P&T Committee Resource Center

2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease

The American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Clinical Practice Guidelines has commissioned this guideline to consolidate existing recommendations and various recent scientific statements, expert consensus documents, and clinical practice guidelines into a single guidance document focused on the primary prevention of cardiovascular disease. This guideline also includes newly generated recommendations for aspirin use, exercise and physical activity, and tobacco use, in addition to recommendations related to team-based care, shared decision-making, and assessment of social determinants of health.

ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System

Guidelines published 2008; reviewed by ASHP 2012 and found to still be appropriate. Details formulary system, role of P&T committees, managing formularies, evaluating drug for inclusion; strategies for managing medication use; incorporating patient safety in decision making

ASHP Principles of a Sound Drug Formulary System

Position paper (published 2000 and reviewed 2011) from coalition of organizations to develop guiding principles specifying essential components of a sound drug formulary system

Formulary Management

5-page AMCP paper overview of basic info on formulary management including development and role of P&T committee.

Where We Stand: Formularies

AMCP position paper that supports use of evidence-based formularies to enhance quality of care by encouraging use of medications that are demonstrated to be the safest, mose effective and produce positive patient outcomes.

ISPOR Global Health Care Systems Road Map: Overview of Health Care in the US

Relatively brief (8 pgs) informative treaty on healthcare financing and roles of various decision makers.  Includes drug pricing and reimbusement process and differences between public and private sectors.  Concise discussion of role of P&T committee and data requirements for submission to formulary.

AMCP Format Dossier Requests: Manufacturer Response and Formulary Inplications for One Large Health Plan

Study evaluated pharmaceutical manufacturers' response to request for a product dossier prepared using AMCP format and to determine if dossier receipt was associated with a favorable fromulary placement.

Pharmacy and Therapeutics Committee: Leadership Opportunities in Medication Safety for Medical Toxicologists

Discusses importance of P&T committees to do assessment of safety of newly approved drug and the committee's role in investigating adverse drug events to improve drug utilization processes.

The right drug, but from whose perspective? A framework for analysing the structure and activities of drug and therapeutics committees.

Study was based on both US and European drug and therapeutics committees (DTCs - same as P&T).  Informative discussion of goals, organization and decision-making process including importance of promoting evidence-based medicine to change the behavior of physicians.

Literature review on structure and operation of Pharmacy & Therapeutics Committees

Conclusion was that most influential factors in decision-making process were clinical trial results or drug cost rather than pharmacoeconomic studies.

How Formularies Make an Impact (Blog)

Discussion of pros and cons of formulary mgmt in general and statewide formularies in particular.

Drug and Device Manufacturer Communications With Payors, Formulary Committees and Similar Entities - Questions and Answers: Guidance for Industry and Review Staff

Solicitation of comments and suggestions for FDAMA 114

FDAMA 114: Improving the Exchange of Pharmacoeconimic Data

Proceeding from AMCP Partnership Forum, Mar 2016. Diverse group of stakeholders to provide FDA with considerations for disseminating guidance document on sharing of HCEI to those responsible for formulary decision making

FDA Says Yes to Pre-Approved Communications with Payors but Reaffirms its Approach to Restrictions on Off-Label Communications

Article (written by associate at Becker, Epstein & Green; healthcare law firm) that analyzes FDA Guidance from a legal standpoint

Medicare Modernization Act: 2007 Final Guidelines - Formularies

CMS Strategy for affordable access to comprehensive drug coverage.  Guidelines for reviewing prescription drug plan formularies and procedures.  Requirements of P&T committees

Where We Stand: Government-Mandated Pharmacy Benefits

AMCP position statement against mandates imposed by gov't which lead to restrictions on MCO's ability to deliver a quality product and decrease the affordability and financial sustainability of the benefit.  These include mandated formulary content, mandated coverage parity terms and mandated coverage of medications.  Discussion of intended consequences to these mandates.

Observations on Trends in Prescription Drug Spending

Informative statistical info on drug spending and factors leading to rise in spending 2010-2014

The Changing Roles of P&T Committees: A Look Back at the Last Decade and a Look Forward to 2020

Scope of P&T committees has expanded as larger health systems have emerged servicing both inpatient & outpatient needs in multiple hospitals & ambulatory care centers and as new drugs and biotech therapies enter the market

Reinventing the Pharmacy and Therapeutics Committee

Current challenges to P&T committees include exploding number of  complex pharmaceuticals with a wider array of indications at unprecedented costs.  At the same time, value-based reimbursement and accountable-care models force focus on cost containment and care mgmt strategies.  Discusses how P&T committees should evolve.

Tranforming the P&T Committee

Letter to Editor response to above article.  Offers additional thoughts on new, expanding role of P&T Committees

AMCP Seeks an End to 20 Years of Confusion over FDAMA Section 114

Discussion of regulations needed to clarify boundaries of promotion of pharmacoeconomic data

FDA Revisits Rules on Drug and Device Communication

Discussion of draft guidance on HCEI which clarifites and expands the types of info companies can send P&T and formulary committee under FDAMA 114. Also discussion of Section 204 where drug and device manufacturers want to be able to supply data beyond what is developed through clinical trials.