Extracting Information from Summary of Product Characteristics for Improving Drugs Prescription Safety

Author(s):  
Stefania Rubrichi ◽  
Silvana Quaglini ◽  
Alex Spengler ◽  
Patrick Gallinari
2021 ◽  
Vol 11 (6) ◽  
pp. 2663
Author(s):  
Zhengru Shen ◽  
Marco Spruit

The summary of product characteristics from the European Medicines Agency is a reference document on medicines in the EU. It contains textual information for clinical experts on how to safely use medicines, including adverse drug reactions. Using natural language processing (NLP) techniques to automatically extract adverse drug reactions from such unstructured textual information helps clinical experts to effectively and efficiently use them in daily practices. Such techniques have been developed for Structured Product Labels from the Food and Drug Administration (FDA), but there is no research focusing on extracting from the Summary of Product Characteristics. In this work, we built a natural language processing pipeline that automatically scrapes the summary of product characteristics online and then extracts adverse drug reactions from them. Besides, we have made the method and its output publicly available so that it can be reused and further evaluated in clinical practices. In total, we extracted 32,797 common adverse drug reactions for 647 common medicines scraped from the Electronic Medicines Compendium. A manual review of 37 commonly used medicines has indicated a good performance, with a recall and precision of 0.99 and 0.934, respectively.


Author(s):  
Monika Lexow ◽  
Kathrin Wernecke ◽  
Gordian L. Schmid ◽  
Ralf Sultzer ◽  
Thilo Bertsche ◽  
...  

Summary Background Potential additive effects of polypharmacy are rarely considered in adverse events of geriatric patients living in long-term care facilities. Our aim, therefore, was to identify adverse events in this setting and to assess plausible concomitant drug causes. Methods A cross-sectional observational study was performed in three facilities as follows: (i) adverse event identification: we structurally identified adverse events using nurses’ interviews and chart review. (ii) Analysis of the concomitantly administered drugs per patient was performed in two ways: (ii.a) a review of summary of product characteristics for listed adverse drug reactions to identify possible causing drugs and (ii.b) a causality assessment according to Naranjo algorithm. Results (i) We found 424 adverse events with a median of 4 per patient (range 1–14) in 103 of the 104 enrolled patients (99%). (ii.a) We identified a median of 3 drugs (range 0–11) with actually occurring adverse events listed as an adverse drug reaction in the summary of product characteristics. (ii.b) Causality was classified in 198 (46.9%) of adverse events as “doubtful,” in 218 (51.2%) as “possible,” in 7 (1.7%) as “probable,” and in 1 (0.2%) adverse event as a “definitive” cause of the administered drugs. In 340 (80.2%) of all identified adverse events several drugs simultaneously reached the highest respective Naranjo score. Conclusion Patients in long-term facilities frequently suffer from many adverse events. Concomitantly administered drugs have to be frequently considered as plausible causes for adverse events. These additive effects of drugs should be more focused in patient care and research.


2002 ◽  
Vol 36 (9) ◽  
pp. 1351-1354 ◽  
Author(s):  
Christine Liautard ◽  
Ana-Maria Correa Nunes ◽  
Thierry Vial ◽  
Fabienne Chatillon ◽  
Claire Guy ◽  
...  

BACKGROUND: A possible association between low-molecular-weight heparins (LMWHs) and thrombocytosis was suspected from spontaneous reports to the French Pharmacovigilance System. This association is not mentioned in LMWH's summary of product characteristics. METHODS: All case records in the French Pharmacovigilance database were reanalyzed for relevance and causality, and the case/noncase approach was used including reports of thrombocytosis as cases and all other reports as noncases. RESULTS: Fifty-one patients treated with LMWHs had platelet counts >500 × 103/mm3. All patients were asymptomatic, and 1 had a positive rechallenge. There were 143 cases of thrombocytosis among the 174 213 reports in the database, with 61 of 4644 involving LMWHs. The calculated relative reporting ratio is 27.5 (p < 0.0001; 95% CI 19.5 to 38.9). CONCLUSIONS: There is a highly significant association of thrombocytosis reported with LMWH treatment.


2019 ◽  
Vol 104 (7) ◽  
pp. e2.31-e2
Author(s):  
Ibrahim Vhora ◽  
Andrew Taylor

AimThe trust has implemented the use of therapeutic drug monitoring (TDM) of teicoplanin on intensive care following research that identified great variability in population pharmacokinetics in children.1–3 The summary of the research available showed that patients are not achieving target concentrations. This retrospective audit aimed to evaluate whether patients were achieving target serum concentrations. It also evaluated whether teicoplanin TDM was correctly completed for each patient. The following objectives were set based on grey literature and the Summary of Product Characteristics:4 Evaluate if serum concentrations are being taken on or after day 4 post initiation (steady state), and within 1 hour pre-dose (trough) Assess if serum concentrations reach target concentration with standard initial BNFC dosing appropriate for the indication of treatment.MethodsA retrospective report of teicoplanin serum concentrations was provided by the biochemistry labs covering a 6 month period. This report was used to identify the patients for the audit. For each patient: dose information, times and clinical particulars were obtained via the electronic prescribing system, Meditech version 6. If needed, clinical records were obtained from the medical records archive.Results71 serum concentrations were identified. 11 were excluded due to unobtainable or incomplete data. Serum concentrations were then evaluated for accuracy. The criteria set for determining accuracy were: Serum concentration taken on or after day 4 post initiation (steady state) Serum concentration taken within 1 hour pre dose (trough) Patient prescribed correct BNFC dosing regimen 55% (n=33) of patients had all 3 criteria met for an accurate concentration to be determined. This meant 45% of our patients serum concentrations could not be used to accurately evaluate if current dosing regimens promptly achieve target concentrations. Using the patients’ serum concentrations that followed the above criteria, it was found that 64% of these patients did not reach their desired target concentration. This included patients with: endocarditis (n=5) – aiming for trough greater than 30 mg/L cystic fibrosis (n=1) – aiming for trough greater than 20 mg/L other infections such as sepsis (n=27) – aiming for trough greater than 15 mg/L No patient included in this audit that required a higher target concentration reached their target before the first serum concentration.ConclusionIt is evident that teicoplanin TDM, which is still in its infancy at the trust, requires further support to improve practice. From the serum concentrations that were carried out correctly, this audit begins to illustrate a number of issues surrounding teicoplanin dosing in paediatric patients, especially those with difficult to treat infections. Further research is required to assess how these correlate to clinical outcome in practice as well as evaluating patients not in an intensive care setting. This study can be a driving force for a larger scale study to be carried out so that recommendations can be established and a change of practice can be implemented.ReferencesRamos-Martín V, Paulus S, Siner S, et al. Population Pharmacokinetics of Teicoplanin in Children. J Antimicrob. Chemother 2014;58: 6920–6927Harding I, Macgowan AP, White LO, et al. Teicoplanin therapy for Staphylococcus aureus septicaemia: relationship between pre-dose serum concentrations and outcome. J. Antimicrob. Chemother 2000;45:835–841.Reed MD, Yamashita TS, Myers CM, et al. The pharmacokinetics of teicoplanin in infants and children. J. Antimicrob. Chemother 1997;39:789–796.Targocid 400mg [Internet]. Targocid 400mg - Summary of Product Characteristics (SmPC) - (eMC). Available from: https://www.medicines.org.uk/emc/product/2927 (Accessed 20 February 2018)


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