PTCE: The Basics of Patient Safety and Quality Assurance

KNOWLEDGE DOMAIN 3.0
- Knowledge Area 3.1: High-alert/risk medications and look-alike/sound-alike [LASA] medications
- Knowledge Area 3.2: Error prevention strategies (e.g., prescription or medication order to correct patient, Tall Man lettering, separating inventory, leading and trailing zeros, bar code usage, limit use of error-prone abbreviations)
- Knowledge Area 3.3: Issues that require pharmacist intervention (e.g., drug utilization review [DUR], adverse drug event [ADE], OTC recommendation, therapeutic substitution, misuse, adherence, post-immunization follow-up, allergies, drug interactions)
- Knowledge Area 3.4: Event reporting procedures (e.g., medication errors, adverse effects, and product integrity, MedWatch, near miss, root-cause analysis [RCA])
- Knowledge Area 3.5: Types of prescription errors (e.g., abnormal doses, early refill, incorrect quantity, incorrect patient, incorrect drug)
- Knowledge Area 3.6: Hygiene and cleaning standards (e.g., handwashing, personal protective equipment [PPE], cleaning counting trays, countertop, and equipment)

Skills You Need To Know:
- Describe safety procedures, including infection control standards and handling and disposal requirements.
- Identify possible sources of medication errors, including the role of each party in

Sample Quality-Related Event (QRE) Documentation

Issues That Require Pharmacist Intervention
Multiple situations require pharmacist intervention. Drug utilization review (DUR) is a structured, comprehensive review strategy that is employed by pharmacists to review a patient’s prescriptions, health history, and medication data. Changes in drug therapy may be necessary based on results of the DUR. According to the Academy of Managed Care Pharmacy, these reviews are performed on every prescription, help maintain accuracy in drug therapy, and improve patient outcomes.
Adverse drug events (ADE) are checked during the DUR process. During a prospective DUR, the patient’s therapy is checked for accuracy and optimal care. Part of this process includes verifying that drug-drug interactions are not present. Drug-drug interactions can occur between prescription drugs or even between prescription and over-the-counter medications. It is important to resolve any ADE because drug-drug interactions can result in a change in the effect of the drug.
Over-the-counter (OTC) recommendations should never be made by a pharmacy technician. Pharmacy personnel should take a thorough patient history at the in-window. This should include the patient’s medication history, as well as both the prescription and over-the-counter medications that the patient is taking. All medications should be reviewed. The pharmacist on duty should handle any requests for over-the-counter medication recommendations. Pharmacists should select a proper medication and strength based on the patient’s allergies and prescription drug profile.
Therapeutic interchanges allow for the substitution of a medication to an alternative, usually from a non-preferred drug to one that is preferred. Many factors help determine the need for a therapeutic substitution, including cost. It is important to recognize that the patient needs to be informed of the therapeutic substitution.
Misuse of a medication is taking a medication for any reason other than the one for which it was prescribed. A misuse could be intentional or unintentional. Pharmacy personnel should be observant and proactive when dealing with patients who exhibit misuse or abuse tendencies. Misuse and abuse can be differentiated by looking at the patient’s intentions and motivations.
According to the CDC’s National Center for Health Statistics, in 2013, drug misuse and abuse resulted in more than 3.7 million cases of emergency department (ED) visits. 


The spectrum of prescription drug abuse

With intentional misuse, the patient becomes dependent upon the medication and requires a larger dose than prescribed.
- The patient may take the medication inappropriately, including taking the prescription medication more often than prescribed.
- The patient may be taking someone else’s prescription, often to self-medicate.
- The patient may take the prescription medication after it is no longer needed.

With unintentional misuse, the patient may or may not be dependent upon the medication.
- The patient may use an asthma inhaler all day long, even though it is meant for emergencies.
- The patient may take double the dose to relieve urgent pain. As time goes on, the patient becomes addicted to or reliant on increased doses due to tolerance issues.

