Discharge medication delivery location and postpartum blood pressure control in patients with hypertensive disorders of pregnancy.

OBJECTIVE: This study examined whether use of bedside medication delivery (Meds to Beds, M2B) or on-campus pharmacy at discharge was associated with improved postpartum blood pressure (BP) control compared to outside pharmacy use in patients with hypertensive disorders of pregnancy (HDP). STUDY DESIGN: This was a secondary analysis of 357 patients with HDP enrolled in STAMPP-HTN (Systematic Treatment and Management of Postpartum Hypertension Program) who were discharged from delivery admission with antihypertensives between October 2018 and June 2020. Patients were grouped by discharge medication location: M2B/on-campus pharmacy (on-site) versus outside pharmacy (off-site). MAIN OUTCOME MEASURES: The primary outcome was BP values at the immediate postpartum visit. Secondary outcomes included six-week visit BP values, attendance at both visits, and readmission within six weeks. RESULTS: Median BP values were no different based on pharmacy location at immediate postpartum visit for both systolic ((135 [IQR 127, 139] on-site vs 137 [127, 145] off-site, p = 0.22) and diastolic (81 [74, 91] vs 83 [76, 92], p = 0.45) values. Similar findings were noted at six weeks. Patients who used an off-site pharmacy had higher attendance rates at the immediate postpartum visit but this difference was attenuated after adjusting for group differences (OR 0.67 [95 % CI 0.37-1.20], p = 0.18). Readmission rates were also not different between groups (12.2 % on-site vs 15.8 % off-site pharmacy, p = 0.43). CONCLUSION: In the context of a preexisting multicomponent HDP quality improvement program, on-campus pharmacy and bedside medication delivery use was not associated with additional improvement in postpartum BP control, follow-up rates, or readmission rates.

A comprehensive analysis of the association between placental pathology and recurrent preterm birth.

BACKGROUND: Histologic examination of the placenta is often performed after preterm birth. Although placental examination cannot change the index pregnancy outcome, it may inform the risk of adverse outcomes in a subsequent pregnancy. Previous research has examined the association between individual histologic lesions and pregnancy outcomes without consistent results. OBJECTIVE: This study aimed to determine the independent contributions of the major placental pathology histologic types to recurrent preterm birth. STUDY DESIGN: This was a retrospective cohort study of deliveries at a tertiary care center from January 2009 to March 2018. Individuals with ≥2 births, an index birth of <37 weeks of gestation, and a placental pathology report from the index pregnancy were included. The presence of maternal vascular malperfusion, fetal vascular malperfusion, acute inflammation, and chronic inflammation was extracted from the pathology reports for each index placenta and classified as none, low grade, or high grade. A log-binomial model incorporating all 4 placental pathology histologic types, index gestational age, race, and maternal age was used to estimate the associations between each placental histologic type and risk of recurrent preterm birth. Moreover, 2-way interaction terms were studied among placental histologic types. In addition, 2 stratified analyses were completed on the basis of characteristics of the index preterm birth: (1) by late preterm (gestational age of 34-36 weeks) vs early-to-moderate preterm birth (<34 weeks) and (2) a subgroup analysis of those with spontaneous preterm birth. RESULTS: A total of 924 pregnancy pairs met the inclusion criteria. Only high-grade chronic inflammation was independently associated with an increased risk of recurrent preterm birth (adjusted risk ratio, 1.37; 95% confidence interval, 1.03-1.81). Stratified analysis by gestational age group demonstrated maternal vascular malperfusion was associated with recurrent preterm birth only among those with early preterm birth (adjusted risk ratio, 1.40; 95% confidence interval, 1.01-1.93). Among participants with spontaneous preterm labor, no association was found between pathology histologic types and risk of preterm birth. CONCLUSION: Among index preterm pregnancies, high-grade chronic placental inflammation was associated with recurrent preterm birth. Low-grade maternal vascular malperfusion was associated with recurrent preterm birth only among those with an early or moderate index preterm birth (<34 weeks of gestation). These findings may be useful in determining the risk profile for individual patients and may generate hypotheses as to the pathogenesis of recurrent preterm birth.

