51 Prescription for change: advocacy and legislation in pharmacy
Kevin Cowart, PharmD, MPH, BCACP, CDCES
Veronica Vernon, PharmD, BCPS, BCACP, NCMP
Cortney Mospan, PharmD, BCACP, BCGP, CPP
At the end of this case, students will be able to:
- Compare and contrast collaborative practice agreements, standing orders, and protocols
- Describe the impact of pharmacist utilization of collaborative practice agreements, standing orders and protocols to advance patient care
- Identify potential barriers and solutions to utilization of collaborative practice agreements, standing orders, and protocols in pharmacy practice
The role of the pharmacist has evolved from primarily distributive in nature to one that is more directly involved in patient care. Advancements in scope of pharmacy practice have been implemented in many states under collaborative practice agreements (CPA) – defined as formal practice relationships between a pharmacist and healthcare practitioner, allowing the pharmacist to assume responsibility for delegated patient care functions.1 Such agreements have allowed pharmacists to work in interdisciplinary settings to improve clinical and economic outcomes related to several chronic diseases such as diabetes and hypertension.2,3 For example, a CPA for diabetes management typically allows for a pharmacist to initiate, adjust, or discontinue antidiabetic medications, order laboratory tests to monitor efficacy of treatment, and provide diabetes-related lifestyle and medication counseling. CPAs may be implemented in a variety of clinical settings including inpatient, ambulatory, community, and managed care. Although most states permit pharmacist-prescriber collaborative practice authority through CPAs, state laws vary widely, and CPAs must be customized to the laws and regulations under each state’s pharmacy practice act and regulations.4 For example, some states restrict pharmacists to only enter CPAs with physicians, excluding agreements with mid-level practitioners.
Effective implementation of a CPA is crucial and will ensure compliance with local institution requirements, regulatory bodies, and state level rules (i.e., those endorsed by the state Boards of Pharmacy and Medicine). Infrastructure and process change may be necessary to integrate pharmacists’ patient care services under a CPA within an organization, especially if no prior pharmacist services exist. Initial and ongoing education to stakeholders (chief medical officer, billing/compliance personnel, physicians/medical providers, and patients) may be necessary to build trust and ensure an understanding of the role of each party defined within a CPA.5
Although CPAs are a useful tool in expanding the role of the pharmacist to meet patient needs, they may be restrictive. CPAs can be patient-specific, meaning that a CPA must be authorized for each individual patient, or they can be population-specific, meaning they apply to a designated group of patients.6 In contrast to a CPA, statewide standing orders and protocols do not require pharmacists to find an individual prescriber to authorize prescribing abilities. These can be used to address larger public health needs where CPAs may not be practical. Standing orders and statewide protocols are used to broaden access to care and have been used by several states to allow pharmacists to provide medications. These two methods can be especially useful for public health needs (Table 1).
Examples of medications relevant to these methods include contraception, tobacco cessation medications, immunizations, HIV pre- and post-exposure prophylaxis, and naloxone. Under a standing order, a state official (typically the state health official) authorizes pharmacists to dispense select medications. Most states utilize a standing order for pharmacists to provide patients with naloxone.7 On the other hand, protocols are a version of autonomous prescribing where a state agency, such as the Board of Pharmacy, authorizes pharmacists to prescribe if a designated protocol is followed. Another option for increasing patient access to care is the use of unrestricted or categorical prescribing by pharmacists.
Table 1. Collaborative practice agreements, standing orders, and protocols
|Description||Allows the prescriber to enter into an agreement which delegates certain patient care functions to a pharmacist after a diagnosis is made||Written instructions that authorizes pharmacists without prescribing authority to supply specific medications when certain conditions are met that applies to a broad population
Licensed independent practitioner who authorized is the prescriber
|Allows for pharmacist initiation of a medication for a patient to meet a public health need. Utilized commonly for conditions and needs that do not require independent diagnosis and often executed for a certain activity
Pharmacist is the prescriber
|Examples||Management (pharmacologic, non-pharmacologic, and monitoring) of hypertension||Contraception, naloxone, tobacco cessation, immunizations||Contraception, naloxone, tobacco cessation, immunizations, post-exposure prophylaxis|
Table 2. Board of Pharmacy statewide protocol and CPA
|STATEWIDE PROTOCOL FOR TOBACCO CESSATION MEDICATIONS||A pharmacist may prescribe medication(s) for tobacco cessation medication if the following requirements are met:
Medications covered: Any FDA-approved medication for tobacco cessation medication
Education/training requirements of pharmacist: Active pharmacist license
Screening: The pharmacist shall utilize and document a health screening procedure based on the Clinical Practice Guideline for Treating Tobacco Use and Dependence.
Documentation: The pharmacist shall keep the health screening information and all documentation related to treatment per the medical record keeping requirement by the state. The pharmacist must document what medication(s) were prescribed, including the directions and refills.
