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FACULTY OF PHARMACEUTICAL SCIENCE
PHARMACOTHERAPEUTICS ER20-24T
Chapter 1: Pharmacotherapeutics
Topic 3. Essential Medicines lists
Presented by- Ms. ALKA
Assistant Professor
FACULTY OF PHARMACEUTICAL SCIENCE
RAMA UNIVERSITY UTTAR PRADESH
KANPUR, INDIA
2023-2024
1
FACULTY OF PHARMACEUTICAL SCIENCE
2
Essential Medicines List
Essential Medicines (EM) are those that satisfy the healthcare needs of most of the population
and therefore should always be available in appropriate amounts and in appropriate dosage
forms.
 History of EML
 The first country in the World to compose its Essential Medicine List (EML) was Tanzania
in 1970.
 WHO published the first EML in 1977, which has been updated successively every 5 years in
view of changing world scenario regarding the medical needs and availability of new and
better drugs. The first EML for Children was published in 2007 by WHO.
FACULTY OF PHARMACEUTICAL SCIENCE
3
 In India, The Government of India, Ministry of Health & Family Welfare (MOHFW) is
mandated to ensure a quality healthcare system by assuring the availability of safe and
efficacious medicines for its population. MOHFW publishes the National List of Essential
Medicines (NLEM)
 Ministry of Health and Family Welfare, Government of India hence prepared and released
the first National List of Essential Medicines of India in 1996 consisting of 279
medicines. This list was subsequently revised in 2003 and had 354 medicines. Later in 2011,
the list was revised and had 348 medicines. Till 2021, 399 medicines (including 4 medical
devices) are regulated under Revised Schedule – I based on the NLEM, 2015.
 National List of Essential Medicines (NLEM)
FACULTY OF PHARMACEUTICAL SCIENCE
4
Sr. no NLE
M
No. of medicines
1. 1996 279
2. 2003 354
3. 2011 348
4. 2015 376
5. 2021 399
6. 2022 384 medicines (34 medicines have been added and 26
medicines have been deleted from NLEM, 2015)
FACULTY OF PHARMACEUTICAL SCIENCE
5
 Salient features of the Latest NLEM 2015
1. There were 348 medicines listed in NLEM 2011. A total of 106 Medicines has been added,
and 70 medicines have been deleted to prepare NLEM 2015 which now contains a total of
376 medicines.
2. Medicines in NLEM are listed with reference to the levels of healthcare, namely, Primary
(P), Secondary (S) and Tertiary (T). 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).
List of Sections of NLEM 2015
There are Total 30 Sections in NLEM 2015 (In NLEM 2011, there were 27 sections)
FACULTY OF PHARMACEUTICAL SCIENCE
6
Consideration
for Framing the
NLEM 2015
Public Health
Relevance
Clinical Efficacy
and Safety
Cost-effectiveness
Patient Accessibility
and Equity
Rational Drug
Use
Global and Regional
Guidelines
Healthcare
Infrastructure
Stakeholder
Engagement
Local Production
and Supply
Regular Review and
Update
FACULTY OF PHARMACEUTICAL SCIENCE
7
 Selection criteria of Essential medicines
1. Be licensed/ approved in the country by the Drugs Controller General of India.
2. Be useful in disease which is a public health problem in India.
3. Have proven efficacy and safety profile.
4. Be comparatively cost-effective.
5. Be aligned with the current treatment guidelines for the disease.
6. Be stable under storage conditions.
7. While comparing more than one medicine of the same therapeutic class, prefer prototype or
best-suited medicine.
