PCI's Pharmacy Practice Regulation 2010 to mandate norms for registered pharmacists

The Pharmacy Practice Regulations 2010, framed by the Pharmacy Council of India to regulate the pharmacy profession and soon to be notified by the Union Government, may give a new dimension to the pharmacy profession of the country, it is learnt.

Besides escalating the pharmacy career into a noble domain of social service, the regulations will make clear the role and responsibilities of the pharmacists who have to practice methods of practice founded on scientific basis. The draft of the regulations has been circulated to all the state drug control authorities for their feedback and it will become a rule with its notification by the central government soon, said Dr B Suresh, president, PCI.

The regulations that mandate certain norms for the registered pharmacists emphasize the need for improving their knowledge and skills which should be made available for the benefits of the patients. The draft of the PPR says a person having qualification in any other system of pharmacy will not be allowed to practice modern system of pharmacy in any form. The registered pharmacist is bound to uphold the dignity and honour of his profession. Once the rule is notified, it will become mandatory for the pharmacist to attend two refresher courses in pharmacy of minimum one day duration each in a span of five years organized by PCI or government agencies or professional bodies recognized by the Council.

Another significant clause is that for the advancement of the profession, a registered pharmacist should affiliate with associations and societies of allopathic pharmacy professions and involve actively in the functioning of such bodies. He should also participate in professional meetings as part of Continuing Pharmacy Education programmes organized by reputed professional academic bodies or any other authorized associations.

According to the draft regulations, the pharmacist has to undertake a pharmaceutical assessment of every prescription presented for dispensing. Pharmaceutical assessment means the point at which registered pharmacist applies his knowledge to establish the safety, quality, efficacy and rational use of drugs treatments specified by a prescriber. He should be ready to respond to the calls of the sick and the injured and be mindful of the high character of his mission and the responsibility he discharges in the course of his professional duties.

Centre should engage more pharmacists to make up shortfall of medical personnel: Dr.Suresh

Union government should look at utilising the large pool of one million pharmacists in the country to support the growing shortfall of health workers in primary and community health centres. Although considerable efforts are being made by the Centre to take on pharmacists to support its shortfall of medical personnel, a lot more needs to be done, stated Dr B Suresh, president, Pharmacy Council of India and vice chancellor, JSS University, Mysore.

There are a large number of pharmacists which are underemployed in the country at the government medical and regulatory institutions. For instance, the government had set up 12 pharmacovigilance centres in the country and 11 of these facilities are manned by medical professionals with only one centre offering an opening for a pharmacist. This should change and pharmacists should be selected for many of these assignments, Dr Suresh told Pharmabiz on the sidelines of the 62nd Indian Pharma Congress which was held at Manipal between December 17-19, 2010.

"The only way to achieve the goals of the Pharma Vision 2020 would be to ensure pharmacists get the right opportunity and serve as a link between patient and the doctor. Going by the serious shortage of doctors, pharmacists can pitch in to support the healthcare services in the areas of medication management, outcome monitoring and dosage monitoring," he added.

"The pharmaceutical industry which has come up to a level of recognition now needs to take the assistance of pharmacists in the areas of promoting safe, effective, rational medicine use and patient counselling for India to be able to achieve the Pharma Vision 2020 mandate."

Currently, the country has the largest qualified pharmacists pool compared to the developing countries of Africa and South Asia. While it is estimated by the World Health Organisation that funds to the tune of US$ 2.5 billion will be needed to train the pharmacists in these countries, Indian government should tap the opportunity of allowing pharmacists to take assignments in these countries under a mutual agreement between nations facing a shortfall of healthcare workers, pointed out Dr Suresh.

Therefore the qualified pharmacists in India now need to increase their expertise and expand their knowledge base in the areas of high tech tailored drug therapies for not just communicable diseases but also maternal and ageing population diseases.

Over the last four IPCs beginning from Mumbai in 2006, Pharmacy Council of India and the IPCA have taken up the onus to create an awareness at these platforms on the importance of pharmacy regulations, building trust, safety and efficiency in healthcare. "We have made inroads as far as extensive and intensive information, education and communication exercises are concerned. Now the government should ensure that pharmacists are utilised in many areas of the healthcare services", he stated.

A pharmacist can play a wider role in reducing fatalities arising out of medication errors, maternal healthcare, child immunisation programmes, besides controlling the spread of AIDS, HIV and tuberculosis. The government will be able to reduce the disease burden if their services are well utilised opined Dr. Suresh. Therefore the need of the hour is to sensitize the indispensable role of pharmacists in the healthcare space, he added.

Schedule N of D&C Act needs to be revised laying down norms for community pharmacy: S L Nasa

India’s drug regulatory authority should look at revising Schedule N of the Drugs & Cosmetics Act 1940 to lay down standards for space, equipment and staff for community & hospital pharmacies, stated S L Nasa, president , 62nd Indian Pharmaceutical Congress Association 2010.

