SecondEdition

The Handbook on

Storing & SecuringMedications

Edited byThomas 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 WyllieManager, Publications: Victoria GaudetteAssociate Director, Production: Johanna HarrisAssociate Director, Editorial Development: Diane BellExecutive 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 MansurASHP Editor: Thomas E. KirschlingASHP 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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Contributors ..........................................................................................iv

ForewordAn Important Obligation ........................................................................v

IntroductionEstablishing a Paradigm for Complying with Medication Storage and Security Standards............................................ix

Chapter 1Current Concepts in Medication Storage and Security............................1

Chapter 2Principles and Practices of Medication Storage ....................................15

Chapter 3Maintaining Medication Security ..........................................................71

Chapter 4Case Scenarios in a Continuous Quality Improvement Approach to Medication Storage and Security ....................................103

Appendix 1ASHP Technical Assistance Bulletin on Hospital Drug Distribution and Control ............................................119

Appendix 2Drug Standardization, Storage, and Distribution Self-Assessment......129

Appendix 3List of Sound-Alike and Look-Alike Drug Names from the United States Pharmacopeia ................................................163

Appendix 4Controlled Substances Procedure ........................................................191

Index....................................................................................................203

ContentsContents

CONTRIBUTORS

Robert J. Weber, R.Ph., M.S., F.A.S.H.P.Executive Director, Department of Pharmacy and TherapeuticsUniversity of Pittsburgh Medical CenterPittsburgh, Pennsylvania

Thomas E. Kirschling, Pharm.D., M.S.Manager, Pharmacy OperationsDepartment of PharmacyUniversity of Pittsburgh Medical CenterPittsburgh, Pennsylvania

Joanne G. Kowiatek, R.Ph., M.P.M.Assistant Professor, University of Pittsburgh School of PharmacyPharmacy Manager, Medication Patient Safety, University of Pittsburgh Medical CenterPittsburgh, Pennsylvania

Kathy Crea, Pharm.D., B.C.P.S.Patient and Medication Safety Coordinator, Riverside Methodist HospitalColumbus, OhioAssociate Professor, University of Findlay School of PharmacyFindlay, 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 TherapeuticsUniversity of Pittsburgh School of PharmacyDirector of Pharmacy, Department of Pharmacy and TherapeuticsUniversity of Pittsburgh Medical CenterPittsburgh, Pennsylvania

Sue Skledar, R.Ph., M.P.H., F.A.S.H.P.Associate Professor, University of Pittsburgh School of PharmacyDirector, Drug Use and Disease Management ProgramDepartment of Pharmacy and TherapeuticsUniversity of Pittsburgh Medical CenterPittsburgh, Pennsylvania

IV THE HANDBOOK ON STORING AND SECURING MEDICATIONS, 2ND EDITION

It was a quiet night in a university hospital when the calm was interrupted by a callfor help from the nursing staff—an unresponsive elderly patient was found in hisroom. 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 fromprofound hypoglycemia with a blood sugar of 45 mg/dl. The patient’s situation wasremedied 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 beengiven an oral hypoglycemic agent at a schedule of four times daily instead of a differentmedication that was prescribed to treat the patient’s dementia. Further review of theerror indicated that the oral hypoglycemic had been placed in the second drug’s storagebin in the pharmacy due to the medications’ very similar-sounding names. The errorcould have been prevented through real-time awareness of the “sound-alike” nature ofthese two drugs and knowledge that oral hypoglycemic agents are not administered fourtimes daily.

Other storage errors with dramatic consequences have been reported: eye dropsbeing confused with drops to test for occult blood in the stool; household cleaningproducts mistakenly administered as oral liquid medications; administering concentrat-ed electrolyte solutions mistakenly stored on nursing units; mix-ups in foil-packedintravenous medications; oral floor stock of furosemide given intravenously; and errorsrelated 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

