1. GS1 Healthcare Provider Advisory Council (HPAC) Webinar Implementation in a hospital pharmacy in Argentina GS1 Global Office 13 March 2014

2. © 2014 GS1 HPAC Case Study Webinars 2 This is the SECOND Webinar ; the FIRST implementation case study! “Implementation in a hospital pharmacy in Argentina” It will be recorded! Webinars will take place monthly

3. © 2014 GS1 HPAC Case Study Webinars 3 Details here: http://www.gs1.org/healthcare/hpac_webinars

4. Traceability of Drugs: “Implementation in a hospital pharmacy in Argentina” Dra. Heidi Wimmers Hospital Alemán 13-MAR-2014/Webinar

5. Issues in our Hospital Increased pressure to improve patient safety. Increased pressure to improve patient safety. Risk of medication errors at the point-of- care with the manual processes for ordering. Risk of medication errors at the point-of- care with the manual processes for ordering. Lack of unit-dose bar coding of each medication. Lack of unit-dose bar coding of each medication.

6. Solution in our hospital Implementation of medication traceability system with Electronic Patient Record system (EPR) Implementation of medication traceability system with Electronic Patient Record system (EPR) Installation of an automated repackager station with bar coding for unit dose. Installation of an automated repackager station with bar coding for unit dose. Bar code verification at point of use to ensure the five patient rights. Bar code verification at point of use to ensure the five patient rights.

7. The five well-known rights: Right patient, Right patient, Right drug, Right drug, Right route, Right route, Right time Right time and Right dose and Right dose

8. What is traceability of drugs? It is a tool that allows us to know the history of the drug along all its steps: It is a tool that allows us to know the history of the drug along all its steps: - verification of its ORIGIN. - register of records all along its DISTRIBUTION CHAIN. DISTRIBUTION CHAIN.

9. Acquisition of drugs directly from audited laboratories and drugstores (GLN). Dispensation and Administration of right drug in daily dose. Reception of traceable drugs with record of lot and expiration date, GTIN and serial number. Traceability

10. Drug traceability: why and how to use it in hospitals?

11. Drug safety: global scenario - The true extent of the counterfeiting is unknown. - In developing countries, WHO estimates that counterfeit drugs may exceed 30% *. - The huge growth in sales of drugs over internet contribute to this problem. - The governments are drafting legislations to make it harder to the counterfeiters. *World Health Organisation (WHO); “Counterfeit Medicines”; *World Health Organisation (WHO); “Counterfeit Medicines”;http://www.who.int/mediacentre/factsheets/fs275/en/

12. Drug safety - Counterfeit medicine is fake medicine. - Counterfeit medicine has a negative effect on a global scale. - A solution with tangible benefits for patient safety is urgently needed. - An efficient supply chain is a must.

13. International background :FDA The FDA has recommended pharmaceutical laboratories to start using Radio Frequency Identification (RFID) to improve the traceability of their products. The FDA has recommended pharmaceutical laboratories to start using Radio Frequency Identification (RFID) to improve the traceability of their products. (WHO N°275/ Feb. 2006). (WHO N°275/ Feb. 2006). RFID chip “tag” next to a grain of rice RFID chip “tag” next to a grain of rice They can hold a lot of data They can hold a lot of data They can be read without needing They can be read without needing to pass a scanner directly over the tags

14. National background Apr-2011 The National Ministry of Health established the creation of the SNT of drugs, in order to ensure the control of these products and limit the use of illegal drugs. Apr-2011 The National Ministry of Health established the creation of the SNT of drugs, in order to ensure the control of these products and limit the use of illegal drugs. It has been instrumented by ANMAT : National Administration of Drugs, Food and Medical Devices of Argentina It has been instrumented by ANMAT : National Administration of Drugs, Food and Medical Devices of Argentina

15. The first stage of the SNT in Argentina include : traceability of about 200 medicines with “high cost and low incidence”, such as Cancer, HIV, Hemophilia, Rheumatoid Arthritis, Cystic Fibrosis. traceability of about 200 medicines with “high cost and low incidence”, such as Cancer, HIV, Hemophilia, Rheumatoid Arthritis, Cystic Fibrosis.

16. ... in March-2012 and deadline is 15-JUN-2012 !! ANMAT added: ANMAT added: …2.300 more traceable …2.300 more traceable medicines medicines

17. And finally the last stage of the SNT in 2013 was … 11 more Active Pharmaceutical Ingredients (API) 11 more Active Pharmaceutical Ingredients (API) Complete list today : around 3.000 medicines

18. How to implement traceability at the Hospital Alemán?

19. The traceability-system involves 4 specific steps in our hospital : hospital reception hospital reception single dose fractioning single dose fractioning dispensing dispensing administration administration … it’s a big teamwork !!

20. It is possible to make changes, recognising the positive effects… And implementing traceability with the 4 E´s: Engage Engage Educate all levels of staff Educate all levels of staff Execute standardising processes Execute standardising processes Evaluate Evaluate

21. The Quality Program : “standardising processes” the Traceability Manual is drafted the Traceability Manual is drafted all multitask personnel is trained all multitask personnel is trained it is focused towards a continued improvement. it is focused towards a continued improvement.

