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PubMed1990

[Quality assurance in clinical studies: a necessity].

Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP) are the constituents of a new concept for quality assurance in pharmaceutical research. They are to establish standards for preclinical and experimental research in animals (GLP), for the manufacturing of drugs (GMP), and for trials on medical products in human beings (GCP), respectively. Each of the 3 entities is characterized by the same principles of control; these involve written instruction describing the general operations to be performed, the so called Standard Operating Procedures (SOP), and Quality Assurance Units being responsible for surveying the operations in accordance with the SOP, and ensuring that the generated data will satisfy the requirements for quality. As far as clinical trials are concerned, the SOP is represented by the study protocol and a Monitor provides for the surveying of the trial. GCP is further characterized by ethical principles, which aim primarily at protecting personal integrity and welfare of the trial subjects. The Declaration of Helsinki is the accepted basis for clinical trial ethics. Following the Declaration of Helsinki during the planning, conducting, surveying and evaluating of clinical trials provides for a degree of seriousness being the real hallmark of Good Clinical Practice.

Animals↗
PubMed1998

[Development of anti-cancer drugs under new renewed GCP--from the viewpoint of drug development company developer].

During the past 7 years since the enforcement of Japan's first GCP in October 1990, various standards and guidelines have been introduced in Japan. On the other hand, the harmonization of GCP has been the subject of major discussion at ICH in order to allow the mutual acceptance of clinical data from different countries. In order to further improve the reliability and consistency of clinical data and the ethics of clinical trials in Japan, the new GCP was enforced in April 1997. A clinical study is conducted by the sponsor, but will only be successful with the collaboration of trial subjects, medical institutions, heads of medical institutions, investigators, subinvestigators, pharmacists, nurses, laboratory technicians, and other assisting staff. Before the full enforcement of the new GCP, we, as sponsors of clinical trials, carried out a survey of the current status of clinical trials centering on the reactions of medical institutions to the new GCP, future of clinical trials on anti-cancer drugs in Japan, and differences in time from clinical trials to registration in Japan, the United State and Europe. We sent a questionnaire by facsimile to 21 pharmaceutical companies which have developed or are developing anti-cancer drugs and obtained replies from 20 companies (95%) from August 25 to 30, 1997. This paper reports issues concerning clinical trials on anti-cancer drugs based on the results of our survey.

Antineoplastic Agents↗
PubMedDate not supplied

Designing a strategy to promote safe, innovative off-label use of medications.

Innovative off-label medication use (defined as prescribing with reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns, yet is not clinical research) is common practice and provides challenges to ensuring high-quality health care and patient safety. This article describes a strategy to promote policy and standardization of innovative off-label medication use, ensure oversight of patient safety, and prospectively assess efficacy. A multidisciplinary group developed a policy and process to regulate innovative off-label medication use that standardizes formulary review, maximizes peer expertise input, and minimizes institution liability by evaluating the effectiveness of use, promoting evidence-based practices, and ensuring ethical obligations to patients and society. This strategy has been implemented through institutional staff structure. The review process balances benefits/risks for biologically plausible therapy that lacks rigorous data support. The authors' strategy illustrates collaboration that enables a priori consideration for innovative off-label medication use while providing safety surveillance and outcomes monitoring.

Drug Labeling↗
PubMed2001

Proof of principle trials: exploratory open studies.

The aims of the observational, early phase IIa studies are usually several in number and often competing, and therefore the priorities should be clearly defined. The preclinical data, particularly the mode(s) of action of the drug and the results on experimental models, can help to build hypotheses on the agent's potential efficacy for individual seizure types and syndromes. For ethical reasons, the population selected for the initial clinical trials of antiepileptic drugs (AEDs) should be patients with continuing seizures (e.g. no less than two to four partial seizures/month) in spite of several therapeutic attempts using other appropriate AEDs, taken in monotherapy and in various combinations. Although the inherent bias in open, observational studies has limited their use in comparing treatments in epilepsy, they have several advantages over controlled trials, including lower cost, greater timeliness and inclusion of a broader range of patients. Observational, open studies with well-chosen patients and an adequate design tailored to answer precise predefined questions (including go/no go criteria) are most valuable for experienced clinicians in determining the clinical benefit of the drug, and for the pharmaceutical company in assessing the commercial merit of proceeding with further clinical testing.

