Background. Stevens-Johnson syndrome (SJS) is an acute life-threatening condition often elicited by drugs. The government's 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/μl 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,). 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.

Actual performance against the levels that the pilot sites should reach to minimize HIVDR was low. Improvements in follow-up procedures, internal adherence support, monitoring for drug stockouts, and adherence are all aspects that need support to ensure that all records are complete. This pilot study may help to inform the South African government as EWI monitoring is implemented.

This cross-sectional study used the Delphi technique to classify 48 generic tumour sites into sites that would be most likely ("difficult") and least likely ("not difficult") to give rise to discordant results among coders. Reports received from the Charlotte Maxeke Academic Hospital were manually recoded by five coders (2 301 reports, e.g. approximately 400 reports each) for intracoder agreement; and by four coders (400 reports) for inter-coder agreement. Unweighted kappa statistics were calculated and interpreted using Byrts' criteria. After four rounds of the Delphi technique, consensus was reached on the classification of 91.7% (44/48) of the sites. The remaining four sites were classified according to modal expert opinion. The overall kappa was higher for intra-coder agreement (0.92) than for inter-coder agreement (0.89). "Not difficult" tumour sites reflected better agreement than "difficult" tumour sites. Ten sites (skin other, basal cell carcinoma of the skin, connective tissue, other specified, lung, colorectal, prostate, oesophagus, naso-oropharynx and primary site unknown) were among the top 80% misclassified sites. The repeatability of manual coding at the NCR was rated as "good" according to Byrts' criteria. Misclassified sites should be prioritised for coder training and the strengthening of the quality assurance system.Peer reviewed.