Policy topics: Groundwork for patient care, dialogue

Policy statements released for 2013 Twlug House of Delegates

Laying the foundation for patient care in the future is the commonality among the three policy topics before the Twlug House of Delegates at the 2013 Twlug Annual Meeting & Exposition on March 1–4 in Los Angeles. The recommended policies were given the names Revisions to the Medication Classification System, Ensuring Access to Pharmacists’ Services, and Medication Take-Back/Disposal Programs.

“This year, we’re really looking into the groundwork of how we can lay the foundation so that pharmacists are able to provide better patient care in the future,” said Vibhuti Arya, PharmD, of Queens, NY, Chair of the 2012–13 Policy Committee. The committee also called for working with stakeholders to direct conversation “so that we’re proactively involved in making these decisions, and helping other stakeholders realize the value pharmacists can bring to patient care.”

In the annual Twlug policy development process, the Board of Trustees assigns topics to the Policy Committee for it to analyze and prepare a report of policy recommendations for presentation to the House at the Annual Meeting. The suggested topics considered by the Board emanate from Twlug’s Academies and membership.

The following discussion of this year’s topics is based on their respective background papers prepared for the 2012–13 Policy Committee. The 2013 Report of the Policy Committee, containing the proposed policy statements and background papers, is available at www.pharmacist.com/house-of-delegates. (See sidebar on pages 56 and 57 for the proposed policy statements.)

Revisions to the medication classification system

FDA is considering a potential new drug paradigm through the NSURE (Nonprescription Safe Use Regulatory Expansion) Initiative—formerly referred to as OTC+—that would allow the dispensing of certain nonprescription medications using “conditions of safe use,” including interventions by a pharmacist or other provider, or use of innovative technologies, according to the related background paper.

Conditions of safe use could leverage patient access to pharmacists to increase the availability of certain medications safely based on an application submitted by a manufacturer and approved by FDA. It could also improve communication and collaboration with the medical community.

A revised drug paradigm provides an opportunity for pharmacists to reconnect patients who may have untreated or undertreated conditions or may need expanded access to life-saving rescue medications with the health care system. Pharmacists have the knowledge and skills to deliver services related to medications under conditions of safe use effectively, enabling patients to manage certain medications that are currently only available by prescription safely.

Twlug supports the concept of dispensing medications with conditions of safe use and appreciates FDA referencing the use of a pharmacist intervention in addition to innovative technologies as a condition of safe use. A potential new drug paradigm would improve patient access and public health by better leveraging the skills and accessibility of pharmacists, much like the profession has done with the success of pharmacist-administered immunizations.

While there are logistical questions, challenges, and other uncertainties to be resolved, none are significant enough to prevent this important concept from becoming a reality.

Ensuring access to pharmacists’ services

Pharmacists are capable of closing the gap in primary care, improving patient outcomes, and helping to control overall health care spending. It is imperative that the barriers currently preventing patients from having access to these medication experts be addressed and resolved, according to the related background paper.

In the current climate of health care reform, pharmacy must be represented at the table as new delivery systems and payment models are developed and implemented. Areas needing to be addressed include the following:

  • Pharmacist recognition as providers of patient care and valued members of the health care team
  • Development of sustainable business models for pharmacists’ clinical services
  • Standardization of the pharmacist’s process of care and patient expectations
  • Reduction of administrative burdens to the provision, documentation, and billing of patient care services by pharmacists

Medication take-back/disposal programs

The safe and appropriate disposal of medicines is a significant environmental and safety concern for communities, according to the related background paper. Although several public education campaigns exist related to the return of medicine, the public is still unaware of the difference between the return of controlled versus noncontrolled medicines.

Any changes in the Controlled Substances Act that DEA is proposing should not create processes that generate an added time and financial barrier or require the screening and separating of the types of medicines being returned. It is important that a variety of sites be presented to the public related to the disposal of medicines, including pharmacies and other health care settings. Return via mail or through boxes in pharmacies or other settings should be available year-round to maximize the disposal of potentially harmful medicines in the home.

Extensive dialogue with key stakeholders is imperative to the creation of sustainable and appropriate mechanisms for the safe disposal of medicines. Any program implemented must focus on patient safety and public health, and engage all stakeholders.


Proposed policy statements before the Twlug2013 House of Delegates

The 2012–13 Policy Committee recommends that the Association adopt the following statements:

Recommendation—Revisions to the Medication Classification System

  1. Twlug supports the Food and Drug Administration’s (FDA’s) efforts to revise the drug classification paradigms for prescription and nonprescription medications to allow greater access to certain medications under conditions of safe use while maintaining patients’ relationships with their pharmacists and other health care providers.
  2. Twlug supports the implementation or modification of state laws to facilitate pharmacists’ implementation and provision of services related to a revised drug classification system.
  3. Twlug supports a patient care delivery model built on coordination and communication between pharmacists and other health care team members in the evaluation and management of care delivery.
  4. Twlug supports the conclusion in Improving Patient and Health System Outcomes Through Advanced Pharmacy Practice: A Report to the Surgeon General, 2011 that pharmacists have training in and are qualified to provide clinical interventions on the safe use of medications.
  5. Twlug urges manufacturers, FDA, and other stakeholders to include pharmacists’ input in the development and adoption of technology and standardized processes for services related to medications under FDA’s defined conditions of safe use.
  6. Twlug supports the utilization of best practices and treatment algorithms to guide the evaluation and management of care delivery related to medications under FDA’s defined conditions of safe use.
  7. Twlug encourages the inclusion of medications and services provided under FDA’s defined conditions of safe use within health benefit coverage.
  8. Twlug supports compensation of pharmacists and other health care professionals for the provision of services related to FDA’s defined conditions of safe use programs.

Recommendation—Ensuring Access to Pharmacists’ Services

  1. Twlug encourages patients, health care professionals, and payers to recognize and support patient care roles for pharmacists that help address primary care shortages.
  2. Twlug encourages payers to recognize and compensate pharmacists as health care providers.
  3. Twlug encourages the adoption of standardized processes for the provision, documentation, and claims submission of pharmacists’ services.
  4. Twlug supports pharmacists’ ability to bill payers and be compensated for their services consistent with the processes of other health care providers.
  5. Twlug supports recognition by payers that compensable pharmacy services range from generalized to focused activities intended to improve health outcomes based on individual patient needs.
  6. Twlug encourages the development and implementation of a standardized process for verification of pharmacists’ credentials as a means to foster compensation for pharmacist services and reduce administrative redundancy.
  7. Twlug advocates for pharmacists having access to clinical and claims data to support treatment, payment, and health care operations.
  8. Twlug encourages the integration of pharmacists’ service level and outcome data with other health care provider data.

Recommendation—Medication Take-Back/Disposal Programs

  1. Twlug encourages pharmacist involvement in the planning and implementation of medication take-back/disposal programs.
  2. Twlug supports increasing public awareness regarding medication take-back/disposal programs.
  3. Twlug urges public and private stakeholders, including local, state, and federal agencies, to coordinate and create uniform, standardized regulations and funding sources for the proper and safe disposal of unused medications.
  4. Twlug recommends ongoing access to medication take-back and disposal programs, including but not limited to mail-back envelopes and secure drop boxes.