Zahra Khudeira, PharmD, MA Medication Safety Manager Sinai Health System - Chicago, Illinois February 1, 2012 Webinar for Pharmacy One Source

Zahra Khudeira, PharmD, MA Medication Safety Manager Sinai Health System - Chicago, Illinois February 1, 2012 Webinar for Pharmacy One Source

Describe potential vulnerabilities in the medication use process Discuss various strategies that can improve the medication use process and increase patient safety Share implemented improvement strategies Provide a practical medication safety initiative checklist for possible implementation at your site

Mount Sinai Hospital community teaching and research hospital Licensed 319 bed Safety Net Hospital Level I Trauma Center Pediatric Hospital Level III NICU All services except transplant and burn Schwab Rehabilitation Hospital Licensed 102 beds

Serve both hospitals Open 24/7 No satellites 1.9 million doses dispensed annually Orders processed daily Hybrid CPOE and paper orders ADC and carts Management Hierarchy Director Operations Manager Clinical Coordinator Medication Safety Manager IS Pharmacist Clinical Specialists MICU ED Pediatrics Decentralized Pharmacists M F AM shift only SICU Medicine Telemetry Oncology PM shift centralized Overnight shift centralized, two pharmacists, two technicians Two PGY1 residents Twenty technicians (delivery tech) One lead technician Offer several student rotations

Computerized Prescriber Order Entry (CPOE) except peds, am care and ED Bar-Code Medication Administration (BCMA) for Rehab and Psych unit only Automated Dispensing Cabinets (ADC) MedCarousel High Speed Packager - PacMed Smart infusion pumps

Each site is unique Every pharmacy department is unique Some of the suggestions may involve capital funds and it will not be feasible to implement at your site Other interventions have no financial investment associated with their implementation Some initiatives involve hospital wide implementation You need to analyze your site and adopt what is practical

A discipline of pharmacy that focuses on the entire medication use process and tries to reduce adverse events and mitigate risks to maximize optimal patient outcomes Errors will happen. Humans are involved. Errors can be prevented by designing systems that make it hard for people to do the wrong thing and easy for people to do the right thing. Adapted from To Err is Human- Building a Safer Health System We are perfecting the medication delivery system to be safe for every patient, every time, while making it easy for caregivers to do the right thing, and impossible to do the wrong thing.

Medical errors are the eighth leading cause of death and are estimated to account for somewhere between 44,000 and 98,000 deaths in the United States each year (IOM, 1999). Where are we now? Preventing medication errors, which account for nearly 20% of adverse events overall and affect about 4% of all hospital stays, is a goal among patient safety organizations, and healthcare providers.

Do not forget the procurement stage=inventory management Many look alike items can be eliminated at the purchasing stage Think of system changes Accept that errors will happen and build a system around that Perform DUEs around the monitoring stage

High Risk Areas NICU, Chemo Clinic High Risk Processes Chemo, TPNs High Risk Routes Epidurals, IV Complex processes PCA, Chemo Complex Treatments Chemo, TPNs, weight based heparin, argatroban High Risk Patient Populations Peds, NICU, Oncology, Geriatrics, HD High Risk Medications Heparin, chemo, PCAs, anticoagulants, anesthetics, NMB, thrombolytics

From most effective to least ISMP 2006

Favorites list for physicians Orders limited based on unit (ICU meds are not viewable in general medicine unit) Check order sentences Use q12 hrs not BID, when appropriate (antiarrhythmics, anti-hypertensives, etc) Streamline products Order sets that reflex labs Clinical decision support

Most disregarded phase of med use process Pharmacists please do not forget this phase Analyze sedation, pain, BP, infection cure rates, length of therapy, etc. Analysis of amp/gent use in neonates length of therapy of amp/gent vancomycin monitoring vitamin K routes/doses adherence to ACCP guidelines darbepoeitin appropriateness

Personnel and technology Drug information software Communication Drug storage Environmental factors Employees competency, education, CE, modules. Hire well. Patient information available to staff IS lock out any order entry if height and weight is not documented Scales now locked to kg only