Notification of the PCP: If a primary care provider exists, the pharmacist must notify the primary care provider that a prescription was provided to the patient within 7 business days.
|COLLABORATIVE PRACTICE AGREEMENTS||Under collaborative practice agreements, pharmacists are authorized to implement predetermined drug therapy, which includes diagnosis and product selection by the patient’s physician, modify prescribed drug dosages, dosage forms, and dosage schedules, and to order laboratory tests pursuant to a drug therapy management agreement that is physician, pharmacist, patient, and disease-specific.|
1. Compare and contrast the use of a CPA, standing order, and statewide protocol for managing tobacco cessation. Discuss the benefits and drawbacks to each option.
2. What initial strategies might be necessary to identify external stakeholders and internal resources for your pharmacy to implement the statewide protocol to address tobacco cessation?
3. Assume you practice in a state where you cannot prescribe any medications under a CPA, statewide protocol, or standing order. How might you work to change your state’s policies?
4. In what situations or conditions would it be useful to have a standing order or statewide protocol rather than a CPA? Hint: Consider patient location, practice site, and public health concerns and consider state level data, such as that from https://www.americashealthrankings.org/.
5. What are the public health benefits for independent prescriptive authority for pharmacists (authority not dependent on a CPA, standing order, or statewide protocol)? Would it be useful to consider this policy option in this scenario or in any other situations?
6. A local obstetrician/gynecologist approaches you, as they would like you to help manage contraception for patients in your community. Under your state policy, what would you be permitted to do? What is a limitation under the current policy? What could you and the OBGYN do to improve the policy?
Pharmacists have the ability to improve access to care and improve public health through CPAs, standing orders, and statewide protocols.5 As the profession of pharmacy continues to evolve, pharmacists must be innovative in designing patient care services that add value – in terms of both revenue and clinical outcomes.8 When crafting policy related to pharmacist prescriptive authority, careful attention must be given to how the greatest number of patients can be served. Policies should be framed in a manner that reduces barriers and allows pharmacists to practice within the standard of care. Arbitrary restrictions, such as training and documentation requirements beyond what is required for other health care professionals and patient age limits, should be avoided. Pharmacists are the most accessible healthcare professionals, and limits on who the pharmacist may treat should be avoided. Pharmacists should be encouraged to use their best professional judgement in determining if they are best served to meet the needs of a patient, or if the patient warrants referral to another provider. Policies that allow pharmacists to practice at the top of their education and training are ideal. Consideration must also be given in polices related to billing and reimbursement.
Pharmacists have an opportunity to lead efforts in designing and implementing public health programs that address the needs of the population in light of an ongoing primary care physician shortage. In order to successfully implement a policy related to pharmacist prescriptive authority, all stakeholders need to be involved in early discussions, including, but not limited to pharmacists, pharmacy technicians, pharmacist interns, public health officials, other prescribers (such as physicians, nurse practitioners, physician assistants, etc.), employers, and payers. This will help prevent barriers and ensure the needs of the population are met. Developing relationships with individuals and organizations outside of the profession of pharmacy is also essential. Public health officials, patient advocacy groups, health care provider organizations, and employer groups can help support policies that will improve access to care. National organizations can also be great partners, and many have state offices to assist with policy work (such as the American Lung Association, American Cancer Society, American College of Obstetricians and Gynecologists, AIDS United, and others). Most importantly, it is important to educate legislators and government officials about the vital role pharmacists play in public health and the diverse practice settings across the profession.
Patient Approaches and Opportunities
Policy approaches that permit the pharmacist to practice at the top of their license and training significantly benefit patients. After implementing a statewide protocol for pharmacist-prescribed contraception in Oregon, an estimated 51 unintended pregnancies were avoided, which saved the state $1.6 million.9 When considering the best policy approach for expanding patients’ access to care through pharmacist services, special consideration should be given to autonomous prescribing. One study revealed fatal overdoses were significantly reduced in states that provided direct authority for pharmacists to provide naloxone.10
When implementing new laws and regulation aimed at public health efforts and increasing access to care, pharmacists must take many factors into consideration. Workflow and time constraints tend to be the biggest concerns,11,12 alongside payment. Ensuring pharmacist services are covered by patient insurance is crucial, in addition to determining how to assist patients who are uninsured or underinsured. When crafting policy, pharmacists must start conversations with stakeholders, such as physicians, patients, public health officials, insurance companies, employers, professional organizations, and colleges of pharmacy immediately. This will assist in navigating barriers to policy solutions early in the process and increase the impact on patient care. Pharmacists also need to ensure that policies are implemented correctly. Offering training opportunities and including other personnel, such as technicians and students, can help to successfully launch and sustain new services.
