Storing & Securing Medications

Second

Edition

The Handbook on

Storing & Securing

Medications

Edited by

Thomas E. Kirschling,

Pharm.D., M.S.

Foreword by

Robert J. Weber,

R.Ph., M.S., F.A.S.H.P.

Senior Editor:Robert A. Porché, Jr.

Project Manager:Christine Wyllie

Manager, Publications:Victoria Gaudette

Associate Director, Production:Johanna Harris

Associate Director, Editorial Development:Diane Bell

Executive Director:Catherine Chopp Hinckley, Ph.D.

Vice President, Learning:Charles Macfarlane, F.A.C.H.E.

Joint Commission/JCR Reviewers:Jorge D. Carrillo, Sophie M. Duco, Victoria Gaudette, Jeannell Mansur

ASHP Editor:Thomas E. Kirschling

ASHP Contributors:Thomas E. Kirschling (Foreword, Chapter 1); Joanne G. Kowiatek (Chapter 1, Chapter 2); Kathy Crea (Chapter 2); Scott M. Mark (Chapter 3); Susan J. Skledar (Chapter 4)

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ISBN: 978-1-59940-302-1

Library of Congress Control Number: 2009920154

Contributors ...iv

Foreword

An Important Obligation ...v

Introduction

Establishing a Paradigm for Complying with

Medication Storage and Security Standards...ix

Chapter 1

Current Concepts in Medication Storage and Security...1

Chapter 2

Principles and Practices of Medication Storage ...15

Chapter 3

Maintaining Medication Security ...71

Chapter 4

Case Scenarios in a Continuous Quality Improvement

Approach to Medication Storage and Security ...103

Appendix 1

ASHP Technical Assistance Bulletin on

Hospital Drug Distribution and Control ...119

Appendix 2

Drug Standardization, Storage, and Distribution Self-Assessment...129

Appendix 3

List of Sound-Alike and Look-Alike Drug Names

from the United States Pharmacopeia ...163

Appendix 4

Controlled Substances Procedure ...191

Index...203

C

ONTRIBUTORS

Robert J. Weber, R.Ph., M.S., F.A.S.H.P.

Executive Director, Department of Pharmacy and Therapeutics University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania

Thomas E. Kirschling, Pharm.D., M.S.

Manager, Pharmacy Operations Department of Pharmacy

University of Pittsburgh Medical Center Pittsburgh, Pennsylvania

Joanne G. Kowiatek, R.Ph., M.P.M.

Assistant Professor, University of Pittsburgh School of Pharmacy

Pharmacy Manager, Medication Patient Safety, University of Pittsburgh Medical Center Pittsburgh, Pennsylvania

Kathy Crea, Pharm.D., B.C.P.S.

Patient and Medication Safety Coordinator, Riverside Methodist Hospital Columbus, Ohio

Associate Professor, University of Findlay School of Pharmacy Findlay, Ohio

Scott M. Mark, Pharm.D., M.S., M.Ed., F.A.S.H.P., F.A.C.H.E., F.A.B.C.

Assistant Professor, Department of Pharmacy and Therapeutics University of Pittsburgh School of Pharmacy

Director of Pharmacy, Department of Pharmacy and Therapeutics University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania

Sue Skledar, R.Ph., M.P.H., F.A.S.H.P.

Associate Professor, University of Pittsburgh School of Pharmacy Director, Drug Use and Disease Management Program

Department of Pharmacy and Therapeutics University of Pittsburgh Medical Center Pittsburgh, Pennsylvania

I

t was a quiet night in a university hospital when the calm was interrupted by a call for help from the nursing staff—an unresponsive elderly patient was found in his room. The patient was comatose, cold, and clammy but still breathing and with a pulse. After the medical team arrived, they determined the patient was suffering from profound hypoglycemia with a blood sugar of 45 mg/dl. The patient’s situation was remedied with a glucose injection, but the hypoglycemia puzzled the interns and resi-dents. A review of his medications, however, revealed the cause: The patient had been given an oral hypoglycemic agent at a schedule of four times daily instead of a different medication that was prescribed to treat the patient’s dementia. Further review of the error indicated that the oral hypoglycemic had been placed in the second drug’s storage bin in the pharmacy due to the medications’ very similar-sounding names. The error could have been prevented through real-time awareness of the “sound-alike” nature of these two drugs and knowledge that oral hypoglycemic agents are not administered four times daily.

