria (BG). Romania (Rom), Macedonia (Mac), Bosnia Herzegovina (BiH). For the assessment of the availability of NDP structures a questionnaire focused on seven main NDP components was used. These components are: legislation and regulations; essential drug selection and drug registration; drug allocation in the health budget/public sector financing policy; public sector procurement procedures; public sector distribution and logistics; price policy; information and continuing education on drug use. According to the survey the most developed NDP structures are drug legislation and regulations (incl. quality control), drug registration and drug distribution. We can assume that the people have access to different drugs of appropriate quality and in time. The systems for public drug financing, procurement and price policy are under developing or not efficient enough. The financial availability of drugs is difficult. There is a lack of objective drug information and postgraduate education is not oriented on the ED. It means that there is no guarantee for rational drug prescription and usage of drugs on the markets.

Bosnia and Herzegovina↗
PubMed2006

[Did a reform strategy in drug management improve doctors' prescribing habits in Montenegro: the example for the cardiovascular drugs].

BACKGROUND/AIM: A comprehensive reform strategy in drug management has been applying for a few years in Montenegro in order to promote a rational use of drugs. The reform strategy covered: an information system named "The Control of Distribution and Use of Drugs", a new List of Essential Drugs (that are reimbursed by the Republic Fund for Health), legislative and regulatory measures in order to establish a better control of drug prescribing and more efficient processing of the prescriptions. The aim of this study was to evaluate the effects of the reform strategy on the doctors' prescribing habits and the subsequent use of cardiovascular drugs within the outpatient setting of Montenegro. METHODS: A retrospective-prospective pharmacoepidemiologic study included a sample of 100% of cardiovascular drugs that were taken with prescription from state pharmacies during 2000 and 2004. The results were presented by the number of defined daily doses (DDD) per 1000 inhabitants per day. All the drugs were classified according to the uniform anatomical-therapeutic-chemical (ATC) classification of the drugs. The Wilcoxon test for matched pairs was used in order to calculate the significance of difference in cardiovascular drugs utilization before and after the introduction of new measures. RESULTS: Although prescribing and the resulting outpatient use of cardiovascular drugs (ATC group C) that were reimbursed by the Republic Fund for Health was increased approximately by 13% in 2004 in comparison with 2000 (67.98 vs. 60.17 DDD/1000 inh./day), we did not find a statistically significant difference (p > 0.05). Prescribing of ACE inhibitors (C09A) increased approximately by 45% during the investigated period (15.30 vs. 22.17 DDD/1000 inh./day). The selection of drugs was also altered: cilazapril, ramipril and quinapril were left out, captopril and enalapril were more prescribed, and a newly-induded fosinopril was prescribed mostly (31.5%). Calcium-channel blockers (C08) were prescribed 33.7% more (7.12 vs. 9.52 DDD/1000 inh./day), mostly because of seven times higher prescribing of amlodipine in 2004. Pentaerythritol tetranitrate was left out, but isosorbide dinitrate and isosorbide mononitrate were prescribed more frequently. High-priced atorvastatin was replaced with the older simvastatin, that was prescribed three times more. CONCLUSION: The reform strategy in drug management mostly improved the doctors' prescribing habits and the subsequent use of cardiovascular drugs within the outpatient setting. For the most part, the noticed changes were in accordance with the actual recommendations, but some cases need additional measures. Regulatory policy, however, could not compensate for the continual education of doctors that prescribe drugs.

Cardiovascular Agents↗
PubMed1992

Antimalarial drug sensitivity patterns in the western province of Zambia. Implications for the management of primary health care (PHC).

The management of acute malaria consists of chemotherapy aimed at restoring the normal function of all organs. Appropriate treatment is dependent upon extensive knowledge of the drug sensitivity patterns of the malaria parasites in the area. This is also important for chemoprophylaxis. Drug sensitivity patterns and recrudescence rates for Mongu (Western Province in Zambia) are suggestive of a likely increase in resistance to both chloroquine and sulfadoxine-pyrimethamine (Fansidar). We found RI (19.4%), RII (1.5%) and RIII (4.4%) resistance to chloroquine and RII (4.3%) resistance to Fansidar. This calls for careful consideration of treatment schedules, legislation pertaining to the distribution of drugs in the general public and alternative antimalarial control strategies.

Adolescent↗
PubMed1997

Setting goals for drug policy: harm reduction or use reduction?

Historically, United States drug policy has focused on use reduction; harm reduction is a prominent alternative. This paper aims to provoke and inform more debate about the relative merits of these two. Since harm is not necessarily proportional to use, use reduction and harm reduction differ. Both terms are somewhat ambiguous; precisely defining them clarifies thinking and policy implications. Measures associated with use reduction goals are poor; those associated with harm reduction are even worse. National goals influence the many decentralized individuals who collectively make drug policy; clearly enunciating goals makes some policy choices transparent and goals serve a variety of purposes besides guiding programmatic decisions. We recommend that the overall objective be to minimize the total harm associated with drug production, distribution, consumption and control. Reducing use should be seen as a principal means of attaining that end.

