Basic Error Prevention, Errors of Omission & REMS Programs

ISMP’s Medication Error Prevention ‘Toolbox’

• ISMP published a toolkit to help provide guidance to pharmacists looking for ways to decrease their risk of medication errors.

• ISMP Tips:

  • Forcing functions and constraints (i.e. removing potassium chloride vials from all patient care areas, using specially designed oral syringes that cannot be connected to parenteral lines)

  • Automation and computerization (i.e. Computerized Physician Order Entry [CPOE], drug information systems, fail-safe design mechanisms on IV pumps)

  • Drug protocols and standard order forms (standardize safe order communication)

  • Independent double check systems and other redundancies (don’t check your own work)

  • Rules and policies (these should be used to support more effective error prevention strategies rather than to control people’s actions)

  • Education and information (important to reducing errors, but CANNOT be used alone)

Basic Error Prevention Strategies

• Minimize clutter

• Use barcodes

• Don’t do every step on your own

• Involve the patient

• Trust your gut

• Be proactive

• Track errors

Minimize Clutter

• Counter Tops

  • Clean off the counter tops of any unnecessary

    paperwork, notes, supplies, etc. at the end of

    each day to ensure you start as clutter free as

    possible in the morning

• Work Stations

  • Work stations should only have the necessary

    tools to complete the processes needed.

    Example: Verification station, doesn’t need all

    sizes of vials readily available

• Patient Care Areas

  • Patient care areas should have minimal

    clutter. Vaccine/medication administration

    areas should have only the necessary

    supplies and emergency medical kit.

• Electronic Clutter

  • EMRs are vast resources, but unnecessary

    information in patient notes or charts can make

    it hard for others to find the required

    information. Keep it brief.

Use Barcodes

• Do NOT use workarounds

  • Scan every vial

  • Do not keep lists of barcodes for commonly used medications handy, scan the actual vial

  • Do not scan the barcodes out for 5 patients and then go back and fill all the prescriptions

• Patients and Medications have barcodes

  • Use your barcodes

Don’t do every step on your own

• You are not alone, rely on your people

  • Compounding products, filling prescriptions, batch prepping IV’s, whatever the task is, try to share the workload

• Try not to check your own work when possible*

  • Are you working with another pharmacist? Have them check the work that you completed and vice versa.

  • It is not always possible, but extra diligence should be used when doing the entire process on your own.

Involve the patient

• Does the patient know what medications they take?

  • Involving the patient or caregiver in medication dispensing process (At pick-up) can reduce errors

• Does the patient know what medical conditions they have?

  • Is your medication list missing or have extra medications based on the indications

Trust your gut

• You have spent a long-time preparing to or being an active pharmacist

  • If something seems off…Ask

  • If something doesn’t make sense…Ask

  • If something seems strange…Ask

Be proactive

• Stay on top of tasks

• Don’t be afraid to be the first at completing a task, or asking questions

• Can you work ahead and NOT effect the quality of patient care

Track errors

• Error reporting is an important part of error prevention

• Go above reporting errors, ensure you follow up to see what happened

Common Prescription and Transcribing Errors

• Errors of Omission: Leaving out crucial information

• Can be seen in variety of healthcare settings

  • Prescribing, transcribing, medication labels, patient charts

Abbreviations

• Do they actually save time?

• Potentially for someone writing the order…but on the other side the abbreviation can be misinterpreted or cause confusion

Stemming

• Creating shortened versions of drug names that are easily misinterpreted

• Ex:

  • A physician ordered Rheomacrodex (a low molecular weight dextran) called the order to a nurse as “Rheo 10 cc/hr”

  • The nurse interpreted the order as ReoPro (abciximab) 10 cc/hr and immediately transcribed the order without verifying with the physician through reading it back.

  • Pharmacy processed the order, and the patient received the incorrect drug for over 24 hours (no harm to the patient in this case)

Abbreviations that should NOT be used:

• Abbreviations for drug names

• Any abbreviation for the word daily

• The letter U in place of ‘unit’

• ‘µg’ for microgram (use mcg)

• ‘sq’ or ‘sc’ for subcutaneous (use subcut)

• ‘a/’ or ‘&’ for the word ‘and’

• ‘cc’ for cubic centimeter (use mL for milliliter instead)

• ‘D/C’ for either discontinue or discharge

Weight, Volume, and Units

• Prescribers should use the metric system to express all

measurements rather than the outdated apothecary

system

• USP does not recognize the apothecary system

• Weight:

