Introduction: Despite the establishment of pharmacovigilance systems, there is a recognised paucity of information specifically on the safety of paediatric medicines. Data linkage techniques offer real potential for linking routinely collected population based primary and secondary care datasets, using the Community Health Index (CHI) as a patient linkage key, to monitor the safety of new drugs and treatments. Aim: To explore the validity of routinely acquired NHS data and the utility of linking this data to support a routine mechanism for post-marketing surveillance of paediatric medicines. Methods: The internal and external validity of the Scottish national Prescribing Information System (PIS) was assessed using retrospective cohort studies combined with data linkage techniques. This PhD programme assesses the consistency of unique patient identifiers; the completeness and accuracy of the data; and the extent to which well established associations between drugs and adverse events can be reproduced using routinely collected NHS data. Results: For routine prescribing data a CHI number was found present on nearly 95% of dispensed items. In the first cohort study, insulin prescriptions within PIS were identified for 96% (95% CI 0.96-0.97) of children hospitalised for type 1 diabetes (SMR01). The rates of newly prescribed insulin were concordant with published rates in both Scottish and non-Scottish populations. In the second study asthma prescribing in children was observed to be complete (sensitivity 0.96 (95% CI 0.95-0.98)) and accurate (PPV 0.87 (95% CI 0.83-0.9)) when compared with a gold standard patient registry. Finally, patients newly prescribed NSAID therapy were observed to be 1.51 (95% CI 1.24-1.85) to 3.97 (95% CI 1.27 – 12.46) times more likely to experience first time hospitalisation for a gastrointestinal event than unexposed. Significant risk factors for a GI event were age and concurrent use of antiplatelet and anticoagulant therapy. These results are concordant with the published literature. Conclusions: Routine Scottish prescribing data is consistent, complete and accurate; however several key variables such as indication, dose and frequency, which are essential for robust pharmacovigilance, are currently missing from routinely collected data.
| Identifer | oai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:633283 |
| Date | January 2014 |
| Creators | Kirby, Bradley |
| Publisher | University of Aberdeen |
| Source Sets | Ethos UK |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
| Source | http://digitool.abdn.ac.uk:80/webclient/DeliveryManager?pid=215567 |
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