Decision Making↗
PubMed2006

Prevention and monitoring: tasks of the federal states in Germany.

Antimicrobial drugs in livestock farming are not used for therapeutic purposes, only, but also to conceal deficiencies in animal husbandry and management. Use of antibiotic drugs should be restricted by specific regulations, since some veterinarians seem to have an interest in increasing their income by treatment of diseases instead of performing health management. The above-mentioned requirements have been fulfilled by section 56 a (2) of German Pharmaceuticals Act, which regulates the usage and dispensary of pharmaceuticals according to the current standards of veterinary science. These current standards of veterinary science are described by common scientific positions and specific opinions of certain relevant committees. There is no single institutional committee available at present. Therefore, members of the German Federal Chamber of Veterinarians and members of the Committees of the German Federal States, which are responsible for the compliance with regulations and acts, defined a common position on current standards of veterinary science, concerning correct treatment with antibiotic drugs within a Working Group of the Federal States for Veterinary Pharmaceuticals (former ArgeVet, now AG TAM), the so-called "antibiotic guidelines". These antibiotic guidelines should help veterinary practitioners to use and prescribe those substances only, which are accurate for treatment of the diagnosed disease concerning the used class of antibiotic, amount, and duration of usage. The responsible authorities have to proof the prudent and proper use of antibiotic drugs in the range of their surveillance. The surveillance by the authorities is complicated, since the burden of proof of improper usage of antimicrobial drugs lies within the responsibility of the authorities. Prevention can primarily be conducted by informing the responsible veterinarians of the proper forms of treatment and by strict regulations for registration of pharmacologically active substances. Every additional label use and the usage of existing old registrations may undermine the surveillance of improper usage of pharmacologically active substances in livestock animals. The responsible authorities of the German Federal States, which may vary in their organization among the states, have to administrate the following duties: (1) Surveillance of manufacture and distribution of pharmaceuticals. (2) Inspection and control of proper usage of pharmaceuticals. Thus, the surveillance of distribution of veterinary pharmaceuticals has a broader range of requirements in comparison to surveillance of human pharmaceuticals. It is necessary to record and to control the amount of used drugs as well as their ways of distribution to perform a sufficient surveillance. The legal authorization was created by the 11th Amendment of the German Pharmaceuticals Act, but these specifications are still too imprecise to support the surveillance in the current process. Hence, the actual surveillance process is more focussed on usage and dispensary of pharmaceuticals and less focussed on manufacture and distribution. Therefore, the current surveillance with the aim to limit unnecessary usage of pharmacologically active substances according to the current legislation is limited. It is necessary to change legislation with regard to control of distribution of pharmaceuticals as well as integration of self-control of livestock owners for a sustainable increase of efficacy.

Animal Husbandry↗
PubMed1983

delta 9-Tetrahydrocannabinol and therapeutic research legislation for cancer patients.

The Controlled Substances Board evaluated the implementation of the National Cancer Institute (NCI) program in Wisconsin that distributes delta 9-tetrahydrocannabinol (delta 9-THC) to cancer chemotherapy patients with nausea and vomiting refractory to conventional antiemetic drugs. The board concluded that the distribution mechanism for delta 9-THC is appropriate and adequate in Wisconsin. The drug does relieve nausea and vomiting in some cancer chemotherapy patients, but adverse side effects are prevalent. Important questions about its safety and effectiveness remain and should be resolved through scientific research and within the existing framework for testing investigational drugs that are controlled substances. "Marijuana therapeutic research" legislation, similar to that passed in 32 states, was introduced in Wisconsin after implementation and evaluation of the NCI program, but failed to recognize the existing legal framework for approving new drugs and threatened to disrupt the NCI program. With assistance from the American Cancer Society, the State Medical Society, and volunteers and professionals in cancer research, the legislation was adapted to the existing legal and administrative framework.

Antineoplastic Agents↗
PubMed1988

Order on the possession, distribution, dispensing, and administration of the pharmaceutical specialty Mifegyne 200 mg. in tablet form, 28 December 1988.

This French Order has been made having regard to an Order of 22 November 1988 inserting Mifepristone (RU 486) in division II of Schedule A of the Poisons Schedules. The following are among the principal provisions. Division I sets out duties of the manufacturer and wholesale distributors of the pharmaceutical specialty Mifegyne 200 mg in tablet form (Sections 1-5). Under Section 2, pharmaceutical establishments manufacturing or distributing this specialty must keep it in locked cupboards or premises. Under Section 3, every purchase or transfer by a wholesale pharmaceutical establishment, even without charge, must be recorded in a special register, following the procedures indicated. Requirements as to reporting are laid down in Section 4. The register referred to in Section 3 must be retained for 10 years. Division II covers the purchase of the pharmaceutical specialty Mifegyne 200 mg, in tablet form, by establishments performing voluntary terminations of pregnancy, and the dispensing and administration of this specialty (Sections 6-16). Detailed provisions are laid down concerning the procedures to be followed in purchasing, dispensing, etc. the specialty. In particular, a special numbered booklet is to be kept, containing a series of vouchers. The procedures for completing such vouchers and the conditions for their retention are indicated. Under Section 13, pharmacists may supply the specialty only to physicians entitled to prescribe it (and with their names and signatures filed with the pharmacist) or to the person in charge of a department in which voluntary terminations of pregnancy are performed. Section 14 lays down that only physicians performing such terminations are authorized to prescribe and administer this specialty. It is laid down in Section 15 that the pharmacist is to undertake, in the presence of the director of the establishment, a monthly inspection of the cupboard within the department where the specialty is kept.

