This might form part of an integrated assessment but it should not be possible to compensate for a poor performance in this area by a good performance in other items. Student formulary. Medical students are often overwhelmed by the large number of drugs that they encounter during their training. This can be demoralizing and lead to a lack of clarity and objectivity in learning. This has already been done in a number of medical schools in Europe and elsewhere. The list should contain 50— drugs that are commonly prescribed and used to treat common diseases.
The students should also learn about the principles for stopping irrational drug therapy. The list of core drugs can be organized by organ system and set alongside the common therapeutic situations in which they are used. Delivering the core CPT curriculum. Variability in the structure of medical courses will require local solutions for delivery of the CPT curriculum.
In these circumstances, CPT learning objectives must compete simultaneously with many others, usually dispersed across many different modules and through several years of the course. This poses practical difficulties for CPT teachers coordinating learning opportunities across many modules over which they have limited influence.
Nevertheless, the importance of CPT should be emphasized in all clinical modules in which there are continuous opportunities to observe and appraise critically the patient drug charts, see the beneficial and adverse effects of drugs and practice relevant skills e. CPT leadership. A key factor in the successful implementation of the CPT core curriculum, particularly in an integrated course, will be strong and enthusiastic leadership.
All medical schools should be able to identify an individual who will oversee delivery and ensure that the generic principles of safe and effective use of drugs are highlighted throughout the course. This role should ideally be undertaken by a senior individual with a background and training in CPT, helped by colleagues in the discipline some of whom may be trainees in CPT. In medical schools without CPT departments, other specialists with an enthusiasm for ensuring that principles of CPT are prominent throughout the curriculum should be identified.
They too should be encouraged to emphasize these principles and remind students about the effects of drugs beyond individual organ systems. Simply providing a link between drugs and clinical conditions is insufficient to develop an appreciation of the complex considerations that surround the decision to initiate a prescription. All schools should ensure that, in each case, students are helped to tackle the practical issues of weighing the harms and benefits of drug therapy, prescribing the drug and monitoring the impact of therapy.
Clinical pharmacists who are usually available in greater numbers than CPT specialists also have an important role to play in reinforcing learning during clinical attachments, working with other pharmacotherapeutic experts. Learning styles. The successful delivery of the core curriculum may involve a variety of learning styles e. These can be undertaken in live time, even within relatively large groups, or researched and discussed at intervals over several weeks. Other approaches to CPT involve writing case reports containing discussion about therapeutic aspects e.
Certainly, it is important that students should be exposed to and trained in the principles of electronic retrieval of reliable drug information. This may also be applicable in many developing countries. Assessment drives learning and is critical in emphasizing the importance of CPT in the course and ensuring that graduates are fit to practice. All medical schools should have validated and reliable schemes of assessment in place to ensure that students demonstrate that they have achieved the curricular outcomes.
The objective structured clinical examination OSCE is an ideal format for this kind of assessment. Relatively few schools now have a traditional CPT examination as changes to the curriculum bring the assessments of diverse learning objectives together in integrated examinations. Where this is the case, there should be a clear, identifiable and robust component devoted to the knowledge and skills that support rational prescribing. Quality assurance. All schools should have some form of external quality assurance to ensure that the CPT learning opportunities and assessments they provide are fit for purpose, i.
Such reviews might examine whether the goals outlined earlier in this section have been met. The appointment of external examiners with CPT expertise might also help to ensure that appropriate standards are met. The previous section outlines the importance of developing a firm platform on which to build postgraduate training. Curricula for specialist training and related assessments will be critical in promoting the importance of CPT principles and knowledge. The emergence of new prescribing groups e.
There are several important challenges for postgraduate CPT education. Perhaps the greatest is to find the necessary time in already busy clinical schedules. The ways in which clinical pharmacological services could be integrated in healthcare systems were first outlined in the WHO Technical Report referred to earlier [ 1 ]. In , a working group employed by the WHO Regional Office for Europe elaborated further on services that the discipline ought to undertake in patient care [ 28 ] which was followed up by WHO a decade or so later [ 17 ].