ForewordForeword

I was responsible for an error related to abowel-cleansing medication. An order was writ-ten for the solution to be given in “4 ounce dosesuntil clear.” The medication was stored on thenursing units; a very experienced nurse who wasnot a member of the regular staff called me andasked, “So do I give four of the solution?” towhich I hurriedly said, “Yes.” The nurse thenproceeded to reconstitute and attempt to give thepatient “four” bottles of the preparation with1,500 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 beeneasily prevented by sending a single bottle of thebowel-cleansing medication from the pharmacyalong with labeling that describes the correctadministration directions. We discussed this errorat a staff meeting and we removed the drug fromall nursing unit floor stock, and worked with thegastroenterology division to develop hospitalstandards and a pre-printed order for bowelcleansing procedures. Finally, we revised our dis-pensing process in the pharmacy to ensure thatthe 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 wasstunned that it happened and that I had beenresponsible for a patient’s adverse event. Manyquestions ran through my mind: How could Ihave missed the intent of the nurse’s question?Why didn’t the nurse know that attempting togive six liters of the bowel cleanser to a patientwas a blatant overdose? Why did we store thedrug on the nursing unit? Could I have prevent-ed this error? This incident gave me a newappreciation that errors in storing and securingmedications were unpredictable and that everydrug stored on the nursing unit or elsewhere inthe hospital has the potential to cause an error.The error also taught me that pharmacists areobligated to commit to processes that can deter-mine any potential for error (for example, fail-ure mode analysis) and implement systems toprevent all error potential.

Adding technology may not be the answerto safely storing and securing medications.Nursing or procedure unit-based automateddevices for storing medications present a newand different type of potential for medicationerrors. For example, pharmacy technicians canload incorrect medications into unit-basedmedication cabinets. The most recent and dra-matic example of this error occurred when apharmacy technician mistakenly loaded theanticoagulant heparin, 10,000 units/mLstrength in an automated medication cabinetbin designated for heparin 1,000 units/mLresulting in a series of terrible adverse effects.Additionally the procedures for medicationorder review (for example, allergy review, dosechecking) may be bypassed if the medicationfor the first dose is available to the nursethrough the cabinet. Unsafe quantities of med-ications may be placed into the cabinet. Anerror occurred at a university medical centerwhere a bulk bottle of methadone was placed ina bin designated for unit-dose liquid, resultingin the nurse administering an overdose ofmethadone from the bulk bottle. Also, healthcare professionals with substance abuse issuesstill continue to find ways to divert medicationfrom automated medication cabinets. An exam-ple of this occurred when an automated cabinethad been configured to have acetaminophenand acetaminophen/hydrocodone in adjacentlocked bins. A nurse accessed the acetamino-phen bin and used a hemostat to break into theadjacent pocket containing the acetamino-phen/hydrocodone tablets. Video surveillancecaptured the scenario.

As a result of the potential for diversion,pharmacists have a legal responsibility to ensureproper use of controlled substances and protectpatients by preventing diversion and potentialabuse by health care providers. This arearequires knowledge of federal and state lawsrelated to controlled substances as well as appli-cation of cutting-edge technology to track thesemedications.

VI THE HANDBOOK ON STORING AND SECURING MEDICATIONS, 2ND EDITION

Assuring the safe storage and security ofmedications is a fundamental pharmaceuticalcare process that serves as a foundation for anyhospital pharmacy safety program. Examples ofproper storage and security of medicationsinclude confirming that refrigerated items arestored under proper conditions; that externalproducts are stored separately from medicationsadministered internally; developing and main-taining a list of “high-alert” drugs; developingpolicies that require certain dangerous drugs bedistributed only by the pharmacy; and assuringstored products are clearly labeled and that onlyauthorized individuals have access to controlledsubstances. Routine inspection of drug storageareas by the pharmacy in the hospital is oftenviewed as tedious and “extra” work; as a result,noncompliance with this process often results ina recommendation from The Joint Commissionor the state’s Department of Health. To preventregulatory issues, pharmacy directors and man-agers should strive to develop monitoring sys-tems for drug storage and security that becomean integral part of the daily work. Thisapproach heightens awareness of proper medica-tion storage and security by all members of apharmacy department. Also, as the pharmacydevelops a daily method for tracking medicationstorage and security, its importance can be pro-moted to nursing units, housekeeping, respira-tory therapy and emergency departments, oper-ating rooms, radiology suites, GI procedureareas, and cardiovascular intervention laborato-ries.