Other storage errors with dramatic consequences have been reported: eye drops being confused with drops to test for occult blood in the stool; household cleaning products mistakenly administered as oral liquid medications; administering concentrat-ed electrolyte solutions mistakenly storconcentrat-ed on nursing units; mix-ups in foil-packconcentrat-ed intravenous medications; oral floor stock of furosemide given intravenously; and errors related to various methods of pharmacy packaging of medications stored in patient-specific bins (for example, “look-alike” bar-coded medications and unit-dose liquids).

An Important

Obligation

Foreword

I was responsible for an error related to a bowel-cleansing medication. An order was writ-ten for the solution to be given in “4 ounce doses until clear.” The medication was stored on the nursing units; a very experienced nurse who was not a member of the regular staff called me and asked, “So do I give four of the solution?” to which I hurriedly said, “Yes.” The nurse then proceeded to reconstitute and attempt to give the patient “four” bottles of the preparation with 1,500 mL of solution contained in each bottle. After the patient experienced nausea, vomiting, and excessive dehydration, the error was discov-ered and corrected. The error could have been easily prevented by sending a single bottle of the bowel-cleansing medication from the pharmacy along with labeling that describes the correct administration directions. We discussed this error at a staff meeting and we removed the drug from all nursing unit floor stock, and worked with the gastroenterology division to develop hospital standards and a pre-printed order for bowel cleansing procedures. Finally, we revised our dis-pensing process in the pharmacy to ensure that the drug was available in a timely manner, elimi-nating the need for storage on the nursing unit.

As unusual as this error may seem, I was stunned that it happened and that I had been responsible for a patient’s adverse event. Many questions ran through my mind: How could I have missed the intent of the nurse’s question? Why didn’t the nurse know that attempting to give six liters of the bowel cleanser to a patient was a blatant overdose? Why did we store the drug on the nursing unit? Could I have prevent-ed this error? This incident gave me a new appreciation that errors in storing and securing medications were unpredictable and that every drug stored on the nursing unit or elsewhere in the hospital has the potential to cause an error. The error also taught me that pharmacists are obligated to commit to processes that can deter-mine any potential for error (for example, fail-ure mode analysis) and implement systems to prevent all error potential.

Adding technology may not be the answer to safely storing and securing medications. Nursing or procedure unit-based automated devices for storing medications present a new and different type of potential for medication errors. For example, pharmacy technicians can load incorrect medications into unit-based medication cabinets. The most recent and dra-matic example of this error occurred when a pharmacy technician mistakenly loaded the anticoagulant heparin, 10,000 units/mL strength in an automated medication cabinet bin designated for heparin 1,000 units/mL resulting in a series of terrible adverse effects. Additionally the procedures for medication order review (for example, allergy review, dose checking) may be bypassed if the medication for the first dose is available to the nurse through the cabinet. Unsafe quantities of med-ications may be placed into the cabinet. An error occurred at a university medical center where a bulk bottle of methadone was placed in a bin designated for unit-dose liquid, resulting in the nurse administering an overdose of methadone from the bulk bottle. Also, health care professionals with substance abuse issues still continue to find ways to divert medication from automated medication cabinets. An exam-ple of this occurred when an automated cabinet had been configured to have acetaminophen and acetaminophen/hydrocodone in adjacent locked bins. A nurse accessed the acetamino-phen bin and used a hemostat to break into the adjacent pocket containing the acetamino-phen/hydrocodone tablets. Video surveillance captured the scenario.

