National List of Essential Medicines & Rational Drug Use

ESSENTIAL MEDICINES
AND RATIONAL DRUG
THERAPY
Dr.Raghavendra S.Hegde, PharmD., MBA., PGDHMDHL

Learning objectives
 Introduction to Essential Medicines
 National List of Essential Medicine(NLEM)
 Purpose of NLEM
 Criteria for inclusion of a medicine in NLEM
 Criteria for deletion of a medicine from NLEM
 Salient Features of NLEM 2015
 NLEM and Pharmaceutical Pricing Policies
 Introduction to RDU
 Factors leading to Irrational Use of Drugs
 Examples of Irrational Drug Use
Thursday, June 25, 2020
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Dr.Hegde Lectures(DHL)

Introduction to Essential Medicines
 Essential medicines are those that satisfy the priority healthcare
needs of majority of the population.
 The first country in the world to compose its Essential Medicines
List (EML) was Tanzania in 1970.
 Subsequently, the concept of essential medicines was introduced by
WHO in 1977.
 In nineties, WHO EML was recognised as important guiding
document mainly for the public sector for the procurement,
distribution, rational use and quality assurance of medicines.
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 It has now been adopted by many countries, non-governmental
organizations
and international non-profit supply agencies.
 The list is made with consideration to disease prevalence, efficacy,
safety and comparative cost-effectiveness of the medicines.
 It considers the standard treatment guidelines (STG) keeping in mind the
healthcare needs of the majority of the population.
 Medicines listed in the EML are intended to be available in adequate
amounts, in appropriate dosage forms and strengths with assured
quality and the cost that an individual or community can afford.
 Careful selection of a limited range of essential medicines results in a
higher quality of care, better management of medicines and more
cost-effective use of health resources.
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National List of Essential Medicines(NLEM)
 The Govt of India, MOHFW is mandated to ensure the
 Quality Healthcare system by assuring availability of safe and
efficacious medicines for its population.
 With the aim of Promotional of Rational use of medicines on the
basis of Cost , safety and efficacy and to promote prescription by
generic names.
 GOI has been preparing List of Essential medicines in 1966, which
comprises of 279 medicines.
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National List of Medicines(NLEM)
 To address the issues of :
 Changing disease prevalence
 Treatment modalities
 Introduction of newer medicines
 Identification of Unacceptable Risk-Benefit Profile.
 Therapeutic profile of some medicines.
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 NLEM is continuously revised in 2003,2011,2015 containing 354, 348,
376 medicines respectively.
 Experts from different disciplines from medical and pharmaceutical
institutes, hospitals from across the country and concerned govt
agencies participate in formulation of list.
 India is the second most populous country in the world.
 With the improvement in public health care and socioeconomic status,
India faces the twin epidemic of continuing/emerging infectious
disease as well as Non-communicable disease, lifestyle disease etc.
 The temporal landscape of India's health care priorities makes NLEM
as unique example.
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Thursday, June 25, 2020Dr.Hegde Lectures(DHL)
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 Criteria to prepare nations specific list include country’s disease
burden, priority health concerns, affordability concerns.
 For e.g. Polio, TB, Malaria, and diarrhoeal diseases are priority
health care concerns in India and other under developed or
developing ,but it may not be so, for developed countries.
 Secondly, India has large geographical area with huge diversity in
climate,foodhabits,culture,etc.
 With differences in healthcare priorities within the country and
across different regions.

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 Multiple drug resistant TB and malaria or epidemic like H1N1,
dengue etc are emerging challenges in the nation and such
change in disease pattern needs to take in account.
 A medicine may be essential considering the population at
large. Hence, a medicine which is critical for a specific
condition may not be listed in NLEM if the disease condition
for which it is indicated has low prevalence or if medicine has
safety issue.
 For example, Desmopressin is the specific medicine for
Diabetes Insipidus but because of the rarity of the condition it
may not find a place in the NLEM.

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 Pioglitazone is also useful in specific diabetic conditions but has not been
considered essential inspite of being effective for a specific diabetic
condition due to safety concern of bladder cancer.
 In India, a substantial part of health expenditure is out of pocket and the
health insurance schemes are often underutilized.
 Therefore, cost of medicines should be considered balancing it with
effectiveness and safety.
 A drug in different salt form available for same indication or it may be
available in different dosage form.
 In general, the medicine which is most safe with moderate effectiveness
can be selected if it is affordable than the
most effective costlier medicine.

