The application of unique knowledge and skills of the pharmacist to improve the health of the people is called pharmacy practice. It includes hospital, clinical and community pharmacy. A practicing pharmacist shares responsibilities with other healthcare professionals (doctors, nurses etc) and with patients for the outcome of therapy. The patient and the community are the primary beneficiaries of the pharmacist's actions.
Principles of pharmacy practice
Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. The outcomes of treatment are:
● Cure of disease
● Elimination or reduction of symptoms
● Arresting/slowing disease process
● Preventing a disease or symptoms
Pharmaceutical care is a component of pharmacy practice that entails the direct interaction of the pharmacist with the patient for the purpose of caring the patient's medication-related needs. Translated into everyday practice, pharmaceutical care is what an individual pharmacist does when he or she:
● Evaluates a patient's drug-related needs
● Determines whether the patient has any actual or potential drug-related problems,
● Works with the patient and other healthcare professionals to design, implement and monitor a pharmacotherapeutic plan that will resolve/prevent the problem
Areas:
● Disease state management
● Clinical interventions (refusal to dispense a drug, recommendation to change and/or add a drug to patient's pharmacotherapy, dosage adjustments, etc)
● Professional development
● Pharmaceutical care
● Extemporaneous pharmaceutical compounding
● Communication skills
● Health psychology
● Patient care
● Drug abuse prevention
● Prevention of drug interaction, including drug-drug interactions or drug-food interactions
● Prevention (or minimization) of adverse events
● Incompatibility
● Drug discovery and evaluation
● Detect pharmacotherapy-related problems, such as 1) patient is taking a drug which he/she does not need 2) patient is taking a drug for a specific disease, other than one affliction the patient 3) patient needs a drug for a specific disease, but is not receiving it 4) patient is taking a drug underdose 5) patient is taking drug overdose 6) patient is having an adverse effect to a specific drug 7) patient is suffering from a drug interaction
Pharmacy practice in pharmaceutical care
By virtue of being an expert on the knowledge of drugs and their use, a trained and competent pharmacist is the only professional in the healthcare team who can effectively handle a drug related problem.
The presence of any of these drug related problems will harm the patient. Hence, a meaningful solution of a drug related problem would certainly benefit the patient. True! The doctors are experts in the diagnosis and treatment of diseases and their efforts need to be constantly supplemented by contributions from all the healthcare professionals. One of the ways to supplement this role is by providing current, reliable and authentic information on medicines and their use.
As drug use is increasing, there is increased risk of drug related morbidity and mortality. Expenditure on the healthcare has also increased due to irresponsible use of medications. In India, the level of self-medication is very high as one can buy any medication across the counter. A pharmacist is the right professional to handle the drug related situations.
The importance of pharmaceutical care has been driven by several factors. Perhaps the most influential factor is the recognition of the impact of medication related morbidity and mortality. Among ambulatory patients, medication related morbidity and mortality contributes to 3-10 per cent of hospital admissions, half of which are caused by preventable medication related errors. In 2000, the estimated cost of preventable medication related morbidity and mortality among ambulatory patients was $177 billion. By preventing medication related problems through pharmaceutical care, pharmacists can play a valuable role in reducing patient risk. Therefore, an important outcome for pharmacy graduates hinges on their ability to provide pharmaceutical care.
Challenges: The number of medicines on the market has increased dramatically over the last few decades, bringing some real innovations and along with it considerable challenges in controlling the quality and rational use of medicines.
In developing and industrialised countries efforts to provide healthcare, including pharmaceutical care, are facing new challenges. These include the rising costs of healthcare, limited financial resources, shortage of human resources in the healthcare sector, inefficient health systems, huge burden of disease and the changing social, technological, economic and political environment which most countries face.
Common goal of pharmaceutical industries and pharmaceutical profession should be to protect the wellbeing of patients in all parts of the world by ensuring quality, proven safety and efficacy of all medicinal products.
Another major challenge is ensuring the rational use of medicines. This requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time and at the lowest cost.
In addition, there is growing concern over the increase in the global spread of antimicrobial resistance, a major public health problem.
These challenges - both to access to medicines of assured quality and to their rational use - underscore the urgency of the need for global health sector reform. Against this backdrop of ongoing and profound changes in healthcare delivery systems, a paradigm shift in pharmacy practice is occurring. Public health interventions, pharmaceutical care, rational medicine use and effective medicines supply management are key components of an accessible, sustainable, affordable and equitable healthcare system which ensures the efficacy, safety and quality of medicines.
It is clear that pharmacy has an important role to play in the health sector reform process. To do so, however, the role of the pharmacist needs to be redefined and reoriented. Pharmacists have the potential to improve therapeutic outcomes and patients' quality of life within available resources. Hence they must position themselves at the forefront of the healthcare system. The movement towards pharmaceutical care is a critical factor in this process. While efforts to communicate the correct information to patients are as important as providing the medicine itself, pharmacists also have to make a vital contribution to patient care through managing drug therapy and concurrent non-prescription or alternative therapies.
