PTCB -- Patient Safety and Quality Assurance

Medication error

any preventable event that may lead to inappropriate medication use or patient harm

Adverse drug event (ADE)

harm experienced by a patient that results from exposure to a medication. More serious than a side effect and have the potential to be life threatening. Must be documented in a patient's chart to minimize risk of it occurring again and reported to FDA FAERS

**Not all medication errors lead to ADE

Institute for Safe Medication Practices (ISMP)

non-profit organization that educates on error prevention and is known as the gold standard for medication safety

Tall-man lettering

the use of mixed-letter cases to emphasize the difference in drug names that look or sound alike

EX: BuPROpion/BusPIRone

HydrALAZINE/HydrOXYzine

PredniSONE/PrednisoLONE

Leading zero

Must keep the leading zero to prevent patients from receiving doses that are much higher than intended

EX: Use 0.5 g instead of .5 g (which could be mistaken as 5g)

Trailing zeroes

Don't use trailing zeroes

EX: Use 5 g instead of 5.0 g (can be mistaken for 50 g if decimal isn't seen)

Inventory Separation

- high risk medications may be stored separately from other medications

- medications with similar names may be divided by a divider

Avoid error-prone abbreviations

Don't use abbreviations that can be misinterpreted; if you think it might be misinterpreted or is not clear, best rule of thumb is to just write it out

EX: IU (international units) can be mistaken for IV (intravenous)

QD (every day) can be mistaken for QID (4 times daily)

SS (one-half) can be mistaken for 55

The Joint Commission

an independent, not-for-profit organization that evaluates and accredits healthcare organizations for patient safety. Designates a DO NOT USE list of certain abbreviations

Verbal order read back

CPhT's and pharmacists can receive call in prescriptions. Always reduce the order to writing, then read back to the prescriber to ensure the accuracy of the order.

Barcode and QR code scanning

Barcode and QR code scanning can be used in pharmacies to reduce dispensing errors

What info do barcodes include when scanned?

NDC: National Drug Codes

First segment of NDC

drug manufacturer; up to 5 numbers

Second segment of NDC

drug; up to 4 numbers

Third segment of NDC

package size; up to 2 numbers

E-prescriptions

- can help reduce errors that might occur from misinterpreting handwritten prescriptions

- reduces the number of lost paper prescriptions

- speeds up the process of insurance verification and saves paper, time, and physical storage space

7 rights of medication administration

Right...

1. Patient

2. Medication

3. Dose

4. Route

5. Time

6. Indication

7. Documentation

Distractions

lapses in judgment when interrupted or multi-tasking

Omissions

an ordered dose of a medication is not administered

American Geriatrics Society (AGS)

oversees the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults -- Beers Criteria

Beers Criteria

- Beers medications have been associated with poor outcomes for older patients (confusion, falls, mortality)

- Pharmacists receive warnings for Beers Criteria medications; prescribers are contacted to discuss if therapy is appropriate or if alternative therapies would be safer

Drug classes in Beers Criteria

- First-generation antihistamines (diphenhydramine)

- Antiparkinson agents (bromocriptine)

- Antithrombotics (clopidogrel)

- Anti-infective (nitrofurantoin)

- Alpha-1 blockers (terazosin)

- Benzodiazepines (alprazolam)

- Hypnotics (zolpidem)

- NSAIDs (ibuprofen)

- Tricyclic antidepressants (nortriptyline)

- Skeletal muscle relaxants (cyclobenzaprine)

Tasks for Pharmacists

1. Drug Utilization review (DUR)

2. Therapeutic substitution

3. Patient counseling -- including OTC recommendations

4. Final verification of prescriptions (QV2)

Drug Utilization Review (DUR)

pharmacists review prescriptions and OTC's being used with a focus on drug-drug interactions and potential adverse drug events

Therapeutic Substitution

allos for a medication to be switched to a different medication in the same drug class without checking with the prescriber. Common in hospitals in which cases analyses of safety, effectiveness, and cost often determine which limited supply of drugs will be maintained on site. Different than generic substitution

Misuse

public health crisis in which a person uses medication in the wrong way. Pharmacy personnel must be vigilant regarding fraudulent prescriptions and changes in patient behavior to identify cases of misuse and abuse

EX: taking someone else's sertraline to self-medicate for depression. Taking lorazepam more often than prescribed

MedWatch

a voluntary program established by the FDA to report adverse events or sentinel events that are observed in human medical products

FDA Adverse Event Reporting System (FAERS)

database that contains info on adverse event and medication error reports submitted to the FDA. These reports are received from healthcare professionals and consumers

Vaccine Adverse Event Reporting System (VAERS)

co-sponsored by FDA and CDC, program to collect and analyze data from adverse events after vaccination. Goal is to identify new safety concerns that were no discovered during clinical trials

MEDMARX

anonymous, online error-reporting program designed for hospitals and health systems. US Pharmacopeia (USP) oversees this program

Hygiene and cleaning standards

- Counting trays should be cleaned once daily with 70% isopropyl alcohol

- Medication storage areas, including refrigerators, cannot contain food or drinks.

