Curriculum for pharmacology in pharmacy institutions in India: Opportunities and challenges

Abstract

The curriculum of pharmacy institutions in India is regulated by the All India Council for Technical Education (AICTE) and the Pharmacy Council of India (PCI) at degree and diploma levels. However, it has been over two decades that the syllabi have been revised by these regulatory agencies. Considering the dynamic character of pharmacology, it is essential to prepare a syllabus that caters to the contemporary needs of the academic institutions and pharmaceutical industry, the community. Pharmacists are also witnessing a greater role in community pharmacy practice as well as in several healthcare sectors. Considering these facts, a panel discussion was held at IPSCON 2013, (the Annual Conference of Indian Pharmacological Society) at Bangalore. The discussion saw several recommendations for syllabi for institutions offering various pharmacy courses to meet the objectives of teaching, learning and research in Pharmacology. This article documents a summary of the discussion. For B. Pharm. course, a balance between industry-oriented pharmacology and clinical pharmacy has been recommended. Redundant animal experiments should be replaced with the simulation experiments or those which are feasible in the light of stringent regulations of the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA). It is recommended that the M. Pharm curriculum should focus on preclinical research with the inclusion of molecular biology and experiments on gene expression, proteomics, pharmacogenomics, cell culture and tissue culture. In general, at all levels, exposure of students to hospitals and clinicians is needed. Pharm. D., syllabus too should lay lesser emphasis on experimental pharmacology. Present experiments in the D. Pharm. course have no relevance to the program objectives and hence, only experiments through demonstrations or simulated preparations or interactive videos maybe undertaken. Regulatory bodies as well as universities should design a comprehensive syllabus and plan an effective pedagogy to prepare graduates who are competent and capable of bringing positive changes in the community and healthcare in India.

Introduction

Pharmacology is taught to the students of medicine, pharmacy, nursing, dentistry, veterinary, and even to basic sciences. Pharmacy institutions have multiple roles to play like development of newer and safer drugs, development of novel formulations that ensure better patient compliance. They also educate the community about safe and optimal use of medicines. The curriculum of pharmacy institutions in India is regulated by the All India Council for Technical Education[1] (AICTE) and the Pharmacy Council of India[2] (PCI) at degree and diploma levels, respectively. Pharmacy education in India is traditional and has been industry and product oriented. To practice as a community or clinical pharmacist in India, one needs at least a diploma in pharmacy, which is awarded after two years of study and three months of practical training.[3,4]

In most of the universities in India, D. Pharm. syllabus contains one year for pharmacology; B. Pharm. syllabus contains two years or four semesters for Pharmacology and in case of M. Pharm., pharmacology is exclusively taught for one year or two semesters followed by one year of thesis work. In 2008, Pharm. D. regulations came in to force after publication of the official Gazette. Regulations were framed under Section 10 of the Pharmacy Act, 1948 (8 of 1948).[5] The syllabus has not been extensively revised by the regulatory agencies since then. For M. Pharm, the respective universities formulate the curriculum. No specific guidelines are issued by any of the regulatory agencies like AICTE, PCI or UGC (University Grants Commission), although, attempts have been made by the AICTE to provide uniform syllabuses. This has however not been possible so far. There have been several issues with respect to the trends in pharmacy education in India.[6] The question therefore, arises as to why we need a change in syllabus in pharmacology? The change is not an option, but a necessity. With the initiative of Indian Pharmacological Society, an extensive brain storming was carried out at IPSCON 2013 to formulate recommendations for a curriculum that may serve as a guide to any institution or university to meet the objectives of teaching, learning and research in Pharmacology. This paper documents these recommendations. An attempt has been made to describe the need and challenges foreseen for revision of syllabus in pharmacology at pharmacy institutions. Certain changes are required for model syllabus for different courses have been recommended.

