Pharmaceutical publication planning

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Pharmaceutical publication planning is the activity of planning the dissemination of scientific and clinical data on a drug to healthcare professionals at scientific congresses and medical society meetings and in peer reviewed medical journals.

Drug Chemical substance having an effect on the body

A drug is any substance that, when inhaled, injected, smoked, consumed, absorbed via a patch on the skin, or dissolved under the tongue causes a physiological change in the body.

Peer review evaluation of work by one or more people of similar competence to the producers of the work

Peer review is the evaluation of work by one or more people with similar competences as the producers of the work (peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. Peer review methods are used to maintain quality standards, improve performance, and provide credibility. In academia, scholarly peer review is often used to determine an academic paper's suitability for publication. Peer review can be categorized by the type of activity and by the field or profession in which the activity occurs, e.g., medical peer review.

A public health journal is a scientific journal devoted to the field of public health, including epidemiology, biostatistics, and health care. Public health journals, like most scientific journals, are peer-reviewed. Public health journals are commonly published by health organizations and societies, such as the Bulletin of the World Health Organization or the Journal of Epidemiology and Community Health. Many others are published by a handful of large publishing corporations that includes Elsevier, Wolters Kluwer, Wiley-Blackwell, Springer Science+Business Media, and Informa, each of which has many imprints. Many societies partner with such corporations to handle the work of producing their journals.

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Pharmaceutical publication planning involves developing a detailed plan that outlines the timely presentation of verified scientific and clinical data to appropriate types of healthcare professionals such as physicians, pharmacists, nurses, as a drug undergoes clinical trials and after it is marketed. Because of scientific and therapeutic advances, pharmaceutical publication planning has become a well-established and important function by pharmaceutical companies in order to educate healthcare professionals accordingly about new drugs and marketed drugs with new clinical uses or safety information.

Physician professional who practices medicine

A physician, medical practitioner, medical doctor, or simply doctor, is a professional who practises medicine, which is concerned with promoting, maintaining, or restoring health through the study, diagnosis, prognosis and treatment of disease, injury, and other physical and mental impairments. Physicians may focus their practice on certain disease categories, types of patients, and methods of treatment—known as specialities—or they may assume responsibility for the provision of continuing and comprehensive medical care to individuals, families, and communities—known as general practice. Medical practice properly requires both a detailed knowledge of the academic disciplines, such as anatomy and physiology, underlying diseases and their treatment—the science of medicine—and also a decent competence in its applied practice—the art or craft of medicine.

Pharmacist healthcare professional who practices in pharmacy

Pharmacists, also known as chemists or druggists, are health professionals who practice in pharmacy, the field of health sciences focusing on safe and effective medication use. Pharmacists undergo university-level education to understand the biochemical mechanisms and actions of drugs, drug uses, therapeutic roles, side effects, potential drug interactions, and monitoring parameters. This is mated to anatomy, physiology, and pathophysiology. Pharmacists interpret and communicate this specialized knowledge to patients, physicians, and other health care providers.

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.

Within pharmaceutical companies, publication planning is usually overseen by medical or clinical affairs professionals. In this effort, pharmaceutical companies frequently use the assistance of medical communication agencies with publication planning expertise and professional medical writers.

A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use, and other medical information. The medical writers also ensures that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure.

Medical communication agencies

Medical communication agencies include a broad range of organizations, including those that focus largely or exclusively on publication planning. When developing and executing a publication plan on behalf of a pharmaceutical or biotechnology client, medical communication agencies employ professional publication strategists, scientific medical directors, medical writers and project managers. Working as a team, this group of individuals delves deep into their client's scientific discoveries, and propose the most effective and efficient ways to spread the word about new potential therapies to physicians and other healthcare providers.

Biotechnology Use of living systems and organisms to develop or make useful products

Biotechnology is the broad area of biology involving living systems and organisms to develop or make products, or "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use". Depending on the tools and applications, it often overlaps with the (related) fields of molecular biology, bio-engineering, biomedical engineering, biomanufacturing, molecular engineering, etc.

There has been some discussion in the media regarding disclosure as it pertains to the use of professional medical writers in this endeavor. Some agencies and professional organizations focused on publication planning have been and continue to develop and refine ethical guidelines and standards for disclosure and transparency.

Media are the communication outlets or tools used to store and deliver information or data. The term refers to components of the mass media communications industry, such as print media, publishing, the news media, photography, cinema, broadcasting, and advertising.

