Essential drug concept and rational prescribing

Dr. Satabdi Ghosh

MBBS, MD
Assistant Professor
Department of Pharmacology &
Therapeutics
Concept of Essential drugs
Essential drugs are neither to be understood as only consisting
of live saving drugs or nor as medicines for treatment of rare
diseases.

The concept includes all the drugs needed for most commonly
encountered diseases including life-saving conditions.

The concept was mentioned in of the 0 points of 978 Alma

Ata Declaration on Primary Health Care (PHC).
 Cont..
A particular drug may be essential in a particular country but
need not be so in every country.

Thus snake bite is common in India and anti-snake venom

serum is officially an essential drug in india.

But, need not be so in New Zealand which is officially a snake-

free country.
 Cont..

So, implementation of concept of essential medicines is

intended to be flexible and adaptable to many different
situations.

It remains the responsibility of states within a national

framework, exactly which medicines are regarded as essential.
 Cont..

Essential medicine are selected with due regard to

- disease prevalence and public health relevance

- evidence of clinical efficacy and safety and

- comparative costs and cost-effectiveness

Essential medicine ************
Definition: Essential medicines, as defined by the WHO
are “those drugs that satisfy the health care needs of the
majority of the population, they should therefore be
available at all times in adequate amounts and in
appropriate dosage form, at a price the community can
afford”.
√ Essential medicines advocated by WHO in Geneva, during the
 WHO simple definition

Essential medicines are those that satisfy the

priority health care needs of the population.
 Cont..
In 977 WHO published its first list.
The choice of an essential drug depends on several factors:
******
. First only generic drugs would be considered.
2. The drugs were chosen by disease pattern.
3. The following selection criteria are used for inclusion of drugs
on list
√ Sound and adequate data supporting efficacy and safety from
clinical studies.
 Cont..
√ Availability in a form in which quality, including adequate

bioavailability can be assured.

√ Stability under anticipated conditions of storage and use.

√ Total cost and relative cost effectiveness of the treatment

√ Preference for single compounds

● The WHO model list of essential medicines has been updated

every 2 years since 977.
Pioneer countries in access to essential medicines
****
. Mozambique
2. Peru
3. Srilanka
Selection criteria ***********
. Freely available
2. Safe
3. Efficacious
4. Cost effective
5. Provide favourable risk benefit ratio
6. Keeping conformity with the disease profile of the country.
7. Should be selected by their generic name (INN)
[International non-proprietary name]
8. Majority of the people can be treated (cover 85% population)
 Cont..
9. Preference should be given to those drug that are thoroughly
studied. (pharmacokinetic, pharmacodynamic and toxicity profile)
10. It is not constant, changeable and varies from country to
country.

SANE criteria
S- safety
A- Affordability
N- Need to the community
E- Efficacy
 Cont..

EM 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

- at a price individual and community can afford

Essential drug list *****
WHO essential drug list contains a core list and a
complementary list.
Core list: Presents a list of minimum medicine needs for a basic
health care system listing the most efficacious, safe and cost-
effective medicines for priority conditions.
Core list based upon: - Efficacy
- Safety
- Cost-effectiveness
Exam: Paracetamol, Antacid
 Cont..
Complementary list: Presents essential medicines for priority
diseases, for which specialized diagnostic monitoring facilities are
needed.
● About 25% of items are in complementary list. Some medicine
are listed as both core and complementary.
Complementary lists require special
√ Diagnostic or monitoring facilities
√ Medical care
√ diagnostic equipments
Objective ********

. To develop and improve drug supply system.

2. To assist in developing national drug policy.

3. To ensure availability of safe, effective drugs at lowest

possible cost in support of primary health care for all the
people.

