Essential Drug List & Rational Use of Drug

Presented By- Santu M.Pharm (p’cology) ISCP Moga.

The concept of essential medicines

A limited range of carefully selected essential drugs leads to

Better health care

Better drug management

Lower costs

Definition of essential medicines

Essential medicines are those that satisfy the priority health care needs of the population at all time.

Essential medicines

History of the WHO Model List of Essential Drugs

1977 First Model list published, ± 200 active substances

List is revised every two years by WHO Expert Committee

April 2003 revised Model list contains 315 active substances

2007, a separate list for children up to 12 years was included.

Latest, The 18th edition for adults and the 4th edition for children were released in April 2013

Number of countries with a national list of essential medicines

National Essential Drugs List

< 5 years (127)> 5 years (29)No NEDL (19)Unknown (16)

156 countries with EDL

1/3 within 2 years

3/4 within 5 years

Full description of essential drugs(Expert Committee Report, April 2002)Definition: Essential medicines are those that satisfy the priority health care needs of the populationSelection criteria: Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectivenessPurpose: Essential medicines are intended to be available within the context of functioning health systems at all times, in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford. Implementation: The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility.

The Essential Medicines Target

S S

All the drugsin the world

Registered medicines

National list ofessential medicines

Levels of use

Supplementaryspecialistmedicines

CHWdispensary

Health center

Hospital

Referral hospital

Private sector

National List of Essential Medicines of India

The first National List of Essential Medicines of India was prepared and released in 1996.

The list was subsequently revised in 2003. 2011, publication of revised list containing 348 drugs. In comparison to NLEM 2003, number of medicines deleted

is 47 and 43 medicines was added. 3 category included P→ Primary S → Secondary T → Tartiary

o P,S,T containing 181 drugso S,T containing 106 drugso T containing 61 drugs.

The WHO Model List of Essential Medicines is amodel product, model process and public health tool

Model product: list of essential drugs with information

Core list: minimum drug needs for a basic health care system, listing the most cost-effective drugs for priority conditions (selected on the basis of burden of disease and potential for safe and cost-effective treatment).

Complementary list: essential drugs for priority diseases which are cost-effective but not necessarily affordable or for which specialised health care facilities may be needed; and essential drugs for less frequent diseases

Seven steps to get a new medicine onthe WHO Model List of Essential Drugs

1. Identification of public-health need for a medicine2. Development of the medicine; phase I - II - III trials3. Regulatory approval in a number of countries

> Effective and safe medicine on the market4. More experience under different field circumstances; post-marketing

surveillance5. Price indication for public sector use6. Review by WHO disease programme; define comparative

effectiveness and safety in real-life situations, comparative cost-effectiveness and public health relevance

> Medicine included in WHO treatment guideline7. Submission to WHO Expert Committee on Essential Drugs

> Medicine included in WHO Model List

PROCESS ADOPTED FOR REVISION OF NLEM India (2011)

National List of Essential Medicines 2003

(Base document)

Consultation meetings with Experts

Deliberation on Evidence based criteria for addition and deletion of

medicines from the NLEM

Therapeutic area wise group discussion

(Group composition: Clinicians, Pharmacologists, Pharmacists,

Scientists and Regulators)

REVISION PROCESS contd…

Presentation by groups in open house discussion

Deliberations/ discussion and reasoning for additions/

deletions/modifications

Draft recommendations for NLEM

Consideration and adoption of NLEM by the Core

Committee

Resource Materials: WHO Model List of Essential

Medicines 2010, WHO model formulary,

National Formulary of India 2010 (Pre print Version),

Textbooks of Pharmacology, Internal Medicine,

Drug compendia, Indian Pharmacopoeia,

Internet facility

Resource Support: Scientists, Senior Residents,

Junior Residents and PhD Scholar of Dept of

Pharmacology, AIIMS, New Delhi

Content of EDL 1 Anaesthetics 1.1 General anaesthetics and oxygen 1.2 Local anaesthetics 1.3 Preoperative medication and sedation for short-term procedures

2 Medicines for pain and palliative care 2.1 Non-opioids and non-steroidal anti-inflammatory drugs (NSAIDs) 2.2 Opioid analgesics 2.3 Medicines for other common symptoms in palliative care

3 Antiallergics and medicines used in anaphylaxis 4 Antidotes and other substances used in poisonings 4.1 Non-specific 4.2 Specific

