Medication Safety & Quality Improvement

3 Categories of transmission-based precautions by CDC

1. **Contact precautions 1) Intended to prevent transmission of infectious agents a. spread by direct & indirect contact b. w/ the pt and pt's environment 2) *single pt rooms are *preferred a. if not available, keep >/= *3 feet spatial separation b/t beds b. to prevent inadvertent sharing of items b/t pts 3) Healthcare personnel caring for these pts wear a gown & gloves for all interactions 4) contact precautions are recommended - for pts colonized w/ MRSA & VRE 2. **Droplet Precautions 1) Intended to prevent transmission of pathogens spread through close *respiratory contact w/ respiratory secretions 2) single pt rooms are preferred - if not available, keep >/= 3 feet spatial separation and drawing a *curtain b/t beds - esp. important for dz transmitted via droplets 3) Healthcare personnel wear a *mask for close contact w/ pt a. *mask is donned upon entry to the pt's room b. a *respirator is *NOT necessary 4) Droplet precautions are recommended - for pts w/ a. active B. pertussis b. influenza virus c. adenovirus d. rhinovirus e. N. meningitides f. group A strep - for the first 24 hrs of antimicrobial tx 3. **Airborne Precautions 1) Intended to prevent transmission of infectious agents a. that remain infectious over *long distances b. when suspended in the *air 2) Pt should be placed in an *airborne infection isolation room (AIIR) a. a single pt room b. equipped w/ *special air and ventilation handling pressure rooms c. the air is *exhausted directly to the *outside or re-circulated through *HEPA filtration b/f return 3) healthcare personnel wear a *mask or *respiratory (N95 level) - donned prior to room entry 4) Airborne precautions are recommended - for pts w/ a. rubella virus (measles) b. varicella virus (chickenpox) c. M. tuberculosis

Look Alike-Sound Alike

1. **Tall Man Lettering - *TJC requires tall man lettering 2. **ISMP list is used as the *Gold Standard

ways to reduce errors associated with look-alike names

1. *Changing the drug names (by FDA or the manufacturer's initiative) if drug mix-ups have occurred. 2. Using "**TALL Man" lettering, - to help avoid confusion between the two drugs. - for example writing glipiZIDE and glyBURIDE 3. Including *both brand and generic names on the prescription. 4. *Spelling out the drug name on a *verbal order. 5. Putting the *indication on the prescription.

**Methods to decrease Medication Errors

1. *MTM 1) Comprehensive medication review (CMR) 2) Patient medication record (PMR) is prepared 3) Medication-related action plan (MAP) is developed 4) Targeted pts a. w/ multiple chronic conditions b. taking multiple drugs c. likely to incur annual costs for covered drugs that exceed a predetermined level 5) Goal a. to improve non-adherence b. to identify cost-savings - switches to generics or more affordable brands - suggesting pt assistance programs or low income subsides 2. *Medication reconciliation 1) Per TJC - Med Rec is the process of comparing a pt's medication orders to all of the meds that the pt has been taking 2) done to avoid med errors a. omissions b. duplications c. dosing errors d. drug interactions 3) should be done at every transition of care and at discharge 3. *Barcoding 1) most important medication error reduction tool available 2) Barcode follows the drug through the medication use process 3) automatically populate on the medication administration record 4. *LASA/High-Alert Drugs 1) should be stored in different locations w/in pharmacy or ADC 2) Alert, ideally pop-ups that require a confirmation when meds w/ high potential for mix-up in a given setting - can reduce error risk 5. *DNU abbreviations 1) Abbreviations are unsafe and contribute to many medication errors 2) TJC standards include recommendations against the use of unsafe abbreviations 6. *COPE 1) allow direct entry of medical order by prescribers 2) minimize the ambiguity resulting from handwritten orders 3) greater benefit w/ combination of - COPE + clinical decision support (CDS) tools 4) include standard order sets and protocols 5) clinical guidelines and pt labs can be built into CPOE 6) alerts can notify a prescriber if inappropriate or unsafe 7) pharmacists are actively involved in creating, updating and monitoring the CDS tools 7. Other 1) Include indications for use and proper instructions on prescriptions a. help pharmacists ensure appropriate prescribing and drug selection - if a pharmacist does not know the indication for med --> should contact prescriber b. "as directed" is not acceptable 2) Use of Metric system 3) do not rely on medication packaging for identification purpose - look alike packaging can contribute to errors 4) Avoid multiple-dose vials if possible a. pose risk for cross-contamination and over-dosing b. if used, - should be designated for a single pt and labeled appropriately 5) Use safe practices for emergency medications/crash carts a. staffs must be properly trained to handle b. the meds should be unit-dose and age-specific c. should be stored in sealed and locked containers in a locked room 6) Dedicated pharmacists to the ICU, Pediatric units and ED 7) Monitor for Drug-Food interactions routinely 8) Education