22. Reception and administration Reception and administration of traceable medicines in hospital directly linked to ANMAT Website

23. The history of the drug goes from its reception to the moment it is used by patients: traceability inside the hospital. The system based on GS1-Standards.

24. GTIN: Global Trade Item Number Each individual package has a unique, unrepeated random code : Each individual package has a unique, unrepeated random code : (01)GTIN and (21)serial number It is placed by the laboratory/drugstore. It is placed by the laboratory/drugstore. It will allow the patients to verify the authenticity of the product. It will allow the patients to verify the authenticity of the product. human readable barcode

25. This unique identification is placed on the secondary packaging with one of the three Data-Carriers: Linear bar code Linear bar code DataMatrix DataMatrix RFID RFID

26. Data Capture scanner GTIN/serial number is read at the reception with: A) batch/lot number A) batch/lot number B) expiry date B) expiry date associated with GLN Code GLN is the identification number of the institutional provider

27. Once the drug is received, ANMAT is informed and an ID is obtained: The traceability of the drug is verified at ANMAT’s Website using the transaction ID: The traceability of the drug is verified at ANMAT’s Website using the transaction ID: -from GLN of origin -to GLN of destination (Hospital Alemán as informant agent)

28. GLN of origin to GLN of destiny

29. Reception of traceable drugs in the HA: Inicial status (JUN-15-2012) and current (up to JAN-15-2014)

30. TOTAL TRACEABLE PRODUCTS INFORMED TO ANMAT June 2012

31. TOTAL TRACEABLE PRODUCTS INFORMED TO ANMAT January 2014

32. Single dose fractioning at the Pharmacy in the Inpatient Ward

33. Unit dose re-packaging is done through an aseptic process. The tabletop-repackager is an easy-to-use option for the in-house repackaging.

34. This single unit packages for pills, tablets or capsules : Identify their contents accurately. Identify their contents accurately. Protect their contents from environmental effects. Protect their contents from environmental effects. Allow quick, easy and safe use. Allow quick, easy and safe use.

35. For this single-unit packages: drugs were re-labeled with GS1-code: we can only print these labels for the number of units indicated in the original package. we can only print these labels for the number of units indicated in the original package. 60 tablets = 60 labels with 60 tablets = 60 labels with the same DataMatrix code We hope that in the future we will have regulation for the primary packaging based on the GS1 DataMatrix identification.

36. We also labeled each vial or ampoule… with a DataMatrix-code printer It was hard work to adapt the size of the label so that it could be read by the scanner in the case of the smallest ampoules. curvature It was hard work to adapt the size of the label so that it could be read by the scanner in the case of the smallest ampoules. curvature

37. Quality of the re-packaging-process: A programme of preventive maintenance is implemented in order to control the machine, the printers and the labels. A programme of preventive maintenance is implemented in order to control the machine, the printers and the labels. The work of the technician is under the close surveillance of a The work of the technician is under the close surveillance of apharmacist.

38. Administration to inpatient from the Nurses’ Station

39. Role of the Nurses Prior to administering the medication to a patient, nurses read the bar code of the medicine dispensed by the pharmacy. Prior to administering the medication to a patient, nurses read the bar code of the medicine dispensed by the pharmacy. Then they confirm usage of the drug in the Electronic Patient Record system (EPR) Then they confirm usage of the drug in the Electronic Patient Record system (EPR)

40. Electronic prescription orders at 3 p.m.

41. Dispensation to outpatient from Outpatient HA-Pharmacy: Scan reveals possibility of counterfeit, expired and recalled medication

42. Bill that the outpatient receives with GTIN/serial after buying his medicine

43. The patient can validate the legitimacy of the medicine on ANMATs webpage before consuming it.

44. Conclusion All employees at hospitals are only human, that means that errors are made in all hospitals around the world. All employees at hospitals are only human, that means that errors are made in all hospitals around the world. We can be tired from working long hours, which may lead to wrong medicine dosage or giving the medicine to the We can be tired from working long hours, which may lead to wrong medicine dosage or giving the medicine to the wrong patient.

45. Conclusion clover The traceability-system with the standards will increase patient safety, focused on ensure genuine products, preventing counterfeit, fraud and smuggling. The traceability-system with the standards will increase patient safety, focused on ensure genuine products, preventing counterfeit, fraud and smuggling. It improves patient care reducing medication errors and gives quality to the healthcare supply chain. It improves patient care reducing medication errors and gives quality to the healthcare supply chain.

46. To continue improving the traceability process in the hospital it is essential… to train the personnel constantly, keeping a great compromise between all members of the team. to train the personnel constantly, keeping a great compromise between all members of the team.

47. In our hospital: * decisions about the traceability process are first taken with patient safety in mind, decisions about the traceability process are first taken with patient safety in mind,but… it is a daily challenge !! it is a daily challenge !! * ©2014 Health First

48. Thank you for your attention! hwimmers@hospitalaleman.com

49. © 2014 GS1 HPAC Case Study Webinars 49 Details here: http://www.gs1.org/healthcare/hpac_webinars

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51. Contact Details Janice Kite E janice.kite@gs1.orgjanice.kite@gs1.org W www.gs1.org/healthcarewww.gs1.org/healthcare