Clinical pharmacology in in Health care, Essays (university) of Pharmacology

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IV Clinical Pharmacology in Health Care, Teaching and Research

Foreword and acknowledgments

this position paper regarding the roles of clinical pharmacology in health care, teaching and research was composed and edited by representatives of the International Union of Basic and clinical Pharmacology (IUPHar), the world Health organisation (wHo) and the council for International organizations of medical sciences (cIoms). It is an updated and edited version of a recent publication entitled “clinical Pharmacology in research, teaching and Health care- considerations by IUPHar, the International Union of Basic and clinical Pharmacology” which was published in the journal Basic and clinical Pharmacology and toxicology (BcPt) in 2010, Volume 107, pages 531 – 559. this document contains new chapters of special relevance to global health.

we thank Professor kim Brøsen, the editor of BcPt, the publishers of the journal, and the original and new authors for generous collaboration during the editorial process.

we gratefully acknowledge financial support for the printing and publication of this paper from:

the world Health organisation

the council for International organizations of medical sciences

the International Union of Basic and clinical Pharmacology

the British Pharmacological society

the swedish Foundation for clinical Pharmacology and Pharmacotherapy

For wHo lembit rägo

For cIoms gunilla sjölin-Forsberg

For IUPHar michael orme (liverpool, Uk), Folke sjöqvist (stockholm, sweden), and donald Birkett, (sydney, australia).

contents

21. addendum I.

• abbreviations
• 1. executive summary......................................................................................................................................................................................................
• 2. Introduction
• 3. definition of clinical Pharmacology
• 4. History of clinical Pharmacology
• 5. the global medicine scene: the Place of clinical Pharmacology
• 6. the clinical Pharmacologist in Patient care
• 7. drug therapy in Paediatric Patients
• 8. drug therapy in geriatric Patients.................................................................................................................................................
• 9. teaching clinical Pharmacology
• 10. research domains of clinical Pharmacology
• 11. emerging roles of clinical Pharmacology: Biologics and Biosimilars.............................
• 12. clinical Pharmacology and the Pharmaceutical Industry
• 13. governments: essential roles for clinical Pharmacology.....................................................................
• 14. the clinical Pharmacologist and traditional medicines
• 15. collaboration with other drug experts.................................................................................................................................
• 16. organisation: structural models for clinical Pharmacology.............................................................
• 17. the central Place of clinical Pharmacology in global Public Health................................
• 18. overview
• 19. references................................................................................................................................................................................................................................
• 20. editors and contributors.................................................................................................................................................................................
  • therapeutics and Prescribing for medical students........................................................................................ model core curriculum for clinical Pharmacology,
  • model curriculum for medical specialisation in clinical Pharmacology........................... 22. addendum II.

1

I deFInItIon clinical Pharmacology is the scientific discipline that involves all aspects of the relationship between drugs and humans. It is a multidisciplinary science that encompasses professionals with a wide variety of scientific skills including medicine, pharmacology, pharmacy, biomedical science and nursing. the term ’clinical pharmacologist’ is commonly used in the professional sense to refer to physicians who are specialists in clinical pharmacology. they have undertaken several years of postgraduate training in many aspects of the above relationship involving health care, teaching, and research. such clinical pharmacologists have as their primary goal that of improving patient care, directly or indirectly, by developing better medicines and promoting the safer and more effective use of drugs.

I aIms this document aims to set the scene for clinical pharmacology in the early part of the 21st century following the concepts of an earlier report by the world Health organisation in 1970 (1). this document is aimed primarily at decision makers in a variety of organisations, particularly in governments and their health care ministries, in addition to chief executives and board level directors of primary and secondary care systems and directors in pharmaceutical companies. It lays out in detail the great benefits that expertise in clinical pharmacology can bring to the delivery of better health care for all populations.