Ethics branch of philosophy that systematizes, defends, and recommends concepts of right and wrong conduct

Ethics or moral philosophy is a branch of philosophy that involves systematizing, defending, and recommending concepts of right and wrong conduct. The field of ethics, along with aesthetics, concerns matters of value, and thus comprises the branch of philosophy called axiology.

Professional publication planning associations

Professional organizations for individuals involved in pharmaceutical publication planning include the International Society of Medical Publication Professionals (ISMPP) [1] and The International Publication Planning Association (TIPPA). [2] The purpose of these organizations is to create a forum where individuals involved with pharmaceutical publication planning and biomedical publications can meet and share knowledge and experience. They serve to promote career opportunities and professional development of individuals involved with pharmaceutical publication planning, as well as to promote standards of excellence in ethical professional medical writing and the biomedical publication process in disseminating scientific and clinical data on pharmaceutical products.

Medical research research

Biomedical research encompasses a wide array of research, extending from "basic research", – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine.

Professional development is learning to earn or maintain professional credentials such as academic degrees to formal coursework, attending conferences, and informal learning opportunities situated in practice. It has been described as intensive and collaborative, ideally incorporating an evaluative stage. There are a variety of approaches to professional development, including consultation, coaching, communities of practice, lesson study, mentoring, reflective supervision and technical assistance.

In 2009, ISMPP began a certification program for publication planning professionals.

Related Research Articles

Medical psychology is the application of psychological principles to the practice of medicine, and is clearly comprehensive rather than primarily drug-oriented, for both physical and mental disorders. The specialty of Medical Psychology and the National Alliance of Professional Psychology Providers (www.nappp.org) has been instrumental in advocacy and professional publications in increasing the awareness of Governmental Agencies, Scientific Societies, and the World Health Associations about the limited effect of "medication only approaches" to mental disorders and many related chronic physical disorders. A Medical Psychologist is a specialist who holds board certification in Medical Psychology from the American Board of Medical Psychology (www.amphome.org) and approved by the national psychology practitioner association in psychology(www.nappp.org). A specialist in Medical Psychology holds a doctoral degree in one of the clinical specialties in psychology, has done post doctoral graduate or approved didactic training in biomedical and pharmaceutical sciences and physical disease with behavioral and lifestyle components, and has completed a supervised residency providing advanced clinical diagnoses, prescribing or collaborating on medication and psychological treatment interventions in a comprehensive treatment plan, and they have passed one of the acceptable national written examinations, and supplied reviewed work product, and passed an Oral Examination. Medical psychologists are prepared to provide leadership and active roles in primary care and specialty healthcare facilities or consultation services essential for these facilities. A psychopharmacologist is very different from a Medical Psychologist, though one state uses confusing language in its laws.

A patient's bill of rights is a list of guarantees for those receiving medical care. It may take the form of a law or a non-binding declaration. Typically a patient's bill of rights guarantees patients information, fair treatment, and autonomy over medical decisions, among other rights.

Medical ethics system of moral principles of the practice of medicine

Medical ethics is a system of moral principles that apply values to the practice of clinical medicine and in scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal. It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics. However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation.

Health informatics discipline at the intersection of information science, computer science, and health care

Health informatics is information engineering applied to the field of health care, essentially the management and use of patient healthcare information. It is a multidisciplinary field that uses health information technology (HIT) to improve health care via any combination of higher quality, higher efficiency, and new opportunities. The disciplines involved include information science, computer science, social science, behavioral science, management science, and others. The NLM defines health informatics as "the interdisciplinary study of the design, development, adoption and application of IT-based innovations in healthcare services delivery, management and planning". It deals with the resources, devices, and methods required to optimize the acquisition, storage, retrieval, and use of information in health and bio-medicine. Health informatics tools include computers, clinical guidelines, formal medical terminologies, and information and communication systems, among others. It is applied to the areas of nursing, clinical medicine, dentistry, pharmacy, public health, occupational therapy, physical therapy, biomedical research, and alternative medicine, all of which are designed to improve the overall of effectiveness of patient care delivery by ensuring that the data generated is of a high quality.

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals, energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries.

Good clinical practice (GCP) is an international quality standard for conducting clinical trials that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.

