Knowledge, attitudes and practices of health care professionals towards adverse drug reaction reporting in public sector primary health care facilities in a South African district.

PURPOSE: Adverse drug reactions (ADRs) have an appreciable impact on patients' health. Little is known however about ADR reporting in ambulatory care environments especially in low- and middle-income countries. Consequently, our aim was to determine knowledge, attitudes and practices (KAP) among health care professionals (HCPs) towards ADR reporting in primary health care (PHC) facilities in South Africa. The findings will be used to direct future activities. METHODS: Descriptive, cross-sectional design using quantitative methodology among 8 public sector community health care centres and 40 PHC clinics in the Tshwane Health District, Gauteng Province. A self-administered questionnaire was distributed to 218 HCPs, including all key groups. RESULTS: A total of 200 responses were received (91.7%). Although an appropriate attitude towards ADR reporting existed, the actual frequency of ADR reporting was low (16.0%). Of the respondents, 60.5% did not know how to report, where to report or when to report an ADR and 51.5% said the level of their clinical knowledge made it difficult to decide whether or not an ADR had occurred. Over 97.5% stated they should be reporting ADRs with 89% feeling that ADR reporting is a professional obligation and over 70% that ADR reporting should be compulsory. When results were combined, the overall mean score in terms of positive or preferred practices for ADR reporting was 24.6% with pharmacists having the highest scores. CONCLUSION: Under-reporting of ADRs with gaps in KAP was evident. There is a serious and urgent need for education and training of HCPs on ADR reporting in South Africa.

Publication trends of clinical trials performed in South Africa.

BACKGROUND: Investigators and sponsors of clinical trials have an ethical obligation to disseminate clinical trial results, whether positive or negative, in a timely manner. OBJECTIVES: To determine the publication rate and average time to reporting for clinical trials carried out in South Africa (SA) and to explore factors indicating whether a study is published or not. METHODS: A registry-based quantitative retrospective analysis of 79 SA clinical trials for new medicines registered between January 2008 and December 2010 was performed. The relevant trial identification number in the register was used to track all peer-reviewed publications subsequent to registration. Tracking of clinical trials was done through a systematic literature search of the electronic journal databases of the South African Medical Journal (SAMJ), the Cochrane Library, Public Library of Science Medical Journal (PLoS Medicine) and BioMed Central, all of which are indexed on MEDLINE via PubMed. In addition, a manual search of the Open Access Journal of Clinical Trials databases and reference lists on articles related to the trial medicine was performed. RESULTS: Of the 79 clinical trials surveyed, 72 were concluded by December 2014. Only 35 (48.6%) of them had the results published in a peer-reviewed journal, the current benchmark for dissemination of trial results. The majority (82.9%) of those published had a positive outcome. Of the 35 trials that were published, 77.1% were published within 2 years. The average time from completion to initial reporting was 22 months. Fewer than half (40.5%) of the clinical trials surveyed were placebo controlled. CONCLUSION: The absence of complete outcomes data from SA clinical trials warrants utmost attention. The study puts forward a case to the regulatory body and research ethics committees to compel all data from clinical trials to be made accessible to clinicians and the public in general by being published in an easily accessible form and in a timely manner.