Over the past 40 years, the pharmacist's role has changed from that of a compounder and dispenser to one of drug therapy manager. This involves responsibilities to ensure that quality products are selected, procured, stored, distributed, dispensed and administered, wherever medicines are provided and used, so that they contribute to the health of patients. The scope of pharmacy practice now includes patient centred care with all the cognitive functions of counselling, providing drug information and monitoring drug therapy, as well as technical aspects of pharmaceutical services, including medicines supply management. It is in the additional role of managing drug therapy that pharmacists can now make a vital contribution to patient care.
Pharmacy practice education in India
Pharmacy education in India for the past several decades has been industry centred. It does not meet the requirements of patient care and pharmacy practice.
Today, pharmacy education is mostly governed by bodies other than its own. The institutions imparting pharmacy education are affiliated to the medical university or technical university, while the standards and norms for running the institute are prescribed by All India Council for Technical Education (AICTE). The Pharmacy Council of India (PCI), the statutory body of the profession, derives satisfaction in being a silent spectator and as a member of other bodies governing the pharmacy profession, rather than amending the Pharmacy Act to broaden the objectives and functioning of the council. The pharmacy degrees are awarded by faculties of science, technology or medicine, but rarely by the faculty of pharmacy.
In India a pharmacist has no public image. In hospitals, they are still serving as compounders rather than counsellors. The pharmacists do not play any useful role in the healthcare of the country. Even the new health policy of the government of India (2002) has not recognised the services of a pharmacist.
There must be a paradigm shift from present industry centred curriculum to patient centred so as to achieve the ultimate objective to produce a seven star pharmacist; like the caregiver, decision-maker, communicator, community leader, manager, lifelong learner, and role model with a social commitment.
Harmonisation of curriculum at undergraduate level is essential so that it will judiciously focus on industry, community and hospital industry settings. So that future pharmacist is prepared by knowledge centres of today to serve global market/community confidently.
Drawbacks in existing pharmacy practice system
The decade long journey of pharmacy practice curriculum in India provides some key insights. They are:
● The profession is restricted only to the hospitals linked to a pharmacy practice school: With the completion of a decade there are few pharmacy schools providing specialisation in pharmacy practice. Due to lack of job avenues, prospective postgraduates cannot opt to work as a clinical pharmacist in Indian hospitals as the value of clinical pharmacy services is not recognised
● Regulatory framework does not recognise the need for clinical pharmacist at the national level: There are no regulatory guidelines for having qualified clinical pharmacists in an Indian hospital. Even if the regulations are framed in due course, a point to ponder is whether there will be any experienced pharmacists left to practice in the clinical set up as there is a mass migration of trained clinical pharmacist to pharmaceutical industry.
Though clinical pharmacists have gained the confidence and acceptance of the medical fraternity, that acceptance alone will not help to overcome the shortcomings, like lack of a regulatory framework or scarce job opportunities. Pharmacy councils and professional leaders need to take initiative by lobbying with relevant government authorities to create a position in the hospital set-up where a trained clinical pharmacist can fit in.
● Exodus of trained clinical pharmacists toward industry as there is almost no opportunity in the hospital setting: As there is no recognition of the job done by the clinical pharmacist at the regulatory level, the profession failed to create job opportunities in hospitals for qualified clinical pharmacy postgraduates. Students are forced to either seek jobs in industries (clinical research) or continue in academics at times teaching subjects which are out of scope of clinical pharmacy (as not many university hospitals have pharmacy practice school). The last option is to move to countries where the pharmacy profession is well recognised.
● The need for adding industry relevant topics in course curriculum - Dilemma of dilution Vs evolution: There is a widening gap between the number of students graduating from pharmacy practice institutions and the number actually employed as pharmacy practitioners. There is a need to take key steps to either create a niche for clinical pharmacy professionals in the hospital or make them competent to take up other challenging jobs in the industry.
Model guidelines for better pharmacy practice
With more emphasis on Pharm.D programme by Pharmacy Council of India and gradual evolution of pharmacy practice towards clinical setting, there is pressure for an expanded pharmacy practice in community pharmacy, clinical pharmacy and hospital pharmacy in the country.
Enhancing community pharmacy through advanced pharmacy practice experiences: Due to increased emphasis on medication therapy, management services provide an additional career opportunity for pharmacy graduates. Pharmacy colleges should offer advanced pharmacy practice experiences (APPE) in the community setting designed to prepare students for these opportunities.
This experiential education settings will overcome greatest interface exist between pharmacy practice and pharmacy education. This interface is integral to the continued evolution of community pharmacy practice. Without real world examples of the application of pharmaceutical care concepts, graduates may find it difficult to adopt this model in the future and this could stifle further expansion of pharmaceutical care practice.