Anticonvulsants↗
PubMedDate not supplied

Onset of illegal use of mind-altering or potentially addictive prescription drugs among pharmacists.

OBJECTIVES: To determine the temporal and descriptive aspects of pharmacists' decision-making processes regarding illegal use of mind-altering or potentially addictive prescription drugs (PAPDs) and to measure the effects of social factors associated with being and becoming a pharmacist on pharmacists' decisions to use PAPDs illegally. DESIGN: One-time, written, mailed survey. SETTING: United States. PARTICIPANTS: Random sample of licensed practicing pharmacists who were members of the American Pharmaceutical Association in fall 1996. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Responses to items on the survey. RESULTS: Nearly 40% of respondents indicated that they had used a form of PAPD without first obtaining a physician's authorizing prescription. A significant portion of the sample showed signs of repeated use-20% of the respondents reported 5 or more lifetime PAPD-use episodes, and 6% reported more than 10 such episodes. Almost 6% of the respondents identified themselves as being drug abusers at some point during their pharmacy careers. Moreover, a full 88% of these pharmacists began such illegal PAPD use after entering college, 51% used more than one type or class of PAPD, and 69% directly violated their professional code of ethics and state and/or federal laws by either stealing PAPDs from their place of employment (61%) or forging prescriptions (8%) to obtain them. CONCLUSION: A considerable percentage (40%) of the pharmacists surveyed had, on at least one occasion, used some form of PAPD without first obtaining a physician's authorizing prescription, and about one-fifth of respondents reported repeated use. The onset of such illegal PAPD use by pharmacists almost always occurred after the individuals had entered college. Interpersonal factors, such as positive reinforcement of self-medication practices from peers and increased levels of one's own approval for self-medication, appear to increase the likelihood that a pharmacist will engage in such illegal PAPD use.

Adult↗
PubMed1997

Monotherapy clinical trials of new antiepileptic drugs: design, indications, and controversies.

The focus in assessing new antiepileptic drugs (AEDs) varies with the needs of the assessor. Patients and doctors seek evidence-based clinical information, regulatory agencies look for efficacy and safety, and the health-care industry demands data on the risk-benefit ratio attached to a product. The pharmaceutical companies attempt to satisfy the interests of all parties involved. Most new AEDs obtain a first license based on placebo-controlled, randomized clinical trials as add-on therapy in patients with chronic refractory partial epilepsy, a method which, in fact, explores the efficacy of different drug combinations rather than measuring the efficacy of the new drug itself. Although that methodology satisfies the requirements of the licensing authorities, it fails to provide the clinical community with the information necessary to make rational treatment decisions, as would be derived from monotherapy studies. This article reviews controversies surrounding monotherapy studies and the design of comparative monotherapy clinical trials. A persuasive argument can be made that the goal of clinical trial design should be ethically acceptable, clinically meaningful studies in which new AEDs are compared with optimal doses of standard AEDs to inform clinical practice, meet licensing requirements, guide reasonable marketing efforts, and allow appropriate reimbursement.

Acetates↗
PubMed2001

Pharmaceutical drug promotion: how it is being practiced in India?

The pharmaceutical industries (PI) throughout the World are heavily involved in aggressive drug promotions, with a clear aim to change the prescribing habits of physicians and to encourage the self-medication of patients. Broadly, drug promotion refers to all the informational and persuasive activities of the PI, the effect of which is to induce prescription, supply, purchase, and use of medicinal drugs. It includes the activities of medical representatives, drug advertisements to physicians, provision of gifts and samples, drug package inserts, direct-to-consumer advertisements, periodicals, telemarketing, holding of conferences, symposium and scientific meetings, sponsoring of medical education and conduct of promotional trials. The PI has the right to promote its products, but it should do so in a fair, accurate, and ethical manner. The promotional claims need to be reliable, truthful, informative, balanced, up-to-date, and capable of substantiation in good taste. However, now a days, whilst the promotional methods have become very sophisticated and effective, it was found that while promoting their products, the PI does not adhere to these ethical principles. Hence, in most situations, these lead to irrational use of drugs. This unfortunate situation could be tackled only by the multiple prong strategy involving government, PI, doctors, medical associations and consumers. The government is required to formulate some guidelines in addition to developing their own code. The doctors and consumers are required to be educated on the promotional practices and abuses committed by the PI and different ways to tackle those. Various medical and consumer groups should also intervene to improve the scenario of promotion.

