Abstract
Background:
The purpose of this study was to assess patients’ experience and satisfaction with pharmacy-only refill program (PRP) and to compare those who were removed from the PRP with those still in the program.
Methods:
A sample of 446 patients was selected from 1503 patients on antiretroviral therapy that had been enrolled in the PRP for at least 24 months. The study used interviewer-administered questionnaires to assess patients’ experience and satisfaction with PRP.
Results:
Of the 446 patients, 133 (29.8%) were removed from the PRP. By multivariate analysis, it was found that wanting to see a clinician before their scheduled clinic visit, Christian religion, and not understanding why they were enrolled in PRP were associated with having been removed from the PRP. Patients felt that the greatest benefit from the program was the time that they saved to do other activities. Patients preferred to collect their medication every 3 months instead of every month.
Conclusion:
All patients interviewed scored the program high, and all recommended that the PRP should continue. Stable patients prefer to see clinicians less frequently and visit clinic less often.
Introduction
Antiretroviral therapy (ART) has transformed HIV infection into a chronic, manageable disease. Current ART models are labor intensive; they exacerbate the human resources for health crisis. 1 –3
Coping with high patient load is one of the biggest challenges many centers in sub-Saharan Africa battle with. Patients’ waiting time is very long at the ART clinics and could become longer with increased patient numbers receiving care. 4 Given the limited number of human health resources, especially doctors, ART delivery models should take into account the local human resource constraints and thus be context specific. 5
Models meant for acute care need to be redesigned to meet the demands of chronically ill patients. 6 Special consideration should be focused on patients’ perspective and how HIV-positive patients could return to a normal life following an improved quality of life. 6,7
HIV-positive patients endure lifelong medication adherence and frequent clinic visits for clinical monitoring, laboratory tests, and counseling, which are intensive and demand patient commitment. Indirect costs for these frequent visits including transport, missed employment days, and out-of-pocket expenses pose major barriers. 8 –10 Once the quality of life of the HIV-positive patient improves, he or she needs to start working again in order to pay for school fees, food, and rent like other people. 11
At the Infectious Diseases Institute (IDI) clinic in Kampala, Uganda, task shifting using nurses to offer care was introduced in 2005, to cope with the overwhelming numbers of patients requiring ART. In 2006, a pharmacy-only refill program (PRP) was introduced. 12 Clinically stable patients who were receiving cotrimoxazole prophylaxis with or without ART were managed by pharmacy technicians during their monthly PRP visits; they were seen every three months by a trained nurse and every 6 months by a physician. In the first year of implementing the PRP, the program was found to reduce patient waiting time and to be more cost effective than the standard of care. 4,13 The PRP solved the problem of providing care for the increasing number of patients with HIV infection. However, one-third of the patients referred to the PRP was removed from the program within less than 12 months and were referred back to the general clinic for standard doctor visits. This raised concerns about the effectiveness of the PRP. The purpose of this study was to assess the patients’ experience and satisfaction with the PRP after 24 months in the program and to compare those who were removed with those still in the PRP.
Methods
Study Setting
The Infectious Diseases Clinic (IDC) is based at IDI, Makerere University College of Health Sciences in Uganda. It is a national referral center for patients with HIV infection requiring specialist treatment. The population of patients at the IDC grew from 250 patients per day in 2005 to 400 per day in 2007. The study setting was described previously in detail. 14
The PRP
The PRP began on May 15, 2006, and currently serves about a third of the IDC population. By May 30, 2009, a total of 2867 patients (each patient counted once) had been referred to the PRP, but over 800 patients were removed from the PRP over 3 years.
Study Design
In September 2009, a sample of 446 HIV-positive patients was randomly selected from the 1503 patients on ART, who had been enrolled in the PRP of the IDC in Kampala, Uganda, for least 24 months. The sample selection process used the IDC numbers of all patients on ART, who had been referred to the PRP (Figure 1). The study used interviewer-administered questionnaires to assess patients’ experience and satisfaction with the PRP.
Flow chart showing the sample selection process to evaluate the pharmacy-only refill program (PRP).
