1. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Improving Safety in Medication Storage Patricia C. Kienle, RPh, MPA, FASHP Director, Accreditation and Medication Safety Cardinal Health Pharmacy Solutions patricia.kienle@cardinalhealth.com

2. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 2 Common Questions Who says we have to control med storage? What departments have meds? Where are meds throughout the hospital? What can I do to make med storage safer for patients and my co-workers? What areas are priorities to fix? © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.

3. 3 Laws, Regulations, and Best Practice Regulatory Bodies Centers for Medicare and Medicaid Services (CMS) State Accrediting Organizations Joint Commission Healthcare Facilities Accreditation Program HFAP – The American Osteopathic Association National Integrated Accreditation for Healthcare Organizations NIAHO – Det Norske Veritas

4. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 4 Storage of Medications Secure Safe Protect the integrity of the product It’s all about patient safety ….

5. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 5 Drug Security Before 2008 –All drugs must be locked Since 2008 –All drugs must be secure, and locked when appropriate

6. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 6 Medication Security CMS Hospital Conditions of Participation §482.25 All drugs and biologicals must be kept in a secure area, and locked when appropriate Controlled Drugs must be kept locked within a secure area Only authorized personnel may have access to locked areas

7. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 7 Medication Storage in the Organization Drugs IV solutions Irrigation solutions Contrast media Glucose tolerance beverage Kits with local anesthetics Samples Pharmacy Nursing Units Materials Management Radiology OR Anesthesia Cath Lab Nuclear Medicine

8. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 8 Security of Controlled Substances Must be locked Only those with legal access to medications may be authorized to access controlled substances Who has legal access?

9. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 9 Controlled Substances Requirements Control from point of entry to administration, wastage, or return Deliver directly to pharmacy Sign invoices Lock refrigerators (or containers) Policies for wastage –Pharmacy –Patient care units – fentanyl patches, infusions

10. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 10 Emergency Medications All emergency containers Crash carts Malignant hyperthermia carts Rapid sequence intubation (RSI) kits Contrast reaction kits Transport boxes

11. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 11 Secure Storage of Emergency Meds List on the outside Lock to secure Log to document

12. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 12 Medication Safety High-alert drugs –Insulin –Anticoagulants –Concentrated electrolytes Look- and sound-alike drugs Hazardous drugs

13. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 13 Safety: High Alert Medications Identified by ISMP, Joint Commission, IHI and others High potential for causing errors in the medication use system –Selection –Storage –Ordering –Dispensing –Administering –Monitoring

14. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 14 High Alert Core List Concentrated electrolytes –Potassium chloride –Potassium acetate –Sodium chloride greater than 0.9% Insulin Anticoagulants Narcotics and opiates

15. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 15 Additional High Alert Medications Chemotherapy Drugs used in neonates and pediatrics TPN Sterile water –Injections greater than 10 mL –Irrigation bags Others as determined by the facility

16. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 16 Safety: LASA Medications Joint Commission requires accredited organizations to select 10 pairs from a list Special storage requirements should be implemented throughout the facility

17. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 17 Safety: Hazardous Drugs First defined by ASHP in a document in 1990 In 2004, further defined by the National Institute for Occupational Safety and Health (NIOSH)

18. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 18 Hazardous Drugs Any drug that has at least one of the following properties: –Carcinogenicity, teratogenicity or developmental toxicity –Reproductive toxicity in humans –Organ toxicity at low doses in humans or animals –Genotoxicity –New drugs that mimic existing hazardous drugs in structure or toxicity

19. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 19 List of Hazardous Drugs NIOSH Alert has list in Appendix A –Draft update published in April 2009 Intended as a starting point for a hospital’s list –Many organizations use this list Includes (this is not a complete list) –Antineoplastic agents (“chemo”) –Antiviral agents –Hormones –Oxytocin –Finasteride (Proscar ®, Propecia ® )

20. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 20 Identifying Hazardous Drugs Hospital-approved list Suppliers should mark the outside of packages with a warning There is no official “hazardous drug” symbol

21. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 21 Medication Integrity Temperature Expiration dates Beyond-use dates Recalled medications

22. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 22 Integrity: Temperature Need control and documentation for anything outside of room temperature –Refrigerators –Freezers –Warmers Sterile products and preparations also require room temperature monitoring Must store per manufacturers’ recommendations

23. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 23 Freezers and Warmers Freezers –Vaccines –Cervidil ® Warmers –Solutions in OR and Obstetrics –Injectable contrast in Imaging

24. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 24 Integrity: Vaccine Storage CDC recommendation is inspected and surveyed as a requirement Temperature of vaccine storage areas must be recorded twice a day –7 days a week –All areas – Pharmacy, ED, Employee Health, clinics, etc. –Many state vaccine plans have additional requirements

25. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 25 Integrity: Expiration Dates The maximum time period that a manufactured product may be used, based on the storage requirements in the package insert Inspection and accreditation standards require you to use the manufacturers’ information Every manufactured medication product has an expiration date Your inspection process needs to control this

26. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 26 Integrity: Beyond Use Dates The date or time after which an open product or a compounded preparation cannot be stored or administered Two United States Pharmacopeia chapters address this –Nonsterile preparations – USP –Sterile preparations – USP The BUD is determined from the date (or time) compounded and the temperature at which it is stored

27. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 27 BUD for Non-Parenteral Agents Expiration date acceptable to use unless the manufacturer requires a shorter date

28. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 28 BUD for Parenteral Agents Compounded sterile preparations (CSPs) determined by the shorter of –USP sterility limits –Stability of the drug Single and multiple dose vials –FDA limit of 28 days –Manufacturer’s information

29. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 29 Maximum Storage Time for Vials If opened and maintained in ISO 5 air quality If opened outside or taken outside of ISO 5 air quality AmpuleUse immediately and discard remainder Single-dose vial6 hours1 hour Pharmacy bulk package 6 hoursN/A Multiple-dose vial28 days

30. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 30 Designating Beyond Use Dates BUDs must be applied to multiple dose vials that are being stored This is different from an “open date” Use before _____________ Opened by _______ on ________

31. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 31 Recalls Process to retrieve recalled products Documentation

32. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 32 Strategies to Implement Educate those who do medication inspections Control all emergency medications Separate insulins Identify LASA throughout the facility Check vaccine temperatures twice a day Mark multiple dose vials with beyond use date

33. © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. 33 It’s all about patient safety

34. Questions? © 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.