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PubMed2004

Nailing Jell-O to a wall: regulating Internet pharmacies.

The growth of the Internet pharmacy industry is challenging the ethical and regulatory systems that govern the sale and distribution of prescription drugs. New forms of regulation are necessary to prevent abuse and minimize mistakes by consumers, doctors, and pharmaceutical companies. Unfortunately, the mercurial nature of the Internet makes trying to regulate it "like trying to nail Jell-O to a wall." Effective regulation will require greater coordination among state, national, and international regulatory bodies. In addition, consumereducation programs are necessary to inform the public of the problems that are caused by the impersonal and commercial nature of marketing drugs over the Internet. At a minimum, the author suggests that states should uniformly adopt laws that prohibit a physician from prescribing drugs without any face-to-face communication between the physician and the patient, and the United States should work to make this a uniform international standard.

Ethics↗
PubMed2007

Integration of pediatric aspects into the general drug development process.

Drug treatment of children is today less regularly based on formal clinical testing than adults. This has led to concerns regarding the safety and efficacy of pediatric medicines and resulted in public action in the United States and the European Union. The reasons for the increasing awareness include better understanding of child physiology, increased trust in GCP (good clinical practice), improved treatment of several severe childhood diseases, a changed view of the child as a subject in society, and more. The US has successfully introduced pediatric legislation that facilitates participation of children in phar maceutical innovation, and comparable approaches are now being discussed in Europe and Japan. While the outcome of the EU pediatric regulation in the near future is still open, the US pediatric legislation has been highly successful over the past 8 years and will be revised before it expires in September 2007. Innovative drugs are today being developed by global pharmaceutical companies. Adding pediatric aspects to this development process is a complex task where companies need to build up internal competency. Bureaucratic procedures that could be harmful to the companies' economic fundaments need to be avoided, and an appropriate ethical framework is required. This needs to be addressed by all partners in healthcare, including regulatory authorities, the pharmaceutical industry, pediatricians, patients and others in a sense of shared responsibility.

Chemistry, Pharmaceutical↗
PubMed2003

Ethical guidelines for orthopaedists and industry.

During the past decade, there has been a gradual erosion of the ethical principles that guide relationships between physicians and industry. Two areas in which the decline has been most notable are gifts to physicians and the relationships of industry to educational and research activities. The gifts have become more valuable and industry representatives make gifts available under circumstances where frequently there is no educational program. Research support continues at a high level but researchers increasingly find themselves in positions that present conflicts of interest with the interests of patients who are research subjects. These changes have taken place during an era in which professionalism also has declined and physicians are losing control of their practices to government and to the corporate sector. A solution to this dilemma is suggested through strict adherence to the existing ethical principles by physicians and industry. Physicians must renew observance of professionalism and improve oversight and discipline. Medicine cannot impose restrictions on the pharmaceutical and manufacturing industries but can appeal to industry's leadership. Oversight and discipline also must govern marketing and sales representatives of industry. There must be an ethical common ground if a new physician and industry relationship is to succeed in producing a climate of mutual respect and higher ethics; patients will benefit and physicians and industry will regain the public trust.

Codes of Ethics↗
PubMed1993

Proposed guidelines for housestaff interaction with pharmaceutical companies.

The relationship between the medical profession and the pharmaceutical companies is complex, since industry depends on physicians for research and development, and for sales of its products. As a result, physician interactions with industry could undermine the patient-centered medical ethic, and jeopardize the physician-patient relationship. There is evidence that physicians are influenced by their encounters with the pharmaceutical industry. Particularly troubling is the increasing interaction of pharmaceutical companies and housestaff through detailing and educational support. Several studies have documented the pervasiveness of such relationships in training programs. Although professional bodies have developed criteria to help physicians in their dealings with the pharmaceutical industry, no principles have yet been formulated to address the unique aspects of resident contact with pharmaceutical companies. Guidelines designed to answer this need are proposed in this article.

Conflict of Interest↗
PubMed1993

Criteria for the use of monoclonal antibodies, legislation and ethical considerations.

The criteria governing the in vivo use of monoclonal antibodies in humans are based upon a number of legal requirements with respect to radiation hygiene, pharmaceutical legislation, radiopharmaceutical legislation and regulations with respect to products arising from biotechnology. This in itself has led to a complicated situation which has undoubtedly restricted the development of valuable diagnostic and potential therapeutic agents. From the ethical point of view there are also important considerations, firstly with respect to the methods of producing antibodies, which has resulted in the discontinuation of the raising of antibodies in murine ascites, and secondly in consideration of the ethics of administering labelled antibodies to healthy volunteers and to patients who may not necessarily benefit personally from the procedure. These factors must be evaluated in the light of the EEC document 'Good clinical practice for trials in medicinal products in the European Community from the CPMP working party on Efficacy of Medicinal Products'.

Animals↗
PubMed2001

Developing drugs for the developing world: an economic, legal, moral, and political dilemma.

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of economic, social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on (1) the prospects for a reasonable profit and (2) the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry's efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying.

Beneficence↗
PubMedDate not supplied

The American Pharmaceutical Association: a lens for viewing pharmacists (from compounders to therapeutic judges).

OBJECTIVE: (1) To document the changes that have occurred in pharmacy in the last century and (2) to investigate the role played by the American Pharmaceutical Association (APhA) during the changes. DATA SOURCES: Journal of the American Pharmaceutical Association (JAPhA). STUDY SELECTION: Sample articles published in JAPhA pertaining to practice and ethical issues. DATA EXTRACTION: Examples of articles at 10-year intervals from 1912 through 1997. DATA SYNTHESIS: Short reviews of the articles are included containing their purpose and topic. Authors' notes are included where appropriate. The research was performed using a qualitative/historical method. CONCLUSION: The changes that have occurred in pharmacy throughout the 20th century are seen through JAPhA. APhA has been a stabilizing social structure over the years, and continues to serve society in this manner.

