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 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.

The maximum amount that can be bought by an individual customer is 3.6 grams per day and 9 grams in a 30-day period. Note that this refers to the base chemical, not the overall tablet strength of the product.
The act also requires that any products containing ephedrine, pseudoephedrine, or phenylpropanolamine 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 Risk Evaluation and Mitigation Strategies (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, laboratory tests, etc.

One example is isotretinoin, which can be very teratogenic if given to a pregnant women. The Isotretinoin Safety and Risk Management Act outlines the requirements to prevent disastrous effects. 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 7-day time frame in which to fill his or her prescription and can only be given a 30-day supply.

Calculations Required

Here is an example of a calculation that is relevant to the CMEA of 2005:

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

3.6 gram daily limit per CMEA of 2005. 3.6 grams = 3,600 milligrams
3,600 milligrams / 24.6 base milligrams per tablet = 146 tablets
Each box contains 24 tablets, meaning this patient could legally purchase no more than 6 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 that might have been affected. The state BOP and 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 in a similar manner as that 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 who 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 U.S. 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, cardiac pacemakers, etc.

Supplies

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

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, misleading product label claims, etc.

Recall Classifications

The Food and Drug Administration (FDA) may request a drug manufacturer to recall or remove a drug from the market for commercial use. There are a variety or 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.