Tripathi Rational Use of Drugs

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Rational Use of Drugs

The India Perspectives and Contexts

Dr Santanu K Tripathi MD, DM

Professor of Pharmacology

Burdwan Medical College, Bardhaman, INDIA

[email protected]



Presentation Plan History and definitions

Problems and concerns in India Strategies / interventions recommended

to improve the drug use situation

Efforts and struggle in India towardschanging the scene

Much more needed



Rational Drug Use Historical PerspectiveRational Use of Drugs

SIR,-In common with other medical practitioners I have received a copy of the

very helpful booklet' which sets out the relative cost of proprietary

preparations and their equivalents. Recently, when wishing to prescribea suitable preparation for threadworm infestation, I referred to thebooklet to see whether there was any difference in cost between" elixir antepar " and the B.N.F. equivalent, elixir piperazine citrate.Discovering that the latter is considerably cheaper, I duly ordered that.However, the dispenser actually issued the proprietary, as that was theonly preparation in stock. As a result, my earnest endeavour to play apart in the much-needed drive for economy was frustrated. What is the

answer to this ? I imagine that this is by no means an isolatedexample. -I am, etc., - Halifax. Yorks. MALCOLM B. BUTLER.REFERENCE: N.H.S. Pharmaceutical Services: Costs of British National

Formulary and Proprietary Preparations. July, 1958.

1536 DEC. 20, 1958 CORRESPONDENCE BRITISH MEDICAL JOURNAL



What is Rational Use of Drugs?

The rational use of d rugs requires that

patients receive medicines appropriate totheir clinical needs, in doses that meet their own individual requirements, for anadequate period of time, and at the lowest

cost to them and the community.---------- (WHO conference of experts, Nairobi 1985 )



What is Rational Use of Drugs?

1. Receive medicines

- Availability Industry/Govt Policy2. Appropriate to clinical needs- Diagnosis, Right Choice Physician Education3. Dose/durn - individual need- Individualisation Physician Education4. Lowest cost

- Affordability Industry/Govt Policy

The 1. and 4. are in fact components of ACCESS

The rational use of drugs

requires that

patients receive medicines appropriate to

their clinical needs ,

in doses that meet their

own individual requirements ,

for an adequate period of time,and at the lowest cost to them

and the community.



Major Stakeholders in RUD

People

Care providers Industry

Government

University



Irrational use of medicines a global concern

Irrational use of medicines is a major problemworldwide.

WHO estimates that more than half of allmedicines are prescribed, dispensed or soldinappropriately, and that half of all patientsfail to take them correctly.

The overuse, underuse or misuse of medicines results in wastage of scarceresources and widespread health hazards.



Examples of irrational use of medicines#Use of too many medicines per patient ("poly-pharmacy")#Inappropriate use of antimicrobials, often in inadequate dosage,

for non-bacterial infections

#Over-use of injections when oral formulations would be moreappropriate#Failure to prescribe in accordance with clinical guidelines#Inappropriate self-medication, often of prescription-only

medicines#Non-adherence to dosing regimes

- Joint NGO/WHO briefing presentations on Rational Us e of Medicines,60th World Health Assembly, 2007



RUD : Barriers and Problems in India

Problems of availability and affordability

Far too many products in the market Unethical promotion of products

Irrational prescribing - quackery

Lack of diagnostic facility



Irrational Prescribing - Rampant

- Use of drugs when no drug therapy is needed

- Use of wrong drugs

- Use of drugs with doubtful efficacy

- Use of drugs with uncertain safety status

- Unnecessary use of injections and antibiotics

- Incorrect administration, dosages, or duration



RUD : Barriers and Problems in India

Lack of medicine literacy among people

Poor adherence

Inadequate or inappropriate dispensing Ignorant or ill-informed self-medication

Inadequate control and poor enforcement

No clear strategy by the government



Affordability Problem and Self Medication

Illnessseen inhospital

Illness seen versus costs incurred - OTC Policy?