Missed or skipped doses can occur for many reasons. The patient may have forgotten to take the dose or may have even run out of the medication. The caregiver could have failed to give the patient the medication on time, or the caregiver may have forgotten to give the patient the dose altogether. These situations require counseling from the pharmacist because patients should not assume that the missed dose can simply be taken with the next dose. Pharmacists can help identify and resolve situations that may be affecting optimal drug therapy. Continuing to miss doses can ultimately affect a patient’s health.
Adherence, specifically medication adherence, can be defined as the extent to which a patient takes a medication as prescribed. This includes multiple factors, such as getting prescriptions filled, picking up medications, remembering to take the medication, and following directions. Poor adherence can interfere with the ability to treat the disease and can result in complications. The consequences of non-adherence can involve both human lives and money. Up to two-thirds of all medication-related hospitalizations are attributed to non-adherence. Other complications of non-adherence include withdrawal syndromes, clotting, hypertension, return of an infection, or retitration. Pay particular attention to patients who are consistently late getting refills and/or have difficulty paying for medications. Also, patients on specialized medications that use devices, such as inhalers or insulin pens, should receive counseling on proper techniques.
Post-immunization follow-up can help prevent and manage immunization-related adverse effects. Adverse effects may be classified as local (redness or swelling) or systemic (fever, muscle pain, headache), frequent or rare, or they may be classified by severity of reaction with anaphylaxis and shoulder injury related to vaccine administration (SIRVA) as an adverse outcome. Protocols vary, but generally patients should be observed for 15 minutes post-immunization for signs of weakness, dizziness, or paleness that may result in syncope. Patients, pharmacists, or other immunizers can report any adverse events to the Vaccine Adverse Event Reporting System (VAERS). Pharmacists should be trained in basic life support (BLS) in the event of anaphylaxis. Shoulder injuries can also be prevented by employing proper administration techniques for all IM injections. Many states require pharmacists to complete training in immunization delivery and may also require the pharmacist to notify the patient’s primary physician of the immunization.

Sentinel Event
A sentinel event is an unexpected event that is not related to the natural course of the patient’s illness or underlying condition. This patient safety event results in death or serious physical or psychological injury. The term “sentinel” is used to describe these events because they require immediate attention, investigation, and response. Sentinel events include a patient’s suicide, an unanticipated death of a full-term infant, the abduction of a patient, the discharge of an infant to the wrong family, a rape, assault, or homicide of a patient, and a rape, assault, or homicide of a staff member, licensed independent practitioner, visitor, or vendor. Hospitals are expected to identify and respond appropriately to all sentinel events. Appropriate responses include conducting a root-cause analysis (RCA), developing an action plan to implement improvements in order to reduce risks, implementing those improvements, and monitoring the effectiveness of those improvements.

High-Alert Medications
The Institute for Safe Medication Practices (ISMP) defines high-alert medications as “drugs that bear a heightened risk of causing significant patient harm when they are used in error.” These medications are most likely to cause significant harm to the patient, even when used as intended. Safeguards—including DUR reviews, pharmacist checks, and patient education—are all important steps in reducing errors and minimizing harm. 

Look-Alike/Sound-Alike [LASA] Medications
These medications may look similar when written and/or tend to sound the same when spoken. Ultimately, these medications require pharmacists and pharmacy technicians to take extra precautions. The Institute for Safe Medication Practices (ISMP) maintains a list of common look-alike/sound-alike drugs.
In order to avoid errors, these drugs should be separated on the pharmacy shelf. Other strategies include the use of tall man lettering. This tactic requires the use of capital letters to designate areas of words that are dissimilar. For example, the insulin drugs NovoLog and Novolin may look or sound the same. The use of tall man lettering highlights the differences between these drug names: NovoLOG and NovoLIN.




