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CLINICAL PHARMACOLOGY AND THE LAW

Safeguards are needed to protect mental patients participating in research Additional safeguards are justified where persons, such as the institutionalised mentally disabled, have their rights and freedoms severely restricted. Only research that can be obtained only from the institutionalised mentally disabled should be performed on them. Legal guardians and/ or parents should not be able to volunteer an unwilling mentally disabled patient unless that particular research activity is sufficiently therapeutic and the risk-benefit ratio low. The mentally disabled should have the opportunity to choose whether to participate in research, and non-beneficial research should be limited to that where the risks are minimal and the activity cannot be studied in any other group. Institutional review committees must ensure that no unfair inducements to participate are offered. Institutional Review Boards should be required to report their proceedings to a central clearing house, which would make periodic reports, serving to educate the many boards, disseminate information, encourage self-policing and help develop uniformity of procedures, ethics and decisions.

Some legal problems of the pharmaceutical manufacturer There has been an increasing number of physician malpractice and drug manufacturer product liability lawsuits. Although there have been few specifically concerned with injury resulting from clinical research it is important to be aware of the issues involved.

e The appropriate standard of care must be established and be proved to have been violated. It is also often crucial whether the event could have been foreseen.

e The adequacy of preclinical pharmacology and toxicology should be a shared responsibility of the sponsor and the investigator.

e Adequate informed consent from each investigational subject is of major legal importance and a detailed accurate record should be kept of information supplied to (or withheld from) the subject. Signed statements to waive liability for negligence are oflittle legal benefit and violate FDA regulations.

e Complete and accurate case histories should be prepared by the investigator; not by subordinates. e Adverse effects should be reported promptly and in detail. e Information placed before institutional review committees is an important legal record from a potential liability standpoint.

The Freedom of Information Act vs the need for confidentiality Information in FDA files will lose its confidential status if it is released to the public, even inadvertently. IND sponsors and NDA applicants are confronted with a conflict between fostering free scientific discussion and preserving the exclusivity ofthe IND and NDA vis-a-vis competitors, making public disclosure of safety and effectiveness data a problem. While there is a strong case to support release of such information, viewed more realistically, the incentive to drug manufacturers to undertake the financially risky and costly effort needed to bring a new drug to the market could be impaired or destroyed.

Both physician and pharmacist now involved in malpractice claims 'The clinically orientated pharmacist is here to stay, and this will be regarded as a positive step for both pharmacy and medicine.' As pharmacists shift their orientation from the product to the patient, they will have to shoulder responsibilities - with little legal precedent for evaluating how courts will view their actions. To what extent is the pharmacist liable, and to what extent does liability rest with medical consultants?

'The physician and the pharmacist are increasingly finding themselves in the same boat with regard to malpractice claims. Increased communication concerning the therapy of patients will bring to bear the expertise of both groups in an effort to not only enhance patient care but to reduce potentia/liability exposure.'

Symposium on Clinical Pharmacology and the Law: Journal of Clinical Pharmacology 16: 592-608 (Oct 1976)

lNPHARMA 30th October, 1976 p 15