I tHe clInIcal PHarmacologIst In PatIent care clinical pharmacology has developed a number of ways in which the clinical care of patients can be improved (see chapter 6). the prime aim is to improve the rational Use of medicines both for

individual patients and for patient populations wherever they may reside. clinical care of paediatric and geriatric patients needs special attention from the clinical pharmacologist and these special interests are addressed in chapters 7 and 8. the clinical pharmacologist is expert in the critical evaluation of new and old therapies, and uses drug utilisation studies and pharmacoepidemiological services to help in this task as well as skills such as pharmacogenetics. clinical pharmacologists have an important role on drug and therapeutics committees where they help the rational introduction and use of new and expensive medicines into the delivery of health care. clinical pharmacologists provide, in collaboration with other health care staff such as pharmacists, drug information services to a wide variety of prescribers. specialist services may include therapeutic drug monitoring, involvement in clinical drug toxicology and pharmacovigilance. adverse reactions to drugs still cause many problems for patients, and health care systems could do more to prevent these since most of them are predictable through a knowledge of pharmacology.

the concept of personalised medicine is one where drug therapy can be based on the pharmacogenetic or other characteristics of a particular patient. while in its infancy as a discipline there are now good examples whereby adverse effects can be minimised and drug efficacy enhanced by a knowledge of the genetic makeup or other characteristics of the individual patient.

I teacHIng clInIcal PHarmacologY the teaching of clinical pharmacology is a vital part of the work of a clinical pharmacologist (see chapter 9 and addenda I and II). Perhaps the most important area is the training of new prescribers,

executive summary

primarily medical students and new physicians. with the increasing trend for nurses and pharmacists to prescribe, usually in particular areas, attention needs to be paid also to their training in prescribing. the ability of new young physicians to prescribe safely and effectively has been criticised in recent years, and new systems are being developed to enhance these skills in the training of medical students. since assessment drives learning, the assessment systems are being improved too. specialist training of physician clinical pharmacologists is addressed in addendum II, since there is a world wide shortage of such specialists. However the needs, the resources, and the regulatory arrangements available in different countries mean that the approach suggested is a general one.

I researcH domaIns oF clInIcal PHarmacologY research is a vital part of the training and everyday work of a clinical pharmacologist (see chapter 10). the endeavour of a pharmacologist working in the clinical environment is to develop methods and strategies that improve the quality of drug use in individual patients and in patient populations. clinical pharmacological research has always been translational in the sense that the discipline aims to translate new scientific data on drugs into rational patient care. an increased engagement of clinical pharmacologists in the design, conduct and execution of clinical trials, particularly early phase I studies, would be advantageous. However, enhanced training in these areas may be required.

I clInIcal PHarmacologY and tHe PHarmaceUtIcal IndUstrY the pharmaceutical industry has been at the forefront of helping to train clinical pharmacologists (see chapter 12). while many of the skills acquired

in such companies are useful for the general training of a clinical pharmacologist (e.g clinical trials) a long term career in such a company requires a new set of skills for which training and experience is needed.

I goVernments: essentIal roles For clInIcal PHarmacologY governments need clinical pharmacologists to help deliver the goal of ensuring safe and effective drug therapy for their populations, whether the clinical pharmacologists are working in hospitals, regulatory agencies or in Health technology assessment (Hta) (see chapter 13). with a few notable exceptions the discipline of Hta has emerged in the absence of contributions from clinical pharmacology.

clinical pharmacologists have a crucial role to play in helping to deliver the wHo agenda of ”guidelines for the development of national drug Policies” to which more than 150 countries are now signed up (2). the policies aim to ensure:

• the quality, safety and efficacy of medicines
• equitable access to medicines for all the population
• the rational/quality use of medicines
• a viable and responsible local pharmaceutical industry.

clinical pharmacologists are paying increasing attention to the health needs of those peoples who have in the past been marginalised. they include children, those with rare diseases, and those with conditions that are endemic in the poorest parts of the world. the training of clinical pharmacologists to meet these needs is rather different from that envisaged in 1970 when the first wHo report was published (1).