Racial Differences in Readmissions in Hypertensive Disorders of Pregnancy.

Hypertensive disorders of pregnancy (HDP) are associated with maternal and neonatal morbidity as well as postpartum hospital readmission. This study seeks to characterize differences among patients with postpartum readmissions related to HDP. This is a retrospective study of patients with HDP admitted at an urban tertiary care center from January 2019 to November 2019 following the implementation of a standardized readmission workflow for patients with HDP at a single institution. Medical information up to 6 weeks postpartum was collected by chart review. The primary outcome was readmission. Secondary outcomes included reason for readmission, location of initial evaluation, and blood pressure values at time of readmission. A total of 729 patients with HDP delivered over the study period, 79.7% (N = 581) of whom were Black and 11.0% (N = 80) of all patients were readmitted within 6 weeks of delivery. Patients who were older, privately insured, and with chronic hypertension/cardiac disease were more likely to be readmitted. There was no difference in readmission rate by race. However, Black patients were more likely to be readmitted for preeclampsia with severe features (43.3% vs 10.0% non-Black, p = 0.01). Black patients who were readmitted were more likely to be initially evaluated in the emergency room compared to non-Black patients (43.3% vs 15.0%, p = 0.03). Our results suggest although readmission rates did not differ by race, there are significant differences at the patient and system level between Black and non-Black patients readmitted to the hospital after a pregnancy affected by HDP.

History of respiratory problems in prior infant and respiratory morbidity in subsequent pregnancy.

OBJECTIVE: Respiratory distress syndrome (RDS) is a common cause of morbidity in preterm neonates. Late preterm births (34 0/7 to 36 6/7 weeks of gestation) account for three-quarters of preterm births. Delivery in the late preterm period is a well-established risk factor for RDS.1 Whether history of a neonate with respiratory morbidity at birth relates to respiratory morbidity in a subsequent pregnancy is not well characterized. In this research letter, we have described how maternally reported respiratory morbidity in a neonate in a previous pregnancy is associated with respiratory morbidity in a neonate in a subsequent pregnancy. STUDY DESIGN: This was a secondary analysis of a randomized controlled study of antenatal corticosteroids in the late preterm period (antenatal betamethasone for women at risk for late preterm delivery).2 Multiparous patients with a singleton pregnancy were included. The institutional review board at The University of Chicago (approval number IRB 21-0141) deemed this study exempt. Respiratory morbidity of a previous infant was maternally reported in a questionnaire specifying any "respiratory problems at birth" in their live neonates (yes or no). Major respiratory morbidity (MRM) in the current pregnancy was defined as any of the following: continuous positive airway pressure or high-flow nasal cannula for ≥12 hours in the first 72 hours of life, ventilator use in the first 72 hours of life, extracorporeal membrane oxygenation, oxygen requirement of FiO2 of ≥0.3 for ≥24 total hours in the first 72 hours of life, or stillbirth or neonatal death at <72 hours of age. This was abstracted from maternal and neonatal medical records. The presence of any respiratory morbidity (MRM, RDS, or transient tachypnea of the newborn [TTN]) was compared by history of a previous infant with any respiratory morbidity. Chi-square and Wilcoxon rank-sum tests were used for bivariable analyses, and logistic regression was performed to adjust for confounders. The analysis was repeated, stratified by any betamethasone use. RESULTS: We included 1412 multiparous patients, 195 with a previous infant with maternally reported respiratory morbidity and 1217 without. RDS, MRM, and a composite of RDS, TTN, and apnea were more likely among those who had a sibling with respiratory morbidity, per maternal report (adjusted odds ratio [aOR] of RDS, 2.17 [95% confidence interval (CI), 1.28-3.70]; aOR of MRM, 1.9 [95% CI, 1.20-3.02]; aOR of RDS, TTN, and apnea, 1.85 [95% CI, 1.22-2.70]). When stratified by administration of betamethasone, the risk of MRM was only persistent in those without betamethasone use (aOR, 1.84; 95% CI, 1.00-3.39). Similarly, the risk of RDS and a composite risk of RDS, TTN, and apnea were only persistent in those without betamethasone use (aOR, 2.37 [95% CI, 1.16-4.84]; aOR, 1.82 [95% CI, 1.05-3.17]) Tables 1 and 2. CONCLUSION: A maternally reported history of respiratory morbidity in a previous late preterm or term infant was independently associated with respiratory morbidity, including RDS, in a subsequent infant. When stratified by betamethasone use, the risk of respiratory morbidity was only persistent in those neonates without betamethasone exposure during the late preterm period.

