Medication adherence: a review of policy and education in South Africa

Medication adherence is a patient's active and voluntary participation in following all the recommendations and instructions agreed upon with a health care provider such as a pharmacist. Adherence is a multidimensional phenomenon determined by the interplay of five factors: patient-related factors, socioeconomic factors, condition-related factors, health system-related factors, and therapy-related factors. Medication non-adherence is a problem in many countries, especially low to middle-income countries, including South Africa (SA). In low to middle-income countries, non-adherence is often worse due to insufficient health resources and inequities in access to health care. Medication adherence is a global problem and has raised the need for research and review. Many healthcare professionals, especially pharmacists, have an essential role in promoting medication adherence. This study described, explained and evaluated the policies in SA relating to the pharmacist's role in promoting medication adherence. Furthermore, it described medication adherence-related education at four universities in South Africa. The study was qualitative, and a two-phased approach was employed. In the first phase, a document analysis of the pharmacist’s role in supporting medication adherence was conducted as described in national policies and guidelines in SA. A total of 38 documents were analysed, including critical documents such as the South African Pharmacy Council Good Pharmacy Practice Manual and Associated SAPC rules (GPP) manual, National Drug Policy (NDP), Standard treatment guidelines (STGS) and Integrated Adherence Guidelines. The READ approach was used in conducting the document analysis and involved (1) preparing materials, (2) extracting data, (3) analysing data, and (4) distilling findings. The critical roles of pharmacists in medication adherence that were identified were in drug use, supply and management, dispensing, therapeutic drug monitoring, pharmacovigilance, pharmaceutical care, and special programmes like antimicrobial stewardship (AMS), multi-drug resistant tuberculosis (MDR-TB) care and antiretroviral treatment (ARV) and chronic conditions. In the second phase, in-depth interviews were conducted with lecturers to investigate and report on the inclusion of medication adherence and the teaching thereof in the curriculum of the Bachelor of Pharmacy Degree (BPharm) in pharmacy institutions in SA. Purposive sampling was used, and seven lecturers from four different institutions participated in the interviews. The interviews were conducted via Zoom® and were transcribed and analysed using thematic analysis. The teaching of medication adherence in the BPharm curriculum of the respective interviewed pharmacy institutions was explored. It was found that the topic of medication adherence was integrated into all subjects throughout the curriculum and not taught as a formal course. Although medication adherence is taught in many disciplines, it is predominantly in pharmacy practice in all institutions. The teaching methods identified included lectures, case studies, workshops, tutorials, practicals, readings, tasks, assignments and videos. The perceived effectiveness of the teaching methods was explored; also the time spent teaching medication adherence and the time efficiency. Student understanding, interest and engagement with the topic were explored and determined through their assessment performance and class attendance. In conclusion, from policies, the pharmacist's role concerning adherence is indirectly integrated into many other roles. It is often not distinguishable from that of other healthcare professionals and is often implied as part of a more generic role. Pharmacy students are educated on medication adherence and the skills and knowledge required to identify, monitor and support patient adherence to therapy. However, there is scope to increase the course content on medication adherence. There is a need to identify effective strategies for preparing pharmacists to assist patients in medication adherence.Thesis (MPharm) -- Faculty of Pharmacy, 202

Implementation of Option B and a fixed-dose combination antiretroviral regimen for prevention of mother-to-child transmission of HIV in South Africa: A model of uptake and adherence to care.

INTRODUCTION:Initiating and retaining pregnant women on antiretroviral therapy (ART) to prevent mother-to-child HIV transmission (PMTCT) remains a major challenge facing African HIV programs, particularly during the critical final months prior to delivery. In 2013, South Africa implemented its "Option B" PMTCT regimen (three-drug ART throughout pregnancy and breastfeeding, regardless of maternal CD4 count) and introduced once-daily fixed-dose combinations and lifelong ART. Currently, the uptake of Option B and its possible impact on adherence to PMTCT during the critical final months of pregnancy is unclear. MATERIALS AND METHODS:We prospectively collected visit data from a cohort of adult, HIV-infected, pregnant women between July 2013-August 2014 to estimate three models of adherence to PMTCT during the final 16 weeks immediately preceding delivery. Adherence was defined according to possession of antiretroviral drugs, which was inferred from clinic visit records under varying assumptions in each model. We describe uptake of the PMTCT regimen, gestational age at initiation, and model possible scenarios of adherence through delivery after the implementation of Option B. RESULTS:Among 138 women enrolled (median (IQR) age 28 years (24-32), median CD4 count 378 cells/mm3), median (IQR) gestational age at initiation was 22 weeks (16-26). Estimates of adherence during the final 16 weeks of pregnancy prior to delivery ranged from 75% (52-89%) under the best case scenario assumptions to 52% (30-75%) under the worst case scenario assumptions. Estimates of the proportion of women who would achieve 80% adherence to PMTCT were <50% across all models. CONCLUSIONS:Despite the switch to Option B and once-daily dosing, South African women continue to initiate PMTCT late in pregnancy, and estimations of regimen adherence, as modelled using PMTCT visit attendance data, is poor, with <50% of women reaching 80% adherence during final months of pregnancy across all models. Further guideline changes and interventions are needed to achieve vertical transmission goals. TRIAL REGISTRATION:ClinicalTrials.gov NCT01710397 South African National Clinical Trials Register DOH-27-0213-4177

Correction: Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.