4. Provide national use of drug in the globe.

Healthcare system and Essential Medicines**
● Non-availability of medicines can block operation of healthcare
system.
● Attendance of health services, credibility and effectiveness of
healthcare system depend to a large extent on patient being able
to obtain relevant drugs at right time.
● A patient values services only if he/she obtains necessary
treatment and medicines.
● A good diagnosis is of not much use if patient cannot obtain
necessary treatment.
Reasons for the necessities of EMs*******
. To avoid irrational prescribing.

2. For developing prescribing behavior rational and scientific.

3. To exert the accessibility of the most necessary drugs.

4. Small amount of budget in health sector for average number of

people.

5. Unequal distribution of wealth in urban and rural population

6. Avoidance of unnecessary use of non-essential drugs

 Cont..

7. Tradition to use medicine instead of emphasizing hygiene and

nutrition.

8. Utilization of resources available in a country.

9. For optimum benefit to the population prescriber.

Should keep in mind that fewer drug better therapy and

newer drug is not always the better drugs.
Impact of essential medicine
A limited range of carefully selected essential medicines leads to

● Better health care

● Better drug management and health outcome (including

procurement, storage, distribution, and improved quality of
prescribed medicines)

● Cost-effective use of health resources.

WHO model list of essential medicines
√ It is list of essential medicines created by the World Health
Organization (WHO).
√ It serves as a guide for the development of National and
Institutional Essential Medicine Lists (EML)
√ Most countries worldwide now have national lists and some have
provincial or state lists.
√ National lists of essential medicines usually relate closely to
national guidelines for clinical health care practice which are used
for training and supervision of health workers.
WHO Model EML
●WHO EML is updated and revised every 2 years by WHO Expert
Committee on the selection and use of Essential Medicines.
●The list was first published in 977 and included 208 medicines.
th
● 4 list was published in 2005 and contained 306 medications.
th
● 9 list was published in 20 5 and contained 4 0 medications.
th
●20 list was published in 20 7 and contained 433 medications.
● Current 2 st list was published in 20 9 and it contained 460
medications.
WHO model lists of essential medicines
●A separate list for children up to 2 years of age, known as the
WHO Model list of Essential Medicines for Children (EMLc), was
created in 2007.

●It was created to make sure that the needs of children were
systematically considered such as availability of proper
formulations.
th
● In 20 9, 7 list EMLc was published.
Impact and Use of Model WHO EML
● Worldwide, the concept of WHO EML has been accepted as a

powerful tool to promote health equity.

● Its impact is remarkable, as essential medicines are considered

to be one of the most cost-effective elements in health care.

● Model WHO EML is customizable to

- clinical guidelines for healthcare practice

- region-specific public health issues

 Cont..

- least costly or most accessible therapeutic equivalent and can

be implemented on a country, state or industrial level.

● More than 55 developed and developing countries have created

national lists of essential medicines based on WHO EML.
Essential drug list (EDL) in Bangladesh ( st list, 982)
●It is the list of essential drugs that have been recommended to be
used by the various levels of the health care personnel in
Bangladesh.

● PHC (village, level health worker) = 2

●SHC (UHC, thana level) = 33

● THC (Zilla sadar hospital, Medical college) = 05

● Total drug of EDL ( 982) in BD = 50

Essential Drug List (EDL) in Bangladesh **********
● EDL of BD published in 982 contained 50 medicine

● EDL of BD published in 2008 contained 209 medicine

● Current EDL of BD published in 20 6 having 285

medicine.
Advantages ******
. Reduction in the number of pharmaceutical products.

2. Improve the quality of drug utilization.

3. Facilitating the use of drugs that are more economic and

rational.

4. Overcome the primary health care problems by providing safe,

efficacious, cost-effective drugs.

5. Stimulation of local pharmaceutical industries.

P drug concept
***********
P – drug means *******
- Personal drug
- Priority drug
- Prefer drug
- Primary drug

P drug is a methodology of learning.