this document aims to set the scene for clinical pharmacology in the early part of the 21st century by updating the concept of the original wHo report. we have gathered a group of distinguished clinical pharmacologists who have written the individual sections which are designed to address the essential role of clinical pharmacology in health care, teaching and research as well as describing the discipline’s link with industry and governments. we hope that the document will prove useful to many people, perhaps particularly young doctors who are looking to establish themselves in a clinical specialty and who

have a particular interest in improving drug therapy and making it safer and more effective as exemplified in the wHo’s rational Use of medicines policy (9). However, this document is particularly aimed at decision makers in a variety of organisations, in governments and their health care ministries as well as chief executives and board level directors of primary and secondary care organisations and directors in the pharmaceutical industry. the document details the great benefits that expertise in clinical pharmacology can bring to the delivery of better health care for all populations.

clinical Pharmacology is the scientific discipline that involves all aspects of the relationship between drugs and humans. Its breadth includes the discovery and development of new drugs, the application of drugs as therapeutic agents, the use of drugs, the beneficial and harmful effects of drugs in individuals and society, and the deliberate misuse of drugs. clinical pharmacology is a multidisciplinary team science that encompasses professionals with a wide variety of scientific skills including medicine, pharmacology, pharmacy, biomedical science and nursing. other professionals who are important in various aspects of clinical pharmacology include social and behavioural scientists, dentists, economists, epidemiologists, geneticists, toxicologists, mathematicians and computer scientists.

the descriptor ‘clinical pharmacologist’ is normally used in a professional sense to refer to physicians involved in the medical care of patients who are specialists in clinical pharmacology. they have usually undertaken several years of postgraduate training (see addendum II) focussing on important aspects of clinical pharmacology including clinical trials, drug evaluations, pharmacoepidemiology, pharmacoeconomics, pharmacovigilance and clinical drug toxicology. some countries have accreditation programmes for clinical pharmacology as a physician specialty but many do not. the present document refers essentially to medical clinical pharmacologists.

definition of clinical Pharmacology (^3)

clinical pharmacology is both old and young. the practice of drug therapy goes back to ancient times and the discovery of drugs such as quinine, reserpine and artemisinin which were first used as herbal medicines. william withering’s publication on the use of foxglove in the treatment of heart failure (see10) may very well be considered the first scientific account of the discipline but it took 200 years before the pharmacology of digitalis was explored with accurate, clinical pharmacological methods. as a scientific discipline, clinical pharmacology is young having originated from the middle of the 20th century. It is difficult to find who first coined the name as opinions differ between countries. several distinguished pharmacologists active in the middle of the century brought pharmacology and clinical know-how about drugs together and helped to transform drug evaluation from the trial and error state to a scientific discipline. In the anglo- saxon literature, Harry gold at cornell (10,11) is commonly quoted as the person who first introduced the name clinical pharmacology in the early 1940s. However, in 1914, a textbook was written by Hans Horst meyer and rudolf gottlied in german the title of which was translated as ‘Pharmacology, clinical and experimental’. In addition, also in the german literature, Paul martini, professor of medicine in Bonn, published his monograph in 1932 entitled ‘methodology of therapeutic Investigation’ and he is considered by some as the first clinical pharmacologist (12). according to shelley and Baur, his contributions escaped the attention of the english- speaking world (12). In the english literature, there is a long tradition of ‘materia medica’, particularly in scotland. In 1884, John mitchell Bruce wrote his textbook entitled ‘materia medica and therapeutics. an Introduction to the rational treatment of disease’ and this, in its 20th edition, became dilling’s ‘clinical Pharmacology’. this book was published in 1960, the same year as desmond laurence’s textbook entitled ‘clinical Pharmacology’.

there is no doubt that the most vigorous attempts to develop clinical pharmacology as an academic discipline were made in the United states (13,14). Important landmarks are the first edition of goodman and gilman’s ‘the Pharmacological Basis of therapeutics’ and the successful attempt (1960) by walter modell, also at cornell, to launch the first scientific journal in the subject entitled ‘clinical Pharmacology and therapeutics’.

In the early 1960s, the United states became the world centre for the training of clinical pharmacologists. the nIH chief James shannon and his colleagues Bernard B. Brodie and Julius axelrod introduced biochemical pharmacology as a science and drug measurements in body fluids as tools in clinical pharmacology. several centres of excellence in clinical pharmacology offered training to potential clinical pharmacologists from all parts of the world. the efforts to improve clinical drug evaluation by louis lasagna, a pupil of Harry Beecher at John Hopkins Hospital, should be especially recognised (13,14). In1966, lasagna published a brilliant, still valid, account in science of the present status and future development of clinical pharmacology (14). the birth of clinical pharmacogenetics can be ascribed to the pioneering contributions of werner kalow and a.g. motulsky (15,16).

