caf’ NEWSLETTER
`
`
`rll al|!
`bes
`The Official Journal of the Anesthesia Patient Safety Foundation
`
`www.apsf.org
`
`Ha N11
`
`|
`
`Volume25, No.1, 1-20
`
`Circulation 84,122
`
`Spring 2010
`
`
`
`APSFHosts Medication Safety Conference
`Consensus Group Defines Challenges and Opportunities for Improved Practice
`by John H. Eichhorn,MD
`
`prioritized byall the attendees. The resulting
`consensus recommendations include:
`
`Standardization
`* High alert drugs (such as phenylephrine and
`epinephrine) should be availablein standardized
`concentrations/diluentsprepared bypharmacyin
`‘ ready-to-use (Polusorinfusion) form that 6
`appropriate for both adult and pediatric patients.
`Infusions should be deliveredby an electronically
`controlled smart device containing a drug library.
`* Ready-to-use syringes and infusions should
`have standardizedfully compliant machine-
`readable labels.
`
`Overview
`
`oe
`On January26, 2010, the Anesthesia Patient Safety
`Foundation (APSF) convened a consensus conference
`of 100 stakeholders from manydifferent backgrounds
`to develop newstrategies for “predictable prompt
`improvement” of medication safetyin the operating
`oom, The proposed new paradigm to reduce
`medication errors causing harm to patients in the
`operating room is based on Standardization,
`Technology, Pharmacy/Prefilled/Premixed, and
`Culture (STPC). This new paradigmgoesfar beyond
`the importantbuttraditional emphasis on medication
`labelformatand the admonition to “alwavsread the
`.
`label.” Small group sessions on eachof the 4 elements
`of the new paradigm (STPC) debated and formulated
`specific recommendations that were organized and
`
`VSSeAMMaaic
`ky
`
`¢ Establish a culture of education, understanding, and
`accountability via a required curriculum, CME/CE,
`and disseminationof dramatic storiesin the APSE
`Newsletter and educationalvideos.
`° Establisha Cultureofcooperation and recognitionof
`thebenefitsofSTPCwithin andbetweeninstitu-
`naeprofessionalorganizations,and accreditation
`5
`,
`;
`;
`.
`_
`It was agreed that anesthesia professionals will
`likely surrender someof their “independence,”
`adapting their medication preparation anddelivery
`preferences and habits into more standardized prac-
`tice patterns(involving guidelines and checklists),
`utilizing more standardized and premixed medica-
`tions (input and supply by pharmacyservices), and
`relying more on technology. Facilities and their
`Technology
`administrators that are sensitive to the economic
`¢ Everyanesthetizing location should have a mecha-
`waeofSafety(feturmon LTEEeee
`nism toidentifymedicationsbeforedrawing upor
`‘
`UPE
`8
`8
`administering them (bar code reader) and a mecha-
`and for provision of financial supportfor change.
`nism to provide feedback, decision support, and
`Practitioners in the operating room maytake some
`’
`’
`documentation (automated information system).
`convincing, but culture and patient safety can
`improve and medication errors causing morbidity
`Pharmacy/Prefilled/Premixed
`and mortality can be dramatically reduced—justas
`happened with intraoperative monitoringyears ago.
`* Routine provider-prepared medications shouldbe
`discontinued wheneverpossible.
`CONFERENCE REPORT
`. Clinical pharmacists should be partof the periop-
`APSF is proud to have partnered with ECRI Institute
`Persistent reports of medication accidents occur-
`CTSTea MSTelele LL erativeoperating room team.
`ring in the operating room with resultant harm or
`PaWand Say Organization) to develop an 18 minute
`* Standardized pre-prepared medicationkits by
`potentialharm to patients prompted theAPSF to con-
`oe Palla ghar boy osnotied of
`case type should be used wheneverpossible.