P drug concept
● A problem solving model was developed in 1982 in
the department of pharmacology and clinical
pharmacology, University of Groningen, the
Netherland by Theodore Rice.
Importance of P-drug concept
1. To change the basis of prescribing from empiric to scientific.
2. More practical approach to teaching in pharmacology class.
Criteria of P-drug
●Efficacy
● Safety
● Cost
● Suitability
The process of rational prescribing by using P-drug
This process consists of 6 steps
1. Define the patient’s problem/diagnosis
2. Specify the therapeutic objective
3. Varify whether your P-treatment is suitable for this
patient
4. Start the treatment
5. Give information, instruction and warnings
6. Monitor the treatment and if necessary then stop it.
Guidelines for selecting P-drugs **********
1. Define the diagnosis: When selecting a P-drug, it is
important to remember that you are choosing a drug of first
choice for a common condition.

2. Specify the therapeutic objective:

e.g: To decrease the diastolic blood pressure to a certain level.

To cure an infectious disease.
 Cont……
3. Make an inventory of effective group of drug
e.g: β blocker, benzodiazepine, penicillin
● There are two ways to identify effective groups of drug
a) looking at formularies or guidelines exist in health system,
hospital, WHO guideline.
b) Checking the index of good pharmacological reference
book.
● In most cases we find only 2-4 groups of drugs which are
 Cont…..
4. Choose an effective according to criteria.
Criteria for comparing the effective drugs
a) Efficacy: based on the grounds of absorption, distribution,
metabolism, excretion.

b) Safety: Possible side effects and toxic effects

c) Cost: Always look at the total cost of treatment rather the

cost per unit.
Rational drug prescribing
Rational use of medicine *********
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.
Cornerstones of rational use of medicine *********
. Appropriate diagnosis
2. Right drug
3. Right dose
4. Right duration

Other concern of cornerstones of RUM

- Essential drug list
- Generic prescribing
- National drug policy
- Clinical guidelines
Objectives of rational use of medicine*********
. To identify the magnitude and nature of inappropriate medicine

utilization.

2. To identify factors which influences the decision making

process.

3. To identify the factors which influence the behavior of the

prescribers.
Common types of irrational medicines use are **********
. The use of too many medicines per patient (polypharmacy).

2. Inappropriate use of antimicrobial often in inadequate dosage

for non-bacterial infection.
3. Over use of injections when oral formulations would be more
appropriate.
4. Failure to prescribe in accordance with clinical guidelines.
5. Non-adherence to dosing regimen.
6. Inappropriate self-medication, often of prescription only
medicines.
Impact of irrational use of drugs *********
. Serious morbidity and mortality, particularly for childhood

infections and chronic diseases like HTN, DM, epilepsy.

2. Antibiotic resistance – due to overuse of antibiotics as well as

their use in sub-therapeutic dosage.

3. Increased cost.

4. Risk of infection: due to non-sterile infections that leads to

abscess, transmission of hepatitis, HIV/AIDS and other blood born
disease.
 Cont..

5. Increased unwanted effects such as ADR.

6. Waste of resources – reduced availability of other vital drugs

and increased cost.

7. Drug dependence – such as due to overuse of opioids and

sedatives.

8. Psychological impact – Stimulate inappropriate demand of the

patient.
Reasons for irrational use of drugs ***********
Factors underlying irrational use of drugs or obstacles exit in
rational drug use:
. Lack of objective information and of continuing education and

training in pharmacology.

2. Defective drug supply system and ineffective regulation

3. Lucrative promotional activities of pharmaceutical industries.

[ Lucrative: Producing a great deal of profit]

4. Use of medicine when no medicine is indicated.

 Cont..
5. The prevalent belief , that “every ill has a pill”.

[Prevalent= Widespread in a particular area]

6. Sometimes expired drugs are available in market.

7. Artificial shortage of essential drug

8. Wrong interpretation of prescription.

9. Inadequate labeling

0. Lack of diagnostic facilities

Pre-requisites of rational drug use
. Critical assessment and evaluation of benefits and risk drugs

used.

