Well, I wrote this blog for the India Pharmacists Convention 2014 organized by the Udyog Development Foundation an NGO on 3rd August 2014 at the India International, Lodhi road, New Delhi to study and discuss the basic problems being faced by the pharmacists in India. The highlight was the participation of Dr. Jitrendra Bhai Patel, National President, Medical Association along with the Dr Narendra Saini , Secretary general IMAand the FDA Commissioner, Maharashtra Mr Mahesh Jagade IAS.
This was the only convention in my 5 decades of pharmacy professional life that gave me satisfaction and feel good and worth feeling.
I attended this convention as one of the panel speaker. I found this convention more interesting, worthy and meaningful because of its theme and objectives:
I thank Mr Amitav Joyprakash Choudhury Young and goal oriented founder President of Udyog Development Foundation, Delhi for organizing such a meaningful event and for all the pains he has been taking to uplift the profession.
Theme: "Pharmacists involvement in national health system and Policy"
Dr Bhatia, President IMA assured all support for the growth and development of Pharmacy and to involve them with due recognition in the National Health Policy and system in the best interest of patient's safety and well being.
Mr Mahesh Jagade IAS while appreciating the theme and objective of the convention lamented that the Drugs Act and Rules and the Pharmacy Act and Rules enacted by the Government to safeguard the patients has lost focus on the patient and is being fully exploited by the LICENSEES for their own self aggrandizement.
I solute both the dignitaries for their view and concern on the patient safety.
There were days when clinicians, Medical officers, medical administrators, health officers so to say the entire health system could never think of working without a 'Compounder'. The 'Compounder' of yester years has metamorphosed into a 'Pharmacist' with much better knowledge and skill. But, demand, recognition and identity are unmatchably so low and his presence in the midst of healthcare professional is more a notional to fulfil to statutory needs and the pharmacist has remained an 'Alien'. Nevertheless, whether the National health sector, national health policy accepts or not "Pharmacist' has been, is and will continue to be involved professionally in the National Healthcare Team. But, had it not been for his patient attitude and for his aptitude to serve the mankind with a fond hope of getting recognized, the pharmacy as a profession would have been totally wiped out from the Indian scenario.
Hence more than anywhere in the world the 'Pharmacist' of India deserves to be congratulated and complemented. 'Pharmacist' in India is in no way inferior to any healthcare professionals and he is also a well qualified 'Professional'.
Hence the theme of the convention, the issues on the agenda and the simple demands being put forth is quite apt and appropriate.
'Professional' is a person who is indispensable for the job / service he does. That means he is a person having specialized expertise with knowledge and skill. A clinician, Nurse, physiotherapist, technicians in radiology, laboratory, advocate, painter, carpenter, cobbler, Taylor, Electrician, mechanic are all called professionals with their own professional freedom to do their job. They are indispensable in their job. Likewise the pharmacist is also a person with specialized knowledge on all aspects of the drugs from its genesis to its application through the technology of processing. Hence justifiably the law of the land has accorded a 'professional' status on him with a title 'Pharmacist'.
The highlight of the law is that the 'The Drugs & Cosmetics Act 1940 and The Pharmacy Act 1948' do not accord the rights and privileges given to the 'Pharmacist' on any other healthcare professional including clinicians. Hence, it is forgone conclusion that the 'pharmacist' is a technical professional.
But pharmacist in India is losing his professional ground by deliberately and knowingly allowing all and sundries to do his job. The lending of one's 'Registered pharmacist' certificate has been the biggest menace in this country which is a punishable under Section 42 of Pharmacy Act 1948.
Hereby I call upon all my fellow pharmacists:
O Please immediately withdraw your certificates if you have lent it or attend full time at your pharmacy.
O Please wear a white coat with a name plate while on duty and let the people know you by name that makes you professional in look.
O Please resolve that you will never place the patients in the hands of quack pharmacists
O This will only enhance your image and fetches you better status and remuneration
We have a robust regulatory sector both under the Central and state governments to enforce the laws and Rules under the Drugs & Cosmetics Act and Pharmacy Act. Yet such mal-practices defined as 'Professional misconduct' under section 25 of the Pharmacy Act 1948 are happening openly in broad daylight under the very nose of the regulatory authorities and the public.
Such a situation not only deprives the public from getting professional service but also has undermined the dignity and status of the pharmacists.
I Hereby call upon the regulatory authorities to:
O Please enforce the both the Drugs and Cosmetics Act & the Pharmacy Act 1948 under your authority and see that no patient is served by a quack pharmacist.