Compliance with these recommendations has varied between countries but has been generally unsatisfactory. Advances in drug development provide patients with new drugs, novel drug combinations, expensive biological drugs and targeted drug therapy adapted to the molecular characteristics of the disease [ 29 , 30 ]. Today, patients and patient organizations are eager to explore what new therapies can offer in terms of health benefits compared to existing treatments, but new drugs and drug combinations may not be affordable for all patients and healthcare institutions. Clinical pharmacology with its emphasis on critical drug evaluation is strategically positioned to bridge the knowledge gap between stakeholders such as patients, clinicians, pharmacists, administrators, politicians and pharmaceutical companies within and outside healthcare institutions.
The quality of drug therapy can be improved in all healthcare settings irrespective of the wealth of the country. The gap between knowledge about drugs and their use in clinical practice needs to be reduced in order to promote the principles governing the RUD. These principles have to be communicated, learnt and practised by students, doctors, healthcare staff and patients in their daily clinical practice [ 35 ]. The principles of RUD have to be integrated with healthcare planning and with resource allocation given the scarcity of resources that healthcare institutions are facing.
Clinical pharmacologists with their focus on drug evaluation and on the principles of RUD are needed in patient care [ 29 , 33 , 35 ]. They should train healthcare staff in the principles of drug evaluation and promote the use of guidelines and drug recommendations based on scientific evidence. Unbiased decisions free from improper influence by special interest groups is particularly important in view of the relentless increase in the cost of new drugs. Key clinical pharmacological services. These services are not listed in any particular order as their importance will vary from country to country.
Clinical pharmacologists have a responsibility to train DTC members in critical drug evaluation. They should ensure that these drug recommendations are based on scientific evidence and medical needs as assessed by independent drug experts in various pharmacotherapeutic areas. Clinical pharmacologists should also participate in the development of a National Medicines Policy that aims to improve patient care within the budget available see also section 6.
Critical drug evaluation should be a key theme in CME of clinical colleagues and other healthcare professionals. Drug utilization studies and pharmacoepidemiological services are closely linked to the work of DTCs and to quality assurance of drug therapy in clinics and in hospitals [ 36 , 37 ]. Ideally, a multiprofessional approach is preferred involving experts in clinical specialities, pharmacoepidemiology, pharmacoeconomics and clinical pharmacology. This service is important for a systematic introduction and monitoring of new drug therapies in health care and can then be linked to forecasting of future drug use in healthcare organizations [ 34 ].
Drug information services are primarily meant to guide clinicians in evaluating and solving drug problems in patients. A drug information service is also helpful for provision of unbiased drug information in academic drug detailing, which is well documented to improve adherence to drug recommendations and guidelines and should be part of the activities of the DTCs [ 38 ]. Services in pharmacovigilance may include the responsibility to be a coordinating centre for reports of ADRs from clinicians and other prescribers at a regional or national level [ 39 ].
The reports should be evaluated systematically and the conclusions fed back to the reporting clinicians. Ideally, selected cases should be examined with available methods for drug analysis. Regional clinical pharmacology centres for pharmacovigilance have been successfully implemented in countries such as France and Sweden [ 39 ]. Continuing medical education. The focus should be on major pharmacotherapeutic areas, on the principles of RUD and on new drug therapies and drug combinations. CME should preferably be interactive as this will foster the best involvement of clinical colleagues.
Therapeutic drug monitoring TDM and pharmacogenetic services are ideally provided by a Division or Department of Clinical Pharmacology. Assay of drugs can be done in many laboratories but true TDM services also involve clinical interpretation of the data taking diagnoses, drug interactions, kidney function and pharmacogenetics into consideration. An important service, particularly for elderly patients, is to ensure that drug dosages are adapted to the reduction in kidney function that occurs with age. An example of successful translation of the scientific development of pharmacogenetics into the clinic is the abacavir hypersensitivity syndrome which now can be prevented [ 40 ].
Moreover, the discipline of personalized medicine is rapidly growing, particularly in the field of cancer. Measurement of drug concentrations for the diagnosis and prevention of drug abuse and other toxicological services. In many hospital settings, clinical pharmacologists are involved in toxicological services such as diagnosis and treatment of drug intoxication.
A new function in some countries is to participate in the prevention of the abuse of doping agents such as anabolic steroids among athletes and in society at large [ 41 ]. Direct Patient Services. Clinical pharmacologists can provide care of patients in a variety of ways. In some countries, clinical pharmacologists take responsibility for the direct care of patients with particular clinical problems e. In some countries, clinical pharmacologists are mainly used for their skills in the evaluation of clinical drug problems such as therapeutic failures, ADRs, drug interactions and inappropriate polypharmacy.
