APhA Policy Manual

Drug Supply Shortages and Patient Care

1. APhA supports the immediate reporting by manufacturers to the U.S. Food and Drug Administration (FDA) of disruptions that may impact the market supply of medically necessary drug products to prevent, mitigate, or resolve drug shortage issues and supports the authority for FDA to impose penalties for failing to report.
2. APhA supports revising current laws, regulations, and policies that restrict the FDA’s ability to provide timely communication to pharmacists, other health care providers, health systems, and professional associations regarding potential or real drug shortages.
3. APhA encourages the FDA, the Drug Enforcement Administration (DEA), and other stakeholders to collaborate in order to minimize barriers (e.g., aggregate production quotas, annual assessment of needs, unapproved drug initiatives) that contribute to or exacerbate drug shortages.
4. APhA should actively support legislation to hasten the development of an efficient regulatory process to approve therapeutically equivalent generic versions of biologic drug products.
5. APhA encourages pharmacists and other health care providers to assist in maintaining continuity of care during drug shortage situations by
   1. creating a practice site drug shortage plan as well as policies and procedures;
   2. using reputable drug shortage management and information resources in decision making;
   3. communicating with patients and coordinating with other health care providers;
   4. avoiding excessive ordering and stockpiling of drugs;
   5. acquiring drugs from reputable distributors; and
   6. heightening their awareness of the potential for counterfeit or adulterated drugs entering the drug distribution system.
6. APhA encourages accrediting and regulatory agencies and the pharmaceutical science and manufacturing communities to evaluate policies/procedures related to the establishment and use of drug expiration dates and any impact those policies/procedures may have on drug shortages.
7. APhA encourages the active investigation and appropriate prosecution of entities that engage in price gouging and profiteering of medically necessary drug products in response to drug shortages.

“Beyond-Use Dating” by Pharmacists

APhA recommends that all pharmacists place a “beyond-use date” on the labeling of all medications dispensed to patients as recommended by the United States Pharmacopeia National Formulary or manufacturer.

Expiration Dating

APhA supports manufacturers of prescription and non-prescription drugs including on the package label adequate information regarding storage requirements and a date after which the product should not be used.

Medication Verification

APhA encourages including a description of a medication’s appearance on the pharmacy label or receipt as a means of reducing medication errors and distribution of counterfeit medications.

Identification of Prescription Drug Products

APhA supports a federal requirement that a name, trademark, number, or code be included on the drug dosage form.

Manufacturer’s Name Included on Labels

APhA supports requirements for the name of the actual manufacturer of the dosage forms on all drug products.

National Drug Code: Uniform Identification Numbers

APhA supports modification of the National Drug Code system to provide uniform identification numbers for the same drug entity, dosage form, strength, and quantity in addition to a manufacturer’s identification number.

Standardized Manufacturers’ Control Numbers

APhA encourages manufacturers to adopt a standardized system of control numbers that meets the following guidelines:

1. The number should be legible.
2. The numbers should be placed in a standard position on the label.
3. The date of manufacture should be obvious from the control number.
4. The number should be on both the carton and the original container.

Gluten Content and Labeling in Medications

1. APhA supports labeling of all prescription and nonprescription products, as well as dietary supplement products, to indicate the presence of gluten.
2. APhA encourages manufacturers to formulate drug products without use of wheat, barley, rye, or their derivatives whenever possible.
3. APhA supports additional research on the effects of gluten intolerance and celiac malabsorption, particularly as it relates to medication absorption.
4. APhA supports pharmacist education regarding celiac disease and non-celiac gluten sensitivity.
5. APhA encourages the development of analytical methods that can accurately detect lower levels of gluten than the current standard (20 ppm) and for the establishment of evidence-based gluten-free standards for the labeling of foods, excipients, dietary supplements, and prescription and nonprescription products.

Disclosure of Ingredients in Drug Products

APhA supports requirements for full disclosure of therapeutically inactive, as well as active ingredients of all drug products.

Regulation of Dietary Supplements

1. APhA shall work with Congress to modify the Dietary Supplement Health and Education Act or enact other laws, regulation, or policies to require that dietary supplement manufacturers provide evidence of efficacy and safety for all products, including products currently in the marketplace.
2. APhA supports the establishment and implementation of clear and effective enforcement policies to remove promptly unsafe or ineffective dietary supplement products from the marketplace.
3. APhA shall work with the FDA to improve dietary supplement product labeling to ensure full disclosure of all product components and their source with associated strengths and recommendations for use in specific patient populations.
4. APhA supports the development and enforcement of dietary supplement good manufacturing practices (GMPs) and compliance with USP/NF standards to ensure quality, safe, contaminant-free products.
5. APhA encourages health care professionals, manufacturers, and consumers to report adverse health events associated with dietary supplements. APhA encourages the FDA to create a database with this information and make it available to all interested parties.