The bioMérieux solution Did you know? VITEK2 has been challenged with ESBL in http://www.lahey.org/studiesSite of Lahey Clinic, where tables are updated for several studies.The broader scope has been B-lactamases with amino-acid sequences published by Livermore et al.
A comparative review of the list of essential
medicines of three Indian states: Findings
Introduction: Essential medicines lists are a key instrument for improving quality
and equitable access to health care. The National List of Essential Medicines of India 2011 is modeled on the WHO Essential Medicines List and Indian states (adopting the National List) are free to include other medicines as needed. Materials and Methods: National List of Essential Medicines of India 2011 contains
a total of 287 medicines for provision at primary and secondary level of health facilities. The International Nonproprietary Name of these medicines was compared with the List of Essential Medicines (LEM) of three states, that is, Bihar, Rajasthan and Tamil Nadu for the inclusion patterns. Results: A large number of medicines from
the National List of Essential Medicine (NLEM) were missing from the state LEM's, especially Bihar. The sections on Anticonvulsants, Diuretics, Psychotherapeutic, Antiallergics and Oxytocics were comprehensively included by both Rajasthan and Tamil Nadu. Furthermore, the analgesic and anti-infective medicines were largely included. However, the sections of antidotes, diagnostic agents and ophthalmological preparations were grossly defi cient. Similarities were found across states in their patterns of both inclusion and exclusion of medicines. Conclusion: The analysis
reveals that the extent of inclusion of NLEM medicines in state LEM's is defi cient with variable patterns across states. This in turn has implications for drug availability, prescription patterns, and rational drug use. As some drugs are repeatedly there in NLEM but not included by states, a discussion based consultative approach for better coherence across the lists could lead to further optimization and utilization Venkatesh Narayan,
of LEM's which would aid in improved access to medicines.
Key words: Essential medicines, inclusion of medicines, India essential medicine list
International Clinical Epidemiology Network, 1Indian Institute of Public Health, New Delhi, India Address for the Correspondence:
WHO defi nes Essential medicines as those that satisfy the health care needs of the majority of the Dr Venkatesh Narayan, population and are selected with due regard to public health relevance, evidence on effi cacy and Flat No. 351, Sector A, Pocket C, Vasant Kunj, safety, and comparative cost-effectiveness. Availability of a limited list of carefully selected essential New Delhi - 110 070, India.
medicines within the context of functioning health systems is among the key instruments to improve quality and equitable access to health care. WHO published the fi rst WHO Model list of essential medicines (EML) in 1977 thereby providing a template which could help countries prepare their own lists as also emulated by the 17th WHO model EML 2011. The Indian National List of Essential Access this article online
Medicine (NLEM) preface states that it is modeled on the WHO EML. India's fi rst NLEM was prepared and released in 1996 which got revised in 2003 and the current 2011 version is its 3rd revision. Website: www.ijmedph.org Within the recent debates over Universal Health Coverage in India, the issue of access to medicines has Quick response code: received signifi cant attention. State schemes of free access to medicines as demonstrated by Rajasthan and Tamil Nadu have paved the path for universal access to medicines. Several Indian states have developed their state LEM's. Often, the state-level technical advisory committees study the WHO list, NLEM and also the disease pattern prevalent in the state to derive state LEM. States adopting the National List are free to include other medicines as considered adequate to treat additional diseases of local importance. While comparative analysis of LEM's has been carried out by few earlier studies, often, the focus is on specifi c sections[10,11] (such as Reproductive Health, Maternal and Child health) or an overall International Journal of Medicine and Public Health Jan-Mar 2015 Vol 5 Issue 1 Narayan, et al.: Essential medicine list review of three Indian states comparison of LEM's of countries against the WHO lists. Health criterion for noninclusion was the absence of NLEM medicines being a state subject in India, adequate focus needs to be devoted to the INN in the state LEM. Medicines are additionally characterized state LEM's for improving the drug availability at health institutions. by their strength, dosage form (e.g., syrup, cream, injection) and As Government of India takes hesitant steps toward universal access fi xed dose combinations (FDC's). However, the alphabetical list to medicines by asking states to review and adopt NLEM as per state comprising of all the 348 NLEM medicines has listed only the INN requirements, this review attempts to aid the process. Since earlier of the medicines. Thus, for the purpose of comparison, listing of studies have not specifi cally addressed the state LEM's, this study the INN in the state list was considered as inclusion irrespective hopes to contribute to the knowledge in this arena.
