ICAHN Targeted Focus Area: Drug Information and Drug Standardization and Distribution Matthew Fricker, RPh, MS, FASHP Program Director, ISMP Rebecca Lamis, PharmD, FISMP Medication Safety Analyst, ISMP March 27, 2014 Objectives Describe examples of safety concerns related to the lack of available drug information, a tightly controlled drug formulary, and the safe storage of medications on patient care units Review the ICAHN aggregate self assessment results for these areas Provide strategies that can be implemented to ensure pertinent drug information is readily accessible to practitioners, a controlled formulary is established, and medications are safely supplied to and stored on care units 2 Key Elements Key Element Mean % VI Drug Device Acquisition, Use, Monitoring 51% VIII Staff Competency and Education 55% I Patient Information 56% II Drug Information 56% IX Patient Education 63% X Quality Processes and Risk Management 63% IV Drug Labeling, Packaging, Nomenclature 65% III Communication of Drug Orders and Other Drug Info. 70% V Drug Standardization, Storage, Distribution 73% VII Environmental Factors, Workflow, Staffing Patterns 81% Total 63% 3 1
Core Characteristic #2: Essential drug information is readily available and considered (57%) 4 Drug Information Leape LL, et al. JAMA. 1995 35% of all preventable ADEs directly related to inadequate drug information Majority of errors occurred during the prescribing and administration phases 5 Drug Information Issues Lack of readily accessible and up to date references Failure to use standardized drug protocols Background or hidden alerts/notifications on the emar Information technology systems that fail to detect unsafe orders, or alerts are overlooked by staff Limited availability of pharmacists to healthcare practitioners 6 2
Protocols / Charts / Guidelines / References 7 Outdated References 30 All drug reference texts, including commercially available charts and guidelines in the organization are checked annually; all outdated reference materials are removed from use and replaced as necessary. (Reference materials are outdated after 1 year of publication or whenever the next edition is available). 7% 71% 21% 8 Access to Drug References 31 32 Pharmacists and pharmacy technicians have easy access (e.g., on each computer terminal, electronic handheld devices) to user friendly, up to date, computerized drug information systems, which include information on over the counter, herbal, and alternative medicines. Prescribers and other non pharmacy practitioners have easy access (e.g., on each computer terminal, electronic handheld devices) to user friendly, up todate, computerized drug information systems, which include information on over the counter, herbal, and alternative medicines. 0% 7% 93% 0% 21% 79% 9 3
Drug Information Remove outdated and/or personal drug references Standardize references used (online references are preferred) Ensure references are readily accessible Discard handwritten, borrowed/unapproved, and outdated protocols and compounding recipes/instructions Check for old memos and guidelines Look in the medication room on bulletin boards and behind the doors! 10 Radiology Guidelines 11 Found in 2012, dated 2004 12 4
Internal Drug Information Tools 39 All internally developed drug information tools (e.g., pocket references, drug information cards, standard order sets, protocols or checklists, patient drug education materials, compounding recipes) undergo a formal approval process before use, which includes review by a pharmacist and those who will be using the tool, and an annual evaluation to ensure accuracy. 14% 57% 29% 13 Drug Information Place standardized emergency drug reference sheets/infusion titration charts on resuscitation carts Drugs/concentrations should match the concentration of medications provided in the cart and smart pump Provide guidelines for preparation and administration of emergency drugs Include current Broselow tapes in pediatric code carts Provide staff with readily accessible information through the use of up to date, approved charts / reference sheets / pocket references Do not crush Equianalgesic 14 Emergency Drug Dosing Guidelines 33 Standardized, organization approved emergency drug dosing guidelines are available on adult and pediatric (e.g., Broselow system) code carts, and the information provided corresponds to the dosage forms and concentrations of drugs available in the code carts. 0% 29% 71% 15 5