Publication Trends of Clinical Trials Performed in South Africa

BACKGROUND:Investigators and sponsors of clinical trials have an ethical obligation to disseminate clinical trial results; whether positive or negative; in a timely manner.OBJECTIVES:To determine the publication rate and average time to reporting for clinical trials carried out in South Africa (SA) and to explore factors indicating whether a study is published or not.METHODS:A registry-based quantitative retrospective analysis of 79 SA clinical trials for new medicines registered between January 2008 and December 2010 was performed. The relevant trial identification number in the register was used to track all peer-reviewed publications subsequent to registration. Tracking of clinical trials was done through a systematic literature search of the electronic journal databases of the South African Medical Journal (SAMJ); the Cochrane Library; Public Library of Science Medical Journal (PLoS Medicine) and BioMed Central; all of which are indexed on MEDLINE via PubMed. In addition; a manual search of the Open Access Journal of Clinical Trials databases and reference lists on articles related to the trial medicine was performed. RESULTS:Of the 79 clinical trials surveyed; 72 were concluded by December 2014. Only 35 (48.6%) of them had the results published in a peer-reviewed journal; the current benchmark for dissemination of trial results. The majority (82.9%) of those published had a positive outcome. Of the 35 trials that were published; 77.1% were published within 2 years. The average time from completion to initial reporting was 22 months. Fewer than half (40.5%) of the clinical trials surveyed were placebo controlled.CONCLUSION:The absence of complete outcomes data from SA clinical trials warrants utmost attention. The study puts forward a case to the regulatory body and research ethics committees to compel all data from clinical trials to be made accessible to clinicians and the public in general by being published in an easily accessible form and in a timely manner

2,4-D adsorption to biochars: effect of preparation conditions on equilibrium adsorption capacity and comparison with commercial activated carbon literature data.

Batch isotherm experiments were conducted with chars to study adsorption of the herbicide 2,4-dichlorophenoxyacetic acid (2,4-D). Chars generated from corncobs, bamboo and wood chips in a laboratory pyrolyzer at 400-700 °C were compared with traditional kiln charcoals collected from villages in S/SE Asia and with activated carbons (ACs). 2,4-D uptake by laboratory chars obtained from bamboo and wood chips after 14 h of pyrolysis at 700 °C, from wood chips after 96 h of pyrolysis at 600 °C, and one of the field-collected chars (basudha) was comparable to ACs. H:C and O:C ratios declined with pyrolysis temperature and duration while surface area increased to >500 m(2)/g. Increasing pyrolysis intensity by increasing temperature and/or duration of heating was found to positively influence adsorption capacity yield (mg(2,4-D/g(feedstock))) over the range of conditions studied. Economic analysis showed that high temperature chars can be a cost-effective alternative to ACs for water treatment applications.

Efficient taste and odour removal by water treatment plants around the Han River water supply system.

Seven major water treatment plants in Seoul Metropolitan Area, which are under Korea Water Resources Corporation (KOWACO)'s management, take water from the Paldang Reservoir in the Han River System for drinking water supply. There are taste and odour (T&O) problems in the finished water because the conventional treatment processes do not efficiently remove the T&O compounds. This study evaluated T&O removal by ozonation, granular activated carbon (GAC) treatment, powder activated carbon (PAC) and an advanced oxidation process in a pilot-scale treatment plant and bench-scale laboratory experiments. During T&O episodes, PAC alone was not adequate, but as a pretreatment together with GAC it could be a useful option. The optimal range of ozone dose was 1 to 2 mg/L at a contact time of 10 min. However, with ozone alone it was difficult to meet the T&O target of 3 TON and 15 ng/L of MIB or geosmin. The GAC adsorption capacity for DOC in the three GAC systems (F/A, GAC and O3 + GAC) at an EBCT of 14 min is mostly exhausted after 9 months. However, substantial TON removal continued for more than 2 years (>90,000 bed volumes). GAC was found to be effective for T&O control and the main removal mechanisms were adsorption capacity and biodegradation.

Views of general practitioners and pharmacists on the role of the pharmacist in HIV/Aids management

