Ten strategic reforms required in higher education system of our state

Our higher educational system has not gone through substantial reforms and changes vis-à-vis curriculum innovation over the past several years. We continue to offer same post-graduate programmes in Science, Arts, Commerce, Social Science and Education faculties since decades with little innovations although their internal review and updation is carried out from time to time. Consequently our curriculum is lacking in dynamism and flexibility and we are failing to offer new programmes in tune with changing times and global trends. On the contrary, multidisciplinary campuses of private universities that are coming up across India are offering most innovative and modern courses to students and we are terribly lagging behind in keeping pace with them. Rigidity and paralysis of our course curriculum, improper selection, organization, implementation and evaluation of curriculum content and the irrelevance of curriculum to the needs of our society are some of the problems associated with our higher education system. For any meaningful advancement to be made in our education system a mid and long-term strategic orientation of our curriculum needs to be undertaken and some time-bound goals need to be fixed to achieve the desired results.

A core committee of experts from diverse fields needs to be framed that will undertake the responsibility of identification, design, restructuring and renovation of our curriculum offered at college and university level in a manner to make our courses learner-centered, problem-based and research-driven. Curriculum renovation that is realistic and student-centered, that is quick in rejuvenating and revitalizing hope and passion for acquisition of broad-based knowledge that is worthwhile in a learner should be the focus of our higher education structure. Methodology that will aid self discovery and problem-solving ability which allows learners the opportunity for creativity should be entrenched in our curriculum. Quality and relevance are the two main features that curriculum development in our University system needs at present. At the same time changes and innovations of our higher education system must involve the emergence of elastic curricula models and educational policies which emphasize interdisciplinary courses, open-ended systems, inter-generational and inter-professional relationships and sustainability.

A ten-point proposal for the strategic reforms in our higher education system calling for a complete paradigm shift is presented as under:

INNOVATION AND DIVERSIFICATION

Lack of initiative, innovation, skills, independent constructive mindset and creative ideals characterize today’s system of our higher education. We need to shift from a system that encourages memorization in learning processes and theoretical explanation to areas that need practical illustration. Our present system favours cognitive development above other domains of education. Therefore need of the hour is to keep pace with brisk technological advancements in teaching learning process. We should not lag behind in adopting the latest technology in every sphere of our education system, be it in teaching, devising syllabi, evaluation methods, certification and automation. The role of a teacher in our education should change from knowledge disseminator to knowledge creator. At University level as well as college level, innovation and greater diversification of our subjects is the need of the hour. For ages same courses are being offered by our colleges and universities with little scope for newer specializations and upcoming programmes. Therefore we need to offer more specializations in all existing subjects and faculties and introduce new subjects wherever not available at present, so that a broader choice is made available to the students and they emerge as specialists in one specific area rather than ending up being generalists.

There is need to start new courses like industrial production, biomedical technology, nanotechnology, fashion technology, microprocessor technology, embedded systems, nuclear science technology, hotel management, microbiology, polymer chemistry, textile chemistry, hydro-chemistry, petrochemistry, electro-chemistry, chemistry of natural products, astrophysics, geophysics, nuclear physics, optical physics, particle physics, economic botany, phytochemistry, phytomedicine, phytopathology, entomology, paleontology, rural and urban management, hospital management, investment management, education management, enterprise management, entrepreneurship development, business law, e-commerce, corporate tax planning, consumer protection, rural finance and credit, advertising, international business, agricultural marketing, genetics, microbiology, cell biology, molecular biology, biophysics and structural biology, immunology, biostatistics, radiation biology, virology, privatization and deregulation, environmental economics, political economy, public policy and regulation, resource economics, visual communications, travel and tourism, interior design etc to name a few.

MODERNIZATION AND AUGMENTATION

There is need to modify conventional teaching methodologies and introduce recent advances in technology into the teaching-learning process.  We must switch over from chalk and talk to more interactive modes of teaching and learning by making use of audio-visual aids, e-contents, databases, e-learning objects etc. Adequate infrastructure, faculty, staff, funds and other facilities should also be made available to all university teaching departments and other affiliated higher educational institutions. Faculty strength of our educational institutions has to be augmented in order to face the challenges of globalization. Adhocism and contractualism in higher education that has led to mediocrity should be abolished. Prior to opening up of new colleges and new university campuses, adequate infrastructure, faculty and other facilities should be made available. Diversion of faculty from old to new institutions or from main to satellite campuses must be done away with.

INTEGRATION AND INTERACTION

Integrated efforts should be made by all stake holders in converting our higher educational institutes into the centres of knowledge and excellence. All players should contribute their bit in enhancing knowledge capital of our youth and building a knowledge based society. There is need for greater integration, collaboration and better coordination between primary, secondary, higher secondary and university level education in the state and to have a supervisory council with advisory status for integration of these three units. Academia-industry and academia-society interactions must be enhanced at all levels. There should be greater autonomy to institutions of higher learning. Concept of autonomous colleges needs to be seriously considered.