of the strength or dosage forms. Listing of the INN, even within FDC was considered as the inclusion in the state LEM. For example, MATERIALS AND METHODS
ferrous sulfate combination with folic acid was taken as inclusion of both of these chemical entities. The drugs under National Health The study aims to compare the inclusion of the medicines listed in the Programs (e.g., Tuberculosis, Malaria, HIV) are often supplied NLEM across three states. The methods were adapted from earlier through separate programs under central support and thus were studies[10,11] on the subject and the methodology was suitably modifi ed considered to be included for state lists. Thus, the noninclusions to compare India's LEM with state LEM's. The state selection was derived from this analysis are conservative estimates, allowing for carried out purposively. Rajasthan has recently launched a recent free the above considerations, barring which the extent of noninclusions medicines scheme and was thus selected to see if their LEM offered would be even larger.
an adequate inclusion of medicines. The state of Tamil Nadu is well known for its successful health initiatives including its Tamil Nadu Medical Services Corporation (TNMSC) model and was thus included. To also review a state with comparatively poorer health indicators Comparison of Bihar list of Essential Medicines
and performance, Bihar LEM was chosen to assess its inclusion. 2009 with National list of Essential Medicine
Rajasthan Medical Services Corporation maintains a publically available The Bihar LEM 2009 lists the drugs alphabetically for each institution collection of selected essential medicines lists at http://www.rmsc.nic.
both for outdoor and indoor. The Outdoor list for District Hospital in/Drug_Procurement.html which contained lists from four states that corresponds with secondary level of health facility comprises of (Rajasthan, MP, Bihar, TN) at the time this study was conducted. total 41 medicines that also includes Plaster of Paris. It also includes For this study, the essential medicines lists for the requisite states were four FDC's (e.g., Dicyclomine with Paracetamol). It comprises of then selected, resulting in three unique state lists for analysis. These were certain ambiguities such as simply writing "cough syrup/sedative" then compared from NLEM available at drug regulatory authority of without specifying the actual contents and listing of the medicine India, the Central Drugs Standard Control Organization (http://www.
Rabeprazole as alternative to Ranitidine. The Indoor list comprises cdsco.nic.in). The lists were downloaded and reviewed by comparing a total of 193 medicines that also includes items such as dressing them with each other. Each LEM was evaluated for concordance with and sutures. Typological errors such as atropine being written twice the medicines listed in the NLEM by the lead authors. Any discrepancies and spelling mistakes exist in the list. Furthermore, antibiotics such were adjudicated by the third author.
as Amoxiclav and Vancomycin which have been listed by NLEM at tertiary level are listed at District Hospital. Against the 287 medicines National List of Essential Medicine 2011 has categorized medicines listed in NLEM for primary and secondary level, a total of 182 according to therapeutic area. Thus certain medicines appear in >1 medicines were found to be present in the Bihar LEM with the rest category. The list comprises a total of 348 medicines (excluding 105 medicines not being included [Table 1].
