Patient Safety and Quality Assurance Study Guide for the PTCB Exam

Pharmacist Intervention

A pharmacist should always be available in the pharmacy in case of questions or concerns. Developing a collaborative relationship and knowing when to consult your pharmacist colleagues will help you be successful as a pharmacy technician. Whenever a question or concern arises that relates to a clinical matter, you should notify the pharmacist that they are needed for an intervention. A pharmacy technician should never handle a clinical problem or provide clinical information, as this is one of the many responsibilities of the pharmacist on duty.

Drug Utilization Review (DUR)

Pharmacists are to conduct DURs prior to dispensing a new medication or refilling an existing order. The DUR should include a comprehensive review of the patient’s prescription and over-the-counter (OTC) medications, with a special focus on drug-drug interactions and potential adverse drug events (ADEs). Pharmacists should be consulted in case patients have questions or concerns about any of their medications (including OTCs) or if they suspect drug misuse or abuse.

Adverse Drug Event (ADE)

ADEs are unwanted reactions that occur as a result of the normal use or potential misuse of a medication. These events can be due to a medication error or an adverse reaction from practical use. Adverse events from a medication are more serious than a side effect and have the potential to cause injury or even be life-threatening. Any adverse event, regardless of its origin, should be documented in a patient’s chart to minimize the risk of it occurring again in the future. Also, it is important for such events to be reported to the Food and Drug Administration’s Medwatch for quality assurance purposes.

OTC Recommendation

An OTC medication is one that does not require a prescription to be obtained from the pharmacy. OTC medications typically treat symptoms of minor ailments like mild pain, cough/cold symptoms, seasonal allergies, or insomnia. Examples of OTC medications include acetaminophen, phenylephrine, cetirizine, and diphenhydramine. The pharmacist should always be available at the pharmacy counter to assist with any OTC questions or recommendations.

Even though OTC medications do not require a prescription, it is still important for the pharmacist to be available to help recommend the best OTC product to treat the customer’s specific ailment. Some customers may be drawn to a product that they saw on TV or heard about on the radio. This is where the pharmacist steps in to ensure the safety and proper selection of an OTC product given the patient’s medication and medical history.

Therapeutic Substitution

Therapeutic substitution allows for a medication to be switched to a different medication in the same drug class (though not the same drug) without first checking with the prescriber. This practice is especially common in hospitals and federal facilities, where analyses of safety, effectiveness, and cost often determine which limited supply of drugs (closed formulary) will be maintained on site. It is important to note that therapeutic substitution is different than generic substitution, which occurs when the generic version of a drug is substituted for the brand name drug (e.g., Zoloft is prescribed, but the generic sertraline is dispensed).

Misuse

Medication misuse, whether intentional or unintentional, is a public health crisis. Medication misuse can occur in a number of different ways. For example, a person taking someone else’s sertraline to self-medicate for depression, a person taking lorazepam more often than prescribed because of increasing anxiety, and a person intentionally taking oxycodone in an effort to get high are all examples of misuse. Regardless of the cause or intent, pharmacy personnel should be vigilant regarding fraudulent prescriptions and changes in patient behavior to help identify cases of misuse and abuse.

Calculation Example

One of your essential tools for ensuring medication isn’t being misused is the prescription itself. Let’s consider an example situation.

Based on the following prescription, at a minimum, how long should one fill of the following prescription last?

• Lorazepam 0.5 mg tablet by mouth 3 times daily as needed for anxiety
• Quantity: 90 tablets
• Refills: 3

Solution

Ninety tablets divided by three tablets a day equals 30 days. Which means, at a minimum, this prescription should last 30 days.

Since the prescription indicates “as needed,” the patient does not necessarily have to take it regularly. So, the prescription may last longer than 30 days, but not less. If the patient went back to the pharmacy in 15 days trying to refill the prescription, it could be an indicator of potential misuse or abuse.

Adherence

Identifying the underlying causes of missed doses can help prevent treatment failures and adverse outcomes moving forward. Much like medication errors, the cause of a missed dose may be multifactorial. Monitoring a patient’s medication profile for lapsed refills can help identify the problem. Additionally, pharmacist counseling on the importance of medication adherence and adherence strategies can help get patients and caregivers back on track.

Calculation Example

Jane Doe takes her furosemide 20 mg by mouth twice daily. She has 14 tablets left on her current prescription. How many days does she have left of her medication?