Cost transfer

Illness seenby general

practitioner

Self-care not seenby medical service

Hospital costs

GP costs

Self-treat-ment

Innovative

Prescription

Medicines

Self-MedicationMedicines



Unscientific FDCs Historical connection with the RUD

movement in India many battles

fought in the Court of Law

The publication of the National EDLmay be considered to be an

outcome of such legal battle.



FDCs - Irrationalities

Ranbaxy, others to scrap 60 drug combinations Leading drug makers - Ranbaxy, Cipla, Cadila, Nicholas Piramal

and Wockhardt, will soon withdraw about 60 drug combinations

from the market. The voluntary move comes a year after theIndian DRA had asked them to withdraw the combinationdrugs' as they are "unnecessary" and may pose healthhazards.

The DCGI had banned 294 combination drugs sold under nearly1,053 brand names from the market in June 2007. Since then,

the pharma industry and the the drug authority have beenlocked in a legal battle. Source: P B Jayakumar & Joe C Mathew / Mumbai/New

Delhi July 7, 2008. Business Standard Oct 12, 2008



RUD - Drug Quality and Safety For patients, quality means consistently

and reliably meeting their needs.

Controlling GMP requirements not enough - shift the paradigm from GMPcontrol to risk control.

This necessitates better interpretationof risk.



RUD - Drug Quality and Safety Risk is the probability and severity of undesired

effects, that can be measured through product

performance. Risk-based assessment system focuses on

evaluating critical quality attributes that areessentially associated with the molecule,

formulation behaviour and manufacturingprocess in relation to the product performance.

The issue oversimplified in India - emphasis on GMP only,that too with dual standards.



Dual standards in GMP compliance

The industry in India adopting dualstandards in compliance to GMPrequirements - separate facilities fordomestic supplies and internationalsupplies.



How to ensure RUD? Monitoring medicine use and using the collected

information to develop, implement and evaluatestrategies to change inappropriate medicine usebehaviour are fundamental to any nationalprogramme to promote the rational use of medicines. A mandated national body to co-ordinate all activitiesand sufficient government funding are critical tosuccess.

-- WHO Policy Perspectiveson Medicines - Promoting rational use of medicines:core components, 2002



RUD Principles

RUD means therapeutically sound and cost-effective use of medicines by health

professionals and consumers achieved at alllevels of the health system, and in both thepublic and the private sectors

This is crucial both to reducing morbidity and

mortality from communicable and non-communicable diseases, and to containingdrug expenditure.



RUD Principles

RUD integrates two major principles:

Use of drugs according to scientific dataon efficacy, safety and compliance

Cost-effective use of drugs within theconstraints of a given health system



RUD ParametersParameters that are linked to RUD are Treatment guidelines

Essential Drug list Perception of drug quality Medical education and culture Patient education

Prescriber monitoring Incentives for providers and physicians Dispensing rights for physicians



RUD Programme A sound RUD programme in any country has three

elements:

RUD strategy and monitoring -- implementing and monitoring anational strategy to promote RUD by health professionals andconsumers, and securing responsible medicines promotion.

RUD by health professionals -- developing and updatingtreatment guidelines, national essential medicines lists andformularies, and supporting training programmes.

RUD by consumers -- supporting the creation of effectivesystems of medicines information, and empowering consumersto take responsible decisions regarding their treatment.



K ey interventions to promoting RUD

as advocated by WHO

Establishment of a multidisciplinary national body tocoordinate policies on medicine use

Use of clinical guidelines Development and use of national essential medicines list

Establishment of drug and therapeutics committees indistricts and hospitals

Inclusion of problem-based pharmacotherapy training inundergraduate curricula

Continuing in-service medical education as a licensurerequirement



K ey interventions to promoting RUD

as advocated by WHO

Supervision, audit and feedback

Use of independent information on medicines

Public education about medicines

Avoidance of perverse financial incentives

Use of appropriate and enforced regulation

Sufficient government expenditure to ensureavailability of medicines and staff.