- Contaminated crash carts must be disinfected.

- Countertops must be cleaned daily with 70% isopropyl alcohol.

- Shelves, floors, and storage areas must be cleaned routinely and free of clutter.

Handwashing

important part of infection control. Always wash hands before compounding or direct contact with drug product

Personal Protective Equipment (PPE)

1. Remove outer garments, jewelry, makeup, artificial nails, piercings, etc. before putting on any PPE.

2. Start with shoe and hair covers including any facial hair.

3. Put on a face mask or face shield.

4. Wash your hands with appropriate handwashing technique.

5. Use a compounding-specific gown.

6. Don sterile gloves and use alcohol to continue to sterilize your gloved hands between drug products.

Counting trays

should be cleaned regularly before use and periodically throughout the work shift with 70% isopropyl alcohol. This reduces risk of contamination between medication products. Separate trays should be used for penicillins or sulfur-containing drugs

Important daily cleaning tasks

- dusting equipment and medication storage areas

- wiping down of keyboards, phones, and all working surfaces and tools used for medication preparation

- vacuuming or mopping the floors

- removing trash from the pharmacy work area

- cleaning patient areas

Adherence

identifying underlying causes of missed doses can help avoid treatment failures and adverse outcomes moving forward. Missed doses may be multifactorial; pharmacist counseling will help patients get on track with taking medications

Post-Immunization Follow-Up

in the even to an adverse reaction to an immunization, the pharmacist should document:

1. Patient demographics

2. Ordergin prescriber

3. Dose give

4. Route and site of administration

5. Vaccine lot number and expiration date

6. Name of immunizer and date administered

Allergies

complete and running list of patient's allergies, including reaction type, should be documented before dispensing any pharmacy product. Pharmacy staff should review patient allergies with them to note any changes

Product integrity

any pharmaceutical product that is dispensed should be genuine and its integrity should be up to the pharmaceutical manufacturer's standards. Product integrity can be compromised due to:

1. Inadequate storage

2. Temperature changes

3. Moisture levels

4. Expiration date

Near miss

occurs when a medication error has taken place but by chance does not reach the patient. This should be reported internally for process improvement purposes.

Root-Cause Analysis (RCA)

- used to determine the underlying root cause of a problem

- encompasses looking at the processes set in place for filling and dispensing a prescription and at what point did an error occur

Abdominal doses

can result in over/underdose, leading to adverse reactions or a failure in treatment.

Pharmacist must be alerted to abnormal doses so the prescriber can correct it

Early refill

- not an issue for non-controlled medications

- insurance will typically reject the claim when pharmacy tries to refill early

- EXCEPTIONS: lost medications, therapy change, international travel -- overrides refill too early

- controlled cannot be refilled early by federal and state regulations; prescriber can still grant a refill but insurance may reject

- pharmacies allow 1-2 day early fill leeway so patient isn't completely out of medication

- dr's can add a do not fill until date to prescriptions to limit controlled substance misuse

Incorrect quanitty

- legal to dispense less than the quantity authorized on a prescription

- Never dispense more than what is written

- double count to avoid dispensing the incorrect quantity

Incorrect patient

If 2 patients have the same name, check date of birth, then check street address to select correct patient

Incorrect drug

can occur at data entry or during product selection due to negligence or when medications sound alike/look alike

Causes of Medication Errors

Illegible handwriting.

Look-alike/sound-alike drugs.

Ambiguous abbreviations.

Lack of patient information.