8. Considered the total treatment price not the unit price of a medicine.
9. Medicine in NLEM will be based on the P/S/T level of healthcare.
FACULTY OF PHARMACEUTICAL SCIENCE
8
 Criteria for exclusion of medicine from NLEM
1. A medicine has been banned in India.
2. If any safety concerns are reported.
3. The criteria of safety, efficacy, and cost-effectiveness of any medicine were not fulfilled.
4. The disease burden for which medicine is indicated is no longer a national health concern.
5. In the case of antimicrobials, if the resistance pattern has rendered a medicine ineffective.
 List of Essential Medicines: The list of essential medicines can vary by country and is
typically compiled and updated by national health authorities or international organizations
like the World Health Organization (WHO). These lists include medications that are
considered essential for addressing the most important health needs in each region or
globally. some examples of essential medicines include:
FACULTY OF PHARMACEUTICAL SCIENCE
9
Anaesthetics and
Sedatives:
Midazolam
Antihypertensive Medications:
Amlodipine, Hydrochlorothiazide
Antifungal Medications:
Fluconazole, Amphotericin B
Opioid Analgesics:
Morphine, Codeine
Antidiabetic Medications:
Metformin, Insulin
Antiepileptic Medications:
Phenobarbital, Phenytoin
Cardiovascular Medications:
Aspirin, Enalapril
Respiratory Medications:
Salbutamol, Beclometasone
Essential Vitamins and
Minerals: Vitamin A, Iron,
Ketamine
Antipsychotic Medications:
Haloperidol, Chlorpromazine
Immunosuppressant
Medications: Cyclosporine,
Azathioprine
Anticoagulants and
Antiplatelet Medications:
Warfarin, Aspirin
Gastrointestinal
Medications:
Omeprazole, Loperamide
Hormonal Contraceptives:
Combined oral contraceptives.
Levonorgestrel-releasing
intrauterine system.
Antimalarial Medications:
Artemisinin-based
combination therapies (ACTs)
Diagnostic Agents and
Supplies:
Insulin syringes
Tuberculin skin test antigens
Antiviral Medications:
Oseltamivir (Tamiflu)
Zidovudine (AZT)
Antibiotics:
Amoxicillin
Penicillin
Ciprofloxacin
Analgesics and Pain Relievers:
Paracetamol (acetaminophen)
Ibuprofen
Antiretroviral Medications
(for HIV/AIDS):
Tenofovir
Lamivudine
FACULTY OF PHARMACEUTICAL SCIENCE
10

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Pharmacotherapeutics chapter 1 topic3 (EML).pptx

  • 1. FACULTY OF PHARMACEUTICAL SCIENCE PHARMACOTHERAPEUTICS ER20-24T Chapter 1: Pharmacotherapeutics Topic 3. Essential Medicines lists Presented by- Ms. ALKA Assistant Professor FACULTY OF PHARMACEUTICAL SCIENCE RAMA UNIVERSITY UTTAR PRADESH KANPUR, INDIA 2023-2024 1
  • 2. FACULTY OF PHARMACEUTICAL SCIENCE 2 Essential Medicines List Essential Medicines (EM) are those that satisfy the healthcare needs of most of the population and therefore should always be available in appropriate amounts and in appropriate dosage forms.  History of EML  The first country in the World to compose its Essential Medicine List (EML) was Tanzania in 1970.  WHO published the first EML in 1977, which has been updated successively every 5 years in view of changing world scenario regarding the medical needs and availability of new and better drugs. The first EML for Children was published in 2007 by WHO.