`vene a consensus conference of 100 stakeholders from
`actime==peter=a ascaal
`Me
`manydifferent backgroundsonJanuary26, 2010,in
`é
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`Culture
`seo Medication
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`Page
`Manyofthesefiresareonthe upperbodyincludingthe
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`after root cause analyses. This video utilizes the ASA
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`Medication Conference Consensus Recommendations Chart...Page 7
`Information to the video content is offered in the
`Dear SIRS—Why Do New Defaults Turn Off CO, and Apnea Alarms?.......... Page 10
`Q&A—Exposureto Ultraviolet Radiation in OR wesssssssesssssesseesseseeseeee
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`separated into For Anesthesia Professionals and For ENT
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`"Sedation Safety" and "Glidescope Injuries”.......ssssssssssessssssssesssssesssssseseeeees Page 15
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` Hospital Coalition Group Endorses APSF PCA Recommendationa............. Page 17
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`a
`
`‘
`
`ication
`
`Safe
`
`3
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC — Exhibit 1016 — Page 1
`
`

`

`APSF NEWSLETTERSpring 2010
`
`PAGE 2
`
`APSF Funds New Registry: The
`Neurologic Injury after Non-Supine
`
`Shoulder Surgery (NINSS) Registry #
`
`by Lorri Lee, MD
`
`The APSF Newsletter has published numerous
`articles over the last 2 years on severe brain and
`spinal cord injuries occurring after shoulder surgery
`in thesitting or beach chair position. Many of these
`cases have beenassociated with the use of deliberate
`
`to identify that the most commoncause of postopera-
`tive visualloss after spine surgery was being caused
`by something other than globe compression. Once
`this information was well dispersed,other periopera-
`tive events and characteristics began to emerge as
`potential predisposingrisk factors, such as duration
`of surgery and magnitude of blood loss.
`
`NEWSLETTER
`The Official Journal of the Anesthesia Patient Safety Foundation
`
`
`
`=
`RITTER
`ayia bens Onan
`
`—
`cageamen
`
`
`
`The Anesthesia Patient Safety Foundation
`or permissive hypotension,typically at the requestof
`Newsletteris the official publication of the nonprofit
`The NINSS Registry is a voluntary registry col-
`surgeons, to decrease bleeding and improve visual-
`Anesthesia Patient Safety Foundation andis pub-
`lectingall cases of new or worsened central (brain or
`ization during arthroscopic shoulder surgery. Several
`lished quarterly in Wilmington, Delaware. Annual
`spinal cord) neurologic injury after shoulder surgery
`theories existasto the etiology of these catastrophic
`contributorcost: Individual-$100, Corporate-$500.
`This and any additional contributions to the
`in the non-supine position. The injury must occur
`neurologic injuries including 1) the loss of venous
`Foundation are tax deductible. © Copyright,
`either during surgery or within theinitial 24 hrs post-
`return and decreased cardiac outputin the upright
`Anesthesia Patient Safety Foundation, 2010.
`operatively; and the minimum patientageis 12 years.
`position; 2) loss of a compensatory sympathetic
`Theopinions expressedin this Newsletter are not
`necessarily those of
`the Anesthesia Patient Safety
`Exclusion criteria include 1) any case wheredirect
`response to positional changes caused by anesthesia;
`surgical trauma could causecerebral or spinal cord
`3) failure to correct for the difference in height
`Foundation. The APSFneither writes nor promulgates
`injury; 2) perioperative cardiac arrest, intraoperative
`betweenthesite of blood pressure measurement and
`standards, and the opinions expressed herein should
`not be construed to constitute practice standardsor
`hypoxic events, or uncontrolled surgical hemorrhage;
`the headlevel; 4) the use of deliberate or permissive
`practice parameters. Validity o opinions presented,
`3) lack of adequate medical recordsincluding preop-
`hypotension; 5) dynamic vertebralartery stenosis or
`drug dosages,accuracyand completeness ofcontent
`erative history and exam,anesthetic record, and post-
`occlusion with rotation of the head; and 6) air emboli.
`
`are not guaranteedbytheAPSE.
`operative follow-up and studies. Case submissions
`These articles have generated significant interest and
`APSF Executive Committee:
`are voluntary and anonymous,with IRB approval for
`alarm amongthe anesthesia and orthopedic commu-
`Robert K. Stoelting, MD, President; Nassib G.
`this study from the University of Washington. Please
`nities. Many groups have reported by word of mouth
`Chamoun,Vice President; Jeffrey B. Cooper, PhD,
`Executive Vice President; George A. Schapiro,
`visit our website at www.asaclosedclaims.org and
`a changein surgical and anesthetic practice based on
`Executive Vice President; Matthew B. Weinger, MD,
`click on the brain and spinal cord iconto direct you to
`this information. However, manyanesthesia care pro-
`Secretary; CaseyD. Blitt,MD,Treasurer;SorinJ.Brull,
`submission forms.The directlink is http: //depts.
