From,
Bhagwan P. S, B. Pharma, Frmr. Registrar, KSPC, Frmr. Dy Director (PHARMACY), HFW dept, Govt. Of Karnataka.
• To
• The Secretary,
• PCI,
• Dear Archana. Mudagal ji,
• Greetings & Good wishes.
• Sub: Creating a Pharmacy service system in the Indian Healthcare system.
• Well madam, as you are aware that an organized pharmacy service system does not exist in Indian healthcare system and as such pharmacists with different qualification, specialization and capabilities are deprived of an opportunity to serve in the healthcare sector.
• Needless to say the notifications you as Secretary PCI issuing from time to time including the ppr 2015 and it’s latest amendment hardly provides any clue or a clear roadmap for the policy makers and Bureaucrats to consider or discuss.
• Govt being the largest healthcare service provider in India needs to be apprised from all angles (1) structural, (2) functional with (3) financial implications. But we from PCI can provide the (1) and (2) leaving the (3) to the Government to decide.
• Hence, with my experience and knowledge gained in Govt service I submitting to you a draft proposal to uplift the Indian healthcare system that needs and provides a comprehensive #Pharmacare support service for onward submission to the Govt of India.
•# PharmaCare – A concept to upgrade Indian Healthcare System,
👉Introduction
• Indian Healthcare system is a very huge and complex service system catering to ……. millions of people in India. The system involoves a massive preventive sector and an equally large curative sector. Considering the dictum that ‘The Medical care begins the moment the Healthcare fails’ the Govt of India is spending very heavily on the preventive sector to ensure the medical care is minimized as much as possible.
• Though the system to address the healthcare and medical care is in place there are some serious lacunae that are causing serious deficiencies in the servive that are just ignored or accepted on default but seldom assessed and openly admitted due to some obvious reasons.
• What the public are seeing and appreciating is glamorous looks and some relief they are getting with no knowledge of hidden threats of loaded molecules the consequences of which are just accepted to ignore or go in for one more round of treatment either as a new problem or an accepted ongoing exercise.
• Indian medical practice is being very very poor in documentation it is humanly impossible to trace back and investigate to find out the trouble shooting black spot. So to say, the Indian medical practice is far behind #Evidence Based Therapy.
• Amidst the massive drugs movement that is happening the cry due to scarcity of the vital drugs at the terminal service point and financial burden due to illogical vendor driven procurement and the consequence wastage and demand for more and more funds is an equally a massive challenge.
• But, knowingly the Indian Healthcare system is continuing the weak traditional system and deliberately avoiding the solution that warrants professional management with Logistic Pharmacists and Clinical pharmacists.
• Situation analysis
• In India, we have a National Drug Policy which is industry oriented but not Healthcare oriented and we do not have a ‘National Medication Policy’ to ensure rationale and evidence-based medication. The National Health Policy document published annually seldom touches this problem and the need.
• Hence it is necessary for each healthcare professional and institution to be on their own guard, by study of literatures and maintaining their own clinical reports of drugs they use and monitor the compliance, results and Adverse Drug Events.
• ‘Pharmacovigilance’ is a figment of Clinical Pharmacy and is a routine duty of the Clinical Pharmacist and to a lesser extent of the logistic pharmacist also including retail pharmacist. Somehow making it a National vertical program under CDSCO is not convincing.
• As per the data from AIOCD AWACS more than 3000 products are launched in India every year. It is humanly impossible for any Clinician to understand and digest the intricacies of these new molecules. Formulations along with hundreds of ‘Me-too’ formulations let alone remembering their therapeutic indications, worthiness, possible toxicities, contraindications, incompatibilities etc.
• The irony is the clinicians prescribe the formulations that they never have seen but with the information they received.
👉 Drug Quality
• Everybody wants Good medicine. What is good medicine? 1. The one that gives good relief, the one with least side or after effect/d, the one that is safe, the one is affordable and effective with least side or after effect. Law says a Good medicine is one that passes the tests of standard which is only a In-Vitro parameter. Clinical satisfaction and patients satisfaction is a variable factor though is important.
• It is true that drugs and formulations under go quality check while during process and also before being released into the market. That means each batch is as per standardized well tested and established procedure.
• Unfortunately, the fact is:
• “What is tested is not available for use and what is available for use is a presumptive quality”.
• Nothing wrong and it is inevitable but warrants only an additional care to keep evaluating at Clinical level too with due documentation of observations, experience and feedback on its affordability, acceptability, patients comfort, clinical or therapeutic response, Adverse events etc . But, these aspects of therapy are observed and experienced only in the clinic.
• Clinicians changing their own prescription for unknown reason to a different make of a same molecule or formulation are almost an everyday happening at the cost of the patient. This is going on undocumented and nobody dares to question?. The Therapeutic quality assessment though variable from one Clinician to the other and one clinic to the other can also be standardized near to reliable accuracy through documentation which forms the backbone of pharmacare service. This documentation particularly at thr institutional level can for a part of the evaluation of tender while fixing Contract.
• This warrants an in-house comprehensive ‘Pharmacare’ department to carry out in-house evaluation of all the medication related issues so that what reaches the Clinician and the patient at least in and from an institution would be of a well-studied and clinically evaluated formulation. That ensures evidence-based medication therapy.
