Jeff Little, PharmD, MPH, BCPS, FACHE, FASHP
Hannah Van Ochten, PharmD, MPH
Public health policy
At the end of this case, students will be able to:
- Describe why advocacy in the profession of pharmacy is important
- List various strategies pharmacists can use to engage in advocacy
- Explain how legislation and regulatory authority are related
One commonly defined goal among healthcare professions is to advocate on behalf of patients. The American Pharmacists Association (APhA) Code of Ethics states that “[a] pharmacist serves individual, community, and societal needs” and “seeks justice in the distribution of health resources.”1 Furthermore, the APhA Oath of a Pharmacist contains the following two clauses: “I will consider the welfare of humanity and the relief of suffering my primary concerns,” and “I will embrace and advocate changes that improve patient care.”2 Finally, the American Society of Health-System Pharmacists (ASHP) Statement on Advocacy as a Professional Obligation states, “pharmacists should stay informed of issues that affect medication-related outcomes and advocate on behalf of patients, the profession, and the public. These issues may include legal, regulatory, financial, and other health policy issues, and this obligation extends beyond the individual practice site to their broader communities.”3
Other healthcare professions have similar statements. The American Medical Association (AMA) Code of Medical Ethics states that “physicians, individually and collectively through their professional organizations and institutions, should participate in the political process as advocates for patients (or support those who do) so as to diminish financial obstacles to access health care,” and that “the medical profession must work to ensure that the societal decisions about the distribution of health resources safeguard the interests of all patients and promote access to health services.”4 The American Nurses Association (ANA) Code of Ethics with Interpretive Statements states that “nurses must lead collaborative partnerships to develop effective public health legislation, policies, projects, and programs that promote and restore health, prevent illness, and alleviate suffering.”5 These statements indicate how these professions view advocacy not only as something which is inherent to each profession, but something which extends beyond being an advocate for an individual patient and involves advocating for policy and societal changes.
Being a successful pharmacy advocate requires an understanding of the legislative and regulatory framework which impacts the practice of pharmacy and the medication use process. Important to understand is the relationship between legislation and regulation, which starts with the structure of the government. The executive branch is in charge of carrying out the laws created by the legislative branch, and is made up by the President, Vice President, the President’s Cabinet, and most federal agencies. The Cabinet is an advisory body appointed by the President, which includes the secretaries of the fifteen executive departments of the federal government.6 Notable cabinet positions with healthcare oversight include the Secretary of Health and Human Services and the Secretary of Veterans Affairs (VA). The executive branch also enjoys broad regulatory power over healthcare through various federal agencies. The Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), Health Resources and Services Administration (HRSA), and Centers for Disease Control and Prevention (CDC) are all examples of agencies impacting healthcare which roll up under the executive branch. It is important to note that while the executive branch runs these agencies, the authority for these relationships comes from laws passed by the legislative branch (i.e. Congress). If agencies have regulatory authority over an issue, they can use a rule making process to make changes. However, sometimes agencies may require new legislation to have authority over an issue. The judicial branch of the government impacts healthcare as well, with courts in recent years hearing many challenges to healthcare related laws on issues such as access to care, the Affordable Care Act, abortion restrictions, and pharmacy benefit managers.
Another issue to keep in mind as a pharmacy advocate is state versus federal issues. The practice of pharmacy is regulated at the state level through state laws and healthcare agencies and licensing boards. When advocating for any issue, it is crucial to know if the proposed change will require new laws or new rules, and if the issue is a state or federal issue. Not only do pharmacists have an obligation to be advocates, but pharmacists also have a history of successful advocacy. Collaborative practice agreements (CPAs), pharmacy technician immunization authorization, state-level provider status for pharmacists, and legislation around drug shortages are all examples of successful advocacy efforts led by pharmacists through grassroots efforts.7 These examples demonstrate how pharmacists can impact patient care through advocacy.
You are an emergency department pharmacist working at an inner-city hospital where you see many patients who develop complications when they are unable to afford their medications. You were discussing this frustration with a friend who is a nurse at a local long-term care facility. They mention that they waste dozens of bubble packs of medications daily when patients change doses, change locations, discharge, or die. You want to find a way to get these wasted medications to people who need them.