ISMP’s list of high-alert medications in acute care settings





ISMP’s list of high-alert medications in community/ambulatory health care

Reducing Errors Using Safety Strategies
Errors can occur anywhere and at any time. Pharmacies take many measures to eliminate errors, including separating inventory, using tall man lettering, using vial grippers to keep labels on vials facing up so they are easy to read, educating their staff on the use of leading or trailing zeros, and limiting the use of error-prone abbreviations. (Note that a list of error-prone abbreviations can be found in Appendix J.)
Separating inventory is an important step in eliminating errors. Medications with similar names should be separated on the pharmacy shelf. High-risk medications should be stored separately from regular stock medications. Similar medication formulations should be placed together (e.g., liquid medications should be placed together, IV medications should be placed together, and ointments and creams should be placed together). This strategy allows the medication seeker to look only in the specific area of the formulation needed, resulting in less chance of an error. Care should also be taken to ensure that medications are stored and labeled properly. Multi-dose vials must be labeled to prevent them from being used beyond the expiration date.
Medication reconciliation (especially during periods of care transition), including admission, discharge, and subsequent follow-up in the ambulatory setting, is another strategy that can be used to improve medication safety. Likewise, providing patients with relevant patient education, including information on why the medication is needed and communication regarding the reasons for changes to a patient’s medication regimen, can be used to ensure understanding and facilitate patient compliance.
Tall man lettering highlights areas of similar-sounding or similar-looking words to emphasize the dissimilarities. In addition to being used as a technique to limit errors when identifying look-alike/sound-alike drug names, manufacturers have even adapted this technique and often use it on the medication bottle to bring attention to the drug name. The technician should consult with the pharmacist on any look-alike/sound-alike medications.




HydrALAzine/HydrOXYzine tall man lettering

Tip:
Remember, periods are sometimes difficult to see. This can lead to a 10-fold error. Be sure to be as clear as possible!
Another way to eliminate medication errors is to avoid the use of error-prone abbreviations. Many abbreviations may be misinterpreted. The abbreviation “QID” may be misinterpreted as “QD.” “D/C” may be interpreted as either “discharge” or “discontinue” depending upon the circumstance. 
Mathematics and calculations are an imperative part of the pharmacy. Errors can occur when pharmacy personnel do not follow the same techniques when writing numbers with decimal points. Writing decimals incorrectly can lead to medication errors. Two common errors are trailing zeros and naked decimal points. To avoid trailing zeros, write 5 instead of 5.0. To avoid naked decimal points, write 0.5 instead of .5.

Can you read the prescription shown below?



Sample Digoxin medication order

This prescription should read “Digoxin 0.5 mg.” A dose of 5 mg would have resulted in the patient receiving 10× the prescribed dose.

How about the figure below? Can you read it?



Sample insulin medication order
Lantus is long-acting insulin. In this particular prescription, the amount of Lantus may be misread and interpreted as 80 units instead of 8 units.

Event Reporting Procedures
Medication error reporting, review, and information dissemination are essential tools for improving processes in pharmacy services. Pharmacies should strive to be proactive in their approach at identifying areas of improvement and ultimately preventing more serious events. Some pharmacies assemble an adverse drug event committee to review and analyze medication errors, whereas others may utilize a leadership team to review errors.
A root-cause analysis (RCA) analytically identifies the underlying reasons for the occurrence of an adverse drug event or a near miss error for the purpose of identifying preventable measures. Evaluating root causes can lead to changes that can break the chain of events that would normally lead to an error. A root-cause analysis answers the following questions:
- What happened?
- Why did it happen?
- Who was involved?
- What typically happens?
- What should have happened according to policies and procedures?
- What was the missing or weak step in the process?
- What caused the missing or weak step?
- What is currently being done to prevent future failures during this step?
- What will prevent these failures from happening again?
- What actions need to be taken?
- How will outcomes be measured?