repetitions), which also includes all the medicines being provided under various National Health Programs. From the total of 348 Comparison of Rajasthan and Tamil Nadu list
medicines in NLEM, 181 medicines have been categorized for of Essential Medicines (2012) with National list
health institutions at all levels (P-primary, S-secondary, T-tertiary) of Essential Medicine
whereas 106 medicines have been listed for institutions at secondary and tertiary (S, T) levels. The remaining 61 drugs are categorized The Rajasthan LEM listed a total of 477 medicines and also the only for tertiary level health institutions and more than half of these category (Primary, Secondary, Tertiary) of health institution for its comprise of anticancer drugs. This analysis being more focused on drug inclusions and access at primary and secondary level, the tertiary Table 1: Comparison of Bihar, Rajasthan
category and its 61 medicines were excluded from the comparative and Tamil Nadu LEM with NLEM
analysis. Thus, from these 348 medicines listed in NLEM 2011, a Rajasthan Tamil Nadu
medicines list comprising a total of 287 (181 P, S, T + 106 S, T) Included medicines (out medicines up to secondary level health institutions was derived.
of 287 in NLEM)Nonincluded medicines The comparison was carried out on the basis of the International (out of 287 in NLEM) Nonproprietary Name (INN) of these 287 medicines and the NLEM = National list of essential medicine, LEM = List of essential medicine International Journal of Medicine and Public Health Jan-Mar 2015 Vol 5 Issue 1 Narayan, et al.: Essential medicine list review of three Indian states availability. The Tamil Nadu LEM listed a total of 260 medicines of which both Rajasthan and Tamil Nadu had included two each. with their strengths, but without the category of health institutions. While the NLEM has listed Diclofenac as medicine only for As evident from Table 1, of the 287 medicines listed in NLEM up tertiary level health institutions, Rajasthan LEM includes FDC's to secondary level, 236 (82.2%) have been included by the Rajasthan of Diclofenac and Ibuprofen with Paracetamol even at Primary LEM as against 207 (72.7%) in Tamil Nadu LEM. Thus, as compared Health Centers. Section 6 of NLEM comprises of a total of 63 to the NLEM, 51 and 78 drugs are not included by Rajasthan and Antiinfective Medicines. While Rajasthan had included 58 of them, Tamil Nadu respectively.
55 anti-infectives had also been listed by Tamil Nadu.
Utilizing the availability of updated 2012 therapeutic area wise While assessing the therapeutic categories which had the most LEM's of both states, comparisons across sections were carried number of excluded medicines [Figure 2], while the NLEM consisted out to look further into these inclusions. The section-wise of 13 antidotes and other substances used in poisonings, only six detailed analysis for the fi ve most included sections [Figure 1] and four of these had been included by Rajasthan and Tamil Nadu revealed identical patterns for both states. For Section 5 of respectively. The most defi cient section was that of diagnostic agents Anticonvulsants/Antiepileptics, Section 16 of Diuretics, and comprising a total of 11 ophthalmic and radiocontrast agents of Section 24 of Psychotherapeutic Medicines comprising of which while Rajasthan had included fi ve medicines, Tamil Nadu six, four and eight medicines respectively, all drugs listed in included only one. Similarly, another defi cient category was section NLEM were also included in the state LEM's. For Section 3 of 21 of NLEM comprising of 15 Ophthalmological Preparations of Antiallergics and Medicines used in Anaphylaxis and Section 22 which Tamil Nadu had included six preparations whereas Rajasthan of Oxytocics and Antioxytocics, which comprised of nine and had most (11) of them.
fi ve medicines respectively, only Dexchlorpheniramine Maleate and Terbutaline were missing in corresponding therapeutic Similarities across Rajasthan and Tamil Nadu list
category of both states.