EXTENSION AND APPLICATION

Knowledge Commission report aims at increasing the number of Universities across India to 1500 from the present 378 so that the gross enrolment ratio increases to 15% from the current level of 11% by the year 2015. We need to augment residential facilities available to students as well as teachers at district, sub-district and block level. Extended library facilities should be made available beyond normal working hours in all degree colleges. In view of limited intake capacity in colleges and universities, distance mode of education should be fostered and expanded to enhance accessibility to education. Quality of research work has to be drastically improved. Research work has to be made more applied, socially relevant and productive.

ASSESSMENT AND ACCREDITATION

Objectives of higher education should be properly defined and total quality management procedures adopted in teaching, research and extension at the institutions of higher education. A teacher must be evaluated not only for his teaching but also for his research and extension activities. Regular assessment of teachers should be carried out through students. Carry out regular review and reforms of conventional examination and evaluation patterns. Not only academic but non-scholastic aspects of the learners’ personality should also be assessed. Assessment of all educational institutes by NAAC, NAB etc should be made mandatory and financial support should be provided in accordance with the ranks obtained therein. All university departments and affiliated institutions offering technical courses must offer courses duly approved by AICTE and other relevant Councils like MCI, PCI, Nursing Council of India etc.

INCENTIVIZATION AND HARMONIZATION

Creative skills and competitive spirits of the students of university education should be encouraged in order to make them accomplished achievers rather than passive knowledge-seekers. In order to make our students better citizens, value based education for inculcating ethics and morality among them needs to be reinforced. Link education with livelihood and make it job-oriented. Professional and vocational education should be fostered and employability promoted to alleviate skill-deprivation among students. There has to be better harmonization between student-teacher and teacher-society relationships. Our academia must remain sensitive to the problems in the society.

PARTNERSHIP AND PRIVATIZATION

Role played by private players in renovation and modernization of our education and skill-upgradation of our youth cannot be denied by anyone. However partnership should be the key to development rather than complete privatization of the education sector. Privatization of education should be allowed in a controlled fashion and subject to a strict regulatory mechanism under the aegis of a regulatory authority or higher education council. Initiatives of private players may however be encouraged wherever required with proper enforcement of regulations. Partnership with industry must also be fostered in as many disciplines as possible.

TRANSPARENCY AND ACCOUNTABILITY

In order to elevate accountability in the system, implement reports and recommendations of various expert committees and statutory bodies like UGC, AICTE, higher education dept. etc. Alongside providing better perks and remuneration to teachers, they should be made more accountable. Transparency in educational institutions should be increased and teachers should have a greater realization of their responsibilities towards the society. Recruitment and transfer procedures and policies in educational institutions should also be made more transparent. Admission policy in colleges and universities needs to be streamlined and made fool-proof. Political interference in academic matters like admissions, appointments, promotions, transfers etc has to be got rid of. There should be a provision for incentives for better performance so that right kind of talent gets nurtured and commitment to work gets duly appreciated.

PLANNING AND IMPLEMENTATION

Prior to opening up of new colleges, adequate infrastructure, faculty and other facilities need to be made available. Haphazard and unplanned expansion of higher educational institutes has to be halted. Promulgate a new robust and comprehensive state education policy. Disparities between state and central policies need have to be removed. Bridge the gap between academia and policy-makers and frame policies after mutual consultation with academia. There should be equitable participation and involvement of academicians in framing policies related to higher education. Policies once framed must be properly implemented and there must be continuous monitoring and regular review of all policies apart from an annual external audit by some independent agency.

ORIENTATION AND CONSOLIDATION

All these structural and functional changes notwithstanding, to start with, we need to address gross academic issues like admissions, syllabi, coordination, faculty strength, teacher training, research etc effectively. Regular review and updation of syllabi as well as reforms in evaluation/examination patterns should be carried out by all educational institutes. Curriculum developers should also adopt the interdisciplinary approach to curriculum. Training and placement of pass-outs should be made an integral part of higher education besides conducting orientation programmes, refresher courses, methodology workshops and QIPs for teachers on regular basis. We also need to diversify our education by making more subject combinations available. Orientation of students towards professional subjects needs to be done at an earlier stage so as to provide greater avenues for employment and foster their inherent capabilities in one particular stream rather than making them study all kinds of subjects irrespective of their personal interests and inclinations.