Transcription Dispensing 6% 4% Ordering 56% Administration 34% Errors Resulting in Preventable Adverse Drug Events. Bates et al. JAMA. 1995;274:29-34

ICU Pharmacists rounding reduced preventable ADEs by 66% Leape LL, Cullen DJ, Dempsey Clapp M, et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA 1999;282:267-70. Med/Surg pharmacist rounding reduced preventable ADEs by 78% Arch Intern Med. 2003;163:2014-2018 ER Med Rec for patients that are admitted Choosing appropriate therapy and reducing costs Decreasing medication errors and ADRs Pediatrics

Continuous reinforcement of safety I am known as the safety queen by other depts Always on stage for staff to highlight safety issues Discuss errors and how we can prevent them Email, staff meetings, morning huddles All new employees receive a two-hour session during orientation Medication errors, ADRs, human errors, examples of actual pharmacy errors Discuss policies and procedures Educate nurses during orientation about reporting ADRs and medication errors In a just culture, reckless behavior is not tolerated, but mistakes caused by system failures are seen as learning opportunities.

Manager Expectations & Actions Promoting Patient Safety 1. My manager says a good word when he/she sees a job done according to established patient safety procedures. 68% agree, 11% disagree 2. My manager seriously considers staff suggestions for improving patient safety. 79% agree, 8% disagree 3. Whenever pressure builds up, my manager wants us to work faster, even if it means taking shortcuts. (negatively worded) 79% disagree, 3% agree 4. My manager overlooks patient safety problems that happen over and over. (negatively worded) 63% disagree, 18% agree

Lucian Leape, MD, Harvard School of public Health The single greatest impediment to error prevention in the medical industry is that we punish people for making mistakes. Story of Eric Cropp Healthcare can be safe but not risk-free

Creating an open, fair, and just culture Creating a learning culture Designing safe systems Managing behavioral choices

Every one must report near misses, medication errors and ADRs Data collection leads to the identification of a problem Authorized personnel need to take action on data and provide feedback to reporter

Internally developed system Minimal data is asked in report Used for trending The goals of reporting is to analyze the information and identify ways to prevent future errors from occurring Most staff members provide details in person The reporting of incidents is tied to the annual pharmacist performance review (ADRs, and pharmacist interventions are also included in annual review).

Operations must be solid Analyze categories of interventions Determine if a P & T approved intervention can be endorsed by P & T. It will save time for pharmacists. Example simvastatin and amiodarone interaction pharmacist can decrease dose of simvastatin to 20 mg. Example no baseline INR available pharmacist can order baseline INR if warfarin is needed

Use data to prioritize and improve medication management Transform data into information Reduce variation in med management process Do not be a drip Data-rich, information poor Use the data to prioritize and improve medication safety Use the data to improve processes not punish staff

Anticoagulation INR greater than 5, PTT greater than 120 Digoxin levels above 2 Use of kayexylate Use of naloxone BG levels less than 50

Percentage of digoxin levels above 2 mg/dl 20 Supratherapeutic Digoxin Levels for MSH 2011 18 16 14 12 10 8 6 4 2 0 JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Trigger tool INR > 5 or PTT >120 Monthly review presented to pharmacists, Med Exec team Weight issues scales now locked to kg only Weight must be documented per visit no medications can be verified until the patient s weight is in the demographic area Order form revised Pharmacist reviews, calculates dose, monitors nurse as she programs pump Heparin vials for boluses no longer on units Pharmacy draws up boluses Hand delivered to nurse Heparin drip only stocked in pharmacy

Chemicals in the pharmacy - Glacial acetic acid Oral keterolac Bicillin Propoxyphene/APAP (Darvocet) Rosiglitazone before the FDA s action Heparin variety no 10,000 units/ml vials! 5000 units vial for VTE prophylaxis 1,000 units/ml (10 ml vial) for boluses and HD area 1,000 units/0.5 ml PF for NICU TPNs

Metformin/Metronidazole 500 mg Stocked next to each other Some mistakes did occur in picking ISMP recommends to stock only the metronidazole 250 mg tablets to avoid error Brought issue and resolution to the Med Safety Committee ID physician did not agree to extra pill burden Pharmacy manually highlighted and segregated metronidazole 500 mg until new technology implement (now MedCarousel barcoding)

