Rob Summers

Risk of nevirapine-associated Stevens-Johnson syndrome among HIV-infected pregnant women: The Medunsa National Pharmacovigilance Centre, 2007 - 2012

BACKGROUND Stevens-Johnson syndrome (SJS) is an acute life-threatening condition often elicited by drugs. The governments indecisiveness in deciding to stop the use of nevirapine (NVP) in HIV-infected pregnant women owing to the increase of SJS among this population group in South Africa prompted this investigation. OBJECTIVES To investigate if pregnancy is a risk factor for SJS among HIV-infected women taking NVP-containing regimens and registered within the Medunsa National Pharmacovigilance Centre database. METHODS A matched case-control study with 5:1 matching was conducted. Women with SJS (cases) taking NVP-containing regimens were matched with women without SJS (controls) taking NVP-containing regimens. Controls were randomly selected and matched to cases by hospital, age, treatment duration and CD4 count. Conditional logistic regression was used to determine if pregnancy was a risk factor for SJS. RESULTS Six SJS cases were identified and 30 controls selected. The median age of both cases and controls was 29 years and the average CD4 counts were 237 and 234 cells/microl respectively. Subjects were on NVP treatment for 18 - 31 days before the onset of SJS. Controls did not develop SJS after treatment of between 1 and 365 days. Pregnancy increased the chances of developing SJS 14-fold (OR 14.28, p = 0.006, 95% CI 1.54 - 131.82). CONCLUSIONS NVP-containing ARV regimens taken during pregnancy increase the risk of developing SJS. Healthcare workers are advised to offer informed consent to patients and recommend effective contraception methods if NVP treatment is considered. In the light of our findings, further studies of the association between NVP, pregnancy and SJS are necessary before general conclusions can be reached.

The bioavailability, absorption characteristics and formulation of four commercially-available controlled-release theophylline products

Abstract The multiplicity of sustained-release preparations of theophylline. the variety of formulations used and the efficacy claims for the products led to the need for a comparative bioavailability study. Direct in vivo methods were applied to 4 products and a standard preparation. The extent of bioavailability of the 4 products examined, measured relative to a standard solution of theophylline, varied from (mean ± S.D.): 78% ± 40% to 123% ± 23%. Cumulative absorption profiles determined using the Wagner-Nelson method also showed large differences among products. The results are discussed with reference to formulation of the products. Older methods of controlling the release of drugs from solid oral forms performed relatively poorly compared with modern systems.

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

Abstract 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.

Lipid emulsion content and vitamin A stability in TPN admixtures

Abstract Vitamin A stability in TPN regimens may be influenced by the different lipid content in lipid, 3-in-1 and aqueous admixtures. In this study vitamin A losses were investigated by HPLC, in a paediatric lipid emulsion, a paediatric 3-in-1 admixture, an adult aqueous glucose/amino acid admixture and an adult 3-in-1 admixture. The admixtures were stored in PVC containers under typical storage and administration conditions. Pharmaceutically significant vitamin A losses under storage conditions occurred only from the paediatric 3-in-1 admixture. These losses could have been caused by the presence of trace elements from Ped-el ® . On exposure to ward light and temperature, the only admixture with a t 90% less than 24 h was the adult aqueous admixture. Under these conditions there was an inverse linear correlation between fat content and vitamin A loss. Fat emulsions in TPN afford protection from light to vitamin A. Hence, the vitamin should be added to lipid emulsions where possible.

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.

Serum creatinine levels during cardiac surgery: absence of effect by aminoglycosides

The literature indicates that the relative nephrotoxicities of the three drugs used in this investigation are gentamicin > tobramycin ≥ netilmicin. Serum creatinine levels over time were used in an attempt to elucidate the situation. They varied widely in all three groups and in controls in theatre. No definite trend was shown. Measurements performed for the ICU period showed continued variation.

INFLUENCE OF CONTAINER ON VITAMIN A STABILITY IN TPN ADMIXTURES

Abstract Losses of vitamin A from a paediatric TPN lipid emulsion stored at 30°C under ward lighting and from an aqueous glucose/amino acid solution stored at 2–8°C in the dark were determined when different containers were used. Vitamin A assay was performed by reverse-phase HPLC. In the first instance, a PVC bag and a Buretrol showed little difference in t 90% (20 days and > 21 days, respectively). In the second case, t 90% in both a PVC bag and a glass container was ∼- 12 days. Hence, the material of the container has little effect on vitamin A stability in these two admixtures.

Trends in Sun Protection

We now know that the damage caused to human skin by the sun is not limited to sunburn as was once thought. The chronic problems which result from accumulative sun exposure range from the less serious premature skin ageing, through solar keratosis and on to squamous and basal cell carcinoma and malignant melanoma (Food and Drug Administration, 1978;MacKie and Aitchison, 1982), which is life-threatening.