Write NLEM drugs
The World Health Organization (WHO) has defined ‘essential medicines’ as those that satisfy the priority health care needs of the population. The WHO also says that the essential medicines should be available “at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford”.
The Alma Ata Declaration adopted by the World Health Assembly in 1978 was the first international declaration, a milestone, which brought primary health care to the forefront. It outlined provision of essential drugs as one of the essential components of primary health care. In the same year, the World Health Assembly passed a Resolution urging Member States to establish national lists of essential medicines and adequate procurement systems.
India too joined hands with the WHO and the first National Essential Drugs List was published in 1996. It was revised in 2003 as the National List of Essential Medicines (NLEM). The latest revision was notified on December 23, 2015. The NLEM 2015 includes 376 medicines listed according to the level of health care: Primary, secondary and tertiary
Many criteria are considered to include a drug in the 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. • 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 Essential drugs satisfy the priority healthcare needs of the large majority of the community. And, if a drug is listed in the essential medicines list, this means that it has to be “affordable, available at all times in adequate amounts with assured quality to meet the health care needs”. The NLEM assumes particular importance to India where out of pocket expenditure on health care is quite high and only a few have health insurance.
An article published in the February 2015 issue of the Indian Journal of Medical Research says “Healthcare access in India is affected with 70:70 paradox; 70 per cent of healthcare expenses are incurred by people from their pockets, of which 70 per cent is spent on medicines alone, leading to impoverishment and indebtedness.”
The United Nations Sustainable Development Goal (SDG) 3 “Ensure healthy lives and promote well-being for all at all ages” has outlined access to safe, effective, quality and affordable essential medicines for all in Target 3.8, which states: “Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”
IMA believes that health care should be within reach of every person in the country. It should be affordable, with provisions for people from all economic strata. IMA is also committed to the 17 SDGs and their 169 targets.
Hence, IMA recommends that its members should write NLEM drugs, instead of prescribing expensive non NLEM drugs to those who cannot afford them. But, this does not mean that drugs not included in the NLEM are non-inferior drugs. If you prescribe a non-NLEM and more expensive drug, explain to the patient why you are doing so.
The Alma Ata Declaration adopted by the World Health Assembly in 1978 was the first international declaration, a milestone, which brought primary health care to the forefront. It outlined provision of essential drugs as one of the essential components of primary health care. In the same year, the World Health Assembly passed a Resolution urging Member States to establish national lists of essential medicines and adequate procurement systems.
India too joined hands with the WHO and the first National Essential Drugs List was published in 1996. It was revised in 2003 as the National List of Essential Medicines (NLEM). The latest revision was notified on December 23, 2015. The NLEM 2015 includes 376 medicines listed according to the level of health care: Primary, secondary and tertiary
Many criteria are considered to include a drug in the 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. • 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 Essential drugs satisfy the priority healthcare needs of the large majority of the community. And, if a drug is listed in the essential medicines list, this means that it has to be “affordable, available at all times in adequate amounts with assured quality to meet the health care needs”. The NLEM assumes particular importance to India where out of pocket expenditure on health care is quite high and only a few have health insurance.
An article published in the February 2015 issue of the Indian Journal of Medical Research says “Healthcare access in India is affected with 70:70 paradox; 70 per cent of healthcare expenses are incurred by people from their pockets, of which 70 per cent is spent on medicines alone, leading to impoverishment and indebtedness.”
The United Nations Sustainable Development Goal (SDG) 3 “Ensure healthy lives and promote well-being for all at all ages” has outlined access to safe, effective, quality and affordable essential medicines for all in Target 3.8, which states: “Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”
IMA believes that health care should be within reach of every person in the country. It should be affordable, with provisions for people from all economic strata. IMA is also committed to the 17 SDGs and their 169 targets.
Hence, IMA recommends that its members should write NLEM drugs, instead of prescribing expensive non NLEM drugs to those who cannot afford them. But, this does not mean that drugs not included in the NLEM are non-inferior drugs. If you prescribe a non-NLEM and more expensive drug, explain to the patient why you are doing so.
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