[This corrects the article DOI: 10.1371/journal.pmed.1002015.]

A case-control study of risk factors for incident hepatitis B virus infection in South African blood donors.

OBJECTIVES: Hepatitis B virus (HBV) infection remains a global health problem. Risk factors for HBV infection are usually assessed in prevalent rather than incident infections. To identify demographic and behavioral risks associated with incident HBV among South African blood donors. METHODS: A case-control study was performed between November 2014 and January 2018. Cases were blood donors testing positive for HBV DNA with or without hepatitis B surface antigen but negative for antibody to hepatitis B core antigen. Participants completed an audio computer-assisted structured interview on exposures during the previous 6 months. Sex-specific multivariable logistic regression yielded independent associations between risks and HBV infection. RESULTS: 56 females and 37 males with incident HBV were compared to 438 female and 439 male controls, respectively. For females, risk factors were accepting money or goods for sex, using agents to prepare ones anus prior to anal sex, penetrating injury, non-Black race, and lower educational status. Men reporting homosexual or bisexual orientation or sex with other men, previous injury, referral for HBV testing, or lack of medical insurance were at increased risk. For both sexes, having more than two male sexual partners increased risk. CONCLUSIONS: Sexual behaviors predominated over parenteral exposures as risks for incident HBV in both female and male blood donors

A case-control study of risk factors for incident hepatitis B virus infection in South African blood donors

Objectives: Hepatitis B virus (HBV) infection remains a global health problem. Risk factors for HBV infection are usually assessed in prevalent rather than incident infections. To identify demographic and behavioral risks associated with incident HBV among South African blood donors. Methods: A case-control study was performed between November 2014 and January 2018. Cases were blood donors testing positive for HBV DNA with or without hepatitis B surface antigen but negative for antibody to hepatitis B core antigen. Participants completed an audio computer-assisted structured interview on exposures during the previous 6 months. Sex-specific multivariable logistic regression yielded independent associations between risks and HBV infection. Results: 56 females and 37 males with incident HBV were compared to 438 female and 439 male controls, respectively. For females, risk factors were accepting money or goods for sex, using agents to prepare one's anus prior to anal sex, penetrating injury, non-Black race, and lower educational status. Men reporting homosexual or bisexual orientation or sex with other men, previous injury, referral for HBV testing, or lack of medical insurance were at increased risk. For both sexes, having more than two male sexual partners increased risk. Conclusions: Sexual behaviors predominated over parenteral exposures as risks for incident HBV in both female and male blood donors

Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial

<div><p>Background</p><p>High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit.</p><p>Methods and Findings</p><p>RapIT (Rapid Initiation of Treatment) was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC) and a hospital-based HIV clinic. Adult (≥18 y old), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study (“rapid arm”) received a point-of-care (POC) CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB) test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV) dispensing. Patients in the standard-initiation arm of the study (“standard arm”) followed standard clinic procedures (three to five additional clinic visits over 2–4 wk prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml) within 10 mo of study enrollment. Secondary outcomes included initiation of ART ≤90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis was conducted comparing attrition from care after ART initiation between the groups among those who initiated within 90 d. Three hundred and seventy-seven patients were enrolled in the study between May 8, 2013 and August 29, 2014 (median CD4 count 210 cells/mm³). In the rapid arm, 119/187 patients (64%) initiated treatment and were virally suppressed at 10 mo, compared to 96/190 (51%) in the standard arm (relative risk [RR] 1.26 [1.05–1.50]). In the rapid arm 182/187 (97%) initiated ART ≤90 d, compared to 136/190 (72%) in the standard arm (RR 1.36, 95% confidence interval [CI], 1.24–1.49). Among 318 patients who did initiate ART within 90 d, the hazard of attrition within the first 10 mo did not differ between the treatment arms (hazard ratio [HR] 1.06; 95% CI 0.61–1.84). The study was limited by the small number of sites and small sample size, and the generalizability of the results to other settings and to non-research conditions is uncertain.</p><p>Conclusions</p><p>Offering single-visit ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. This intervention should be considered for adoption in the public sector in Africa.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="https://clinicaltrials.gov/ct2/show/NCT01710397" target="_blank">NCT01710397</a>, and <a href="http://www.sanctr.gov.za/" target="_blank">South African National Clinical Trials Register</a> DOH-27-0213-4177.</p></div

Baseline characteristics of study sample (<i>n</i> = 463).

<p>Baseline characteristics of study sample (<i>n</i> = 463).</p

Standard initiation of treatment and rapid initiation procedures and visit schedule.

<p>Standard initiation of treatment and rapid initiation procedures and visit schedule.</p

ART initiation, 10-mo retention in care, and 10-mo viral suppression.

<p>ART initiation, 10-mo retention in care, and 10-mo viral suppression.</p

Study enrollment and randomization.

<p>Study enrollment and randomization.</p