They can be integrated into electronic medical journals and linked to lists of prescribed drugs. These services are predicted to become of particular importance with the accelerating spread of mobile phones and Internet access in poor countries. Overview and the industry environment. Pharmaceutical companies have until recently driven the discovery, development and marketing of new and established drugs.
More importantly, the clinical pharmacologist can integrate knowledge of the drug target, disease pathophysiology, context and management and preclinical and clinical data to guide drug development in an ethical, informed and efficient manner. Globally, pharmaceutical companies operate in a complex environment where evolving economic, regulatory, social and political influences constantly force change. At another level, consumers, health insurers and governments are increasingly focusing on paying for health outcomes rather than drugs, and sales and marketing approaches used in the industry are being questioned with a resulting reduction in trust.
What changes are being driven by these factors? The previously separate silos of discovery, preclinical development and clinical development are being vertically integrated into development teams that include functions from early discovery through to pharmacoeconomics and marketing.
Companies will increasingly market medicines coupled with related services and diagnostics to identify responsive patients and there is growing recognition of developing markets and neglected diseases as targets for drug development and marketing. Despite the problems facing the industry, the demand, and therefore the market, for medicines is likely to rise during the second decade of the 21st century owing to ageing populations and the emergence and growth of new markets particularly in developing countries.
Companies are consolidating through mergers and acquisitions and this trend is set to continue. Paradoxically, they may become less homogeneous, with niche market, biotechnology and generics companies all emerging as significant players. Overall, this is a dynamic and interesting environment for a clinical pharmacologist to work in.
Clinical pharmacologists can work in a wide range of roles across companies, but will need to develop skills and expertise beyond those normally associated with the discipline in the academic or hospital setting. The types of roles available, and the knowledge, skills and attitudes required are discussed below. Roles and career paths for clinical pharmacologists in industry. Traditional roles: The clinical pharmacologist in industry customarily has been involved at the early stages of clinical drug development — planning, design, conduct, analysis, interpretation and reporting of Phase I and Phase II studies in humans.
These activities include:. Phase II proof of concept clinical trials to establish efficacy in a restricted patient population. Specialized roles: Clinical pharmacologists can have diverse areas of special interest within the discipline, and many of these are applicable in the industry setting [ 43 - 45 ].
Some examples are. Other activities: Clinical pharmacologists in industry will become involved to greater or lesser extents in a range of other activities which may include. Advisory — arranging and managing scientific and clinical advisory boards, interactions with key scientific and clinical advisers to ensure appropriate product development.
Due diligence activities — involvement in scientific and clinical analysis of data and the scientific, clinical and market potential of products or companies. Management and financial activities — human and physical resources — planning most efficient development paths — quicker development gives higher net present value. Roles in small pharmaceutical or biotechnology companies: The clinical pharmacologist in this setting will fulfil a much broader role, being involved in overall discovery, development and marketing.
The role will usually involve a broader strategic planning, management and financial focus.
Clinical pharmacologists will find themselves involved in many aspects of the overall business including raising funding on the financial markets, development strategies in relation to funds available, and making decisions about developing to market stage, or licensing or sale of the product at an earlier development stage.
Career paths. Pharmaceutical companies usually have distinct scientific and management career streams. Clinical pharmacologists will normally start in the scientific stream, but are well placed because of their broad background to advance along either career line. Knowledge, skills and attitudes. The clinical pharmacologist in industry will normally have basic training as a physician and specialist training in clinical pharmacology.
The areas involved may include.
Core business skills — including the structure of the industry, a broad understanding of the business issues and models in the industry, the differences between industry sectors, and how product value is created and measured. Ethical and societal perspectives and broad industry issues — attitudes and ethical practices in a company or industry sector, medical versus marketing department perspectives, values and activities.
A career in the pharmaceutical industry can be interesting, challenging and satisfying for a clinical pharmacologist. After all, the goal of drug development should be to convert intellectual and scientific creativity into medicines that are valuable in terms of both benefits to patients and a sustainable business model for the company.
