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Article ; Online: Impact of Drug Recalls on Patients in The Netherlands: A 5-Year Retrospective Data Analysis.

Annema, Pieter A / Derijks, Hieronymus J / Bouvy, Marcel L / van Marum, Rob J

2024 Volume 115, Issue 6, Page(s) 1365–1371

Abstract: Drug recalls occur frequently and have the potential to impact considerable numbers of patients and healthcare providers. However, in the absence of a comprehensive overview the extent of conducted recalls and their impact on patients remains unknown. To ...

Abstract	Drug recalls occur frequently and have the potential to impact considerable numbers of patients and healthcare providers. However, in the absence of a comprehensive overview the extent of conducted recalls and their impact on patients remains unknown. To address this, we developed a comprehensive overview of drug recalls affecting patients. We compiled this overview based on the drug recall registrations from the Jeroen Bosch Hospital (JBZ), the University Medical Center Utrecht (UMCU), and the Royal Dutch Pharmacists Association (KNMP). A retrospective data analysis was conducted to identify drug recalls that affected patients. Specifically, we defined these as drug recalls that required patients to actively switch their drug to a different batch or brand of the same drug or to switch to a drug within the same or a different class of drugs. To quantify the impact, we used real-world drug dispensing data. Between January 1, 2017, and December 31, 2021, we identified 48 drug recalls that necessitated patients to make active changes to their medications an estimated 855,000 times. Most of the affected patients (292,000) were required to switch to a different brand of the same drug, whereas in 95,000 cases patients had to switch to a drug from another drug class. Our study suggests that a significant number of patients are affected by drug recalls. Future efforts are needed to elucidate patients' experiences and preferences regarding drug recalls, which could provide valuable insights to aid decision-making by relevant (national) authorities concerning drug recalls.
MeSH term(s)	Humans ; Netherlands ; Retrospective Studies ; Drug Recalls ; Drug Substitution/statistics & numerical data
Language	English
Publishing date	2024-02-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.3220
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Article ; Online: Capillary blood sampling for the determination of clozapine concentrations: analytical validation and patient experience.

Breken, Bianca D / Grootens, Koen P / Vermeulen Windsant-van den Tweel, Annemieke M / Hermens, Walter A / Derijks, Hieronymus J

International clinical psychopharmacology

2023 Volume 39, Issue 1, Page(s) 23–28

Abstract: Patients may be reluctant to start clozapine (CLZ) because of the frequent blood sampling needed for white blood cell monitoring, but also therapeutic drug monitoring of CLZ. Finger prick, instead of venepuncture, might lower the threshold to CLZ use. ... ...

Abstract	Patients may be reluctant to start clozapine (CLZ) because of the frequent blood sampling needed for white blood cell monitoring, but also therapeutic drug monitoring of CLZ. Finger prick, instead of venepuncture, might lower the threshold to CLZ use. The aim of this study was to determine whether CLZ concentrations are the same in capillary and venous blood samples. Capillary blood was drawn by finger prick and collected in the Hem-Col tube. Paired capillary and venous blood samples were collected from inpatients and outpatients of a mental health institute. Patients were asked to rate pain, experience, and preference for blood sampling method. Passing-Bablok analysis of 40 paired samples showed that CLZ concentrations were statistically equal in capillary and venous samples {slope 0.96 [95% confidence interval (CI): 0.88-1.04], intercept -6.86 (95% CI: -30.75 to 24.13)}. Venepuncture was the preferred method based on the experience ( P = 0.009) and preference ( P = 0.043) items. In conclusion, CLZ concentrations were similar in venous and capillary blood samples. Venepuncture appeared to be preferred to finger prick for blood sampling. Our results emphasize the importance of consulting patients' individual preference for blood sampling method.
MeSH term(s)	Humans ; Clozapine/therapeutic use ; Blood Specimen Collection/methods ; Drug Monitoring/methods ; Capillaries ; Patient Outcome Assessment
Chemical Substances	Clozapine (J60AR2IKIC)
Language	English
Publishing date	2023-08-07
Publishing country	England
Document type	Journal Article
ZDB-ID	632837-4
ISSN	1473-5857 ; 0268-1315
ISSN (online)	1473-5857
ISSN	0268-1315
DOI	10.1097/YIC.0000000000000494
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Article ; Online: The use of artificial intelligence to optimize medication alerts generated by clinical decision support systems: a scoping review.