“There is an urgent need to focus on the revision of Schedule N and lay down the Good Pharmacy Practice guidelines which should be applicable to the hospital and community pharmacy. From the regulator’s perspective, it would call to strengthen the infrastructure, increase the number of drug inspectors, augment laboratory testing facilities and legal cells to implement the Drugs & Cosmetics Act, stated Nasa in his presidential address at the inauguration of the recently concluded event at Manipal.

Delving on the theme of the 62nd IPC 2010, ‘Pharma Vision 2020:Pharmacist for a Better Tomorrow’, Nasa said that pharmacists provide vital support to healthcare sector from the bench to the bedside. Although for a pharmacist, drug dispensing was a primary function, their role could include services like patient counselling, prescription monitoring to drug therapy monitoring, rational drug prescription and be accountable for safe, appropriate and cost effective use of medicines.

Based on the need for serving the healthcare sector, the country has over 12 universities and colleges offering post graduate courses in Hospital Pharmacy in India. The dedicated curriculum would help mould a candidate in the course. Going the theme of 62nd IPC, there is a need to work towards making a pharmacist as a responsible member of the healthcare system. This would mandate revision in the pharmacy curriculum with the implementation of patient focused pharmacy training. This is where the Pharm D or Doctor of Pharmacy course is a step in the right direction where a student after 12th standard undergoes a 6 years intensive training. The first batch of candidates which pass out of the course in 2014 need to be provided with a conducive environment for hospital-based practice, he added.

In order to be ready with the required infrastructure for the qualifying D Pharm candidates, there is a pressing need for a legal support to ensure that the hospitals with over 200 beds should come under a pharmacist and a full fledged Department of Pharmacy should be set up to commence the service. The Medical Council of India should also be persuaded to lay down the minimum standards of hospital pharmacy in terms of space, staff and equipment before granting the permission to the hospitals attached to these medical colleges.

As part of improving the over all standards of the pharmacy profession, the IPCA president also stressed on the need to upgrade Diploma in Pharmacy (D Pharm) to B Pharm as a minimum qualification to register as a pharmacist.

Expressing concern about the issue of mushrooming of pharmacy colleges in the country, Nasa cautioned that it would be detrimental going by the slow demand in employment as against an increased supply coming out of the over 1,000 colleges. In this regard, he called upon the stakeholders to work along with the pharmacy colleges to help evolve a system and adopt changes which will help to adapt to the newer expectations of the profession.

Betterment of Pharmacy Profession

1. We may shout from rooftops that we are professionals, like doctors, architects or lawyers, but we must also admit that the society still considers our retail or hospital pharmacists as traders and compounders. Therefore, we must launch a sustained stress relation programme to focus the role of the pharmacist as a vial link between a doctor and the patient and also to the society. Only words or speeches are not enough for creating this new image for a pharmacist. What is needed is action. This could be achieved by better interaction with various groups of the people, participation in their social programmes and also organising blood-donation and eye-donation programmes and such other social activities as well as counseling the patient. Both, PCI and State Councils should take up this activity on a priority basis.

2 Diploma in pharmacy courses should not be discontinued ascontemplated but they should be re-structured and should be given a new look, weeding out non-essential topics and giving more thrust on topics, which would serve the pharmacist well in future. There should be specialization after the first year level, where a student gets thorough grounding in basic subjects. Presently less than 1% of Degree holders join retail-hospital pharmacists.
 

3 There should be separate representation for hospital
Pharmacists and teachers in Diploma colleges, both, in Central and State Councils to make it more representative.

4 The pharmacy Act, 1948 requires that a prescription be
dispensed by a regd. Pharmacist only, whereas the Drugs and Cosmetics rules require that this activity could be carried out under the supervision of a Registered Pharmacist. This anomaly in the two legislations on the same requirement needs to be remedied immediately.

5 PCI & State councils should impress on government that the
owner of a retail pharmacy must be a registered pharmacist. A provision on these lines is necessary in the drugs and cosmetics rules. Such a provision existed in Goa before it formed a part of India.

6 Pharmacy Education, both at Diploma and Degree level
Should be treated as a separate professional qualification and should no be equated with other Engineering’s qualifications, and should not be clubbed with AICTE. PCI should be the sole authority to decide on the syllabi and course-contents. The present arrangements give the profession of pharmacy and PCI a secondary role and position.

7 There should be more interaction between the central and state councils and all programmes workshops etc. sponsored by PCI should only be through the state councils. It is not proper that the PCI should sponsor such programmes in collaboration with other educational or professional institutions directly, since, a state council exists and is the right authority to get such programmes organized.

There could be many more suggestions, which I may not have been able
to cover, but, have tried to take a comprehensive view of the entire matter so that a profession of the pharmacy gets a respectable position, not only in health services of the country but also in hearts of the people.