The Need for Change in Pharmacology Syllabus

One of the characteristics of pharmacology is its dynamic nature that requires integration of knowledge from several basic and medical sciences. Previously known as ‘Materia Medica’ in the nineteenth century, pharmacology has witnessed many advances since it emergence as a subject.[7] In the twentieth century pharmacology has witnessed four revolutions: Chemical revolution (1900-1940s, beginning with the discovery of the chemical compounds isolated from plants and animal sources to the discovery of antibiotics); Biological revolution (1930s-1960s with the understanding of drug receptor interactions and biochemical basis of diseases and mechanism of action of drugs); Molecular Revolution (1970s-2000s with the understanding of signal transduction mechanisms, cascade of molecules involved in the action of drugs and realization of several drug targets); and finally the Genetic revolution (2000 onwards with the appreciation of the significance of genetic and genomic basis of pathophysiology of diseases and its likelihood of being drug targets). The current century may witness either the fruits of all these revolutions or may see another revolution taking shape that may include bioinformatics and nanotechnology. Thus pharmacology as a subject requires adequate knowledge from cellular to molecular levels of tissue and organs to appreciate the principles of physiology and pathology, necessary for development of safe and effective medicines. It goes beyond post-marketing and monitoring of medicines. A sound knowledge of nanotechnology, biotechnology, bioinformatics, drug metabolism and pharamcokinetic studies, Clinical Pharmacology, newer diagnostics methods and medical devices are needed. Pharmacology has always been borrowing freely from various disciplines and requires integrative biosciences. In the era of ‘information explosion’ where there is free access to information, the generic skills and attitudes of professionalism and sustainability are increasingly required.

Not just the content, the teaching tools have also changed in last couple of years. Lectures are now interactive with a generous use of tools like powerpoint, animations and other audiovisual aids. Practicals in laboratories now require the usual generic skills along with a knowledge of cell culture and informatics. Stimulation of animal preparations and laboratory situations (in vivo and in vitro experiments) are available. Problem/case scenario based discussions that are resource intensive and self/peer directed are used in tutorials. Wide spread application of audio visual technology including video conferencing, simulations, the internet, virtual labs and lectures, virtual teacher, distance learning, mobile phones, blended learning, virtual learning environment/mobile learning Engine, blogs, podcasts, clickers are now being used by the students. Peer and differential teaching and learning, self-directed learning, independent learning, scenario-based teaching, integrated medical course and inter-professional teaching have changed the way of conventional teaching that has been carried out till date.

The requirements or employment opportunities for the graduating students are also changing. Besides, drug discovery research and development, competence, know-how and enthusiasm are required for meeting the challenges of health care, clinical research and clinical trials. In the early years, pharmacologists from pharmacy background were usually employed for research and development laboratories. During the late 1980s, the trend shifted towards product management and later with the emergence of opportunities in clinical trials and clinical research, especially in India. Employment of pharmacologists has increased particularly in the areas related to clinical research divisions. A pharmacologist from Pharmacy College may be expected to have a sound understanding of regulatory affairs. Patients’ expectations have also changed. Today the patients expect more scientific communication about their ailment and medicines they consume. They are known to educate themselves through internet and similar sources.

A teacher in pharmacology is now expected to be actively involved in research, which is globally collaborative, grant supported, interdisciplinary, measured and competitive. Teachers must exhibit administration skills for leadership and entrepreneurial activity with adequate knowhow in intellectual property rights, exploitation of ideas and commercialization abilities.

In light of above facts, it is suggested that the syllabi be revised to meet the following objectives:

• Ensure that students are trained to acquire the knowledge, skills and attitude (including professional and personal ethics) as required for their professional careers

• Address the contemporary learning needs of the students

• Generate income and meet employer's needs in the ever changing and dynamic environment of employment

• Enable sound research to be carried out and attract research funding

• Meet the requirements of regulatory authorities.

SWOT Analysis of the Current Syllabus in Pharmacology

A SWOT analysis of the current syllabus of pharmacology in pharmacy institutions can be described as follows:

Strengths

The existing curriculum is extensive in its coverage from general pharmacology to systemic pharmacology; all topics being discussed thoroughly and in-depth. Drugs in each category are also discussed. Mechanism of action of drugs in every category is emphasized. The emphasis is on preclinical studies. Structure-Activity-Relationship (SAR) in each category of drugs with their mode of mechanisms of actions is discussed preferably under Medicinal Chemistry.

Weaknesses

The curriculum is not based on precise objectives defined as per the ambit of the character of B. Pharm. course. The purpose of pharmacology subject in pharmacy curriculum appears to deal with information related to drug action in human body. There is always a dilemma whether the profession of pharmacy should be oriented towards needs of pharmaceutical industries or needs of the patients in hospital (Clinical Pharmacy) or drug stores (Community Pharmacy).

