Précis
The use of outpatient pharmacy protocols for glucose testing and insulin administration supplies should be expanded to assist patients in the self-management of diabetes.
Objectives
Self-management of diabetes requires supplies that are frequently covered by insurance with a prescription, but the time involved in contacting prescribers and obtaining prescriptions can create a delay in access. A protocol allowing pharmacists to enter and modify orders for blood glucose testing and insulin administration supplies was implemented in the outpatient pharmacies of the University of Illinois Hospital and Health Sciences System. The objectives of this research study were to (1) quantify the utilization of the protocol following its implementation, (2) measure pharmacists’ and prescribers’ satisfaction and comfort with the use of the protocol at the medical center, and (3) measure the interest of outside outpatient pharmacists in Illinois in implementing a similar protocol at their practice site.
Study Design
The study was a retrospective chart review study that looked at the number of protocol orders entered in the electronic medical record (EMR) over the course of 2 years following the implementation of the protocol. Surveys were administered to measure pharmacists’ satisfaction with utilization of the protocol, prescribers’ comfort with pharmacists utilizing the protocol, and outside outpatient pharmacists’ interest in implementing a similar protocol at their institution.
Methods
Data on protocol utilization were obtained by running reports through the EMR to identify pertinent supplies ordered for patients with diabetes (eg, insulin syringes, pen needles, blood glucose monitors, test strips, and lancets) by outpatient pharmacists at the medical center. Data on nonprotocol orders were obtained by running reports through the pharmacy system to identify phone and verbal orders for the same supplies during the same time frame. Outpatient pharmacists at the medical center were surveyed about their satisfaction with utilizing the protocol. Prescribers at the medical center were surveyed about their comfort with pharmacists utilizing the protocol. Additionally, outpatient pharmacists at outside pharmacy institutions were surveyed about their comfort level and interest in the implementation of a similar protocol in their practice setting. Descriptive statistics were used to characterize the data.
Results
Outpatient pharmacists at the medical center entered a total of 1038 protocol orders over 2 years following the implementation of the protocol compared with 566 nonprotocol orders. Further, 75% of the outpatient pharmacists at the medical center were satisfied with utilizing the protocol, and 96% of the prescribers at the medical center felt comfortable with the pharmacists utilizing the protocol. Additionally, 96% of the nonaffiliated outpatient pharmacists reported that their practice site would benefit from having a similar protocol in place.
Conclusions
The significant number of orders generated through the use of this protocol reflects its positive uptake and utility. Outpatient pharmacists at the medical center were satisfied with utilizing the protocol and prescribers at the medical center were very comfortable with the pharmacists’ utilization of it. The nonaffiliated outpatient pharmacists broadly agreed that this type of protocol would be beneficial at their practice site. Amending state practice acts to support this expansion of services for pharmacists would be a significant step in ensuring patients with diabetes have timely access to self-management supplies.
Introduction
With more than 11.6% of the US population living with diabetes, the discussion of proper self-management of blood glucose is becoming increasingly relevant.1 Self-management of diabetes involves regular blood glucose testing, taking medications as prescribed, and incorporating healthy dietary and lifestyle modifications. Adequate diabetes self-management education and adherence to these behaviors have been correlated with positive health outcomes, including improved blood glucose control.2 Self-management of diabetes requires tools, supplies, and resources beyond medications for the treatment of diabetes; commonly needed supplies include syringes or pen needles to administer insulin; and glucometers, lancets, and blood glucose testing strips to monitor blood sugar.3,4
Despite the rising number of people with diabetes, there continue to be barriers that prevent patients from accessing the necessary supplies for engaging in self-management behaviors. The annual financial burden of diabetes for patients is substantial, and financial constraints are among the most common barriers to effective self-management of diabetes.2,5 Although it is possible to purchase blood glucose management supplies OTC, a valid prescription is required for supplies to be covered by a patient’s prescription insurance. In 2022, it was found that the average annual cost of OTC medical supplies for people with diabetes was nearly $4000 with health insurance.6 In many cases, the cost to the patient and laws that restrict the number of supplies to be sold without a prescription may limit access.