CHANGES SUGGESTED BY CSF ACCEPTED FOR INCLUSION IN DRAFT DRUG POLICY OF J&K

           
CHANGES SUGGESTED BY CIVIL SOCIETY FORUM ARE GIVEN IN RED:

            To provide cost-effective and efficient procurement and supply management system for drugs. (ACCEPTED)

Although, there may be about 20,000 medicines/ combinations available in the market, with about 300 drugs recommended by the World Health Organization and 348 drugs in the National List of Essential Medicines, 2011 adopted by the Government of India, it would be possible to tackle almost all disease conditions. (ACCEPTED)

State Drug Committee which would be responsible for initially preparing and subsequently updating every two years the essential drug list for the public sector.  The Committee will comprise Clinicians, Pharmacologists, Microbiologists, qualified Pharmacists and independent experts in the field besides senior functionaries of the Department...(ACCEPTED)

         In some cases the choice may be influenced by other factors such as pharmacokinetic properties or by local considerations such as the availability of facilities for storage. Other local considerations as listed below shall be considered for this purpose:

a.                Effects of local diseases or conditions and food habits on drug effectiveness (e.g., malnutrition, liver diseases etc).

b.                Local differences in sensitivity and resistance of micro-organisms.

c.                 Differences in climate, topography and other environmental factors. (ACCEPTED)

Medicines selected must be available in a form in which adequate quality, including bioavailability and stability can be ensured. (ACCEPTED)

 

    The warehouses/stores shall be managed by appropriate number of skilled and qualified personnel (which will include qualified pharmacists) in line with the principles of good store management.

a.       Drugs shall be stored as per good storage practices and in accordance with FEFO (first-expiring-first-out) and FIFO (first-in-first-out) fashion.

b.       Cold chain storage shall be maintained, wherever required.

c.        Procurement of bulk/loose drugs shall be avoided to prevent contamination and pilferage due to manual handling.

d.       Transport facilities will have to be strengthened for proper and timely distribution to all districts and blocks.

e.        Appropriate disposal of banned, expired and recalled drugs shall be effected in accordance with well-   established norms e.g., WHO guidelines and special care shall be taken for the disposal for antibiotics. (ACCEPTED)

       The said organization needs to be strengthened through a capacity building process by augmenting infrastructure, manpower and financial resources. Adequate communication, transportation, accommodation, and legal assistance facilities shall be provided to the inspectorate staff in all districts. All provision of Drugs and Cosmetics Act relating to AYUSH medicines shall be enforced. Necessary laboratories for testing of Cosmetics shall be established. (ACCEPTED)

      The drug testing laboratories would be accredited with national and, where possible, international accreditation bodies to ensure the reliability of tests as per national/international standards.  Annual testing load and average testing time of the existing drug testing laboratories shall be fixed for greater accountability. (ACCEPTED)

       Private sector laboratories may also be involved to ensure the quality of drugs in the State. However, these would need to be approved, accredited and supervised by the State or central authorities, as the case may be. (ACCEPTED)

     Therefore a statistically designed, scientifically managed, statewide survey shall be conducted collecting samples from every nook and corner of the state and testing them for their quality and authenticity, to measure the extent of spurious drug menace in J&K state. (ACCEPTED)

     Creation of  intelligence cum legal cell to facilitate busting of spurious drug rackets and their prompt prosecution respectively will receive thrust. (ACCEPTED)

     Drug sale licences shall be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments shall be made in the relevant Acts to enforce this provision.  (ACCEPTED)

      Proliferation of drug distribution outlets will not be encouraged.  (ACCEPTED)

      A separate policy for drugs belonging to AYUSH systems of medicine shall be framed. (ACCEPTED)

      In-house Quality Control cells will be established in every major hospital as part of their comprehensive Quality Assurance system. Services of qualified pharmacy graduates in all division, district and sub-district level hospitals shall be made available. (ACCEPTED)

       Clinical Pharmacy and Pharmaceutical Care Services shall be established in all hospitals for maximizing the clinical outcomes of drug therapy and bridge the communication gap between doctors and patients. (ACCEPTED)

      Sale, storage and use of drugs specified under Schedule X of the Drugs and Cosmetics Act, 1940 shall be regulated with a greater vigil by the inspectorate working under Drug and Food Control Organization, J&K. Record-keeping of such drugs shall be made indispensable and the same shall be checked regularly by the inspectorate. Special checking squads under the leadership of deputy drugs controllers will be framed and authorized to undertake periodic necessary inspections in this regard along the length and breadth of the state. License to sell, stock and distribute drugs pertaining to Schedule X shall be restricted to dealers with absolutely spotless track record and should not be issued to those indulging in any sort of unlawful activities. (ACCEPTED)

      J&K Pharmacy Act 2011 (samvat) will be updated and strengthened and the J&K Pharmacy Council shall endeavour to constitute its executive committee and frame Pharmacy Education Regulations and implement them as soon as possible so that minimum standards can be prescribed for colleges and institutes offering diploma or degree courses in Pharmacy. This will make sure that nobody enters the profession of pharmacy without earning a legal qualification. (ACCEPTED)

       In keeping with the constant needs and constraints, special provisions shall be made to facilitate availability of blood and blood products through a substitute storage system, in peripheral areas where good blood banking system is still in the process of development. (ACCEPTED)