A RCA can apply to one event or to a series of events and involves collecting data, developing recommendations, implementing corrective action, and establishing systemic controls to avoid a recurrence of that event.
Near miss errors are medication errors that are identified before the patient receives the medication. Typically, these errors are identified during the final pharmacist check. The identification of near miss errors allows for these occurrences to be reviewed and action to be taken to prevent potential errors from occurring in the future. A near miss log can be maintained to document the error, identify causes and trends, and develop an action plan.
Medication errors, adverse drug effects, product quality problems, and therapeutic failures can be reported directly to the FDA through a monitoring system called MedWatch. This voluntary reporting system is available online and allows both health professionals and consumers to report issues with prescription and OTC medications, biologics, medical devices, combination products, special nutritional products, cosmetics, foods, and beverages. Similarly, post-vaccine related adverse effects can be reported to the Vaccine Adverse Event Reporting System (VAERS), a national program managed by the CDC and the FDA. The Institute for Safe Medication Practices has a similar reporting system called the ISMP National Medication Errors Reporting Program (ISMP MERP), which is open to health care professionals to report medication errors that have occurred in the workplace. ISMP also has a program for both health care professionals and consumers to report vaccine-related errors called ISMP National Vaccine Errors Reporting Program (ISMP VERP).

Hygiene and Cleaning Standards
Infection control is a process that is used to prevent nosocomial, or health care-associated, infections. Increasing antimicrobial resistance and the emergence of new pathogens prompted concerns for new standards of infection control. Hazardous materials and drugs produce adverse effects for the preparer.
The Occupational Safety and Health Administration (OSHA) requires employees to be protected from hazardous chemicals through handwashing and through the use of personal protective equipment (PPE), including gowns, gloves, goggles, feet and hair covers, and masks. Glove selection depends upon the type of preparation being compounded and the presence of allergies, which may adversely affect the employee or the patient. Non-powdered gloves may be used when handling hazardous drugs, waste, or contaminants. Non-latex gloves may be used by preparers and/or patients who are allergic to latex.
Facilities are expected to implement infection prevention and control processes. Hands should be appropriately washed and decontaminated before and after patient interactions, prior to the production of any aseptic compounds, and upon contact with blood or other infectious materials. Proper handwashing procedures can be completed by using the following steps. First, remove debris from under your fingernails using nail cleaner and water. Then, wash your hands vigorously, making sure to include the forearm up to the elbow for a minimum of 30 seconds using
antimicrobial soap and water. Scrubbing brushes should not be used on the skin as they can damage the skin or cause shedding. Last, completely dry the skin using lint-free wipes or an electronic hand dryer.
The use of appropriate PPE must be based on the risk of contamination and the type of compounded preparation. All equipment should be cleaned and disinfected before and after the preparation of medications. Counting trays and spatulas must be disinfected using 70% isopropyl alcohol. Additional caution should be given to the preparation of antibiotics, including penicillins and sulfonamides that have allergy potential. The use of a designated counting tray and a spatula for these types of medications is appropriate and should be labeled as such. Laminar flow hoods should be cleaned before and after batch preparations and maintained as required by law. Counters should be clutter free and clean of any debris. Non-sterile compounding areas and sterile compounding areas should be cleaned and maintained as described in USP <795> and USP <797>.

Summary
- Errors may occur due to actions of the prescribers, administrators, pharmacy personnel, or even patients or their family members.
- It is important to determine the source of the error and then come up with a plan to resolve the situation and eliminate future errors.
- The pharmacist should always review look-alike/sound-alike and high-risk drugs before having the technician fill a prescription.
- Pharmacists should perform a drug utilization review (DUR) for each prescription to determine if any potential changes need to be made.
- Prescriptions should be screened for potential adverse drug events (ADE). Therapeutic substitutions can also be made to help patients with cost savings.
- Pharmacy personnel must understand when to use leading and trailing zeros.
- Pharmacy inventory should be separated by formulation as well as by usage. Medications with similar names should be separated on pharmacy shelves.
- Abbreviations on ISMP’s list of error-prone abbreviations should not be used.
- Event reporting procedures are used to identify areas for improvement and prevent the occurrence of future adverse drug events.