As the health care professionals responsible for interfacing with prescribers and dispensing diabetes management supplies, outpatient pharmacists are ideally positioned to address these access issues. Patients with type 2 diabetes are aware of this as well, and they have voiced that improvements could be made in the roles of pharmacists to provide further support for medication adherence and continuity of blood glucose management supplies.7
Currently, outpatient pharmacists generally must contact providers to obtain prescriptions necessary to bridge access gaps, and there are numerous situations in which a pharmacist would need to do so for blood glucose management supplies. For example, a provider may send a new or revised prescription to the pharmacy for insulin without an accompanying prescription for pen needles or syringes for the patient to administer the medication. Another potential situation in which a patient would require a new prescription for a blood glucose monitor and testing supplies is upon switching insurance providers, or if their existing insurance makes changes to their formulary. Though the patient previously had prescriptions for a particular brand of glucose monitor and testing supplies that were covered by their insurance, the change in coverage may limit access to that brand. In both scenarios, patients experience a delay in being able to access the necessary supplies.
In recent years, there have been efforts made by various states to broaden the role of outpatient pharmacists with a goal of improving timely access to care, such as thorough assessment and consultation of patients to dispense hormonal contraceptives, and pre- and post-exposure prophylaxis of HIV.8-10 Pharmacists have been successful in providing timely and cost-effective care when given the authority to initiate or adjust a prescription without consulting the physician, given that the changes fell under an approved health care protocol.7 In specific regard to diabetes management, since 2017, outpatient pharmacists in Idaho have been authorized to prescribe a subset of medications, devices, and clinical supplies, including blood glucose testing supplies, pen needles, and syringes, under collaborative practice agreements and statewide pharmacy guidelines.11 The Idaho Board of Pharmacy continues to expand upon these guidelines, as pharmacist involvement has been shown to improve patient education and outcomes.11 In addition, Oregon grants pharmacists prescriptive authority to provide blood testing supplies and injection supplies for patients with diabetes under a collaborative practice agreement with a qualified practitioner.12 Thus, a precedent exists for outpatient pharmacists to improve insulin administration and blood glucose management supply access via the use of a pharmacy protocol.
The purpose of this study was to gauge the utilization of and degree of satisfaction with such an outpatient pharmacy protocol by outpatient pharmacists and providers within a medical center. The goal of this study was to initiate a discussion regarding the use of this protocol in other outpatient pharmacy settings to improve timely patient access to insulin administration and blood glucose management supplies.
Materials and Methods
Protocol Description
An outpatient pharmacy protocol was implemented in 7 of the outpatient pharmacies within a large, academic medical center. Key pharmacy stakeholders were identified to collaborate in developing a clinical care protocol aligned with the institution’s protocol development procedures. The target population was identified as all medical center patients filling prescriptions at the outpatient pharmacies at the institution. The clinical care protocol was reviewed by the hospital’s Pharmacy and Therapeutics Committee and Guideline and Protocol Oversight Committee before receiving final review and approval by the Medical Staff Executive Committee. All University of Illinois Hospital and Clinics pharmacists who completed the mandatory training module and passed the assessment quiz were granted authorization to provide pharmacy services per the protocol. Allowable prescription orders and modifications were defined in the protocol (Table 1). All orders were entered via the electronic medical record (EMR) system as “Per protocol: cosign required” and routed to the prescriber of the original order or the primary care physician for authentication per the hospital’s medical orders policy. Authentication of orders by a physician was not required for orders to be acted upon, but served as a way to communicate the new or modified orders to the prescriber and meet potential insurance requirements.