Postpartum Outcomes With Systematic Treatment and Management of Postpartum Hypertension.

OBJECTIVE: To test the ability of a hospital-wide, bundled quality-improvement initiative to improve postpartum maternal blood pressure control and adherence to postpartum follow-up among patients with hypertensive disorders of pregnancy. METHODS: This quality-improvement initiative consisted of a bundle of clinical interventions including health care professional and patient education, a dedicated nurse educator, and protocols for postpartum hypertensive disorders of pregnancy care in the inpatient, outpatient and readmission setting. We implemented this initiative in patients with hypertensive disorders of pregnancy starting in January 2019 at the University of Chicago. The study period was divided into four periods, which correspond to preintervention, distinct bundle roll outs, and postintervention. Our primary outcome was postpartum hypertension visit adherence. Secondary outcomes included blood pressure values and antihypertensive medication use in the immediate postpartum and outpatient postpartum time periods. We then stratified our outcomes by race to assess whether the effect size differed. RESULTS: A total of 926 patients who delivered between September 2018 and November 2019 were included. Postpartum hypertension visit adherence improved from preintervention period compared with the full implementation period (33.5% vs 59.4%, P<.001). Blood pressure in the first 24 hours postpartum decreased from preintervention compared with full implementation (preintervention median [interquartile range] systolic blood pressure 149 mm Hg [138, 159] vs 137 [131, 146] in postimplementation; P<.001). After implementation, fewer patients experienced a blood pressure of 140/90 mm Hg or higher at the first postpartum blood pressure check, when compared with preintervention (39.1% vs 18.5%, P=.004). The effect size did not differ by race. CONCLUSION: A bundled quality-improvement initiative for patients with hypertensive disorders of pregnancy was associated with improved postpartum visit adherence and blood pressure control in the postpartum period.

Evidence-based protocol decreases time to vaginal delivery in elective inductions.

BACKGROUND: Labor induction accounts for over 1 in 5 births in the United States. There is large variability in practices of induction of labor. Standardizing aspects of induction of labor has been shown to have beneficial maternal and fetal effects. OBJECTIVE: This study aimed to investigate the impact of the implementation of an evidence-based labor induction protocol on maternal and neonatal outcomes. STUDY DESIGN: In February 2018, a contemporary labor induction protocol composed of standardized cervical ripening and early amniotomy was implemented in the labor and delivery unit at a large academic center along with comprehensive training of staff. Maternal and fetal outcomes were compared between patients undergoing induction over a 9 month period following the implementation of the protocol and those undergoing induction 9 months earlier, excluding a 2 week washout period while training occurred. RESULTS: We studied 887 patients who underwent induction of labor of a live singleton at >24 weeks' gestation during our study period (387 patients before the implementation of the protocol and 500 patients after the implementation of the protocol). Baseline characteristics of maternal age, previous vaginal deliveries, and birthweight were similar in patients before and after the implementation of the protocol. There was a significant increase in the number of elective inductions occurring after the implementation of the protocol. There was a significant decrease in time from start of induction to rupture of membranes in all women under the protocol (13.3 hours before the implementation of the protocol vs 10.4 hours after the implementation of the protocol; P≤.001) and decrease in time from start of induction to delivery (21.2 hours before the implementation of the protocol vs 19.7 hours after the implementation of the protocol; P=.04). When the analysis was stratified by elective and nonelective inductions of labor, we found that time from induction of labor initiation to vaginal delivery was shortened after the implementation of the protocol for those undergoing elective induction (18.5 hours vs 14.6 hours; P=.03). There was no difference in cesarean delivery rate (P=.7), chorioamnionitis (P=.3), postpartum hemorrhage (P=.7), or newborn intensive care unit admission (P=.3). CONCLUSION: The implementation of an evidence-based labor induction protocol was associated with decreased time to delivery, primarily driven by decreased time to vaginal delivery among those undergoing elective inductions of labor, without compromise of maternal or neonatal outcomes.