`vidersare still being faced with surgical requests for
`MD; Robert A. Caplan, MD; David M. Gaba, MD;
`washington.edu/asaccp /NINS/index.shtml. It is
`deliberate hypotension in these cases, because of the
`Patricia A. Kapur, MD;Lorri A. Lee, MD;Robert C.
`only with the help of our dedicated professionals in
`Morell, MD;A. William Paulsen, PhD; Richard C.
`sparsity of data on this topic.
`Prielipp, MD;Steven R. Sanford, JD; Mark A. Warner,
`the anesthesia community that we can collect enough
`MD.Consultants to the Executive Committee: John H.
`information to offer guidance on the topic of blood
`Eichhorn, MD; Maria Magro, CRNA, MS, MSN.
`pressure managementin the beach chair position.
`Newsletter Editorial Board:
`Robert C. Morell, MD, Co-Editor; Lorri A. Lee,
`MD,Co-Editor; Sorin J. Brull, MD; Joan Christie,
`MD;Jan Ehrenwerth, MD;John H. Eichhorn, MD;
`Susan R. Fossum, RN; Steven B. Greenberg, MD;
`RodneyC.Lester, PhD, CRNA; Glenn S. Murphy,
`MD;Karen Posner, PhD; Andrew F. Smith, MRCP,
`FRCA; Wilson Somerville, PhD; JefferyVender, MD.
`respondenceto: “
`subsp
`Addressall
`, contributor, and
`iption cor-
`
`The APSFBoard of Directors Workshop,held last
`October in New Orleans,further explored this poten-
`tially lethal, yet preventable, patient safety issue by
`inviting numerous national and international experts
`on the topics of cerebral perfusion, cerebral function
`monitoring, deliberate hypotension, and shoulder
`surgery. Most speakers and attendeesagreed that the
`use of deliberate hypotension in these shoulder sur-
`gery casesin thesitting position should be discour-
`aged until we have better research on this topic. One
`of the suggestions for future research from the break-
`out groupsat the workshop wasto create a national
`voluntary registry to collect these rare cases of neuro-
`logic injury after non-supine surgery (NINSS).
`
`In follow-up to the workshop recommendations,
`the APSF has funded thecreation of the NINSS
`Registry in collaboration with the ASA Closed Claims
`Project at the University of Washington.It will be
`modeledafter the ASA Postoperative Visual Loss
`Registry, with the goalof identifying commonperiop-
`erative characteristics that may guidefuture research.
`Prior to data from the ASA Postoperative Visual Loss
`Registry, the anesthesia community was being
`blamedfor inadequateprotection of patient eyes in
`the prone position resulting in blindness. With the
`voluntary efforts of anesthesiologists, nurse anesthe-
`tists, and somepatients, enough data werecollected
`
`Dr. Lee is Co-Editor ofthe APSF Newsletter, Director ofthe
`NINSSRegistry, and Associate Professor ofAnesthesiology
`at the University ofWashington, Seattle, WA.
`
`NINSSRegistry
`Neurologic Injury after
`Non-Supine Shoulder Surgery
`
`e
`
`Click on the link below to submit cases of
`central neurologic injury (brain or spinal cord)
`occurring after shoulder surgery in the non-
`supine position.
`http://depts.washington.edu/asaccp/
`NINS/index.shtml
`
`Administrator, Deanna Walker
`Anesthesia Patient Safety Foundation
`Building One, Suite Two
`8007 South Meridian Street
`Indianapolis, IN 46217-2922
`e-mail address: walker@apsf.org
`FAX: (317) 888-1482
`Address Newslettereditorial comments, questions,
`letters, and suggestions to:
`Robert C. Morell, MD
`Editor, APSF Newsletter
`c/o Addie Larimore,Editorial Assistant
`DepartmentofAnesthesiology
`Wake ForestUniversitySchoolofMedicine
`9th Floor CSB
`Medical Center Boulevard
`Winston-Salem, NC 27157-1009
`e-mail: apsfeditor@yahoo.com
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC — Exhibit 1016 — Page 2
`
`

`

`APSF NEWSLETTER Spring 2010
`
`PAGE 3
`
`Medication Safety Conference Develops New Strategies
`
`“Medication Safety,” From Page 1
`
`Phoenix, Arizona. The goal of the conference was to
`create actionable statements that could result in “pre-
`dictable prompt improvement” of medication safety
`in the operating room.