of Essential Medicine's
As states are showing similar and related patterns of inclusion
Section 2 of NLEM has two subsections. The Analgesics and and noninclusion, Table 3 was derived comprising of the fi ve Antipyretics (nonsteroidal antiinfl ammatory drugs, Opioids) had most included sections by Rajasthan and Tamil Nadu along with total six medicines of which while Rajasthan had all, Tramadol had the cardiac, gastrointestinal and respiratory medicines w.r.t. the not been included by Tamil Nadu [Table 2]. The total medicines for Gout and Rheumatoid Disorders listed in NLEM were seven, Figure 1: Most included sections from National List of Essential
Figure 2: Most nonincluded sections from National List of Essential
Medicine in List of Essential Medicines of Rajasthan and Tamil Nadu Medicine in List of Essential Medicines of Rajasthan and Tamil Nadu Table 2: Analgesics and antiinfectives
LEM Tamil Nonincluded medicines
Section: 2 — Analgesics and antipyretics (NSAID's, opioids) Medicines for gout and rheumatoid disorders Allopurinol, colchicine, sulfasalazine, hydroxychloroquine phosphate, lefl unomide Section: 6 — Anti-infective medicines (also includes the Piperazine, praziquantel, sulphadiazine, medicines under National Health Programmes for leprosy, nystatin, diloxanide furoate tuberculosis, HIV, KalaAzar and Malaria)Total NLEM = National list of essential medicine, LEM = List of essential medicine, NSAID's = Nonsteroidal anti-infl ammatory drugs International Journal of Medicine and Public Health Jan-Mar 2015 Vol 5 Issue 1 Narayan, et al.: Essential medicine list review of three Indian states Table 3: Similarities across Rajasthan and Tamil Nadu LEM's
LEM Tamil Nonincluded medicines (only Tamil Nadu*)
Section: 7 — Antimigraine medicines Dihydro ergotamine Section: 9 — Antiparkinsonism medicines Section: 10 — Medicines affecting blood Iron dextran, protamine sulphate, warfarin Section: 15 — Disinfectants (4) and antiseptics (8) Acrifl avin + glycerin, chlorhexidine*, potassium permanganate Section: 20 — Muscle relaxants and cholinesterase inhibitorsSection: 12 — Cardiac medicines Metoprolol, adenosine, losartan* Section: 17 — Gastrointestinal medicines Famotidine*, ondansetron*, 5-ASA, hyoscine*, ispaghula Section: 25 — Medicines acting on the respiratory Beclomethasone dipropionate*, ipratropium*, iextromethorphan*, codeine phosphate NLEM = National list of essential medicine, LEM = List of essential medicine NLEM. The nonincluded medicines were similar across both onwards by Rajasthan. While FDC's are to be avoided in LEM's, states and comprised of medicines such as Dihydro ergotamine, their inclusion probably refl ects patient demand and also doctor's Bromocriptine, Iron dextran and Warfarin.
preference for these analgesics.
Also, Section 12 of NLEM that listed a total of 24 Cardiac medicines About the antiinfectives, interestingly [Table 2] most from NLEM are of which both Rajasthan and Tamil Nadu had not included present in LEM's of both Rajasthan (58 of 63) and Tamil Nadu (55 Metoprolol and adenosine. Section 17 of gastrointestinal medicines of 63). LEM's are a necessary step for controlling antibiotic misuse had total of 15 medicines in NLEM. Rajasthan had included most and thus preventing drug resistance. However, an earlier study of them (13 out of 15) and ten drugs were included by Tamil Nadu. in Delhi shows that though certain higher antibiotics are provided However, section 25 for Medicines acting on the respiratory tract only for restricted usage, they get prescribed frequently probably provides a different pattern. While the NLEM has six medicines due to doctor's preference of or the unavailability of alternative of which fi ve are included by Rajasthan, only two have been listed antibiotics. Studies have pointed out the nonjudicious selection by Tamil Nadu.
