Clinical relevance of alerts from a decision support system, PHARAO, for drug safety assessment in the older adults

• Published in: BMC geriatrics 2019-06, Vol.19 (1), p.164-164, Article 164
• Main Authors: Hedna, Khedidja, Andersson, Marine L, Gyllensten, Hanna, Hägg, Staffan, Böttiger, Ylva
• Format: Article
• Language: English
• Subjects: Adverse drug reaction; Adverse drug reactions; Aged; Analysis; Annan medicin och hälsovetenskap; Anticholinergics; Clinical decision support system; Constipation; Decision making; Decision support systems; Decision Support Systems, Clinical - standards; Drug interaction; Drug Interactions; Drug Therapy, Combination - adverse effects; Drug-Related Side Effects and Adverse Reactions - diagnosis; Drug-Related Side Effects and Adverse Reactions - etiology; Drugs; Elderly; Elderly patients; events; Farmaceutiska vetenskaper; Farmakologi och toxikologi; Female; Geriatrics; Geriatrics & Gerontology; Geriatrik; Gerontologi, medicinsk/hälsovetenskaplig inriktning (Samhällsvetenskaplig inriktn.under 50999); Health aspects; Humans; Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi; Hälsovetenskap; impact; Male; Medical Order Entry Systems - standards; Medical records; Medical Records - statistics & numerical data; Medical research; Medication Therapy Management - organization & administration; Medication Therapy Management - standards; Medicin och hälsovetenskap; Medicinska och farmaceutiska grundvetenskaper; mortality; Older adults; Older people; Patient safety; Patients; Pharmacodynamics; Pharmacology and Toxicology; Pharmacovigilance; Pharmacy; Prescription drugs; Prescriptions (Drugs); prevalence; Quality Improvement; risk; Risk factors; Side effects; Software; Sweden; Validity
• ISSN: 1471-2318; 1471-2318
• DOI: 10.1186/s12877-019-1179-y

PHARAO is a decision support system developed to evaluate the risk for a set of either common or serious side-effects resulting from a combination of pharmacodynamic effects from a patient's medications. The objective of this study was to investigate the validity of the risk scores for the common side-effects generated by PHARAO in older patients. Side-effects included were sedation, constipation, orthostatic symptoms, anticholinergic and serotonergic effects. The alerts generated by PHARAO were tested in 745 persons ≥65 years old. Dispensed prescriptions retrieved from the Swedish prescribed drug register were used to generate the pharmacological risk scores of patients' medications. Symptoms possibly related to side-effects were extracted from medical records data. The PHARAO system generated 776 alerts, most often for the risk of anticholinergic symptoms. The total specificity estimates of the PHARAO system were 0.95, 0.89 and 0.78 for high, intermediate and low risk alerts, respectively. The corresponding sensitivity estimates were between 0.12 and 0.37. The negative predictive value was 0.90 and the positive predictive value ranged between 0.20-0.25. The PHARAO system had a high specificity and negative predictive value to detect symptoms possibly associated with the of patients' medications, while the sensitivity and positive predictive value were low. The PHARAO system has the potential to minimise the risk of over-alerts in combination with a drug-drug interaction alert system, but should be used in connection with a medical evaluation of the patient.