Real life outpatient biomarker use in management of hypertensive pregnancies in third trimester in a low resource SeTting: ROBUST study.

OBJECTIVES: The utility of angiogenic biomarkers in a low resource outpatient setting is not well known. This study evaluates the clinical utility of angiogenic biomarkers, soluble fms-like tyrosine kinase 1 (sFlt1) and placental growth factor (PlGF) among patients at risk for preeclampsia in a low resource outpatient setting. STUDY DESIGN: This was a prospective pilot study among high risk third trimester outpatients conducted in Bengaluru, India. Serum sFlt1/PlGF was measured between 28 and 37 weeks. Patients with high risk ratio were managed with close observation, intermediate risk had serum redrawn in one week, and those with low risk ratio received routine care. Delivery decisions were made based on local protocols. MAIN OUTCOME MEASURES: Maternal complication rate, development of preeclampsia with severe features, and latency to delivery was examined by sFlt1/PlGF ratio. RESULTS: The study included 50 patients. Compared to women with a low risk ratio, women with a high-risk ratio were more likely to have preeclampsia with severe features (90.91% vs 8.00%, p < 0.0001), a higher composite maternal complication rate (18.18% vs 0%, p = 0.04) and deliver at earlier gestational ages (32.57 [30.43, 34.71] vs 37.43 [36.86, 38.14] weeks, p = 0.0001). CONCLUSION: Angiogenic factors may have utility in the low resource outpatient setting for women with a hypertensive disease. Low sFlt1/PlGF levels were associated with a longer latency to delivery and no maternal complications. This study confirms the broad clinical utility of biomarkers in the real world.

Hospitalization Duration Following Uncomplicated Cesarean Delivery: Predictors, Facility Variation, and Outcomes.

Objectives This study was designed to: (1) characterize stay duration following cesarean delivery, (2) ascertain whether facility variation exists, and (3) determine whether shorter stays are associated with rates of readmission or costs. Study Design The 2017 Nationwide Readmissions Database was used to identify uncomplicated cesarean deliveries. Hierarchical logistic regression was used to assess for facility variation in percentage of patients discharged within 2 days. Similar models were used to assess for associations between probability of readmission within 30 days and facility-level rates of discharge within 2 days. Results In total, 456,312 patients from 1,535 hospitals were included. The median facility discharged 46.8% of patients within 2 days, with the 25th percentile of hospitals 23.7% and the 75th percentile 71.2%. In adjusted regression, there was significant facility heterogeneity ( p < 0.0001). The overall readmission rate was 1.7%, and proportion of patients discharged within 2 days of cesarean delivery was not associated with readmission probability (adjusted relative risk: 1.02, confidence interval: 0.90-1.16), but was associated with lower inpatient costs (adjusted incremental cost: $111, confidence interval: -181 to -41). Conclusion Unexplained facility variation in percentage of patients discharged within 2 days of cesarean delivery was not associated with differences in readmissions. Key Points We find significant facility-level variation in outcomes following uncomplicated cesarean delivery in the United States.High rates of early (postoperative day 2) discharge was not associated with differences in readmission rates in adjusted analyses but was associated with lower inpatient costs.

Continuous Professional Development for Public Sector Pharmacists in South Africa: A Case Study of Mapping Competencies in a Pharmacists' Preceptor Programme.