Administer the drug at a rate no greater than 25 mg/minute. If the patient reports burning at the injection site, stop the IV immediately to evaluate for possible arterial placement or perivascular extravasation FROM ISMP WEBSITE

Removed vials from ADCs, except in ED (for IM only) Built an order set for IV administration only Dispensed from the main pharmacy only Use has decreased

New confused medications now are stocked Communicate with nurses Post flyer on ADC

Colors: Midazolam 2mg/2mL, Lorazepam 2mg/mL, Morphine 2mg/mL, Morphine 10 mg/ml

Streamline stock Design, layout Open line of communication with staff NMB in separate refrigerator Clearly labeled Outsourcing of cardioplegia, PCAs, epidurals, etc. Separate location for pediatric/nicu medications

IV medications are associated with 61% serious and life threatening errors IV push boluses are administered too fast 73% Harmful errors occur most often as the administration phase

The most impactful strategy to improve patient safety Share a story of one patient and how the pump prevented an error from reaching the patient at a staff meeting or morning huddle

Buretrols increase the risk of medication being infused without being properly prepared and labeled in the pharmacy. Smart pumps made buretrols obsolete. Used in OR/PACU area Spoke to stakeholders Agreed to remove stock

No financial commitment Naloxone dilution Clinimix bag activate bag Phenytoin use filter Ampules use filter needle/straw

A two year review of medication errors revealed 12 errors or near-misses Clear and brief alerts were formulated to avoid alert fatigue Alerts addressed: Drug dosing Preparation Administration Appropriateness Peer-checking One year review revealed one error Acetaminophen dose miscalculated, no harm

Fentanyl patches in ED Alteplase 50 mg and 100 mg housewide Atypical antipsychotics depot from Psych unit Pharmacy prepares individual doses in syringe Hand deliver to nurse Parenteral vitamin K (newborn doses are an exception)

Immediate huddle with all involved individuals COO CMO CNO Risk Manager Patient Safety Officer Others depending on error

F = Find a problem O = Organize a team C = Clarify the problem U = Understand a problem S = Select an intervention P = Plan D = Do S = Study A = Act

How will the next patient in your work area be harmed? How can we prevent this harm? Please provide a suggestion or solution to address this issue Ask questions at a staff meeting written - anonymous

Optimize patient labels Organize pediatric stock Use oral syringes Streamline Chemical Stock TALLman lettering implemented in ADC and order entry system

Anesthesia trays look alike labels, sealed with tamper proof tape, high alert labels, quantities determined with OR staff Changed daily Wrapped in plastic Back ups in pharmacy and Anesthesia stock room

Two chamber amino acid and dextrose Needs to be activated (mixed) before infusing Different concentrations Used for day 1 of life for preemies ISMP reported on several cases that occurred Was that ISMP newsletter shared with NICU staff? Did it occur at Mount Sinai? Now an ADC alert and picture of activation in ADC

95% NICU, 5% Adult Review order form first Is all pertinent labs/information on form? Analyze one month s worth of forms Did any patient develop high triglyceride? Overfeeding? Refeeding syndrome TPN panel in lab can now be ordered

Outsource High Risk Compounds Heparin 2 units/ml NICU Epidurals Fentanyl drips PCAs morphine and hydromorphone

Infusion bags are not stocked on unit Heparin boluses drawn up in Pharmacy and hand delivered to the nurse Pharmacists also dose heparin and monitor PTTs

PCA Argatroban Alteplase for vascular patients Heparin for vascular patients

Medications that have the highest risk of causing injury when misused are known as high-alert medications. The top five high-alert medications identified by the ISMP study are insulin; opiates and narcotics; injectable potassium chloride (or phosphate) concentrate; intravenous anticoagulants (heparin); and sodium chloride solutions above 0.9 percent.

