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 is of the clinical aspect, it is your cue to notify the pharmacist that he/she is needed for an intervention. A pharmacy technician should never handle a clinical problem or provide clinical information, as this is one of the many duties of the pharmacist on duty.

Drug Utilization Review (DUR)

Pharmacists are to conduct drug utilization reviews (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 drug misuse or abuse is suspected.

Adverse Drug Event (ADE)

Adverse drug events (ADEs) are unwanted reactions that occur from 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 FDA Adverse Event Reporting System (FAERS) for quality assurance purposes.

OTC Recommendation

An OTC (over-the-counter) 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, in which cases 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 “sertraline” [generic for Zoloft] is dispensed).

Misuse

Medication misuse—whether intentional or unintentional—is a public health crisis. Medication misuse may occur in a number of different ways; for example, a person may take someone else’s sertraline to self-medicate his or her depression, a person may take lorazepam more often than prescribed because of increasing anxiety, or a person may intentionally take oxycodone in an effort to “get high.” 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.

Adherence

Identifying underlying causes of missed doses can help avoid 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, and pharmacist counseling on the importance of medication adherence and potential adherence strategies can help get patients and caregivers back on track.

Post-Immunization Follow-Up

When a pharmacist administers a vaccine, certain information should be documented in the event an adverse reaction occurs post-immunization. The following should be documented when a vaccine is administered regardless if 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 post-immunization and 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 CDC and FDA. This reporting is important to help monitor vaccine safety and help identify any adverse event trends or patterns.

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 it being 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, he/she reviews the patient’s profile and medication list to take into account any potential for drug-drug interactions. Some drug-drug interactions may warrant specific counseling points or monitoring parameters for the pharmacist to go over with the patient prior to dispensing. However, some potential drug-drug interactions may warrant a call to the provider’s office for alternative therapy if severe or life threatening.

For example, omeprazole is a medication used to treat GERD and clopidogrel is an antiplatelet medication. If taken concurrently, omeprazole significantly decreases the antiplatelet effect of clopidogrel, which could be life threatening to the patient. 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 in addition to 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 practice of pharmacy.

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 on behalf of 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 in the Adverse Drug Event (ADE) section above, adverse effects or reactions to a medication should be reported to the FDA Adverse Event Reporting System (FAERS). If an abundance of ADEs are reported on the same medication, the FDA will take action on 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, etc. Also, a medication that has bypassed its expiration date should never be dispensed, as the product integrity is suboptimal. For example, the cap to a melatonin sublingual tablet bottle was not secured tightly enough after last use. Upon inspecting the tablets, they look powdery and are very brittle. Due to inadequate storage, these 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. MedWatch forms can be accessed at https://www.fda.gov/Safety/MedWatch/.

Near Miss

A near miss in layman’s terms is just a close call. A near miss occurs when a medication error has taken place but by chance does not reach the patient. A near miss should also be reported internally for process improvement purposes. For example, you as the pharmacy technician are returning prescriptions back to stock that have not been picked up within 14 days of filling. You notice Mr. B’s blood pressure medication was in the same bag as Mrs. C’s heartburn medication. If dispensed, Mrs. C could have received Mr. B’s blood pressure medication, which would have been considered a dispensing error. However, since it never reached the patient and was discovered by chance, it is deemed a near miss.

Root-Cause Analysis (RCA)

A root-cause analysis is used to determine the underlying root cause of a problem. In pharmacy, this typically encompasses looking at the processes set in place for filling and dispensing a prescription and at what point did an error occur. It is important to know the origin of a medication error for process improvement and to prevent it from recurring. For example, Mr. Z 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. After a root-cause analysis was performed, you find out that the pharmacy technician filled his prescription for warfarin 2.5MG instead of warfarin 4MG and the pharmacist did not catch the mistake at the final check. To improve on this, the pharmacy implemented 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.