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 However, criteria of 'Non-toxicity' should never be compromised.
For example, the NLEM 2015 contains Iron sucrose injection.
 The other salts viz, Iron dextran have safety issues whereas ferric
carboxymaltose is most effective and safe but costliest.
 Because of various other advantages such as therapeutic value,
stability, ease of handling and storage etc. the costlier form may
also include in addition to the cheaper form of medicine.
 The total price of the treatment schedule is taken into consideration
and not the unit price alone.
 A costlier drug with low frequency of administration may be
economic as compared to a frequently administered low cost
medicine.

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 Sales turnover on the basis of volume or value in terms of
moving annual total (MAT) in the country cannot be
considered as criteria for inclusion of a medicine in NEML.
 Sale of medicine is governed by many factors like marketing
strategy, prescribers' choice, public healthcare awareness
and advertisement etc.
 These factors vary from country to country and various
regions within country itself. For examples, multivitamin
medicines have higher value on MAT list due to sales
turnover but these are not essential.

Purpose of NLEM:
 The medicines in NLEM should be available at affordable costs and
with assured quality.
 The medicines used in the various national health programmes,
emerging and re-emerging infections should be addressed in the list.
 The essential medicines list needs to be country specific addressing
the disease burden of the nation and the commonly used medicines at
primary, secondary and tertiary healthcare levels.
 The NLEM is a dynamic document and feedback from all stakeholders
is welcome which will help in its revision at regular basis.
 Healthcare delivery institutions, health insurance bodies, standards
setting institutions for medicines, medicine price control bodies, health
economists and other healthcare stakeholders are involved in the
preparation of NLEM.
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Purpose of NLEM:
 The list of essential medicines should act as guide to formulate
hospital drug policies, procurement and supply of medicines in
public sector, medicine cost reimbursement and medicine
donations.
 It helps in monitoring the pricing of medicines.
 This list serves as a reference document for correct dosage form
and strength for prescribing.
 Use of NLEM is expected to improve prescribing practices as well
as the health outcomes.
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Purpose of NLEM:
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 The appropriate use of medicines selected in the NLEM
promotes rational use of medicines. Such rational use of
medicines, especially antimicrobial drugs, reduces
development of drug resistance.
 The list also serves as a reference for assessing the
healthcare access of the population.
 NEML serves as a tool for public education and training
of healthcare providers.

Criteria for inclusion of a medicine in NLEM:
 The medicine should be approved/licensed in India.
 The medicine should be useful in disease which is a public
health problem in India.
 The medicine should have proven efficacy and safety
profile based on valid scientific evidence.
 The medicine should be cost effective.
 The medicine should be aligned with the current treatment
guidelines for the disease.
 The medicine should be stable under the storage
conditions in India
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 When more than one medicine are available from the same
therapeutic class preferably one prototype/ medically best
suited medicine of that class to be included after due
deliberation and careful evaluation of their relative safety,
efficacy, cost-effectiveness.
 Price of total treatment to be considered and not the unit
price of a medicine.
 Fixed Dose Combinations (FDCS) are generally not
included unless the combination has unequivocally proven
advantage over individual ingredients administered
separately, in terms of increasing efficacy, reducing adverse
effects and/or improving compliance.
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 The listing of medicine in NLEM is based according to
the level of health care, i.e. Primary (P), Secondary
(S) and Tertiary (T) because the treatment facilities,
training, experience and availability of health care
personnel differ at these levels.
 For example, analgesics, antibiotics, anti-malarials
etc. are provided at Primary health care outlets
whereas high-end antimicrobials, and medicines for
conditions like resistant tuberculosis, malaria, kala-
azar; oncology medicines etc. will be required more in
tertiary care.

Criteria for deletion of a medicine from NLEM:
 The medicine has been banned in India.
 There are reports of concerns on the safety profile of a
medicine.
 A medicine with better efficacy or favourable safety
profiles and better cost-effectiveness is now available as
an alternative.
 The disease burden for which a medicine is indicated is no
longer a national health concern in India.
 In case of antimicrobials, if the resistance pattern has
rendered a medicine ineffective in Indian context.
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Salient Features of NLEM 2015
 The important features of NLEM 2015 are listed below. For detail
description reader should refer the original document.
 The NLEM 2015 has been prepared adhering to the basic principles
of Efficacy, Safety, Cost-Effectiveness; consideration of diseases as
public health problems in India.
 NLEM 2015 which now contains a total of 376 medicines.
 Medicines in NLEM are listed with reference to the levels of
healthcare, namely. Primary (P), Secondary (S) and Tertiary (T).
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 There are 209 medicine formulations listed for all levels of health care (P, S,
T), 115 medicine formulations for secondary and tertiary levels (S, T) and
79 medicine formulations for the tertiary level (T).
 The essentiality of a medicine has been considered in terms of its dosage
form and strength also.
 Any dosage form of a medicine, other than the dosage form included in
NLEM, but
In same strength and route of administration, which does not have
significant
difference in terms of pharmacokinetics/ pharmacodynamics / efficacy-
safety
profile over the dosage form mentioned in the list will be considered as
included.
For example, tablet and capsule of an API of equivalent strength.
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 Innovation in medicine is encouraged. The formulations
developed through incremental innovation / novel drug
delivery systems like lipid / liposomal formulations,
sustained release/controlled release etc. should be
considered as included only if specified in the list against
any medicine.
 Otherwise, the NDDS form of the medicine is considered
different and though the conventional form is mentioned
in the list, such innovative formulations are exempted.