While the subjects like anatomy, physiology and health education (APHE) are taught in the first or second year of B. Pharm., the subject of pharmacology, at many institutions it is not taught subsequent to the training in APHE in next two years. Further, the logical linkage of physiology to pathophysiology is not interfaced with medicine and pharmacotherapy and the special emphasis to pathology of diseases in teaching learning process is not given.

The curriculum in pharmacy institutions is relatively less clinically oriented. Earlier, practicals involving animal studies were adequate in the curriculum. However, due to regulatory pressures, and their mandates that animal should not be sacrificed for the purpose of training, most of the practical content is now in the form of demonstrations alone. As a result, except in the curriculum of Pharm. D., students neither acquire any additional skills nor have orientation about clinical relevance of the medicines.

Opportunities

Since the number of drugs, either alone or in combination, has increased tremendously, it is not humanly possible for any clinician to remember adverse drug reactions, dosages, drug-drug or drug-food interactions, as well as drug-additive/container interactions. Databases for such information in a computerized form are available. Such information, on demand, can be more appropriately provided by pharmacists. Pharmacists may play the role of “drug educator” to the patients, especially for chronic diseases.

Development of appropriate software with an interface with clinical responsibilities is another emerging opportunity. Pharmacists have opportunity to develop database for patients to help physicians. Opportunities also exist in the medical department of pharmaceutical industries, especially in clinical trials wherein, extensive and accurate documentation are required like for example (protocol design, pharmacovigilance, data-management and bio-statistics).

Threats

One of the major threats is competition that professionals in pharmacy face from various other allied professionals including software engineers and professionals from other systems of medicine like Ayurveda and Homeopathy.

Clinical Pharmacology

Pharmacists need to learn to interact effectively with patients. It is essential to develop necessary communication skills and empathy towards patients’ needs. Knowledge of detailed case history, both of the disease and the drugs coupled with effective communication skills can help pharmacist to complement the healthcare team in patient care.[8]

Counselling of patients on diet, drugs and lifestyle in a sustained manner is needed for increasing the effectiveness of pharmacotherapy as well as for rehabilitation. Pharmacists with adequate knowledge and training in clinical pharmacology can help in improving the confidence of the patients in the community. At D. Pharm. level, drug-drug interactions and toxicology must be included in the syllabus of Pharmacology. Clinical pharmacology for B. Pharm. students must include patient oriented problem solving skills, in form of illustrated cases. This should be more rigorous to the students of Pharm. D. students must be taught about various treatment strategies for special populations like pediatrics, geriatrics and pregnancy along with special emphasis on pharmacokinetic and pharmacodynamics changes in such special situations. Age-associated diseases like cardiovascular disorders, cancer, arthritis, cataract, osteoporosis, type-2 diabetes, hypertension and Alzheimer's disease should also be given special attention. A similar emphasis must be made for common childhood diseases like malnutrition, diarrhea, respiratory infections, chickenpox (Varicella zoster), whooping cough, in the syllabus.

Pharmacists should also be responsible partners in the documentation of clinical trials. They can also be involved in Dossier preparation for new drug applications (NDAs).[9,10] Inclusion of ICH-Good Clinical Practice (GCP) guidelines, Schedule Y, and clinical trial protocol is the need of the hour. At postgraduate and doctoral levels, research efforts should also be directed to highly prevalent diseases of Indian origin, tropical diseases evaluation and biological standardization of medicinal plants for treatment of these pharmacovigilance, preparation of Essential Medicines Lists. These areas of research are often neglected, since these do not usually find willing sponsors.

Besides lecture and practical modes of teaching, it is desirable to have a problem based learning.[11] Case history, the clinical presentation, earlier and current pharmacotherapy, possible effects of these drugs on the outcome of disease should be discussed in detail. Students must be trained to understanding and respond to clinical queries that may arise from clinicians. Web-based learning may complement the traditional literature search methods here.[12]

At M. Pharm. level, therapeutic drug monitoring (TDM) of selected drugs, techniques of analytical estimation of drugs, interpretation of TDM, information on timing of taking sample should be provided to pharmacists. At all levels, from clinical pharmacy point of view, hospital exposure of students to patients for a better understanding on interactions of drugs, adverse reactions to drugs needs to be promoted. Information on personalized medicine based on genomic variation in patients should be included. The clinical impact of human genome on treatment of certain diseases should be included.