due to lack of knowledge, time or the need to fi nish the near expiry drugs.[13,20] It has been demonstrated that in addition to fi nancial considerations, perceived demand and expectation from the patients has also promoted antibiotic overuse. The results above point out specifi c issues, the most remarkable being the limited overall number of medicines included in state LEM's as compared to NLEM. Noninclusion of 105 drugs in Bihar The possible reasons for noninclusion could be multi-fold as it is LEM shows incorporation of the limited number of drugs when possible that certain drugs in NLEM may be expensive and thus compared against NLEM and also the LEM of Rajasthan and Tamil not included. Certain drugs are consistently missing across states Nadu pointing out its relative inadequacy [Table 1]. In contrast refl ecting that they are either unnecessarily included in NLEM, that to this, the states of Rajasthan and Tamil Nadu has included 236 is, inclusion could have been avoided or the prevailing disease and (82.2%) and 207 (72.7%) medicines in their respective state LEM's. prescription patterns in the state does not require these drugs. This is The fi nding corroborates with the success of the free medicines seen [Table 2] for the medicines for Gout and Rheumatoid Disorders scheme and TNMSC model in the states of Rajasthan and Tamil (total seven), of which both Rajasthan and Tamil Nadu included two, Nadu respectively. Figure 1 also shows their comprehensive that is, majority were not considered as fi t for inclusion by the states.
inclusion patterns as evident from the comparison of the most included sections.
Some exclusions are explained on pharmacological basis. The noninclusion of the antiallergic Dexchlorpheniramine Maleate Nonsteroidal antiinfl ammatory drugs
by both Rajasthan and Tamil Nadu can be explained for by the simultaneous presence of Chlorpheniramine Maleate as also pointed The section on [Table 2] Analgesics and Antipyretics having six out by Manikandan and Gitanjali. Also, drugs with limited usage drugs in NLEM are comprehensively included by Rajasthan (all six) like ether would have been intentionally excluded by states. These while Tamil Nadu has excluded only Tramadol. This is explained by explanations are also supported by a study done by Delhi Society earlier studies which show that analgesics are consistently among for Promotion of Rational Use of Drugs (DSPRUD) which showed the most commonly prescribed drugs.[13,17] Also, though the NLEM that from 16 states, 14 states used criteria such as safety, effi cacy includes Diclofenac only at tertiary level, the FDC's of Diclofenac and cost while selecting the medicines for LEM. Also, as the and Ibuprofen with Paracetamol are included from primary level LEM's get updated at a gap of few years, the changes in NLEM International Journal of Medicine and Public Health Jan-Mar 2015 Vol 5 Issue 1 Narayan, et al.: Essential medicine list review of three Indian states may refl ect in state LEM after a certain period based on evaluation such errors are absolutely undesirable as also pointed out earlier by the state committee.
for NLEM[21,24] which also includes spelling mistakes and incorrect statistics. Also, in DSPRUD study, only seven states mentioned Since states frequently follow the pattern of WHO EML while consulting the NLEM while preparing the state LEM. Rather, preparing their own LEM, it can also explain some exclusions by in some states the Health Department was not even aware of the states. For the specifi c categories of radio contrast and ophthalmic NLEM. This refl ects a lack of utilization and awareness coupled preparations, earlier reviews have expressed dissatisfaction over with limited advocacy and dissemination of NLEM at that time.
the NLEM including six ophthalmic antiinfectives and eight radio contrast media whereas the WHO lists only three medicines against each of these categories.[21,22] While this probably also refl ects the growing dependence on diagnostics, utilization of items such as Mistakes in LEM in turn have multiple consequences. It infl uences the diagnostic reagents is often constrained by absence of the requisite prescription patterns, treatment guidelines, national health programs, equipment's or personnel at the health institutions. Also, there rational use of medicines and has far reaching consequences in could be local procurement for certain items and higher drugs, addition to the economic and logistic implications. LEM being a especially at specifi c specialty centers or blood banks but even then, tool that often gets utilized for procurement of medicines and the they should be listed in the state LEM.
medicines in the list become a standard, this at times infl uences the manufacturing of pharmaceutical companies due to assured demand. Similarities across states
In several states, the LEM's are prepared based on NLEM thereby Similarities across states in patterns of inclusion and exclusion are incorporating and further propagating its mistakes. These issues seen for several categories [Table 3]. This therapeutic category wise with LEM's often don't get rectifi ed probably because the LEM's analysis also points out possible reasons for noninclusion of certain are not being utilized or implemented for their mandated purpose. medicines. As depicted in Table 3, the fi ve sections of maximum The lack of reliable data and evidence for disease prescription and drug inclusions by both Rajasthan and Tamil Nadu have related utilization patterns might be responsible for nonrequisite medicines patterns of exclusion. It is noteworthy that provision of drugs to enter the LEM's, either from unrealistic WHO standards or such as Warfarin (not included by both states) and heparin, which other vested interests including industry infl uence.