History, 20th Century↗
PubMed2005

The involvement of professional medical writers in medical publications: results of a Delphi study.

OBJECTIVE: Using a Delphi Consultation process, a group of medical writers established by the European Medical Writers Association (EMWA) set out to determine the current thinking on the problems of ghostwriting in medical publications and what should be done about them. In this context, ghostwriting is where a professional medical writer prepares a manuscript on behalf of a named author, but the writer is not listed as an author. METHODS: A 4-round Delphi consultation process was conducted via email to generate statements about the main issues in ghostwriting. Participants rated their agreement with the statements on a scale of 0-10. RESULTS AND CONCLUSIONS: Members of the task force strongly believed that professional medical writers can improve the quality of scientific papers, but that fact is often not recognised outside the medical writing profession. At least in part, this is because of a perception that ghostwritten papers may have been inappropriately influenced by pharmaceutical companies. One theme that emerged strongly from the discussions was transparency. Members thought it very important that the existence of a ghostwriter should always be made clear to the reader. Another strong theme was the importance of defining in detail what practices relating to ghostwriting are ethical, and what practices are not. This definition of ethical ghostwriting should be widely known, and unethical ghostwriting should be strongly condemned. Use of the term 'ghostwriting' itself was questioned. Members of the task force felt that use of a more neutral term should be encouraged. The task force suggested various activities for ensuring that above the objectives could be met, including discussions with other interested parties, such as journal editors and pharmaceutical companies, educating medical writers about ethical practices, further research into ghostwriting, and developing guidelines for ethical medical writing.

Accreditation↗
PubMed1999

The institutional turn in professional ethics.

The traditional ideal in which professionals alone or in small groups serve their patients and clients in accord with a public-spirited goal is giving way to practice in which professionals serve in organizations that value mainly their expertise and expect them to act in accord with the organization's goals. The study of professional ethics has not kept pace with this trend and, as a result, has neglected the institutional aspects of ethical problems. I focus attention on these aspects by considering a case that raises 2 problems that are particularly relevant in the context in which professionals now practice: the problem of representation (whom does the professional act for) and the problem of authority (who has the right to make the policy for the institution).

Administrative Personnel↗
PubMed1998

Supply of medicines: paternalism, autonomy and reality.

Radical changes are taking place in the United Kingdom in relation to the classification of, and access to, medicines. More and more medicines are being made available over the counter both in local pharmacies and in supermarkets. The provision of more open access to medicines may be hailed as a triumph for patient autonomy. This paper examines whether such a claim is real or illusory. It explores the ethical and legal implications of deregulating medicines. Do patients benefit? What is the impact on pharmacists? Are the true beneficiaries of change largely the pharmaceutical industries?

Beneficence↗
PubMed2006

Revisiting pharmacists' refusals to dispense emergency contraception.

Pharmacists' refusals to fill prescriptions for emergency contraceptives for reasons of conscience have contributed to a national debate regarding the permissibility of such actions. Some in the medical community assert that pharmacists ought not to refuse to dispense emergency contraceptives on this basis. Three lines of argument have become prominent in defense of that position: 1) the professional status of pharmacists does not allow for refusal to dispense legitimately written prescriptions, 2) the medical facts regarding the mechanism of action of emergency contraception are often misunderstood, misrepresented, or both, and 3) refusals by pharmacists to fill legitimate prescriptions undermine patient care. In this commentary, these arguments are rejected as missing the central point of the issue, which is that pharmacists are autonomous, moral agents who are accountable for their choices and entitled-within limits-to decide in which activities they will participate. Pharmacists' professionalism is defended, their responsibilities in the provision of drug therapy are set forth in the context of pharmaceutical care, and these lead to the conclusion that pharmacists' refusals may be ethically justified. There are important limits on how pharmacists may respond when they are being asked to participate in actions they find morally objectionable. Notably, they must ensure that these prescriptions are filled by someone else in a timely manner and must refrain from any abusive or demeaning treatment of patients, as summed up in our Principle of Conscientious Refusal to Dispense.

Contraceptives, Postcoital↗
PubMedDate not supplied

Public information about clinical trials and research.

Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

Clinical Trials as Topic↗
PubMed2003

Pharmaceutical firms' generosity and physicians: legal aspects in Belgium.

In this article we will examine the relation between physicians and (representatives of) the pharmaceutical industry. More in particular we want to discuss the appropriateness of some of the gifts that are given to physicians by companies in the pharmaceutical (and medical equipment) industry, since there has been growing concern about the potential negative consequences of these so-called 'gift-giving practices'. Although the relation between physicians and industry can result in impressive medical advances, they also create opportunities for bias and can result in unfavourable public perceptions, over-consumption and misuse of public money. First of all, a concise factual summary of the different types of gift-giving will be given, since not every gift can automatically be considered as inappropriate: depending on the extent to which the gift serves a function beneficial to patient care and on whether the same benefits can be realised through less costly promotional activities, gifts can be appropriate. In connection with that remark, we will next outline the positive and negative impact pharmaceutical promotion has on patient welfare, according to advocates as well as opponents of 'gift-giving'. We will not take position in the discussion whether 'gift-giving' is appropriate or not. This paper focuses on the position the (Belgian) legislator, following a European Directive of 1992, takes in this controversy. For the answer to that question the following documents are of crucial importance: the Belgian Law on Medicinal Products of 25 March 1964, the European Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use and the Belgian Crown Order of 7 April 1995 on the advertising of medicinal products for human use. To round up, we will examine how the principles laid down in these documents are being interpreted in the Belgian case-law.

Belgium↗