The clinical pharmacologist has the background and even responsibility to influence industry practices along appropriate ethical, societal and medical lines. However, it has to be recognized that this will not always be easy, or even feasible, in the context of a large, financially driven organization. A final caveat is perhaps that a career in industry can be fragile, as constant restructuring and reorganization result in a sometimes tenuous hold on the position.
Flexibility and mobility are desirable attributes! The clinical pharmacologist is a physician who has had systematic training in the evaluation of drug therapy and drug products. Governments should be involved in the ethical, scientific and developmental aspects of medicines. Activities in all these three dimensions are complementary and underpin the most important role of any government: to protect its citizens through support and promotion of public health.
Governments and their respective institutions have to take all necessary measures to make sure that clinical research involving its citizens is not doing them harm or ignoring their basic human rights. This challenging task involves making sure that the research to decide which medicines or other healthcare interventions are authorized for use in human beings provides enough grounds to ensure safety.
It also involves the task of assessing whether planned clinical research follows scientific principles that can justify both the harms and the expected benefits from this research. This forms the ethical dimension of the role of governments. Ethics committees and regulatory bodies. A fundamental requirement for application of ethical considerations is submission of a research proposal to independent evaluation by an ethics review committee. Nowadays, many governments define procedural aspects of the work of ethics committees in detail. For example, the European Commission has laid down strict timelines for processing research applications which affect the work of ethics committees in all 27 European Union Member States.
In addition, governments have to ensure that only effective, safe, good quality medicines are used to treat their citizens. Nowadays, all medicines are subject to marketing authorization approval before they are prescribed. The approvals are based on assessment of the quality, safety and efficacy of the products.
The safety monitoring of medicines during their whole life cycle from marketing authorization to potential withdrawal from the market is also a task for governments. In a broad sense, the role of the NMRA is to cover multiple dimensions and is derived from their mission. A clear mission statement, which includes the national regulatory authority goals, is necessary to guide its work. Goals usually include the protection and promotion of public health by ensuring the safety, efficacy and quality of medicines, and their appropriate use; and ensuring the appropriateness of medicines information provided to the public and health professionals.
These are two examples of mission statements. The one from EMEA addresses the three aspects described above: ethical, scientific and developmental. It is very important that regulators involved in the evaluation of safety and efficacy of medicines have the best possible scientific education and background. They should also be able to make a critical scientific evaluation of the clinical data and to understand what, at the time of the assessment, is known and what remains unknown about each drug under review.
Some of the NMRA also have units focusing on clinical pharmacology. For example, the U. Nowadays, safety surveillance, pharmacovigilance, is also a responsibility of the regulators. Clinical pharmacologists in government. In most countries, governments, directly or through their specialized agencies, are also involved in taking decisions about the selection of medicines for public procurement, developing national treatment guidelines and proposing inclusion of medicines in reimbursement lists.
Clinical pharmacologists are usually closely involved at the government level in developing and delivering a National Medicines Policy. It is important that such individuals work in an environment that has political support but also where there is a good prospect of continuity of support when governments change. An example of governmental institutions involved in such activities is the National Institute for Health and Clinical Excellence in the United Kingdom.
Clinical pharmacologists have proved themselves to be well prepared to meet the challenges of the complex assessment of medicines. Working at the government level, clinical pharmacologists are well trained to work in the area of HTA. As mentioned previously, clinical pharmacologists have usually not been closely involved in the past but many of the assessments are very much in the field of new drug assessments, especially the new molecular biology drugs, as well as in the administration of drugs by new technologies.
Recent history gives evidence that not all the research necessary for developing and promoting public health by medicines is possible using only private sector initiative and funding. Thus, governments may also be involved in delivering financial support for clinical research involving medicines. Clinical pharmacologists are well positioned to help in making judgements about the scientific value of proposals for governmental funding of research projects. An important emerging issue is electronic patient health records which have been implemented or are on their way in many countries.
Although these may be perceived as mostly administrative tools, they include a huge scientific potential for monitoring the safety and quality of drug therapy. There is already evidence that electronic health records can offer greatly added value for research in pharmacovigilance [ 52 ]. Clinical pharmacologists should be actively involved in designing and using electronic patient health records because of the enormous potential for future clinical research including monitoring of rational drug use and safety.
Future challenges. However, effective methods for pharmacovigilance and safety studies in the context of early market access need to be created and tested and clinical pharmacologists have an important role to play [ 53 , 54 ]. Clinical pharmacologists also contribute to the topic of pharmacoepidemiology. Similarly, pharmacoeconomics attempts to give a financial cost and value to everyday drug use which may become the basis for rational reimbursement systems.