Background: Sub-Saharan Africa is home to 25.8 million people living with HIV/Aids. In November 2003; the South African government approved The Operational Plan for Comprehensive Treatment and Care for HIV and Aids; which aimed to provide antiretroviral treatment to 500 000 patients by the end of 2007. The successful implementation of this operational plan requires many healthcare providers trained in aspects of HIV. This study aimed to establish and compare the views of general practitioners and pharmacists on the role of the pharmacist in HIV/Aids management and to elucidate an appropriate role for pharmacists. Ethical approval was obtained from the MEDUNSA Research Ethics and Publications Committee. Methods: The study population consisted of general practitioners in the province of Gauteng and community pharmacists in Gauteng and the Western Cape. Two hundred medical practitioners were selected at random from the 7 157 registered in Gauteng. Pharmacist respondents (293 from 879 community pharmacies in Gauteng and 200 from 493 in the Western Cape respectively) were selected randomly. The respondents were contacted individually by telephone and asked to complete a pilot-tested 10-statement questionnaire on their views of aspects relating to a role for pharmacists in HIV/Aids management. Results: Mean values for positive responses were calculated and analysed (two-sided t test). The response rates for general practitioners and pharmacists were 44.5and 38.1respectively. The responses were grouped into two categories; dispensing and advice and testing and treatment. Both groups agreed about the dispensing and advice category. Of the general practitioners surveyed; 95.5agreed that pharmacists should counsel patients on the correct use of medications and 100agreed that the pharmacist should be aware of all related side effects and drug interactions of HIV medications; i.e. the general practitioners were comfortable with pharmacists providing a dispensing and advisory role. The groups differed significantly about the testing and treatment category. Conclusion: GPs were generally not in favour of pharmacists being involved in the testing and treatment of HIV/Aids. The pharmacists surveyed; on the other hand; indicated their willingness to assume an expanded role in HIV/Aids management. A potential role for pharmacists was elucidated. It complements the role of the pharmacist in HIV/Aids management described in the South African Pharmacy Council Position Paper. The differences in views identified in the survey hold serious implications as South Africa struggles to contend with the HIV/Aids epidemic

Views of General Practitioners and Pharmacists on the Role of the Pharmacist in HIV/Aids Management

Background: Sub-Saharan Africa is home to 25.8 million people living with HIV/Aids. In November 2003; the South African government approved The Operational Plan for Comprehensive Treatment and Care for HIV and Aids; which aimed to provide antiretroviral treatment to 500 000 patients by the end of 2007. The successful implementation of this operational plan requires many healthcare providers trained in aspects of HIV. This study aimed to establish and compare the views of general practitioners and pharmacists on the role of the pharmacist in HIV/Aids management and to elucidate an appropriate role for pharmacists. Ethical approval was obtained from the MEDUNSA Research Ethics and Publications Committee.Methods: The study population consisted of general practitioners in the province of Gauteng and community pharmacists in Gauteng and the Western Cape. Two hundred medical practitioners were selected at random from the 7 157 registered in Gauteng. Pharmacist respondents (293 from 879 community pharmacies in Gauteng and 200 from 493 in the Western Cape respectively) were selected randomly. The respondents were contacted individually by telephone and asked to complete a pilot-tested 10-statement questionnaire on their views of aspects relating to a role for pharmacists in HIV/Aids management.Results: Mean values for positive responses were calculated and analysed (two-sided t test). The response rates for general practitioners and pharmacists were 44.5 and 38.1 respectively. The responses were grouped into two categories; dispensing and advice and testing and treatment. Both groups agreed about the dispensing and advice category. Of the general practitioners surveyed; 95.5 agreed that pharmacists should counsel patients on the correct use of medications and 100 agreed that the pharmacist should be aware of all related side effects and drug interactions of HIV medications; i.e. the general practitioners were comfortable with pharmacists providing a dispensing and advisory role. The groups differed significantly about the testing and treatment category.Conclusion: GPs were generally not in favour of pharmacists being involved in the testing and treatment of HIV/Aids. The pharmacists surveyed; on the other hand; indicated their willingness to assume an expanded role in HIV/Aids management. A potential role for pharmacists was elucidated. It complements the role of the pharmacist in HIV/Aids management described in the South African Pharmacy Council Position Paper. The differences in views identified in the survey hold serious implications as South Africa struggles to contend with the HIV/Aids epidemic

Randomized, controlled trial of prescribing training in a South African province.