`Multiple reports and analyses of “syringe swaps”
`and incorrect syringe labels, look-alike labels, look-
`alike medication vials and ampoules, incorrect injec-
`tion sites (into epidural or arterial catheters), and
`infusion pump confusion or programming errors have
`appeared in the Anesthesia Patient Safety Foundation
`Newsletter and other journals in recent years.1-3 APSF
`conducted its 2008 Annual Workshop on “Innovations
`in Medication Safety in the Operating Room,” with
`the report of this meeting being published in the
`Winter 2008-09 APSF Newsletter.3 Other reviews and
`editorials have considered distinctive label format for
`medication containers and syringes, uniform drug
`labeling standards, and a more universal role of phar-
`macy services.4-7 While all those are relevant, little, if
`anything, has changed. Operating room medication
`errors continue to occur, many with significant mor-
`bidity and/or mortality. Anesthesia professionals in
`the operating room have a unique role and responsi-
`bility in that they are the only medical personnel who
`prescribe, secure, prepare, administer, and document
`medications— a process that can take up to 41 steps—
`usually within a very short time interval.2 In addition
`these steps occur in real time, autonomously, often in a
`distracting environment, and typically without stan-
`dardized protocols.
`Because past efforts to improve medication safety
`have not been particularly successful, the purpose of
`this conference was to develop new ideas and
`approaches. Reference was made to the quotation
`popularly attributed to Einstein that the definition of
`insanity is doing the same thing over and over and
`expecting a different result. The conference title was
`“Medication Safety in the Operating Room: Time for a
`New Paradigm.” The theme of the “new paradigm”
`had 4 elements: Standardization, Technology,
`Pharmacy/Prefilled/Premixed and Culture (STPC),
`representing a new 4-pronged approach to the
`persistent problems of medication safety in the
`operating room.
`Robert K. Stoelting, MD, APSF president, served
`as the overall moderator for the intense 1-day confer-
`ence. He opened with the video Beyond Blame, pro-
`duced in 1997 and distributed by the Institute for Safe
`Medication Practices. The video contains interviews
`with an anesthesiologist, an ICU nurse, and a pharma-
`cist, each of whom was involved with a fatal medica-
`tion error. The video stresses, “It could happen to
`anyone.” Despite the passage of 13 years the issues in
`the video remained highly relevant in 2010. Dr.
`Stoelting also noted the often-cited statistic that there
`is 1 significant anesthetic medication error in every
`133 anesthetics administered and, of those errors, 1
`out of 250 is fatal.1 This translates to nearly 1000
`deaths a year in the United States. Acknowledging the
`
`general value of evidence-based medicine, he stressed
`that the traditional approach involving multiple ran-
`domly controlled prospective blinded trials simply
`cannot apply to preventing rare unpredictable adverse
`events—and that waiting or hoping for such results
`can actually be counterproductive for safety. He
`emphasized that safety is doing the right thing
`because it makes sense. Dr. Stoelting noted that anes-
`thesia safety has been improved by many small steps
`over the years, that have made a big difference in the
`aggregate.
`Dr. Stoelting introduced a novel format consisting
`of 20 invited speakers from widely varying disciplines
`and backgrounds (clinical anesthesia, research [includ-
`ing human factors], surgery, operating room nursing,
`administration, pharmacy, regulators, and the pharma-
`ceutical/medication device industry). Each speaker
`had a 15-minute time slot—but all with the same topic:
`“Time for a New Paradigm: Standardization, Technology,
`Pharmacy, Culture.” Each was asked to address relevant
`elements of the paradigm from their special perspec-
`tive. Following these 20 presentations the entire assem-
`bly was divided by interest and expertise into 4 small
`group breakout sessions, one for each component of
`the STPC paradigm. The assignment to each group was
`to generate a list of actionable items in order of impact
`that, if implemented, would produce “predictable
`prompt improvement” in operating room medication
`safety. A final combined session set the stage for devel-
`opment of consensus statements as the primary prod-
`uct of the conference.