 In cases, where vaccines/immunoglobulins/sera are
listed in NLEM, irrespective of variation in source,
composition and strength, all the products of the same
vaccines/immunoglobulins /sera as approved by the
licensing authority are considered included.
 In general, medicines have been mentioned with
respect to their active moieties. without mentioning the
salts.
 However, in cases where there is significant difference
between the salts, the medicine finds mention as its
specific salt.
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 In cases where an active moiety is available as
different isomers/analogues/ derivatives, they are
considered as separate entities, and inclusion of
one does not imply inclusion of all
isomers/analogues/derivatives.
 It is suggested that the single and multi-dose pack
sizes of injections be considered as separate
entities for purposes such as procurement/pricing
etc.

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 In general, Fixed Dose Combinations (FDCS) have not been
included unless, the combination has unequivocally proven
advantage over individual ingredients administered separately, in
terms of increasing efficacy, reducing adverse effects and/or
improving compliance.
 The medicines in various National Health Programmes have been
considered for inclusion in NLEM.
 Any medicine/vaccine, as and when recommended under a
National Health Programme will be deemed to have been included
in NLEM.

Pharmaceutical Pricing Policies
 In order to make medicines affordable, Government of India
promulgated the National Pharmaceutical Pricing Policy, 2012
bringing all medicines with specified dosage and strength included
in NLEM under price control.
 Accordingly, Drug Price Control Order, 2013 was issued by
Department of Pharmaceuticals under Ministry of Chemicals and
Fertilizers for fixing the ceiling price of medicines included in NLEM,
2011.
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Pharmaceutical Pricing Policies
 Average cost of all the brands of a particular medicine (same
API, strength and route of administration) contributing for its
1% market share is considered as the ceiling price of those
medicines.
 Ceiling price plus 16 % margin to retailer and local taxes
extra is the retail price of the medicine.
 The calculated price remains fix for period of a year. But it is
also dynamic process, where every year the authority takes
review and change prices of the medicines.
 Various factors like cost of raw material (API), innovations
claimed by the formulator and outbreak of disease affects the
price of the medicines.
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Summary
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 EML :Satisfy the priority healthcare needs of majority of the population.
 WHO EML was recognised as important guiding document mainly for the public sector for
the procurement, distribution, rational use and quality assurance of medicines.
 The list is made with consideration to disease prevalence, efficacy, safety and
comparative cost-effectiveness of the medicines.
 Careful selection of a limited range of essential medicines results in a higher
quality of care, better management of medicines and more cost-effective use
of health resources.
 Not considered on Sales turnover on the basis of volume.
 National Pharmaceutical Pricing Policy(NPPP)2012, DPCO

Rational Drug Use(RDU)
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 Prescribing right drug, in adequate dose for the sufficient
duration and appropriate to the clinical needs of the patient at
lowest cost.
 The concept of RDU is old, but currently attained more significance
in terms of medical ,socio-economical and legal aspect.
 Several Factors were responsible for recognition of RDU are as
follows:
1. Development of Resistance: Irrational Use of Drugs
2. Drug Outburst in the market: increase in number of brands
3. Growing Awareness: World of Internet(Right selection of Drug)
4. Increased cost of the treatment: Economic Burden and Misuse of
cheaper and substandard drug

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5. Consumer protection act(CPA):Restrict the irrational use of drugs
6. Adverse effects of irrational use of drugs:
The ill effects may be immediate or gradual, and may lead to:
a. Ineffective and unsafe treatment
b. Exacerbation and prolongation of illness.
c. Distress and harm to the patient.
d. Wastage of resources
e. Loss of Faith in medical profession
f. Increase in cost of the treatment.

Factors leading to irrational use of drugs
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1. Lack of information
2. Inadequate training and education of medical graduates.
3. Poor communication between health professional and patient
4. Lack of diagnostic facilities/uncertainty of diagnosis
5. Demand from the patient
6. Defective drug supply system and ineffective drug regulation
7. Promotional activities of pharmaceutical industries.

Examples of Irrational drug use
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Antibiotics:
 Antibacterial agents
 Selection: Sound Clinical expertise
 Sensitivity test against suspected organism.