Nominally, all patients with an active prescription for insulin, a glucometer, test strips, and/or lancets being filled at a medical center–affiliated pharmacy were eligible to receive prescriptions generated under the protocol at the dispensing outpatient pharmacist’s discretion. However, medical center policies inherently restricted protocol uses in 2 notable ways. First, because the medical center limits its pharmacies to filling prescriptions written by the medical center’s providers, patients prescribed insulin and/or diabetic testing supplies by outside providers were functionally excluded from protocol use. Second, because the pharmacies of the medical center are not contracted to bill Medicare Part B for diabetic testing supplies, patients utilizing Medicare Part B to obtain diabetic testing supplies were also functionally excluded from protocol use.
Study Design
This research study was conducted to (1) quantify the utilization of an outpatient pharmacy protocol for pharmacists at the medical center to order blood glucose testing and insulin administration supplies over the course of the 2 years following implementation of the protocol, (2) measure providers’ and pharmacists’ satisfaction with the use of the protocol at the medical center, and (3) measure the interest of outside outpatient pharmacists in implementing a similar protocol. The study was approved by the University of Illinois Chicago Institutional Review Board.
Data on protocol utilization were obtained by running reports through the EMR to identify pertinent supplies ordered for patients with diabetes (eg, insulin syringes, pen needles, blood glucose monitors, test strips, and lancets) by outpatient pharmacists over 2 years. Data on nonprotocol orders were obtained by running reports through the pharmacy system to identify phone and verbal orders for the same supplies during the same time frame. Descriptive analysis was used to characterize the number of protocol and nonprotocol orders.
Additionally, surveys were administered via Qualtrics to 3 groups of people. Outpatient pharmacists at the medical center were surveyed about their satisfaction with the protocol. Prescribers at the medical center were surveyed about their comfort in allowing pharmacists to utilize the protocol. Finally, pharmacists practicing in outside community and outpatient pharmacies in Illinois were surveyed about their comfort level and interest in the implementation of a similar protocol in their practice setting. Survey participants were recruited via email.
Results
At the outpatient pharmacies in the medical center, a total of 469 orders for insulin pen needles and syringes, 171 orders for glucose monitors, 200 orders for test strips, and 198 orders for lancets were initiated using the protocol over 2 years. Nonprotocol prescriptions included 250 orders for insulin pen needles and syringes,
110 orders for glucose monitors, 108 orders for test strips, and 98 orders for lancets (Figure 1). Of the medical center outpatient pharmacist respondents (n = 12), 75% were satisfied with the utilization of the protocol, 92% stated that they utilized the protocol at least once per week, and 66% reported that it generally takes more than 1 day for prescribers to respond to refill requests (Table 2). Of the medical center prescriber respondents (n = 71), 96% stated that they felt comfortable allowing pharmacists to utilize the protocol, 66% felt that this protocol would save them a significant amount of time, and 97% reported that it generally takes more than 1 day to respond to refill prescription requests (Table 3).
Of the nonaffiliated Illinois outpatient pharmacist respondents (n = 84), 60% practiced in retail or community pharmacies, 15% practiced in outpatient pharmacies that are part of a medical center, 16% practiced in an independent pharmacy setting, and 9% practiced in other outpatient pharmacy settings. Only 17% reported that they were able to utilize a protocol to order insulin administration or blood glucose testing supplies. In contrast, 96% of the nonaffiliated outpatient pharmacists reported that their practice site would benefit from having a similar protocol in place. Additionally, 89% reported being comfortable with utilizing a protocol to enter a prescription order for insulin pen needles and syringes, and 95% felt comfortable to order a glucose monitor and associated testing supplies (Table 4).