Advertising↗
PubMed1980

[Use and abuse of drugs: possibilities and limitations of education, information, and regulation].

Medicines have on a given person desired (therapeutic) effects and undesired (secundary) effects. Similarly, there are desired use and undesired use (abuse) of pharmaceutical drugs by individuals and society. Examples are given and their causes evoked. The means available to fight abuse and promote adequate behavior are particularly information, education, and regulation. For the author, the problems with information are the absence of objectives in terms of attitudes and behaviors, the absence of feedback, the difficulty in selecting information and the temptation of giving preference to the "thrilling". Health education answers these criticisms (it should have clear objectives, allows for feedback through interpersonal contact...), but requires more resources, especially for the adequate training of the (numerous) persons who have to provide it. Regulation is certainly useful, although it goes to an extent counter to the desirable responsabilization of the consumer. The various sectors concerned must commit themselves, ethically and practically, to use these means to the full extent of their possibilities. The article also describes a recent wavelike fad with the abusive consumption of a popular analgesic drug among youth in the part of Switzerland where the author works.

Communication↗
PubMed2006

Health industry practices that create conflicts of interest: a policy proposal for academic medical centers.

Conflicts of interest between physicians' commitment to patient care and the desire of pharmaceutical companies and their representatives to sell their products pose challenges to the principles of medical professionalism. These conflicts occur when physicians have motives or are in situations for which reasonable observers could conclude that the moral requirements of the physician's roles are or will be compromised. Although physician groups, the manufacturers, and the federal government have instituted self-regulation of marketing, research in the psychology and social science of gift receipt and giving indicates that current controls will not satisfactorily protect the interests of patients. More stringent regulation is necessary, including the elimination or modification of common practices related to small gifts, pharmaceutical samples, continuing medical education, funds for physician travel, speakers bureaus, ghostwriting, and consulting and research contracts. We propose a policy under which academic medical centers would take the lead in eliminating the conflicts of interest that still characterize the relationship between physicians and the health care industry.

Academic Medical Centers↗
PubMed1988

Testing for drug use, Part 1: Analytical methods.

Issues surrounding the screening and testing of individuals for drug use, including analytical and legal aspects of the procedures and social, political, and ethical problems and concerns, are reviewed. Historically, professional and societal debate regarding drug taking, drug-use problems, and the utility of drug testing programs occurs in cycles. Analytical methods commonly used to test for drug use include breath analysis for alcohol and urine drug assays. Blood alcohol concentrations are determined by laboratory assay methods or by portable devices used in the field. While poor laboratory procedures can invalidate test results for both breath and urine tests, urine screening test results can be further invalidated by improper handling of specimens or by tampering on the part of the subject. Also, test results are meaningful only if they are correlated with a clinical state. Legal issues have been raised concerning the validity of testing procedures used and the reliability of evidence obtained, especially in relation to pre-employment drug screening. From an ethical standpoint, drug testing tends to focus efforts to combat drug abuse on the drugs themselves instead of on the social context of the problem. With a recycled interest in drug-use testing and screening, primarily attributable to technological advances, little attention is being given to other approaches to controlling drug use. Additional research is needed to better describe the nature and extent of our drug-use problems and their impact on society.

Humans↗
PubMed1978

Self-medication.

Self-medication and drug interaction have been a problem in recent years. Pharmacists in ethical pharmacies and neighborhood establishments can best monitor these problems through use of patient profile records and consultations. The pharmacist should advise the public on over-the-counter (OTC) purchases. Auxiliary labels are recommended for use on containers to prevent drug interactions. Members of the black community have some specific problems with respect to self medications. These are addressed in this article. Self-medication, under supervision, is proper and can be controlled.