Sharps Disposal

1. *Never compress the contents of a sharps container. 2. Do *not remove the needle - the syringe, with needle attached, - should be dropped into a sharps container. 3. If it is about *3/4 full, replace with a new container. 4. If the facility has syringes that draw the needle back into the barrel, or cover the needle with a protective cap after use, - this is preferable to reduce the risk of needlestick injuries.

Common types of Hospital (Nosocomial) Acquired Infections

1. *UTIs 1) from indwelling *catheter (very common) - remove catheter as soon as possible 2) prevent CAUTI is one of TJC's NPSG 2. *Blood stream infections from 1) *IV lines - central lines have highest risk 2) *catheter 3. *Surgical site infections 4. Decubitus ulcers 5. Hepatitis 6. **C. difficile, other GI infections 7. *Pneumonia (mostly d/t *ventilator use), bronchitis

Causes of Medication errors

1. *most common cause of medication errors 1) NOT individual error 2) but problems w/ the design of the medical **system itself 2. Goal - to prevent medication errors from reaching a pt

Sentinel event

1. *unexpected occurrence involving *death or *serious physical or psychological *injury or risk thereof. 2. Sentinel events often refer to a death in the institution, but the definition is more broad.

Joint Commission's National Patient Safety Goals that focused on the safe use of antithrombotics

1. A baseline INR and regular (current) INR - should be available for all patients using warfarin. 2. A warfarin prescribing *protocol should have been in place that included an appropriate *starting dose. 3. The *Dietary Department should be notified of all patients receiving warfarin. 4. If a physician orders a warfarin dose *out of the hospital's protocol, a pharmacist must *verify the dose. 5. A CPOE system could have *alerted the prescriber or pharmacist that the dose was high or that an INR was not performed.

Patient Counseling

1. An educated patient will often know 1) if the drug is not working, 2) if it's toxic, 3) if, by chance, they are given the wrong medication. 2. The more the patient knows, the more equipped they will be to help 1) reduce the risk of medication errors 2) increase medication efficacy and safety. 3. The majority of dispensing errors are not detected by the pharmacist during the final check but are *detected during *counseling. - Counseling protects patients and the pharmacist.

High-alert meds

1. Any "high alert" drug, including insulin, can be placed in a *brightly colored bin with *warnings on the front. - 2. Items that should be dispensed with the drug, 1) *MedGuides or oral syringes, 2) can be placed inside the bin. 3. *Warnings on the front of the bin could include 1) alerts for *name mix-ups, 2) alerts to check *mg/kg weight (if applicable), and 3) other notices. 4. Medications that are often mixed up should be physically *separated in the pharmacy (not side-by-side on the shelf, for example). 5. High-alert Meds 1) Insulin is high risk - d/t hypoglycemia 2) opioids - d/t respiratory depression 3) anticoagulants - d/t bleeding risk-or clot risk if under-dosed 4) sedatives - d/t risk of over-sedation, hypotension, delirium and respiratory depression)

Barcode

1. Barcodes may be the **most important medication error reduction tool we currently have. 2. Barcodes help us ensure - the *right drug is going to the *right patient. 3. Barcodes are becoming ubiquitous. 4. They provide a medication use *trail, - which improves the medication use process. 5. They are likely very **cost-effective, - given the number of errors they prevent. 6. Barcodes are also used on *pumps and with *IV infusions. 7. Bar coding is having a "UPC" symbol 1) on each unit-dose (single dose in a small package) 2) on a syringe or IV piggyback (whatever the patient will receive). 8. Prior to giving the drug to the patient, 1) the drug and the patient's wristband is scanned with a hand-held scanner. 2) If the patient does not have that drug and dose on their profile, --> the scanner will "beep" and alert the nurse not to give the drug.