Lifelong learning among healthcare practitioners is crucial to keep abreast of advances in therapeutic and service delivery approaches. In South Africa, continuous professional development (CPD) was mandated (2019) for re-registration of pharmacists to illustrate their learning according to the South African Pharmacy Council's (SAPC) competency standards. This paper uses a preceptor programme linked to the University of the Western Cape School of Pharmacy's service learning programme to map the competencies employed by pharmacist preceptors in primary care public healthcare facilities in Cape Town in an attempt to encourage completion of their annual CPDs and strengthening the academic-service partnership. Competencies identified were divided into input competencies related to the preceptor's role in designing and implementing the educational programme in their facilities and assisting students to complete their prescribed learning activities, and output/outcome competencies that emerged from preceptors identifying the facility needs and employing their input competencies. Input competencies pertained to education, leadership, patient counselling, collaborative practice and human resources management. Output competencies related to pharmaceutical infrastructure, quality assurance, professional and health advocacy, primary healthcare, self-management and patient-centred care. The preceptor programme enabled pharmacist preceptors to employ several competencies that are aligned with the SAPC's competency framework.

Access to Reproductive Health Care in Juvenile Justice Facilities.

STUDY OBJECTIVE: The juvenile justice system houses adolescents with unique and unmet reproductive needs, including family planning. The purpose of this study was to identify access to contraceptive counseling and methods for young women in the juvenile justice system. DESIGN: We administered a cross-sectional survey that was used to examine services related to reproductive health care, including contraceptive counseling, and ability to initiate or continue contraceptive methods in custody. SETTING: Juvenile justice systems in the United States. PARTICIPANTS: State-level health care administrators in juvenile justice systems. INTERVENTIONS AND MAIN OUTCOME MEASURES: We analyzed responses to determine the ability of young women in custody to continue or initiate specific contraceptive methods, in addition to other measures of reproductive health access. RESULTS: Twenty-one respondents representing systems in 20 US states were included in analysis. All participating sites provided contraceptive counseling and all allowed at least 1 form of preincarceration contraception to be continued. Eighty-one percent (17/21) of systems enabled young women to initiate contraception while in custody, with the most common method available on-site being birth control pills. Twenty percent (4/20) of sites provided long-acting reversible contraceptive methods. CONCLUSION: This study shows that it is feasible to provide contraception in this setting. However, there exists considerable variability in availability of methods across the United States. Continued work is needed in increasing access to contraception and standardization of care in the juvenile justice system.

Balanced nutrition and hand hygiene for children in South Africa.

Globally, ∼5.9 million children under the age of 5 years died in 2015, with the challenges of child mortality and morbidity being common in developing countries. Many of these deaths are preventable and poor nutritional and hygienic practices contribute greatly to these rates. The spread of infectious disease through unhygienic practices, such as inadequate hand hygiene, remains high due to lack of education regarding hygienic infection control practices at home and in the workplace. The aim of this research was to design and implement a participatory health promotion intervention for caregivers at the Rhodes Day Care Centre (RDCC) that highlighted these important public health issues. We conducted a pre-intervention group feedback discussion with caregivers at the RDCC to identify current practices and to establish the current baseline knowledge of the caregivers. Health workshops with caregivers was facilitated by the researcher, and health information leaflets (HILs) were designed for and used during these workshops. Caregivers at RDCC exhibited fair baseline knowledge on the importance of providing nourishing meals to the infants, including the need for exclusive breastfeeding, and the importance of hand hygiene in preventing the spread of disease. This basic knowledge was positively built upon in the two health promotion intervention workshops. This initiative, held at RDCC, was able to catalyse the development of health knowledge that could have a substantial impact on the understanding of health literacy of the caregivers and on the promotion of adequate child health in the community.

Gender and leadership for health literacy to combat the epidemic rise of noncommunicable diseases.