Abortion, Induced↗
PubMedDate not supplied

One-way distribution system for water for injection: process management, microbiological quality control, and meeting regulatory requirements.

The specifications for pharmaceutical water, the qualification and validation of water preparation facilities, strategies to prevent contamination by water-borne bacteria and lastly, the monitoring of microbiological purity are the topics of frequent seminars on Pharma Water Total Quality Management. The same subdivisions are used in the following paper on the process management and microbiological control of a one-way distribution system for Water for Injection. Since 1990, such a system has been in use in the production department of Pharma Hameln GmbH, a contract manufacturer of parenterals. Using this system as an example, the twin needs for flawless microbiological process control and for suitable measures to monitor water quality are discussed, which, together with extensive documentation of the qualification of the production and distribution system, ultimately led to acceptance of the system by regulatory authorities.

Drug Compounding↗
PubMed2004

The Xyrem risk management program.

Sodium oxybate, also known as gamma-hydroxybutyric acid (GHB), was discovered in 1960 and has been described both as a therapeutic agent with high medical value and, more recently, a substance of abuse. The naturally occurring form of this drug is found in various body tissues but has been studied most extensively in the CNS where its possible function as a neurotransmitter continues to be studied. Sodium oxybate has been approved in different countries for such varied uses as general anaesthesia, the treatment of alcohol withdrawal and addiction, and, most recently, cataplexy associated with narcolepsy. During the 1980s, easy access to GHB-containing products led to various unapproved uses, including weight loss, bodybuilding and the treatment of sleeplessness, sometimes with serious long-term effects. The availability of these unapproved and unregulated forms of the drug led to GHB and its analogues being popularised as substances of abuse and subsequent notoriety as agents used in drug-facilitated sexual assault, or 'date rape', eventually leading to the prohibition of GHB sales in the US. Legal efforts to control the sale and distribution of GHB and its analogues nearly prevented the clinical development of sodium oxybate for narcolepsy in the US. However, following extensive discussions with a variety of interested parties, a satisfactory solution was devised, including legislative action and the development of the Xyrem Risk Management Program. Amendments to the US Controlled Substances Act made GHB a schedule I drug, but also contained provisions that allow US FDA-approved products to be placed under schedule III. This unique, bifurcated schedule for sodium oxybate/GHB allowed the clinical development of sodium oxybate to proceed and, in July 2002, it was approved by the FDA as an orphan drug for the treatment of cataplexy in patients with narcolepsy as Xyrem(sodium oxybate) oral solution. To promote the safe use of sodium oxybate, as well as alleviate concerns over possible diversion and abuse following product approval, a proprietary restricted drug distribution system was created, called the Xyrem Success Program. Components of the programme include a centralised distribution and dispensing system, a physician and patient registry, compulsory educational materials for patients and physicians, a specially trained pharmacy staff, a method for tracking prescription shipments, and an initial post-marketing surveillance programme. The system has created a unique opportunity to provide both physician and patient education and ongoing patient counselling, promoting greater drug safety and enhanced patient compliance.

Administration, Oral↗
PubMed1999

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

The production, distribution and sale of counterfeit or substandard pharmaceutical products on the world market are of increasing concern to drug authorities and the international agencies that recommend standards for ensuring the quality, efficacy and safety of drugs. This report of an international group of experts convened by the World Health Organization presents recommendations concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. It looks at activities related to the further development of The international pharmacopoeia and also covers good manufacturing practices, inspection and monitoring, and drug regulatory legislation. The aim of the report, of particular relevance to drug regulatory authorities, is to provide guidance to promote harmonization at an international level and encourage countries to establish and strengthen their own regulatory systems through national legislation and training programmes. A number of annexes attached to the report further develop areas where countries might themselves take action, and include detailed examples of provisional legislation and guidelines on specific aspects of good manufacturing practice, the inspection of drug distribution channels, and the development of training programmes for the inspection and examination of counterfeit pharmaceuticals.

Drug Compounding↗
PubMed2002

[Good drug distribution practice and its implementation in drug distribution companies].

Good Distribution Practice is based on the Directive of the Board of the European Community 92/25/EEC regarding the wholesale distribution of drugs for human consumption. It is stated in the Directive that the whole drug distribution channel is to be controlled from the point of drug production or import down to the supplies to the end user. In order to reach the goal, the drug distribution company must create the quality assurance system and facilitate its correct functioning. This aim requires development of the rules of the Good Distribution Practice. Those rules set the general requirements of the Good Distribution Practice for distribution companies that they must conduct. The article explains main requirements postulated in the rules of the Good Distribution Practice and implementation of the Good Distribution Practice requirements in drug distribution companies.

Drug Industry↗