INFORMATION SYSTEM FOR EXPERT EVALUATION OF MEDICINES INTERCHANGEABILITY

The article dwells upon the development and implementation of a computerised information system for automation of expert work related to evaluation of medicines interchangeability parameters. The article analyses the results of application of a process-oriented approach to the development and implementation of an interchangeability evaluation algorithm in an expert institution. The article suggests step-by-step solutions for the development of an information system that will make it possible to automate standard operating procedures and help substantiate expert conclusions. The article provides basic legal and regulatory as well as scientific and technological information necessary for the creation of an information systems project for the development of a single intranet environment of an expert institution ensuring the automation of all key technological processes that rest upon single systematic approaches and principles. It was demonstrated that introduction of the designed information system in the institution ensures efficient implementation of standard operating procedures when assessing medicines interchangeability.

1. Chaudhry B, Wang G, Wu S, Maglione M, Mojica W, Roth E, et al. Systematic Review: Impact of Health Information Technology on Quality, Efficiency, and Cost of Medical Care. Ann Intern Med. 2006;144(10):742–52.

2. Federal Law of the Russian Federation, April 12, 2010, No. 61-FZ «On Circulation of Medicines» (In Russ.)

3. Romanov BK, Bunyatyan ND, Olefir YuV, Bondarev VP, Prokofiev AB, Yagudina RI, et al. Recommendations on the Procedure for Determining the Interchangeability of Medicinal Products. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2015;(2):3–8 (In Russ.)

4. Decree of the Government of the Russian Federation, October 28, 2015, No. 1154 «On the Procedure for Determining the Interchangeability of Medicinal Products for Medical Use» (In Russ.)

5. Merkulov VA, Bunyatyan ND, Koshechkin KA, Sboev GA. Current Status and Future Development of Single Information Space of the FSBI «SCEMAP» of the Russian Ministry of Health. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2013;(4):38–41 (In Russ.)

6. Rychikhina EM, Koshechkin KA, Alyautdin RN, Avchurinsky SV, Boytsov MV, Koptelov KV, et al. Information System «Assessment of interchangeability» on the Intranet Portal. Certificate of State Registration of the Computer Program No. 2016662206; 2016 (In Russ.)

7. Order of the Ministry of Health of the Russian Federation, September 23, 2016, No. 731n «On Amendments to the Procedure for Maintaining the State Register of Medicinal Products for Medical Use, Approved by Order of the Ministry of Health of the Russian Federation, February 9, No. 80n» (In Russ.)

8. Koshechkin KA, Olefir YuV, Merkulov VA. Management of Information Support of the Life Cycle of Medicines. Concepts of Using Elements of CALS/PLMtechnologies for Information Support of the Life Cycle of Medicines. Moscow: Polygraph-Plus; 2015 (In Russ.)

9. Koshechkin KA. Perspectives of Using CALS/PLMtechnologies in the Pharmaceutical Industry of the Russian Federation. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2014;(1):47–50 (In Russ.)