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PubMed2006

Exempt preparations: Historical perspectives.

This article is part of a supplemental issue of the journal devoted entirely to papers on how abuse liability of medications is affected by their formulation for medical use. This article reviews the history of the development of the concept of "exempt preparations" from its first use internationally to its current use, both nationally and internationally. The role of the WHO Expert Committee on Drug Dependence (ECDD) and the College on Problems of Drug Dependence (CDPP) is presented. Examples of exempt preparations are given and the use of the concept to permit useful therapeutic agents to be marketed with reduced regulatory control is discussed.

Drug Prescriptions↗
PubMed1993

Reproductive genetic testing: regulatory and liability issues.

Analysis of current law demonstrates that the responses of state and federal governments and the legal system to reproductive genetic testing both have shaped the development of and reflect society's views about these techniques. Access to testing has been increased by governmental provision of services and enactment of insurance requirements and by the state courts' frequent approval of individual litigants' claims that they were inappropriately denied genetic information. Many state legislatures, however, have tried to limit testing by failing to provide funds, by forbidding private lawsuits and by limiting access to abortion.

Abortion, Eugenic↗
PubMed1980

Payton v. Abbott Laboratories: an analysis of the Massachusetts DES class action suit.

In Payton v. Abbott Laboratories, U.S. District Court Judge Walter J. Skinner recently granted class certification to an action brought by twenty-seven Massachusetts women against major manufacturers of DES. This is the first case in which a judge has interpreted the requirements of Rule 23 of the Federal Rules of Civil Procedure to allow women exposed in utero to DES to sue as a class to determine liability for their injuries. This Note reviews the Payton certification in light of prior class action decisions involving DES and other types of claims, and of legal commentary on Rule 23. This Note contends that Judge Skinner's application of the Rule 23 requirements in Payton was procedurally correct, and recommends the class action device as an effective method for litigating such controversies. Finally, this Note analyzes the implication of this landmark ruling for plaintiffs seeking class certification in DES suits and in suits presenting analogous factual situations.

Diethylstilbestrol↗
PubMed1983

[Liability for unsuccessful sterilization?].

In 1980 the Bundesgerichtshof (German Federal Supreme Court) handed down two leading decisions. In both cases the doctor who was responsible for the failure of a sterilisation was sentenced to pay the parents' damages incurred by the support for the unwanted child. Doctors and lawyers have vehemently criticised these decisions. Recently these decisions were consciously ignored by the Frankfurt Regional Court of Appeal which decided, in a new case, that "a child can not be considered a damage" and, therefore, has rejected the claims of the parents, disappointed at the birth of their child. The reluctant mother's claim for immaterial damages was also rejected. The author's arguments also support a change of the Supreme Court's decision.

Female↗
PubMed1989

Implementing medical staff malpractice insurance requirements.

Hospitals have recently begun to explore and adopt medical staff membership criteria that go beyond simply determining a practitioner's ability to practice medicine. Medical competence and expertise will always play a central role in medical staff membership decisions. However, the increasing competition among hospitals for patients with the attendant pressure to contain health care costs has caused hospitals to consider business factors in the composition of their medical staffs. To ensure their own survival, hospitals need to be efficient and sensitive to the financial dynamics of the industry as they determine the composition of their medical staffs. One response to the new business reality of health care by hospitals is the adoption of minimum medical malpractice insurance requirements for medical staff members. In large part, hospitals have adopted these requirements at the insistence of certain insurance carriers. Although there has not been much litigation over this issue, a handful of cases has held that such requirements are reasonable because they help to protect the hospital's assets and to ensure that patients have a source of funds for recovering damages caused by malpractice. These courts have recognized that it is a board's duty to protect the financial well-being of the hospital and that such requirements help to satisfy this duty. This article will describe the case law that upholds such requirements, analyze the problem regarding practitioners who cannot comply with a hospital's insurance requirements because such coverage is not available to them, and discuss the problems and possible resolutions regarding adoption and implementation of such a requirement.

Insurance, Liability↗
PubMed1980

Contribution of patient and hospital characteristics to adverse patient incidents.

The 1974 medical malpractice "crisis" brought about extensive legislation and insurance regulation in the United States. Hospitals in many states are now required to support risk management programs that include investigation and systematic analyses of adverse patient incidents. However, no research supports the hypothesis that systematic analysis of adverse patient incidents can identify contributory factors. In this study, a simple prediction model was used to estimate relationships between adverse incidents and selected patient and environmental characteristics in a large hospital. While some of the incident-characteristic relationships were significant, none of the estimated equations yielded results that could be logically translated into policy recommendations for the hospital. These results point to the need for further research. The benefits that positive research results would have for patients, hospitals, an the bill-paying public are obvious. Additional negative results would suggest that many legislative bodies and regulatory agencies were presumptions in requiring hospitals to conduct analyses of incidents.

Accident Prevention↗
PubMed1996

Identifying adverse events caused by medical care: degree of physician agreement in a retrospective chart review.

