Research
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Role of Pharmacists in Outcomes Research 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.
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Clinical Investigations in Children 02/13/2019 Revised
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AMCP supports clinical research focused on meeting the unique therapy needs of children where safety and appropriate use are protected and where appropriate, there is prior experience in the adult population. |
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Complementary and Alternative Medications |
AMCP supports the demonstration of safety and efficacy of complementary and alternative medicines, based on well-designed scientific studies. AMCP recognizes the importance of patient autonomy regarding the use of complementary and alternative medicines in making their health care decisions, and health care professionals should help to educate patients who choose to use complementary and alternative medicines. |
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Funding Health Services Research
02/13/2019 Revised |
AMCP advocates for the establishment of government and private funding for health services research and implementation of programs that optimize and distribute research outcomes by pharmacists and pharmaceutical organizations. |
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Investigational Drug Use
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AMCP supports the involvement of pharmacists in the management of drugs used in clinical research studies. In addition, AMCP supports pharmacist participation with pharmacy and therapeutics committees and institutional review boards in the design and performance of medication-related clinical research. |
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Pharmacogenomics 02/21/2018 Reapproved |
AMCP supports further research and assessment of the economic, clinical, and humanistic impact of pharmacogenomics on managed care pharmacy practice. AMCP supports the pharmacist's leadership role in the review and evaluation of scientific evidence and the subsequent development of pharmaceutical care processes involving these therapies through collaboration with other health care practitioners and consumer organizations. Pharmacy and Therapeutics Committees in collaboration with Health Technology Assessment committees should be involved in the decision-making process related to coverage of genetic tests and utilization management strategies. |
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Regulation of Dietary Supplements |
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.
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Comparative Effectiveness of Prescription Drugs |
The purpose of comparative effectiveness research is to assist consumers, clinicians, purchasers and policymakers to make informed decisions that will improve health care at both the individual and population levels. The Academy supports research and the development of practical tools to provide guidance on the comparative effectiveness and value of prescription drugs to improve patient outcomes. Recent legislation, including the Affordable Care Act, has directed new funding toward this research. The Academy believes that the federal government must continue to assume principal responsibility for sponsoring this type of research. Such research is a fundamentally necessary component of any rational approach to determining the value and usefulness of prescription drugs. Currently, only limited authoritative research exists that distinguishes the effectiveness and safety profile offered by any particular drug as compared to other drugs in the same or a similar treatment class. The Academy believes that patient treatment decisions must take into account the clinical effectiveness and safety of prescription drugs and that a decision to utilize prescription drugs must be based upon the strength of credible scientific evidence and best practices. |
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Biosimilar Drug Therapies |
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.
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