  • 3. FACULTY OF PHARMACEUTICAL SCIENCE 3  In India, The Government of India, Ministry of Health & Family Welfare (MOHFW) is mandated to ensure a quality healthcare system by assuring the availability of safe and efficacious medicines for its population. MOHFW publishes the National List of Essential Medicines (NLEM)  Ministry of Health and Family Welfare, Government of India hence prepared and released the first National List of Essential Medicines of India in 1996 consisting of 279 medicines. This list was subsequently revised in 2003 and had 354 medicines. Later in 2011, the list was revised and had 348 medicines. Till 2021, 399 medicines (including 4 medical devices) are regulated under Revised Schedule – I based on the NLEM, 2015.  National List of Essential Medicines (NLEM)
  • 4. FACULTY OF PHARMACEUTICAL SCIENCE 4 Sr. no NLE M No. of medicines 1. 1996 279 2. 2003 354 3. 2011 348 4. 2015 376 5. 2021 399 6. 2022 384 medicines (34 medicines have been added and 26 medicines have been deleted from NLEM, 2015)
  • 5. FACULTY OF PHARMACEUTICAL SCIENCE 5  Salient features of the Latest NLEM 2015 1. There were 348 medicines listed in NLEM 2011. A total of 106 Medicines has been added, and 70 medicines have been deleted to prepare NLEM 2015 which now contains a total of 376 medicines. 2. Medicines in NLEM are listed with reference to the levels of healthcare, namely, Primary (P), Secondary (S) and Tertiary (T). 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). List of Sections of NLEM 2015 There are Total 30 Sections in NLEM 2015 (In NLEM 2011, there were 27 sections)
  • 6. FACULTY OF PHARMACEUTICAL SCIENCE 6 Consideration for Framing the NLEM 2015 Public Health Relevance Clinical Efficacy and Safety Cost-effectiveness Patient Accessibility and Equity Rational Drug Use Global and Regional Guidelines Healthcare Infrastructure Stakeholder Engagement Local Production and Supply Regular Review and Update
  • 7. FACULTY OF PHARMACEUTICAL SCIENCE 7  Selection criteria of Essential medicines 1. Be licensed/ approved in the country by the Drugs Controller General of India. 2. Be useful in disease which is a public health problem in India. 3. Have proven efficacy and safety profile. 4. Be comparatively cost-effective. 5. Be aligned with the current treatment guidelines for the disease. 6. Be stable under storage conditions. 7. While comparing more than one medicine of the same therapeutic class, prefer prototype or best-suited medicine. 8. Considered the total treatment price not the unit price of a medicine. 9. Medicine in NLEM will be based on the P/S/T level of healthcare.
  • 8. FACULTY OF PHARMACEUTICAL SCIENCE 8  Criteria for exclusion of medicine from NLEM 1. A medicine has been banned in India. 2. If any safety concerns are reported. 3. The criteria of safety, efficacy, and cost-effectiveness of any medicine were not fulfilled. 4. The disease burden for which medicine is indicated is no longer a national health concern. 5. In the case of antimicrobials, if the resistance pattern has rendered a medicine ineffective.  List of Essential Medicines: The list of essential medicines can vary by country and is typically compiled and updated by national health authorities or international organizations like the World Health Organization (WHO). These lists include medications that are considered essential for addressing the most important health needs in each region or globally. some examples of essential medicines include:
  • 9. FACULTY OF PHARMACEUTICAL SCIENCE 9 Anaesthetics and Sedatives: Midazolam Antihypertensive Medications: Amlodipine, Hydrochlorothiazide Antifungal Medications: Fluconazole, Amphotericin B Opioid Analgesics: Morphine, Codeine Antidiabetic Medications: Metformin, Insulin Antiepileptic Medications: Phenobarbital, Phenytoin Cardiovascular Medications: Aspirin, Enalapril Respiratory Medications: Salbutamol, Beclometasone Essential Vitamins and Minerals: Vitamin A, Iron, Ketamine Antipsychotic Medications: Haloperidol, Chlorpromazine Immunosuppressant Medications: Cyclosporine, Azathioprine Anticoagulants and Antiplatelet Medications: Warfarin, Aspirin Gastrointestinal Medications: Omeprazole, Loperamide Hormonal Contraceptives: Combined oral contraceptives. Levonorgestrel-releasing intrauterine system. Antimalarial Medications: Artemisinin-based combination therapies (ACTs) Diagnostic Agents and Supplies: Insulin syringes Tuberculin skin test antigens Antiviral Medications: Oseltamivir (Tamiflu) Zidovudine (AZT) Antibiotics: Amoxicillin Penicillin Ciprofloxacin Analgesics and Pain Relievers: Paracetamol (acetaminophen) Ibuprofen Antiretroviral Medications (for HIV/AIDS): Tenofovir Lamivudine