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

This second edition of The Handbook onStoring and Securing Medications provides anupdate on professional standards and legal andregulatory requirements on medication storageand security. In addition, the Handbook pro-vides information on cutting-edge technologythat may be useful in helping hospitals andother organizations properly store and securemedications. The format of the Handbook issimilar to the first edition in using case studies,an examination of standards and legal require-ments, and an in-depth look at the many systemissues surrounding drug storage and security.This edition also continues to provide processes,structures, and outcomes to form the basis forany organization’s medication safety strategicplan.

A collaborative approach to solving medica-tion storage and security issues is also stressed inthe Handbook, including input and attention byboth patients and co-workers. In addition, aself-assessment tool provided by the Institute forSafe Medication Practices will help organiza-tions establish a baseline for compliance andserve as a tool for measuring improvement insafe practices for medication storage. TheHandbook on Storing and Securing Medications isan important addition to our organizations andwill positively support our efforts to ensure thatdrug products are safely and securely stored,protecting patients from harm. I applaud thework of the editor, Dr. Thomas Kirschling, andexpert contributors for their fine work in updat-ing this second edition of The Handbook onStoring and Securing Medications.

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

Pharmacy and TherapeuticsUniversity of Pittsburgh Medical Center

Foreword: An Important Obligation VII

VIII THE HANDBOOK ON STORING AND SECURING MEDICATIONS, 2ND EDITION

Medication storage and medication security are distinct processes that inter-relate to provide a key part of the medication use system. Medication stor-age defines medication location, such as the drug cabinet, automated dis-

pensing cabinet (ADC), refrigerator, or medication cart, as well as proper methodsfor storing medications. Medication security addresses keeping medication in a stor-age area such that unauthorized personnel are prevented from obtaining access to themedication.

Growing evidence of the number of medical errors that occur throughout theU.S. health care system has prompted increased interest and attention to this publichealth 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 usingthe United States Pharmacopeia (USP) MEDMARX® program (J. Kowiatek, M.P.M.,

Establishing a

Paradigm for

Complying with

Medication Storage

and Security

Standards

IntroductionIntroduction

unpublished data, December 2008).* Nearly1.2% (more than 1,700) of all reported medica-tion errors resulted in significant harm topatients—harm that required additional treat-ment or increased hospital stay and/or resultedin temporary or permanent injury or death (J.Kowiatek, M.P.M., unpublished data, December2008). The problem of medication safety alsoextends to long term care facilities, where therisks of adverse drug events (ADEs) in the elder-ly are well known due to poly-pharmacy anddiffering responses to medications in the elderly,particularly anticoagulants and narcotic anal-gesics.

More than 39,000 (26%) of the totalMEDMARX–reported errors in the searchabledatabase for 2007 occurred during the processof medication administration, with approxi-mately 1,493 of these errors caused by break-downs in storing and securing medicationprocesses related to storage proximity andADCs. When these 1,493 errors were furtheranalyzed, approximately 35 (2.3%) werefound to have resulted in significant patientharm (Category E–I errors, as defined by theNational Coordinating Council forMedication 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 aserious error. Most important are the tragediesthat result in these system breakdowns:■ Two 16-year-old patients undergoing knee

surgeries each suffer an acute myocardialinfarction from inadvertent administration ofepinephrine dispensed from an operatingroom floor stock.

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

■ A unit inventory restocking error results indeaths and injury from misadministration ofa skeletal muscle relaxant.

■ A diabetic medication mistakenly stocked ina bin for storing an Alzheimer’s disease med-ication results in serious hypoglycemia in anelderly patient.

■ Concentrated electrolyte solutions taken froma nursing unit stock and administered to apatient results in death.

■ Administration of intravenous vancomycinfrom a dialysis unit floor stock to a patientwith a vancomycin allergy and without priorpharmacist review (in other words, “over-ride”) results in circulatory shock and death.