  • Apothecary: dram (3) mistaken for tablespoon (T), grain (gr)

  • Metric: gram (g)

• Volume:

  • Apothecary: minims

  • Metric: milliliter (mL)

• Units

  • Apothecary: one-half (ss)

Decimals and Spaces

• Major source of errors

• Easily missed, especially on lined order sheets, carbon copies, or faxes

• Avoid using decimal places when not mandatory

  • Examples:

    • 500 mg instead of 0.5 g

    • 125 mcg instead of 0.125 mg

• Leading Zeros

  • NEVER leave a decimal point “naked”

  • Always use a decimal point for a valueless than 1

  • Example: 0.1 (not .1)

• Trailing Zeros

  • NEVER use a trailing zero (zero behind a decimal point) when not necessary

  • Example: 10 (not 10.0)

Incomplete Orders

• Prescribers can leave off vital information on a prescription/order

  • Route of administration

  • Strength of medicaion

  • Quantity

• Some orders are incomplete due to vagueness

  • “Continue all medications”

  • “Resume all home medications”

• Examples:

  • “Tylenol 2 tabs prn for pain”

  • “10 of insulin“

  • “give an amp of magnesium sulfate”

Unreconciled Medications

• Institute for Healthcare Improvement

  • Poor communication of medical information at transition points is responsible for up to 50% of all medication errors and up to 20% of adverse drug events in hospitals

• JCAHO (Joint Commission) and National Patient Safety Goal (NPSG)

  • Requires hospitals to reconcile medications across the continuum of care

  • Medication Reconciliation is a NPSG for hospitals, ambulatory care, assisted living, behavioral health, home care and long-term care organizations. NPSG 03.05.01

‘Hold’ Orders

• Errors are likely when orders are placed on ‘hold’ with no explicit directions for restarting

  • Medication may:

    • Inadvertently not be resumed

    • Resumed too soon

• If orders do not have explicit resume instructions, medications should be discontinued

  • Medications can be easily forgotten about, and not re-started when appropriate

  • Some systems can generate daily summary of current prescribed therapies and recently discontinued medications

Legibility

• Poorly written orders can delay administration of medications, and delay overall care of the patient

• When clarifying orders due to poor handwriting, workflow is interrupted which increases the chance of errors

• In 90,000 malpractice claims over a 7-year period, misinterpreted prescriptions ranked second in expense and prevalence

• Penmanship, Computerized Physician Order Entry (CPOE), Preprinted/Standard Order Sets

Standardized Order Sets

• Goal → not only to avoid illegible handwriting, but to reduce variation in how care is provided to patients

• Considerations

  • Should be based on institution or department (NOT individual prescribers)

  • Printed forms providing a list of medications to choose from should be avoided (easy to circle the wrong drug)

  • Often include medications that cover all possible scenarios, and every patient might not need every medication option

Spoken or Verbal Orders

• Avoid when possible

  • Errors are likely to occur when an order is spoken by one person and transcribed by another

  • A pharmacist receiving a verbal order from a nurse must assume that the nurse heard the prescriber correctly and is pronouncing everything correctly

• Fraudulent Orders

  • Lay-person may attempt to call in prescription for medication (often a controlled substance)

  • Be suspicious when an unfamiliar prescriber calls in a prescription

    • Always get a call-back number

    • Can verify number matches medical directories or can call the office back to confirm the prescription is valid if there is concern

Spoken or Verbal Orders — Suggestions for Reducing Errors

• Limit spoken orders to those for true emergencies or when the prescriber is physically unable to send a written form

• Always read-back spoken orders to confirm prescription

• When reading back spoken orders, confirm the dose by expressing the number as single digits

• Prohibit certain high-alert medications from spoken orders

• Have a second person listen to spoken order when possible

• For all neonatal and pediatric prescriptions, require the milligram per kilogram dosage along with the patient-specific dose

• Both prescriber and receiver should spell unfamiliar drug names using “T as in Tom”

• Immediately transcribe spoken orders to prescription or patients chart (using scrap paper creates another opportunity for error)

Sample Medications

• Samples are usually dispensed prior to computerized safety checks such as drug interactions, duplicate therapies, allergies and contraindications

• Often dispensed by physicians without an independent double check by another health care professional

• Patient might not receive any written instruction on how to take the medication or may be written on a separate form and not near the medication

• Packaging of samples can be confusing

• Can be overlooked in drug recalls and regular checks of expiration dates

• Unsecured storage of samples allows unauthorized access to prescription and nonprescription drugs