As a result of the potential for diversion, pharmacists have a legal responsibility to ensure proper use of controlled substances and protect patients by preventing diversion and potential abuse by health care providers. This area requires knowledge of federal and state laws related to controlled substances as well as appli-cation of cutting-edge technology to track these medications.

Assuring the safe storage and security of medications is a fundamental pharmaceutical care process that serves as a foundation for any hospital pharmacy safety program. Examples of proper storage and security of medications include confirming that refrigerated items are stored under proper conditions; that external products are stored separately from medications administered internally; developing and main-taining a list of “high-alert” drugs; developing policies that require certain dangerous drugs be distributed only by the pharmacy; and assuring stored products are clearly labeled and that only authorized individuals have access to controlled substances. Routine inspection of drug storage areas by the pharmacy in the hospital is often viewed as tedious and “extra” work; as a result, noncompliance with this process often results in a recommendation from The Joint Commission or the state’s Department of Health. To prevent regulatory issues, pharmacy directors and man-agers should strive to develop monitoring sys-tems for drug storage and security that become an integral part of the daily work. This

approach heightens awareness of proper medica-tion storage and security by all members of a pharmacy department. Also, as the pharmacy develops a daily method for tracking medication storage and security, its importance can be pro-moted to nursing units, housekeeping, respira-tory therapy and emergency departments, oper-ating rooms, radiology suites, GI procedure areas, and cardiovascular intervention laborato-ries.

An important message that must continue to be heard related to any error in drug storage is that rather than focusing on the health profes-sionals involved in the errors, we must focus on improving our broken processes of error-prone storage conditions and other system problems.

This second edition of The Handbook on Storing and Securing Medicationsprovides an update on professional standards and legal and regulatory requirements on medication storage and security. In addition, the Handbook pro-vides information on cutting-edge technology that may be useful in helping hospitals and other organizations properly store and secure medications. The format of the Handbookis similar to the first edition in using case studies, an examination of standards and legal require-ments, and an in-depth look at the many system issues surrounding drug storage and security. This edition also continues to provide processes, structures, and outcomes to form the basis for any organization’s medication safety strategic plan.

A collaborative approach to solving medica-tion storage and security issues is also stressed in the Handbook,including input and attention by both patients and co-workers. In addition, a self-assessment tool provided by the Institute for Safe Medication Practices will help organiza-tions establish a baseline for compliance and serve as a tool for measuring improvement in safe practices for medication storage. The Handbook on Storing and Securing Medicationsis an important addition to our organizations and will positively support our efforts to ensure that drug products are safely and securely stored, protecting patients from harm. I applaud the work of the editor, Dr. Thomas Kirschling, and expert contributors for their fine work in updat-ing this second edition of The Handbook on Storing and Securing Medications.

Robert J. Weber,R.Ph., M.S., F.A.S.H.P. Executive Director, Department of

Pharmacy and Therapeutics University of Pittsburgh Medical Center Foreword: An Important Obligation VII

M

edication storage and medication security are distinct processes that inter-relate to provide a key part of the medication use system. Medication stor-agedefines medication location, such as the drug cabinet, automated dis-pensing cabinet (ADC), refrigerator, or medication cart, as well as proper methods for storing medications. Medication securityaddresses keeping medication in a stor-age area such that unauthorized personnel are prevented from obtaining access to the medication.