Thus, following points should be considered for
selection of Antibiotics:
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 Activity of agent against proven or suspected organism.
 Site of infection.
 Mode of administration of antibiotic.
 Metabolism and excretion.
 Renal and hepatic function of the patient.
 Duration of treatment/frequency of dose.
 Toxicity/cost.
 Local rates of resistance for that antibiotic.

Reasons for development of drug resistant microbes
are as follows:
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 Irrational selection of antibiotic
 Incomplete dose or discontinuation of therapy.
 Uncontrolled sale and easy availability of antibiotics even like OTC
medicine.
 Unethical marketing by pharmaceutical companies.
 Practice by untrained doctors from varied educational background, like
ayurvedic, homeopathy etc.
 Microbiologically untested brands of antibiotics and its fixed dose
combinations.
Thus to monitor the use of antibiotic government of India has introduced
schedule H1, a special schedule in the category of prescription drugs.

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 Government of India has banned 344 FDC extending about 6000 brands on
10th March 2016 citing health risk.
 Rationality of FDC and insufficient safety data was the main reason
behind the ban of the FDCS.
 Objective of ban was to ensure only safe products are available in the
market.
 In January 2015, a show-cause notice was given to 1083 FDCS demanding
proof of their safety and efficacy.
 It means that India may be the first country in the world with about 1100
FDCS in use.
 About 50-60% FDCS in India are for analgesic-antipyretic category and
cough mixtures. Some of the FDCS from banned drugs have been
marketed in India over period of more than 30 years.

The facts and assumptions considered to impose
ban were:
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 Multiple drugs from the same therapeutic group are causing anti-
microbial resistance.
 The usage of FDCS could even result in organ failure.
 FDCS are reviewed for several times and there is evidence from
research papers and studies to show these medicines are irrational
combinations.
 Most of the FDC formulations available in India are unavailable in
either UK or U.S.
 The side effects of these drugs mostly go unreported since patients
do not generally return to the doctors to consult.

Role of Community Pharmacist in Promotion of RDU.
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 All the healthcare stakeholders must take action at their
professional level in promoting rational use of drugs.
 Government policies must be placed for regulating manufacturing,
distribution, selling, dispensing and promotional activities by
pharmaceutical industries to promote rational use of drugs.
 An adequately trained community pharmacist can supervise in
rational distribution and dispensing of drugs.

Pharmacist can contribute to promote rational drug use in the
following ways by:
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 Adopting pharmaceutical care approach in interpreting the therapy
and physician's orders in view of improving safety.
 Maintaining a complete patient medication profile (PMR) of
individual patient.
 Analyzing clinical data to prevent any drug reactions from occurring,
due to unnoticed or undocumented history of drug allergies and
specific genetic composition.
 The community pharmacist should develop proficiency and
techniques in analysing clinical conditions, laboratory date and
usage of medicine by patient.

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 Counselling and sensitizing, the patient regarding completing the
course of therapy and encouraging them to follow the instructions
provided on the prescription.
 Avoiding dispensing prescription medicines without a proper
prescription.
 Educating the public on good prescription habits.
 Sensitising public about proper use of medicines, about adverse
effects of irrational use of medicines and laws related to medicines.
 Practising medicine dispensing/selling ethically and restricting
suggesting
prescription medicines to consumers upon enquiry.

A community pharmacist can adopt the following strategies
to promote rational antibiotic use:
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 Create awareness among communities/locality for rational use and resistance to
antibiotics; this can be done by displaying various issues of antibiotic resistance in
front of the pharmacy establishment and directly communicating to the consumer.
 Dispensing full and complete dose of antibiotics as advised in prescription.
Incomplete dose is major reason for development of antibiotic resistance. Several
studies disclosed that 90% of the community pharmacist did not think that
incomplete dose could lead to an increase in resistance as they were giving
antibiotics for only a few days.
 Some pharmacists say that, they resorted to such practices for fear of losing patient
and lack of awareness about the importance of rational use of antibiotics.
 Educate the customers while dispensing the prescription containing antibiotics and
clarifying the concepts of resistance due to overuse and/or non-compliance to
antibiotics therapy. Such behaviour of non-compliance towards antibiotics is termed
as irrational.

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 Encourage patient and care givers not to self-medicate antibiotics.
Ask them to discourage self-medication in families, friends and
neighbours. Must not practice dispensing antibiotics on patient's
demand without prescription and discourage patient for refilling old
prescriptions.
 This could lead to unnecessary and overuse of antibiotics leading to
either ineffective therapy, high burden of cost, adverse drug
reactions and
resistance of microbes.
 Motivate patient to complete the full course of antibiotics prescribed
though they feel better.

National List of Essential Medicines & Rational Drug Use

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