Until recently, the noncommunicable diseases (NCDs) epidemic has been considered only a significant burden to men in high-income countries. However, latest figures indicate that half of all NCD-related deaths affect women, especially in low- and middle-income countries (LMICs), with global responses to the NCD epidemic overlooking the significance of women and girls in their approaches and programs. This case study highlights the burden of disease challenging South Africa that disproportionately affects women in the country and suggests that the country, along with other LMICs internationally, requires a shift in the gender-based leadership of health literacy and self-empowerment.

Hypertension and Diabetes Mellitus: A Preliminary South African Health Promotion Activity Using Service-Learning Principles.

A marked increase in the chronic non-communicable diseases such as hypertension and diabetes mellitus in the South African population is in concert with global trends. A health promotion activity carried out by pharmacy students for school learners during the Sasol National Festival of Science and Technology (SciFest) in South Africa was used as a service-learning opportunity. Pilot tested quizzes on hypertension and diabetes were used to determine the level of knowledge of attendees before and after taking the computer based quiz. Posters, information leaflets and interactive models on these two conditions were also used to reach out to the larger population. Of the 203 participants for the hypertension quiz, 169 completed both the pre- and post-intervention quizzes. Similarly, 86 of the 104 participants for the diabetes quiz, completed both the pre- and post-intervention quizzes. The results show that the post-intervention quiz resulted in a significant increase in the scores from 78.2 to 85.6 % in the case of Hypertension while a marginal increase from 94.2 to 95.5 % was obtained in the case of diabetes. The knowledge of the SciFest attendees with regard to both conditions is above average and improved further after the educational intervention. Health promotion activities which include interactive educational methods and culturally appropriate materials carried out by pharmacy students during service-learning courses are important for improving the awareness on the prevention of these chronic health conditions. Heath promotion service-learning courses can assist in addressing the health care gaps which arise because of a lack of co-ordinated efforts between NGO's and local Government to address the prevention and management of non-communicable diseases such as hypertension and diabetes mellitus.

Knowledge of HIV and its treatment among health care providers in South Africa.

BACKGROUND: In South Africa, availability of antiretroviral (ARV) drugs has increased largely in the public sector since it became available in 2004. Follow-up of stabilized patients on ARV drugs are done in primary health care (PHC) facilities run by nurses, often without specialized training. This has deep impact on the patients' drug adherence. OBJECTIVE: To investigate health care providers' (HCPs) knowledge about human immunodeficiency virus (HIV) and antiretroviral therapy (ART) in the Eastern Cape Province, South Africa. The aim was also to investigate nurses' knowledge and experience regarding adverse drug reaction (ADR) reporting. SETTING: Public PHC clinics in one district of the Eastern Cape Province. METHOD: Personal interviews, using a structured questionnaire, were conducted with 102 HCPs (nurses and auxiliary staff) working at six PHC facilities, one community health centre and one health post. MAIN OUTCOME MEASURE: Knowledge about HIV and ART among nurses and auxiliary staff. RESULTS: Both nurses and auxiliary staff had some basic knowledge about symptoms of HIV and modes of transmission, but great uncertainty was seen regarding specific topics including ARV drugs, ADRs and HIV complications. The PHC staff were uncertain about how to administer ARV drugs--with or without food--and some of them would advice their patients not to take ARV drugs at times when food was lacking. Both nurses and auxiliary staff knew that HIV was treated with ARV drugs. Only 60 % of the HCPs claimed that ART was the only effective treatment for HIV, whereas 39 % claimed that nutritious food also could treat HIV. Nurses showed lacking ability to manage ADRs. They also had very little knowledge about ADR reporting, and very few had ever submitted a report at all. CONCLUSION: The study shows that both nurses and auxiliary staff are unable to provide the patients with adequate advice about administration of the ARV drugs and management of ADRs. Serious lack of knowledge among HCPs regarding the treatment of HIV presents structural barriers to the patients' adherence.

Maxillary movement in cleft patients treated with internal tooth borne distractor.