Growing evidence of the number of medical errors that occur throughout the U.S. health care system has prompted increased interest and attention to this public health problem. A significant concern of patients, health care organizations, and cli-nicians is that medication errors occur at an alarming rate. More than 148,000 med-ication errors were reported in the searchable database of 447 U.S. hospitals using the United States Pharmacopeia (USP) MEDMARX®_{program (J. Kowiatek, M.P.M.,}

Establishing a

Paradigm for

Complying with

Medication Storage

and Security

Standards

Introduction

Introduction

unpublished data, December 2008).* Nearly 1.2% (more than 1,700) of all reported medica-tion errors resulted in significant harm to patients—harm that required additional treat-ment or increased hospital stay and/or resulted in temporary or permanent injury or death (J. Kowiatek, M.P.M., unpublished data, December 2008). The problem of medication safety also extends to long term care facilities, where the risks of adverse drug events (ADEs) in the elder-ly are well known due to poelder-ly-pharmacy and differing responses to medications in the elderly, particularly anticoagulants and narcotic anal-gesics.

More than 39,000 (26%) of the total MEDMARX–reported errors in the searchable database for 2007 occurred during the process of medication administration, with approxi-mately 1,493 of these errors caused by break-downs in storing and securing medication processes related to storage proximity and ADCs. When these 1,493 errors were further analyzed, approximately 35 (2.3%) were found to have resulted in significant patient harm (Category E–I errors, as defined by the National Coordinating Council for

Medication Error Reporting [NCCMERP]) (J. Kowiatek, M.P.M., unpublished data, December 2008).

Noncompliance with safe medication stor-age and security practices and systems potential-ly causes medication misuse that may result in a serious error. Most important are the tragedies that result in these system breakdowns:

■ _{Two 16-year-old patients undergoing knee}

surgeries each suffer an acute myocardial infarction from inadvertent administration of epinephrine dispensed from an operating room floor stock.

■ A 7-year-old boy dies of the same error while undergoing ear surgery.

■ _{A unit inventory restocking error results in}

deaths and injury from misadministration of a skeletal muscle relaxant.

■ _{A diabetic medication mistakenly stocked in}

a bin for storing an Alzheimer’s disease med-ication results in serious hypoglycemia in an elderly patient.

■ _{Concentrated electrolyte solutions taken from}

a nursing unit stock and administered to a patient results in death.

■ Administration of intravenous vancomycin from a dialysis unit floor stock to a patient with a vancomycin allergy and without prior pharmacist review (in other words, “over-ride”) results in circulatory shock and death.

The Need for a

Systems Approach

When you examine the root cause of error in these cases, a common factor is that these errors are the result of faulty medication storage and security systems and not the negligence of indi-viduals. Processes for storing and securing med-ications in health care organizations must be examined from a systems perspective, with all broken parts fixed and all potential for error eliminated. The way to fix broken systems in hospitals and other health care organizations is to establish a culture of safety by providing health care professionals with the appropriate resources for understanding the systems’ problems. This should be done using evidence-based medicine, as well as the best “tools” to fix the problem.1_A

culture of safety is believed to be more important today than ever before as technological barriers are found to be more infrequent.2

About This Guide

The Handbook on Storing and Securing Medications(Handbook), published collabora-tively by the American Society of Health-System Pharmacists (ASHP) and Joint Commission Resources (JCR), identifies and discusses com-X THEHANDBOOK ONSTORING ANDSECURINGMEDICATIONS, 2NDEDITION

* In a decision to focus full attention and resources on its core standards-setting activities, USP transferred the MEDMARX reporting program to Quantros in December 2008. All queries about MEDMARX should be addressed to Quantros (http://www.quantros.com).

mon issues related to storing and securing med-ications that may lead to noncompliance with Joint Commission and ASHP standards. The

Handbook’s main purpose is to provide you with an additional resource to improve the safety of your organization’s medication use process. Further, the Handbookbroadly addresses and clarifies medication storage and security terms, safe practices, tips, and processes for health care professionals.

The Handbookprovides the following valu-able information for organizations to continu-ously improve their systems and processes for medication storage and security:

■ _{The Handbookprovides case studies and}

sce-narios (brief descriptions of medication secu-rity and storage issues) to show how to plan and implement safe systems for medication storage and security.