Our Co-professionals mainly the clinicians have also contributed to the loss of ground to the pharmacist by assuming themselves the role of the pharmacists even when the service of the pharmacist is available on the one hand and by accepting pharmacy support service from quack-pharmacist on the other, though they desire to have skilled and knowledgeable support team for the nursing care and diagnostic procedures and such other services.
But whether a person in the garb of the pharmacist likes or dislikes, there is no second opinion that professional technical service is required in the procurement, storage, distribution and dispensing of drugs in the interest of safeguarding the quality of the drugs, safety of the patient and therapeutic efficacy.
Further, the Drugs and formulations are invariably patient-specific and I am sure that my clinical friends would agree with me that two prescriptions looking alike cannot be considered identical. There are issues like cause of illness, age, sex, physiological conditions, history of previous medication, sensitivity, tolerance etc.
In principle, the pharmacist can be a small check-gate between the clinician and the medicine (like an accountant) to verify the prescription so that any inconsistency can be brought back to the clinician and get corrected in the best interest of the patient
In the best interest of the patients, I appeal to all clinicians in India:
O Please entrust the total drugs management system with professional freedom to the pharmacist,
O Please do not allow your prescriptions to be dispensed by a QUACK pharmacist and
O Please discourage your patients from visiting pharmacies where you find that the Registered Pharmacist is totally absent.
The poor employment potential, lack of identity, poor recognition and very poor remuneration compared to peer group in other profession have further compounded the issue forcing the pharmacist to look for alternate means to earn more resulting in loss of professional shine in the Pharmacist.
I hereby recommend that:
O A Pharmacist who with D.Pharm qualification who studies 10+2+2yr D.Pharm course should be paid a minimum salary of Rs 20,000.00 PM with PF and leave facility, so that he can lead a respectable life without a need to go in search of alternate income to supplement his needs and it paves the way for enforcing the duties and responsibilities accountably.
Unfortunately, neither the consumer nor the quack-pharmacist realizes the importance of the professional pharmacists service. The clinician is apprehensive to give any freedom to the pharmacy as there is no guarantee that his prescription will be filled by the qualified pharmacist.
O Hence, I hereby appeal to all the healthcare administrators, Hospital administrators and drugs dealers in India to:
- Please understand the gravity of the problem and make way for the people to get professional pharmacy service in the interest of the safety of medicines and patients.
I can quote from my own hospital-service and administrative experiences where I was thanked profusely by the clinicians when:
O I prevented a young boy from getting a 60mg Phenobarbitone on a prescription for phenobarbitone 1 daily (strength not mentioned) at bed time,
O I prevented a teenage girl from taking away 100 Tetracycline 250mg capsules on a prescription to take one a day for 100 days,(A debatable issue)
O I prevented the distribution of Sulphadimidine loose tablets stored in a lab- chemical bottle in a children's ward,
O I corrected the use of 2x250mg Tetracycline capsules twice a day against a prescription for 500mg twice a day.
O I prevented a hospital from using Formaldehyde contaminated IV fluids, prepared by a quack pharmacist.
O I helped a clinician in optimizing the drug effect by rescheduling medication timings, which otherwise would have resulted in alternate prescription or alternate clinician.
O Each Pharm D student is coming across dozens of Adverse Drugs Events (ADEs) many of which are very serious.
Likewise, thousands of medication errors are happening every day all over the country but they do not see the light of the day as there is no system for documentation, monitoring and reporting. The Pharmacy professional can carry out literature search study and help the clinician in preventing preventable medication hazards.
The grave errors in dispensing and legal violations that are happening due to professional misconduct, uncontrolled and unguided self medication are going totally uncontrolled.
The consumer in India cannot be faulted and is a scapegoat as he has to bear the impact of mistakes of both the prescription and dispensing on the one hand and lack of counselling on medication management at home on the other. He has accepted the system as he has neither seen nor tasted the professional pharmacy service to feel the difference.
Hence hereby, I appeal to the public and the consumer's forum to:
O Please realize the seriousness and demand the service from an Approved Registered Pharmacist whenever you go to pharmacy to procure your medicine.
O It is your right given under the law to demand identity of the pharmacist for your own safety.
