Maven J. Myers

Drug expenditures in a balanced strategy for healthcare policy.

SummaryThe US, like many countries, has turned its public focus onto its healthcare system, with drug prices drawing particular atention. Expenditure trends indicate that drugs do not represent a large portion of the overall healthcare picture; the typical US consumer, however, feels these costs more personall y because large portions of outpatient drugs in the US are purchased with out-of-pocket funds. Using data trends for US expenditures, we contrasted projections in the year 2000 under the current US system relative 10 a strategic policy with full coverage of prescription drugs. Under this proposed scenario, drugs still captured just a small portion of overall healthcare expenditures, but with major shifting to private insurance and government programmes. Thus, as society increasingly views some level of healthcarc as a basic human right, effective policies for the healthcare system-including the drug sector-must balance competing regulalOry and market pressures.

A Comparison Between China and U.S. Drug Laws

AbstractThe Peoples Republic of China, with one quarter of the worlds population, has a long and rich pharmaceutical history. While drug regulation in China can be traced back three thousand years, the current major drug control law was enacted in 1984. By way of contrast, the United States is a relatively young country; however, it has a highly developed system of pharmaceutical regulation.Major differences between the two systems include the impact of traditional Chinese medicine on the system in China, different systems of responsibility for drug control in the two countries, more stringent regulation of drug manufacturing and distribution in the United States, and the relative lack of a substance abuse problem in China. Drawing on the highly developed regulatory system in the United States, suggestions are offered to assist in perfecting drug regulation in the Peoples Republic of China.

Liability Aspects of Drug Product Selection

In exercising source selection of drug products, the pharmacist may be subject to liability based on (1) the premise of negligence in selecting the source, i.e., breach of duty to exercise due care, or (2) breach of warranty, most probably in the form of breach of implied warranty of merchantability or of breach of warranty of sale by description. The pharmacists familiarity with drug recalls, compendial standards, manufacturer reputation and bioavailability problems are discussed as these relate to his liability. Increased responsibility for source selection of drug products may increase the pharmacists liability, but the extent of the liability in this area does not appear to be great.

Dynamic Competition as an Exploratory Model of Healthcare Policy for the Antihypertensive Market

SummaryDynamic competition based on innovation, rather than classical competition based on price, may better explain the research-intensive pharmaceutical market. In an exploratory comparison of these models, economic indicators of annual change in price and price elasticity of demand were tested in a repeated-measures design by analysis of variance.Between 1990 and 1992, updated US prescribing guidelines for hypertension provided a framework in which the contrast between 2 newer classes and 2 older classes of first-line therapies served as a marker for innovation. The principal hypothesis was that newer classes would be less elastic than older classes, but with such innovation-based differences eroding over time. Although temporarily greater inelasticities for newer classes supported dynamic competition, initially extreme inelasticities for newer classes indicated a market distortion or a shifting demand curve.These exploratory results, although requiring substantiation, point toward using dynamic competition in crafting healthcare policy for the pharmaceutical market.

The New Drug Application Process in the People's Republic of China

AbstractThe 1984 Drug Control Law (DCL) of China provides authorization for the Ministry of Public Health to issue regulations on the New Drug Application Procedure. These regulations, which became effective in July, 1985, apply both to new chemical drugs and new traditional Chinese natural drugs. For each of these types of drugs, five categories have been defined with differing requirements concerning the new drug application procedure and the information required. An application for clinical investigation must be filed and approved prior to the commencement of the clinical investigation in an approved hospital. After completing the clinical investigation, application is made for a New Drug Certificate and Approval Number. New drugs in categories 1 and 2 may receive only a two year tentative manufacture approval during which distribution is limited. Following this two year period, final approval may be granted.

Drug Law in the People's Republic of China

A comprehensive Drug Control Law for the Peoples Republic of China was enacted in September, 1984. The Ministry of Public Health has nationwide responsibility for administration and enforcement of the law; various health administrative agencies have this responsibility at the provincial, city and county levels. An English language translation of the 1984 Drug Control Law is provided. The law consists of 11 chapters covering control and inspection over drugs and their manufacture; drug control in hospital pharmacies; management of new drugs, drug quality, imported drugs, and adulterated drugs; drug packaging and advertising; drugs under special controls; and sanctions for violations.