TBC follows all contacts to active TB cases. These contacts are evaluated to determine if they have active disease or latent infection. Those with latent infection must be treated to avoid becoming infectious with active TB. Most of these individuals who agree to be treated are seen by physicians in Nassau County contracted hospital. At this facility, medication is dispensed directly to the contact requiring treatment. TBC receives documentation from the contracted facility. However, when contacts are treated by private physicians, follow-up becomes more difficult. TBC sought to create an innovative tool for tracking and monitoring contacts being treated for LTBI who see private physicians. The goal was to monitor treatment adherence of contacts diagnosed with LTBI thereby mitigating TB transmission in the community. There were four primary objectives for the project.
- Develop a Pharmacy Verification process and collaborate with pharmacies in the community to obtain prescription data;
- Create a tool to monitor contacts adhering to LTBI treatment using Microsoft Excel;
- Implement the process and the tool;
- Improve monitoring process, increase TBC efficiency and reduce loss to follow-up.
TBC recognized the need to address the issue of systematically following contacts managed by private physicians. TBC met over several weeks in early 2015 to discuss the steps necessary to accomplish this. At the time, TBC consisted of the administrator of the program, the clinical director, the epidemiologist, case management staff, field staff, and an intern. Pharmacists needed to be part of the process and therefore were engaged early on. The process needed to be regular and simple, so any staff could perform it. TBC created a script to use when speaking to pharmacies. The tool required specific fields necessary to follow patients satisfactorily, as well as a structure by which cells would be flagged depending upon refill pick-up timing. A color-coded alert system was embedded into the spreadsheet formulas Finally, periodic review of the contact monitoring identified issues requiring contacts and provider follow-up, completion of treatment, loss to follow-up and evaluation of the Pharmacy Verification process.
The process was piloted in 2015 with two contacts and implemented over time. In 2016, TBC had enrolled twelve contacts in the program. At that point, TBC had seen good results, but not enough to be considered evidence-based. To date, in 2018, 43 contacts have been tracked using the tool and the process has now been successfully running for nearly three years.
TBC achieved the goals and the objectives of this innovative program by collaborating with partners and by streamlining operations within TBC.
Objective 1 was met by creating a process for Pharmacy Verification through collaboration. Overall, Pharmacy Verification's development was a collaboration among many stakeholders from a variety of backgrounds, including academia. It was originally envisioned as an improvement process used in TBC to aid in efficiency and to decrease loss to follow-up. In 2015, TBC interviewed and selected an intern from Creighton University. Nassau County Department of Health (NCDOH) is committed to working with universities and schools to create public health learning environments that stretch from the classroom to the health department and then the community at large. To this end, since 2011, NCDOH has created memoranda of understandings between the health department and academic institutions to create internships that are mutually beneficial. Bethany Abrahams, a doctoral student in pharmacology, spent a semester with TBC. Because of her expertise in pharmacology, TBC staff had the opportunity, and now the additional manpower, to develop what would become the Pharmacy Verification process to track contacts with LTBI. This idea and improvement process were initially conceived because TBC did not have a formalized, structured mechanism to track contacts with LTBI, beyond occasional phone calls and follow-up. With the assistance of the intern, the realization of the idea was begun. She contributed work effort and pharmacological knowledge. TBC staff provided the expertise in regulatory requirements, TB pathology, and case management skills, and intimate understanding of the process of contact investigations in the office.
A second key collaborating partner was the pharmacist. TBC has always appreciated the pharmacists' roles in disease prevention, as noncompliance remains the most significant barrier to treatment. With that understanding, TBC engaged the pharmacists within our community, in late Spring of 2015. It was an opportunity to remind fellow healthcare partners the role of TBC. The conversations personalized the connection and importance of aligned efforts between pharmacies and TBC. The conversations established the details of the Pharmacy Verification process that TBC was about to launch. After learning about the program, the pharmacists had a greater involvement in disease prevention and provided additional feedback for the mechanism. Ultimately, the pharmacists understood that they would provide the information needed to collect the necessary data monthly on the prescriptions such as medication name and dose, date of pick-up and days supplied. The pharmacists became an essential collaborating entity, one that remains today, as TBC continues to speak with them monthly.
During the planning stage, TBC also addressed issues of confidentiality. TBC provided information to pharmacy staff about the Health Information Portability and Accountability Act of 1996, (HIPAA) regulations. TBC staff discussed with pharmacies that the Act permits public health employees to gather information necessary for preventing and controlling communicable diseases.
Finally, in addition, to streamlining communication between TBC and pharmacies, a script was created. This script allows any TBC staff member to make calls and collect the information in a professional, consistent manner. The script introduces TBC, explains the verification process, provides contact information and requests medication information.
Objective 2 was met by creating an Excel Workbook to monitor treatment adherence. Patients who visit private doctors and receive their medication for LTBI from pharmacies are identified as eligible for tracking. The Pharmacy Verification tool used to monitor medication adherence is comprised of many fields. These include index case, contact demographics, physician information, treatment regimen, pharmacy, call log, treatment start date, expected completion date and monthly medication pick up log. Embedded formulas alert the user by flagging critical information. This alert system allows for timely case management and intervention to reduce loss to follow-up. This calculation is performed using the date the first prescription was picked up by the contact being treated for LTBI, the date the most recent prescription was picked up, the amount of days supplied from the last prescription, and the total amount of days supplied that was picked up from all the prescriptions. Completion of a six-month course of therapy within 9 months and completion of a nine-month course of therapy in 12 months' time are criteria for successful LTBI therapy regimen. A formula embedded in the spreadsheet calculates and flags the number of missed days of treatment to ascertain completion status. Therefore, the tool was designed to have monthly input and indicate a green, yellow, or red alert system. For example, a contact having missed less than 30 days of therapy displayed green indicating generally good adherence. If a contact missed at least 30 days but less than 90 days of therapy, a yellow indicator would alert the viewer that there may be a risk for unsuccessful treatment completion. Any contact cell having missed 90 days or more of therapy displayed red, indicating that the patient may not be able to successfully complete LTBI treatment. These cells in which indicators turned yellow or red provided important information for proper follow-up for case managers to confer with physicians or the patients themselves to discuss treatment.