In your searching, you come across National Conference of State Legislatures (NCSL) information about currently existing medication repositories that do exactly this. These programs allow for unused medications to be repurposed for other patients. As of 2018, NCLS has identified that 21 states and Guam have functioning medication repository programs.8 Some of these programs have provided millions of dollars of medications to tens of thousands of patients across their state.
1. At the federal level, the website allows advocates to search for issues and to provide comment. Based on the NCSL report, you find most medication repository programs operate at a state level, so coming up with this program will involve advocacy at the state level to establish something similar within your state. How would you determine what your current laws are related to medication repositories?
2. Based on this NCSL report, identify and research one currently operating state repository and identify some of their characteristics and metrics of success.
3. If the state Board of Pharmacy can make this change, how can the pharmacist advocate for it?
4. If the state Board of Pharmacy does not have the authority to make this change, a change in legislation will likely be required. Identifying the appropriate members of congress will be the next step. Who are the individuals who represent you and which state committees would be the most helpful in furthering this bill?
5. Who, outside of legislators themselves, can help secure this legislative change? Are there any national pharmacy organizations that have policies in support of medication repositories?
6. Once appropriate legislators are identified, what are the different methods that may be used to get in contact with them and advocate for change?
7. Drafting the message to a legislator is a critical part to advocacy. What would an appropriate brief email look like to a legislator regarding medical repositories?
8. What are some strategies for advocating directly to elected officials?
Patient Approaches and Opportunities
When drafting an email, phone script or another advocacy message, several key components will help a message be effectively delivered. First, introduce yourself and your current role. Healthcare professionals hold power and have the potential to be strong advocates for their patients. Pharmacists are experts in evidence-based medicine, they understand the healthcare system, they see many of the areas where patients fall through the cracks and are motivated by professional ethics to have the patient’s best interest at heart. As a highly trusted profession, providing your message as a pharmacist gives you power and influence within a room of policy makers.9 Second, state why an issue is important and your relationship to the issue. This relationship can come from personal experience, experience with patients or other experiences from professional training or work. Third, ask for action. Ask for direct support, for their signature on a bill, for them to publicly speak out about an issue. Ensuring they have a tangible way to act on this important information that was just provided to them is crucial. Fourth, if this is a conversation- provide adequate time to listen, answer questions, address concerns, find the congresspersons relationship to this issue. The American Psychological Association has laid out guidance that can be applied to other issues within pharmacy or healthcare.10
While learning all of this, one important resource is professional organizations. They can help identify the correct path for change on an issue and can also help to ensure the profession has a consistent message which is so important in dealing with elected officials. National pharmacy organizations include APhA, ASHP, the American College of Clinical Pharmacy (ACCP), the College of Psychiatric and Neurologic Pharmacists (CPNP), and the Academy of Managed Care Pharmacy (AMCP). Many states have state-specific chapters of these organizations. The size of these groups and the impact of the individuals within these interstate groups give them more sway when it comes to developing state or federal policy. These groups try to influence policies by putting pressure on elected officials, like during pharmacy legislative days, or by providing information to these policy makers to help create better informed policies. They can also educate their members on political actions they can take to further the interest of the interest group. Examples include voting on state legislation that expands the scope of practice of pharmacists.
Related chapters of interest:
- The “state” of things: Epidemiologic comparisons across populations
- Prescription for change: advocacy and legislation in pharmacy
- Journal articles
- American Pharmacists Association. Oath of a pharmacist. . Accessed May 24, 2021.
- American Society of Health-System Pharmacists. ASHP statement on advocacy as a professional obligation. Am J Health-Syst Pharm 2019;76:251-4.
- American Medical Association. Financial barriers to health care access: Code of Medical Ethics opinion 11.1.4. . Accessed May 24, 2021.
- American Nurses Association. ANA Code of Ethics with Interpretive Statements. . Accessed May 24, 2021.
- American Pharmacists Association. Code of ethics. . Accessed May 24, 2021.
- The White House. Our government: the executive branch. . Accessed May 24, 2021.
- Knoer S, Fox ER. Advocacy as a professional obligation: practical application, Am J Health Sys Pharm 2021;77(5):378-82.
- National Conference of State Legislature. State Prescription Drug Return, Reuse and Recycling Laws. August 4, 2020. . Accessed June 15, 2021.
- Gallup. U.S. Ethics Ratings Rise for Medical Workers and Teachers. December 22, 2020. . Accessed June 15, 2021.
- American Psychological Association. How to write a letter or email. . Accessed June 15, 2021.