Drug Interactions↗
PubMed1993

Interactions between physicians and the pharmaceutical industry: what does the literature say?

OBJECTIVE: To determine the effect of three types of interaction between physicians and the pharmaceutical industry--company-funded clinical trials, company-sponsored continuing medical education (CME) and information for physicians supplied by pharmaceutical detailers--on orientation and quality of clinical trials, content of CME courses and physicians' prescribing behaviour. DATA SOURCES: MEDLINE and HEALTH searches for English-language articles published from 1978 to 1993, supplemented by material from the author's personal collection. STUDY SELECTION: A total of 227 papers from the MEDLINE and HEALTH searches and about 2000 items from the author's library were initially reviewed. The following selection criteria were used: studies conducted in Australia, Canada, New Zealand, Britain and the United States; studies conducted after 1977; quantitative surveys containing details of the survey methods; studies on the orientation and quality of company-funded clinical trials and on the content of CME courses giving explicit criteria used in the evaluation; and reports on the outcome of interactions stating how the outcomes were assessed. Thirty-six studies met these criteria. DATA EXTRACTION: Information was extracted on five topics: physicians' attitudes toward drug industry interactions, frequency with which physicians participate in the interactions, orientation and quality of company-funded clinical trials, content of company-sponsored CME courses and changes in physicians' prescribing behaviour as a result of an interaction. DATA SYNTHESIS: Although most physicians participate only occasionally in company-sponsored clinical trials, most see detailers and attend company-sponsored CME courses. However, physicians do not have a very high opinion of the information from detailers or of company-sponsored CME events. Many doctors regard pharmaceutical companies as an important source of funding for clinical trials, but they also have concerns about accepting money from this source. Company funding of clinical trials may affect the quality of the trials and the types of research that physicians undertake. Company-sponsored CME courses may have a commercial bias even if conducted under guidelines designed to ensure the independence of the event. All three types of interactions affect physicians' prescribing behaviour and, in the case of obtaining information from detailers, physicians' prescribing practices are less appropriate as a result of the interaction. CONCLUSIONS: Physicians are affected by their interactions with the pharmaceutical industry. Further research needs to be done in most cases to determine whether such interactions lead to more or less appropriate prescribing practices. The CMA's guidelines on this topic should be evaluated to see whether they are effective in controlling physician-industry interactions. Further measures may be necessary if the guidelines fail to prevent negative effects on prescribing practices.

Attitude of Health Personnel↗
PubMed2006

Food for thought.

Do certain kinds of food contain pharmacologically active substances in concentrations that are high enough to have druglike effects when consumed? Are biologically active compounds in food indicative of therapeutic value? Is traditional drug development suitable for testing the merits of food? Is it ethical to test food as a drug on patients? Will dietary disease management remain a pipedream? Is it a fact or fantasy that the Mediterranean diet is beneficial to health? Is a vegetarian diet an elimination therapy, or one of supplementation? What can be learned from animals? Are humans losing the capability of listening to their bodies? In this review, we will address these questions--providing food for thought.

Animals↗
PubMed2002

In vitro neuromuscular activity of snake venoms.