The drugs logistic system in almost all hospitals and corporate pharmacies is either headed or managed by clinicians or non-technical administrators. The heirarchial gap between the ground staff (Pharmacist) and the administrators is so wide effective communication has become a casualty. The loss of money, irrational inventory, loss of storage space, scarcity of essential medicines and wastage of drugs due to expiry and unwanted stocks are all going unaccounted on the fear of 'Self-goal'. Besides, no hospital keeps data on No of patients turned out / died for want of specific drugs particularly in rural India, again for fear of 'Self-goal'.
Hence, I suggest that:
O There should be system to monitor every patient approaching the hospital for service irrespective of whether treated or untreated. Reasons should be recorded for not treating the patient.
A Good pharmacy practice has two kinds of audits built into it: inventory audit and performance audit whereas performance audit is totally absent and unheard of in medical practice in India. The performance audit is inherrant in 'Pharmacy-practice' that covers Pharmaco-vigilance activity, that extends from Prescription to Dispensing audit.
It is heartening that the Government of India has recently initiated Pharmacovigilance program and has established Adverse Drugs Reaction monitoring and reporting centres all over the country.
A statistical report from one hospital in India is quite alarming:
[I congratulate the authors for their dedicated study and findings and I apologize for quoting their findings without seeking their consent due to want of time and accessibility]
If this is the status in one hospital one can imagine seriousness and magnitude collectively under the whole healthcare sector in the country. I have a suspicion that may be they are being hushed up and swept under the carpet in the name of idiosyncrasy and masked out behind the showcased glamour of medical services and procedures.
However, my apprehension is that the Pharmacovigilance program may not last long as ADR monitoring and Reporting activity has been happening in isolation by the appointed staff without involving all the clinicians, Pharmacists and Nurses. The Pharmacovigilance staff are being seen as aliens in the hospital even by the other pharmacists in the hospital, as if they have come to snatch away all the freedom and authority they are enjoying. The appointed Pharmacovigilance pharmacists do not foresee any scope to grow in the profession. They have joined as associates and may retire as associate with a fixed salary. This may result in migration of experienced skilled staff or they feel frustrated and lose dedication and interest which would be a serious setback for the entire program.
O Hence I appeal to CDSCO and PvPI to please provide attractive placement and promotional ladder for the pharmacists working for Pharmacovigilance program.
Drug dispensing is not an end by itself. The job is not just trading or mechanical transfer of medicine from one hand to the other as has been made out in the current market and hospital practice. The Pharmacist's service is to continue to provide professional cover to the patient till the therapy is complete.
Further, the responsibility extends to counselling on Domestic Drugs Management (DDM) so that the drugs retain their consistency and potency, the patient adheres to the prescribed medication regimen for optimized efficacy and misuse and abuse of drugs can be prevented.
Nobody including non-pharmacy healthcare professionals can be a substitute to the Pharmacist for such kind of dedicated patient-specific pharmacy services.
Hence I appeal to the policy makers and administrators to:
O Please review the healthcare infrastructure and make hospital based 'Pharmacare' system a mandatory facility and infrastructure in all the hospitals and healthcare Centres.
O Please provide opportunity to the pharmacists to render their professional service by positioning them at key respectable levels with authority suitable to their qualification to ensure accountable drug logistics and dispensing system with Total Quality Management in the healthcare system.
The Indian pharma academe has derailed long back, perhaps right from its inception, the Drugs & Cosmetics Act, Rules and The Pharmacy Act too are all outdated and do not suite the current day requirement of pharmacy practice. There are glaring mismatches and inconsistencies that are affecting the pharmacists like:
a. Students learn practice of pharmacy to get their Diploma / Degree but, they seldom get license to practice pharmacy.
b. Pharmacists after obtaining their diploma or degree in pharmacy register their name in State Pharmacy Councils and get a 'Registered Pharmacist's certificate that bestows on them all rights and privileges to 'Practice pharmacy' under Pharmacy Act 1948. Yet, they cannot practice! They have to seek Drugs license from the Regulatory authority.
c. The Regulatory authority issues license to 'Sell, Stock and Distribute drugs' (not for practicing pharmacy) to the pharmacist based the Registered Pharmacist's certificate he possesses, Under the Drugs & Cosmetics Act 1940. - An ironical mismatch between the Education Regulation, Pharmacy Act and Drugs & Cosmetics Act.
d. Doctors have stopped writing prescriptions based on Materia-medica and National formulary almost 4 decades ago. There are no prescriptions for Mist Alba, Mist. Card Co, Mist. Sod Sal, Mist. Alkaline, Ung. Sulfa, salicylate, Lin. Terpentine, Lotio. Lead, Powder boric etc. But, the Drugs and Cosmetics Act 1940 is still maintaining the obsolete definition of 'pharmacy' that applies to formulating chemist.
