ESSENTIAL DRUG CONCEPT & RATIONAL USE OF DRUGS

RDU: The use of appropriate, efficacious, safe and cost-effective drug given for the right
indication, in the right dose and formulation, at right intervals and for the right duration of time
through right route of administration.
Advantages of RDU
• Safe
• Effective
• Economical
• Used, only when required
Promotion of RDU:
• Adoption of Essential drug concept
• Training of health professionals in rational drug use
• Development of evidence-based clinical guidelines
• Unbiased and independent drug information
• Continuing education of health professionals
• Consumer education
• Regulatory strategies
Why RDU is very important
• Irrational drug use leads to unsafe and ineffective treatment
• Worsening of prolonged illness
• ADRs
• Higher hospitalization costs
• Drug resistance
• May be fatal
Eg: Irrational Drug Use:
• Prescribing drugs of no proven value
• Prescribing empirically
• Unnecessary prescribing for self-limiting conditions
• Over/ Under dosing
• Prescribing costly drugs & formulations when cheaper drugs are available
• Using injectables when oral drugs would be enough
 • Using ‘available’/‘favoured’ drugs when stocks of ideal drugs are not available.
Essential Drugs
• Drugs that satisfy the health care needs of the majority of population.
• They must be available at all times in adequate amounts and in the appropriate dosage
forms.
• They are selected with due regard to public health relevance, evidence on efficacy and
safety, and comparative cost-effectiveness.
• 1st WHO model list – 1977
• 1st edn for children – 2007
• 19th edn 2015 adults, and children 5th edn
• National List of Essential Medicines of India – 1996
• NLEM 2015 with 376 medicines
• WHO list is considered as the guide
• Each country can make their separate and own EDL

Principles of Preparing EDL

• Adoption of EDL should be a part of National Drug Policy.
• Those drugs for which adequate scientific data available are only selected.
• Keeping quality standards.
• Accurate comprehensive drug information, drawn from unbiased sources should
accompany the list.
• Each country should appoint a selection committee.
• Selection should be based on results of benefit and safety evaluation.
• Regulations should be there about quality.
• Generic names should be used wherever necessary.
• Cost is a major selection criteria.
• Influence of local diseases is considered for selection.
• When several drugs are available for the same indication, consider the one with the
highest benefit to risk ratio.
• Fixed drug combination is useful only if;
• Clinical documentation should justify concomitant use
 • The therapeutic effect is greater than the sum of each
• Cost benefit
• Improved compliance
• Allowed for dosage adjustment
• List should be reviewed
Advantages of Essential drugs
• Integral part of primary health care practice.
• Better material management: easy procurement, storage, supply.
• More cost effective.
• Improved drug use in terms of safety and efficacy.
• Better and uniform patient information.
• Matching to the epidemiological pattern.
• Program evaluation is easy.
• Easy identification of ADR possible with drug list.
• Improvement in quality possible with limited number of drugs.
• Restricted production depending on local requirement.
• Less chance for the market forces to influence the drug utilization.
Role of Pharmacist in RDU
1. Drug procurement:
• Selection and range of drugs should be based on the EDC relevant to needs of the
situation.
• Strict inventory control and cost-effective procurements should be practiced.
4 strategic objectives of pharmaceutical procurements:
• 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
2. Inventory control:
• Monitoring drug stocks and minimizing ‘out-of-stock’ can be achieved by good inventory
control.
• Use drug formulary or drug list to restrict the number and brands of drugs.
 • Drugs with overdue expiry dates should not be dispensed or stored.
• All drugs required for the health facility should be kept in stock and patients should not
be turned away due to unavailability.
3. Information and Education:
• Pharmacist should interact with other healthcare professionals and inform them of the
introduction of new drugs, drug policy changes in the hospital, availability of drugs and
drug-related problems.
• Verbally or written; drug bulletin, ADR reporting.
• Patient counseling on drug use and patience compliance, promote RDU by educational
programs.
4. Pharmaceutical care:
• Aims to optimize the patients’ health-related quality of life and achieve positive and cost-
effective clinical outcomes.
• Evidence-based therapy, risk-benefit ratio must be adopted.
• Assured all drug supplies, and be given information and assistance to carry out the drug
therapy plan.
• Monitoring of treatment outcomes and suggestions to modify the treatment plan.

Investigating Drug Use in Health Facilities

• WHO in 1993: Identified a number of objective measures or indicators used to describe
drug use patterns in country, region or individual health family.
– to describe treatment practices,
– to compare prescribing behaviour in different areas or facilities,
– to assess the impact of an intervention designed to improve drug use.

Prescribing Indicators: Complementary Indictors:

• Average number of drugs per • Percentage of patients treated without drugs
prescriptions • Average drug cost per encounter
• Percentage of drug prescribed by • Percentage of drug cost spent on antibiotics
generic name • Percentage of drug cost spent on injections
• Percentage of encounters with an • Prescription in accordance with treatment
antibiotic prescribed guidelines
• Percentage of encounters with an • Percentage of patients satisfied with the care
injection prescribed they received
• Percentage of drugs prescribed from • Percentage of health facilities with access to
an essential drug list or formulary impartial information

Patient care Indicators: Facility Indicators:

• Average consultation time • Availability of copy of essential drug list or
• Average dispensing time formulary
• Percentage of drugs actually • Availability of key drugs
dispensed
• Percentage of drugs adequately
labeled
• Patient’s knowledge on correct
dosage

Medication use in India

• Regulatory factors: process for marketing approval of new drugs, controls on ‘OTC’
drugs, more effective definition of a prescriber, quality assurance of products, assurance
of good drug distribution systems, availability and price control of essential drugs,
availability of unbiased drug information and control of drug promotion practices by
industry.
• Prescriber factors: heavy work load, poor diagnostic support, empirical treatment or ‘shot
gun’ therapy, no evidence-based guidelines readily available, lack of continuing
education for all healthcare professionals.
• Patient factors: want quick response to treatment – use of multiple forms of therapy, lack
of knowledge – non-compliance, availability of drugs as OTC, preference of injections to
oral use, overuse of tonics and antibiotics.