CPOE

1. CPOE allows *direct entry of medical orders. 1) It helps reduce errors by minimizing the ambiguity of hand-written orders 2) but a much greater benefit is seen with the combination of CPOE and *clinical decision support tools (such as the inclusion of protocols for the safe use of antithrombotics) and *labs. 2. Some of the CPOE design (and in some settings most of it) is intended to direct the prescriber towards the preferred (often less expensive) medications.

DUE

1. DUEs are **retrospective analyses of 1) patient drug usage 2) of physician prescribing habits 3) pharmacy dispensing activities. 2. They can be used to *identify problems or lapses that can be targeted for *interventions. 3. They can be helpful 1) in guiding therapy to guidelines 2) in saving money 3) both.

At-Risk Behavior that can compromise patient safety

1. Drug and Patient-related 1) failure to check/reconcile home meds and doses 2) dispensing meds w/o complete knowledge of the med 3) Not questioning unusual doses 4) Not checking/verifying allergies 2. Communication 1) Not addressing questions/concerns 2) Rushed communication 3. Technology 1) Overriding computer alerts w/o proper consideration 2) Not using available technology 4. Work environment 1) Trying to do multiple things vs focusing on a single complex task 2) Inadequate supervision and orientation

High-Alert Drugs

1. Drugs that bear heightened risk of causing significant pt harm when used in error 2. Examples 1) insulin 2) oral hypoglycemics 3) anticoagulants 4) concentrated electrolytes - injectable KCl - phosphate - Mg - hypertonic saline 5) antiarrhythmics 6) anesthetics 7) chemotherapeutics 8) opioids 9) inotropic medications 10) epidural/intrathecal meds 3. *ISMP "high-alert" list represents 1) the *most common agents that are high risk 2) but an *institution's list may include *additional drugs - based on experience in that setting 4. High-alert meds can be used more safely by 1) developing *protocols or *order sets for use 2) using *premixed products 3) *limiting concentration 4) *stocking high-alert products only in the pharmacy

Errors of Omission and Commission

1. Error of Omission 1) Something was left out that is needed for safety 2) example - failing to warn a pt about an important SE w/ a new med 2. Error of *Commission 1) something was done *incorrectly 2) example - prescribing bupropion to a pt w/ a hx of seizures

Hazardous Drugs that require special handling to avoid toxicity

1. Hazardous drugs are 1) teratogenic 2) carcinogenic 3) genotoxic - damage DNA and can cause cancer 4) Have reproductive toxicity 5) cause organ toxicity at low dose 2. Drugs 1) All pregnancy category X drugs, many category D's and few C's 2) chemotherapy drugs 3) 5-alpha reductase inhibitors - durasteride - finasteride 4) hormones - contraceptives - estradiol - testosterone 5) transplant drugs - mycophenolate - tacrolimus - cyclosporine - everolimus - sirolimus 6) others - colchicine - dronedarone - fluconazole - MTX - misoprostol - mifepristone - paroxetine - spironolactone - ribavirin - risperidone - raloxifen - rasagiline - ziprasidone

Response to Medication Errors

1. Internal notification - who should be *notified w/in the institution and w/in what *time frame? 2. External reporting - Who should be *notified outside of the institution? 3. Disclosure 1) what information should be *shared w/ the pt/family? 2) who will be *present when this occurs? 4. Investigator - what is the process for immediate and long-term internal investigation of an error? 5. Improvement - what process will ensure that immediate and long-term preventative actions are taken?