In order to implement these various dimensions, governments have to create laws and regulations, the necessary infrastructure in terms of governmental institutions and necessary resource allocations to support the infrastructure. One of the key resources is properly trained specialists, capable of taking decisions based on the best possible scientific methods and evidence. Good ethics cannot do without good science; good science can be ethical, whereas bad science can never be. The training of clinical pharmacologists should be better tailored to meet the needs of various government services in order to ensure that the best scientific knowledge is used to make decisions in public health.
Historically, clinical pharmacology developed either from departments of pharmacology or from departments of internal medicine. Clinical pharmacology is now an independent medical speciality in many countries. In countries where it is not a separate medical specialty, clinical pharmacology should be recognized as a scientific discipline in its own right.
Clinical pharmacology is usually organized in separate units headed by a clinical pharmacologist. Depending on local and national circumstances, the unit could either be a division of clinical pharmacology in a clinical or in a pharmacology department. It could also be a separate department or institute of clinical pharmacology. Irrespective of which model is used, the optimal setting is in a university hospital as it supports all three major functions of clinical pharmacology: research, teaching and health care.
County or district hospitals and primary health care also need experts in clinical pharmacology. Such expertise can be provided from the university hospital if the local availability of clinical pharmacologists is limited. There are several models of organization, described below. In some countries, clinical pharmacology has developed to such an extent that a separate department in a university hospital has been created. Such departments have sufficient staff for the manifold interests of clinical pharmacology in research, teaching and clinical service.
Such staff will comprise both clinical pharmacologists and other drug experts such as pharmacists and drug analytical staff and often include basic pharmacologists. The department may have beds, and clinical pharmacologists are then fully responsible for the treatment of patients. The advantage of this arrangement is that the clinical pharmacologist is fully integrated in the clinical work in the hospital making it easier for them to relate to clinical colleagues.
Thus, in many countries, clinical pharmacologists are not directly responsible for patient care. There are advantages and disadvantages in both models see above and which model is chosen should reflect the national and local traditions, circumstances and needs.
Collaboration between basic and clinical pharmacologists enables achievements to be made that are rare when the disciplines work on their own. Finally, the department will need staff with other skills such as nurses, computer experts, statisticians, laboratory technicians and secretaries to fulfil its role properly. In many countries, this model for clinical pharmacology is more appropriate.
It is likely to be the pattern where it is impractical to have a fully independent department. This may result in the creation of an independent department in due course. In some cases, a clinical pharmacology unit or division has been organized in close association with or has developed from a department of basic pharmacology. The advantages of such an arrangement have been discussed above. There will be a considerable disadvantage if the basic pharmacology department is sited some distance from the hospital. Many clinical pharmacology organizations start small, but as they grow over the years in response to the healthcare needs of their communities, they develop new skills and require different staff groups.
Thus, there are examples of clinical pharmacology organizations that have developed from basic pharmacology but now have individual clinical pharmacologists who provide direct health care to patients, e. Equally, there are clinical pharmacology organizations that have developed from providing direct patient care to become more involved in the basic science of pharmacology — for example the use of molecular biology skills to understand pharmacogenetic variability and thereby to provide a more personalized approach to drug therapy.
The rise in clinical pharmacology in the s was in a large part due to the realization of basic pharmacologists that their discipline was too far removed from the practice of medicine but also due to the desire of prominent clinicians specializing in pharmacotherapy to develop their science and improve the quality of drug therapy. Clinical pharmacologists at the time had to have fruitful collaboration with both pharmacology and internal medicine and usually had considerable training in both disciplines.
Clinical pharmacology at its best now requires a much broader view of all aspects of medicine in which drugs are used be it internal medicine, paediatrics, psychiatry, geriatric medicine or oncology. The role of clinical pharmacology in all these areas should be to educate other physicians, to perform collaborative research and to disseminate information about the principles of drug evaluation and RUD. These roles are facilitated by having access to diversified methods for monitoring and improving drug therapy.