The Need for a Systems ApproachWhen you examine the root cause of error inthese cases, a common factor is that these errorsare the result of faulty medication storage andsecurity systems and not the negligence of indi-viduals. Processes for storing and securing med-ications in health care organizations must beexamined from a systems perspective, with allbroken parts fixed and all potential for erroreliminated. The way to fix broken systems inhospitals and other health care organizations is toestablish a culture of safety by providing healthcare professionals with the appropriate resourcesfor understanding the systems’ problems. Thisshould be done using evidence-based medicine,as well as the best “tools” to fix the problem.1 Aculture of safety is believed to be more importanttoday than ever before as technological barriersare found to be more infrequent.2

About This GuideThe Handbook on Storing and SecuringMedications (Handbook), published collabora-tively by the American Society of Health-SystemPharmacists (ASHP) and Joint CommissionResources (JCR), identifies and discusses com-

X THE HANDBOOK ON STORING AND SECURING MEDICATIONS, 2ND EDITION

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

mon issues related to storing and securing med-ications that may lead to noncompliance withJoint Commission and ASHP standards. TheHandbook’s main purpose is to provide you withan additional resource to improve the safety ofyour organization’s medication use process.Further, the Handbook broadly addresses andclarifies medication storage and security terms,safe practices, tips, and processes for health careprofessionals.

The Handbook provides the following valu-able information for organizations to continu-ously improve their systems and processes formedication storage and security:■ The Handbook provides case studies and sce-

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

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

■ The Handbook provides Joint Commissionand ASHP guidelines and standards so youcan self-assess your medication storage andsecurity.

Organization and Content of the GuideThe Handbook has been written by pharmacypractitioners with extensive experience inpatient safety and who actively participate inASHP’s programs. In addition, each contributor

has considerable experience with The JointCommission survey process and has seen thepositive changes that have occurred in the evo-lution of Joint Commission standards in thepast 25 years. The information in these chaptersis the result of their collective experience andknowledge in these areas and in the continuousquality improvement (CQI) process.

Chapter 1 (“Current Concepts inMedication Storage and Security”) discusses theimportance of maintaining safe storage andsecurity of medications and highlights theimportance of developing a comprehensiveorganizational oversight of this issue. The chap-ter provides strategies for hospitals and otherhealth care organizations to best involve all dis-ciplines in medication storage and security, par-ticularly the role of the Pharmacy andTherapeutics Committee in establishing themost appropriate system. A key ingredientstressed in this chapter is leadership within thepharmacy (as exemplified by the pharmacydirector), which is necessary to create an effec-tive medication security and storage system.Finally, the most current ASHP and JointCommission standards are presented andexplained.

Chapter 2 (“Principles and Practices ofMedication Storage”) focuses specifically onmedication storage, providing help in estab-lishing a system for tracking the storage ofmedications throughout a facility. The chapterlists 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 theemergency department.

Chapter 3 (“Maintaining MedicationSecurity”) addresses security of medications andreviews the various methods for securing med-ications, ranging from technology to facilityplanning. The case studies in this chapter dealwith three very important issues related to

Introduction: Establishing a Paradigm for Complying with Medication Storage and Security Standards XI

security, including developing a security systemplan for the pharmacy and effectively dealingwith the Food and Drug Administration in anarcotic diversion case.

Chapter 4 (“Case Scenarios in aContinuous Quality Improvement Approach toMedication Storage and Security”) discusses theCQI process related to storing and securingmedications and applies the CQI method tocases involving investigational drug dispensingand the problem of medication “override” withautomated dispensing devices.

There are also several appendixes in theHandbook consisting of tools to improve thesafety of medication storage and security. Inparticular, we have included assessment ques-tions from the Institute for Safe MedicationPractices safety survey that relate to medicationstorage. We encourage all readers of thisHandbook to complete the survey as a founda-tion for developing quality improvement efforts.

References

1. Leape L.L.: Reporting of adverse events. N Engl J

Med 347:1633–1638, 2002.

2. Leape L.L, Berwick D.M.: Five years after ‘To Err Is

Human’: What have we learned? JAMA

293:2384–2390, 2005.

AcknowledgmentsJCR and ASHP are grateful to the contributorswho revised the chapters of this second edition.Their professional perspective and invaluableinsights have greatly enhanced the quality andscope of this publication.

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

We wish to express our appreciation toMichael R. Cohen of the Institute for SafeMedication Practices and Shawn C. Becker ofthe United States Pharmacopeia for their assis-tance with the appendixes, as well as to JackBruggeman of the ASHP. We would particularlylike to thank Thomas E. Kirschling, who servedas editor of this second edition.

XII THE HANDBOOK ON STORING AND SECURING MEDICATIONS, 2ND EDITION