Reporting

1. Medication errors should be *reported 1) changes can be made to the system to *prevent similar errors 2) *w/o reporting a. may go unrecognized and will likely happen again b. b/c others will not learn from the incident 2. In community pharmacy 1) the staff member who discovers error should *immediately report it to a. the corporate office b. the owner (regarding independent pharmacy) - who is involved w/ the **QA program 2) to *develop pharmacy system and workflow processes designed to *prevent medication errors 3) error ***investigations need to take place quickly - w/in ***48 hrs 4) ethical requirement - errors be reported to *pt and *prescriber as soon as possible 3. In hospital setting 1) the staff member should report the medication error a. through hospital's specific medication event reporting system b. electronic but some still maintain a paper reporting system 2) The hospital's P&T committee and Medication Safety Committee - should be informed of the error

PCA

1. PCA devices contain 1) *narcotics 2) sometimes, *anesthetics used for synergy. 2. The set-up, maintenance and education involved with these devices requires **coordinated health care teams. 3. PCAs enable the patient to treat *severe pain at the *onset - results in *lower doses required. 4. **cost-effective. 5. beneficial when PCAs can be used for *post-op pain control. 6. Educate staff about morphine and hydromorphone mix-ups; - Hydromorphone is about 6 times as potent as morphine. 7. Friends and family members can*not give PCA doses 1) TJC does not permit it. 2) In some cases (such as with neonates) there may be exceptions, but not in adults. 8. Need to *assess pain, sedation and respiratory rate - on a scheduled basis in all patients receiving opioids from a PCA. 9. *Not all patients may be appropriate candidates for PCAs. 10. *Barcode technology may help *reduce dosing errors associated with PCAs.

Medication Reconciliation

1. Patients admitted to a hospital commonly receive new medications or have changes made to their existing medications. 2. As a result, the new medication regimen prescribed at the time of discharge may inadvertently *omit needed medications that patients have been receiving for some time. 3. Medication reconciliation refers to the process of avoiding these problems across transitions in care 4. by reviewing the patient's complete medication regimen 1) at the time of admission 2) transfer 3) discharge --> comparing it with the regimen being considered for the new setting of care.

Medication Error

1. Per NCC MERP "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer" 2. Include errors made in 1) prescribing 2) order communication 3) product labeling and packaging 4) compounding 5) dispensing 6) administration 7) education 8) monitoring #ADRs - not avoidable --> it's different from medication errors # sentinel events - unexpected occurrence involving death or serious physical or physiological injury or risk thereof

for patients to *return used sharps

1. Pharmacies 2. Police and fire departments 3. Public *drop boxes and *mail boxes 4. Hazardous waste *pick-up days or collection sites - Wherever the patient is working, he/she will need to know where local residents are supposed to bring sharps. - In many communities there exists residential hazardous waste pick-up where home users place the used sharps in a special "sharps" container and, much like a recycling container, it is set outside for pick-up by special waste handlers.

help avoid incorrect use of antithrombotics

1. Require the use of *protocols that include 1) recommended dosing 2) any dosing outside the protocol recommendations must be justified and approved by a pharmacist. 2. Monitor INRs 1) at baseline 2) at scheduled intervals - which should be indicated on the protocol. 3. Use programmable pumps for heparin (i.e., not gravity drips). 4.Educate patients and families on correct use of the medications. Involve dietary team when inpatients are involved. 5. Have a pharmacist monitor each patient taking warfarin daily to assess for drug interactions and appropriateness of dose.

Evaluating Medication Errors and Quality Improvement

1. Root Cause Analysis (*RCA) 1) *retrospective investigation of event that has *already occurred 2) reviewing the *sequence of events that led to error 3) used to *design changes that will hopefully prevent future errors 4) Findings from RCA can be applied *proactively to analyze and improve processes and systems b/f fail again 2. Targeting *corrective measures at identified root causes 1) to prevent similar problems from occurring in the future 2) complete prevention of recurrence by a single intervention is NOT always possible --> *repetitive process --> viewed as *continuous quality improvement (CQI) tool 3. analysis can be done **prospectively 1) to identify pathways that could lead to errors 2) to identify ways to reduce the error risk 3) Failure mode and effects analysis (***FMEA) a. a *proactive method b. used to *reduce frequency and consequences of errors c. used to *analyze the design of the system - to evaluate the *potential for failures - to determine what *potential effects could occur i. when med delivery system changes in any substantial way ii. if a potentially *dangerous new drug will be *added to the formulary