Data Collection
Using the IDC numbers, study patients’ phone contacts and their next clinic visit dates were identified. Their files were marked with a sticker for easy identification. When patients arrived at the reception area of the clinic, they were directed to research assistants for the PRP evaluation study. The purpose of the study was explained; and if patients agreed to participate, they had to sign an informed consent form. Study patients were taken through an interviewer-administered questionnaire. Information on sociodemographics and socioeconomical characteristics, as well as their experience and satisfaction with the PRP, was obtained. Those who were removed from the program were asked whether they were informed of the reason for their removal.
Patients that missed their clinic appointment or for whom return clinic visit dates were missing were contacted by phone to ascertain a date of their coming back to the clinic. The process was repeated until the total number of all selected study participants was interviewed. Questionnaires were checked for completeness and correctness. Data were double entered into EpiData data entry software, cleaned, edited, coded, and exported to STATA statistical software for analysis. Information was analyzed anonymously.
Statistical Analysis
The primary outcome of this study was being removed from the PRP at 24 months. Confirmation of those who were removed from the PRP was ascertained from the IDI database and patient files.
We compared the differences between patients who were removed from the PRP and those still in the PRP. Student t test was used to compare the mean and chi-square test for proportions. We used 2-tailed tests and an α-level of .05 for all our analyses. Risk factors were first explored using univariate logistic regression analysis. Then in a multivariate model, hypothesized risk factors and confounders were included based on a univariate P value ≤.2. All statistical analyses were performed with STATA software, version 10.0 (StataCorp, College Station, Texas).
Ethics
The study was approved by the IDI Scientific Review Committee and the institutional review boards of IDI, Makerere University College of Health Sciences, and the Uganda National Council for Science and Technology. Informed consent was obtained from all the study participants.
Results
Twenty-four months after enrollment in the program, 313 patients (70.2%) were still in the program and 133 (29.8%) were removed. Patients’ characteristics of those still in the program and those who were removed are shown in Table 1. None of the patients themselves ever requested to be removed from the program. All decisions concerning removal of patients from the program were based on medical reasons. In all, 117 (88.0%) knew the reason of their removal from the program. Of the 117, 68 (58.1%) were removed because of a decreased CD4 count, 21 (17.9%) because they had to change their antiretroviral regimen, 12 (10.3%) because they were pregnant, 4 (3.4%) because they were not adherent to the ART, 2 (1.7%) because of drug toxicity, and 10 (8.5%) because of other medical problems.
Comparing the Characteristics of Patients still in the PRP with those Removed from the Program: Bivariate Analysis.
Abbreviations: PRP, pharmacy-only refill program; SD, standard deviation.
In multivariate analysis, Christian religion, not understanding why they were enrolled in the PRP and wanting to see a clinician before their scheduled clinic visit were associated with being removed from the PRP (Table 2). Age, sex, marital status, occupation, education, and distance from health facility were not associated with being removed.
Risk Factors for Being Removed from the PRP: Multivariate Analysis.
Abbreviations: CI, confidence interval; PRP, pharmacy-only refill program.
Patients’ experiences and satisfaction with the PRP are shown in Table 3. Majority of patients (409 [91.9%]) were pleased with the PRP because it reduced waiting time at the clinic, was less stressful, and allowed them to send a relative or a friend to pick up the drugs. Only 36 (8.1%) stated that being in the PRP had no benefit. In all, 260 (58.3%) reported that PRP helped them save time to do other activities, 34 (7.6%) mentioned that it allowed them to better plan such activities, and 8 (1.8%) said it allowed flexibility in going to the clinic, but 144 (32.3%) said being in PRP never affected other activities. Nearly all (96.6%) did not experience any problem while in the PRP. Only 15 (3.3%) reported to have experienced side effects of the medication.
Patients’ Experiences and Satisfaction with the PRP, Comparing those still in the Program and those Removed from the Program.
Abbreviations: IQR, interquartile range; PRP, pharmacy-only refill program.