November 2: An important day in the history of Pharmacy profession in J&K

So November 2nd will henceforth be a big day in the history of Pharmacy profession within J&K state for on this day many long-pending demands of pharmacy professionals were accepted and incorporated in the draft drug policy of J&K. It was a marathon, three hour long brainstorming session with senior bureaucrats/officials of health department of J&K and even though many people from other fields were on my side too, but I was the only technical person speaking for the required change, it was so hard to convince them, but we drove the nail in with our perseverance and performance. Meeting was unofficial because there was no scope for an official meeting at this juncture since memo had already been issued for clearance of the previous, half-baked draft drug policy during the recently held cabinet meeting at Srinagar. Hope you've read health minister informing GK that policy will be through in a week's time. It was withheld only on our insistence. Therefore we were told not to make the issue public. I was very eager to share this good news with my students and couldn't hold it back on the eve of Eid. That doesn't mean I broke my commitment because they didn't tell us not to share it even with my students and it struck my mind that I can confine this status update to my students only, and that is exactly what I did. Only my students are able to see this.

After hectic lobbying and advocacy, Govt. of J&K agreed among other things during the meeting to engage pharmacy graduates in all hospitals of the state, start clinical pharmacy services and establish quality control cells in all major hospitals, make serious efforts towards restricting drug sale licences to diploma and degree holders in pharmacy only by framing education regulations, update and ammend J&K Pharmacy Act, fix annual testing load and average testing time of our drug testing laboratories, make necessary accomodation, communication, transportation and other facilities available to drug inspectorate of the state. These things and many others were incorporated in writing into the draft drug policy of the state which is likely to be declared in the next cabinet committee meeting later this month. Many other changes were made which I can't elaborate upon over here. However we are more interested in the points mentioned above because this is what we pharmacists have been dreaming for so many years now. Finally our long-cherished dream seems to be getting realized. Regarding gazetted cadres of DIs, I tried to push it through but due to resistance from some unexpected and unwanted quarters, couldn't materialize this time. Some people simply can't accept positive changes just for the sake of their big egoes, what to do. So after two months of hectic lobbying and advocacy through meetings, seminar etc we finally achieved our goal, during which we undertook a series of meetings with Governor, CM, Health Minister and six other ministers besides senior bureaucrats to get the necessary changes incorporated in the draft. Thanks to other office bearers and members of CSF (Civil Society Forum) without whose relentless efforts nothing would have moved. Now we need to have lot of patience and perseverance to translate the policy into action because you know how long it takes in govt to get things done. Last time in 2003 we framed and moved a proposal for creation of 90 posts of drug inspectors which got materialized only recently in 2009. We (alongwith J&K pharmacy graduates association) had to move the file literally from table to table during the six long years. Let us hope it won't take so long this time. I have sown the seed, now it is for others to nourish it so that it changes into a sapling, than a plant and finally a big tree that can provide shade to so many aspirants of our profession. Let everybody reap the fruits in the end.God Bless.

