ABSTRACT   Qualitative and Quantitative Assessment of the Essential Medicines List of Delhi State: A Time Series Analysis. Gupta U, Sangeeta S, Baishya RN, Bapna Js, Chaudhury RR. Delhi-INRUD and Directorate of Health Services, Delhi. Problems Statement: The Government of Delhi state implemented a drug policy in 1994 to enhance access to Essential Medicines (EM) in public hospitals and health care centers and to promote rational use of EM. The cornerstone of the policy was compiling an EM list (EML) meant for all level of health care system. The policy statement included the revision of EML at regular intervals. Objectives: To assess qualitative and quantitative aspects of EML revision including the process used for revision, and additions and deletions made in the EML. Design: Retrospective time-series design. Setting and Population: 2 teaching hospitals, 3 super-specialty hospitals, 14 peripheral hospitals, 156 health centers and other health schemes run by state government. Intervention: Regular update of the EML to incorporate need based demand from hospitals and health centers in 1996, 1998, 2001 and 2003. Outcome Measures: The process followed for revision, total number of medicines deleted and added including strengths and dosage forms during each revision. Deletions and additions in outpatient, inpatient and restricted sections of hospitals and outpatient sections of health centers. Results: During each revision, demand from hospitals and health centers has been a major determinant for additions and deletions. The EML is strictly used for procurement and supply in hospitals and health centers. Evidence on efficacy, safety and cost has been considered when adding and deleting. Total number of active substances increased from 296 in 1994 to 328 in 2003 with parallel increase in dosage forms and strengths. There were more additions during first revision in 1996 and current revision in 2003. during these revisions, additions of EM outnumbered deletions. However, there was no change in total number of EM during 1998 and 2001 revisions. During the current revision, the EML has been matched with medicines prescribed in the Standarad Treatment Guidelines for Delhi state hospitals and health centers. EM those are expensive and required to be used by trained personnel are denoted as “Restricted Medicines”. The number of “Restricted Medicines” was 59 in first list (1994) and increased during each revision resulting into 87 in 2003 revision. Similarly the number of EM exclusively earmarked for inpatients increased from 118 in 1994 to 153 in 2003 revision. Conclusions: The EML for Delhi state hospitals and health centers is dynamic. Additions and deletions are considered simultaneously. To promote rational use of EM, further consideration is given to medicines that should be made available for outpatients and inpatients in hospitals and for outpatients in health centers. Study Funding: India – WHO Essential Drugs Programme.

BACKGROUND AND SETTING   Govt. of Delhi state implemented Drug Policy in 1994 to enhance access to Essential Medicines in Public Hospitals & Health Centers. Developing EML for all level of Health care System was cornerstone of Policy. Policy statement included Regular update of EML. EML to be used for Procurement and Supply of Medicines.

STUDY AIMS   To Assess Quantitative and Qualitative aspects of Delhi State EML. To Assess if Revision were made at Regular Interval as stated in Policy Statement. To Assess the Process and Criteria used for Revision each time.

METHODS – 1 Analysis has been Conducted in Two Parts - · Part 1.   Analysis has been Conducted in Two Parts - ·                 Part 1. Qualitative Evaluation of EML viz., Process & Data used for Development; Schedule of Revision; Process used for Revision; Criteria for Selection & Addition of Medicines in List; Structure & Format of EML Information Collected by Interviewing Key Persons and Records Scrutiny.

METHODS – 2   ·                 Part II. All Lists from 1994 to 2003 were entered into an Excel Spread Sheet. Changes over years with regards to Additions & Deletions were Qualitatively & Quantitatively Evaluated. While Expressing Total Number of EM, Active Substances (Generics) have been Considered. Number of Items has not been Considered.

QUALITATIVE EVALUATION OF DELHI STATE EML RESULTS – 1   QUALITATIVE EVALUATION OF DELHI STATE EML ·                 EML made in 1994, Revised in 1996, 1998, 2001 and 2003. ·                 WHO Model List, Morbidity Data, Existing Lists Formed Basis. ·                 Separate Lists for Hospitals & Health Centers. ·             Medicines for Health Centers drawn from Hospital List.

QUALITATIVE EVALUATION OF DELHI STATE EML RESULTS – 2   QUALITATIVE EVALUATION OF DELHI STATE EML ·                 Medicines Delineated for Outpatients, Inpatients and “Restricted Use”. ·                 Outpatients Medicines also Available for Inpatients. ·                 Medicines Listed according to Therapeutic Category. ·                 Additions & Deletions Strictly on basis of Recommendations from Hospitals & Health Centers. ·                 Evidence on Efficacy, Safety, & Cost Considered for Addition.

QUANTITATIVE ANALYSIS OF DELHI STATE EML RESULTS - 3 QUANTITATIVE ANALYSIS OF DELHI STATE EML    YEAR TOTAL MEDICINES OPD IPD F + D RATIO F + D / MEDICINE RM IN HC 1994 296 178 118 446 1.5 59 90  1996 309 172 137 515 1.6 69 92 100 102 1998 312    140  535 70 2001  312  180 132 585  1.8 78  2003  328  175 153 594 87 UNDER PREPA RATION  IPD – INDOOR PATIENTS OPD – OUT PATIENTS  F + D - FORMS & DOSAGES HC - HEALTH CENTERS

QUANTITATIVE ANALYSIS OF DELHI STATE EML RESULTS – 4  QUANTITATIVE ANALYSIS OF DELHI STATE EML    YEAR ADDITIONS DELETIONS NET NO. OF MEDICINES MOVED FROM IPD TO OPD 1996 41 28  13 4    1998 19 16 3 2001  25 25 NIL 5 2003 44 6    IPD – INPATIENTS OPD – OUTPATIENTS

RESULTS – 5 MATCHING EML WITH STGs 174 Drugs from STGs Could not be Included in EML due to more than two choices for a Disease. 50 Drugs in EML were not included in STGs viz., Contrast Media, GA, LA, Skeletal Muscle Relaxants. 280 Drugs were common in EML & STGs.

SUMMARY AND CONCLUSION - 1   ·                 EML for Hospitals and Health Centers used for Supply of Medicines. ·                 Revision process ensured Need Based Additions & Deletions. ·                 In Hospitals allocation of 10% of total budget to buy medicines not included in list, indicates Flexibility. ·                 Delineating Medicines for OPD IPD & “Restricted Medicines” helps in Promoting RUD.

SUMMARY AND CONCLUSIONS - 2   ·                 In 1996, Addition of Section on ENT resulted into more additions. ·                 In 2003, besides Recommendations from Hospitals & Health Centers, List Matched with STGs resulting into more additions. ·                 Preparing EML only on the basis of STGs Not practical. Mixed approach needs to be Adopted. ·                 Regular Update & Need Based Additions & Deletions are Major Factors for acceptability and Sustained Implementation of EML.