need intensive monitoring may not be feasible at ill equipped health The study fi ndings are constrained by its methodological limitations. institutions. For Gastrointestinal medicines, the excluded drugs Essential drug selection is a state-specifi c process with decisions include medicines such as Famotidine and Ondansetron. An earlier made upon consideration of several factors including budgetary review has questioned the inclusion of Famotidine in NLEM when allocations, disease prevalence, drug prescription and utilization Omeprazole and Ranitidine are already on the list. The inclusion patterns and population morbidity profi le. Though the study does of additional medicines of same class without any major advantages propose these as the probable reasons behind exclusion of certain in effi cacy and safety clearly violates the selection principles of drugs, it doesn't carry out an state specifi c analysis of these factors LEM. The similarity across state LEM's has also been discussed in and thus provides a limited understanding of the actual reasons a DSPRUD study where several states mentioned consulting LEM's behind these decisions. This however would require a further of other states while preparing their own LEM. They observed in-depth study comprising of analysis of state specifi c processes that in many state LEM's, the drugs included were similar with a including fi eld visits and interviews with key people which lies minor difference in certain groups of drugs.
outside the scope of this particular study and could be taken up as Other issues
a separate study altogether.
Though the therapeutic category wise analysis couldn't be carried Earlier studies have shown the differential extents of adoption of out for Bihar, its LEM presents with several issues for consideration. WHO list across countries.[10-12] This study takes the analysis to The inclusion of irrational FDC's such as a combination of the state level adding to the previous studies on NLEM[9,21] and Dicyclomine with Paracetamol is entirely in violation of principles thereby contributing to the understanding on adoption of National of LEM. The listing of nonspecifi c medicines such as simply writing list across the states. With the increased emphasis on utilizing the "cough syrup/sedative" without specifying the actual contents and NLEM for state LEM's, these fi ndings assume greater importance. providing the nonessential medicine Rabeprazole as an alternative Though the study could provide conservative estimates only due to to the essential drug Ranitidine defeats the whole purpose of LEM the methodological considerations, it still provides valuable insights preparation. Another important aspect is of tertiary level antibiotics into the inclusion patterns of which the underlying rationale could such as Amoxiclav and Vancomycin being listed at secondary level be explored by further studies into the issue.
health institutions as such discrepancy has implications for drug resistance. These inconsistencies are augmented by typological errors of repetitions (atropine listed twice) and simultaneous inclusion of surgical items such as dressing, Plaster of Paris and This analysis reveals that the extent of inclusion of NLEM medicines sutures. It needs reemphasis that these being reference documents, in state lists is variable that infl uences the resultant processes towards International Journal of Medicine and Public Health Jan-Mar 2015 Vol 5 Issue 1 Narayan, et al.: Essential medicine list review of three Indian states access to medicines. Such NLEM comparisons with state LEM could 11. Hill S, Yang A, Bero L. Priority medicines for maternal and child health: A be utilized to improve the comprehensiveness of State LEM's and global survey of national essential medicines lists. PLoS One 2012;7:e38055.
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International Journal of Medicine and Public Health Jan-Mar 2015 Vol 5 Issue 1
Lasers Med SciDOI 10.1007/s10103-008-0545-3 Results of fractional ablative facial skin resurfacingwith the erbium:yttrium-aluminium-garnet laser 1 weekand 2 months after one single treatment in 30 patients Mario A. Trelles & Serge Mordon & Mariano Velez &Fernando Urdiales & Jean Luc Levy Received: 13 December 2007 / Accepted: 17 January 2008 # Springer-Verlag London Limited 2008