Graafsma, Jetske / Murphy, Rachel M / van de Garde, Ewoudt M W / Karapinar-Çarkit, Fatma / Derijks, Hieronymus J / Hoge, Rien H L / Klopotowska, Joanna E / van den Bemt, Patricia M L A

Journal of the American Medical Informatics Association : JAMIA

2024

Abstract: Objective: Current Clinical Decision Support Systems (CDSSs) generate medication alerts that are of limited clinical value, causing alert fatigue. Artificial Intelligence (AI)-based methods may help in optimizing medication alerts. Therefore, we ... ...

Abstract	Objective: Current Clinical Decision Support Systems (CDSSs) generate medication alerts that are of limited clinical value, causing alert fatigue. Artificial Intelligence (AI)-based methods may help in optimizing medication alerts. Therefore, we conducted a scoping review on the current state of the use of AI to optimize medication alerts in a hospital setting. Specifically, we aimed to identify the applied AI methods used together with their performance measures and main outcome measures. Materials and methods: We searched Medline, Embase, and Cochrane Library database on May 25, 2023 for studies of any quantitative design, in which the use of AI-based methods was investigated to optimize medication alerts generated by CDSSs in a hospital setting. The screening process was supported by ASReview software. Results: Out of 5625 citations screened for eligibility, 10 studies were included. Three studies (30%) reported on both statistical performance and clinical outcomes. The most often reported performance measure was positive predictive value ranging from 9% to 100%. Regarding main outcome measures, alerts optimized using AI-based methods resulted in a decreased alert burden, increased identification of inappropriate or atypical prescriptions, and enabled prediction of user responses. In only 2 studies the AI-based alerts were implemented in hospital practice, and none of the studies conducted external validation. Discussion and conclusion: AI-based methods can be used to optimize medication alerts in a hospital setting. However, reporting on models' development and validation should be improved, and external validation and implementation in hospital practice should be encouraged.
Language	English
Publishing date	2024-04-19
Publishing country	England
Document type	Journal Article
ZDB-ID	1205156-1
ISSN	1527-974X ; 1067-5027
ISSN (online)	1527-974X
ISSN	1067-5027
DOI	10.1093/jamia/ocae076
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Article: Proton Pump Inhibitors and Hypomagnesemia in Older Inpatients: An Observational Study.

Anna Vermeulen Windsant-van den Tweel, Annemieke M / Derijks, Hieronymus J / Gadiot, Nadine P P M / Keijsers, Carolina J P W

The Senior care pharmacist

2022 Volume 37, Issue 12, Page(s) 623–630

Abstract: ... ...

Abstract	Purpose
MeSH term(s)	Humans ; Male ; Aged ; Proton Pump Inhibitors/adverse effects ; Magnesium ; Inpatients ; Retrospective Studies ; Hospitalization
Chemical Substances	Proton Pump Inhibitors ; Magnesium (I38ZP9992A)
Language	English
Publishing date	2022-12-03
Publishing country	United States
Document type	Observational Study ; Journal Article
ISSN	2639-9636
ISSN	2639-9636
DOI	10.4140/TCP.n.2022.623
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Article ; Online: Mechanisms, Management and Prevention of Pemetrexed-Related Toxicity.

de Rouw, Nikki / Piet, Berber / Derijks, Hieronymus J / van den Heuvel, Michel M / Ter Heine, Rob

Drug safety

2021 Volume 44, Issue 12, Page(s) 1271–1281

Abstract: Pemetrexed is a cytostatic antifolate drug and a cornerstone in the treatment of lung cancer. Although generally well tolerated, a substantial part of the patient population experiences dose-limiting or even treatment-limiting toxicities. These include ... ...

