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Impact of drug substitution legislation--implications for continuing education for Michigan pharmacists.

In June 1974, Michigan Public Law 155 was enacted. This law permits a pharmacist to exercise drug product selection under specified conditions. The intent of the legislation is to achieve savings in prescription drug costs by encouraging pharmacists to dispense less costly, generically equivalent products. For this legislation to be effective, there have to be many substitutable products for a sufficient number of drugs; there has to be minimal interference with pharmacists' judgment; and pharmacists must be aware of the products available. As part of a survey, we attempted to measure physicians' and pharmacists' knowledge of generically equivalent products. Pharmacists demonstrated a higher level of knowledge of drug products. Continuing education must respond to the needs of more complicated societal demands.

Education, Pharmacy, Continuing↗

AHA/AWH convention report: VE going strong, new threats on the legislative front.

A mood of cautious optimism prevailed at the 1978 annual convention. Attendees were cheered by the success of the Voluntary Effort and recent legislative victories but warned that the next 18 months would be difficult. Two new threats on the legislative horizon--elimination of part B reimbursement for physicians in teaching hospitals and the Administration's national health insurance proposal--were discussed, as well as patient rights, medical record confidentiality, and new JCAH standards.

American Hospital Association↗

Fiscal impact of a potential legislative ban on second trimester elective terminations for prenatally diagnosed abnormalities.

This study was designed to determine the fiscal impact of a theoretical legislative ban on elective terminations for prenatally diagnosed abnormalities at Hutzel Hospital/Wayne State University. A fiscal comparison was completed for patients who had second trimester elective terminations for prenatally diagnosed abnormalities versus not allowing the procedure. An eight-year database of genetics cases and hospital and physician cost estimates for performing elective terminations for prenatally diagnosed abnormalities, and published reports of the average lifetime costs per selected birth defects, were used to calculate the net cost. The estimated lifetime cost for an average cohort year of a legislative ban on elective terminations for prenatally diagnosed abnormalities was found to be at least $8.5 million for patients treated at Hutzel Hospital. Extrapolated, a similar ban on second trimester elective terminations would have a net cost of $74 million in Michigan and $2 billion annually in the United States.

Abortion, Induced↗

Implications of certificate of need legislation for institutional pharmacy practice.

Federal certificate of need legislation (Section 1122 of Public Law 92-603)aimed at the elimination of costly, duplicative or unneeded health care expenditures is discussed. This law applies only to institutional providers receiving federal reimbursements. The key issues for pharmacy are that proposed substantial changes in service and capital expenditures of $100,000 or more must be justified to local and state comprehensive planning agencies prior to implentation. Failure to comply with the legislation can result in a reduction or withholding of federal reimbursement.

Costs and Cost Analysis↗

[Features of medical legislation].

Presents the major characteristics of medical legislation as a legal unit. Special attention is paid to manifestations of common principles of systemic legislation and signs characteristic of specialized laws.

Humans↗

The effects of mental health legislation 1890-1990.

This investigation sought to examine mental health legislation between 1890-1990 and to appraise their effects on the care and social control of the mentally ill. The research activities included the study and analysis of archival documents, Hansard, newspapers and professional journals. The findings show that those who cared for the mentally ill were subjected to the changes brought in by successive mental health legislation. These changes affected the working condition of the "mental nurse", and the social control and rights of the mentally ill person.

History, 19th Century↗

[Legislation or market forces? Apothecaries and druggists in the Interwar Period].

In 1865, Dutch Parliament accepted four laws regulating the national health care system and the organization of the medical profession. Together with the Law on Higher Education, that went into effect in 1876, they led to the raising of pharmacy to academic levels. Many expected this would deal the death blow to the chemist and druggist profession (drogist) and leave the apothecaries with a monopoly. The opposite, however, happened. The number of druggists increased dramatically in the decades following the 1865 legislation; their business was thriving due to the sale of secret remedies, the new synthetic remedies and other remedies that were popular with the public. This article deals with the heated debates between apothecaries and druggists over their position on the pharmaceutical market as well as with their laborious efforts to cooperation, the main question being how to control the sale of medicines: either by state legislation or by market forces. It turns out that the apothecaries expected much of the former but did not, their academic status notwithstanding, reject the latter on fundamental grounds.