OBJECTIVES: Prescribing practices impact greatly on drug use and expenditure. The situation in developing countries is often compounded by a limited health budget. Furthermore, because of role substitution in these countries, prescribers are often not formally trained in rational prescribing. The study described in this paper assesses the effect of a prescribing training intervention for primary health care nurses. DESIGN: A generic training-of-trainers course and a 4-day effective prescribing course were presented to 24 provincial trainers. These trainers then conducted effective prescribing workshops for 20 primary health care nurses per workshop. In 1997, 457 prescribers were trained by this method in South Africa's Northern Province. The study investigated the impact of the training on prescribing practices for two target conditions, in a control and a study group of 11 clinics each, 1 month after and 3 months after the intervention. SETTING: Primary health care clinics in the Lowveld Region of the Northern Province of South Africa. RESULTS: Prescribing practices for the two conditions examined were significantly improved by the training. Changed behaviour was not only seen in prescribing for upper respiratory tract infections, used as an example condition, but also for diarrhoea and/or vomiting, a common condition in the region, which was not included in the training programme. These results show that prescribers not only retained the knowledge gained, but were also able to apply their new skills to other conditions (transfer effect). The change in the study group was maintained for 3 months after training, while there were no significant improvements in prescribing in the control group. INTERPRETATION: The training intervention had a beneficial effect on prescribing practices.

Comparative measurements of microbial activity in drinking water biofilters.

Tetrazolium reduction assays, phospholipid analysis, and 16S rRNA (rDNA) sequence analysis were applied to assess the distribution, composition and activity of microbial communities developing in biofilters treating non-ozonated and ozonated drinking water. The response of media-attached biomass to both operating temperature (3 degrees C vs. > 12 degrees C) and ozone application point was assessed. As judged by 2-(p-iodo-phenyl)-3-(p-nitrophenyl)-s-phenyl tetrazolium chloride (INT) reduction, the dehydrogenase activity in biofilter systems that were operated with non-ozonated water was 55% lower than in identical filters operating with ozonated water. There was no significant difference between the microbiological activity measured in a biofilter series treating ozonated water and an identical series where ozonated water was introduced at an intermediate point. The biomass levels in biofilter systems that were operated with ozonated water were 47% higher on average than identical systems operated with non-ozonated water. Operating temperature had no significant impact on total biomass levels; however, specific dehydrogenase activity was 70% higher in systems operated at ambient temperatures (> 12 degrees C) than in systems held at 3 degrees C. Phospholipid and rDNA analysis suggests that there was a community structure response to ozone application and operating temperature, but no response to different ozone application points.

A national database for essential drugs in South Africa.

In the process of drafting standard treatment guidelines for adults and children at hospital level, the Secretariat of the National Essential Drugs List Committee made use of a database designed with technical support from the School of Pharmacy, MEDUNSA. The database links the current 697 drugs on the Essential Drugs List with Standard Treatment Guidelines for over 400 conditions. It served to streamline the inclusion of different drugs and dosage forms in the various guidelines, and provided concise, updated information to other departments involved in drug procurement. From information on drug prices and morbidity, it can also be used to calculate drug consumption and cost estimates and compare them with actual figures.

Microbial characterization of biological filters used for drinking water treatment.

The impact of preozonation and filter contact time (depth) on microbial communities was examined in drinking water biofilters treating Ohio River water which had undergone conventional treatment (coagulation, flocculation, sedimentation) or solutions of natural organic matter isolated from groundwater (both ozonated and nonozonated). With respect to filter depth, compared to filters treating nonozonated waters, preozonation of treated water led to greater differences in community phospholipid fatty acid (PLFA) profiles, utilization of sole carbon sources (Biolog), and arbitrarily primed PCR fingerprints. PLFA profiles indicated that there was a shift toward anaerobic bacteria in the communities found in the filter treating ozonated water compared to the communities found in the filter treating nonozonated settled water, which had a greater abundance of eukaryotic markers.

Plasma vitamin A levels in measles and malnourished pediatric patients and their implications in therapeutics.

