National List Of Essential Medicine Nepal(5th Revision)2016

  • Background :
     Essential medicines are those medicines that satisfy the priority health care needs of the population. WHO published the first essential medicine list in 1977 and has been updating it every two years since.
     Nepal being a signatory of the Alma Ata declaration (1978) implemented the essential medicine program with a first ever National List of Essential Medicines, NLEM in 1986.
     Since then NLEM revised five times (1992, 1997, 2002, 2011 and 2016) with the support from WHO Nepal.
    Criteria of selection
    The main criteria for selection of the medicines in the NLEM are public health relevance (harmonizing with standard treatment schedule use in primary health care service), efficacy, safety, cost-effectiveness and access.
    Methodology/Process Algorithm
     Meeting of Main committee (for technical guidance)
     Draft committee working as a coordinating task force
     Opinions taken from expert groups (therapeutic experts-clinicians and other stakeholders).
     Wider consultation through organizing workshop with resource personnel, clinicians/expert, draft committee, main committee comprising policy makers and programme managers and other relevant stakeholders based on STG and Evidences
     Draft preparation Closer consultation for minor details and edition
     Finalization of draft NLEM.
     Agenda of DAC for Recommendation
     Approval by the ministry
    Criteria for inclusion of a medicine in NLEM will be as follows:
     Approved/licensed medicine in the country
     Relevance for disease posing public health problem (morbidity)
     Proven efficacy and safety profile based on valid scientific evidence (evidence-based)
     Cost effective
     Aligned with STG (the current treatment guidelines under public health program)
     Stable under the storage conditions
     Preference on relative safety, efficacy, cost-effectiveness (in case there are more than one alternative)
     Fixed Dose Combinations (FDCs) with unequivocally proven advantage over Single (in terms of increasing efficacy, reducing adverse effects and/or improving compliance)
     Access, free drug, SHI
    Criteria for deletion of a medicine from NLEM will be as follows:
     Banned in Nepal
     Reports of concerns on the safety profile of a medicine
     If better efficacy or favorable safety profiles and better cost-effectiveness is available.
     Irrelevant to public health disease burden
     Antimicrobial resistance pattern (In case of antimicrobials, if the resistance pattern has rendered a medicine ineffective in Nepalese and international context)
     Medicine with abuse and misuse potential
    There were 321 medicines listed in NLEM 2011. A total of 86 medicines have been added or deleted from the NLEM 2011in the current list. A total of 62 medicines have been added and a total of 24 medicines have been deleted from the previous list.
    Among the 62 added medicines 56 were added to the main list and 6 to the complementary list. The medicines added in the Antitubercular and Antiretroviral groups are added to match with the National TB programme and HIV AIDS Control Program of Government of Nepal. The new list of NLEM 2016 thus contains 359 medicines.