Reporting Medication Errors:

Institute for Safe Medication Practices (ISMP)

FDA MedWatch

Drug Utilization Review (DUR)

process of reviewing a patient's profile with prescribed medications to ensure patient safety

Benefits of E-Prescribing

· Prevents prescription drug errors

· Provides automated clinical decision support

· speeds up the medication reconciliation process

· supplies instant notification of allergies, drug interactions, duplicate therapies, and other clinical alerts

· tracks patient fulfillment of prescriptions

· reduces the number of lost prescriptions

· enables physicians to electronically prescribe controlled substances in a single workflow

· permits better monitoring of controlled substance prescriptions

· allows the pharmacy staff to spend less time responding to prescription refill requests

· reduces the risk of readmissions

· improves medication adherence

makes it easier to verify insurance coverage

Barcode Usage

1. Used to reduce dispensing and medication errors.

2. Barcode includes the product's NDC number.

3. Used in both community and hospital pharmacies.

4. Can be used to verify the medication prior to the nurse administering it to the patient in the hospital.

5. Can be used to create the label for a patient's prescription vial.

6. Information contained on a medication bar code includes the NDC number, lot number, and expiration date.

7. May be available on paperwork that accompanies the prescription bottle.

Patient Counseling

Technician may ask patients if they have any questions about their medications, but pharmacists are responsible to Counsil the patients

Following Info:

1. Name of medication

2. Dosage form

3. Dosage

4. Route of Administration

Prescribing errors

-route not specified

-allergies

-incorrect strength/drug/dose/conc/rate/dosage form

-incomplete med name

-qty and refills omitted

-additional directions needed

Dispensing Errors

-mechanical errors like calculations, transcription, interpretation of prescript

-judgment errors like making bad decision during counseling, screening, eval

Administration Errors

-oral meds given IV

-enteral given parenterally

-IV given intrathecally

-IM given IV

-IV syringe used to measure oral med dose

-ear med placed in eye

-irrigation solu given IV

Examples of medications that shouldn't be crushed

1. Accutane

2. Actonel

3. Adalat CC

4. Allegra D

5. Ambien CR

6. Augmentin XR

7. Avodart

8. Calan SR

9. Cardizem (CD, LA, XL)

10. Cymbalta

11. Depakote

12. Detrol

13. Ecotrin

14. EES 400

15. Effexor XR

16. Evista

17. Flomax

18. Glucophage XR

19. Indera LA

20. Isotretinoin

21. Janumet XR

22. K-Dur

23. Lithobid

24. MS Contin

25. Nexium

26. Nitrostat

27. Paxil CR

28. Prilosec

29. Ritalin (LA, SR)

30. Seroquel XR

31. Tessalon Perles

32. Wellbutrin (SR, XL)

Causes of Prescription errors (as identified by MEDMARX)

1. Performance deflects

2. Procedure of protocol not followed

3. Transcription inaccurate or omitted

4. Improper documentation

5. Incorrect computer entry

6. Knoledge deflect

7. Communication (lack thereof or incorrect)

8. Written order

9. Incorrect drug distribution center

10. Handwriting illegible or unclear

Workplace issues that may contribute to medication errors

1. inadequate lighting

2. uncomfortable temperature

3. excessive noise

4. clutter and crowding

5. interruptions

6. inappropriate workload for staff

7. inefficient workflow

8. meal breaks not scheduled or taken vacations, resulting in short-staffing.

9. floater (substituting staff) unfamiliar with practice site

10. older technology not replaced

11. staff not healthy or working when ill

12. staff issues of visual acuity or hearing impairment

ISMP (Institute for Safe Medication Practices)

1. "DO NOT CRUSH" list identities oral dosage forms that should not be crushed and the reason for not crushing them.

2. black-box-warnings listing and summary of products with black box warnings

3. Error-Prone Abbreviations list identifies those abbreviations that have been involved in medication errors.

4. Community Pharmacy Medication Safety Tools and Resources.

5. ISMP Confused Drug Name List identifies those drugs that have been mistaken for other medication errors.

6. ISMP List of High-Alert Medications in community, ambulatory healthcare, and long-term care facilities.

7. ISMP Confused Drug Name List contains a list of all medications that are mistaken for other medications.

8. tall man lettering contain sets of look-alike drug names that have been modified using "tall man lettering"

9. Standards Concentration of Neon Drug Infusion provides the standard concentrations of typical neonatal drug infusions.

10. Guideline for Preventing Medication Errors in Pediatrics.

11. Improving medication safety with anticoagulant therapy

12. ISMP List of Products with drug suffixes.

13. patient-controlled analgesia.

high alert medications

drugs that bear a heightened risk of causing significant patient harm when used in error

DO NOT CRUSH LIST

-Slow-release dosage form

-Extended-release dosage form

-Enteric-coated dosage form

-May irritate the mucous membrane

-Rate of absorption may be increased

-Coating of tablet may release the drug over time

-Taste

-Skin irritant

-Liquid filled

-Sublingual dosage form

-Film-coated dosage form

-Efffervescent tablet

-Teratogenic effect (women who are or may become pregnant should not handle crushed or broken tablets because the medication can be absorbed into the body and produce birth defects into the fetus)

