7.9 Preparing Customer Education Resources

Another key way to prevent errors is to provide each patient with sufficient information to correctly take the prescribed medication. You do this through the medication container label, auxiliary labels, and medication information sheets (including the FDA-mandated Medication Guide for some high-risk drugs).

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In some states, the law requires the pharmacist to affix the medication container label to the container after the final check.

Medication Container Label

Medication container labels reinforce the dosing instructions of the prescriber. However, some prescription orders simply state “Take as directed.” If that is the case, the pharmacy technician must verify that the prescriber gave the patient sufficient directions and match them with usual directions for medications, or call the prescriber’s office for a more specific signa. To avoid insurance rejections during an audit, any prescriptions that are clarified with the prescriber’s office should be documented on the prescription and/or in the patient profile. If left with “Take as directed,” the technician might also request that the pharmacist counsel the patient on appropriate use (refer to Table 7.7).

Table 7.7 Patient Container Label Information

  • Prescription’s serial number

  • Pharmacy’s name, address, and telephone number

  • Patient’s name

  • Prescriber’s name

  • All directions for use given on the prescription

  • All necessary auxiliary labels containing patient precautions

  • Medication strength

  • Drug manufacturer’s name

  • Drug quantity

  • Drug expiration date or date after which drug should not be used because of possible loss of potency or efficacy

  • Initials of the licensed pharmacist

  • Number of refills allowed, or the phrase “No Refills”

Colored Auxiliary Labels for Cautionary Directions

Label instructions for containers and packaging are limited, so additional details may be given in the form of colored auxiliary sticker labels. Some medication may be labeled with one or more auxiliary labels as you saw in Chapter 4 that highlight special cautions provided by the pharmacist (see Figure 7.13). Some pharmacy software may automatically print drug-specific auxiliary labels when the medication container label is printed. The technician often affixes all computer-generated auxiliary labels but should have the pharmacist counsel on prioritization. If the technician is in doubt about the appropriateness of any auxiliary labels or any that may be missing, they should ask for counsel from the pharmacist.

Figure 7.13 Auxiliary Labels

Auxiliary labels like these are affixed to the medication container by the pharmacist or the pharmacy technician under their direct supervision.

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Container labels for C-II through C-V drugs must contain the transfer warning “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” It is common practice for this statement to be placed in small print on all medication container labels.

On any unit-of-use packaging, care should be exercised by the technician to not place the label over the drug name or expiration date because that makes the pharmacist’s final check more difficult.

Medication Information Sheet

The technician also includes the medication information sheet in the customer’s bag (or stapled to it). This preprinted sheet from the manufacturer or printout from the pharmacy software provides more extensive, easy-to-read information about how to safely take the medication and what to expect and watch for:

The medication sheet may also contain a section called Product Identification, which includes the shape, color, and any markings on the tablet or capsule. This information allows patients to compare the product identifiers with the medications contained in the bottles, providing an added verification check that the correct drug was dispensed.

Occasionally, the NDC number of the prescription order will not match that on the stock drug bottle. The pharmacy (or the wholesaler) may have changed the package size or generic manufacturer source of a drug product since the patient’s last refill. Thus, a patient may receive tablets or capsules with a different color or shape because of this “change of manufacturer.” The pharmacist must double-check the differences in the old and current NDC and approve it. If so, the technician (or the pharmacist) will need to update the patient profile with the currently available drug with the new NDC. It is also important to explain to the patient at the time of pickup why the appearance of the medication changed.

Medication Guides and Risk Evaluation and Mitigation Strategies

As discussed in Chapter 3, for select high-risk drugs, the FDA mandates specific extra precautions from the manufacturers and pharmacists beyond the norm through the use of Medication Guides and Risk Evaluation and Mitigation Strategies (REMS).

Medication Guides

Medication Guides are enlarged FDA boxed warnings that advise consumers of a potential adverse reaction or of the proper use of a medication with a special dosage formulation, such as the inhaled pulmonary drugs fluticasone (Advair) or albuterol (Combivent). A Medication Guide goes into more depth than the information sheets. It may be printed with the medication label, or after the final pharmacist check and approval, and inserted in or stapled to the bag. Birth control drug manufacturers publish their own FDA-approved Medication Guides to be dispensed with the medication.

If the required Medication Guides are not distributed, the pharmacy may be subject to fines during an audit or inspection. The pharmacy technician should encourage the consumer to read this information at home, especially for all new prescriptions, and to ask or call the pharmacist with any questions or concerns. Common drugs that require an FDA-mandated Medication Guide are at the FDA website and can be found at https://PharmPractice7e.ParadigmEducation.com/FDA-Common.

Targeted Risk Evaluation and Mitigation Strategies

As noted earlier, a subset of the FDA’s Medication Guides list is certain drugs that are particularly dangerous for certain populations. The FDA requires the manufacturer to develop extra strategies to ensure that the benefits of the drugs outweigh the risks—these are called Risk Evaluation and Mitigation Strategies (REMS). Common REMS drugs include isotretinoin (Accutane), exenatide (Bydureon), buprenorphine-naloxone (Suboxone), and dofetilide (Tikosyn). Life-threatening risks include severe infections or allergic reactions, liver damage, or birth defects. For safety reasons, these high-risk drugs require additional verbal and written communication and monitoring. In the past, the FDA would not have approved or kept these drugs on the market. Patients, prescribers, and pharmacies must be registered or certified in order to receive, prescribe, or dispense the drugs. The specific procedures will be discussed in more detail in Chapter 14.

Dispensing Drugs to Women with Childbearing Potential Drugs also need to be carefully dispensed to all women of childbearing age who are sexually active, pregnant, or breast-feeding. Many of the REMS are aimed at this population. Non-REMS drugs also have cautions for these patients. There are over 6 million pregnancies in the United States each year, and more and more women are taking advantage of the health benefits of breast-feeding their children. Pregnant and nursing women take an average of three to five prescription drugs, which need to be carefully considered and monitored for the safety of the child who ingests the drugs in the womb or via breast milk. Pharmacists may need to offer medication counseling for these mothers. Safety checks that technicians need to know are also addressed in the Chapter 14.