RUD Role of CSOs in India

Civil Society Organisations championingthe cause of RUD in India

K SSP, DSF, LOCOST, VHAI, AIDAN, DAF,

CDMU-Bengal, CUTS, CDMU-Orissa, CHMU-Patna,

CM AI, DSPRUD, NETRUM-India



Strategies adopted by NGOs Law suits PILs Awareness campaigns Workshops and Training Programmes Lobbying and Advocacy for Policy Changes Parliament questions Newsletters Bulletins E-Networks and E-Conferences

Research Activities Media coverage Drug Information Centre (DICs)



The Lentin Commission Report 1986

Between January 21 and February 17, 1986, 14 patients died in J.J.Hospital, Bombay of acute renal failure after being administeredadulterated glycerol which contained 18.5% diethylene Glycol

(even 1% diethylene glycol can cause damage).

The Lentin Commission probed into the deaths and succeeded inexposing the nexus between politicians, the Food and Drugs

Administration (FDA) and the drug manufacturers.

In the course of the hearing - between January and September 86,582 formulations were found to be substandard with hardly anyaction taken against the offenders, many of whom were the"reputed" big companies.



The Lentin Commission Report 1986

"These pages describe and illustrate the ugly facetsof the human mind and human nature, projectingerrors of judgment misuse of ministerial power and

authority, apathy towards human life, corruption,Nexus and quid pro quo between unscrupulouslicense holders, analytical laboratories elements inthe industries department controlling the award of rate contracts, manufacturers, traders, merchants,

suppliers, the Food and Drugs Administration andpersons holding ministerial rank."



RUD Newsletters

Newsletters and Bulletins NETRUM-India Newsletter

BODHI CDMU Rational Drug Bulletin

CM AI Rational Drugs

Drug Disease Doctor

Medico Friend Circle Bulletin

TNMSC Times

Bulletin of the Society for Rational Therapy



Curricular Reforms Curricular reforms in medical and

pharmacy education challenges in

implementation

Trainings and workshops



The Delhi Model

Immense role played by DSPRUD

Working mainly with care providersfor capacity building and thegovernment for policy reform bothnational and state



Addressing the Access Issue

Rational procurement model

Tamil Nadu Medical ServicesCorporation (TNMSC) 1994



Access to low cost medicines

India improves access to low cost medicinesMohali | Monday, Oct 13 2008

India has become a leading international player in genericmedicines and has been able to considerably improve access tolow cost medicines for the common people not only within Indiabut in many developing countries.

---- Mr Ashok K umar, Secretary,Department of Pharmaceuticals, Union Ministry of Chemicalsand Fertilizers, India

Source : http://news.webindia123.com/news/articles/India/20081013/1077565.html



Regulatory Agency Changing in India!

Restructuring/Strengthening of regulatoryframework with proposed creation of an

independent Central Drugs Authority (CDA)MOH&F - CD A - DCGI

Bill Pending in Parliament



Proposed Divisions in the CDA

Pharmacovigilance Regulatory Affairs & Enforcement

New Drugs & Clinical Trials Biological & Biotechnology Products Medical Devices and Diagnostics Imports Organizational Services Training and Empowerment Quality Control Affairs Legal and Consumer Affairs



Parliamentary panel rejects proposal for new CD A

The Parliamentary standing committee on

health and family welfare has virtually shot down the proposal for a new Central Drug Authority (CDA) and instead recommendedsetting up of a 'central drug administration.



Who could change the scenario ?

Government Central and State

Universities and Academic Councils

Professional Societies

Civil Society Organisations

Lay Press and Media

Court of Law Industry Corporate Social Responsibility

Hospitals Administrative Authority



Analogy with Indian understanding that

precedes the WHO concept of RUD

Eternal vigilance is required to ensurethat the health care system does not get

medicalised,that the doctor-drug producer axis does not

exploit the people andthat the 'abundance' of drugs does not become

a vested interest in health.- ICMR/ICSSR Health for All Report, 1981



Thank You!

Tripathi Rational Use of Drugs

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