Basal Insulin Administration Nurses inappropriately held basal insulin doses when a patient s blood glucose was normal at the time of the dose Staff found patients with blood glucose readings in the 200 300 mg/dl range ISMP. ISMP Medication Safety Alert! 2014;19(5):2. 16 Survey (equianalgesic potency) HYDROmorphone 1 mg = morphine 4 mg Pre Post RPh% 26 10 Nurses% 35 23 Physicians% 36 11 HYDROmorphone 1 mg = morphine 7 mg RPh% 71 90 Nurses% 49 65 Physicians% 63 84 17 Equianalgesic Dosing Charts 36 Equianalgesic dosing charts for oral, parenteral, and transdermal (e.g., fentanyl patches) opioids have been established and are easily accessible to all practitioners when prescribing, dispensing, and administering opioids. 71% 29% 0% 18 6
Protocols / Guidelines for High Alert Medications 35 Current protocols, guidelines, dosing scales, and/or checklists for high alert drugs (e.g., chemotherapy, anticoagulants, opioids, insulin) are readily accessible to prescribers, pharmacists, and nurses, and used when high alert drugs are prescribed, dispensed, and administered. 7% 36% 57% 19 Electronic Alerts 20 Alerts for Problematic Drug Names 84 Alerts are built into computer order entry systems to remind practitioners about problematic drug names (including drugs with multiple suffixes such as XL, SR, ER, CD, LA), packaging, or labeling. 50% 29% 21% 21 7
Dose Range Checks 42 Computer order entry systems perform dose range checks and warn practitioners about overdoses and underdoses for all high alert drugs and for most other medications. 29% 50% 21% 22 Amphotericin B Dosing Using CPOE, a physician entered an order for amphotericin B conventional 375 mg (5 mg per kg) IV every 24 hours (maximum safe dose for this product is 1.5 mg per kg). A warning popped up on the screen, but quickly disappeared after hitting the Enter key. The pharmacist interpreted the order as the lipid based product; however, conventional amphotericin B was dispensed. The nurse who administered the drug was not aware of the dosing differences between the conventional and lipidbased forms of the drug. ISMP. ISMP Medication Safety Alert! 2013;18(19):2. 23 Serious Alert Overrides 43 Computer order entry systems require practitioners to enter an explanation upon overriding a serious alert (e.g., exceeding a maximum dose for a high alert drug, a serious drug interaction, an allergy). 29% 43% 29% 24 8
System Expectations Unclear expectations about what is available and functioning Clearly communicate system abilities Periodically test the system Drug drug interactions Maximum dose warnings (single and cumulative) Wrong route of administration 25 Test for / Build Dose Alerts for High Alert Drugs 41 Information technology systems used in the hospital (e.g., pharmacy computer system, computerized prescriber order entry [CPOE] system, smart pump technology, automated compounding devices) are routinely tested to assure that maximum dose alerts are present for high alert drugs, and alerts are built for those that are not present. 36% 43% 21% 26 Order Entry Systems Tested for Clinical Alerts 56 Computer order entry systems are tested after adding a new drug to the formulary to verify that important clinical warnings (e.g., serious drug interactions, allergies, cross allergy alerts, maximum dose limits) are functional; and if a serious alert is not yet functional through the drug information system vendor, a temporary free text alert or similar mechanism is added so that it appears on the screen during order entry. 43% 36% 21% 27 9
http://www.ismp.org/selfassessments/hospital/2011/faq.pdf 28 http://www.ismp.org/selfassessments/hospital/2011/faq.pdf 29 Electronic Alerts Goal: Effective warning system Warn about significant problems Clinicians to consider and act on the warning Problem: Alert fatigue 98% of alerts were drug interactions 9% acceptance rate Isaac T, et al. Arch Intern Med. 2009. 30 10