Collaboration with drug experts representing other professions is equally important, not least with basic pharmacologists and pharmacists whose training in many ways complements that of a clinical pharmacologist. Fruitful collaboration across the three professions is particularly well documented in Drug and Therapeutics Committees and drug information services. In pharmacoepidemiology and pharmacovigilance, collaboration with epidemiologists is necessary. In TDM, collaboration with drug analytical experts is vitally important to maintain accreditation of the analytical methods used.
Such experts are usually trained in chemistry or pharmacy. Collaboration with persons knowledgeable in molecular biology is of increasing importance, particularly in pharmacogenetics. Many clinical pharmacologists depend on their collaboration with trained nurses who fulfil a valuable role in areas such as drug utilization, measurement and evaluation.
In the last three decades, drugs produced or extracted from biological sources e. The patent on human insulin was filed in the early s and expired in Other patents have also ended or are about to expire. Currently, about biopharmaceuticals are under clinical development. About half are used in treating cancers.
As many of them are expensive, it is important that generic products can be provided to produce cost savings. It is thus clear that the remit of the clinical pharmacologist has expanded very significantly since the original WHO document appeared in Owing to their production process and mechanism of action, biologics have a different pattern of potential adverse effects compared with chemically synthesized drugs, which deserve special attention [ 56 ].
Most biologics are very large, complex molecules or mixtures of molecules. The production is based on recombinant DNA technologies and the process is often a secret [ 55 ]. Therefore, unlike classical drugs, a medicine produced by such a process in order to mimic an already licensed biologic the reference drug is a product that is similar to but not the same as the innovator drug.
Because of the complex science involved, the EMEA recognized that the generic approach is scientifically not appropriate for these products. Therefore, EMEA has stipulated that a regulatory framework should be established to minimize the risk to patients by requiring extensive testing before approval in order to ensure that biologics are safe and effective.
This means that a multistage process will be developed. Currently, it is permitted to extrapolate results on efficacy in a specific therapeutic area to others, e. However, this current opinion is subject to further review. As mentioned above, immunogenicity is a major problem of biologics. As they are proteins, an immune response such as the formation of antibodies is more likely than in conventional pharmaceutical products.
Thus, in patients treated with epoetin alpha, an isolated erythroblastopenia pure red cell aplasia occurred as a consequence of the generation of neutralizing antibodies against erythropoietin [ 58 ]. In general, the immunogenic potential of biopharmaceuticals depends on the production process, and also on the mode of application, dosage, duration of treatment and specific characteristics of the individual patient.
Therefore, careful pharmacovigilance is needed, as immunological reactions may be without clinical consequences, may sometimes lead to loss of efficacy, or in rare cases may cause improved efficacy or severe adverse reactions. The extensive requirements of regulatory authorities concerning preclinical and clinical studies of biosimilars impose substantially higher developmental costs than those for usual generic drugs. It requires the expertise of molecular biologists, immunologists and clinical pharmacologists in order to take advantage of these challenging new medications.
The opportunities for clinical pharmacologists in this field are considerable provided the necessary training in molecular biology is taken on board in addition to the standard training that clinical pharmacologists undergo. Since the first edition of the WHO Technical Report in [ 1 ], the medical world has changed dramatically.
With this as background, it can be argued that the most important single development that has expanded the role of clinical pharmacologists in global public health has been the recognition by many developed and developing countries of the value of a National Medicines Policy. More than countries now have their own policies in varying stages of implementation. Clinical pharmacologists have clear and demanding roles in the implementation of at least the first three of these key ingredients.
In many countries, clinical pharmacologists contribute substantially to drug regulation. These are standard roles for clinical pharmacologists in developed countries and there is a strong case for providing positions in less developed countries for the same purposes. For many developing countries, limited resources mean that most new medicines approved for marketing have already been used for years elsewhere, and there is a greater probability that their safety has been more fully characterized, allowing for differences in pharmacogenetic variations from country to country.
In whichever context, the clinical pharmacologist should have a major role in the setting up of spontaneous reporting systems, in reviewing and suggesting action on reported adverse events, and in providing data not only to guide decisions in the home country but also to contribute to the global database [ 64 ]. When challenged in the courts of several countries, the right of access to essential medicines has been upheld as an extension of the right to health [ 66 ].