`World Class Experts
`The keynote speaker was Alan F. Merry, MBChB,
`head of anesthesiology at the University of Auckland,
`New Zealand, former chair of the Patient Safety
`Committee of the World Federated Societies of
`Anesthesiologists, and founder of Safer Sleep, LLC, a
`company that provides technology intended to
`increase anesthetic medication safety. He cited the
`recently adopted “Guidelines for the Safe
`Administration of Injectable Drugs in Anaesthesia”
`from the Australian and New Zealand College of
`Anaesthetists that focus on standardization of
`medication administration as opposed to the
`traditional approach of each practitioner
`independently making these decisions. He also noted
`that the International Standards Organization most
`recent publication regarding content of adhesive
`syringe labels includes the class of drug (“induction
`agent,” “muscle relaxant,”) as well as the drug name
`along with space to write the concentration and date
`and, also, a bar code. Another component of
`standardization is in the anesthesia workspace, in that
`he suggests a uniform arrangement of medications,
`syringes, empty drug containers for every case by
`every provider. Because of human nature, errors will
`occur at points in the drug administration process, and
`Dr. Merry suggested orientation toward managing
`predictable errors rather than the futile attempt to
`eliminate all errors. Having a satellite pharmacy in the
`
`operating room area is a forward step. Having
`medication containers come into the operating room
`with attached peel-off detailed labels ready to go on
`the syringe is another related step. Application of the
`increasingly effective “checklist mentality,” especially
`if a second person or a device such as a bar-code
`reader with spoken voice repetition of the name
`checks the drug about to be given, was emphasized.
`Finally, from a “culture” perspective, he noted that
`anesthesia professionals may exhibit problems with
`denial and also believe they are all above average, but
`that these features must be overcome with a genuine
`reporting system that recognizes and records errors,
`enabling analysis and subsequent system modification
`to prevent repetition.
`
`Donald E. Martin, MD
`
`Systematic improvement of the human perfor-
`mance required in anesthetic drug administration was
`the theme of Donald E. Martin, MD, from Penn State
`College of Medicine. The usual human factors associ-
`ated with accidents, led by inattention (but also fail-
`ures of memory, knowledge, or motivation), are
`associated with drug errors in the operating room. He
`presented an analysis of the 41 steps involved in first-
`time administration of a drug during an anesthetic
`and noted 36 were automatic behavior with muscle
`memory and 5 required conscious attention, deci-
`sions, and judgment—a setup for inattention to the 5
`critical steps. Ways to help direct attention by the
`anesthesia professional to the key parts of drug
`administration were presented, including both ergo-
`nomics of the anesthesia workspace (a recurrent point
`from many presentations) and larger and louder stim-
`uli to target multiple senses. Dr. Martin made analo-
`gies to function in the cockpit of a commercial airliner,
`particularly noting the beneficial use of checklists and
`also the concept of the “culture of safety” where indi-
`vidual autonomy of action is surrendered and the pre-
`scribed “standard operating procedure” is the only
`acceptable behavior. He ended with a plea to involve
`the entire operating room team in the effort to
`improve medication safety.
`
`See “Medication Safety,” Next Page
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1016 – Page 3
`
`

`

`APSF NEWSLETTER Spring 2010
`
`PAGE 4
`
`Experts Offer Insight into Causes of Errors
`
`“Medication Safety,” From Preceding Page
`
`there, and the ICU nurses entering the program
`would already have medication safety skills. Support
`was generated through the survey process for a
`nationally standardized curriculum as well as gener-
`ous use of simulation to teach safety skills for medica-
`tion administration to CRNA students.
`
`Robert A. Caplan, MD
`
`Robert A. Caplan, MD, member of the APSF
`Executive Committee and medical director of Quality
`at Virginia Mason in Seattle, in a particularly poignant
`presentation, emphasized the importance of the “cul-
`ture” of medication labeling by recounting a tragic
`accident that occurred in his organization in 2004. A
`patient who was undergoing an interventional radiol-
`ogy procedure accidently received a fatal injection of
`chlorhexidine (a prep solution) instead of contrast dye
`because both solutions were in similar, unlabeled con-
`tainers on the procedure table. As a result of this event,
`the leadership and safety teams at Virginia Mason
`made several key discoveries about the existing “cul-
`ture” of medication labeling. First, medication label-
`ing was regarded as desirable but not mandatory.
`Second, the strongest motivation for not labeling was
`convenience. And third, it was not possible to justify
`non-labeling behavior with clinical, ergonomic, or eco-
`nomic arguments. As a result, Virginia Mason devel-
`oped an explicit, standardized process for medication
`labeling. The process is now used throughout the
`organization. Dr. Caplan noted that this event and its
`associated lessons have accelerated the implementa-
`tion of other related safety strategies.