5 Anticonvulsants/antiepileptics 6 Anti-infective medicines 6.1 Antihelminthics 6.2 Antibacterials 6.3 Antifungal medicines 6.4 Antiviral medicines 6.5 Antiprotozoal medicines

7 Antimigraine medicines 7.1 For treatment of acute attack 7.2 For prophylaxis etc,……………………………………….

Contents…. Hormones, other endocrine medicines and cont Immunologicals Ophthalmological preparations Vitamins and minerals Medicines for diseases of joints Ear, nose and throat medicines in children Cardiovascular medicines Antiparkinsonism medicines Diagnostic agents Diuretics Gastrointestinal medicines

etc…………………………

State EDL (Punjab)

Rational use of drugs

Rational use of Drug The rational use of drugs requires that patients receive medications

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 their community.

WHO conference of experts Nairobi 1985

correct drug

appropriate indication

appropriate drug considering efficacy, safety, suitability for the patient, and cost

appropriate dosage, administration, duration

no contraindications

correct dispensing, including appropriate information for patients

patient adherence to treatment

Examples of Irrational Drug use

Prescribing drugs of no proven value. Prescribing empirically. Unnecessary prescribing for self limiting

conditions. Over dosing and under dosing. Prescribing costly drugs. Using injections when oral drugs would sufficient.

Why does irrational use continue?

Very few countries regularly monitor drug use because…

They have insufficient funds. They lack of awareness. There is insufficient knowledge of concerning the

cost-effectiveness of interventions.

Many Factors Influence Use of Medicines

Treatment Choices

Prior Knowledge

HabitsScientific Information

Relationships

With Peers

Influenceof Drug

Industry

Workload & Staffing

Infra-structure

Authority & Supervision

Societal

Information

Intrinsic

Workplace

Workgroup

Social &Cultural

Factors

Economic &

Legal Factors

Overview of Rational use of Drug

Strategies to Improve Use of Drugs

Economic: Offer incentives

– Institutions– Providers and patients

Managerial: Guide clinical practice

– Information systems– Drug supply / lab capacity

Regulatory: Restrict choices

– Market or practice controls– Enforcement

Educational: Inform or persuade

– Health providers– Consumers

Use of Medicine

s

Educational StrategiesGoal: to inform or persuade Training for Providers

Undergraduate education Continuing in-service medical education (seminars, workshops) Face-to-face persuasive outreach e.g. academic detailing Clinical supervision or consultation

Printed Materials Clinical literature and newsletters Formularies or therapeutics manuals Persuasive print materials

Media-Based Approaches Posters Audio tapes, plays Radio, television

Managerial strategies Goal: to structure or guide decisions

Changes in selection, procurement, distribution to ensure availability of essential drugs Essential Drug Lists, morbidity-based quantification, kit systems

Strategies aimed at prescribers targeted face-to-face supervision with audit, peer group monitoring,

structured order forms, evidence-based standard treatment guidelines

Dispensing strategies course of treatment packaging, labelling, generic substitution

Economic strategies:

Goal: to offer incentives to providers an consumers

Avoid perverse financial incentives

Regulatory strategiesGoal: to restrict or limit decisions

Drug registration Banning unsafe drugs - but beware unexpected results

substitution of a second inappropriate drug after banning a first inappropriate or unsafe drug

Regulating the use of different drugs to different levels of the health sector e.g. licensing prescribers and drug outlets scheduling drugs into prescription-only & over-the-counter

Regulating pharmaceutical promotional activities

PHARMACIST’S ROLE

A) Drug Selection : The selection and range of drugs should be

based on the essential drug concept. Strict inventory control and cost effective

procurement should be practiced. Procure the most cost effective drugs in the right

quantities. Select reliable suppliers of high quality products. Ensure timely delivery. Achieve the lowest possible total cost.

B) Inventory control : Monitoring of drug stocks and

minimizing out of stock. Restrict the number and brands of

drugs. Drugs with overdue expiry dates should

not be dispensed or stored. All the drugs required to health facility

should be kept in stock.

C) Information and education Interact with other healthcare

professionals and inform them about new drugs and availability of drugs.

Suitable programes should be evolved to raise awareness of ADR.

Patient should be counseled.

D) Pharmaceutical care : This aims to optimize the patients health

related quality of life and achieve positive and cost effective clinical outcomes.

An evidence based approach must be adopted.

Pharmacists must collect subjective information regarding the patient’s health.