Despite this assertion of principle and intent, WHO estimates that as many as two billion people worldwide do not currently have access to essential medicines. For the poorest populations, lack of finances may be the major cause. With no regular acceptance of the need for medicine prices to be proportional in some measure to national per capita income, the costs of many medicines are beyond the limited resources of the poorer countries as the figures above predict. This requires clinical pharmacological skills. Several governments worldwide now engage clinical pharmacologists as part of the pharmacoeconomic team to address these issues specifically.
In countries where the cost of medicines to the individual is subsidized by government, a list of selected medicines is maintained. Clinical pharmacologists are commonly involved in this selection process in developed countries but much less so at present in the developing world — partly because there are so few of them. Having medicines of high quality that are accessible to all does not guarantee that they will be used in the best possible way.
More money can be saved and health objectives met by ensuring the highest standard of use. Over the past two decades, methods for measuring and evaluating the quality of use of medicines have been developed and implemented. One of the first steps in improving the way medicines are used in any community is definition of the potential or actual problems. Measuring medicine use and relating it to clinical indication in a community, hospital, clinic or at a national level is not the easy task it would be if there were databases that could be linked with proper attention to confidentiality of the records.
Commonly, utilization has to be measured prospectively by data collection in a defined area for an adequate time, to ensure representative results. In many countries, this task has fallen to pharmacists who have had special training in the methods. However, when the results are being interpreted, clinical input is required. Clinicians with speciality training may be needed in order to judge whether prescribing has been appropriate. This role can be filled by a clinical pharmacologist with broad clinical training and experience.
Standard treatment guidelines below that have been endorsed for a country, hospital or community serve as the reference standard and help to define inappropriate practice. The guidelines should also be endorsed by local opinion leaders including government and professional associations and be revised regularly to maintain currency. Clinical pharmacologists commonly have a central role in developing guidelines and their broad training fits them for this task. The essential medicines list should reflect, and derive from, the national standard treatment guidelines.
Ideally, guidelines should be prepared first and the essential medicines list produced from their recommendations. Whatever the sequence, the two documents should always be harmonized at each updating and review. In many developing countries, there is a dearth of objective information for health professionals about medicines, the gap being filled by information provided by pharmaceutical companies, with, not unexpectedly, a promotional bias. Many developed and some developing countries produce drug information journals several times each year.
These deal with topical issues about the use of medicines, review the profiles of newly introduced medicines and discuss adverse effects. Clinical pharmacologists play a major role in the editorial processes and as authors for such publications. Education of health professionals and of consumers see also Section 6.
Further Essentials of Pharmacology for Nurses: Medicine & Health Science Books @ pypahulobi.tk Editorial Reviews. About the Author. Paul Barber is Senior Lecturer at the University of Chester, UK and a registered adult and mental health nurse possessing.
Clinical pharmacologists working within the health system always have a responsibility to be involved in undergraduate, postgraduate and continuing education. Much evidence suggests that doctors prescribe less well than they might [ 62 ]. Whose business is the education of consumers? Peer education is a powerful technique and several studies have demonstrated its effectiveness in improving understanding and use of medicines.
If this is the strategy chosen, the clinical pharmacologist is absolved from being the primary educator but often becomes the adviser who helps to translate the information from medical to everyday language. Largely neglected by Western clinical pharmacology, these traditional preparations have the potential to provide surprises. For example, it is arguable that the most important advance in the pharmacotherapy of malaria in the last decade has been the introduction of the Artemisia derivatives — which come directly from the Chinese herbal tradition.
The concerns that prompted these initiatives were the need to ensure quality control in the manufacture of these products and to evaluate the potential for unexpected toxicity as demonstrated, for example, by aristolochic acids in some traditional medicines as a cause of renal impairment and renal cancer. There is also the difficult problem of assessing the efficacy of products that have had little or no scientific study in the past, and which are produced by an industry that has only limited options for patent protection.
In addition, there are only limited funds available for the necessary clinical trials work and thus many problems remain to be solved. However, research money is beginning to flow from both pharmaceutical companies and from government sources in some countries. In several instances, clinical pharmacologists have been members of the national advisory committees making recommendations to government regulators, and in both Australia and the UK these committees have been chaired by a clinical pharmacologist.
Some preparations that have been in use for many centuries warrant investigation and evaluation — a further role for the clinical pharmacologist in relation to global health. The recognition that medicines are used for treatment or prophylaxis on such a scale in many populations that they assume the same importance as other factors that influence public health has led to the use of epidemiological methods to explore the impact of medicines on populations as a whole.