Objective 3 was met when TBC successfully implemented the Pharmacy Verification process. One designated TBC staff member was tasked with performing pharmacy verification. Using the partnership approach with the pharmacist, the data were collected and then entered in the Pharmacy Verification tool. The staff member verified that the correct medication and dosage was picked up and that the appropriate number of refills remain. Furthermore, any alerts were followed up on by TBC case manager. For example, if the staff member learned that the wrong dosage was provided, the TBC case manager would subsequently confer with the physician for clarification. If the patient neglected to refill the prescriptions, then TBC staff reached out to both the patient and the provider. These issues are addressed the same day. The pharmacy calls occur monthly and a summary of activity is reported on at regular staff meetings.
Objective 4 was met by creating a standardized monitoring process, therefore, increasing program efficiency and reducing contact loss to follow-up. Monthly tracking allows for timely data collection and intervention. Tasking one staff person with monitoring the process increases program efficiency and reduces miscommunication and redundancies. Prior to implementation, field staff made calls to contacts to inquire about on-going treatment. These calls were often a slow process, whereby field staff left messages, awaited call back and often were fruitless. Regardless if the contact called back, field staff had to call providers to inquire about treatment, enlist their assistance in reaching contacts or to verify the treatment status reported by the contact. This effort often occurred over the course of a week for one contact. In addition, field staff made these calls as time permitted, as they were often in the field providing DOT to active cases and were not available to receive and respond to callbacks. Miscommunications occurred when multiple staff received calls, took messages and attempted to resolve issues thus creating redundancies of effort. With this innovative Pharmacy Verification process, one designated staff person is responsible and accountable for gathering the information and conveying issues to the appropriate TBC staff. This individual also serves as the point person so that miscommunications and redundancies are avoided. In addition, this point person is solely responsible for maintaining the Excel workbook so that information is misentered or lost. This also allows for accurate documentation of process progress notes in the Excel workbook. The success of the Pharmacy Verification process is due in large part to the on-going collaboration between TBC, the pharmacist, and physician who all have a vested interest in effectively evaluating and treating exposed contacts.
As is apparent by the collaboration process outlined in achieving the goal of this practice, success cannot be accomplished without the partnership. This partnership has allowed TBC to track patient compliance with a standardized, well-thought-out process. Characteristics of collaborative partner activities include the following principles as we have adapted from the CDC (https://www.cdcfoundation.org/guiding-principles-partner-collaboration)
- Well-defined and substantial public health benefit based on sound science and the public good. This has been well established as pharmacy verification has been used before in other disease states, but not in TB. Proper adherence to medication by DOT for LTBI is not feasible for two field staff and the volume of patients. Pharmacy verification is used as a proxy for this observation. The collaborative partner, the pharmacist, now is actively participating in effectuating sound science.
- Clear, identifiable, substantial leadership role for TBC and a designated lead and champion within the agency. TBC provides the leadership, with the Clinical Director at the helm. She conceived of the idea and with the team and additional collaboration from academia (the intern) provides the leadership necessary should the pharmacists have questions.
- Ideas that have been reviewed and approved by TBC.
- Activities with a manageable size and scope with specific timelines and milestones. The collaboration, while it began in 2015 has been on-going. Timelines are set as per the pathophysiology of TB as well as treatment guidelines for LTBI. As such, pharmacy verification must align to these treatment schedules. The pharmacists also fully understand the importance of adherence to these medications without interruptions.
- Funding that is not revocable or contingent on any action by NCDOH. In the case of TBC's pharmacy verification, the cost of the process is in-kind from staff already working within TBC. The program was designed due to funding restrictions and the inability to hire additional field staff to individually engage the contacts directly. Therefore, this collaboration was created out of the necessity to find a low-cost mechanism to standardize this process.
- Non-exclusivity in the proposed activity meaning other partners may join at any time. By the nature of this project, additional pharmacists do continue to join the effort.
- Outcomes of the activity are not intended for direct monetary benefit for the partner; avoidance of conflicts of interest. This partnership with the pharmacist and the health department do not confer additional funding streams to either. There is no conflict as both entities' priorities are diminishing lost to follow-up.
- Adherence to independence and objectivity of scientific judgment. This collaboration is based on the scientific judgment and the evidence that if LTBI is treated effectively, then active TB can be mitigated.
- Equal access to results of findings for the public and partners. Monthly calls with the pharmacist allow for follow-up information exchanged, valuable to both the pharmacy and TBC.
Additional costs were insignificant. This program requires general office equipment, computer, and telephone. Once the expertise has been used to create the Excel tool, very little modification is necessary as it can be used by multiple staff members. Any cost is in-kind, as it is dependent on health department staff already employed. This program was based on a restricted and limited budget already in place within the county. For that reason, Pharmacy Verification is cost saving, as it requires no field staff intervention and costly time.