Medication Safety

AMCP believes that pharmacists have a responsibility to identify potential and actual drug-related problems, resolve actual drug-related problems, and prevent potential drug-related problems. Therefore, AMCP encourages pharmacists to take responsibility in promoting the development, maintenance, and ongoing evaluation of programs to reduce the risk of ADEs in enrolled populations and individuals through detecting, reporting, and assessing any suspected ADEs. AMCP also encourages pharmacists to take a leadership role within managed health care systems to establish a non-threatening, non-punitive, confidential work place environment that encourages pharmacists and other health care professionals to report actual and suspected adverse drug events in a timely manner.

AMCP is concerned that a distinct brand name on an OTC product does not always refer to the same active ingredient(s).  This inconsistent relationship between brand name and ingredients may be confusing to some patients and may lead to medication errors and adverse events.  AMCP believes that the naming approach should be changed to avoid this confusion.   In conjunction with pharmacists, physicians, and other health care professionals, product names and packaging should be adopted and designed to minimize confusion and prevent adverse outcomes. 

AMCP advocates the modification of the Dietary Supplement Health and Education Act or enactment of other legislation for all products falling under the Act, requiring that dietary supplement manufacturers provide evidence of product efficacy and safety, label products with full disclosure of all components (including source, strength, and recommendations for use), and implement a mechanism to remove promptly unsafe or ineffective products from the marketplace. AMCP encourages expansion of the National Institutes of Health Office of Dietary Supplement's Internet site to include reports of adverse health events from manufacturers, health care professionals, consumers, the Food and Drug Administration, and the Center for Food Safety and Applied Nutrition.

AMCP supports the leadership role of pharmacists within specialty pharmacy, including ensuring the proper use, storage, control, safe handling, preparation, distribution, administration, and care management processes for these medications. Specialty pharmaceuticals are generally high-cost medications, usually prescribed for people with complex or chronic medical conditions, or they may be medications that typically exhibit one or both of the following characteristics:

• drugs that have unique monitoring, storage, or shipment requirements; and 

• drugs that require additional patient education and support from a health care team which includes a pharmacist with specialty medication experience.

AMCP generally opposes any restrictions on the distribution of pharmaceutical products either by the pharmaceutical industry or as a condition for FDA-approval. AMCP acknowledges that circumstances may occur with the use of specific medications that require special distribution, monitoring and management processes. As long as,

1. The requirements do not interfere with the continuity of care for the patient or limit patient access;

2. The requirements preserve the pharmacist-patient relationship and patient choice of pharmacy;

3. The requirements are based on evidence-based medicine, fully disclosed and evaluated by physicians, pharmacists, and others;

4. There is scientific consensus that the requirements are necessary and represent the least restrictive means to achieve safe and effective patient care;

5. The cost of the product and any associated product or services are identified for purposes of reimbursement, mechanisms are provided to compensate providers for special services, and duplicative costs are avoided;

6. All requirements are stated in functional, objective terms so that any provider who meets the criteria may participate in the care of patients;

7. The requirements do not interfere with the professional practice of pharmacists, physicians, or other appropriately qualified healthcare professionals;

(The enumerated principles are drawn from ASHP Principles for Restricted Distribution Systems)

Prescription Drug Importation

Policy 0302

02/01/2003 Introduced
02/01/2008 Revised
02/01/2013 Revised
02/21/2021 Revised

Legislation or regulation that would permit the importation of prescription drugs presents potential patient safety issues. Allowing the importation of prescription drugs raises a challenge to ensure that quality assurance standards and supply chain integrity are maintained. There is scant evidence that importation will meaningfully impact the price of prescription drugs available to U.S. consumers, but ample evidence that it presents a clear threat to the security of our nation’s drug supply. AMCP will oppose legislation or regulation that would allow the importation of prescription drugs for sale in the United States until more conclusive data are available as to its likely impact.

(See also AMCP Managed Care Pharmacy Practice Positions - Prescription Drug Importation)

AMCP supports an abbreviated licensure pathway for the approval of biosimilar biologic drug therapies. In order to strike an appropriate balance between bringing safe and effective drugs to market and maximizing patient access to affordable drugs, the FDA should determine on a case-by-case basis the need for additional clinical studies prior to approval, as well as any post-marketing studies. Manufacturers of approved biosimilars should be allowed to use the same government-approved/international non-proprietary name as the reference product. The FDA should also provide clear rules for the designation of a biosimilar product as interchangeable with a reference product, similar to the current “AB” ratings used for small-molecule chemical drugs. A designation of interchangeability should not be a requirement as a condition for approval of a biosimilar product.

(See AMCP Managed Care Pharmacy Practice Positions - Biosimilar Drug Therapies)