• Clinicians are so hard pressed for time and the patient load being so heavy. It doesn’t allow any comfortable free time for them to do library and literature research to keep themselves abreast with the trend and true picture of the products they are using. They need an in-house reliable dedicated facility to study the medicines they use and appraise them regularly in the best interest of the patients.
• This situation warrants a need for a professional service system that could be called “PharmaCare” system that addresses all challenges cited above professionally to support the Healthcare preventive and curative institutions to ensure Professional Drugs logistic system obviating scarcity and loss on one hand & Evidence based therapy and better patient compliance to support the Clinicians.
•ðŸ‘‰ Objectives of Pharmacare service
• To achieve:
• Economy with reliable drugs logistics
• Zero Prescription and medication error
• Zero defect in the drugs delivered
• Improved patient compliance
• Reduced morbidity rate
• Patient’s records that can match with logistic records
• Streams of Pharmacare service
• Drug Logistics Management (DLM) headed by a Chief Drugs Logistic Pharmacist
• Supportive Clinical Pharmacy Service (SCPS) headed by a Chief Clinical Pharmacist
• 👉Broadly here is how they would be functioning:
• Drug Logistics management (DLM) • Supportive Clinical Pharmacy Service (SCPS)
• Preparation of drugs list with full specification and coding.
• Preparation of Essential list of drugs and quantification
• Budgeting to put forth rational demand
• Defining the stocks for procurement
• Rationale budget management
• Expenditure planning with the available budget
• Defining procurement policy
• Rational inventory management as per priority classification
• Distribution management
• Qualitative dispensing
• Standard Operating Procedure
• total quality management • Preparation of STG, EDL, Formulary
• Supportive service to clinician
• Patient counseling and assistance
• Pharmacovigilance program
• ADR monitoring, reporting and evaluation
• Drug efficacy evaluation in vivo – to eliminate ineffective drugs from the hospital formulary and stocks
• Study of product literatures and technical interaction with Pharma representatives
• Develop standard facility and SOP as per the Act & Rules for clinical trials with due safeguards for the volunteers
• Total quality management
• 👉Benefits to Clinicians
• Hassle-free supply of reliable approved drugs & formulations
• Lessened brain burden on Clinicians as clinical pharmacist would be supporting with case specific drug information
• Pin pointed prescription and minimized ADRs
• Counseling service by clinical pharmacists to each patient on medication regimen
• Separate patient’s medication record– helps in follow up and in avoiding allergic molecules
• In-vivo efficacy evaluation of drug molecules helps in avoiding ineffective drug formulations that saves the time of the clinician as well as that of the patient.
• Clinicians can relax and focus on much higher and finer medical issues and follow-up measures
• Reduced morbidity that increases clinician’s rapport
• Clinic-guided procurement mode
• Benefits to the hospital
• More drugs turn-over with lesser budget
• Medicines at a competitive price
• Nil wastage of drugs due to expiry / idling stock due to Clinic-guided procurement mode
• Reduced hospital stay that increases hospital rapport
• Minimized local panic purchase
• Zero stock of ineffective and irrational formulations
• Benefits to the patient
• Availability and accessibility of all required drugs
• Minimum hospitalization as the system facilitates case specific well-judged pin pointed prescription that reduces manpower loss
• Counseling service by clinical pharmacists to each patient on medication regimen
• Minimizes medication trials
• Boosts patient confidence, improves trust in healthcare system, improve drug adherence
• Improved overall quality-of-life of patient and family
• Manpower and other infrastructure required:
• True, any new hither to non existing professional system warrants additional manpower and updating the skill and knowledge of the existing manpower.
• The existing pharmacy manpower would be fully utilized with due recognition and empowerment. 👉👉👉Besides, we need to employ certain specialized category of Pharmacist and post them with due empowerment to make them serve with responsibility and accountability.
• 👉Here I propose the following organogram for establishing Pharmacare Department in each Hospital: Drug Logistics Management (DLM) headed by a Chief Drugs Logistic Pharmacist (CDLP) and Supportive Clinical Pharmacy Service (SCPS) headed by a Chief Clinical Pharmacist
• Every hospital with a minimum of 100 beds should have a full-fledged Pharmacare department.
• The Pharmacy staff structure for a 100 bed hospital should be:
• Drugs Logistic stream:
• Chief Drugs Logistic Pharmacist (CDLP) - {Reporting to Medical Director of the hospital}
• Chief Pharmacist 1
• Pharmacists 8 ( 2*2 for main and sub stores & 2 + 2 for dispensing)
• One Clerical executive to assist CDLP as secretarial support)
• Supportive Clinical Pharmacy Service:
• Chief Clinical Pharmacist 1 {Reporting to Medical Director of the hospital}
• Unit Clinical Pharmacist One for each Unit.
• Chief Pharmacist – One for each Unit to assist Unit Clinical Pharmacist
• Pharmacist – One for each unit.
• Three Secretarial executive to Chief Clinical Pharmacist
• NB: All Chief pharmacists and Pharmacists are interchangeable between Logistic and clinical pharmacy streams.
• Well, I have tried to inject the Healthcare system with a professional PharmaCare management keeping all aspects of hospital management in view out of my experience, observations, prevailing strength and weakness of the hospitals, their existing managerial burden, freedom required to clinicians and administrators and to the pharmacists to serve with due accountability for patients safety..
• I wish this will materialize.
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