Concept of Essential medicines & Rational use of medicines

1. Dr Abir Pattanayak
PGT 1st year,
Dept. of Pharmacology,
IPGME&R, Kolkata.

2.  Introduction
 Core and complementary item
 NLEM
 Selection of Essential drugs
 Rational & Irrational use of medicine
 Counterfeit medicine
 Orphan drugs
 Conclusion

3.  Health is a fundamental human right and the attainment
of highest possible level of health is a most important
world wide social goal
 Provision of essential medicine is one of the 8
components of primary health care in Alma Ata
Declaration, 1978

4. “Essential medicines are those that satisfy the priority
health care needs of the population.”
They are selected with due regard to public health
relevance, evidence on efficacy and safety, and
comparative cost effectiveness.
Intended to be available within the context of functioning
health systems at all times, in adequate amount(s), in
the appropriate dosage forms, with assured quality and
adequate information and at a price the individual &
community can afford.

5.  1960:International organization of consumers union
(IOCU).
 1970: concept of essential drugs
 1975:WHO expert advisory committee(EM)
 1977:first model list of essential drugs
 2003: “essential medicine” instead of “essential
drugs”(WHO)
 2017 : 20th model list of essential medicines ( WHO)

6. The list is divided into core items and complementary items
 Core items
◦ Most cost effective
◦ Usable with little additional health care resources
 Complementary items
◦ Require additional infrastructure
◦ About 25% of items are in the complementary list

7.  National Essential Drugs List (1996) by MoHFW
 National List of Essential Medicines (2003, 2011,
2015)
 1st State level EML (1994) by MOH, Government of
National Capital Territory of Delhi. (latest revision: 2015)

10. Sources:
1. http://www.who.int/medicines/publications/essentialmedicines/18th_EML_
final_web_8Jul13.pdf
2. http://www.who.int/selection_medicines/country_lists/India_NLME_2011.pdf?ua=1

11.  Depends upon pattern of prevalent diseases, availability
of facilities & trained personnel, financial resources,
genetic, demographic & environmental factors
 Adequate data on efficacy & safety available.
 Should be available in form in which quality, including
bioavailability & stability on storage, can be assured
 In case of two or more similar drugs, choice should be
made on the basis of their relative efficacy, safety,
quality, price & availability.

12.  Cost of total treatment, cost/benefit ratio should also be
considered
 ƒLocal facilities for manufacture and storage should also
be considered
 In general, should contain only single drug

13.  Medicines are listed in EML by International
nonproprietory (INN) name.
 INNs periodically published by WHO for new
pharmaceutical products
ƒ
 Brings uniformity in the names of medicine
ƒ
 Avoids confusion and thereby contributes to patient
safety.

15.  P-drugs (preferred or personal drugs) are the drugs that
the individual doctor has chosen to prescribe regularly,
after they have become familiar.
They are priority choices for given
indications. The P-drug concept is more than just the
name of a pharmacological substance, it also includes
the dosage form, dosage schedule and duration of
treatment.
 EML can guide doctors in developing their own P drugs
basket with which they are fully conversant.

16.  The selection of essential medicines is only one step
towards the improvement of the quality of health care;
selection needs to be followed by appropriate use.
 Each individual should receive the right medicine, in an
adequate dose for an adequate duration, with
appropriate information and follow-up treatment, and at
an affordable cost.

17.  Estimated that worldwide more than 50% of all
medicines are prescribed, dispensed, or sold
inappropriately, while 50% of patients fail to take them
correctly.
 Unfortunately, because of inappropriate use, the
effective medicines of yesterday become ineffective
today.
The classic example is antimicrobial medicines.
Although available and usually affordable, their misuse
is rampant.

18.  The rational use of Medicines (RUM) is defined as
“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 1985)
 The rational use of drug is based on the rule of right: that
means
 The right drug
 To the right patient
 In right dosage
 At a right cost
 With the right documentation.

19.  The use of medicines for trivial complaints (where none
actually indicated).
 The use of too many medicines per patient for the same
indication (polypharmacy)
 Overuse of injections.
 Inadequate duration of use.
 Inappropriate use of antimicrobials, often in inadequate
dosage.
 Use of inappropriate FDCs.