Solution

If she has 14 tablets left and takes two tablets total in a day, simply dividing 14 by 2 gives us seven days. So, on the eighth day, she will be out of medication and should pick up a refill a few days before she is completely out to ensure she does not go without her medicine.

Post-Immunization Delivery Care

When a pharmacist administers a vaccine, certain information should be documented in the event an adverse reaction occurs after immunization. The following should be documented when a vaccine is administered, regardless of whether it is given pursuant to a prescription or standing order:

• patient demographics
• ordering prescriber
• dose given
• route and site of administration
• vaccine lot number and expiration date
• name of immunizer and date administered

It is also beneficial for the pharmacist to fax the ordering physician a copy of the vaccine administration sheet to keep their records up to date. Adverse reactions can occur right after a vaccine is given or even up to 14 days thereafter. It is important for the patient to be vigilant following their immunization and to notify the administering pharmacist of any unusual reactions, regardless of the severity. Adverse events related to immunizations should be reported by the pharmacist to the Vaccine Adverse Event Reporting System (VAERS), which is co-managed by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). This reporting is important to help monitor vaccine safety and identify any adverse event trends or patterns.

Patients should always be seated when receiving a vaccine because it is not uncommon for some people to faint. After a vaccine is administered to a patient, the patient should be monitored for at least 15 minutes to ensure there are no immediate adverse or allergic reactions. Individuals with a history of post-vaccine reactions or with a lengthy allergy list may want to be monitored for longer just to be cautious.

Every pharmacy that administers vaccines should have epinephrine, diphenhydramine, and a blood pressure monitor on hand in case an allergic reaction occurs. Epinephrine could be administered pursuant to a standing order protocol.

Allergies

A complete and running list of a patient’s allergies, including reaction type, should be documented before dispensing any pharmacy product. Periodically, pharmacy staff should review with a patient their allergy list to note any changes. The pharmacist should always review a patient’s allergy list before dispensing a pharmacy product, regardless of whether it is a prescription or OTC medication. If a patient develops an allergy to a dispensed medication, it should be documented and noted to ensure the product is not dispensed in the future.

Drug Interactions

When the pharmacist performs a drug utilization review, they review the patient’s profile and medication list to take into account any potential for drug-drug interactions. Some drug-drug interactions may merely warrant specific counseling points or monitoring parameters for the pharmacist to go over with the patient prior to dispensing. However, potentially severe or life-threatening drug-drug interactions may warrant a call to the provider’s office for alternative therapy.

For example, omeprazole is a medication used to treat gastroesophageal reflux disease (GERD), and clopidogrel is an antiplatelet medication. If taken concurrently, omeprazole significantly decreases the antiplatelet effect of clopidogrel, which could be life-threatening. This drug-drug interaction would warrant a call to the provider to get omeprazole changed to a different proton pump inhibitor, like pantoprazole, which does not cause this interaction.

Event Reporting Procedures

Adverse events and medication errors should be reported and documented both internally and externally for quality assurance purposes. Such reporting is not used for negative or punitive reasons but instead to understand the processes that took place and to better the pharmacy practices.

Medication Errors

Medication errors can occur at any step of the medication-use process, ranging from prescribing and transcribing to dispensing and administering. Even after a medication has been used, if it is not appropriately monitored, an error may occur.

It is important to identify the source of a medication error to avoid future problems. Identifying a singular source may be challenging, however, as medication errors are often multifactorial. If a medication error occurs within the pharmacy, it should be reported internally. The patient(s) involved in the error should also be notified if unaware as well as the prescribing practitioner. This is to help identify and monitor any adverse events that may have occurred due to the error.

Adverse Effects

As stated above, adverse effects or reactions to a medication should be reported to the FDA Medwatch, which helps compile safety data for the FDA Adverse Event Reporting System (FAERS). If an abundance of ADEs is reported on the same medication, the FDA will take action against the drug manufacturer to mitigate or resolve the suspected issue. The outcome from the FDA can range from inclusion of a black box warning on the product, product recall, or even mandatory medication guide issuance whenever the product is dispensed. Medications can even be pulled from the market if the trend of adverse events is severe enough or life-threatening.

Product Integrity

Any pharmaceutical product that is dispensed should be genuine, and its integrity should be up to the pharmaceutical manufacturer’s standards. A product’s integrity can be compromised due to inadequate storage, temperature changes, moisture levels, and other factors. Also, a medication that has bypassed its expiration date should never be dispensed, as the product’s integrity is suboptimal.