ISMP Sound-alike Look-alike Highlighted in med rooms Note on MAR and labels Note on Med Carousels Note on ADC pockets

Proper destruction of patches ISMP articles Policy FDA alert about patches and burns Fentanyl, scopolamine, clonidine, nicotine, etc Built in the CPOE system ADC alert Flyers in MRI suite

Individualized doses Batched in pharmacy Protects patients from over dosing on long acting and intermediate acting insulins Saves money

Implemented several hard stops in CPOE Pregnant status and statins, warfarin, sedatives Beer s criteria STARRT and STOPP Black box warnings CrCl with antibiotics Metformin Glyburide Glipizide in patients over 65 year Zolpidem dose in over 65 years old patients

Anna s slide

One hour session discussing Medication Safety Powerpoint presentation for new pharmacy employees detailing our common errors Sign off for accountability Pharmacy resident and pharmacy manager prepared it Took about two hours total time to prepare presentation with pictures One hour session on USP 797

Reviewed at Med Safety Committee Prepared by PGY1 resident

US FDA Patient Safety News videos on youtube 2 minute videos Mistakenly swallowing Spirvia and Foradil capsules Mix-up between Insulin U-500 and U-100 Preventing dosing errors with alteplase Reporting adverse events to FDA Medwatch Beyond Blame video from ISMP 8 minute video

Outpatient areas Imaging Department Cath Labs Hemodialysis center Inpatient areas where there is no pharmacist assigned to the unit

Assign each pharmacist a topic per year to own and work on during slow times Due date prior to annual review Each gets a standing order assigned to them Each gets a policy to update/ keep current Let them choose a topic of their interest Lead a journal club Organize an area in pharmacy peds, liquids, prepacking, chemo, IV, overstock, supplies, perform sterile technique assessment of techs, etc.

Standing Items ADRs Anticoagulation ADEs and other ADEs Medication errors FDA warnings Actions taken at Sinai Health System IS corner CPOE improvements

My soldiers at the frontline Deputized and entrusted Report back to me if they can not handle an issue Rely on quick feedback and communication Leader competency and trust

IOM To Err is Human ismp.org patientsafetyauthority.org npsf.org cdc.gov fda.gov asmso.org

Statewide mandatory reporting began in June 2004 for hospitals, ambulatory surgical facilities and birthing centers. A few examples below: Anticoagulation Management Service Clostridium Difficile Strategies Contrast-Induced Nephropathy Diagnostic Error Falls in Radiology HYDROmorphone Risk Reduction Insulin Therapy Managing Clinical Emergencies Patient Flow in the Emergency Department Patient Safety Practices Verbal Orders

Nurse AdvisERR Acute Care Quarterly report ASSESS-ERR worksheet

STERILE WATER FOR IRRIGATION Could not eliminate it

Shared mental model Relationships Respectful Make the right connections/contacts Good observers/listeners Choose the low hanging fruit first Builds credibility Celebrate small successes with staff. It will motivate the staff for bigger initiatives.

Status quo is not acceptable Take some action.any action Commit to make a change Consider one project every six months or even year..multiply by the number of pharmacists The patient is at the center of everything that we do! By failing to prepare, you are preparing to fail. Benjamin Franklin

Special thanks to the pharmacy staff for continuously providing ideas on improving medication and patient safety Safety begins with you! Every one owns quality and safety.

Challenge too much to do! Resolve missing medication conundrum More clinical services Initiate ambulatory care pharmacist roles Disease state education to patients asthma, diabetes, HF Implement iv room software FMEA on implementing new iv room technology Build new library for pediatric syringe pump Re-design medication rooms using lean methodology Fully implement TeamSTEPPS & CUSP Imaging dyes dosing tables Fully implement culture of safety Integrate smart pumps with CPOE Roll out CPOE in ED and Peds Implement EMAR house-wide Become 100% cartless Implement scanners at ADC Pharmacist driven Med Rec Utilize lean methodology in central pharmacy processes Shadow nurses on each unit performing medication pass one unit/month Focus on areas where no pharmacist is present IR, imaging, Cath lab, GI lab, etc Join Morbidity and Mortality discussions ICD 9 Codes for Medication Related ADRs Pharmacist to monitor vanco, AMG, warfarin