Although the Government of India enacted the pharmacy practice guidelines in Pharmacy Act 1948 by Gazette notification dated January 15, 2015, the pharmacy practice is a non-starter in the country. It is very much misunderstood and often misquoted by pharmacists to claim that the act empowers them to prescribe medicines.
However the PCI has cleared the air by telling that the act does not speak about prescribing medicines, but assisting the doctors, nurses and patients to provide the pharmaceutical care. While it has cautioned against pharmacists indulging in diagnosis and treatments, it allows them to work with fellow healthcare professionals, patients and health consumers in giving information and guidance regarding medicines.
The guidelines emphasize on pharmacy inputs in clinical practice to achieve the best outcomes in terms of safety and efficacy. Globally the prescription medicines pose a challenge to safety due to multiple factors and issues. All medicines are technical products and carry a huge inherent burden of side effects and mandates to assess the risk benefit analysis, before prescribing the medicine. The prescription medicine are known to cause injuries to health if used indiscriminately.
The pharmacovigilance of prescription medicines is a global initiative to identify signals of danger early in usage. It is an important strategy of protecting public from ill effects. The medicine safety is an elusive aspect of all drugs, for which the regulators and government are supposed be vigilant and to decide upon further marketing rights of the drug license. The drug development programs are traditionally focused on efficacy and sidelining safety is an open secret. All preclinical and clinical data available today is more on efficacy and minimum on safety. However Pharmacovigilance emphasizes on the issue of drug safety, which are documented as and when they occur and the therapeutic guidelines to be rewritten while the drug is in the clinical practice.
The manifestation of adverse drug effects are sometimes dramatically horrible leading to the immediate withdrawal of product and ban of medicine from use for which license was given to market the drug based on available safety data. The drug tragedies of Thalidomide and Diethylstilbestrol are the classic examples of drug injuries which affect the children of the parents who were exposed to medicines prescribed by their doctors. Majority of prescription medicines old or new are causing drug induced injuries so slowly that it is very difficult to identify a safety issue of that drug. It is a white lie to believe that a prescription medicines do not cause harm and are safe to use. It is also true to the core that all prescription medicines are usually given system has an opportunity to reach every organ of our body and is capable of altering the natural biochemical reactions, irrespective of requirement. For example a drug used to kill microbes can cause deafness due to ototoxicity for example Gentamicin. However one can use Gentamicin safely if the blood concentration of Gentamicin is maintained below toxic concentration and above therapeutic concentration, that is the Gentamicin concentration within the in the therapeutic window. This is called as Therapeutic Drug Monitoring (TDM) which is the core of pharmacy practice. Hence all the drugs with dose related safety issues need to be subjected to TDM.
The widespread rampant misuse of antibiotics which is the leading cause for the emergence of multidrug antibiotic resistant infections is a major cause for worry. The abuse of antibiotics is accelerating the emergence of resistant strains of bacteria. Even empirical use of antibiotics in hospitals and community need to be monitored. The World Health Organization has warned against irrational use of antibiotics for viral infections to all healthcare stakeholders. Due to the failure in implementing drug regulations, the antibiotics are freely sold to the public without prescription and are being misused in poultry and animal husbandry.
Due to the lack of transparency and accountability of prescription audit and drug utilization data, big hospitals and clinics have become the hub of multidrug resistant bacteria causing the nosocomial (hospital acquired ) infections. It is the responsibility of the clinical pharmacist to caution the clinical staff to adopt rational use of antibiotics. It is also the responsibility of community pharmacist to discourage the patients and health consumers from self-medication. Here the pharmacy practice plays a major role, where in the pharmacist takes the responsibility of safety and efficacy of dispensed medicine by giving specific instructions while using the antibiotics or any other prescription medicines.
The pharmacists in our country are less oriented towards patient safety as it is unrewarded and unrecognized. The pharmacy practice demands knowledge, commitment and ethical practice. The pharmacists in our country are compartmentalized in professional practice. Mostly the pharmacists who have done diploma in pharmacy are into retail business and are the public face of community pharmacist.