e. The Drugs and Cosmetics Act 1940 do not permit a pharmacist to name his retail drugs store as 'Pharmacy' as it violates the definition of 'Pharmacy' in the Act. Therefore he is forced to suppress his humiliation and name his out let as a Chemist & Druggist / Drug store/ Drugs seller etc.
f. The Drugs and Cosmetics Act 1940 calls the professionally qualified pharmacist an 'Approved person' or 'Qualified person' but seldom addresses him as a Registered pharmacist.
g. Again in the Industrial sector the 'Pharmacist' is called 'Approved Chemist' but not a Pharmacist!
h. The Trading license issued to pharmacist under Drugs and Cosmetics Act has reduced the retail pharmacy to a non-technical trade.
i. Dispensing without verbal or written advisory / counselling to the patient is not an offence.
j. The very spirit of the Pharmacy profession and the Drugs Act Viz. has been silently ignored. Instead hundreds of amendments are have taken place till now addressing only the issues related to Pharma Industry.
k. The legal mandatory provision to display the Registered Pharmacist certificate for the public view is not enforced.
l. Registered pharmacists not wearing the dress code and identity name plate and not carrying the id card have benefitted quack-pharmacists to thrive and operate the retail pharmacy like any shop in the market.
Hence, I appeal to the hon'ble policy makers and administrators to:
O Kindly look into these anomalies and mismatches that are hurting the young pharmacists and hindering their professional progress.
O Please amend the Drugs & Cosmetics Act 1940 and the Rules and also to the Pharmacy Act 1948 to correct the anomalies and mismatches:
v The term 'Chemists & Druggists' should be deleted.
v The term 'Pharmacy' should be redefined to include stocking and dispensing of pre packed and pre-labelled drugs
v The term 'Approved Person' and 'Qualified person' should be replaced by 'Approved Registered Pharmacist'.
v The title "License to Stock, Sell / Distribute" should be replaced by 'License to practice pharmacy".
v The term 'Practice pharmacy ' should defined to include stock management , dispensing and counselling' the patient.
v A new clause should be incorporated to prevent dispensing of drugs if:
SS The prescription is not from a bonafide Registered Medical Practitioner
SS The prescription is not complete with respect to identity of the clinician, identity of the patient, signature and / or illegible
SS The prescription has lost its validity with respect to the course-of-treatment.
SS There exists a suspicion that the drug could be abused / misused.
O Similarly, the Pharmacy Act 1940 also needs amendments to make it Pharmacist friendly and to safe guard the public from inefficient, incapable and non-performing pharmacists:
v Please prescribe a minimum qualification of B.Pharm degree to become eligible for the post of the Registrar.
v Registration in State Pharmacy Council should be made mandatory to all Pharmacists irrespective of the profession they pursue.
v Registration should be made on 'Pan-India' basis with a common register to facilitate hazel-free migration from one state to other and to prevent multiple registrations.
v Section ___ of the Act should be amended to provide 5 years validity instead of 1 year for the Registered Pharmacist certificate with a rider that the pharmacist should submit 'Life-declaration' on or before January 31st each year.
v Submission of Fitness certificate from a Government Medical Board should be made mandatory for the 'Renewal' for the pharmacists aged 60 and above.
v The maximum age limit of 59 years should be fixed for first registration.
v The following issues have remained unaddressed in the Pharmacy Act 1940, due to which certain category of pharmacists are experiencing difficulty:
SS Foreign students with 'Student VISA' obtaining pharmacy diploma / degree from an approved college and university in India
SS Registered pharmacists from a foreign country migrating to India and intending to Register his name in State council.
Well, as regards the Pharma academe, I have the following suggestions to improve the quality and to make the education a need based one:
a. The Pharma curriculum should be restructured and updated once in two or three years to accommodate the latest technology and therapeutic devices and systems.
b. Experienced field professionals should be included in the panel to review the curriculum.
c. Field subjects / topics should be taught 'on-site'.
d. Teachers should accompany students to the hospital, community pharmacy or to the community around when they teach field related topics.
e. Teaching of outdated and obsolete sample prescriptions based on National formulary and material medica should be stopped as they have no relevance to the current field scenario.
f. Faculty should have field experienced professionals.
g. The semester system should be introduced to enhance the depth of knowledge with limited subjects and topics.
h. The publication of guides which have oversimplified the pharmacy education and have deteriorated the standard of study should be banned.
i. There should be facility and opportunity for the overall development of 'personality' so that pharmacist will have equipped himself to face the challenges in the profession
j. The teachers should present themselves in a professional look to motivate professionalism in students. Professional dress code should be made compulsory to the students.
k. The institution should ensure that the students passing out will have 'Initial shine and glow'.
