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At least 271 records · Page 15Linked to original sources
PubMed1979

Evaluation of economic effects of drug product selection legislation.

Drug product selection legislation is intended to achieve savings in the cost of prescription drugs without adversely affecting the quality of care by allowing pharmacists the opportunity to dispense less costly generically equivalent drug products in place of the product which had been prescribed by the physician. Various conditions under which the pharmacists are authorized by state laws to exercise theoption to substitute are discussed. The study then identifies and examines the conditions under which savings may and do occur, using the legislation in Michigan as the model. Over 60,000 acutal prescriptions were examined for the three-year period, April 1, 1974 through March 31, 1977--which covers the period of the year immediately before the legislation became effective and the two subsequent years-to determine: 1) the extent to which substitution is possible; 2) potential savings from generic substitution; and 3) very substantial potential cost savings from drug product selection, the actual savings represent only an extremely small proportion of the potential. This principally is due to the fact of the low rate of substitution among eligible prescriptions. Thus, if the gap between actual and potential savings is to be reduced, more attention must be given to affecting the pattern of drug selection among pharmacists.

Costs and Cost Analysis↗
PubMed1981

The pharmacist as prescriber of drug therapy: the USC pilot project.

Recent legislation in California allows pilot projects to investigate prescribing by pharmacists. The University of Southern California School of Pharmacy project was approved in October, 1978. To be certified as prescribers, pharmacists must successfully complete a physical assessment course and a certifying examination. From an original group of 30 interested pharmacists, 25 were certified; five different pharmacists were added later. Prescribing pharmacists must meet with their supervising physician once every two weeks, and are restricted to the project formulary. A variety of health care settings are represented in the project, with pharmacists prescribing for ambulatory patients with chronic diseases, geriatric patients in extended care facilities, psychiatric patients, and selected inpatients. Project evaluation will continue through 1982 and will focus on safety and quality of care, patient acceptance, and cost of care.

California↗
PubMed2003

Proposed development of Sediment Quality Guidelines under the European Water Framework Directive: a critique.

The Water Framework Directive is the most important piece of water legislation in Europe for many years and will substantially influence the environmental regulation of chemicals, including human and veterinary pharmaceuticals. The development of Sediment Environmental Quality Standards (EQSs) is called for by the Directive, and proposals have been made for achieving this. However, these proposals are technically controversial and could have considerable logistical consequences. This paper describes the background to the Directive and lists questions that must be answered before Sediment EQS derivation is undertaken. Possible answers to these questions are then provided. The main problems with current proposals to the EC are that mandatory 'pass/fail' standards assume that approaches for setting sediment standards are more reliable than is the case, and that suspended sediments are a more appropriate sampling medium than settled sediments for assessing the general risk of sediment-bound chemicals to wildlife.

European Union↗
PubMed1993

Diagnostic and treatment guidelines on elder abuse and neglect.

It is estimated that between 1.5 and 2 million older adults experience abuse or neglect each year in the United States. Elder mistreatment may be physical, psychological, or financial, and it may be perpetrated by family members or by other informal or formal caregivers. Physicians are encouraged to play an active role in assessment, intervention, and prevention.

Aged↗
PubMed1979

Governmental toxicology regulations: an encumbrance to drug research?

The science of toxicology has become infinitely more complex and sophisticated over the past 20 years, a trend which has been particularly marked within the research-based pharmaceutical industry. Governmental rules and regulations have had a strong impact on the types of toxicity test now performed on drugs both in the course of their development and after their introduction on the market, and have thus contributed to the increased cost--in terms of time and money--of drug development. However, it will never be possible to measure or predict the safety of drugs in man by the application of toxicological techniques alone. Close collaboration between toxicologists and the authorities responsible for drawing up toxicological regulations is called for in order to ensure that the rules applied during the important and fascinating process of discovering and developing new drugs do not become unnecessarily burdensome.

Costs and Cost Analysis↗
PubMed2005

[Consequences of the 12th AMG amendment on the conduct of non-commercial clinical trials].

