Postgraduate pharmacology curriculum in medical institutions in India: time for need-based appraisal and modifications.

The need to revise the curriculum for the postgraduate course (M.D.) in Pharmacology has been perceived by the academicians in India since quite some time. The changing professional requirements of the graduating students, the current scenario vis a vis animal experimentation and the emphasis of the Medical Council of India on a competency based curriculum has triggered this felt need. In spite of the fact that most medical institutions and universities in India offer postgraduate courses in pharmacology, the curriculum lacks uniformity with extreme variations observed at some places. This article attempts to analyze the existing curricula in pharmacology in India and suggest modifications that could be recommended to the suitable regulatory bodies for implementation. A revision of objectives in the three domains of learning, development of skills that help develop suitable competencies, adoption of teaching learning methods in addition to the conventional methods, and a rethink on the assessment methods have been recommended. Development and validation of alternatives skill-based modules in lieu of animal experiments are recommended. Additional skills like medical writing and communication skills, professionalism and ethics, multi and inter-disciplinary integration and collaboration and a wider exposure of students to the pharmaceutical, academic, regulatory and research institutions for onsite learning were also recommended to fulfill their future career requirements.

Introduction

A curriculum comprises of objectives, teaching-learning and assessment methods. The overall organization over three years leading to MD Pharmacology in India is primarily knowledge based; be it the teaching-learning components or the assessment. There are 663 postgraduate admissions for MD Pharmacology per year in 229 medical institutes and 17 admissions for D.M. Clinical Pharmacology in seven institutes in India; the numbers may have increased as you read this.[1] The curriculum of postgraduate (PG) education in pharmacology in medical institutes in India is based on broad goals of the Medical Council of India (MCI) mentioned in the Postgraduate Medical Education Regulations, 2000, amended up to May, 2013.[2] The MCI has defined broader guidelines applicable to all PG courses. The postgraduate curriculum shall be competency based including theoretical knowledge; practical and clinical skills, thesis skills, attitudes including communication skills and training in research methodology. Further, “every institution undertaking a PG training program shall set up an Academic cell or a Curriculum Committee, under the chairmanship of a senior faculty member, which shall work out the details of the training program in each specialty in consultation with other faculty and also coordinate and monitor the implementation of these training programs”.[2] These broader guidelines recommend that the curriculum should be competency based and describe the expected levels of competencies in general terms. However, in the absence of clearly defined objectives, non-uniformity exists in curricula across institutions in India.

The plenary discussion held at the Annual Conference of the Indian Pharmacological Society Conference at Bangalore (2013) provided an opportunity to bring together an eclectic mix of academicians of varying seniority and regions from all over India and dwell and deliberate on the postgraduate curriculum in pharmacology. The need for modifying the curricula based on contemporary needs, challenges faced and strategies to overcome these challenges were discussed. Following is a summary of the deliberations during the panel discussion.

Existing Curricula

Currently, a standard uniform curriculum for the M.D. and D.M. Pharmacology does not exist at the national level. Some are contemporary, others archaic.[3] In a typical medical college there is a predominant component of teaching and research related activities based on a “curriculum” (that mostly includes a dissertation, a few animal and paper based experiments, hospital visits for pharmacovigilance and related activities, seminars, lectures and journal club) as well as activities related to day to day management of undergraduate (UG) courses. Few universities have framed their curriculum for MD Pharmacology. Some begin and abruptly end with the mention of objectives alone while others describe a long and meticulous list of “topics.” Most curricula mention an exhaustive list of objectives and skills, many of which are not relevant in the present day context, and hence not implemented in totality.[45678] In order to overcome these lacunae, certain institutions have devised their own innovative teaching and evaluation methods. Individually these innovations as well as curricula are excellent examples of improvisations. These innovations vary from use of paper-based exercises, real patients to use of simulation, computer assisted learning and mannequins. However, most of these emphasize on the traditional approach of knowledge based learning and not on the acquisition of skills and the requisite levels of competency. None addresse the affective domain to the extent that they should. Hence, the basic objectives of postgraduate training are not adequately addressed. The manner in which these curricula are framed and implemented thus leave much to be desired.

Taking a holistic view of the simple model of curriculum [Figure 1] and considering the above stated facts, there is an urgent need to revise the objectives; include innovative and relevant teaching-learning methods and revise the assessment methods.

Figure 1

Components of the curriculum

The scope of the curriculum must include the expanding horizons of the pharmacologist's future role and expectations by others. The demand of trained workforce in pharmacology has witnessed an increase, due to the rise in a number of medical colleges as well as increased demands in the industry.[9] However, due to a reduced faculty requirement by the MCI in medical institutes and the recent slump in the number of clinical trials, this dynamics of demand and supply has changed lately.[10] The career prospects of a postgraduate student in pharmacology are varied, from being an academician to an employee in the pharmaceutical industry, contract research organization, regulatory bodies, and research institutions.[11] Some are also self-employed. However, more often than not students lament a dichotomy between what is taught in the postgraduate course and the actual “demands” of a job. This fact reiterates the need to modify the curriculum toward this outcome too. The postgraduate course must, therefore, prepare the student for the academia and the industry.