25 Grave Deficiencies in the Draft Drug Policy of J&K State

1. Draft drug policy does not lay out the standards of quality that the drugs procured by proposed J&K Medical Sales Corporation have to comply with. Standards of quality and purity of drugs have to be in accordance with Indian Pharmacopoeia, 2010 and National Formulary, 2010.
2. Draft policy just mentions that the drugs will be centrally procured by J&K Medical Sales Corporation and does not specify the policy and procedures of the proposed sales corporation required for tendering, supplier selection, pre-qualification, post-qualification, quality assurance, ordering, payments etc. Thus it is a half-baked policy.
3. No Drug Recall Policy has been specified in the draft. Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
4. Draft policy of the govt. does not put forth any policy parameters required to curb the menace of spurious drugs or on the need for introducing WHO-IMPACT approved anti-counterfeiting technologies in the drug procurement system. There is no mention of constituting legal and intelligence cells for speedy launch of prosecutions and busting of fake drug rackets respectively.
5. There is no roadmap for countering the menace of drug abuse/addiction. This aspect has been blatantly neglected in the draft. Drug licences for selling Schedule X drugs have to be limited only to those retailers with spotless track- record in dealing with such drugs.
6. There is no clarity in the draft as to how drug price control mechanism will function when the available field staff, the drug inspectors are not authorized to take action in cases of overcharging on drugs since as required under law, they are not notified under Essential Commodities Act because of falling under non-gazetted cadre.
7. There is no policy outlined for licensing, monitoring, regulation and control of drugs belonging to AYUSH systems of medicines in absence of which anybody can carry on with illegal business of such drugs with impunity. Provisions relating to such drugs as provided under Chapter-IV A of the Drugs and Cosmetics Act, 1940 need to be enforced and adequate powers need to be delegated to the inspectorate staff.
8. Need for having Drug Inspectors at block level in the state instead of present district level for greater and effective control and vigil has not been emphasized in the draft.
9. Draft talks about Quality Control system but fails to outline the importance of a comprehensive Quality Assurance System that includes perpetual surveillance besides testing and includes not only technical activities but managerial aspects too.
10. Draft mentions about developing human resource in pharmaceutical science but how is that possible in absence of central Pharmacy Act and in absence of any Education Regulations. In absence of pharmacy education regulations anybody can run a pharmacy college without following rules and anybody can enter this profession without earning a legal qualification.
11. Draft drug policy makes no mention of the J&K State Pharmacy Council whose constitution and functioning has been kept restricted and not all-inclusive. There is no representation of academia, hospitals or drug industry in the council. It hasn’t framed its executive committee even after more than a decade of its constitution. Council is responsible for mushroom growth of drug stores along the length and breadth of the state that are sans qualified pharmacists by offering a never ending process of registration.
12. No minimum qualification required for the issuance of drug licences in the state has been specified in the draft policy since at present any Tom, Dick and Hary can get a licence by first registering himself as a pharmacist with the J&K Pharmacy Council.
13. Draft lays down no roadmap for providing medicines free of cost to poor patients living below the poverty line by strengthening and implementing Rashtriya Swastha Bhima Yogna and by constituting State/District Illness Assistance Fund, District Drug Banks and Revolving Funds for BPL families and other central schemes.
14. Annual testing load and average testing time of the drug testing laboratories shall have to be fixed for greater accountability.
15. Draft drug policy while emphasizing upon involving private sector laboratories in ensuring quality of drugs in the state, does not realize the importance of getting such private testing laboratories approved by CDSCO, in absence of which their test reports will not be held valid in the court of law.
16. There is no policy for disposal of expired and unwanted drugs which has of late proved to be a grave environmental concern worldwide owing to their potential to pollute underground water reserves and return back to our bodies.
17. Draft policy does not lay down any policy for establishing in-house Quality Control cells within hospitals and providing clinical pharmacy and pharmaceutical care services to patients within hospitals with a view to maximize clinical outcomes.
18. Draft drug policy does not specify drug budget requirements of the state nor does it fix a minimum per capita per annum expenditure on drugs out of our hospital budgets.
19. Draft drug policy is silent about the provisions of Drugs and Cosmetics Act dealing with regulatory control over sale, storage and distribution of Cosmetics since lack of any regulatory control has led to the flooding of markets with cosmetic products that are either spurious or are not of standard quality.
20. Draft drug policy is also silent about the specific choice of formulations, packaging and labeling requirements to be fulfilled by the suppliers of drugs. While procuring drugs preference must be given to tablets over capsules, reconstitutable powders over injectable solutions and to strip and blister packaging over loose/bulk packaging. Special labeling requests like “only meant for sale by J&K Medical Sales Corporation” have to be accepted by the suppliers.
21. Draft policy does not emphasize upon the need to have a robust system for reporting and recording quality problems at various sites throughout the year.
22. No pre-qualification criteria to be met by the drug suppliers has been outlined in the draft policy that leaves room for wrongful selection of suppliers during tendering process. Other criteria for vendor selection like their ORG rankings, GMP standards, market standing, annual turnover etc have also not been specified in the draft.
23. Draft drug policy does not specify whether drugs will be procured by the J&K Medical Sales Corporation directly from the manufacturers for cost-effectiveness or otherwise.
24. Importance of pre and post-shipment analysis/testing of drug consignments has not been emphasized upon in the draft policy.
25. Draft drug policy of the J&K government is not in consonance with the recommendations of Hathi Committee (1975), National Human Rights Commission (1999), Parliamentary Standing Committee on Petroleum and Chemicals (2001) and Mashelkar Committee (2002).

Generics for greater affordability of medicines

There are two types of drug molecules: innovator molecules and generics. Innovator molecules are the branded products, originally developed by some multinational pharmaceutical company through exorbitant R&D activity. These companies own patents and proprietary rights on such molecules for at least 20 years and therefore sell them on their own brand names. Because of huge expenditure on R&D, hefty marketing expenses and patent royalties, such drugs are costly. On the other hand generics are the pharmaceuticals, on which patents have got expired and nobody holds proprietary rights anymore. Such drugs are sold on their basic chemical names instead of brand names and are much cheaper due to the savings on R&D, royalty and marketing expenditure. These drugs are similar in strength, dosage, appearance, quality and other characteristics to branded drugs but do not bear a brand name. Before allowing them to be marketed, local FDA checks their bioequivalence with branded drugs and then only accords approval to them. Hence there is no cause for worry regarding their quality, safety and efficacy. However since a motley collection of struggling mom-and-pop companies have jumped into the generic trade, it has led to numerous cheap quality me-too products too from every TOM DICK AND HARY. Hence strict regulatory control and in-house quality assurance within hospital is essential to ensure their quality.