`Roots of the Problem
`A different aspect of the question was addressed
`by Maria Magro, CRNA, who is a member of the
`APSF Executive Committee and program director,
`Nurse Anesthesia, at the University of Pennsylvania
`School of Nursing. She described the national survey
`of CRNA training programs she and 2 colleagues con-
`ducted regarding formal training in anesthesia medi-
`cation safety practices. Results revealed the
`impression that drug errors observed or committed
`by CRNA students are under-reported and that medi-
`cation safety can be a stronger component of the cur-
`riculum. The 44% of training programs that did not
`have a formal medication safety module reported
`such reasons as these: medication safety was not a
`problem, incidents at clinical sites would be handled
`
`Maria Magro, CRNA
`
`Jerry A. Cohen, MD
`
`Jerry A. Cohen, MD, first vice-president of the
`American Society of Anesthesiologists and from the
`University of Florida, stated that fragmentation of the
`approach to medication safety problems is itself a sig-
`nificant problem. He maintained, the Swiss-cheese
`model of human error and accidents notwithstanding,
`that attempting to isolate root causes obscures com-
`plex interactive pathways (system function) that lead
`to errors. He cited a host of individual factors that can
`contribute to medication errors, particularly failure to
`standardize the operating room environment, espe-
`cially the anesthesia work area, which leads to chaos
`and distraction and an equally long list of barriers to
`improvement, especially resistance to checklists, com-
`munication silos, and production pressure. Dr. Cohen
`suggested that widespread standardization and also
`the use of pharmacy-prepared bar coded medications
`
`with bar code readers as part of electronic anesthesia
`records and information management systems would
`be central to efforts to improve medication safety in
`the operating room. He concluded with a plea for
`studies to generate data to guide implementation and
`also stimulate appropriate standards and regulations
`that will govern practice.
`A different take on human factors engineering was
`provided by John W. Gosbee, MD, of the University
`of Michigan who presented an elaborate “equation”
`describing operating room medication errors, in which
`the probability of confusion was the product of 6 fac-
`tors: “sound alike, look alike, location expectation,
`location trust, work flow expectation, and work flow
`trust.” He analyzed and provided examples of each
`factor in the anesthesia work station environment in a
`typical operating room. More emphasis came on the
`context of medication use in the work area than on
`labeling itself. He suggested that very simple factors
`such as strict standardization of the anesthesia work
`space, especially the location of stored medications,
`would help improve safety now while more complex
`technologic solutions involving barcodes, readers, and
`computerized records are developed and rigorously
`tested for efficacy.
`Allied Perspectives
`The public policy component was provided by
`Nancy Foster, vice president for Quality and Patient
`Safety Policy for the American Hospital Association.
`She noted that facility administrators are always
`interested in patient safety, but clinicians need to be
`more skilled at presenting safety proposals, particu-
`larly involving resource allocation, as imperatives
`that lead to “win-win” situations. She suggested one
`useful strategy is to “engage” administrators by
`including them on quality improvement teams and
`safety task forces and then give them specific goals
`and assignments that are achievable, thus reinforcing
`their stake in establishing a safety culture and
`improvement of outcome. Also, Ms. Foster noted the
`trend of greater integration of health professionals,
`physicians in particular, into the internal institutional
`organization, which should increase the receptivity of
`administrators to safety proposals. She concluded
`with a reminder that administrators are sensitive to
`the public’s perception of their facility and that the
`public today finds failure to attempt to improve
`patient safety as totally unacceptable.
`A surgical perspective on OR medication safety
`was offered by a member of the APSF Board of
`Directors, William P. Schecter, MD, from UCSF and
`San Francisco General Hospital. He functionally pro-
`vided a “morbidity and mortality conference” based
`on operating room medication errors he had wit-
`nessed over the years. At the outset, he noted the ten-
`sion and complex interaction between human error
`and system failure and how this could relate to
`
`See “Medication Safety,” Next Page
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1016 – Page 4
`
`

`

`APSF NEWSLETTERSpring 2010
`
`Pharmacists Weigh in on Medication Error Prevention
`
`PAGE 5
`
`
`
`Bona E. Benjamin, RPh
`
`“Medication Safety,” From Preceding Page
`
`different types of medication errors (wrong drug or
`doseor route, and adverse reactions). Healso applied
`the STPC paradigm to each case to dissect out causes
`that could be corrected with those elements.In all
`cases, there were both human factors and system
`componentsas root causes. In nearly all the cases,
`standardization of practice and protocols would have
`helped to preventthe error. Theeerily familiar theme
`of accidental injection of a toxic substance into an
`inappropriate injection port with catastrophic out-
`come figured in 3 of the cases. Adherencetostrict
`labeling policies and physical segregation of toxins
`were the suggested remedies.