Experimental Pharmacology

The objective of the experiments in pharmacology is to develop skills for performing in-vitro and in-vivo pharmacological experiments; and correlate the findings to theoretical concepts. The student should be able to apply the skills in the profession of Pharmacy and work efficiently in the industry. Currently in pharmacy institutions, in-vitro experiments include usage of tissues and organs of experimental animals viz., rodents, rabbits and guinea pigs. Recently, there is a decline in the in-vivo experimentation.[13] The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) under ‘The Prevention to Cruelty to Animals Act 59 of 1960’ guides research on animal experiments. Their role has been exemplary in recent years in revolutionizing animal research in the country.[14] The UGC issued the directive that the animal experimentation should be stopped in a phase-wise manner at undergraduate level.[15]

In light of these directives, it is recommended that redundant animal experiments for students may be deleted. More emphasis must be given towards improvement of software-handling skills and use of simulated experimental models, although, there are limitations for the computer simulation experiments.[16] It is also recommended that the associations like Indian Pharmacological Society and Associations of Physicians and Pharmacologists should generate a consensus and evolve a balanced view to sort this impasse.[17]

In D. Pharm program since the present experiments have no relevance to the program with there should be ‘problem-solving exercises’ on drug information, drug interactions and evidence-based medicine. At B. Pharm level program experiments on frog rectus muscle preparation can be replaced with chick ileum, where ever possible. There should be reduction in the number of in-vivo experiments. Live demonstrations could be alternatives to various screening procedures on animals. Data analysis exercises may be emphasized during practical exercises.

For M. Pharm. course, use of otherwise of animal experiments should be considered more carefully. There has to be an ideal mix of in-vitro and in-vivo methods. Experiments must be designed more for new drug discovery and a few experiments on biological and chemical assays be allowed. Exercises involving data analysis, presentation and interpretation on toxicity and efficacy studies be included. Experiments on cell culture, gene expression, proteomics, pharmacogenomics also need to be included. M. Pharm. with specialization in clinical pharmacy should include exercises on clinical trial experiments, protocol design, pharmacokinetic-pharmacodynamic modeling and pharmacoeconomics.

Prior to the commencement of the M. Pharm. project work, the students should be exposed to Good Laboratory Practices, Ethical and safety issues and plagiarism. While the students should be encouraged to carry out research in their parent institute, they should take the help of specialized laboratories at different universities/institutes for instrumental support, if necessary.

Syllabus with Integrated Teaching

At B. Pharm. level a student has to take about 40-50 papers spread in over 15 subjects and in at least 5 disciplines. Under the department of pharmacology in a pharmacy school, subjects like Human Anatomy and Physiology, Health Education, Community Pharmacy, Pathophysiology, Hospital Pharmacy, Clinical Pharmacy are taught in addition to pharmacology and pharmacotherapeutics. It is desirable that the sequence of subjects being taught during the 8 semester curriculum in B. Pharm program should be such that there is an integration at all levels, to so as allow the student to understand the subject better.[18] In the initial stage it essential to teach the basics of Anatomy and Physiology. This should be followed by pathophysiology. In pharmacology, General Pharmacology and autonomic pharmacology with autacoids should be taught first before starting systemic pharmacology for various diseases. Chemotherapy should be taught in the semester when Microbiology is taught. Similarly, medicinal chemistry may be associated with pharmacology topics to correlate the structure activity relationship being taught at both places. Hospital pharmacy and Clinical pharmacy maybe taught together. Clinical pharmacy can be taught towards the end. Alternatively, for each system, pathophysiology, pharmacology and pharmacotherapeutics can be taught at the same time in an integrated manner.

Conclusions

The subject of pharmacology, because of its dynamic nature, requires integration of knowledge from several basic and medical sciences. The practice of pharmacy profession in India is more industry and product based, whereas in developed countries it is clinical pharmacy based. For clinical pharmacy, at all levels, exposure of students to patients and a greater interaction within clinicians and other healthcare providers is necessary for a better understanding of efficacy, interactions and adverse reactions to drugs. Interaction with clinicians, patient counseling and effective communication and documentation skills need to be promoted. Redundant animal experiments should be minimized or deleted, in the best interests of animal care, and replaced with simulation experiments, wherever feasible.