Research

Role of Pharmacists in Outcomes Research

Policy 9927

11/01/1999 Introduced
03/01/2004 Reapproved
12/01/2008 Reapproved
10/01/2012 Reapproved

02/21/2018 Reapproved

AMCP supports the role of pharmacists in outcomes research, including those processes by which health care systems identify treatment and/or procedural issues, complete interventions to correct deficiencies, and conduct evaluations to measure results and improve care in defined patient populations. In order to improve the appropriate use of medications, enhance favorable patient outcomes, and improve the cost-effectiveness and cost-efficiency of health care, managed health care systems must implement strategies based on credible, relevant outcomes research. Pharmacists are well positioned to design and implement programs and policies to influence the practice of prescribers and pharmacists and to evaluate the effect of these programs on patient outcomes.

(See AMCP Concepts in Managed Care Pharmacy – Outcomes Research).

Pharmacogenomics

Policy 0107

03/01/2001 Introduced
11/01/2005 Reapproved
11/01/2009 Revised
02/01/2014 Revised

02/21/2018 Reapproved

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 Where We Stand Position Statement – Biosimilar Drug Therapies)