Discussion
In various outpatient pharmacies, there have been efforts made to implement other types of pharmacy protocols to improve medication access by expanding the prescriptive authority of pharmacists through collaborative practice agreements (eg, prescribing naloxone). However, as this study’s survey results suggest, having a protocol specifically addressing the prescribing and modifying of insulin administration and blood glucose testing supplies is not common in outpatient pharmacies. The large number of prescriptions generated through such a protocol and identified in this study proves that such a protocol can be heavily and successfully used to increase timely access to critical diabetes management supplies. This study also reveals strong support for the protocol by the surveyed medical center’s outpatient pharmacists and physicians, as evidenced by high reported levels of satisfaction with the protocol, comfort with outpatient pharmacists using the protocol, and the implied time saved by having and using such a protocol instead of contacting prescribers for prescriptions. This study’s findings also illustrate a high level of interest among external outpatient pharmacists in Illinois in having this type of protocol in place at their pharmacy practice sites.
Although opinions on the protocol were overall very favorable, the results of this study also highlight potential areas for protocol utilization improvement at the surveyed medical center. A quarter of outpatient pharmacists surveyed were not satisfied with the protocol, and a significant number of nonprotocol prescriptions for testing and administration supplies were identified in this study. Possible explanations for these results warrant further study but could include challenges leveraging the EMR system to input protocol orders, unfamiliarity with the protocol given its relatively new implementation at the time of the study, and/or the relatively small sample size of internal outpatient pharmacy respondents. The protocol continues to be used at the surveyed medical center and requires review and reapproval by medical staff every 3 years. It would be useful to explore how perceptions have or have not changed now that the protocol is more firmly established.
The positive perception of the protocol combined with the high level of interest expressed by external outpatient pharmacists for such a protocol create a compelling case for its implementation more broadly. Indeed, the protocol at the study institution could be used as a framework for other institutions to create their own protocol or collaborative practice agreement, and it could be used as the basis for a statewide protocol in Illinois allowing pharmacists to prescribe supplies for all patients with diabetes. Such protocols could mimic the positive access improvement and workflow efficiency effects suggested by this study. Of note, however, this study did not address the unique requirements and complications involved in billing for supplies through Medicare Part B. Thus, additional research is needed to address how such a protocol could be adapted to meet the needs of Medicare Part B recipients.
About the Authors
Nazia Somani Babul, PharmD, BCACP, is a clinical pharmacist and clinical assistant professor at the University of Illinois Chicago (UIC) Retzky College of Pharmacy.
John Garofalo, PharmD, is a director of Clinical Pharmacy Services and a clinical assistant professor at the UIC Retzky College of Pharmacy.
Christine Hong is a class of 2025 PharmD candidate at the UIC Retzky College of Pharmacy.
Gabrielle Pierce, PharmD, MBA, was previously a PGY-1 specialty pharmacy resident at the UIC Retzky College of Pharmacy.
Samantha Bagnola, PharmD, was previously a clinical pharmacist and clinical instructor at the UIC Retzky College of Pharmacy.
Conclusions
Utilization of an outpatient pharmacy protocol allowing for the prescribing of insulin injection supplies and for the modification of blood glucose management supply prescriptions was assessed by quantifying its use by outpatient pharmacists at an academic medical center. The significant number of orders generated through use of this protocol reflects positive uptake of the program. The surveys that were conducted 2 years following this protocol’s implementation revealed a high degree of satisfaction with the protocol from the medical center’s outpatient pharmacists. The survey responses also revealed that the medical center’s providers broadly support this expanded role for outpatient pharmacists and believe that time can be saved with such a protocol. The external outpatient pharmacists surveyed also overwhelmingly agreed that having this type of protocol would be beneficial to have at their practice site, and that they would feel comfortable utilizing this type of protocol.
Despite the high level of interest and satisfaction among outpatient pharmacists, the results of the study indicate that most outpatient pharmacy practice sites surveyed currently lack an outpatient pharmacy protocol for insulin administration or blood glucose management supplies. Amending state practice acts to support this expansion of services for pharmacists would be a significant step in ensuring that patients with diabetes have timely access to self-management supplies, and it can improve work efficiency for both outpatient pharmacists and prescribers.
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