In 2004, the German Drug Law was reformed substantially putting into effect the European directive 2001/20/EG on Good Clinical Practice (GCP). Investigator initiated trials have to comply with the same requirements as clinical trials for drug development. When registered drugs are used in non-commercial clinical trials some simplifications are possible.Currently, all essential elements of GCP, such as financing of the trial, laying-down of sponsor responsibilities, establishing an extensive quality assurance system as well as immediate reporting of unexpected serious drug reactions, are stipulated by law. Since regulatory authorities and ethics committees have to approve every clinical trial, surveillance is reinforced. The new requirements cannot be met without sufficient financing, qualified personnel and professional structures for clinical trials. Compared to European partners, the research location Germany is at a disadvantage due to high administrative workload and costs.

Clinical Trials as Topic↗
PubMed2006

Customers' and physicians' opinions of and experiences with generic substitution during the first year in Finland.

Medicine expenditures have continuously increased in Finland over the past 25 years. Generic substitution was introduced in Finland in the beginning of April 2003 with the aim of curbing the rise in the medical expenses of society and individuals. Pharmacists are obligated to substitute the cheapest or close to the cheapest medicine for prescribed medicine unless the customer refuses or the physician forbids substitution, which the physician can do for medical or therapeutic reasons. In this study, we explored how customers and physicians view the 2003 reform via two customer questionnaires and by interviewing physicians. The first questionnaires were handed out in 15 pharmacies in 5 geographical areas (hospital districts) in Finland to customers (n=1243, response rate 44%) who had refused generic substitution, and the second in 18 pharmacies in 6 geographical areas to customers (n=453, response rate 47%) who had accepted substituted medicines at least once. The physician interview study was directed to psychiatrists, geriatrists, internists and general practitioners (n=49). Most customers and physicians think generic substitution is a good reform measure. The main reason mentioned for substitution was to save money. The most important reason given for refusing substitution was the customers' positive experiences with medicines they had used previously. About half of the physicians thought not all interchangeable medicines are effective and safe.

Attitude of Health Personnel↗
PubMed2006

Pricing and reimbursement of in-patent drugs in seven European countries: a comparative analysis.

The main objective of this comparative analysis was to assess regulations applied by EU governments to reward potentially innovative drugs. We focused on the pharmaceutical policy for in-patent drugs in seven EU countries: Belgium, France, Germany, Italy, the Netherlands, Spain, and the UK. A common scheme was applied to all seven countries: first, pricing and reimbursement procedures for new and innovative drugs were investigated; secondly, we focused on the use in the regulatory process of economic evaluations. The analysis involved reviewing the literature and interviewing a selected panel of local experts in each country. According to our comparative analysis, a first sensible step might be to classify active ingredients as those addressing neglected pathologies and those for diseases that are already successfully treated, thus offering more limited therapeutic gains by definition. A reasonable solution to reward real innovation could be to admit a premium price for very innovative drugs according to their estimated cost-effectiveness. New drugs with modest improvement could be grouped in therapeutic clusters and submitted to a common reference price, despite patent expiration. Such a "dual approach" could be a sensible compromise to restrict pharmaceutical expenditure while at the same time rewarding companies that invest in high-risk basic research.

Commerce↗
PubMed2007

Conditional reimbursement within the Dutch drug policy.

In The Netherlands, conditional reimbursement is considered to be a promising approach to achieving more effective and efficient pharmaceutical care. Because of its formal status and nationwide regulation, conditional reimbursement may allow governments to better control medical decision-making. To evaluate the effects of conditional reimbursement on medicine use and its performance as a policy tool, we compared observed volumes of medicine use with expected volumes. In addition, we mapped the annual growth by analysing trends in the volumes of use of all conditionally reimbursed drugs; starting with the year the drug entered the market (using macro-level data). Next we explored five cases in depth (using micro-level data) in order to explore what fraction of individual prescriptions met the requirements. We also performed qualitative research (document analysis, interviews (N=65)) in order to obtain the stakeholders' perspectives on how the measure functions, as well as to interpret the case studies data further. The findings suggest that conditional reimbursement may be an effective policy instrument, but that several changes are needed to optimize its impact. These changes are predominantly related to transparency (e.g. conditions are set following clear procedures and criteria), legitimacy (conditions should be consistent with criteria for prioritization), feasibility of procedures to control appropriate use, and timely and appropriate commitment of the stakeholders.

Interviews as Topic↗