Effective collaborations among healthcare team: Pharmaceutical care provides a more formalised relationship among the pharmacist, patient and healthcare provider with the explicit purpose of improving patient outcomes. This increased engagement in the medication use process requires pharmacists to undertake the assessment and evaluation of medication regimens, monitor regimens to ensure desired outcomes, counsel to ensure optimal use of medications, interact with healthcare providers and document care.
In fulfilling this new and expanded role, pharmacists practice the fundamentals of patient care such as patient history taking, conducting basic physical assessment (i.e., vital signs) and assessing therapeutic markers for the purpose of monitoring medication safety and efficacy. The ultimate end product of the process is the avoidance of medication related problems, thereby ensuring more positive patient outcomes.
Harmonization of pharmacy education: It has to be made a global agenda and will encompass the developments that have taken place in basic, medical and pharmaceutical sciences in serving the needs and expectations of the society.
Manufacturing & trading of spurious & substandard drugs: It continues to pose a major threat to public health in India with total failure on the part of the central and state authorities to check this illegal activity. Spurious drugs are mainly the products which are deliberately and fraudulently mislabelled so as to conceal their identity and source of manufacture to cash in on the popularity of fast moving brands. It may or may not contain the active ingredients mentioned on the label.
Make medicines affordable for society: One appreciable step has already been taken in this area. The Department of Pharmaceuticals has proposed over 300 drugs in 16 therapeutic areas to be sold through the planned generic stores, as the industry reacted positively to make the scheme a success. While 25 per cent of the drugs will be sourced from the pharma companies in the public sector, the private sector generic players will be approached to supply the rest at a lower price to make it affordable for the poor sections of the society. Initially the stores will be set up in 12 states in the first phase. It will be extended to other states in the second and third phases.
Pharma dept should introduce quality mark for generic drugs: The Department of Pharmaceuticals should plan to make another attempt to introduce quality mark on the lines of the ISI or Agmark approvals for generics manufactured and sold in the country for ensuring quality of medicines and helping the consumers to identify it. These marks should be awarded only on submission of bio-equivalence and bio-availability studies to the drug controller general of India.
Pharm D - Reviving pharmacy education in India: The Pharmacy Council of India has approved 22 colleges in the country to start Pharm D course from this academic year.
The Pharm D course will be the harbinger for the beginning of a new era in the pharmacy practice in India. Since this programme is similar to the programmes being offered in USA and UK, Indian students perusing this programme will have ample opportunities to work as pharmacists in these countries with a handsome salary. Secondly, this course gives a new dimension to pharmaceutical healthcare by giving more emphasis to patient centred approach.
Need of National Formulary of India: The objective of the formulary is to encourage rational, effective and safe use of drugs. The WHO model formulary is an invaluable and unbiased resource for countries wishing to develop their own national formularies. It will also be useful to those developing hospital formularies and to individual prescribers and students interested in medicines that are globally recognised as essential drugs. Hence it is imperative that Indian government should immediately bring out a national formulary. WHO model formulary will be an excellent scaffold for the development of our own formulary.
Adaptation of better regulation: Time is such that the pharmaceutical world is going after good manufacturing practice, good laboratory practice etc. to sustain its growth prospects. But no one seems to be aware that we require good regulatory practice that governs pharmacy practice in India.
Till today, pharmacy practice in India is governed by The Pharmacy Act 1989, which is not having any specifications to govern different era of pharmacy practice such as hospital pharmacy, clinical pharmacy, community pharmacy etc.
As per this Act diploma pharmacy is a minimum educational qualification required for pharmacy practice, but in the current era to withstand the basic requirements of healthcare system the minimum qualification should be B.Pharm instead of D.Pharm. Many such improvements are required in current pharmacy practice, which should be regulated by good regulatory practice for providing excellent healthcare services to the patient.
The modern regulatory challenge is to develop a regulatory system which can effectively deal with the increasing demand for regulation, inherent bias to regulate and complex nature of regulatory intervention.
The frame work of regulation should be:
● Clear identification of the objectives of regulations
● It should have reasonable compliance rate
● Compatibility with the general body of law, including the statute which it amends, statute which apply to it and general body of the law of statutory interpretation
● It should fulfil performance based requirements that specify outcomes
● Public consultation should occur as widely as possible, given the circumstances in the policy development process. A well designed and implemented consultation programme can contribute to better quality regulation and identification of effective alternatives.
● It should adopt a direct approach aimed at the root cause of an identified problem that will ensure a more effective and efficient outcome, compared to an indirect response
Indian pharmacy practice is in the transitionary stage evolving from an industrial orientation to a patient centred approach. In future clinical and community pharmacy are going to play a major role in the patient healthcare set up of the country.
(The authors are with Veerayatan Institute of Pharmacy Jakhania, Gujarat)