*Organizations that are involved in medication safety

1. The American Society of Health-System Pharmacists (*ASHP) 2. The Joint Commission (*TJC) 3. The Institute for Safe Medication Practices (*ISMP) 4. The Institute of Medicine, The Agency for Healthcare Research and Quality (*IOM; AHRQ) 5. The Food and Drug Administration (*FDA)

Organizations involved in improving medication safety

1. The Joint Commission (TJC) 2. Institute for Safe Medication Practices (ISMP)

Reporting to Organizations that Specialize in Error Prevention

1. The Patient Safety and Quality Improvement Act of 2005 (*Patient Safety Act) 1) authorized the creation of Patient Safety Organizations (PSOs) 2) to improve the quality and safety of health care delivery in US 3) encourage the clinicians and healthcare organizations to **voluntarily report and share quality and patient safety information - *w/o fear of the information being used in *legal proceedings 2. Organizations that specialize in error prevention 1) can analyze the system-based caused of errors 2) make recommendation 3. *ISMP National Medication Errors Reporting Program (*MERP) 1) a confidential national **voluntary reporting program 2) provide expert *analysis of system causes of medication errors 3) disseminates *recommendations for prevention 4) on ISMP website - medication errors and close calls can be reported 5) *Professionals and *consumers should be encouraged to report medication errors using this site - even if the error was reported internally 6) when there are *many report of a particular error, a. manufacturer may take measures to increase safety b. e.g. REMS program, name change, packaging change, etc 4. every pharmacist should read medication error reports and improve their own practice setting

Do Not Use List by *TJC

1. U, u (unit) 1) Potential problem - Mistaken for "0" (zero), the number "4" (four) or "cc" 2) Use Instead - Write "unit" 2. IU (international unit) 1) Potential problem - Mistaken for IV (intravenous) or the number 10 (ten) 2) Use Instead - write "international unit 3. Q.D., QD, q.d., qd (daily) Q.O.D, QOD, q.o.d, qod (every other day) 1) Potential problem - Mistaken for each other - period after Q mistaken for "I" and the "O" mistaken for "I" 2) Use Instead - write "daily" "every other day" 4. Trailing zero (X.0 mg) Lack of leading zero (.Xmg) 1) Potential problem - decimal point is missed 2) Use Instead - write "X mg" "0.X mg" 5. MS MSO4 and MgSO4 1) Potential problem - Can mean morphine sulfate or magnesium sulfate - confused w/ one another 2) Use Instead - write "morphine sulfate" " magnesium sulfate"

The Joint Commission (TJC)

1. an *independent, *non-for-profit organization 2. **Accredits and *Certifies - healthcare organizations and programs in US 1) hospitals 2) healthcare networks 3) long-term care facilities 4) homecare organizations 5) office-based surgery centers 6) independent laboratories 3. Focus on the highest quality and safety of care 4. *Set standards that institutions must meet to be accredited 5. Accredited organization must undergo an ***on-site survey 1) at least **Q3 yrs 2) surveys can be *unannounced 6. National patient safety goals (*NPSGs) are set *annually by TJC 1) for different types of healthcare settings 2) in order to improve pt safety 3) each goal includes a. defined measures called "Elements of Performance" b. *must be met ==> will be included in the institution's protocol

Failure modes and effects analysis (FMEA)

1. analysis done ***prospectively 1) can identify pathways that lead to errors 2) find ways to help prevent future error 2. a *step-by-step approach for identifying all *possible ways in which something might fail. 3. FMEA is used in *different industries. - In pharmacy, it is used to *reduce medication errors.