`
`TheInstitute for Safe Medication Practices (ISMP)
`wasrepresented by Allen J. Vaida, PharmD,its
`executive vice president. The ISMPfocusis on the
`system causes of medication errors and resulting
`system changesthat must be implemented along with
`education to prevent recurring patterns. Dr. Vaida
`stressed employing an open environmentof sharing
`errors internally and externally to safety
`organizationsfor learning, sharing, and bringing
`about change. He notedrelatively poor compliance
`with labeling policies and procedures during drug
`administration and also showed many examplesof
`striking look-alike drug vials (and noted the
`disproportionately great numberof look-alike
`accidents involving muscle relaxants). He also
`stressed thatclinicians (working to achieve consensus
`with pharmacists and manufacturers) need to
`establish and accept a relatively limited set of
`standardized concentrations for drugs. At a 2008
`national consensus conference on thesafety of
`intravenous drug delivery systems, there wasa clear
`preference for manufacturer-prepared completely
`ready-to-use IV medicationinall settings, although
`increased cost and potential inapplicability (such as
`for seldom-used but necessary drugsin the anesthesia
`operating room armamentarium) are drawbacksof
`that approach if standardization is not agreed upon.
`Dr. Vaidaalso noteda clear preferenceforsatellite
`pharmacies in operating room suites but noted that
`whenthatis not possible, there must be organized
`involvementfrom pharmacyfor anesthesia services
`in the operating room to support medication safety.
`
`PharmacyPractices
`Philip J. Schneider, RPh,associate dean of the
`University of Arizona College of Pharmacy, noted
`that evidence-based best practices known to improve
`medicationsafety, particularly unit dosing, have been
`in place for medication administration in hospitals for
`decades, but those concepts are not applied in the
`operating room. Henoted thatall of the key parts of
`the medication administration process (prescribing,
`transcription, dispensing, and administration—the
`points at which mistakes occur)are the responsibility
`
`of the anesthesia professionalin the operating room,
`preventing the traditional safety checks present in
`othersettings. He suggested that providing “ready-
`to-use” medications in the operating room whenever
`possible that are prepared by outsource specialty
`companies who dothat exclusively should decrease
`medicationerrors in the operating room.
`
`Patricia C. Kienle, RPh, an industry representa-
`tive holding the position of director, Accreditation
`and Medication Safety for Cardinal Health,Inc.,
`stressed the need for standardizationofall the key
`functions in the very complextask of anesthetic medi-
`cation administrationin the operating room,illustrat-
`ing her point with multiple photos of actual
`anesthesia workstations with what seemedlike quasi-
`chaotic hodgepodges of medication storage and
`administration. However, she asserted that color-
`coding of medication containers may not be a help
`and mayactually be a detriment in somecases. She
`also noted the USP practice standardforsterility of
`“compounded preparations” and suggested that the
`traditional 100 ml bag of phenylephrine made up
`from an ampoule by many anesthesia professionals at
`the start of a work day does not meetthat standard.
`
`Andrew J. Donnelly, PharmD,director of
`Pharmacy at the University ofIllinois Medical Center
`at Chicago, emphasized that cost of medications and
`associated personnelis a huge issue today for health
`care institutions facing budgetconstraints. Further, he
`also noted that the unique medication use process for
`anesthesia in the operating room has minimal
`involvement of pharmacy andlacks the normal
`checks andbalances. He advocated for a much more
`
`robust presence of pharmacy service in the operating
`room, even withouta satellite pharmacy, in order to
`gain the benefit of a team approach with the pharma-
`cist functionally as the “Perioperative Medication
`Safety Officer” inculcating a culture of safety. This
`would involveallergy verification, dissemination of
`drug information, formulary management,facilita-
`tion (shortages; look-alike, sound-alike), quality
`improvementprojects, and even research projects. Dr.
`Donnelly cited survey research showingthat “ready-
`to-use” medications are strongly preferred by practi-
`tioners, leadingto the idea that collaboration between
`anesthesia professionals and their pharmacists
`should lead to consensus on which medications are
`provided in ready-to-use form in that operating
`room. Healso favored standardization of medications
`
`and concentrations, throughoutan institution and
`even across the entire industry. He commented on the
`large number and quantity of medications in