Alert Fatigue Protect against alert fatigue Fewer, more appropriate alerts Optimize the sensitivity of alert systems 66% severe DI bypassed (non tiered system) 0% (tiered system) (Paterno MD, et al. JAMIA 2009) Evaluate reports of insignificant alerts and false positives Configure hard stops for high severity alerts with high alert medications that require meaningful action to proceed 31 Overridden and Insignificant Alerts Evaluated 44 A designated pharmacist routinely reviews, for quality improvement purposes, reports of selected computer order entry system warnings (e.g., maximum dose alerts, serious drug interactions, allergy alerts) that are overridden. 71% 21% 7% 45 Computer order entry system warnings are periodically evaluated for clinically insignificant and false positive alerts, and action is taken to minimize alert fatigue. 57% 29% 14% 32 Availability of Pharmacists 33 11
Pharmacist Availability 122a 122b 122c At least one pharmacist is physically present onsite 24 hours a day, 7 days a week. A pharmacist at a remote location is available for questions and to enter and screen medication orders before the drugs are removed or dispensed. A night cabinet has been established for when the pharmacy is closed, and a pharmacist is oncall for questions and to come into the hospital if needed. 1 0 0 0 2 4 1 3 3 34 Pharmacist Review of Orders 117 118 Medications are not removed from inpatient unit stock before a pharmacist reviews the specific patient order and screens the order for safety. Exception: Urgent or lifesaving situations where a delay would harm the patient. Medications are not removed from outpatient unit stock before a pharmacist reviews the specific patient order and screens the order for safety. Exception: Urgent or lifesaving situations where a delay would harm the patient. 14% 43% 43% 43% 43% 14% 35 Patient Consultation with Pharmacist 202 Criteria have been established (e.g., selected highalert drugs, high risk patient populations) to trigger an automatic consultation with a pharmacist for patient education. 79% 21% 0% 36 12
http://www.ismp.org/tools/highalertmedications/default.asp 37 Core Characteristic #3: A controlled drug formulary system is established (54%) 38 Formulary Risk Exposure Widespread use of non formulary medications No oversight of drug classes Limited use of standardized protocols Lack of restrictions on use (chemotherapy) Limited tracking of drug use (DUE) Frequent changes in suppliers (brand and generic products intermingled) 39 13
Drug Formulary Manage formulary approvals through the P&T Committee Establishes a system of drug control and oversight that is rational, clinically appropriate, and promotes the safe use of medications Perform systematic reviews of drug classes Limit duplication and standardize use Limit the overall use of non formulary products Prior to dispensing an approved non formulary drug, have pharmacy staff provide important drug information to nurses responsible for administering the drug Review all order sets, protocols, and drug resources to ensure that only approved formulary products are included 40 Minimal Duplication and Use of Non Formulary Products 51 The hospital formulary contains minimal duplication of therapeutically equivalent products. 0% 43% 57% 60 Non formulary products are used only when therapeutically necessary and appropriate (e.g., a patient experiences an adverse effect to a formulary medication; use of an alternative, nonformulary medication during a drug shortage). 0% 29% 71% 41 Uncommon Uses / Atypical Doses 58 In non urgent situations, formulary medications being considered for uncommon uses or in atypical doses are approved through a formal review process (e.g., Pharmacy and Therapeutics Committee) before prescribers order the drug. 43% 29% 29% 59 In urgent situations, a timely informal process is in place for specified practitioner(s) to review formulary medications being considered for uncommon uses or in atypical doses before pharmacists dispense and/or nurses administer the drug. 43% 36% 21% 42 14
Potential for Error is Investigated 52 Before a decision is made to add a drug to the formulary, the potential for error with that drug is investigated by searching the literature and performing an internal risk assessment that includes staff who are involved in the prescribing, storage, preparation, dispensing, and administration of the medication; and the results of this assessment are documented in the drug monograph submitted to the pharmacy and therapeutics committee (or a similar voting body). 7% 57% 36% 43 Safety Strategies for Drugs with Heightened Error Potential 54 When drugs with heightened error potential are approved for addition to the formulary, safety enhancements such as standardized order sets, prescribing guidelines, check systems, reminders, administration guidelines, monitoring protocols, and/or limitations on use, administration, and storage of drugs are established and implemented before initial use. 14% 36% 50% 44 Hospital Wide Surveillance 55 Ongoing hospital wide surveillance for at least 6 months is initiated immediately after adding a drug to the formulary that has been identified as having heightened error potential to monitor compliance and success with established safeguards. 36% 57% 7% 45 15