In all, 210 (47.1%) preferred coming back every 3 months, 105 (23.5%) every 2 months, 88 (19.7%) every month, 4 (0.9%) every 4 months, 32 (7.2%) every 6 months, 2 (0.4%) every 12 months, and 5 (1.1%) had no opinion. Only 47 (10.5%) said they wanted to see a doctor every 3 months instead of a nurse. The rest of them were happy to see a nurse.
All study participants stated that they were satisfied with the program and that the program should continue. In all, 185 (41.5%) participants stated that the program should continue without any modification. Suggestions to improve the system included installing a priority system for PRP patients when they have to see a doctor or nurse, collecting drugs every 3 months instead of every month, and receiving all drugs (antiretroviral and cotrimoxazole) from the same PRP window, a rewarding system for those who are doing well on the program, and more flexibility in the medication pickup time.
Discussion
In all, 29.8% of the patients were removed from the PRP after 24 months. Factors associated with this removal included wanting to see a clinician or a nurse before their scheduled clinic visit, religious beliefs, and not understanding the reason behind their enrollment in the PRP.
Patients wanting to see a clinician or a nurse before the scheduled clinic appointment could have meant that these patients were not ready for the PRP because of their current unstable clinical condition. It could also imply that these patients on ART were insecure of their own health hence felt the need to see a clinician. It is therefore important to find out from the patient how they feel about spending 3 or more months without seeing a clinician before referral to PRP.
Before patients are referred to the PRP, it is important to find out about their religious beliefs, more specifically whether they believe their improvement is because they are taking medication or because God is healing them or both. It is possible that spirituality may have affected patient adherence. “I don’t understand why my CD4 are low yet I believe God is healing me and I feel fine” (female patient during an interview). Born-again Christians have been reported to be at risk of stopping their ART once they feel better. 15 But also patients from other religions may believe that prayers heal HIV and therefore may consider discontinuing care and treatment. 7 ,15,16 In 2007, IDI reported in a prospective observational study that 1.2% of patients discontinued ART because of a belief in spiritual healing. The IDI authors concluded that spiritual beliefs should be assessed as part of ART adherence counseling. 16 Before patients are referred to the PRP, it is important to explain the purpose of the program and to assess the understanding of it. Some patients were referred to the PRP without understanding the reason behind it. At the time when the PRP was started the clinic was heavily congested and it is possible that some patients could have been referred without adequate explanation of the program.
At the IDI, the PRP was implemented based on expert opinion since no other HIV clinic had implemented such a program in a resource-limited setting. Strategies to improve the PRP need to take into account the patients’ feedback.
Most of our patients found the PRP convenient. They reported that their greatest benefit from the program was the time that they saved to do other activities. Patients preferred visiting the clinic less often to collect their medication and seeing the clinician less frequently. Some patients suggested installing a priority system for PRP patients when they have to see a doctor or nurse and to provide all drugs from the same PRP window. Today patients adherent to ART experience an improved quality of life and a close to normal life expectancy. HIV infection therefore should be managed as a chronic disease with patients taking a central role in the management of their own health. 7
All patients who were still in the PRP and even those who were removed appreciated the program, and all recommended that the program should continue. However, a social desirability bias could have contributed to the high level of patients’ satisfaction because patients were interviewed by research assistants from the same clinic from where they received care. The PRP was implemented at IDI, a national referral center, which offers tertiary level care. Results could therefore be different if a similar program is implemented at a health facility of a lower level.
To our knowledge, no other study has evaluated patients’ experiences and satisfaction with a PRP in resource-limited settings. In the process of setting up a PRP, it is important to take into account the patients’ perception of such a program.
Footnotes
Acknowledgments
We would like to thank all the patients and staff for all their contributions toward the data used for this evaluation.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Belgian Technical Cooperation (BTC) provided funds to cover all ethical approvals, logistics for data collection, and paid the research assistants. Gilead, University of California, San Francisco paid the salary of the principal investigator in the course of the study. Infectious Diseases Institute (IDI) provided working space during the patients' interview, data entry, and analysis. IDI staff verified the data.