Cleft lip and palate is associated with maxillary hypoplasia and retrognathism. Surgery and distraction have been the most common treatment approaches used. The aim of this study was to objectively assess the quantum and direction of movement of the anterior maxilla in cleft patients treated with an internal tooth borne distractor. A prospective clinical study design was followed in which 8 consecutive patients with cleft maxillary hypoplasia were included in the age range of 15-25 years. All patients had undergone secondary alveolar bone grafting earlier. Anterior maxillary distraction was performed using a tooth borne appliance in all 8 patients after necessary osteotomy. Lateral cephalograms were obtained preoperatively, predistraction and postdistraction. The angular and linear change at the maxillary anterior segment, rotation of the palatal plane, mandibular plane, increase in lower facial height and vertical changes of the anterior and posterior dentoalveolar segments were measured. The movement of the anterior maxillary segment was demonstrated anteriorly and superiorly in all the patients. The anterior and posterior dentoalveolar heights were increased post-distraction. There was also an increase in lower anterior facial height and the mandibular plane angle. Predictable superior and anterior movement of the anterior maxilla along with significant increase in palatal length could be achieved with the internal tooth borne distractor leading to remarkable improvement in esthetics and better function.

Healthcare providers' experiences with adverse drug reactions and adherence challenges in antiretroviral therapy of HIV patients in the Eastern Cape Province, South Africa.

PURPOSE: To gain insight into the experiences and handling of adverse drug reactions (ADRs) by the staffs of public primary healthcare (PHC) clinics in Eastern Cape Province, South Africa, as well as their perceptions of related adherence challenges in the treatment and follow-up of human immunodeficiency virus (HIV)-positive patients. METHODS: Healthcare providers working at the PHC level in the public sector in the study area were approached and asked to participate in focus group discussions (FGDs). Seven FGDs were conducted with 32 healthcare providers (9 nurses, 23 auxiliary staff). Questions introduced by the moderator of each FGD were freely discussed by the participants. Discussions were audio-recorded and subjected to thematic content analysis. RESULTS: Several challenges in the treatment and follow-up of patients on ART were identified. These include: (1) lack of training of healthcare providers in PHC clinics to confidently identify, manage and treat the ADRs HIV-positive patients receiving ART; (2) patients' difficulty in communicating information on ADRS; (3) insufficient pharmacovigilance; (4) role of poverty. CONCLUSION: Both nurses and auxiliary staff expressed lack of knowledge and confidence regarding ADRs in HIV patients and management of this. More emphasis is warranted on training the healthcare providers to identify ADRs and provide adequate advice for continued treatment of patients experiencing potential drug related problems.

Addressing gaps in pharmacovigilance practices in the antiretroviral therapy program in the Eastern Cape Province, South Africa.

BACKGROUND: The use of antiretrovirals (ARVs) is associated with considerable concern regarding adverse drug reactions (ADRs), including both short- and long-term complications. Currently, there is a general underreporting of ADRs in South Africa. In May 2007, the Eastern Cape regional training centre introduced a pharmacovigilance plan for antiretroviral therapy (ART) to improve reporting practices in the area. OBJECTIVES: The aim of this study was to gain insight on attitudes and experiences regarding ADR detection and reporting among health care providers (HCPs) shortly after the first formal pharmacovigilance plan for ART was introduced. METHODS: Three focus-group discussions were conducted with 12 HCPs. There were 7 nurses, 3 pharmacists, 1 doctor, and 1 auxiliary staff, all recruited from public hospitals and local health authorities in 2 towns in the Eastern Cape Province, South Africa. RESULTS: It was observed that senior HCPs knew that ADRs from ARVs should be reported formally, whereas junior staff did not demonstrate the same knowledge. The participants thought that underreporting from the primary health care level was a major problem. HCPs identified various reasons for underreporting ADRs: problems with filling out the reporting form, lack of training, high workload, lack of feedback, and fears of not being taken seriously. Lack of adequate training in pharmacovigilance led to lack of confidence among the professional nurses in managing ADRs. CONCLUSIONS: Increased focus on pharmacovigilance with adequate, continuous training, especially for nurses managing down-referred patients in primary health care on identification and management of ADRs, and practical use of the ADR form may be necessary to improve pharmacovigilance practices in the area.