-Local anesthesia of the oral mucosa

Examples of patient barriers

-Medication cost

-Side effects treatment

-Personal beliefs and perceptions

-Ignorance

-Forgetfulness

-Lack of resources

-Duration,frequency, and complexity of therapy

-Improper administration technique

-Severity of disease

Drug Adherence

-taking a medication in the manner prescribed by the health care provider

-Patient has an active role in ensuring compliance Factors that can cause a patient to deviate from compliance:

• Cost of drug

• Forgetting doses

• Annoying side effects

• Self-adjustment of doses

• Fear of dependency

-Nurse must be vigilant in questioning patients about their medications

Missed dose

when a patient does not receive a scheduled dose of medication

high-alert medication list

Anesthetics (IV or inhaled), antiarrhythmics, anticoagulants, antithrombotic, chemotherapy, epidural, intrathecal, hypertonic saline, immunosuppressants, inotropic, insulins, magnesium sulfate injection, opioids, oral hypoglycemics, parenteral nutrition potassium chloride and phosphate injections, sterile water injections

drug allergies

Hives, Rash, Itchy Skin

Error Prone Abbreviations

MS, MSO4 for morphine

MgSO4 for mag sulfate

decimal points without leading 0 (use 0.5 mg, not .5 mg)

trailing zero (use 2 mg not 2.0 mg)

U,U, IU units

qd, q.d. for daily

god, q.o.d. for every other day

SC. SQ, subq for subcutaneously

RCA (root cause analysis) questions

1. What happened

2. What usually happens?

3. Why did it happen?

4. What can we do to prevent it from happening again?

5. What actions can be measured?

Monitoring Errors

Healthcare workers incorrectly monitor drugs that require specific laboratory values for medication and dose selections

Medication Adherence

the extent to which people fill and actually take prescribed medicines

Expired drugs

expired drugs must be segregated from in-dated inventory prevent dispensing the expired drug to patients

Short-dated

medications that will expire soon should have a method for identification (colored stickers) to identify which medication to use first

Warning Labels

that identify specific warnings, food or medications to avoid, potential side effects, and other cautionary interactions

TH: Transaction History

includes transaction information going back to the original manufacturing of the product

TI: Transaction Information

is the name, strength, dosage form, NDC (National Drug Code), container size, number of containers purchased, lot number, date of purchase and shipment, and business name of address purchasing

TS: Transaction Statement

is a statement that declares that the manufacturer did not knowingly ship a counterfeit or illegitimate product, has systems in place for proper procedure, and did not knowingly alter any transaction history

CPOE (Computerized Provider Order Entry)

-Eliminates lost orders

-Prevents medical errors

--Improved communication

--More readily accessible knowledge

--Requirement for key pieces of information

--Assistance with calculations

--Accuracy checks performed in real time

--Assistance with medication monitoring

--Decision support

--Rapid response to, and tracking of, adverse events

Root Cause Analysis (RCA)

systematic process used to identify the underlying causes of a medication error, adverse drug reaction, or other significant pharmacy issue

United States Pharmacopeia

Provides drug standards, required in the pharmacy setting

Remington's Pharmaceutical

Provides information for compounding purposes, contains physical characteristics of different drugs and recipes

Facts and Comparisons

Provides drug information in an easy to read format, most updated reference, most used reference

Physician's Desk Reference (PDR)

Provides drug information, mainly inserts from drug manufacturers, limited information, difficult to read

American Drug Index

Provides brief information about all trade and generic drugs available

Handbook of Over the Counter Drugs

Provides information on all OTC drugs on the market, includes active and inactive ingredients

Handbook of Injectable Drugs

Provides information about IV solutions and drug-drug compatibilities, includes charts

Redbook

Provides information concerning the average wholesale pricing of prescriptions for insurance or third party pricing

The Orange Book

Lists therapeutic equivalencies of drugs

MedGuides

FDA-approved documents created to educate patients about how to minimize harm from potentially dangerous drugs such as opioids, antidepressants or anticoagulants

PILS (patient information leaflets)

provided by the drug manufacturer

Concurrent DUR

ongoing monitoring of drug therapy during the course of treatment

wrong time error

Dose is not given at appropriate time

Omission error

prescribed dose is not administered as ordered

Wrong time error

prescribed dose is not administered at the correct time

unauthorized drug error

the wrong drug is administered to the patient

Improper dose errors

Patient received a lower dose, a higher doses of the drug than what was originally prescribed