Measles and protein energy malnutrition (PEM) in children have been associated with low serum retinol levels. Vitamin A supplementation has reduced mortality and morbidity significantly. The purpose of this study was to determine the effect of vitamin A supplementation on plasma retinol levels in children with these conditions. Black, African children, admitted to Ga-Rankuwa Hospital with measles or PEM, were randomly allocated to either a study or a control group. The study group received, in addition to routine treatment, 150,000 units of vitamin A palmitate IM on day 1 followed by 15,000 units orally for 7 days. The patients in the control group received routine appropriate treatment, which may have included 3000 units vitamin A per day. Retinol plasma concentrations of all patients were measured on days 1, 2, and 8. The mean baseline plasma retinol levels (day 1) of both the measles and PEM patients were lower than 11 micrograms/dl. There was a statistically significant increase in plasma levels in the study and control groups for both conditions by day 8 with the mean plasma retinol levels > 30 micrograms/dl. There was no statistically significant difference between study and control groups. This study has shown that there is a high incidence of baseline hyporetinaemia in these patients. The mean retinol plasma levels return to within normal limits after 8 days of either routine treatment or vitamin A supplementation.

Immunogenicity of recombinant hepatitis B vaccine in urban black children from Ga-Rankuwa, Bophuthatswana, South Africa.

Many areas in Southern Africa have a relatively high endemicity for hepatitis B for which the only effective medical measure is vaccination. The aim of this study was to evaluate the antibody response to a recombinant hepatitis B vaccine (Engerix B; Smith Kline-Beecham) in a black urban population, with the use of the recommended regimen and a low dose, short course. One hundred eleven children seronegative for hepatitis B virus (5 to 19 years old) were randomized to receive one of the two vaccination schedules (20 micrograms at zero, 1 and 6 months or 2 micrograms at zero, 1 and 2 months). Antibody to hepatitis B surface antigen was determined 6 to 8 weeks after the last dose by radioimmunoassay (Ausab; Abbott Laboratories). The recommended schedule gave a seroconversion rate of 100% with a geometric mean titer of 585.9 mIU/ml. The low dose, short course schedule produced a seroconversion rate of 63.8% and a geometric mean titer of 73.8 mIU/ml. In the 5- to 9-year-old individuals, however, 71.6% seroconverted (geometric mean titer 114.2 mIU/ml). For cost reasons further investigations on low dose regimens are indicated.

Evaluation of a communications skills workshop for hospital pharmacists.

The ability to communicate is an essential requirement for effective practice. Until recently, however, pharmacy students received no training in this area. The resultant inadequacy was carried forward into practice. Only now has the omission been recognized and attempts made to improve the situation among practising pharmacists. We designed an 8-h workshop on communication skills. It covered the basic principles of communication (Workbook A--preparatory work before the workshop) and their application (Workbook B + case studies, exercises and role-playing--during the workshop). The workshop was presented to a group of hospital pharmacists in the Western Cape. At the end of the workshop participants completed a questionnaire on its usefulness, applicability and presentation on a five-point scale. Responses were counted, averaged and analysed by sex and age. Although the ratings were uniformly high (average 4.3 out of a possible 5.0) there were differences between men and women and between older and younger pharmacists. The possible reasons for and implications of these differences are discussed.

Benzodiazepine use in a small community hospital. Appropriate prescribing or not?

Benzodiazepine (BDZ)-prescribing patterns in relation to indications and to drug characteristics in a small short-stay hospital were examined. In a sample of 800 patients, 183 were prescribed BDZs during their stay. Female patients received more BDZs (BDZ:female patients 1.31:1.0) than males (BDZs:male patients 1.02:1.0), particularly in the 21-40-year age group in which polypharmacy was highest. BDZs were classified according to their elimination half-lives. Our data showed that the majority fell into the long-acting (half-life greater than 24 h) (55%) and intermediate-acting (half-life 12-24 h) (20.7%) categories, despite the fact that most indications (pre-anaesthetic and night-time sedation; total 71.6%) called for the shorter-acting drugs. The merits or otherwise of this situation are discussed, and a number of questions put regarding the validity of this approach. Overall, BDZs accounted for 5.8% of the calculated medications given to the 800-patient sample.