Economics, Pharmaceutical↗

[Animal feeding and feed legislation after the detection of the first indigenous BSE cases in Germany].

In Great Britain, even the earliest tangible signs indicating the epidemiologic significance of meat and bone meal in the spreading of BSE soon gave rise to increasingly rigorous legislative measures regulating animal feedstuffs. In 1994 a ban on the feeding of animal proteins to ruminants was implemented throughout the entire EU. But until the first BSE cases were actually confirmed in locally raised cattle (November 2000), feeding practice and legislation more or less in Germany remained unaffected by the efforts undertaken in Great Britain. This situation was suddenly changed on 1 December, 2000, when the so-called "Verfütterungsverbot" was put into effect, a law which drastically extended bans regarding the feedstuffs (including fishmeal and animal fats) as well as the species concerned (all animals used in food production). In 2001 the "contamination" phenomenon (ingredients of animal origin were detected in mixed feeds) became a vital issue for the feed industry; through the media, the subject "feedstuff safety" gained a previously unseen level of public awareness. Those circles concerned with mixed feed production and animal husbandry were increasingly confronted with the consequences of the "Verfütterungsverbot" (availability and pricing of substitute ingredients; the demand for amino acids and inorganic sources of phosphorus; problems finding adequate substitutes for animal fats; poor digestibility of alternative components such as indigenous legumes or vegetable fats in calf diets; lower utilization rate of original phosphorus in mixed feeds with negative consequences for skeletal development). With the conditional approval of fishmeal (except in feeds for ruminants) the situation has eased again to a certain degree; on the EU level there are increasing signals pointing toward a political intention to reinstate the utilization of by-products of slaughtered animals qualified for human consumption (with the exception of fallen/dead animals and specific risk material) in poultry and swine feeding. In Germany, at least, the question of animal fat utilization for food-producing animals is still unsolved.

Animal Feed↗

Current federal legislation.

Current legislative proposals before Congress that will affect the practice of pharmacy are discussed. Revisions to the Medicare and Medicaid programs and amendment of the HMO Act of 1974 are being considered. Major legislation includes a bill that will regulate the activities of clinical laboratories and a bill that establishes a Presidential commission to oversee biomedical and behavioral research. Also proposed is a reorganization of the FDA which would create a new agency to assume responsibility for scientific and enforcement duties related to drugs and devices. Regulation of vitamins, health manpower and drug utilization improvement are also discussed.

Drug Utilization↗

The effects of a hospital policy and state legislation on resuscitation orders for geriatric patients.

In 1983, The Genesee Hospital, Rochester, NY, enacted a do-not-resuscitate (DNR) policy that was revised in 1988 because of complex state legislation. Using a retrospective chart review, we studied DNR ordering for all patients older than 79 years who died in the hospital during the 6 months before the policy and compared it with two 6-month intervals after the policy and three 6-month intervals after the law. The hospital policy was associated with an increase in explicit ordering of DNR from 21% in 1982 to 76% for the 2 years thereafter. A further nonsignificant increase to 84% was seen in the 3 years after the law. When cardiopulmonary resuscitation (CPR) was ordered, it was performed in 29% before the policy, 56% in the 2 years after, and 92% for the 3 years after the law. We reviewed all CPR attempts for 1988 and found that the overall survival rate for patients older than 79 years was 39% and probably was the result of careful patient selection. Our hospital policy was not adversely affected and may even have been enhanced by the New York State legislation. Despite this progress, we found that less than 25% of decisions about CPR or DNR were the result of informed decision making by patients themselves.

Aged↗

Sterilisation of the intellectually disabled: the need for legislative reform.

This article examines the recent decision of the Full Court of the Family Court in Re Marion dealing with the question of sterilisation of intellectually disabled minors and in particular, the question of whether a parent or guardian can lawfully consent to a sterilisation operation upon an intellectually disabled minor or whether court approval is required before such an operation can lawfully be performed. The article goes on to critically examine legislation in force in various Australian jurisdictions concerning involuntary sterilisations and substituted consent as well as legislative reforms that have been proposed in this area.

Adolescent↗

Refining the definition of death for Australian legislation.