Guidelines for Rational Prescribing

• Define patient’s problem, then specify the therapeutic goal.
• Use drugs only when indicated, and when the potential benefits of drug therapy outweigh
the potential risks.
 • Choose a drug of proven efficacy and safety. It must be suitable for individual patient and
be affordable.
• Choose a dose which suitable for a individual patient.
• Avoid using more than one drug of same chemical class at the same time.
• Inform patient.
• Monitor the effects of treatment
• If treatment has not been effective, try and identify why.
• Continue treatment only if the original therapeutic objective is still relevant.
Rational use of Antibiotics
• Infectious diseases are a major cause of morbidity and mortality in developing countries.
• One-third of drug use is for antibiotics.
• Widely misused for conditions where they are not needed – common cold and URTIs of
viral origin.
• Wrong Practice and antibiotic resistance: Starting antibiotic without diagnosis, frequently
changing antibiotics, giving sub-optimal doses, not completing the course of treatment
and relying on antibiotics without draining pus or removing foreign bodies as indicated.
Guidelines:
• Use antibiotics only when indicated.
• Where appropriate, specimens for Gram stain, culture and sensitivity testing should be
obtained before commencing antibiotic therapy.
• The choice of agent should be based on factors such as spectrum of activity in relation to
the known or suspected causative organism, safety, previous clinical response, cost, ease
of use and potential for selection of resistant organism.
• An adequate dose and duration of treatment is essential
• A history of allergy or other adverse effect to the drug under consideration should always
be sought.
• Prophylactic use of antibiotics should be restricted.
• Empirical antibiotic therapy should be based, where possible, on local epidemiological
data on potential pathogens and their patterns of sensitivity.
• Antibiotic therapy directed at specific organisms should include the most effective, least
toxic and narrowest spectrum agent available.
 • Oral therapy should be used in preference to parenteral therapy wherever clinically
possible.
• Antimicrobial combinations should only be used where indicated
• To extend of spectrum of cover in mixed infections
• To achieve a synergistic bactericidal effect
• To prevent the emergence of resistant organisms -
eg: TB therapy
• Topical antibiotics should be restricted to a few proven indications.
• Reserve new antibiotics

Rational use of injections

Unnecessary use of injections is associated with:
• Higher cost
• Increased need for trained staff
• Increased time to administer the drug
• Possible transmission of a range of serious pathogens, such as hepatitis B, HIV etc
• Risk of abscess formation if injections are unhygenically administered.
• Increased risk of adverse drug reactions
Use of injections should be restricted to the following situations:
• Oral administration is not tolerated or is not possible. eg: swallowing difficulties or
patient is unconscious.
• Absorption problem. eg: vomiting, severe diarrhea
• Drug of choice is only formulated as a parenteral product. eg: insulin, gentamicin
• High tissue concentrations are needed and are not achieved by oral administration. eg:
treatment of meningitis, osteomyelitis.
• Urgent treatment is required due to severe and rapidly progressing illness. eg: septicemia
• Patient is unlikely to comply with oral treatment.
Examples of Irrational use of injections:
• Paracetamol injection to reduce fever,
• Multivitamins, glucose, calcium injections to improve stamina
• Injections of H2 antagonists, PPIs for gastritis,
 • Injections given on patient’s demand
Rational use of OTC Drugs
• In India, almost all drugs can be bought as OTC.
• Misuse of antibiotics and other potent drugs.
• Vitamins and tonics, iron preparations, analgesics, NSAIDs, cough mixtures are widely
used.
• 2 factors:
– Patient’s desire for treatment
– Pharmacist’s desire to please the patient and to make a sale.
• Vitamin tonics as growth stimulant for children.
• NSAIDs and cough mixtures: serious side effects.
• Care must be taken to enquire about other drug therapy so that potential drug interactions
can be avoided.
Persons Involved in Irrational Drug Use
• Patient: Self-medication, Compliance
• Physicians: Inadequate knowledge, Financial interest
• Pharmacist: Errors in dispensing, Financial interest
• Manufactures: Financial interest, Misleading information by Medical representatives
Factors Contributing to Irrational Drug Use
• Unrestricted entry of the prescription drugs
• Lack of drug information
• Inadequate training and skills
• Confusion created by brand names
• Aggressive marketing strategies
• Overwhelming work load for physicians
• Cost factors
• Preferences to company/drugs
• Attitude of people
• Professional competition
• Lack of diagnostic and other facilities
• Erratic supply and shortage of drugs
 • Lack of essential drugs
What does RDU require?
 Adequate diagnosis
 Correct prescribing of drug and non-drug treatment
 Correct dispensing
 Patient adherence with therapy
Rational Drug Use in Hospital Setting
• Formulary
• Drug and therapeutics committee
• Drug use evaluation
• Clinical pharmacists
Role of Pharmacists in Rational Drug Use
• Patient Counseling
• Drug information
• ADR monitoring and reporting
• Drug Therapy Monitoring
• More focused education on patient and disease rather on mere drugs