Supply Chain Management

Drug and Device Recalls

Policy 0009

02/01/2000 Introduced
02/01/2005 Revised
11/01/2009 Reapproved

AMCP supports the use of technologies to enhance communication of recall information to all relevant parties including patients who may have received such products.

Restricted Distribution of Pharmaceuticals

Policy 0119

11/01/2001 Introduced
02/01/2006 Revised
12/01/2010 Revised

04/07/2015 Revised

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;

 2. The requirements preserve the pharmacist-patient relationship;
3. The requirements are based on scientific evidence 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. June 2007)

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 Where We Stand Position Statement – Prescription Drug Importation)

Supply Chain Integrity

(Title prior to 02/21/2021 revision: Pharmaceutical Counterfeiting)

Policy 0505

10/01/2005 Introduced
02/01/2010 Reapproved

02/21/2021 Revised

AMCP encourages all entities involved in the pharmaceutical supply chain to assure that product integrity and stability is maintained throughout the continuum of the distribution system. AMCP supports the purchase and handling of products in ways that enhance the transparency and integrity of the product supply chain and encourages pharmacists to identify instances of product counterfeiting or adulteration. AMCP encourages efforts to provide consumers and health care professionals with information on how to avoid counterfeit or adulterated products and how to recognize, respond to, and report encounters with suspicious products.  

Drug Shortages

Policy 1102

10/01/2011 Introduced

02/21/2021 Reapproved

AMCP encourages health care stakeholders, government agencies, and the pharmaceutical industry to work collaboratively to seek proactive and strategic solutions to minimize the number and impact of drug shortages on the drug distribution process and patient outcomes.