Federal Requirements Study Guide for the PTCB Exam

Restricted Drug Programs

Some medications can be harmful if taken by the wrong patients, such as people who are pregnant or have a specific disease that would be a contraindication for use of that drug. As such, certain potentially harmful medications have specific criteria that must be met before the prescription can be filled. Also, certain over-the-counter (OTC) medications like pseudoephedrine have strict quantity limits to cut down on the potential for illegal misuse.

Pseudoephedrine

The Combat Methamphetamine Epidemic Act of 2005 (CMEA) places restrictions on the sale, storage, and record requirements for products containing ephedrine, pseudoephedrine, and phenylpropanolamine. This act dictates the following:

• The maximum amount that can be bought by an individual customer is 3.6 grams per day and nine grams in a 30-day period. Note that this refers to the base chemical, not the overall tablet strength of the product.

• Any products containing ephedrine, pseudoephedrine, or phenylpropanolamine must be kept behind the pharmacy counter to make sure all the required documentation is completed with the sale and to prevent theft.

• An electronic or written logbook must be kept detailing the personal information of the person purchasing the product and quantity, strength, date, and time of the product sale.

Risk Evaluation and Mitigation Strategies (REMS)

The REMS program between the FDA and drug manufacturers helps limit inappropriate dispensing and protects patients. Each drug has different criteria that must be met and this can include patient education, elements for safe use of the medication, a communication plan between healthcare providers and the patient, and laboratory tests.

One example is isotretinoin, which can be very teratogenic (abnormality-causing) if given to a pregnant woman. The Accutane Safety and Risk Management Act outlines the requirements to prevent disastrous effects (Accutane® is a brand name of isotretinoin). The law requires patients to have a blood test and be counseled on safe use before being given a prescription. The patient also has a seven-day time frame in which to fill their prescription and can only be given a 30-day supply.

Calculations Required

You should know the restrictions of the CMEA. Here is an example real-world situation in which you will need to do the relevant calculations.:

A patient comes to the pharmacy counter to purchase pseudoephedrine HCl 30 MG (24.6 MG base) tablets. Each box consists of 24 tablets. What is the maximum number of boxes the patient can legally buy from your pharmacy today?

Solution

The CMEA dictates that an individual can purchase a maximum of 3.6 grams in a day, which is 3,600 milligrams. Doing the relevant calculations, we’ll get our answer:

3,600 milligrams/24.6 base milligrams per tablet = 146 tablets 146 tablets/24 tablets per box ≈ 6.1

Therefore, this patient could legally purchase no more than six boxes from your pharmacy today.

Recalls

In the event of a drug or product recall, the pharmacy must comply with the recall and keep accurate records to aid in the safety of patients who may have been affected. The state board of pharmacy (BOP) and the Joint Commission’s recommendations must be followed. The pharmacist needs to contact all patients who might have been affected and reconcile the need for the recall. All recall records should be maintained similarly to those for prescriptions.

Recall Targets

The FDA can request a recall of any medical product available on the market. The pharmaceutical manufacturer can also voluntarily recall a product due to a variety of safety concerns or product issues. These recalls are sent to distribution wholesalers, which are then sent to the pharmacies that purchase and then supply to the public. If the recall is severe enough (Class I), it will require the pharmacy to personally reach out to any patients affected.

Medications

Medications can be recalled for a variety of reasons. Recalls are essential to protect the public from imperfect or potentially dangerous medications that are discovered after the medication has reached the US market. The most common reasons for a medication recall include product contamination, presence of impurities, product mislabeling, and adverse effects.

Devices

Medical devices can become defective or a health hazard, which would warrant a product recall. Common medical devices include insulin pumps, glucose meters, infusion pumps, glucose test strips, and cardiac pacemakers.

Supplies

Medical supplies have also been recalled by the FDA or by medical supply manufacturers due to faulty components. Common medical supplies include needles, syringes, surgical gloves, sterile saline and water solutions, and catheters. A syringe with incorrectly printed scale markings or surgical gloves that have a powdered residue are examples of medical supplies that would need to be recalled.

Supplements

Just like prescription and over-the-counter medications, supplements are also recalled from time to time for various health reasons. Common reasons for recall of supplements include contamination, presence of undeclared ingredient(s), super/subpotency, product mislabeling, and misleading product label claims.

Recall Classifications

The FDA may request a drug manufacturer to recall or remove a drug from the market for commercial use. There are a variety of reasons a drug can be recalled, including problems with the dosage, form, or adverse reactions related to the specific medication. There are three types of FDA recalls:

• Class I is the most severe type of recall and involves medication that is likely to cause severe adverse effects or even death. This can also occur if one drug is labeled as another drug.

• Class II occurs when medication may cause temporary adverse health effects that are reversible or if there is a small risk of serious adverse effects.

• Class III is the least severe type of recall. The medication in question is not likely to cause a patient to have adverse effects.

FDA Product Management

The Drug Supply Chain Security Act (DSCSA) was enacted and signed into law in November 2013. It was created to improve the pharmaceutical supply chain ecosystem in the United States. The DSCSA sets standards for electronic tracking and tracing of prescription drugs throughout their entire life cycle. Doing so helps minimize the ability for counterfeit, illicit, illegal, stolen, and contaminated drugs from infiltrating the pharmaceutical market and causing unwanted danger to patients. Key components of the DSCSA include product serialization/identification, tracking and tracing, product handing, and quarantining standards.

Serialization

Every prescription medication package must have a unique product identifier as the serialization requirement of the DSCSA. This unique product identifier is a barcode that can be scanned to identify the product’s NDC, serial/lot number, and expiration date. This enables pharmacies and other suppliers to confirm a medication’s legitimacy.

Tracking and Tracing

To improve the safety and efficacy of prescription drug purchasing and receiving, pharmacies must maintain proper records for the prescription medications they handle. Proper recordkeeping of the following is essential:

• transaction information (TI)—NDC, drug name, dosage, formulation, quantity

• transaction history (TH)—entities in the drug supply chain that handled the product prior to being received

• transaction statement (TS)—confirmation that the prescription drug products are legitimate and were received by legal and authorized channels (e.g., licensed wholesalers)

These important pieces of documentation must be exchanged when a prescription drug changes ownership. Records must be kept for at least six years and readily available in the event they need to be referred to.

Handling

Prescription medications must only be handled by authorized entities and procured through legitimate means. Pharmacies can only purchase prescription drugs through authorized trading partners, like wholesalers or drug manufacturers. Doing so decreases the chance of an illegal or counterfeit product entering the drug market or causing harm to a patient. In some cases, pharmacies are able to purchase prescription drugs from another pharmacy if needed to fulfill the dispensing of a patient’s prescription, since the original pharmacy obtained the drug through legitimate means (e.g., drug wholesaler).

For simplicity, the basic drug supply chain is as follows:

drug manufacturer > drug wholesaler > pharmacy > patient

Examples:

• drug manufacturer—Novo Nordisk
• drug wholesaler—Cardinal Health
• pharmacy—Walgreens
• patient—Jane Doe

Quarantining Requirements

When a medication is identified as being illegal, tainted, misbranded, counterfeit, contaminated, or unsafe, it must be quarantined appropriately so it is not dispensed downstream in the drug supply chain. Quarantining includes keeping the suspect medication away from the regular inventory. The FDA should be notified within 24 hours of discovery. FDA Form 3911 is used to report illegitimate products. The FDA will use the report to investigate how the medication entered the drug supply chain, trace its movement, and identify who may have been affected.