P.A.F. Jansen

Task analysis of information technology‐mediated medication management in outpatient care

Aims Educating physicians in the procedural as well as cognitive skills of information technology (IT)-mediated medication management could be one of the missing links for the improvement of patient safety. We aimed to compose a framework of tasks that need to be addressed to optimize medication management in outpatient care. Methods Formal task analysis: decomposition of a complex task into a set of subtasks. First, we obtained a general description of the medication management process from exploratory interviews. Secondly, we interviewed experts in-depth to further define tasks and subtasks. Setting: Outpatient care in different fields of medicine in six teaching and academic medical centres in the Netherlands and the United States. Participants: 20 experts. Tasks were divided up into procedural, cognitive and macrocognitive tasks and categorized into the three components of dynamic decision making. Results The medication management process consists of three components: (i) reviewing the medication situation; (ii) composing a treatment plan; and (iii) accomplishing and communicating a treatment and surveillance plan. Subtasks include multiple cognitive tasks such as composing a list of current medications and evaluating the reliability of sources, and procedural tasks such as documenting current medication. The identified macrocognitive tasks were: planning, integration of IT in workflow, managing uncertainties and responsibilities, and problem detection. Conclusions All identified procedural, cognitive and macrocognitive skills should be included when designing education for IT-mediated medication management. The resulting framework supports the design of educational interventions to improve IT-mediated medication management in outpatient care.

Cardiale neveneffecten van cholinesteraseremmers: een reden tot terughoudendheid in voorschrijven?

SamenvattingCholinesteraseremmers worden voorgeschreven bij de behandeling van lichte tot matig ernstige dementie. Er is nog relatief weinig bekend over de veiligheid van deze groep geneesmiddelen bij patiënten met cardiale aandoeningen. In deze les presenteren wij twee patiënten waarbij het starten van een cholinesteraseremmer werd gevolgd door een acute cardiovasculaire aandoening. Wij beschrijven de cardiale effecten van cholinesteraseremmers en geven informatie over gerapporteerde cardiale bijwerkingen en potentiele geneesmiddeleninteracties met cardiale consequenties. Hoewel het absolute risico op cardiale bijwerkingen gering is, lijkt het verstandig de cardiale functie goed te monitoren bij patiënten met cardiale problemen, met name indien zij medicatie gebruiken die de negatieve potentiële cardiale effecten van cholinesteraseremmers kunnen versterken.Cardiac effects of cholinesterase inhibitors: a reason for restraint?Cholinesterase inhibitors are prescribed in the treatment of mild or moderate Alzheimer’s dementia. Little is known about the cardiac safety of these drugs. We present two different cases in which cardiac events occurred during the use of a cholinesterase inhibitor. The pathophysiology, the effects of these drugs on the heart, information about the reports of side effects in pharmacovigilance databases and known literature are discussed. Although cardiac risks of cholinesterase inhibitors seem small, we advise to monitor cardiac effects of cholinesterase inhibitors carefully in patients with existing cardiac disease, especially in those using concomitant drugs known to interact with the cardiac risks of cholinesterase inhibitors.

Task analysis of information technology-mediated medication management in outpatient care: Task analysis of IT-mediated medication management

Aims Educating physicians in the procedural as well as cognitive skills of information technology (IT)-mediated medication management could be one of the missing links for the improvement of patient safety. We aimed to compose a framework of tasks that need to be addressed to optimize medication management in outpatient care. Methods Formal task analysis: decomposition of a complex task into a set of subtasks. First, we obtained a general description of the medication management process from exploratory interviews. Secondly, we interviewed experts in-depth to further define tasks and subtasks. Setting: Outpatient care in different fields of medicine in six teaching and academic medical centres in the Netherlands and the United States. Participants: 20 experts. Tasks were divided up into procedural, cognitive and macrocognitive tasks and categorized into the three components of dynamic decision making. Results The medication management process consists of three components: (i) reviewing the medication situation; (ii) composing a treatment plan; and (iii) accomplishing and communicating a treatment and surveillance plan. Subtasks include multiple cognitive tasks such as composing a list of current medications and evaluating the reliability of sources, and procedural tasks such as documenting current medication. The identified macrocognitive tasks were: planning, integration of IT in workflow, managing uncertainties and responsibilities, and problem detection. Conclusions All identified procedural, cognitive and macrocognitive skills should be included when designing education for IT-mediated medication management. The resulting framework supports the design of educational interventions to improve IT-mediated medication management in outpatient care.

Symptomatic hyponatremia due to the use of valproic acid - four cases and support from the WHO database

Introduction: The Netherlands Pharmacovigilance Centre Lareb received four cases of symptomatic hyponatremia during valproic acid (VPA) use. A causal relationship was suspected. This amount of reports doubles the described cases in worldwide literature. Almost 240 reports of hyponatremia and SIADH (syndrome of inappropriate ADH secretion) due to VPA were received by the WHO collaborating centre for international drug monitoring. We studied the strength of this association. Methods: The reported cases are described. In a case/non-case analysis, the strength of the association in the WHO database was established by calculating a reporting odds ratio, adjusted for possible confounding by concomitant medication. Results: The reported cases considered four females aged between 57 and 88 years. Sodium levels ranged from 116 to 125 mmol/l. Other possible causes for hyponatremia, like concomitant medication or co-morbidity, were ruled out or were considered not to be the primary causal factor. In the WHO database VPA was disproportionally associated with hyponatremia and SIADH (adjusted ROR 1.83 [95%CI 1.61-2.08]). Discussion: Hyponatremia may be caused by the use of VPA. The mechanism by which valproic acid could cause hyponatremia has not been fully elucidated. Possibly a combination of effects on the osmoreceptors and a lack of compensation of the salt-water unbalance by the nephrons causes hyponatremia or SIADH in some patients using valproic acid. Since hyponatremia has a high morbidity, health professionals should be aware of this adverse drug reaction. Electrolytes should be monitored closely during treatment with valproic acid in patients with risk factors for hyponatremia or SIADH.Introduction: PDE5i-related arterial thromboembolism is described in literature. Published venous thrombotic events are limited to one case of pulmonary embolism (tadalafil) and of recurrent deep venous thrombosis (DVT) related to sildenafil. Aim of the study: Presentation of two cases of vardenafil associated pulmonary embolisms and of PDE5i related pulmonary embolisms reported to international databases. Methods: Analysis of reports received by the Netherlands Pharmacovigilance Centre and international databases. Results: In the Netherlands, two recent cases of pulmonary embolism in vardenafil users have been reported. A 57-year-old male experienced dyspnoea after start and chest pain 30 min after each ingestion of vardenafil, which was three times used. CT-scan angiography showed a pulmonary embolus of the right lobe. A 62-year-old male experienced DVT in 2006, and pulmonary embolism in 2008, both shortly after vardenafil use. Seventeen cases of pulmonary embolism associated with PDE5i use were reported to the WHO and Eudravigilance ADR databases. Phosphodiestarase is an important regulator of AMP and cGMP mediated signal transduction and is involved in pulmonary vasodilatation. Proposed mechanisms include local pulmonary hypoperfusion due to vasodilatory properties of PDE5i and an interaction of PDE5i-induced raised cGMP may interfere with endothelial function. Also stimulation of phosphodiesterase E2 and E4 may result in increased endothelial adhesion and finally interaction of PDE5is with ions may influence the coagulation cascade. Conclusion: The cases are suggestive for a possible effect of PDE5is leading to pulmonary embolism. Short latencies are in line with vardenafils pharmacokinetic profile and fit in local vasodilatory effects of PDE5is.