It is important to note that at present generic drugs make 75 percent of the prescription medicines sold in the United States and vast majority of these drugs are supplied either by China or India. Currently, Indian pharmaceutical companies produce between 20 and 22 percent of the world’s generic drugs, making it world leader in export of generic drugs but unfortunately its benefits are not proportionately percolating down to poor local masses who cannot afford to pay heavily out-of-pocket for branded drugs, due to several myths attached to their use. Just to cite an example one vial of generic 1gm cefoperazone + 1gm sulbactum costs Rs. 140 as against Pfizer's Rs. 500, BIPL's 458 and CMG Biotech's 456 rupees. The widely held belief that generic medicines are sub-standard is not based on facts because this notion has been nullified by a substantial number of BA/BE (Bioavailability/Bioequivalence) studies on generics. Indian generics marketed in US have also been found to be bioequivalent, having similar quality, safety and efficacy as branded drugs, by the USFDA and then only given marketing approval within US. From 2003 to 2008, in programmes supported by donor organizations like the Global Fund, Indian generic drugs accounted for more than 80% of the drugs used to treat AIDS, including 91% of paediatric antiretroviral products, and 89% of the adult nucleoside and non-nucleoside reverse transcriptase inhibitor markets. India is also the most important source of generic drugs for cancer, heart disease, and other diseases and conditions.

Almost all drugs marketed within India are generics and not innovator molecules because none of the Indian pharmaceutical companies has actually developed them through indigenous costly R&D work. Nearly 97 percent of India’s drug market consists of second-and-third generation (generic) drugs no longer subject to patent protection in the developed world. In 1970, India eliminated patents on drug products. The new intellectual property framework enabled India to develop a strong generic drug industry and positioned India as the “Pharmacy of the developing world”. In 1994 the World Trade Organization negotiated the controversial Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). India was required to extend patent protection to drugs and to implement other new obligations. In 2005 India implemented the changes required by the World Trade Organization. In doing so, India limited patents on new uses or new formulations of drugs unless they differ greatly in properties related to efficacy. Thus when India re-instituted “product” patents, it effectively ended 36 years of protection for Indian companies and terminated legal reverse engineering or copying of patented foreign pharmaceutical drugs. For all these years Indian companies had been using copied or reverse engineered versions of original patented drug molecules of MNCs until Patents Act amendment was brought in force in 2005.

The introduction of product patents in India is actually severely constraining generic competition and supply, particularly for newer medicines. Now, there is a threat that the limited policy space that remains will be further constricted by bilateral or regional free trade agreements. Unfortunately, many free trade agreements that have been concluded or are being negotiated between industrialized and developing countries contain measures that restrict access to medicines. Current free trade agreement negotiations between the European Union and India include measures that delay or restrict competition from generic medicines, including: patent term extensions beyond the 20 years required by TRIPS; data exclusivity (that could delay the registration of generic medicines); and border enforcement measures that could block international trade in generic medicines when they are suspected of infringing patents in the countries through which they transit.

Drugs manufactured in India are classified as Branded-Generics (those generics bearing a brand name) and Generic-generics (those generics sold on their chemical names), both of which are available to the patients at the same cost, but there is huge cost difference in the two for a retailer. Therefore if hospitals purchase generic-generics directly from the manufacturer there will be cost saving for the patient to the extent of 70-80% and drugs will become available to them at as low as 10-20% of the market prices. At present only branded drugs are available in our hospital drug stores. Therefore it is high time to promote use of generics. Drug Policy of every Indian state including that of J&K clearly envisages that all drugs must be identified, listed, prescribed and dispensed only by their generic names.

One important thing to be borne in mind is that just procuring generic or branded drugs from some reputed pharmaceutical companies does not guarantee full quality, safety or efficacy. It is necessary to have stringent regulatory framework besides in-house quality control/assurance system within the hospital that can test the quality of all branded or generic drugs. Further there are some studies that have advised against using generic substitutions in case of drugs having narrow therapeutic/safety index like anti-epileptics, digoxin, warfarin, levothyroxine etc. There are also some studies contesting the therapeutic equivalence of some generics. However quality of all generic drugs cannot be simply rubbished on the basis of false beliefs and perceptions.

Optimizing Clinical Outcomes Through Pharmaceutical Care

Geer Mohammad Ishaq* Ph.D., Mir Javed Iqbal* B.Pharm., Parvaiz A. Koul** M.D.
*Deptt. of Pharmaceutical Sciences, University of Kashmir
**Deptt. of Internal and Pulmonary Medicine, SKIMS, Srinagar

