What To Do or Not To Do? Utility of Medication Traceability to the Patient

Transcription

1 What To Do or Not To Do? Utility of Medication Traceability to the Patient Melsen Kwong, Pharm.D. Associate Director Department of Pharmacy Services Cedars-Sinai Medical Center, Los Angeles, CA, USA

2 Objectives Describe the United States Drug Supply Chain Security Act (DSCSA) Differentiate the US DSCSA from the European Union Falsified Medicine Directive (EU FMD) Outline the implications for pharmacy operations Describe Cedars-Sinai s approach to ensure compliance with the US DSCSA

3 Pharmaceutical Supply Chain Integrity and Safety Worldwide problem with medication integrity, falsified medicines and counterfeit products Significant risk to patients safety World Health Organization (WHO) estimated 10.5% of the medicines in the developing countries could be counterfeit although all countries were affected 1 Both generic and innovative products can be falsified with antibiotics and antimalarials being the most commonly reported

4 Possible Reasons for the Compromised Supply Chain Integrity and Safety Financial gain Drug shortages/inadequate supply Proliferation of Internet Pharmacies (Gray market) Increasing complexity with drug distribution through multiple companies in multiple countries 2 No standard format or mechanism to track and trace the medicines 2.

5 Worldwide Solution to Improve Supply Chain Integrity and Safety Goal is to improve patient safety by eliminating falsified or counterfeit medications Serialization will be a global requirement by More than 40 countries have passed regulations at various stages to track and trace medications 4 Implement uniform product identification and verification requirements across the supply chain from manufacturer to patient European Union Falsified Medicine Directive (EU FMD) Drug Supply Chain Security Act (DSCSA) in USA

6 European Union Falsified Medicine Directive (EU FMD) Effective February 9, 2019 with the exception of Belgium, Greece and Italy Medications in scope prescription medicines and over-thecounter (OTC) medicines with high risk for falsification Medications not in scope free drug samples Each medicine package consists of anti-tampering device and a 2D Data Matrix unique product modifier Marketing Authorization Holder (MAH) responsible for ensuring the in-scope medicines bear these safety features

7 EU FMD Product Identifier Unique modifier consists of: product code, serial number, batch number, expiry date, national reimbursement number, (if applicable) MAH is responsible to upload the product data to a central European Hub, managed by the European Medicine Verification Organization (EMVO) The European Hub interfaces with the National Medicine Verification Organization from each country for verification and decommission of the medicines (removal of product from database) prior to dispensing to the patients SEVeM Spanish Medicines Verification System

8 Obligations of Persons Authorized or Entitled to Dispense Verify the package anti-tampering seal is still intact Retail pharmacies and doctors must verify and decommission medicines immediately before dispensing them to a patient Hospital pharmacies may verify and decommission at any time after receiving the medicines

9 Implications for Pharmacy Operations Profound impact on workload and workflow of pharmacy staff When to verify and decommission? Additional considerations/evaluations Additional staffing need Scanning equipment Interface software that will communicate with the European Hub for verification submissions and/or confirmations Account setup with the country s National NMVO (SEVeM)

10 Drug Supply Chain Security Act (DSCSA) in USA Enacted the law in November 2013 to prevent harmful drugs from entering the supply chain To protect patients from receiving harmful drugs Various phases of implementation span over 10 years from 2013 through 2023 Products exempted from DSCSA: blood products, imaging drugs, IV solutions, medical gases, homeopathic drugs and compounded drugs Compliance is enforced by the US Food and Drug Administration (FDA)

11 DSCSA Full Implementation Timeline Nov 2013 Nov Pharmacies DSCSA enacted into law Manufacturers to serialize their products to verify all products purchased are serialized with unique product identifiers Jan manufacturers to provide T3 Jul pharmacies to manage T Repackagers to serialize products 2019 wholesalers to handle serialized products only Pharmacies able to receive, store, and transmit electronic T2 information and

12 Implications for Pharmacy Operations since January 1, 2015 Pharmacies must have a process to quarantine, investigate and handle suspect and illegitimate prescription drugs Check if the wholesaler or manufacturer is registered Only accept prescription drugs that are accompanied by T3 (transaction information, transaction history and transaction statement) T3 can be paper or electronic format T3 kept for 6-years and ability to retrieve them within 48 hours upon inquiry Provide T3 documentation if selling to a trading partner or pharmacy unless the transaction is for a specific patient

13 Implications for Pharmacy Operations for 2020 Pharmacies can only buy and sell prescription medications that display a unique, serialized product identifier Upon inquiry, pharmacies will be required to verify the unique product identifier back to the manufacturer of at least 3 packages or 10% of the suspect product, whichever is greater and provide the transaction history information for those products

14 Implications for Pharmacy Operations for 2023 Pharmacies must receive secure, electronic T2 (TI/TS) documentation from its immediate supplier for all received prescription products Have a system for storing electronic T2 documentation for a minimum of 6 years Maintain this electronic T2 data and be able to send documentation electronically: Upon an investigation or inquiry Send products to another company/pharmacy

15 Cedars-Sinai Medical Center (CSMC) 860 beds tertiary care hospital 6 pharmacy locations (previously 7 locations) 400+ staff 50% pharmacists, 50% pharmacy technicians 2700 drug invoices received each month with thousands of items

16 CSMC s Approach to Ensure Compliance with DSCSA in 2015 Established policy and trained staff on proper procedure on how to identify, quarantine, investigate and handle the suspect or illegitimate products Manual process or technology to handle the T3 information? Implemented a technology solution to help manage the volume of invoices we have each month and be able to retrieve them upon inquiry within 48 hours Additional staffing was needed to manage this phase of DSCSA

17 CSMC Preparations for 2020 and 2023 Compliance Procedures to verify products are serialized and to respond to an investigation request by 2020 Ensure suppliers able to provide electronic documentation by 2023 Develop solutions to verify, receive, store and transmit the electronic documentation that accompany each medication product in 2023 Anticipate any additional staffing, software and/or equipment needs

18 Benefits of DSCSA Enhance patient safety by eliminating falsified, counterfeit drugs in the supply chain Pharmacy is the last barrier between the medication packages and the patients May help with the recall process or expiration date checking

19 Thank You Very Much!! QUESTIONS??