Parallel developments occurred in europe, particularly in the Uk, where the strong infrastructure in basic pharmacology and clinical medicine formed an excellent basis for a rapid growth of the discipline. names that are usually mentioned in this context are those of sir John gaddum, sir Horace smirk and sir austin Bradford Hill (10). chairs in clinical pharmacology were created at the end of the 1960s in germany, the Uk and sweden, although chairs in materia medica had long been established in scotland. academic growth of the discipline also took place in France (17). IUPHar took early initiatives to

History of clinical Pharmacology (^4)

develop clinical pharmacology. a section of clinical pharmacology was formed in the early 1970s and a division in the 1990s. several IUPHar executives strongly supported the discipline, particularly the first president Börje Uvnäs in sweden, but also sir arnold Burgen in the Uk and Helena raskova in czechoslovakia, who all realised that pharmacology had to reach out to the bedside in order to develop. wHo brought together a study group in 1970 (1) to write a report on the scope, organization and training of clinical pharmacology, led by the late sir derrick dunlop (Uk), and containing, amongst others, the late professors louis lasagna (Usa), Franz gross, (germany) and leon goldberg, (Usa). In 1991, wHo

europe put together a booklet and a series of papers in the european Journal of clinical Pharmacology about the roles of clinical pharmacology in teaching, research and health care (18). For the first time, the potential usefulness of the discipline for the rUm in primary health care was emphasised. several nobel Prize laureates in medicine can be considered as representatives of clinical pharmacological research at its best such as sir John Vane, sir James Black, george Hitchings, gertrude elion and arvid carlsson. they all ‘practiced’ clinical pharmacology during their efforts to introduce new pharmacotherapeutic principles into clinical medicine.

with long-term chronic diseases requiring multiple drug therapy), the greater availability of effective screening measures (especially in the elderly), and the growing expectations of the public, all mean that resources are constrained. one of the reasons for the rapid emergence of Hta facilities, across europe and north america, is because of the necessity to look ever more closely at the clinical efficacy and cost- effectiveness of therapeutic strategies.

I tHe FUtUre ProsPects despite this gloomy outlook, a number of initiatives suggest that remedial action is being taken:

1. drug regulatory authorities themselves recognise the need for change if people are to have access to innovative medicines. Both the Food and drug administration in the United states (19) and the european medicines agency (ema) in the eU (20) have published plans for expediting the regulatory process of innovative medicines that are appropriately safe and effective. 2. the process of drug discovery, confined for most of the 20th century to the laboratories of research-based pharmaceutical companies, has become much more pluralistic. In particular, academic scientists working in universities have become ‘drug hunters’ and some have been spectacularly successful. whereas 25 years ago, major pharmaceutical companies were unwilling to even contemplate developing products that had not been discovered in their own laboratories, they are now prepared to do so with enthusiasm. Indeed, companies are pursuing truly collaborative projects with academic scientists to the extent that they are allowing access to their chemical libraries. 3. an increasing number of not-for-profit organizations such as the Bill and melinda gates Foundation (in seattle) and the Hereditary disease Foundation (in new York) are supporting drug discovery and development in co-operation with both academia and pharmaceutical companies. 4. some major pharmaceutical and biopharmaceu- tical companies are increasingly recognising that their traditional models of discovery, development and pricing no longer meet the needs of patients, healthcare systems or their shareholders (21). changes include moving away from seeking ‘blockbusters’; expanding sales to include the emerging markets in asia; and discussing, with healthcare systems themselves, what future products would bring most value for money.