Pharmaceutical Care is a patient-centered, outcome-oriented pharmacy practice that requires the qualified pharmacist to work in concert with the patient and the patient's other healthcare providers to promote health, to prevent disease, and to assess, monitor, initiate, and modify medication use to assure that drug therapy regimens are safe and effective. The goal of Pharmaceutical Care is to optimize the patient's health-related quality of life and achieve positive clinical outcomes. The pharmacist in the contemporary template is one who provides a vital connect between the health sciences and the pharmaceutical world. Their work in the medical field has become multifaceted, extending from the manufacturing of quality medicines, to the delivery of pharmaceutical care to patients. Pharmaceutical care entails the work of addressing a patient's medication related needs. The involvement of the pharmacist in India in this regard has been somewhat restricted, contrary to trends in developed countries. While seeking medical help, people think of a doctor or a nurse or a medical technician, but seldom does a pharmacist come to mind. This needs correction. Nowadays medicine options have multiplied manifold thus raising the complexity of therapies. Pharmacists have a unique role to play in evaluating these options. Within the team of healthcare professionals, trained pharmacists would have the knowledge and skills to prevent, detect, monitor, and resolve medicine related problems. As the public demands more information on medicines and their effects, to make more informed decisions, pharmacists will have to take on a more pro-active role in patient counseling1.
Defining Pharmaceutical Care

Hepler and Strand2 defined Pharmaceutical care in 1990 as the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. These outcomes include cure of disease; elimination or reduction of a patient's symptomatology; arresting or slowing a disease process; or preventing a disease or symptomatology. Thus Pharmaceutical Care involves four major functions by a pharmacy practitioner on behalf of the patient viz., identifying potential and actual drug-related problems; addressing needs and resolving actual drug related problems; preventing potential drug-related problems and optimizing patient therapy outcomes.

Of late Cipolle and his colleagues3 have redefined Pharmaceutical Care as “a practice in which the pharmacy practitioner takes responsibility for a patient’s drug-related needs and is held accountable for this commitment”. The pharmaceutical care practitioner assures that all of a patient's drug therapy is used appropriately for each medical condition; the most effective drug therapy available is used; the safest drug therapy possible is used, and the patient is able and willing to take the medication as intended. The Pharmacotherapy Workup is the rational thought process that is used by pharmaceutical care practitioners to make drug therapy decisions.

Definition given by Cipolle et al has three components viz. a philosophy of practice; a patient care process, and a practice management system. Most major pharmacy organizations in developed countries e.g., the American Pharmaceutical Association (AphA)4 and the American Society of Health- System Pharmacists5 have since adopted the pharmaceutical care philosophy. ASHP believes that, to ensure proper coordination of patients’ medication therapies, health care systems must be designed to enable, foster, and facilitate communication and collaboration among health care providers.

More recently, in the year 2009, International Pharmaceutical Federation (FIP)6 defined Pharmaceutical Care as, “the responsible provision of pharmacotherapy for the purpose of achieving definite outcomes that improve or maintain a patient’s quality of life. It is a collaborative process that aims to prevent or identify and solve medicinal product and health-related problems. This is a continuous quality improvement process for the use of medicinal products”. Thus Pharmaceutical Care management is a modern approach towards providing seamless and integrated health care through collaboration with pharmacy practitioners.

What is it all about?

Pharmaceutical care is a ground-breaking concept in the practice of pharmacy which emerged in 1990s. It stipulates that all practitioners should assume responsibility for the outcomes of drug therapy in their patients. It encompasses a variety of services and functions – some new to pharmacy, others traditional – which are determined and provided by the pharmacists serving individual patients. The concept of pharmaceutical care also includes emotional commitment to the welfare of patients as individuals who require and deserve pharmacists’ compassion, concern and trust. However, pharmacists often fail to accept responsibility for this extent of care. As a result, they may not adequately document, monitor and review the care given. Accepting such responsibility is essential to the practice of pharmaceutical care7.

Over the past four decades there has been a trend for pharmacy practice to move away from its original focus on medicine supply towards a more inclusive focus on patient care. The role of the pharmacist has evolved from that of a compounder and supplier of pharmaceutical products towards that of a provider of services and information and ultimately that of a provider of patient care. Increasingly, the pharmacist’s task is to ensure that a patient’s drug therapy is appropriately indicated, the most effective available, the safest possible, and convenient for the patient. By taking direct responsibility for individual patient’s medicine-related needs, pharmacists can make a unique contribution to the outcome of drug therapy and to their patients’ quality of life.

The practice of pharmaceutical care is new, in contrast to what pharmacists have been doing for years. Because pharmacists often fail to assume responsibility for this care, they may not adequately document, monitor and review the care given. Accepting such responsibility is essential to the practice of pharmaceutical care. In order to fulfill this obligation, the pharmacist needs to be able to assume many different functions. The concept of the seven-star pharmacist, introduced by WHO and taken up by FIP in 2000 in its policy statement on Good Pharmacy Practice, sees the pharmacist as a caregiver, communicator, decision-maker, teacher, life-long learner, leader and manager8.

What are its objectives?

Main objectives of Pharmaceutical Care revolve around four areas of drug therapy management viz., Indication, Effectiveness, Safety and Compliance to drug therapy and include:

 To evaluate drug related needs of the patients
 To identify actual and potential drug-related problems among the patients.
 To resolve the actual drug-related problems and prevent potential problems from becoming actual problems.
 To work with physicians and patients in designing, implementing and monitoring
an appropriate care plan.
 To make suggestions for any interventions about drug use, whenever required.
 To offer education and counseling services to patients with a view to
optimize therapeutic outcome.