The American Medical Writers Association (AMWA) is a professional association for medical communicators, with more than 4,000 members in the United States, Canada, and 30 other countries. AMWA is governed by a board of directors composed of the elected officers, 6-8 at-large directors, and the chapter advisory council chair. AMWA has regional chapters and provides local networking opportunities throughout the United States and Canada. The association was founded in 1940 by physicians interested in improving the quality of medical writing and editing. The current president is Cyndy Kryder, MS.

The Council for International Organizations of Medical Sciences (CIOMS) is an international nongovernmental organization established jointly by WHO and UNESCO in 1949. CIOMS represents a substantial proportion of the biomedical scientific community through its member organizations. The mission of CIOMS is to advance public health through guidance on health research including ethics, medical product development and safety.

Pharmacotherapy is therapy using pharmaceutical drugs, as distinguished from therapy using surgery, radiation, movement, or other modes. Among physicians, sometimes the term medical therapy refers specifically to pharmacotherapy as opposed to surgical or other therapy; for example, in oncology, medical oncology is thus distinguished from surgical oncology.

A medical science liaison (MSL) is a healthcare consulting professional who is employed by pharmaceutical, biotechnology, medical device, and managed care companies. Other job titles for medical science liaisons may include medical liaisons, clinical science liaisons, medical science managers, regional medical scientists, and regional medical directors.

A patient safety organization (PSO) is a group, institution or association that improves medical care by reducing medical errors. In the 1990s, reports in several countries revealed a staggering number of patient injuries and deaths each year due to avoidable adverse health care events. In the United States, the Institute of Medicine report (1999) called for a broad national effort to include the establishment of patient safety centers, expanded reporting of adverse events and development of safety programs in health care organizations. The organizations that developed ranged from governmental to private, and some founded by industry, professional or consumer groups. Common functions of patient safety organizations are data collection and analysis, reporting, education, funding and advocacy.

Association of the British Pharmaceutical Industry organization

The Association of the British Pharmaceutical Industry (ABPI) is the trade association for over 120 companies in the UK producing prescription medicines for humans, founded in 1891. It is the British equivalent of America's PhRMA, however the member companies research, develop, manufacture and supply 80% of the medicines prescribed through the National Health Service.

Health information management (HIM) is information management applied to health and health care. It is the practice of acquiring, analyzing and protecting digital and traditional medical information vital to providing quality patient care. With the widespread computerization of health records, traditional (paper-based) records are being replaced with electronic health records (EHRs). The tools of health informatics and health information technology are continually improving to bring greater efficiency to information management in the health care sector. Both hospital information systems and Human Resource for Health Information System (HRHIS) are common implementations of HIM.

Medical ghostwriters are employed by pharmaceutical companies and medical-device manufacturers to produce apparently independent manuscripts for peer-reviewed journals, conference presentations and other communications. Physicians and other scientists are paid to attach their names to the manuscripts as though they had authored them. The named authors may have had little or no involvement in the research or writing process.

The Faculty of Pharmaceutical Medicine (FPM) is a Faculty of the three Royal Colleges of Physicians of the United Kingdom. It is a UK-based professional membership organisation with over 1,500 members; physicians with a professional interest in the speciality of pharmaceutical medicine, the science of discovering, developing and testing new drugs, their regulation, and monitoring them for safety both during development and when they are prescribed. The Faculty is a registered charity and ultimately exists to bring about an improvement in health in patients and the general population.

The Physician Payments Sunshine Act is a 2010 United States healthcare law to increase transparency of financial relationships between health care providers and pharmaceutical manufacturers.

The rhetoric of health and medicine is an academic discipline concerning language and symbols in health and medicine. Rhetoric most commonly refers to the persuasive element in human interactions and is often best studied in the specific situations in which it occurs. As a subfield of rhetoric, medical rhetoric specifically analyzes and evaluates the structure, delivery, and intention of communications messages in medicine- and health-related contexts. Primary topics of focus includes patient-physician communication, health literacy, language that constructs disease knowledge, and pharmaceutical advertising. The general research areas are described below. Medical rhetoric is a more focused subfield of the rhetoric of science.

Guidances for statistics in regulatory affairs are applicable to the pharmaceutical industry and medical devices industry. These Guidances represent the current thinking of regulatory agencies on a particular subject. It is to be noted that the term “Guidances” is used in the USA, whereas the term “Guidelines” is used in Europe.

References

  1. MemberClicks Admin. "ISMPP Home". ismpp.org. Retrieved 4 March 2015.
  2. "Healthcare Education Associates". publicationplanningassociation.org. Retrieved 4 March 2015.