PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “ETHICS, PHARMACEUTICAL”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 595 records · Page 33Linked to original sources
PubMed2004

Your client credibility: are your pharmacy practices helping or hindering?

When recommending a specific pharmaceutical, more has to be taken into account than whether the API is indicated for the illness in question. Based on the preceding discussion, product source can have a tremendous impact on efficacy, on therapeutic success, and on practitioners' credibility in the eyes of their clients. However, product source goes beyond simple credibility, encompassing professional ethics and liability. In answering the Ethical question of the month--December 2001 "Should private veterinary practitioners be allowed to produce autogenous vaccines or compound antimicrobial products for use in food producing animals?" Rollin concluded, "one cannot envision a clearer case of unethical behavior." The reality is that quality assurance, efficacy, potency, and safety are not defined for compounded products, and should veterinarians choose to script or dispense one, the responsibility for its quality, efficacy, potency, and safety falls squarely on their shoulders. Ultimately, this also translates into 100% liability should an ADR, illness, or lack of effect, befall the patient. While having access to ELDU and compounded products is crucial in facilitating the treatment of the various diseases that veterinarians face, the regulatory freedom that gives them this choice carries heightened responsibilities when electing this option. In a nutshell, ethical and responsible principles of pharmacy dictate that a veterinarian's first choice should be a veterinary-licensed pharmaceutical for the indication in question. Should this not exist, ELDU of a licensed product with clinically derived therapeutic protocols should be the next choice. Compounded pharmaceuticals should only be used when no licensed (those sporting a DIN) product exists, and extreme cautions should be exercised when using transdermal formulations. Liability dictates that this decision be undertaken with informed consent of the owner and with appropriate due diligence when selecting a compounding service provider. Various articles have been written that provide the veterinarian with guidance when making this decision.

Animal Diseases↗
PubMed2004

AACAP 2002 research forum: placebo and alternatives to placebo in randomized controlled trials in pediatric psychopharmacology.

OBJECTIVE: The use of placebo in the pediatric age group has come under increasing scrutiny. At the 2002 Annual Meeting of the American Academy of Child and Adolescent Psychiatry, the Academy's Workgroup on Research conducted a research forum. The purpose was to identify challenges and their solutions regarding the use of placebo in randomized controlled trials in pediatric psychopharmacology. METHOD: Workgroups focused on problems and solutions in five areas: ethics and human subjects, research design and statistics, partnering with consumers, U.S. Food and Drug Administration and pharmaceutical industry perspectives, and psychosocial treatments. RESULTS: In many but not all circumstances, inclusion of a placebo control is essential to meet the scientific goals of treatment outcome research. Innovative research designs; involvement of consumers in planning and implementing research; flexibility by industry, academia, the National Institutes of Health, and regulatory agencies acting in partnership; and concomitant use of evidence-based psychosocial services can and should assist in making placebo-controlled trials acceptable. CONCLUSIONS: Properly designed placebo-controlled trials remain necessary, ethical, and feasible.

Adolescent↗
PubMed2003

Age discrimination in trials and treatment: old dogs and new tricks.

It is common for drug trials to exclude older people, usually over 65 or 70. Many of the drugs which are successfully tested are then registered and become available either on prescription or over the counter. Healthcare professionals are left in a bind: either they do not prescribe the medications to those in the excluded age groups because of the lack of age-relevant data, or they prescribe, off-label, despite the lack of systematic collection of age-relevant data. Alternatively, if the pharmaceutical is available without prescription, older people may be buying without any inkling or warning that the drug was never tried on people of their own age. Either way, our older fellow citizens are not getting the same ethical treatment as younger adults. Compounding the questionable ethics involved is the fact that as age increases, the ratio of women to men increases. Amplified by the fact that women consume more pharmaceuticals than do men, the discrimination takes on a distinctively sexist slant as well as an ageist one. Two other groups often excluded from trials are (a) minors and (b) pregnant or lactating women. But the rationale for their exclusion is different from that for the exclusion of seniors. A major reason for these two groups' exclusion is the legal incapacity of the young to consent and the concomitant flow-on liability for injuries and damages to the youngsters. The potential exposure to later legal claims may be a strong motivating force for pharmaceutical companies to exclude from their trials people without legal capacity to consent. But the third group of people, seniors, is excluded by reference to their seniority not their inability to give informed consent. While the other two exclusions can be explained in terms of moral, social and legal conventions, seniority alone is based on two practical concerns: firstly, whether seniors are likely to die before the end of the trial, and secondly, the compounding effects of the so-called diseases of old age. Together, these concerns are thought to justify seniority exclusion in the interests of clean science. This paper examines some of the ethical issues, the implicit ageism and sexism in the exclusion of seniors. The discussion considers the ethical consequences of the exclusion, where seniors are either taking drugs in the absence of evidence-based trials on their age groups, or are denied drugs because they are untried on the age groups.

Age Factors↗
PubMed1993

Psychopharmacology and the ethics of resource allocation.

The introduction of clozapine to current psychiatric practice is considered against a background of potential problems of resource allocation posed by the development of a number of 'budget-busting' drugs. It would appear that clinicians may increasingly have to operate within a climate in which the rights of individual patients to expensive treatments will seem to be pitted against the abilities of their communities to afford such treatments. Both clinicians and pharmaceutical companies have roles in the development of such conflicts.

Clozapine↗