Rational Use of Drugs The India Perspectives and Contexts by kAzB31A

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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
       tripathi.santanu@gmail.com
    Presentation Plan
   History and definitions
   Problems and concerns in India
   Strategies / interventions recommended
    to improve the drug use situation
   Efforts and struggle in India towards
    changing the scene
   Much more needed
   Rational Drug Use – Historical Perspective
                        Rational 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 prescribe
    a suitable preparation for threadworm infestation, I referred to the
    booklet 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 the
    only preparation in stock. As a result, my earnest endeavour to play a
    part in the much-needed drive for economy was frustrated. What is the
    answer to this ? I imagine that this is by no means an isolated
    example. -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 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.
     ---------- (WHO conference of experts, Nairobi 1985)
         What is Rational Use of Drugs?

   The rational use of drugs
          requires that           1. Receive medicines
  patients receive medicines      - Availability Industry/Govt Policy
         appropriate to           2. Appropriate to clinical needs
      their clinical needs,       - Diagnosis, Right Choice Physician Education
                                  3. Dose/durn - individual need
    in doses that meet their
                                  - Individualisation Physician Education
 own individual requirements,     4. Lowest cost
for an adequate period of time,   - Affordability Industry/Govt Policy
and at the lowest cost to them
      and the community.          The 1. and 4. are in fact components of ACCESS
Major Stakeholders in RUD
   People
   Care providers
   Industry
   Government
   University
    Irrational use of medicines – a global concern

   Irrational use of medicines is a major problem
    worldwide.
   WHO estimates that more than half of all
    medicines are prescribed, dispensed or sold
    inappropriately, and that half of all patients
    fail to take them correctly.
   The overuse, underuse or misuse of
    medicines results in wastage of scarce
    resources 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 more
  appropriate
#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 Use 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
Illness seen versus costs incurred - OTC Policy?


        Illness
        seen in      Hospital costs                Innovative
        hospital
                                                   Prescription
     Illness seen                                  Medicines
      by general        GP costs
     practitioner



                                                   Self-Medication
Self-care not seen         Self-
                          treat-

by medical service        ment                     Medicines

                                   Cost transfer
    Unscientific FDCs
   Historical connection with the RUD
    movement in India – many battles
    fought in the Court of Law
   The publication of the National EDL
    may 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 the
    Indian DRA had asked them to withdraw the „combination
    drugs' as they are "unnecessary" and may pose health
    hazards.
   The DCGI had banned 294 combination drugs sold under nearly
    1,053 brand names from the market in June 2007. Since then,
    the pharma industry and the the drug authority have been
    locked 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 GMP
    control to risk control.
   This necessitates better interpretation
    of 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 are
    essentially associated with the molecule,
    formulation behaviour and manufacturing
    process 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 dual
    standards in compliance to GMP
    requirements - separate facilities for
    domestic supplies and international
    supplies.
How to ensure RUD?
   “Monitoring medicine use and using the collected
    information to develop, implement and evaluate
    strategies to change inappropriate medicine use
    behaviour are fundamental to any national
    programme to promote the rational use of medicines.
    A mandated national body to co-ordinate all activities
    and sufficient government funding are critical to
    success.”
                           -- WHO Policy Perspectives
    on 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 all
    levels of the health system, and in both the
    public and the private sectors
   This is crucial both to reducing morbidity and
    mortality from communicable and non-
    communicable diseases, and to containing
    drug expenditure.
 RUD Principles
RUD integrates two major principles:
 Use of drugs according to scientific data
  on efficacy, safety and compliance
 Cost-effective use of drugs within the
  constraints of a given health system
RUD Parameters
Parameters 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 a
  national strategy to promote RUD by health professionals and
  consumers, and securing responsible medicines promotion.
RUD by health professionals -- developing and updating
  treatment guidelines, national essential medicines lists and
  formularies, and supporting training programmes.
RUD by consumers -- supporting the creation of effective
  systems of medicines information, and empowering consumers
  to take responsible decisions regarding their treatment.
     Key interventions to promoting RUD
     as advocated by WHO

   Establishment of a multidisciplinary national body to
    coordinate policies on medicine use
   Use of clinical guidelines
   Development and use of national essential medicines list
   Establishment of drug and therapeutics committees in
    districts and hospitals
   Inclusion of problem-based pharmacotherapy training in
    undergraduate curricula
   Continuing in-service medical education as a licensure
    requirement
    Key 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 ensure
    availability of medicines and staff.
RUD – Role of CSOs in India
   Civil Society Organisations championing
    the cause of RUD in India –

    KSSP, DSF, LOCOST, VHAI, AIDAN, DAF,
    CDMU-Bengal, CUTS, CDMU-Orissa, CHMU-Patna,
    CMAI, 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 administered
   adulterated glycerol which contained 18.5% diethylene Glycol
   (even 1% diethylene glycol can cause damage).

The Lentin Commission probed into the deaths and succeeded in
  exposing 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 any
   action taken against the offenders, many of whom were the
   "reputed" big companies.
    The Lentin Commission Report 1986
   "These pages describe and illustrate the ugly facets
    of the human mind and human nature, projecting
    errors of judgment misuse of ministerial power and
    authority, apathy towards human life, corruption,
    Nexus and quid pro quo between unscrupulous
    license holders, analytical laboratories elements in
    the industries department controlling the award of
    rate contracts, manufacturers, traders, merchants,
    suppliers, the Food and Drugs Administration and
    persons holding ministerial rank."
RUD Newsletters
Newsletters and Bulletins
   NETRUM-India Newsletter
   BODHI
   CDMU Rational Drug Bulletin
   CMAI 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 providers
    for capacity building and the
    government for policy reform – both
    national and state
    Addressing the Access Issue

   Rational procurement model
    – Tamil Nadu Medical Services
    Corporation (TNMSC) 1994
Access to low cost medicines
India improves access to low cost medicines
    Mohali | Monday, Oct 13 2008

   India has become a leading international player in generic
    medicines and has been able to considerably improve access to
    low cost medicines for the common people not only within India
    but in many developing countries.
                                   ---- Mr Ashok Kumar, Secretary,
    Department of Pharmaceuticals, Union Ministry of Chemicals
    and Fertilizers, India
Source : http://news.webindia123.com/news/articles/India/20081013/1077565.html
    Regulatory Agency Changing in India!

   Restructuring/Strengthening of regulatory
    framework with proposed creation of an
    independent Central Drugs Authority (CDA)
         MOH&F - CDA - 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 CDA


The Parliamentary standing committee on
  health and family welfare has virtually shot
  down the proposal for a new Central Drug
  Authority (CDA) and instead recommended
  setting 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 ensure
that the health care system does not get
  medicalised,
that the doctor-drug producer axis does not
  exploit the people and
that the 'abundance' of drugs does not become
  a vested interest in health.”
       - ICMR/ICSSR Health for All Report, 1981
Thank You!

								
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