Essential Medicines (Drugs) Concept
Department of Pharmacology
• The WHO has defined Essential Medicines (drugs) as “those that
satisfy the priority healthcare needs of the population.
• They are selected with due regard to public health relevance, evidence
on efficacy and safety and comparative cost effectiveness.
• Essential medicines are intended to be available within the context of
functioning health systems at all times and in adequate amounts, in
appropriate dosage forms, with assured quality and adequate
information and at a price the individual and the community can
afford.
• It has been realized that only a handful of medicines out of the
multitude available can meet the health care needs of majority of the
people in any country, and that many well tested and cheaper
medicines are equally (or more) efficacious and safe as their newer more
expensive congeners.
• For optimum utilization of resources, governments should concentrate
on these medicines by identifying them as Essential medicines.
• WHO has laid down criteria to guide selection of an essential medicine.
 Adequate data on its efficacy and safety
 Quality, bioavailability and stability on storage
 Genetic, demographic and environmental factors.
 Relative efficacy, safety, quality, price and availability.
 Cost-benefit ratio should be a major consideration.
 Pharmacokinetic properties
 Fixed ratio combination products
 Public health action, epidemiological conditions
 Developed treatment guidelines.
• To guide the member countries, the WHO brought out its first Model
List of Essential Drugs along with their dosage forms and strengths in
1977 which could be adopted after suitable modifications according to
local needs.
• This has been revised from time to time and the current is the 17th list
(2011).
• India produced its National Essential Drugs List in 1996 and has revised
it in 2011 with the title “National List of Essential Medicines”.
• This includes 348 medicines which are considered to be adequate to meet
the priority healthcare needs of the general population of the country
Prescription and non-prescription drugs
• As per drug rules, majority of drugs including all antibiotics must
be sold in retail only against a prescription issued to a patient by a
registered medical practitioner.
• These are called ‘prescription drugs’, and in India they have been
placed in the schedule H of the Drugs and Cosmetic Rules (1945) as
amended from time to time.
• However, few drugs like simple analgesics (paracetamol, aspirin),
antacids, laxatives (senna, lactulose), vitamins, ferrous salts are
considered relatively harmless, and can be procured without a
prescription.
• These are ‘non-prescription’ or ‘over the counter’ (OTC) drugs; can
be sold even by grocery stores
Orphan Drugs
• These are drugs or biological products for diagnosis/treatment/
prevention of a rare disease or condition, or a more common
disease for which there is no reasonable expectation that the cost of
developing and marketing it will be recovered from the sales of that
drug.
• Though these drugs may be life saving for some patients, they are
commercially difficult to obtain as a medicinal product.
• Governments in developed countries offer tax benefits and other
incentives to pharmaceutical companies for developing and
marketing orphan drugs (e.g. Orphan Drug Act in USA).
The list includes
 Sodium nitrite
 Fomepizole
 Liposomal amphotericin B,
 Miltefosine
 Rifabutin
 Succimer
 Somatropin
 Digoxin immune Fab (digoxin antibody)
 Liothyronine (T3)
Essential Drug Concept
Essential Drug Concept

Essential Drug Concept

  • 1.
    Essential Medicines (Drugs)Concept Department of Pharmacology
  • 2.
    • The WHOhas defined Essential Medicines (drugs) as “those that satisfy the priority healthcare needs of the population. • They are selected with due regard to public health relevance, evidence on efficacy and safety and comparative cost effectiveness. • Essential medicines are intended to be available within the context of functioning health systems at all times and in adequate amounts, in appropriate dosage forms, with assured quality and adequate information and at a price the individual and the community can afford.
  • 3.
    • It hasbeen realized that only a handful of medicines out of the multitude available can meet the health care needs of majority of the people in any country, and that many well tested and cheaper medicines are equally (or more) efficacious and safe as their newer more expensive congeners. • For optimum utilization of resources, governments should concentrate on these medicines by identifying them as Essential medicines.
  • 4.
    • WHO haslaid down criteria to guide selection of an essential medicine.  Adequate data on its efficacy and safety  Quality, bioavailability and stability on storage  Genetic, demographic and environmental factors.  Relative efficacy, safety, quality, price and availability.  Cost-benefit ratio should be a major consideration.  Pharmacokinetic properties  Fixed ratio combination products  Public health action, epidemiological conditions  Developed treatment guidelines.
  • 5.
    • To guidethe member countries, the WHO brought out its first Model List of Essential Drugs along with their dosage forms and strengths in 1977 which could be adopted after suitable modifications according to local needs. • This has been revised from time to time and the current is the 17th list (2011). • India produced its National Essential Drugs List in 1996 and has revised it in 2011 with the title “National List of Essential Medicines”. • This includes 348 medicines which are considered to be adequate to meet the priority healthcare needs of the general population of the country
  • 6.
    Prescription and non-prescriptiondrugs • As per drug rules, majority of drugs including all antibiotics must be sold in retail only against a prescription issued to a patient by a registered medical practitioner. • These are called ‘prescription drugs’, and in India they have been placed in the schedule H of the Drugs and Cosmetic Rules (1945) as amended from time to time. • However, few drugs like simple analgesics (paracetamol, aspirin), antacids, laxatives (senna, lactulose), vitamins, ferrous salts are considered relatively harmless, and can be procured without a prescription. • These are ‘non-prescription’ or ‘over the counter’ (OTC) drugs; can be sold even by grocery stores
  • 8.
    Orphan Drugs • Theseare drugs or biological products for diagnosis/treatment/ prevention of a rare disease or condition, or a more common disease for which there is no reasonable expectation that the cost of developing and marketing it will be recovered from the sales of that drug. • Though these drugs may be life saving for some patients, they are commercially difficult to obtain as a medicinal product. • Governments in developed countries offer tax benefits and other incentives to pharmaceutical companies for developing and marketing orphan drugs (e.g. Orphan Drug Act in USA).
  • 9.
    The list includes Sodium nitrite  Fomepizole  Liposomal amphotericin B,  Miltefosine  Rifabutin  Succimer  Somatropin  Digoxin immune Fab (digoxin antibody)  Liothyronine (T3)