1. Snake venoms consist of a multitude of pharmacologically active components used for the capture of prey. Neurotoxins are particularly important in this regard, producing paralysis of skeletal muscles. These neurotoxins can be classified according to their site of action (i.e. pre- or post-synaptic). 2. Presynaptic neurotoxins, which display varying phospholipase A2 activities, have been identified in the venoms of the four major families of venomous snakes (i.e. Crotalidae, Elapidae, Hydrophiidae and Viperidae). The blockade of transmission produced by these toxins is usually characterized by a triphasic effect on acetylcholine release. Considerable work has been directed at identifying the binding site(s) on the presynaptic nerve terminal for these toxins, although their mechanism of action remains unclear. 3. Post-synaptic neurotoxins are antagonists of the nicotinic receptor on the skeletal muscle. Depending on their sequence, post-synaptic toxins are subdivided into short- and long-chain toxins. These toxins display different binding kinetics and different affinity for subtypes of nicotinic receptors. Post-synaptic neurotoxins have only been identified in venoms from the families Elapidae and Hydrophiidae. 4. Due to the high cost of developing new antivenoms and the reluctance of many companies to engage in this area of research, new methodologies are required to test the efficacy of existing antivenoms to ensure their optimal use. While chicken eggs have proven useful for the examination of haemorrhagic venoms, this procedure is not suited to venoms that primarily display neurotoxic activity. The chick biventer cervicis muscle has proven useful for this procedure, enabling the rapid screening of antivenoms against a range of venoms. 5. Historically, the lethality of snake venoms has been based on murine LD50 studies. Due to ethical reasons, these studies are being superseded by in vitro studies. Instead, the time taken to produce 90% inhibition of nerve-mediated twitches (i.e. t90) in skeletal muscle preparations can be determined. However, these two procedures result in different rank orders because they are measuring two different parameters. While murine LD50 determinations are based on "quantity", t90 values are based on how "quick" a venom acts. Therefore, knowledge of both parameters is still desirable. 6. In vitro neuromuscular preparations have proven to be invaluable tools in the examination of snake venoms and isolated neurotoxins. They will continue to play a role in further elucidating the mechanism of action of these highly potent toxins. Further study of these toxins may provide more highly specific research tools or lead compounds for pharmaceutical agents.

Animals↗
PubMed1992

Drug retailer training: experiences from Nepal.

Sale of modern medicines by untrained peddlers, general merchants, and other drug sellers is common throughout the developing world. Drug sellers operating in the 'informal sector' are often the first source of health care outside the home. Reasons given by patients for using private drug sellers include expediency, convenience, efficacy of the medicines, dependability of supply, and reasonable cost. At the same time, self-medication through private drug sellers can be ineffective, wasteful, and at times distinctly harmful. Regulatory approaches to controlling drug selling in the informal sector, widely endorsed on paper through national drug control legislation, require a cadre of professional regulatory staff and enforcement mechanisms which are too often beyond the current economic and political reach of countries. In Nepal, where rugged terrain has limited infrastructure development, the doctor to population ratio is 1:23,000, utilization of government health services averages only 0.2 visits per person per year. Retail drug outlets outnumber health posts and health centers by a ratio of 4:1 and private drug sellers often offer the only access to modern medicine for much of the population. Community surveys have found that drug retailers are very often the first and only source of health care outside the home. Given the importance of retail drug outlets and the lack of trained pharmacists, the Department of Drug Administration in 1981 established a 45-hr course for drug retailers which emphasized practical training as well as formal teaching on pharmacology, ethics, storage of drugs, and legal issues. By the end of 1989, 4096 drug retailers had graduated from the course. Still run by the Ministry of Health Department of Drug Administration, the course has proven to be administratively feasible and has been quite popular with drug retailers. Initial reservations expressed by doctors and some pharmacists were soon overcome, and the course is now well accepted by professional groups. Because the course is offered in different locations, geographic coverage has also been very good despite Nepal's logistic constraints. The operating cost of the course averages about U.S. $18 per trainee. Informal evaluations have resulted in plans for refresher training more narrowly focused on safe dispensing and appropriate referral for a limited number of important public health problems. Since 50-90% of pharmaceutical expenditures typically pass through the informal private sector in developing countries, it is suggested that other countries consider focused drug retailer training as a response to the problems of manpower shortages and drug dispensing by unqualified staff.

Costs and Cost Analysis↗
PubMed2006

[The effects of the 12th and 14th amendments to the AMG (Medical Preparations Act) on paediatric pharmaceutical research--a survey of the new regulations].