Key Element V Drug Standardization, Storage, Distribution 46 Drug Storage/Stock on Patient Care Units Unnecessary or unsecured medications available in patient care areas Automated dispensing cabinets Night cabinets Discontinued medications Uncontrolled access to hazardous substances Poor control of floor stock Ability to requisition non approved floor stock items Drug samples not tightly controlled 47 48 16
49 Discontinued Medications 105 Discontinued patient specific medications are appropriately secured and removed from patient supplies in a timely manner (e.g., upon the patient s discharge, discontinuation of the drug, or within 8 hours during the next scheduled pharmacy rounds to patient care units) to prevent accidental administration or borrowing of the medication for another patient. 7% 36% 57% 50 Antidotes and Reversal Agents 107 Antidotes and reversal agents for medications (e.g., methylene blue [methemoglobinemia from oral anesthetic sprays], naloxone [opioid toxicity], flumazenil [benzodiazepine toxicity], lipid emulsion [bupivacaine toxicity]) and accompanying guidelines for emergency use, are readily available near the point of use. 21% 14% 64% 51 17
Drug Preparation and Standardization Lack of a patient specific / unit dose system Drug admixture on patient care units Multiple concentrations of IV infusions leading to potential use of the wrong concentration 52 Patient Specific / Unit Doses 110 111 Patient specific doses are dispensed for at least 90% of all injectable products (including saline and heparin flushes) for adult, pediatric, and neonatal patients. All oral solid medications are dispensed to patient care units in labeled, ready to use unit doses. 14% 36% 50% 7% 0% 93% 112 All oral liquid medications are dispensed to patient care units (including neonatal, pediatric, and critical care units) in labeled, ready to use patient specific doses. 21% 50% 29% 53 Tablet Repackaging 94 Doses that require less than a full tablet (e.g., ½ or ¼ tablet, 1 ½ tablets) are repackaged by the pharmacy into unit dose packages. 57% 14% 29% 54 18
Commercially or Pharmacy Prepared IV Solutions 99 Commercially prepared, premixed IV solutions are used whenever they are available from the manufacturer. 0% 14% 86% 113 IV solutions that are unavailable commercially are prepared in the pharmacy unless needed in emergent lifesaving situations. 0% 43% 57% 55 Elastomeric Pumps / OR solutions Prepared by Pharmacy 114 Pharmacy fills all elastomeric pumps and prepares all IV solutions and irrigations needed in the operating room or procedural areas (including interventional radiology, cardiac catheterization areas), unless needed in emergent lifesaving situations. 43% 36% 21% 56 Standardized Concentrations 96 Concentrations for infusions of high alert drugs such as morphine, heparin, insulin, and vasopressors used for adult patients are standardized to a single concentration that is used in at least 90% of the cases. 0% 29% 71% 97 Concentrations for infusions of high alert drugs such as morphine, heparin, insulin, and vasopressors used for pediatric patients (including neonates) are standardized to a single concentration that is used in at least 90% of the cases. 18%* 46%* 36%* *Based on the number of hospitals that provide pediatric care (n=11) 57 19
Differentiation of Standardized Concentrations 98 When more than one standardized concentration is needed for high alert infusions (for adults or pediatrics), the organization uses consistent terminology (e.g., double strength, quadruple strength) and visual cues to identify and distinguish between the concentrations when communicating drug information (including labels, handwritten or preprinted orders, MARs, chart notations, and electronic formats, including computer screens). 43% 29% 29% 58 Questions? Upcoming Webinar: Drug Devices and Technology (Key Element VI) April 24 th at 1:30 p.m. 59 20