OBJECTIVE: To 1) assess the degree of agreement among physicians on the cause of previously flagged adverse outcomes and 2) relate the findings to systems of quality assurance and performance assessment and proposals for no-fault compensation for medical injuries. DESIGN: Observational study of 7533 pairs of "structured implicit" reviews (subjective opinions based on guidelines) of medical records done by 127 physicians working independently. SETTING: Random sample of 51 inpatient facilities in New York State. PATIENTS: Random sample of inpatient medical records from the selected facilities. MEASUREMENTS: 1) Number of agreed-upon adverse events compared with the number of cases of extreme disagreement and 2) internally and indirectly standardized rates at which physician reviewers found adverse events (injuries to patients caused at least in part by medical management). RESULTS: In 12.9% of cases (971 of 7533), the two physicians in a pair had extreme disagreement about the occurrence of an adverse event. These cases outnumbered those in which both reviewers found an adverse event (10%; n = 757). Agreement was highest for wound infections and lowest for adverse events attributed to failure to diagnose or lack of therapy. The amount of experience the physicians had in reviewing records tended to increase the level of agreement. Even after standardization to the results of the entire sample, individual physicians' rates of finding at least slight evidence of an adverse event varied widely (range, 9.9% to 43.7%) (P < 0.001). CONCLUSIONS: Structured implicit reviews produced disagreement on the causes of adverse patient outcomes. If systems of quality assurance, performance audits, or no-fault patient compensation are to succeed, methods for overcoming the common tendency toward disagreement among experts must be developed.

Humans↗
PubMed2006

Impact of formulation on the abuse liability, safety and regulation of medications: the expert panel report.

A scientific meeting was held in April 2005 to consider how the formulation of medications might impact on their potential for abuse. The background papers prepared for this meeting, as well as abstracts of volunteered presentations, are published in this supplemental issue of Drug and Alcohol Dependence. This paper is the Expert Panel Report summarizing the discussions held following the formal presentations and including the suggested recommendations for additional research that emerged from these discussions. There was overwhelming consensus that formulation does play a role in prescription drug abuse, i.e., a formulation of an abused substance can be developed that will decrease its abuse potential, and several examples were cited. Nevertheless, it is imperative that new formulations have similar efficacy and in no way compromise medication access to doctors and patients. However, there was also consensus that a great deal of research and discussion was needed to fully implement a program of risk management through reformulation of existing products or tailoring the formulation of new products to retain clinical efficacy and safety while minimizing potential for abuse. Those who need to take part in this discussion include scientific groups, pharmaceutical companies, as well as governmental and regulatory agencies. The areas where more research is needed include development of standards for assessing tamper-resistance, improved animal models that can address formulation-related variables (e.g., onset, duration), the redesign of human laboratory studies providing appropriate models for comparing formulations, and improved post-marketing surveillance. Finally, knowledge and experience are needed to translate scientific work into a predictable, transparent and reliable regulatory process.

Chemistry, Pharmaceutical↗
PubMed2006

A multifacited approach to improve patient safety, prevent medical errors and resolve the professional liability crisis.

The current professional liability crisis is the third in the last 30 years. Similarities of the 3 crises are the rising cost of professional liability insurance and a diminishing number of sources available to purchase coverage. Proposed tort reform with caps on noneconomic damages and attorney contingency fees is a back end approach and will do little to solve this crisis or prevent future ones. The current situation can only be solved by placing an increased emphasis on improving patient safety and elimination of all preventable medical errors. A national electronic medical record must be developed and rapid response teams need to be available in most hospitals. The protective devices of privileged communication and peer review are counterproductive and must be eliminated. Full and prompt disclosure of any medical error or injury needs to be made. Physicians must be taught proper communication skills and the importance of teamwork. Providers with frequent patient, nursing or medical staff complaints must be critically reviewed. The present system of risk management needs to move from a reactive position to a role of being proactive for both patient and physician. Claims management should offer the patient early compensation when appropriate and pursue a vigorous defense when medical care is adequate. Experts should be identified who will render fair, unbiased reviews of medical care with all of their findings being disclosed. Similar experts need to devise clear, concise, evidenced based standards of care for common medical conditions.

Humans↗
PubMed1999

Not to worry: directors and officers claims can be managed.

Directors and officers claims have become more prevalent due to the employment litigation surge in this country. This article provides examples of real claims, offers suggestions in managing claims, discusses trends in litigation and provides recommendations for loss prevention.

Administrative Personnel↗
PubMed2004

[New dermatologist's procedure. Research plans for improving secondary prevention of occupational dermatoses].

The dermatologist's procedure was introduced in 1972 by employers' liability insurance funds in the industrial, agricultural, and public sectors of Germany's statutory occupational accident insurance as a "procedure for early detection of occupational skin diseases." So far, it is still the most relevant tool for secondary prevention in occupational dermatology in Germany. According to the intention of this procedure, insured persons with a skin disease in which an occupational etiology is suspected must be offered preventive measures and, if necessary, given appropriate treatment to avoid job-loss. To improve the efficiency of the "classic" dermatologist's procedure, in 1999, on the initiative of the Central Federation of Industrial Professional Associations, a study group was founded in cooperation with the Task Force on Occupational and Environmental Dermatology of the German Dermatological Society and the Professional Organisation of German Dermatologists. In October 2002, a controlled intervention study started in North-western Germany to scientifically evaluate the "optimised" dermatologist's procedure, which was proposed by the study group and compare it to the standard ("classic") procedure. The study results should allow detailed suggestions for an improved dermatologist's procedure before it is introduced nationwide.

Cross-Sectional Studies↗