How can pharmacists increase access to important public health services? The answer – statewide protocols. The term statewide protocol refers to a framework that specifies the conditions under which pharmacists are authorized to prescribe, furnish, or dispense without a prescription a specified medication or category of medications when providing a clinical service. As more and more states pass or are considering passing legislation permitting statewide protocols, I would like to share 7 things that will give you a better understanding about statewide protocols
- Statewide protocol are not the same as collaborative practice agreements.
Collaborative practice agreements allow pharmacists and prescribers to enter an agreement that authorizes the pharmacist to initiate, modify, or discontinue drug therapy for patients or patient populations defined in the agreement. Collaborative practice agreements are developed and implemented between individual or groups of prescribers and pharmacists. Statewide protocols are issued by an authorized state regulatory body pursuant to state laws and regulations and public health problems.
- Statewide protocols allow all licensed pharmacists in the state who meet the qualifications specified in the protocol to implement those protocols into practice.
Statewide protocols allow for a broader applicability in care delivery across the state and may more effectively address significant public health needs. Each protocol specifies the qualifications required for pharmacists to implement the protocol and the procedure(s) that must be followed for patient care needs that do not require a new diagnosis or for which a documented diagnosis is known or readily available.
- Statewide protocols promote access to immunizations, naloxone for opioid overdose, hormonal contraceptives, travel medications, and tobacco cessation medications.
Each state’s legislature determines what protocols would be included in the statewide protocols and each state board of pharmacy determines the details associated with those protocols.
- 25 states have at least one statewide protocol.
Why is this important? There is a 50/50 chance that the state you are practicing in has a statewide protocol. To find out if you have any statewide protocols and what the protocols include, you may want to contact your state board of pharmacy or check their website (available via https://nabp.pharmacy/boards-of-pharmacy/). The most common statewide protocols are for immunizations and naloxone. If you are practicing in a state that does not have a statewide protocol, this blog will be especially helpful.
- Statewide protocols are not all the same.
The variations in statewide protocols include pharmacist prescribing, “furnishing,” standing orders, and dispensing without a prescription. Some examples:
- Idaho and Oregon use the term “prescribe,”
- California uses the term “furnish,”
- Pennsylvania uses “standing order” where the statewide standing order is issued by the Physician General.
Some states authorize medications to be dispensed without a prescription. This is one of the least desired options because the key to ensuring insurance coverage of a prescription medication is the generation of a prescription order.
- National workgroup develops pharmacist statewide protocol policy recommendations.
The National Alliance of State Pharmacy Associations (NASPA) and the National Association of Boards of Pharmacy® (NABP®) have developed policy recommendations for pharmacist statewide protocols. This workgroup was convened because states considering legislation permitting and or expanding statewide protocols have little information regarding the best practices for implementation. These recommendations include key elements that should be included in state laws and regulations authorizing the development of statewide protocols. At the March 15, 2017 announcement of the workgroup recommendations, NASPA Executive Vice President & CEO Rebecca Snead stated:
Statewide protocols present the opportunity for pharmacists to significantly increase patient access to medications and services important to public health. It is critical to have a national set of statewide protocol policy recommendations that are based on the best interests of patients and the education and training of pharmacists. This work builds on and supports the policy considerations from the NASPA/NABP Convened Meeting on Statewide Protocols for Pharmacist Prescribing report from 2016, generously supported by the Community Pharmacy Foundation.
- The Statewide Protocol Workgroup makes recommendations in 7 key areas.
- GENERAL APPROACH
Statewide protocols are preferable over statewide standing orders and other approaches to make certain products or categories of products available from pharmacists.
- SPECIFICITY OF AUTHORITY
Initial authorizing legislation for pharmacist statewide protocols should be general and allow for the specific medications and/or categories of medications to be determined in the regulatory process.
- AUTHORIZED STATE BODY
State board of pharmacy should be the state body primarily responsible for issuing pharmacist statewide protocols. Additionally, the state department of health should be authorized to issue pharmacist statewide protocols for public health needs.
- NON-PHARMACIST STAFF ROLE
State laws and regulations governing pharmacist statewide protocols should be silent with regards to delegation to non-pharmacist staff.
- PRACTICE SETTING
State laws and regulations should be silent with regards to the practice settings where pharmacist statewide protocols could be implemented.
- COMPONENTS OF THE PROTOCOL
Core components should be included in the design of pharmacist statewide protocols.
- ENSURING IMPLEMENTATION AND PATIENT ACCESS
Policy makers should consider whether state laws or regulations need to be modified to ensure that payment and insurance coverage are available and equitable for the products and services rendered by a pharmacist under a statewide protocol. The key to ensuring insurance coverage of a prescription medication is the generation of a prescription order.
Additional detail on the above recommendations are included in the report Pharmacist Statewide Protocols: Key Elements for Legislative and Regulatory Authority which can be accessed on the NASPA website, www.naspa.us.
Statewide protocols, as well as evolving collaborative therapy management agreements and other enhanced services opportunities, promise a brighter future for pharmacists and patients alike. Please contact me (email@example.com) for assistance with development or enhancement of statewide protocols.