Further, the Indian pharma industry is unique in ignoring the pharmacists in their product promotion activity. The industry has failed to take the pharmacists along with the clinicians in updating the product information in them.
This has resulted in making the pharmacist more out-dated and less important in therapeutic team. Inevitably the pharmacist has confined his expertise to MRP!
Attending workshops, seminars and conferences and subscribing to journals has been found not useful as they are more academic oriented and many a time not affordable. He is unable to interpret the prescription and counsel the patients.
His backwardness on current knowledge has lead to inferiority complex, professional dissatisfaction and self-cursing attitude for having become a pharmacist.
Hence, I appeal to Indian Pharma industry to:
O Please provide orientation programs for pharmacy students to update them to the current technology
O Please insist on the Pharmacy Registration whenever you employ a pharmacist and ensure that they do not lend their Registered Pharmacist certificate.
O Please include the pharmacist in your product promotion contact list and activity and take him along at least with minimum information so that your products are safely and rationally used.
Drugs are integral component of healthcare service and pharmacists are appointed to provide support service in pharmacy. But absolutely no professional freedom and authority is given to him to put forth his professional input effectively:
v Pharmacist cannot freely indent what is in demand.
v Pharmacist cannot say that huge stocks of such and such a drug molecule has remained unutilized and should not be indented.
v Pharmacist cannot refuse the stocks found short dated
v Pharmacist cannot send back the expired stocks to the source
v Pharmacist cannot demand the stores key from the medical officer to conduct stock audit
Pharmacists are not included in any committee and their services are not effectively recognised and used in planning of hospital drugs stores, in Preparation of Standard Treatment Guidelines, EDL, drugs selection, drug specification drafting, preparing bid terms and conditions, bid evaluation, quality assessment, quantification process, procurement, stocking pattern, indent preparation, budget planning.
The drugs regulatory authorities should avoid playing the role of the in-house pharmacists on above issues, so that the in-house pharmacists get their due recognition and identity.
But, the painful fact is that there is no place for the pharmacy and pharmacist in the National Health Policy document. 'Pharmacist' has no respectable identity and role in National Healthcare programs. Drugs are procured and stored and managed by non-pharmacy executives including Cold-chain management under Immunization program.
Administrators in both the Central and State Governments and other sectors mentioned above where pharmacists are employed are still continuing their outdated mindset that Medical doctors are the best for managing the drugs, which is unfortunately not true.
Hence, I appeal to Hon'ble policy makers and administrators to:
O Please review the National Health Policy and include "Pharmacare" service as one of the mandatorily required facility and infrastructure in all the hospitals.
O Please provide respectable identity and recognition to the pharmacist in all the healthcare programs
O Please provide the pay scale on par with other diploma holders who study 10+2+2 to get their diploma.
O Please bring out a National medication Policy to prevent irrational medication and to promote production of only rational formulations.
O Please establish a cadre ladder for D Pharm, B Pharm, M. Pharm and Pharm D graduates.
The focus on patient is conspicuously lost both in medical practice and in pharmacy practice (?).
* Doctor doesn't have records to show whom he treated and what medical advise he gave.
* Chemist (Pharmacist?) has no record to show which medicine he dispensed to whom.
* Patient most of the time neither knows the doctor, nor the pharmacist nor the drug he has been dispensed and what to look for in case he should stop medication and report!
In case a drug is banned:
* Doctor gets into gossip discussion with their colleagues and with the medical representatives instead of looking for the patients whereabouts to tell them 'Not TO Use' but to come back for alternate prescription.
* Chemist (Pharmacist?) gets busy in digging out his purchase document to return the stock and claim credit from his principals, instead of looking for the patients whereabouts to tell them 'Not TO Use' but to return the unused stocks.
Hence, I appeal to the Pharmacists to keep track of the drug movement to the last point possible and keep contact with the patients to guide them on proper medication regimen.
The pharmacy profession in India needs a very drastic change from academe to professional practice and regulation, as otherwise it will be cruel to make anyone a 'Pharmacist'.