The alcohol-based hand rubs

1. in general, 1) **more effective 2) do not dry the hands as soap can. 2. They should be used 1) when the hands are *not visibly soiled 2) before putting on gloves 3) after contact with a patient if the hands are not visibly soiled 4) after removing the gloves. 3. They do **not kill *spore-forming bacteria like **C. difficile.

The National Patient Safety Goals (NPSGs)

1. set *each year 2. available for *inpatient and *outpatient settings. 3. **TJC sets goals each year to improve patient safety. 1) reducing the incidence of health-care associated infections a. catheter infections, b. IV line infections, c. pneumonia from ventilators 2) maintaining accurate patient information including a. conducting medication reconciliation b. providing information to patients, c. discharge counseling on their medications before they leave the facility), and others.

purpose of the FDA *REMS program

1. to ensure that the benefits of dangerous drugs outweigh the risks. 2. The FDA requires certain high-risk drugs to implement a Risk Evaluation and Mitigation Strategy (REMS) from the manufacturer 1) to ensure that the benefits of a drug or biological product outweigh its risks. 2) REMS drugs have *specified training and various *restrictions - (patient requirements, user registries, etc) 3) to ensure that the use meets the *safety requirements. - the Clozapine REMS - the iPLEDGE program for isotretinoin

Patient Controlled Analgesia (PCA)

1. to treat pain *quickly - no need to call nurse and wait for the dose to arrive 2. allow the administration of *small doses - can *reduce SEs (particularly over-sedation) 3. PCA drug can *mimic the pain pattern more closely and provide *good pain control 4. PCA is administered w/ *anesthetics for a *synergistic benefit 5. PCA Safety Considerations 1) the device can be complex and require set-up and programming a. significant cause of preventable medication errors b. should be used *only by *well-coordinated healthcare teams 2) pts should be *cooperative and should have a *cognitive assessment prior to use PCA - to ensure they can follow instructions 3) *Friends and family members should *NOT administer PCA doses - per *TJC requirement 4) PCA do NOT frequently cause *respiratory depression but risk is present a. advanced age b. obesity c. concurrent use of CNS depressants ==> increase risk 6. PCA Safety Steps 1) *Limit the opioids available in floor stock a. use *order sets b. *not over-dose 2) *Educate staff 3) Implement PCA *protocols a. include **double-checking of drug, pump setting, dosage b. conc on MAR should match the PCA label 4) Use *barcoding technology - ensure the right pt is getting the med 5) *assess pt's pain, sedation, and RR on a *scheduled basis

the most *common type of medication error

Half of the legal claims against pharmacists are for dispensing the *wrong drug and about 25% are for dispensing the *wrong strength.

Select National Patient Safety Goals

NPSG 01.01.01 "Use at least **2 pt identifiers when providing care, tx and services" - appropriate pt identifiers a. Name b. Medical record # c. DOB NPSG 02.03.01 "*Report critical results of tests and diagnostic procedures on a *timely basis" 1) include lab & BCx results 2) protocol must stipulate acceptable length of *time for reporting NPSGT 03.04.01 "*Label all meds, med containers, and other solns on and off the sterile field in perioperative and other procedural settings NPSG 03.05.01 "Reduce the likelihood of harm associate w/ *anticoagulant therapy 1) use standardize dosing *protocols 2) use programmable *pumps for heparin 3) provide *education to pts and families NPSG 03.06.01 "Maintain and communicate accurate pt med information" 1) Medication Reconciliation 2) provide *written information to pt 3) conduct *discharge counseling NPSG 07.01.01 "Comply w/ the Centers for Disease Control (CDC) *hand hygiene guidelines NPSG 07.03.01 "Reduce *health-care associated infections" w/ MDR organisms 1) e.g. MRSA, CDI, VRE, MDR GN bacteria 2) elements of performance address care of central lines, bloodstream infections and post-surgical infections - catheter-associated UTIs

National Patient Safety Goals (NPSGs)

The National Patient Safety Goals are developed annually and are specific to the institution type. 1. Improving the way antithrombotics are used 2. Improving the use of patient identifiers 3. Improving medication labeling in perioperative settings 4. Improving the timely reporting of critical lab results 5. Compliance with CDC hand hygeine guidelines