OBJECTIVE: The 12th amendment to the German Medical Preparations Act (Arzneimittelgesetz, AMG) implements EU-Directive 2001/20EC in national law and introduces changes with regard to academic research in child and adolescent psychiatry. The 14th amendment implements labelling regulations for drugs. METHOD: This article analyses the effects of these new regulations on safety aspects, on the performance of clinical trials with and without sponsoring (investigator-initiated trials, IITs), and on the development of paediatric drugs. The former regulatory directives are compared with the changes mandated by the 12th amendment, and their effects on off-label use, long-term safety, and so-called dose-finding studies will be pointed out. RESULTS: Current law no longer allows post marketing surveillance studies ("Anwendungsbeobachtungen" and "Therapieoptimierungsstudien"). Requirements and procedural regulations are now standardized for all clinical trials with human beings. The term "group benefit" has now been introduced into German law, which excludes research without any direct or group benefit for children participating in a study. CONCLUSION: While prerequisites for drug development in accordance with GCP guidelines on a high medical and ethical standard are now granted, due to multiple regulatory requirements, investigator-initiated studies in paediatric psychopharmacology will be more difficult to conduct. Moreover, because of the strict regulations, it is very improbable that academic research will be undertaken without sponsoring (IITs).

Adolescent↗
PubMedDate not supplied

A multicenter clinical trial in the Arab world.

Financial, social, and perhaps religious, ethical, and other factors hinder investment and performance of clinical research in Arab countries. We report in that conducting multicenter clinical trials is feasible in the Arab world, describing our experience in planning and conducting one of the first multicenter, multinational, clinical trials in the region. A multicenter clinical trial sought to document the efficacy and safety of Epotin for the treatment of anemia in patients on maintenance hemodialysis. Among 29 centers contacted for participation, a positive response was obtained from 17 (62%) located in eight countries. The initial recruitment period of 3 months was extended to 1 year. Among the participating centers, 16 forwarded their results in time, with one being late. There were minor and a few major protocol violations, the latter requiring exclusion of data from the final analysis. Sponsorship was mainly by a local pharmaceutical company (Julphar). A co-coordinating body was crucial to trace and gather the data. Since conduct of the trial required considerable time and effort from investigators, the use of modern information technology could have reduced the effort and improved the outcomes. We conclude that multicenter clinical trials, which are essential can be conducted in this region. This experience needs to be repeated and refined.

Anemia↗
PubMed2005

Teaching appropriate interactions with pharmaceutical company representatives: the impact of an innovative workshop on student attitudes.

BACKGROUND: Pharmaceutical company representatives (PCRs) influence the prescribing habits and professional behaviour of physicians. However, the skills for interacting with PCRs are not taught in the traditional medical school curriculum. We examined whether an innovative, mandatory workshop for third year medical students had immediate effects on knowledge and attitudes regarding interactions with PCRs. METHODS: Surveys issued before and after the workshop intervention solicited opinions (five point Likert scales) from third year students (n = 75) about the degree of bias in PCR information, the influence of PCRs on prescribing habits, the acceptability of specific gifts, and the educational value of PCR information for both practicing physicians and students. Two faculty members and one PCR led the workshop, which highlighted typical physician-PCR interactions, the use of samples and gifts, the validity and legal boundaries of PCR information, and associated ethical issues. Role plays with the PCR demonstrated appropriate and inappropriate strategies for interacting with PCRs. RESULTS: The majority of third year students (56%, 42/75) had experienced more than three personal conversations with a PCR about a drug product since starting medical school. Five percent (4/75) claimed no previous personal experience with PCRs. Most students (57.3%, 43/75) were not aware of available guidelines regarding PCR interactions. Twenty-eight percent of students (21/75) thought that none of the named activities/gifts (lunch access, free stethoscope, textbooks, educational CD-ROMS, sporting events) should be restricted, while 24.0% (8/75) thought that students should be restricted only from sporting events. The perceived educational value of PCR information to both practicing physicians and students increased after the workshop intervention from 17.7% to 43.2% (chi square, p = .0001), and 22.1% to 40.5% (p = .0007), respectively. Student perceptions of the degree of bias of PCR information decreased from 84.1% to 72.9% (p = .065), but the perceived degree of influence on prescribing increased (44.2% to 62.1% (p = .02)). CONCLUSIONS: Students have exposure to PCRs early in their medical training. A single workshop intervention may influence student attitudes toward interactions with PCRs. Students were more likely to acknowledge the educational value of PCR interactions and their impact on prescribing after the workshop intervention.

Adult↗