In the article Mr. Smith considers the need for reform in the area of defining when death occurs and the various approaches that exist to define death. He then analyses the stages of the developments in the various Australian jurisdictions and discusses the substantive content of the basic definition adopted and the practical implications of any enactment. The author suggests that the concept of death should be legislatively enacted in relevant pieces of legislation which call for a resolution of the question at the present time and a more general separate statement defining death should be avoided at the moment. Conceptually death should be defined as the permanent and irreversible loss of consciousness of the individual as determined by irreversible cessation of the brain stem function. The actual operational criteria of death should form the subject of a circular published by the relevant statutory health authority for the guidance of medical practitioners in relation to the specific problems they face.

Australia↗

Medical students learn policy and advocacy through annual Legislative Day.

Through the collaborative relationship of the South Dakota State Medical Association (SDSMA) and the University of South Dakota School of Medicine (USDSM), there has been increased awareness and interest among medical students in the legislative process and its effect on the practice of medicine and delivery of care. As a result of this educational interest, and through the collaboration of these organizations, a formal "Legislative Day" has been added to the USDSM curriculum.

Anniversaries and Special Events↗

Genetic discrimination and the need for federal legislation.

The advent of the Human Genome Project signaled a new era in preventative care. However, this Project threatens to create a new form of employment discrimination, which legislation has yet to sufficiently address. Courts are attempting to utilize a variety of currently enacted laws to combat such discrimination but it is clear that this may be an inadequate deterrence. To combat this problem, a new set of laws and regulations will need to be enacted to ensure that the interests of employers are upheld while maintaining proper protection of employees from genetic discrimination. This paper focuses on genetic testing in the workplace and the need for Federal legislation.

Employment↗

The licensing of medical practitioners in Tudor England: legislation enacted by Henry VIII.

The medical profession in all developed countries requires national licensing, to identify trained medical practitioners and to proceed against quacks and mountebanks. England began this process in 1421 in the reign of Henry V, but the required legislation was enacted much later, in the reign of Henry VIII. Seven acts of parliament, directed at different elements of medical practice are described, with comments on England under Henry VIII and the persons and institutions proposing these licensing requirements. Whilst some legal aspects of medicine remained unclear, no further legislation of any significance was undertaken in England until the Medical Act of 1858.

Barber Surgeons↗

[Narcotics. Classification of drugs according to legislation].

Based on a historical outline, the survey describes the classifications of narcotic drugs according to present international conventions and Danish legislation. The classification of drugs according to the Danish act concerning euphoriant substances is compared to the classifications in Danish medical and pharmaceutical legislation.

Denmark↗

[Animal welfare legislation and animal experiments in Switzerland--effects and challenges].

The Swiss animal welfare legislation, which restricts experiments on animals, entered into force in 1981. The discussions, the legal prescriptions, the official guidelines and the ethical principles for animal experimentation issued by scientists are treated. The legislation has slowly brought about positive effects. Animal experimentation shows for several reasons a remarkable decline in the last years. Research on alternative methods to animal experiments was substantially promoted. Further improvements in the field of animal experimentation are requested.

Animal Testing Alternatives↗

Physician dispensing: issues of law, legislation and social policy.

Despite the fact that physicians have dispensed prescription drugs for profit for several years, the practice is currently under intense challenge and controversy. This recent flare-up can be explained by several factors including the involvement of the Federal Trade Commission (FTC), increased competition among physicians, alternative delivery systems and drug repackagers. Federal laws including the Food Drug and Cosmetic Act and Controlled Substances Act regulate dispensing practices, but have been interpreted to regulate dispensing by pharmacists, not physicians. All states have laws applicable to the dispensing of prescription drugs by physicians, but the wording of these laws raises unclear legal issues. Both uncertainty about these legal issues and pharmacists' concern over the increase in physician dispensing has promoted state legislative efforts to restrict or regulate the practice. These legislative efforts and the corresponding regulatory actions by state boards have triggered FTC involvement. From a social policy perspective physician dispensing raises significant concerns of ethics, conflicts of interest, patient welfare and economics. Based upon social policy, physician dispensing for profit is not a practice which should be condoned or allowed to flourish.

Drug Industry↗