The exploration of ADRs has led to fresh approaches for the linkage of events with medicines use. Case—control studies [ 69 ] and health database linkage have raised hypotheses, and sometimes provided hard causality evidence about events stemming from drug exposure. The discipline of clinical pharmacology arose from the two imperatives of the need to be able to measure the efficacy of medicines in patients and the even more urgent need to be able to monitor adverse effects. Training of clinical pharmacologists to meet these needs will have to be rather different and much broader than envisaged in Section 3.
Clinical pharmacology is the scientific discipline that involves all aspects of the relationship between drugs and humans and involves research, teaching and delivery of health care, as well as helping to frame policy and giving information and advice about drugs. They have usually undertaken several years of postgraduate training focusing on important aspects of clinical pharmacology including clinical trials, drug evaluations, pharmacoepidemiology, pharmacoeconomics, pharmacogenetics, pharmacovigilance and clinical drug toxicology.
Section 4. Clinical pharmacology is a relatively new medical discipline having been developed extensively in the middle of the 20th century. After a period at the end of the 20th century when the discipline was seen to contract in some countries, there are now new signs of optimism see introduction. Section 5. The Global Scene.
Section 6. Research is a fundamental part of the training and th e work of virtually all clinical pharmacologists. Research in drug evaluation, drug utilization, pharmacovigilance and pharmacoepidemiology has become more important than at the time of the WHO report [ 1 ]. The RUD implies that drugs should be chosen according to their efficacy, ADRs and cost as potentially equally important parameters. Research in clinical pharmacology therefore includes studies that elicit new data about drugs in use such as new indications and treatment in neglected populations.
Research in clinical pharmacology is often interdisciplinary. All clinical pharmacologists will have a considerable role to play in teaching, whether this is at the undergraduate, postgraduate or continuing professional development level. Most attention is currently directed at the undergraduate level because of the increasing demands being placed on new prescribers and because of the evidence that new prescribers are more likely to prescribe less effectively and with more errors than their seniors. This is because there is far greater variability in the availability of staff and resources as well as varying needs around the world in the postgraduate scene than in the undergraduate one.
Patient care. The prime function of a clinical pharmacologist in patient care is to deliver safe and effective drug therapy in what is often termed the RUD.
In some cases, this is done directly where a clinical pharmacologist may have direct charge of patient care but more commonly they will have a range of services to offer colleagues and their patients. Clinical pharmacologists are trained particularly in the critical evaluation of both new and old therapies and so may function on drug and therapeutics committees or by delivering drug information services often in collaboration with other healthcare professionals such as pharmacists.
Special skills are available in drug utilization, pharmacoepidemiology and pharmacovigilance. In addition, many clinical pharmacologists provide a TDM service often linked to pharmacogenetic expertise and this is leading to a personalized medicine approach which in some cases can result in more effective therapy with fewer ADRs. Pharmaceutical industries. The clinical pharmacologist has much to offer the pharmaceutical and biotechnology industry at all levels.
In turn, a career in pharmaceutical companies can be satisfying and rewarding both professionally and financially. It can involve a career that evolves to a broad high level management position, or a focus on a special area of interest within clinical pharmacology, and also provide the opportunity to develop a range of skills and knowledge not often encountered in academic clinical pharmacology. The training of clinical pharmacologists should be better tailored to meet the needs of various government services in order to ensure that the best scientific knowledge is used in making decisions in public health.
In particular, the governments of emerging economies and developing countries could benefit from the expertise of clinical pharmacologists, although few have given the necessary priority to the development of the discipline and many would have difficulty in creating positions that are seen to compete for funds with more mainstream medical disciplines.
Section 7. Clinical pharmacology services can be delivered from a variety of different organizational arrangements. There is little doubt that the most effective system is for the clinical pharmacology services to be delivered from a department or division based within a hospital, whether the hospital is a university hospital or a district general hospital so that all aspects of the discipline can be practised.
The needs of primary care have to be considered, although in many countries this is delivered from the hospital setting. Section 8. The Relationship with Other Drug Experts. Clinical pharmacology is a discipline where the close working relationship with a number of different professional groups is very important. Section 9. Biologics and Biosimilars. Skip to Content. Catalogue Further essentials of pharmacology for nurses. Paperback , Book. Available at All Saints.
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