Pharmaceutical physicians medical departments

The medical department is usually headed by a senior pharmaceutical physician (the medical director), who is supported by a team consisting of other physicians, graduates and administrative staff. The non-medical graduates are normally pharmacists or life scientists and, in addition to providing informed scientific input, may look after some administrative areas. In some companies they, rather than the physicians, may be responsible for staff management, thus allowing the physicians to concentrate on their advisory roles. 

There are certain personal attributes over and above a medical degree and clinical experience that make for a successful pharmaceutical physician. To be valued, the pharmaceutical physician must be able to provide insight into the clinical benefit, and hence the commercial potential, of a compound at any stage in its development. He or she must also have the planning skills to realise that potential, and an ability to communicate at all levels, both inside and outside the company. If the medical department is to act as the compan)r s medical conscience (see Section 10.2),... 

To be effective, the pharmaceutical physician in the medical department has to recognise both... 

The pharmaceutical physician provides a medical direction to marketing strategy and ensures that product literature and promotional material are legal and factually accurate. This is an important contribution to the medical department s role as medical conscience, as discussed in Section 10.2. Medical input remains necessary to the servicing and support of marketed products throughout their life cycle. 

Most of the chapters in this textbook focus on the various aspects of the research, development and licensing of pharmaceuticals. Physicians and non-medical scientists working in departments other than sales and marketing do, however, require some understanding of marketing. The depth of the knowledge that they... 

There has never been any incentive for the pharmaceutical industry to pursue research along these lines even though, as in the case of Vioxx, the end results of neglecting adverse effects may be very costly. The aim of the industry has usually been to extend the market size irrespective of potential risk and attempts to implement effective post-marketing surveillance has received little enthusiasm. It is to be hoped that company medical departments and pharmaceutical physicians will continue to support the need for a broad range of safety evaluation studies to be conducted on new medicinal products. 

Consulting Pharmaceutical Physician, formerly Corporate Medical Advisor, Corporate Department Medical Affairs, Boehringer Ingelheim, Ingelheim-am-Rhein, Germany... 

Doctors working with the pharmaceutical industry as pharmaceutical physicians are encouraged to undertake training in pharmaceutical medicine which is the medical discipline or speciality which encompasses their work in medical departments of the pharmaceutical and related healthcare companies, in clinical research units and regulatory bodies. Courses covering general and specialized aspects of pharmaceutical medicine have been established for many years in a number of European countries and elsewhere around the world. 

The medical director is, of course, not only a senior pharmaceutical physician but a senior manager and needs to be fully conversant with all the issues facing the company and understand all the principles and procedures which govern its operation. Nowadays this will include personnel issues, such as awareness of the laws related to employment. Without this broad understanding, the medical director will not be able to lead the activities of the medical department in a way that is optimal for the organisation whilst maintaining all the required professional and ethical standards. 

The role of the pharmaceutical physician in the OTC division of a major pharmaceutical company is substantially different from that played in the research or medical affairs departments dealing with prescription drugs. One might assume that OTC work is simpler and less involved than that related to prescription medications. In many ways, the opposite is true. 

Every person involved in clinical research, be he/ she a monitor, an auditor, a statistician, a medical adviser, a medical director, a head of department, a co-investigator, a company or health service chief executive, or a university vice-chancellor, should be committed to such a policy and to its publicity, not least to act as a deterrent, in a determination to stamp out fraud in clinical research if it is humanly possible. Every international company, every regulatory authority, and every individual pharmaceutical physician should strive to ensure that there is an effective mechanism in place, in every country, by which anyone who commits fraud can be summarily dealt with. Only the utmost vigor in applying this policy will be successful, but it is in the ultimate interests of patient safety that this happens. 

Marcia Angell, physician, former editor in chief of the New England Journal of Medicine, and senior lecturer in the department of social medicine at Harvard Medical School. She has been a vocal critic of the pharmaceutical industry, arguing that the companies focus on profits at the expense of health, manipulate scientific research, and deceive the public with their advertising. She has also criticized physicians and researchers for their close ties to the drug industry and potential lack of independence in their research. 

This activity often described as The Medical and Social Conscience of a company largely resides in the Medical Affairs department. In most large -and medium-sized pharmaceutical companies this responsibility lies with Medical Affairs. The review of all materials, whether detail pieces provided in person to physicians in practice, slide sets for speakers on behalf of the company, general promotional material that is disseminated via print, radio, TV or web must be reviewed and approved by internal committees comprised of Medical Affairs staff, regulatory and legal personnel. In addition to the company review, this material must be sent to FDA at least by the first day of use. Review by FDA s DDMAC should be sought for TV advertisements. 

A similar model is used to present the recommended levels of service and personnel from a pharmacy department and hospital perspective. Fundamental serviee includes the use of patient profiles, provision of ready to administer medications and parenterals, and adequate quality improvement programs. Desirable pharmacy services include computerized information management systems and an ICU satellite. Optimal pharmacy department services include a 24-hour satellite, physician order entry, and continuous availability of pharmaceutical care services. This document challenges practitioners and institutions to measure their progress and strive for the deli-... 

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