20. The following strategies are recommended by WHO for
promoting rational use of medicines.
 To train the medical students of different levels on RUM.
A WHO manual “Guide to Good Prescribing: a Practical
Manual” is a useful publication for under graduate and
post graduate students is a welcome step in this
strategy.
 The medical practitioners need to keep themselves
updated through attending seminars, conferences, and
other continuing professional development programmes.

21.  They should look for independent publications or drug
information centers for drug-related information, but not
from the medical representatives.
 The hospital formulary is a good source of information.
The essential medicines should be the first choice during
medical practice.
 Finally, they should take care of their clients, the
patients, by spending some time with them explaining
the appropriate use of prescribed medicines. The
patients should be accepted as the partner in drug
therapy.

22.  Step:- I Identify the patient’s problem based on
symptoms & recognize the need for action
 Step:- II Diagnosis of the disease – define the
diagnosis
 Step:- III List possible intervention or treatment (drug or
no drug) – Identify the drug
 Step:- IV Start the treatment by writing an accurate &
complete prescription e.g. name of drugs with dosage
forms, dosage schedule & total duration of the treatment

23.  Step:-V Give proper information, instruction & warning
regarding the treatment given e.g. side effects (ADRs),
dosage schedule & dangers/risk of stopping the therapy
suddenly
 Step:-VI Monitor the treatment to check if the particular
treatment has solved the patient’s problem.
 Passive monitoring
Active monitoring

24.  Injudicious use of antimicrobials: antibiotics in viral fever
and diarrhoea
 Unnecessary combinations
 Use of drugs not related to diagnosis
 Incorrect route
 Incorrect dosing-under or over dose
 Incorrect duration-prolong or short term use
 Unnecessary use of expensive medicines
 Unsafe use of corticosteroids

25.  Lack of information / knowledge
 Lack of diagnostic facilities/Uncertainty of diagnosis-
medicine for all possible causes
 Patient load
 Demand from the patients
 Promotional activities of the pharmaceutical industry
(exaggerated claims and unethical practices)

26.  Ineffective & unsafe treatment
◦ Over treatment of mild illness
◦ Inadequate treatment of serious illness
 Increased morbidity (adverse drug events, prolonged
illness) and mortality
 Distress, harm and cost burden to patient and
community as a whole
 Increased drug resistance

27.  WHO has defined as: ‘À counterfeit medicine is one
which is deliberately and fraudulently mislabelled with
respect to identity and/ or source.
 Counterfeit medicine was first mentioned as à problem
at the WHO Conference of Experts on Rational Drug
Use in Nairobi, Kenya in 1985

28.  An orphan drug is a pharmaceutical agent that has been
developed specifically to treat a rare medical condition.
Examples : deferiprone to treat iron overload in
thalassemia patients, N acetylcysteine to treat
paracetamol poisoning etc.
 Though life saving for some patients but commercially
difficult to obtain.

29.  The Central Drugs Standard Control Organization
(CDSCO) is responsible for safety, efficacy and quality of
drugs, their import, manufacture, distribution, sale and
standards.
 The CDSCO at Centre is headed by Drug Controller
General (India).
 The CDSCO has a network of four Zonal Offices located
at Mumbai, Ghaziabad, Kolkata and Chennai and seven
port offices for ensuring quality of imports.

30.  The report of 2004 by WHO pointed out that
approximately 67% of the population lives
without access to essential medicines.
 For meeting the requirements of medicines at
reasonable prices the Government has
formulated policies and issued drug price control
orders from time to time.
 Individual prescribers need to understand the
spirit of the EML and RUM concepts and apply
these principles to patient care.

31.  We need to start the process of prescription audit
 Drug use is usually the end of therapeutic consultation.
We all have a responsibility to the public to ensure that
the right drug is prescribed, dispensed and taken.
 Improving drug use improves the quality of care and
frequently lowers cost
 The essential medicine concept is relevant to other
health programmes as well and results not only in better
use of resources but also in better practice of medicine.