The cognitive domain predominates in the existing curricula. Major challenges are envisaged in ensuring that the skills and affective domains are emphasized. It is necessary to frame objectives in cognitive (knowledge), psychomotor (skills) and affective (attitude, behavior etc.) domains. The teaching and assessment methods should be suitably modified. For example, acquisition of clinical skills requires that relevant clinical exercises/scenarios be included. Similarly, ethical considerations in research and informed consent are more effectively taught through case scenarios and role play. An emphasis on skills acquisition means introduction of assessment methods like objectively structured practical examination (OSPE) and MiniCEX, to complement the conventional methods.

The sentiments as well as scientific logic given for and against animal experiments are a never-ending issue to the extent that at present this is the most important single issue which has vexed the postgraduate curriculum. In the absence of clear guidelines on whether and to what extent can and should the animal experiments be continued, confusion prevails.[12] A cautious approach towards animal experimentation owing to the recent restrictions has seen some unwelcome consequences. Acquisition of skills in animal experimentation have been reduced to paper-based exercises in many institutions. In the absence of adequate faculty orientation, these paper-based exercises, usually test knowledge, rather than analytical and decision-making skills. Hence, the postgraduate students do not acquire the skills mentioned in the long list of “must do’s” in experimental pharmacology. In many institutes where skills training are imparted, “training” happens just prior to the examination time for want of availability of animals and other difficulties faced in conducting animal experiments. Conduct and performance in the “must do” exercises like the bioassay and certain in vivo experiments is perfunctory, with questions being raised about the actual learning, their value and relevance to the student's career in academics or the industry. While “to do” or “not to do” animal experiments are a major debate, alternative methods of teaching and evaluation are being developed by various instituions. Most departments are not equipped for alternatives to animal experiments. Further, the alternatives where available are also varied and not standardized or validated for their educational value.[13] It is important though that the debate and uncertainty about animal experiments be cleared, and a few questions urgently answered. Which guidelines should be followed (of MCI or CPCSEA)? What is the legal stand on the issue of animal use for teaching and evaluation? Do we really need to teach through animal experiments? Do we have suitable validated alternatives to replace animal experiments and will all institutions be able to adapt them?

In the existing curricula, while due weightage is given to internal assessment in UG courses, this is not the case in postgraduate courses. Most colleges have devised their own systems of assessment of students and do maintain a log book. More often than not, a continuous assessment is lacking or not given adequate weightage during summative assessment.

Suggested Modifications

Objectives

The objectives in the current curricula are ill-defined. They list many animal experiments and a few human experiments. In one such curriculum, clinical pharmacology lists two experiments; dosage calculations and training at a poison center.[45678] The suggestions emphasized modification of objectives. Well-defined objectives in three domains of learning, pertinent to changing roles of pharmacologists, addition of clinically relevant objectives and minimization of animal experiments were suggested. Addition of training in management, counseling, and basic regulatory affairs were suggested. Table 1 summarizes the list of objectives for MD pharmacology, compiled from various curricula and suggested modifications.[45678]

Table 1

Objectives mentioned in existing postgraduate (MD) curricula of Pharmacology and suggested modifications

The practical curriculum in particular requires a major overhaul. A near unanimous outcome of the discussion was a recommendation to make the practical curriculum clinically oriented and relevant to the contemporary needs while preserving the emphasis on basic concepts in pharmacology. Currently, most curricula list numerous animal experiments and very few human based/clinical based exercises. However, some of these are rarely performed except bioassay, effect of drugs on rat blood pressure and few in vivo experiments. Experiments on human volunteers need to be undertaken with care considering the recent changes in compensation rules and the ethical dilemma concerning use of students as volunteers (coercion). Based on the suggestions received and inquiries made by the panelists in certain institutions, one or more of the following experiments have been implemented in different institutions (the list is not exhaustive):

Biochemical Pharmacology including identification of drug/toxin using chemical and biological tests

Quantitative estimation-Use of colorimeter, spectrophotometer and/or other analytical procedures

Computer based alternatives for animal experiments

Preparation of a clinical trial protocol

Preparation and administration of informed consent in human experiments

Clinical case and prescription audit

Interpretation of PK PD data

ADR reporting, data management, analysis and causality assessment

Applied biostatistics as relevant to basic and clinical research

Preparation of Essential Medicines List

Choosing a P drug for a defined disease

Critical review of a published paper

Demonstration of the effect of certain drugs on human volunteers

Critical analysis of drug products and sources of drug information

Pharmacoeconomic analysis of therapy

Teaching and presentation skills

Performing literature search from suitable sources

In vitro experiments (including bioassays)

In vivo experiments and evaluation of preclinical toxicity data.