2. Compare the advantage, disadvantages, safety and cost of the

drug with existing drug for same indication.
Stategies to improve rational prescribing core policies ***
At first, rules and regulation that are given by Government and
DGDA should be followed.
Stategies are
A. Educational strategies
i) Training of prescribers (formal and continuing education,
supervisory visits, group lectures, seminars, workshops).
ii) Printed materials (clinical literature and treatment guidelines,
medicine formularies, leaflets)
iii) Approaches based on face to face contact.
B. Managerial strategies
. Supervision, monitoring and feedback

2. Approaches to selection, procurement and distribution

(limited procurement lists, drug use review and feedback,

hospital and regional drug and therapeutic committees, cost
information).

3. Prescribing and dispensing approaches (structured medication

order forms, standard diagnostic and treatment guidelines)
 Cont..
C. Economic strategies
- Disallowing medicine sales by prescriber

D. Regulatory strategies
- Pharmaceutical registration
- Limited medicine lists
- Prescribing restriction
- Dispensing restriction
Questions (Essential drug and P-drug concept)
. WHO definition of essential medicine? *******
2. What are the factors predispose to choice of an essential drug?
******
3. Pioneer countries in access to essential medicines?
4. Selection criteria of an essential medicine? ********
5. What is essential drug list? ********
6. Objective of essential medicine? *******
7. Relation between health care system and essential medicine?
8. Reasons for the necessities of EMs? ********
 Cont…
9. Impact of essential medicine by using it? *****
0. Write about WHO model EML? ********
. Essential drug list in Bangladesh. Advantage of it? ********
12. What do you mean by P-drug? Importance of P-drug
concept.*********
13. What are the process of rational prescribing by using P-
drug? *********
14. Guidelines for selecting P-drug. ***********
Questions (Rational use of medicine)
. What is rational use of medicine? **********
2. Cornerstone of rational use of medicine. Objective of it? *********
3. Common types of irrational medicines.**********
4. Impact of irrational use of drugs. *********
5. Reasons for irrational use of drugs. *********
6. Prerequisites of rational use of drugs. ***
7. Stategies to improve rational prescribing core policies. ******
Prof questions
1. Write down the steps of choosing of P drug? (May 22)
2. Define and mention the criteria of essential drugs. Write down
steps of choosing a P-drug. (Nov 17, Nov 21)
3. Write down the criteria of rational prescribing. What
measures should you take to prevent irrational prescribing?
(May 21)
4. Define rational use of drugs. What are the hazard of irrational
prescribing? (May 20, May 19, May 17)
5. Short note: Essential drug (Nov 22)
6. List the hazard of irrational prescribing. Mention the steps
that should be taken for rational prescribing. (July 18, May
18)
7. Define essential drug. Write down its selection criteria. (Nov
18)
8. Short Note: R.U. D (May 22, May 17, July 17)
9. Write down the number of essential drugs used in various
levels in our country. (Nov 17)
 Odd roll number Marks: 5X5 = 25 Time: 35 min
. Define & mention the criteria of essential drugs. Write down steps of choosing a P-drug.
2 Write down the criteria of rational prescribing. What measures should you take to prevent
irrational prescribing?
3. What is essential drug list? Describe relation between health care system & essential
medicine.
4. Short note: a) Drug misuse b) Advantage of polypharmacy
5. Following drugs are included in essential drugs list or not. If included, write ‘yes’.
a) Ibuprofen b) Erythromycin c) Propofol d) sitagliptin e) pneumococcal vaccine.

Even roll number Marks: 5X5 = 25

. Define rational use of drugs. What are the hazard of irrational prescribing?
2. Define essential drug. Mention the steps that should be taken for rational prescribing.
3. What do you mean by P-drug? Guidelines for selecting P-drug.
4. Short note: a) Drug abuse b) Disadvantage of polypharmacy