These owners of retail pharmacy are happy in selling the prescription medicines to patients and health consumers. These pharmacists are registered pharmacists who are expected to deliver not only prescription drugs but pharmacy practice services. However there are no initiatives or incentives for providing pharmacy services. Due to lack of training, continuous education program, non-demand by the regulators, the pharmacy practice has failed to take up, irrespective of government initiatives of practice guidelines. Ultimately all the D.Pharm are into the community pharmacy and the B. Pharm and above qualified pharmacists don't join the retail pharmacy as most of them are attracted to the industry which offers growth and a more secure career.
The retail pharmacists in India are happy by selling the prescription medicine more and more, as the revenue and profit are solely by volume of sales. There are no incentives or subsidy given to a pharmacist for patient counseling and pharmacy practice services. Hence the pharmacists are seldom interested to acquire new professional skills by participating in Continued Pharmacy Education.
The registered pharmacists in India are never accounted and questioned for his professional knowledge, as licensing authority are showing laxity by allowing them to renew registration without checking the current knowledge of the pharmacist. In many countries, like Malaysia, Singapore and Dubai, the pharmacists are supposed to write an examination proving the efficiency and expertise for delivering pharmacy services. However in India, the pharmacists are just involved in selling the medicines without giving appropriate information and services to the patients. It is no wonder that the retail trade organizations are demanding the government to do away with registered pharmacist himself. Their argument is, as presently there are no issues of with public or the government, as all prescription are written in English and all medicine are available in sealed container, what is the necessity of a pharmacist to just pick the medicine from the rack and hand over to patient. However according to Supreme Court judgment on this matter, in 1997 has said that without a registered pharmacist, one should not dispense prescription medicine to public.
The need for pharmacy services in current health care delivery has become altogether a necessity. The rise in the complications of diabetes, hypertension, obesity and tuberculosis mandates the supervision of these conditions very closely to control and avoid. All the complications of lifestyle diseases are preventable if the patient is guided on a day today basis by a health care provider. The doctors and nurses serving in hospitals do not have time to give care in the community setting. The pharmacist in developed countries engaged in providing pharmaceutical care helps the patients in self-management of the conditions. The registered pharmacist is required to dispense medicines on the prescription of a registered medical practitioner and can counsel the patient or care giver on medicine to enhance or optimize drug therapy.
The elements of patient counseling include the following which are called as pharmacy services. The pharmaceutical care involves educating the patients regarding, (i) Name and description of the drugs; (ii) The dosage form, dose, route of administration, and duration of drug therapy; (iii) Intended use of the drug and expected action; (iv) Special directions and precautions for the drug; (v) Common severe side effects or adverse effects or interactions and therapeutic contra indications that may be encountered, including their avoidance, and the action required if they occur ; (vi) Techniques for self-monitoring drug therapy; (vii) Proper storage of the drugs; (viii) Prescription refill information; (ix) Action to be taken in the event of a missed dose; (x) To ensure rational use of drugs .
The pharmacist are to be engaged in monitoring the conditions of the patients and alert the patients, nurses and doctors regarding sudden change in the health of the patient. There is a need to create awareness and opportunities for pharmacists to practice.
The pharmacy practice all the new to India, is a necessity owing to the contribution of pharmacist in collaborative health care delivery.
The availability of doctor of pharmacy in India has given enough hopes and impetus to pharmacy practice in the country. These pharmacy doctors are likely to improve the quality of care by working with doctors and nurses in hospital. They are competent enough to handle the requirements of pharmacy related patient care. These services include drug information, poison information, management of ward pharmacy, therapeutic drug monitoring, in patient counselling, hospital formulary management, therapeutic committee services and discharge medication counselling.
The hospital pharmacist are mainly involved in handling the drugs and formulations for the hospitals by making compounding and dispensing. They are also involved in manufacture of IV fluids for the hospital patients. They are also specialized in making oncology preparation which requires skills in handling the anticancer drugs.
The community pharmacists are required to dispense the prescription medicines under the license of Drugs and Cosmetics Act. They are the custodians of all narcotics and psychotropic drugs. They are expected to act as guardians of public health. They are extended services include providing assistances to patients in disease management of chronic diseases by providing monitoring services of the conditions. The role and responsibility of pharmacy practice can only be possible by providing an environment of regulation implementations, proper incentives for services and equity of opportunity for health care practice.
(The author is faculty, Manipal College of Pharmaceutical Sciences, Manipal )