■ The Handbookdiscusses strategies and barri-ers in dealing with common problems of security and storing medications, including “high-alert” medications, look-alike and sound-alike drugs, investigational medica-tions, radiopharmaceuticals, emergency med-ication storage, inventory control manage-ment, and pharmacy automation and tech-nology. Information and strategies presented in the Handbookcan be applied to medica-tion storage and security issues across many clinical settings, such as skilled nursing facili-ties, outpatient surgical and medical facilifacili-ties, and private offices and clinics, as well as out-patient and clinic-based pharmacy sites.

■ _{The Handbookprovides Joint Commission}

and ASHP guidelines and standards so you can self-assess your medication storage and security.

Organization and

Content of the Guide

The Handbookhas been written by pharmacy practitioners with extensive experience in patient safety and who actively participate in ASHP’s programs. In addition, each contributor

has considerable experience with The Joint Commission survey process and has seen the positive changes that have occurred in the evo-lution of Joint Commission standards in the past 25 years. The information in these chapters is the result of their collective experience and knowledge in these areas and in the continuous quality improvement (CQI) process.

Chapter 1(“Current Concepts in

Medication Storage and Security”) discusses the importance of maintaining safe storage and security of medications and highlights the importance of developing a comprehensive organizational oversight of this issue. The chap-ter provides strategies for hospitals and other health care organizations to best involve all dis-ciplines in medication storage and security, par-ticularly the role of the Pharmacy and

Therapeutics Committee in establishing the most appropriate system. A key ingredient stressed in this chapter is leadership within the pharmacy (as exemplified by the pharmacy director), which is necessary to create an effec-tive medication security and storage system. Finally, the most current ASHP and Joint Commission standards are presented and explained.

Chapter 2(“Principles and Practices of Medication Storage”) focuses specifically on medication storage, providing help in estab-lishing a system for tracking the storage of medications throughout a facility. The chapter lists the key areas where medications are com-monly stored in health care organizations. Three case studies describe real-life situations: controlling drug samples in an outpatient clin-ic, voluntarily recalling Vioxx®_{, and}

develop-ing a safe medication stock system in the emergency department.

Chapter 3(“Maintaining Medication Security”) addresses security of medications and reviews the various methods for securing med-ications, ranging from technology to facility planning. The case studies in this chapter deal with three very important issues related to

Introduction: Establishing a Paradigm for Complying with

security, including developing a security system plan for the pharmacy and effectively dealing with the Food and Drug Administration in a narcotic diversion case.

Chapter 4(“Case Scenarios in a

Continuous Quality Improvement Approach to Medication Storage and Security”) discusses the CQI process related to storing and securing medications and applies the CQI method to cases involving investigational drug dispensing and the problem of medication “override” with automated dispensing devices.

There are also several appendixes in the

Handbookconsisting of tools to improve the safety of medication storage and security. In particular, we have included assessment ques-tions from the Institute for Safe Medication Practices safety survey that relate to medication storage. We encourage all readers of this

Handbookto complete the survey as a founda-tion for developing quality improvement efforts.

References

1. Leape L.L.: Reporting of adverse events. N Engl J Med347:1633–1638, 2002.

2. Leape L.L, Berwick D.M.: Five years after ‘To Err Is Human’: What have we learned? JAMA

293:2384–2390, 2005.

Acknowledgments

JCR and ASHP are grateful to the contributors who revised the chapters of this second edition. Their professional perspective and invaluable insights have greatly enhanced the quality and scope of this publication.

Special thanks go to reviewers Jorge D. Carrillo, Sophie Duco, Victoria Gaudette, Natasha Nicol, and Jeannell Mansur. Special thanks also go to Robert J. Weber, who edited the first edition of this book and contributed this edition’s Foreword.

We wish to express our appreciation to Michael R. Cohen of the Institute for Safe Medication Practices and Shawn C. Becker of the United States Pharmacopeia for their assis-tance with the appendixes, as well as to Jack Bruggeman of the ASHP. We would particularly like to thank Thomas E. Kirschling, who served as editor of this second edition.