I conclUsIons these changes in the global medicines scene require the contributions of appropriately trained clinical pharmacologists if innovative new medicines are to reach those in need:

1. clinical pharmacologists should be better equipped to undertake ‘translational’ research, especially the design and execution of Phase 1 studies. 2. too few contemporary clinical pharmacologists are actively engaged in the design and conduct of clinical trials. the founding fathers of the discipline (such as lou lasagna (13)) made crucial contributions to health care by undertaking clinical trials – often in relatively small patient populations - that characterised a compound’s properties (especially dose–response relationships). 3. with a few notable exceptions, the discipline of Hta has emerged in the absence of contributions from clinical pharmacology. this needs to change if Hta is to meet its full potential. 4. clinical pharmacologists could do so much more to meet the health needs of those peoples who have in the past been marginalised. they include children, the elderly, those with rare diseases and those with conditions that are endemic in the poorest parts of the world.

I IntrodUctIon

the ways in which clinical pharmacological services could be integrated in healthcare systems were first outlined in 1970 in a wHo technical report referred to earlier (1).

the quality and outcome of drug therapy in patient care can be greatly improved by using cost-effective and evidence-based treatment with drugs adapted to the needs of patient populations and individual patients. 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 (22,23,24). Increasingly cost-effective generic drugs are available and should be used as first- hand therapies to balance the economic pressures on all healthcare systems today (25). the rate of implementation of this strategy varies widely across health care systems (25). easy access to evidence- based drug information will assist physicians and healthcare staff in monitoring the effectiveness and safety of drug therapy and optimal allocation of limited resources (26,27).this is a priority since 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. It needs also to be considered that newly registered drugs are rarely innovative (24,27). as a result, great emphasis must be placed on the overall cost-effectiveness and safety of new drug therapies from a societal perspective in order to guide drug selection and reimbursement decisions (22,28). the use and value of new drug therapies have to be monitored within the healthcare institutions as part of a systematic introduction and follow-up of new therapies by involving drug experts across medical specialties and systematic use of clinical outcome data (24,28). such a procedure will diminish the gap between documented efficacy in

controlled clinical trials and observed effectiveness in clinical care (24,28). clinical pharmacology with its emphasis on critical drug evaluation, scientific methodology, drug development and involvement in the work of drug and therapeutics committees is strategically positioned to bridge the knowledge gap between stakeholders including patients, clinicians, pharmacists, administrators, politicians and pharmaceutical companies within and outside healthcare institutions (26,27).

the quality of drug therapy can be improved in all healthcare settings irrespective of the resources of the country or of individual health care facilities. Patients can be provided with effective and safe therapy if well- documented drugs are prescribed, and the drugs are used according to medical, social, environmental and financial circumstances. the gap between knowledge about drugs and their use in clinical practice needs to be reduced in order to promote the principles governing the rational Use of medicines (rUm). these principles have to be communicated, learnt and practiced by students, doctors, healthcare staff and patients in their daily clinical practice (24,27,29,30). an optimal strategy for eliminating the knowledge– practice gap in drug therapy is to apply a multifaceted approach including practice-governed quality assurance programmes combined with interactive continuous medical education and prompt electronic access to evidence-based guidelines (24,27,31). the principles of rUm 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 rUm are needed in patient care (22,27,28,29). they should train healthcare staff in the principles of drug evaluation and promote the use of guidelines and drug recommendations based on scientific evidence. at the level of individual hospitals and

the clinical

Pharmacologist in Patient care 6

(b) Drug and Therapeutics Committees (DTC) all institutions, no matter what size, should have some appropriate version of a dtc. It should preferably recruit both hospital based specialists and primary care physicians in order to provide the same type of recommendations irrespective of the level of healthcare (26,27). the membership will vary depending on local circumstances and resources but may include physician clinical pharmacologists, relevant medical staff, clinical and other pharmacists and other staff as appropriate. where available, physician clinical pharmacologists provide a leadership role bridging medical, pharmacy and other staff (26,27). dtcs should issue recommendations for drug use within the facility based on scientific evidence and medical needs at the local level. this will usually take the form of a local formulary or ”Wise List” with the wHo essential drug concept being a useful model (27,34).