For example, if the cap to a melatonin sublingual tablet bottle was not secured tightly enough after the last use, upon inspecting the tablets at a later date, they may look powdery and be very brittle. This is due to inadequate storage, and those tablets should be discarded from inventory and not dispensed to any patient as the product integrity has been compromised.

MedWatch

The FDA has a program called MedWatch, where healthcare providers and patients can report an adverse reaction to a medication. A form is filled out electronically. The FDA pays special attention to multiple reports on a single medication and may issue a medication recall if there is a problem. Appropriate forms can be accessed at the MedWatch site.

Vaccine Adverse Event Reporting System (VAERS)

VAERS is a platform where patients, health care professionals, and even vaccine manufacturers can report adverse events from the administration of vaccines. This data is crucial to ensure vaccines and their components remain safe and effective to the public. The CDC and FDA can use this data to investigate vaccines that may be causing harm and take corrective action, if needed. The VAERS system also includes other helpful information, such as vaccine safety, seasonal flu updates, and vaccine-related learning materials.

Although any undesirable symptom that is the result of vaccine administration can be reported to the VAERS system, it is important to identify the difference between an adverse event (should be reported) and a side effect (does not need to be reported) of vaccine administration.

These are examples of common side effects from vaccine administration:

• muscle ache
• mild fever
• pain near or around the injection site
• soreness, redness, swelling around the injection site
• fatigue
• headache

These are examples of adverse events from vaccine administration:

• itchy rash
• hives
• swelling of the throat, lips, and/or tongue
• difficulty breathing or shortness of breath
• high-grade fever
• loss of consciousness
• increased heart rate or palpitations
• seizure
• infection
• irregular bleeding

Near Miss

A near miss, in layman’s terms, is just a close call. A near miss occurs when a medication error has occurred, but by chance does not reach the patient. A near miss should also be reported internally for process improvement purposes.

For example, a pharmacy technician could be returning prescriptions to stock that have not been picked up within 14 days of filling when they notice Mr. Brown’s blood pressure medication was in the same bag as Mrs. White’s heartburn medication. If the medications had been dispensed, Mrs. White would have received Mr. Brown’s blood pressure medication, which would have been a dispensing error. However, since the medication never reached the patient and was discovered by chance, it is a near miss.

Root-Cause Analysis (RCA)

An RCA is used to determine the underlying root cause of a problem. In a pharmacy, this typically encompasses looking at the processes set in place for filling and dispensing a prescription and determining at what point an error occurred. It is important to know the origin of a medication error for process improvement and to prevent it from recurring.

For example, suppose Mr. Zee called your pharmacy concerned because he picked up his refill for warfarin yesterday and noticed the pills were green this time instead of blue. He wanted to make sure he got the correct medication, as they have always been blue in the past. You would want to perform a root-cause analysis in this situation to determine what had happened. Perhaps you will find out that the pharmacy technician filled his prescription for warfarin 2.5 mg instead of warfarin 4 mg and the pharmacist did not catch the mistake at the final check.

To prevent an error like this from happening again, the pharmacy could implement barcode scanning. Barcode scanning makes the product selection process easier, as it will not allow a prescription to be filled or checked by the pharmacist unless the barcode of the medication is scanned and matches the exact medication that is listed on the prescription label.

Continuous Quality Improvement (CQI)

CQI is the process a pharmacy uses to continuously improve its standards of care. This is an ongoing effort that includes identifying, analyzing, and reducing medication errors while, at the same time, improving the safety of patients as well as workflow processes. Pharmacies collect data in multiple ways and use this data to improve key performance metrics and to reduce medication errors.

CQI in the Pharmacy

Here are examples of CQI actions that should take place in the wake of specific pharmacy errors:

Incident—On multiple occasions, Humulin R U-500 insulin has been mistakenly dispensed instead of Humulin R U-100.

CQI Actions—Separate the two products in the refrigerator, ensuring they are not next to each other. Add an alert pop-up at final verification that requires override by the dispensing pharmacist.

Incident—It is found that medication errors and near misses occur most often during the peak hours of 12 to 5 p.m.

CQI Action—Get additional staffing during peak times to help reduce these errors from occurring.

Incident—Patients are frequently receiving the wrong tablet strength.

CQI Action—Implement barcode scanning in the pharmacy workflow. If the wrong barcode is scanned, the prescription cannot move into the final verification stage within the pharmacy computer system.