Patients can greatly aid in advocacy efforts aimed at public health. Pharmacists can collect patient stories to share with policy makers or ask patients to share their personal experiences directly. Policies, including laws and rules, are aimed at improving and protecting public welfare.
Related chapters of interest:
- The “state” of things: Epidemiologic comparisons across populations
- Smoke in mirrors: the continuing problem of tobacco use
- Hormonal contraception: from emergency coverage to long-term therapy
- Deciphering immunization codes: making evidence-based recommendations
- A pharmacist’s obligation: advocating for change
- Staying on track: reducing missed immunization opportunities in the pediatric population
- A stigma that undermines care: opioid use disorder and treatment considerations
- Travel medicine: what you need to know before you go
- PrEPare yourself: let’s talk about sex
- National Alliance of State Pharmacy Associations. Collaborative practice agreements: resources and more. https://naspa.us/resource/cpa/
- National Alliance of State Pharmacy Associations. Pharmacist prescribing: statewide protocols and more. https://naspa.us/resource/swp/
- Society of St Vincent de Paul. Collaborative practice agreements: an implementation guide for community pharmacies. https://bi3.org/wp-content/uploads/2020/01/1-CPA-Implementation-Guide-1.pdf
- Centers for Disease Control and Prevention. Advancing team-based care through collaborative practice agreements: a resource and implementation guide for adding pharmacists to the care team. https://www.cdc.gov/dhdsp/pubs/docs/CPA-Team-Based-Care.pdf
- American Medical Association. Embedding pharmacists into the practice. https://edhub.ama-assn.org/steps-forward/module/2702554
- Giberson S, Yoder S and Lee MP. Improving patient and health system outcomes through advanced pharmacy practice. A report to the U.S. Surgeon General. Office of the Chief Pharmacist, US Public Health Service. 2011. https://jcpp.net/wp-content/uploads/2015/09/Improving-Patient-and-Health-System-Outcomes-through-Advanced-Pharmacy-Practice.pdf
- SAFE Project. State naloxone access rules and resources. https://www.safeproject.us/naloxone-awareness-project/state-rules
- Journal articles:
- , , , . Current status of prescriptive authority by pharmacists in the United States. J Am Coll Clin Pharm 2020;3:807–17. ,
- National Governors Association. The expanding role of pharmacists in a transformed health care system. 2015. https://www.nga.org/files/live/sites/NGA/files/pdf/2015/1501TheExpandingRoleOfPharmacists.pdf. Accessed May 18, 2021.
- Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc (Wash) 2003;43(2):173-84.
- Carter BL, Coffey CS, Ardery G, Uribe L, Ecklund D, James P, et al. Cluster-randomized trial of a physician/pharmacist collaborative model to improve blood pressure control. Circ Cardiovasc Qual Outcomes 2015;8(3):235-43.
- Centers for Disease Control and Prevention. Advancing team-based care through collaborative practice agreements: a resource and implementation guide for adding pharmacists to the care team. 2017. https://www.cdc.gov/dhdsp/pubs/docs/CPA-Team-Based-Care.pdf. Accessed: June 19, 2018.
- Centers for Disease Control and Prevention. Collaborative practice agreements and pharmacists’ patient care services: a resource for pharmacists. 2013. https://www.cdc.gov/dhdsp/pubs/docs/translational_tools_pharmacists.pdf Accessed May 18, 2021.
- Adams AJ, Weaver KK. The continuum of pharmacist prescriptive authority. Ann Pharmacother 2016;50(9):778-84.
- National Alliance of State Pharmacy Associations. Pharmacist prescribing: naloxone. January 2019. https://naspa.us/resource/naloxone-access-community-pharmacies/. Accessed March 30, 2021.
- Cowart K, Olson K. Impact of pharmacist care provision in value-based care settings: How are we measuring value-added services? J Am Pharm Assoc (2003) 2019;59(1):125-8.
- Rodriguez MI, Hersh A, Anderson LB, Hartung DM, Edelman AB. Association of pharmacist prescription of hormonal contraception with unintended pregnancies and Medicaid costs. Obstet Gynecol 2019;133(6):1238-46.
- Abouk R, Pacula RL, Powell D. Association between state laws facilitating pharmacy distribution of naloxone and risk of fatal overdose. JAMA Intern Med 2019;179(6):805-11.
- Xiong S, Willis R, Lalama J, Farinha T, Hamper J. Perspectives and perceived barriers to pharmacist-prescribed tobacco cessation services in the community pharmacy setting. J Am Pharm Assoc (2003) 2021;S1544-3191(20)30649-X.
- Rafie S, Richards E, Rafie S, Landau SC, Wilkinson TA. Pharmacist outlooks on prescribing hormonal contraception following statewide scope of practice expansion. Pharmacy (Basel) 2019;7(3):96.
Glossary and Abbreviations