(c) Drug utilisation studies and pharma- coepidemilogical services are closely linked to the work of dtcs and to quality assurance of drug therapy in clinics and in hospitals (30, 35). Ideally, a multi-professional approach is preferred involving experts in clinical specialties, pharmacoepidemiol- ogy, pharmacoeconomics and clinical pharmacology. these services are important for a systematic intro- duction and monitoring of new drug therapies in the facility and can then be linked to forecasting future drug use in healthcare organisations. knowledge about the use of drugs is a prerequisite for follow- up studies of the adherence of prescribers to drug recommendations and of the effectiveness of drug information and educational activities (27,30,35).

(d) Drug information services are primarily targeted to guide clinicians in evaluating and solving drug problems in patients. the services provided are usually both descriptive and problem oriented. the latter, addressing problems at a patient level are appropriately provided by physician clinical

pharmacologists or clinical pharmacists depending on the availability of staff at the particular facility. drug information services build on systematic literature searches in databases and reference books combined with an evaluation of the literature on patient-related diagnostic problems. this service should assist dtcs in literature searches as the foundation of evidence- based drug recommendations. 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 (36).

(e) Services in pharmacovigilance may include the responsibility to be a coordinating centre for reports of adverse drug reactions (adrs) from clinicians and other prescribers at a regional or national level (37). adr reports should be evaluated systematically and the conclusions fed back to the reporting clinicians and the dtc. regional clinical pharmacology centres for pharmacovigilance have been successfully implemented in countries such as France and sweden (37). Pharmacovigilance should be given priority in resource poor settings when implementing population based therapies to control major infectious diseases such as HIV/aIds, malaria and tuberculosis (38).

(f) Continuing medical education. the focus should be on major pharmacotherapeutic areas, on the principles of rUm and on new drug therapies and drug combinations. Interactive models for learning such as integration of e-learning tools in academic drug detailing and open access internet should be considered and will help to improve the quality of knowledge in drug therapy in remote healthcare institutions in resource poor countries. continuing medical education should preferably be interactive as this will foster the best involvement of clinical colleagues.

(g) Therapeutic drug monitoring (TDM) and pharmacogenetic services ideally involve the participation of a division or department of clinical Pharmacology. tdm services should always involve clinical interpretation of the data taking diagnosis, drug-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 (see also chapter 8). an example of successful translation of the scientific development of pharmacogenetics into the clinic is the abacavir hypersensitivity syndrome which now can be prevented (39). moreover, the discipline of personalised medicine is rapidly growing, particularly in the field of cancer.

(h) 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. although the availability of causal treatment with antidotes is limited, a correct diagnosis of the drug involved through drug analysis is important for follow-up and future prevention. 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 (40).

(i) Direct Patient Services. clinical pharmacologists provide care for patients in a variety of ways. In some countries, physician clinical pharmacologists take responsibility for the direct care of patients with particular clinical problems (e.g. intensive care), in patients with particular organ diseases such as hypertension or areas such as paediatrics and geriatrics. In some countries, clinical

pharmacologists are mainly used for their skills in the evaluation of clinical drug problems such as therapeutic polypharmacy. clinical pharmacologists can assist in the development, implementation and evaluation of efficacy and safety of combination therapies in the treatment of major infectious diseases such as HIV⁄aIds, tuberculosis and malaria. In both rich and poor countries, drug abuse problems cause considerable harm (41). Preventive programs as well patient care require access to clinical pharmacological expertise supported by adequate drug analytical resources.

(j) Electronic Pharmacological (e-Pharmaco- logical) Services. evidence-based databases for rational drug prescribing are now available through websites in many countries (42,43). they can be integrated into electronic medical journals and linked to lists of prescribed drugs. e-pharmacological services include tools, knowledge databases on drug recommendations, drug–drug interactions, drugs to be used in pregnant or lactating women, adrs and tools for the solution of drug related problems. e-pharmacological services provide a link between published evidence and clinical practice. these services are predicted to become of particular importance with the accelerating spread of mobile phones and internet access in lesser developed countries and will, in the future, require extension to the public and to patients (24). this multidisciplinary field will be of great importance in resource poor settings where the clinical pharmacological community with a natural global professional network can help to provide electronic drug information from different countries. the contents of e-pharmacological services are heavily dependent on expertise in critical drug evaluation.