Teaching Methods and Media

Existing curricula list conventional teaching methods such as lectures, practical classes, etc. However, few emphasize innovative methods like case-based learning, problem-based learning, One min preceptor, interactive teaching techniques, project work, etc. The variations in existing curricula in the teaching-learning methods are many. Some curricula mention “basic principles of statistics” while others mention application of statistics to various research studies. Since objectives drive T-L methods, clarity of the level of competency desired for each skill must be well defined. Surprisingly, some curricula yet advocate skills in animal experiments using frogs, which is an endangered species in India and its use is punishable under law! Some of these curricula do a mention use of alternative computer-based models to replace animal use, but the mention is pefunctionary. A few curricula also mention visit to a CRO or the industry or research organizations for on-site training/awareness in BA– BE studies and clinical trial management.[45678] The MCI emphasizes integrated teaching, which is currently lacking in UG and PG curricula in most medical schools of India. Integrated teaching methods can be adopted in postgraduate teaching as well. It is noteworthy that the integration be interdisciplinary too with collaborations with the pharmaceutical industry, nursing, pharmacy and management institutions. This favors development of multivariate expertise with inputs from experts in the respective fields. Considering the emphasis on rational therapeutics, pharmacovigilance and community-based education, such collaborations become more meaningful. Collaboration with these institutions for onsite training, rotational postings and provision of electives are some measures to overcome the logistic difficulties that may be encountered in implementing these. A major shift in the way teaching-learning materials and methods are being used PG training is envisaged. Patient centric teaching like bedside teaching, management of adverse drug reactions (monitoring, reporting, feedback and communications with prescribers), case studies, rational therapeutics; clinical services including a proactive role in clinical rounds, pharmacy management (including drug inventory), hospital infections control management, hospital formulary management, drug and poison information centers, therapeutic drug monitoring, patient counseling in ADR management, drug interactions and treatment compliance are some areas where a postgraduate trainee needs to acquire the relevant skills. T-L methods should also emphasize on pharmacoeconomics, encouraging good prescribing practices and detecting and preventing medication errors, problem-based exercises, basic resuscitation skills, skills in handling and drug interactions common medical emergencies, palliative and geriatric care, skills training suitable for pharmaceutical industry, training in regulatory bodies and national research institutes. The existing methods and suggested modifications in T-L methods are enumerated in Table 2.

Table 2

Existing teaching-learning methods in postgraduate (MD) curricula in pharmacology and suggested modifications

Assessment

Although it is an accepted fact that assessment drives learning, it is a neglected area, both in UG and PG curriculum. It is too varied and not standardized. Few institutes do conduct continuous internal assessment in PG courses while in most other institutes the students are assessed at the final examinations alone. Even in institutes where regular internal assessment is carried out, there is no provision for its inclusion in the final examination. Final examination is based more on the general impression of the student and performance on the day of examination, rather than on an objective competency based assessment giving an impression that the MD degree is “awarded by teachers” and not “earned by students.” It is said that assessment drives are learning. Hence in the absence of well-defined objectives and assessment plan, the students and teachers remain confused about what is expected from them.

The theory examination also has a scope for improvement. The format, paper wise division of topics and the preferred choice of type of question (essay or SAQ) vary among universities. While some flexibility in these areas is desirable, errors like duplication of questions, imbalanced questions, questions on which very little information is available or choosing too many questions from “may know areas” can be avoided. It is generally implied that “rare” topics are a norm in postgradaute exams and “anything under the sky can be asked.” The belief belies any logic of good teaching and evaluation practices. Similarly, in skill based examination, the “long experiment” (previously carried out in large animals) is mostly paper-based or carried out using rats at some centers. The short “paper-based” also exercises end up evaluating the knowledge rather than analytical and reasoning skills, in the absence of proper construction and adequate validation of these exercises. Surprisingly most curricula mention “microteaching” as a way of assessing teaching skills, when it is a well-known fact that microteaching is a. which can be used to improve a components of teaching/presentation in a non-threatening environment and is a voluntary process.[14] Table 3 mentions the existing assessment and the suggested modifications.

Table 3

Existing assessment methods in postgraduate (MD) pharmacology curriculum and suggested modifications

Strategies to Overcome above Challenges

The plenary group also discussed the strategies to meet the potential challenges of implementing these modifications, given the heterogeneous nature of institutions across the nation in terms of infrastructure, availability of qualified and competent faculty and other resources. The overall strategy is to refine this proposal further based on readers’ comments and suggestions and submit these recommendations to the MCI to frame a uniform standard curriculum for MD pharmacology, which is flexible enough to allow for regional variations. Furthermore, centers, or faculty who have developed and validated innovative teaching or assessment modules are invited to share these with the Indian Pharmacological Society. A common platform like a website for comments, refinement and adaptation by other centers, was proposed. This common platform can function as a peer-reviewed clearing house of the society. Pilot tested methods will be published on the website and journal of the society after a peer review. A revision of the list of requirements of infrastructure and equipments for establishment and recognition of M.D. course by the M.C.I. which was realistic and in tandem with the contemporary curriculum has also been proposed. We hope that these measures will help bridge the gap between the exisitng curriculum and the perceived needs of the academia.