Global Scenario

Pharmaceutical care started in the nineties in the United States and has rapidly extended in many other countries. The present meaning of pharmaceutical care evolved from a term, defined in 1975 by Mikeal et al10 as a subset of medical care, using an analogous definitional format as medical care. It was Brodie11, who developed this concept by including in it the drug needs for a given patient and the provision, not only of the required drugs but also of the services needed for safe and effective therapy, in an environment of changing societal purpose of pharmacy12 and in 1990, Hepler and Strand2 defined pharmaceutical care as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life”

Pharmaceutical care is a generalist practice which has evolved from many years of research that can be applied in all settings: community, hospital, long-term care, and the clinic. It can be used to care for all types of patients with all types of diseases taking any type of drug therapy. Pharmaceutical Care practitioner is not intended to replace the physician, the dispensing pharmacist, nurse or any other health care practitioner. Rather, the pharmacy practitioner is a new patient care provider within the health care system2.

The principal elements of pharmaceutical care are9 that it is medication related; it is care that is directly provided to the patient; it is provided to produce definite outcomes; these outcomes are intended to improve the patient’s quality of life; and the provider accepts personal responsibility for the outcomes.

The Pharmaceutical care is a much needed service as it has direct impact on quality of healthcare and supports audit of outcome of the treatments. One huge study in America involving approximately 1000 hospitals showed that as the number of clinical pharmacists per occupied bed increased mortality, drug costs, total costs of care and length of stay were reduced13. The adoption of Pharmaceutical Care Practice in clinical and community setting is the need of the hour. There is a tremendous scope for the upcoming pharmacists to practice the profession which not only ensures efficacy but also safety of therapy. The benefits of pharmaceutical care have been illustrated in a number of studies worldwide.

Indian Scenario

India is a country with significant problems in medication use, but until recently Indian pharmacists have not been properly educated for a patient-care role14. Clinical Pharmacy on the whole has so far remained neglected within India and there has been resistance on part of the medical professionals to accept the fact that pharmacists too have a clinical role. There has also been reluctance on part of pharmacists themselves towards assuming such clinical role and responsibilities. However this dismal scenario has started undergoing promising changes in the recent past. Many hospitals across India have of late initiated clinical pharmacy and pharmaceutical care services and this step has already started showing positive results. In a six-month long, prospective, open-label study conducted at three primary health centers of a southern Indian district of Tamil Nadu to evaluate the impact of pharmaceutical care on the clinical outcomes of patients enrolled in a pharmacist-coordinated diabetes management program, effective improvement was seen in the clinical outcome and health-related quality of life of diabetes patients in rural India15. Association of Community Pharmacists of India also took an initiative to establish Pharmaceutical Care Clinic at Chinchwad, Pune, first of its kind in India in the year 200916. In another study that was conducted on 115 patients admitted in General Medicine ward of a 1700 bedded tertiary care teaching hospital in South India, to identify and resolve drug-therapy related problems through pharmaceutical care, it was demonstrated that a pharmacist can identify drug related problems and other pharmaceutical care related issues and resolve them by his timely interventions, thereby playing a pivotal role in promoting patient care17.

Status in J&K

Clinical Pharmacy on the whole is in its infancy in the state of Jammu and Kashmir and the concept of Pharmaceutical Care is completely new to most of the physicians, nurses and even pharmacists presently working at the government health facilities. As a result of the patient overload of physicians and some other reasons, they are not in a position to offer detailed counseling, patient education and pharmaceutical care services on individual basis to all their patients. Therefore it is for the trained pharmacy practitioners to step in and fill the void by offering such services with a view to achieve definite therapeutic outcomes that improve a patient’s quality of life. Overall goal is to optimize the therapeutic outcome management and decrease the burden of five D’s viz, death, disease, disability, discomfort and dissatisfaction among patients. Clinical, economic and humanistic outcomes will also shift towards the positive side as a result of these integrated and seamless healthcare services rendered by a pharmacy practitioner.

Therefore need of the hour is to design, implement and monitor models aimed at providing Pharmaceutical Care services to our patients at primary, secondary and tertiary care level so that there is a transition in the focus of the qualified and pharmacists from bench side to bed side and from product to patient for the greater benefit of the patients at large. Pharmaceutical Care being a patient-oriented service will pave way for pharmacist involvement in providing patient education and counseling services, monitoring drug therapy and suggesting interventions wherever required, reporting ADRs and drug interactions, supplying drug information to physicians and nurses, conducting drug-utilization evaluation studies, preparing monographs and hospital formularies and in providing poison control services. Ultimate aim of all these services is only one and that is to optimize the clinical outcomes and thereby improve patient’s health-related quality of life.

REFERENCES:

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