Second Victim

Second Victim Syndrome (SVS) → phenomenon of a clinician becoming victimized by an unanticipated adverse medical event (patient is primary victim, clinician is affected secondarily)

The 5 Rights of Second Victims

• Treatment that is Just

• Respect

• Understanding and Compassion

• Supportive Care

• Transparency and the Opportunity to Contribute

Treatment that is Just

Just Culture uses a non punitive approach of response that can lead to improving the system that allowed the error to occur

Respect

ALL members of a healthcare team are susceptible to errors. Easy to fall into the name-blame-shame cycle which denies colleagues basic respect and decency

Understanding and Compassion

“the very instant preventable and unintentional harm occurs to a patient, their caregivers become patients” –Julie Thao. Caregivers need time to grieve and work through stages (denial, anger, bargaining, depression, and acceptance)

Supportive Care

Caregiver are entitled to psychological support and services

Transparency and the Opportunity to Contribute

Patient safety will be better if caregivers can be more honest and transparent with patients, colleagues and themselves. Risk Management Basics: error prevention is linked to learning from errors (Errors must be reported)

What can we do to help second victims?

• Stage 1: Emotional first aid provided by a trusted colleague or mentor

• Stage 2: Support by trained peers

• Stage 3: Support by mental health professionals

Stage 1: Emotional First Aid

• Involves a post-incident immediate discussion to allow the involved (if desired) to debrief in time following the incident before returning to work

• The trusted colleague or mentor should strive to normalize the providers feelings by recognizing that all providers are human, feel bad about mistakes and suffer when these events occur

Engaging in Effective Emotional First Aid

• Be in a private place away from the clinical event as soon as safely possible

• Use open ended questions like “How are you feeling?” or “Do you want to talk about it?”

• Listen and allow them to control the conversation

• Give the provider time alone to collect their thoughts before returning to clinical duties

  • Some providers may need to leave the worksite (try and facilitate coverage if possible)

Stage 2: Support by Trained Peers

• Administered by specific coworkers who are trained in mentoring and supporting peers after an adverse or traumatic event

• Trained peer will follow up in the days and weeks following the incident to ensure providers wellbeing and referral for other support as needed

Stage 3: Support by Mental Health Professionals

• Should be available to ALL clinical employees and is encouraged if the providers second victim symptoms interfere with their professional or personal lives, or if symptoms fail to improve or worsen over time

• The last stage is crucial to the provider and institutions life plans

  • Drop-out: provider leaves current job, specialty or clinical care altogether

  • Survive: provider stays at current employment but is haunted by event and continue to have long-lasting SVS symptoms

  • Thrive: provider adopts a growth mindset and uses the experience to better the systems processes to benefit future patients

REMS

• A drug safety program that the FDA can require for certain medications that have serious safety concerns

  • Help ensure that benefit outweighs risk

• Designed to reinforce medication use behaviors and actions that support safe use of that medication

• NOT designed to mitigate all of the potential adverse risks of the medication

  • REMS focuses on preventing, monitoring, or managing a specific, serious risk

Roles of Participants in REMS — Patient and Caregivers

• Patient role can vary depending on type of REM

• Patient can receive specific counseling about associated risk, what action may be needed to mitigate risk, or what symptom to watch for/report

• Some REMS will require patient to sign form stating they understand the risks, others will have to go through laboratory testing

• Patients must follow any requirements of REMS to ensure there is not a delay in treatment or therapy

• REMS provide access to medications with serious risks that would not be available otherwise

Roles of Participants in REMS — HCPs and Prescribers

• Prescriber requirements vary for each REMS

• Mostly, prescribers will receive information from manufacturers regarding REMS

• Some REMS programs will require prescribers to enroll in programs, undergo training, and document counseling of patients; enrollment; and overall compliance of patient

Roles of Participants in REMS — Pharmacies and Health Care Settings that Dispense Medications

• Pharmacist role can vary depending on REMS and the setting (community pharmacy v. inpatient setting)

• Some pharmacists will receive REMS communications from the manufacturers

• Some REMS require pharmacy or other health care setting to become certified to dispense that medication

  • Usually involves designating authorized representative to complete training, ensure compliance with policies and procedures, and ensure staff are trained appropriately

• Individual pharmacists may be needed to complete training, verify safe use conditions, or provide counseling or education to the patients

REMS Public Dashboard

• Currently 70 medications with actively approved REMS programs

• Provides information on all past and currently active REMS programs

• Provides REMS Materials, medication guides (as applicable), and history of the medication