Abstract	Pemetrexed is a cytostatic antifolate drug and a cornerstone in the treatment of lung cancer. Although generally well tolerated, a substantial part of the patient population experiences dose-limiting or even treatment-limiting toxicities. These include mucositis, skin problems, fatigue, renal toxicity, and neutropenia. Several studies confirmed that pemetrexed pharmacokinetics can serve as a prognostic factor for the development of toxicity, especially for neutropenia. Preventing and managing toxicity of pemetrexed can help to ensure durable treatment. Several evidence-based strategies are already implemented in clinical care. With the introduction of standard vitamin supplementation and dexamethasone, the incidence of hematological toxicity and skin reactions substantially decreased. In the case of high risk for toxicity, granulocyte colony-stimulating factor can be used to prevent severe hematological toxicity. Moreover, high-dose folinic acid can resolve severe pemetrexed-induced toxicity. There are several experimental options to prevent or manage pemetrexed-related toxicity, such as the use of standard folinic acid, hemodialysis, antidotes such as thymidine, hypoxanthine, and glucarpidase, and the use of therapeutic drug monitoring. These strategies still need clinical evaluation before implementation, but could enable treatment with pemetrexed for patients who are at risk for toxicity, such as in renal impairment.
MeSH term(s)	Folic Acid ; Glutamates/pharmacology ; Glutamates/therapeutic use ; Guanine/pharmacology ; Guanine/therapeutic use ; Humans ; Leucovorin/adverse effects ; Neutropenia/chemically induced ; Neutropenia/drug therapy ; Pemetrexed/adverse effects
Chemical Substances	Glutamates ; Pemetrexed (04Q9AIZ7NO) ; Guanine (5Z93L87A1R) ; Folic Acid (935E97BOY8) ; Leucovorin (Q573I9DVLP)
Language	English
Publishing date	2021-11-06
Publishing country	New Zealand
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1018059-x
ISSN	1179-1942 ; 0114-5916
ISSN (online)	1179-1942
ISSN	0114-5916
DOI	10.1007/s40264-021-01135-2
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Article ; Online: Body weight gain in clozapine-treated patients: Is norclozapine the culprit?

Jessurun, Naomi T / Derijks, Hieronymus J / van Marum, Rob J / Jongkind, Amy / Giraud, Eline L / van Puijenbroek, Eugène P / Grootens, Koen P

British journal of clinical pharmacology

2021 Volume 88, Issue 2, Page(s) 853–857

Abstract: The antipsychotic drug clozapine is associated with weight gain. The proposed mechanisms include blocking of serotonin (5- ... ...

Abstract	The antipsychotic drug clozapine is associated with weight gain. The proposed mechanisms include blocking of serotonin (5-HT
MeSH term(s)	Adult ; Antipsychotic Agents/therapeutic use ; Clozapine/adverse effects ; Clozapine/analogs & derivatives ; Cross-Sectional Studies ; Cytochrome P-450 CYP1A2/metabolism ; Female ; Glycated Hemoglobin A ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Serotonin ; Weight Gain
Chemical Substances	Antipsychotic Agents ; Glycated Hemoglobin A ; norclozapine (1I9001LWY8) ; Serotonin (333DO1RDJY) ; Cytochrome P-450 CYP1A2 (EC 1.14.14.1) ; Clozapine (J60AR2IKIC)
Language	English
Publishing date	2021-08-05
Publishing country	England
Document type	Journal Article
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.14992
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Article ; Online: The effect of Patient's Own Medication use on patient's self-reported medication knowledge during hospitalisation: a pre-post intervention study.

van Herpen-Meeuwissen, Loes J M / van den Bemt, Bart J F / Derijks, Hieronymus J / van den Bemt, Patricia M L A / Maat, Barbara / van Onzenoort, Hein A W

BMC health services research

2022 Volume 22, Issue 1, Page(s) 423

Abstract: Background: Improving patient's medication knowledge and consequently medication use is essential for optimal treatment outcomes. As patient knowledge about medication is currently suboptimal, interventions to optimise medication knowledge are necessary. ...

Abstract	Background: Improving patient's medication knowledge and consequently medication use is essential for optimal treatment outcomes. As patient knowledge about medication is currently suboptimal, interventions to optimise medication knowledge are necessary. Implementation of Patient's Own Medication (POM) in which patients bring their outpatient medication to the hospital, and nurses administer these during admission, may increase medication knowledge. The aim of this study is to explore the impact of POM use on self-reported medication knowledge of hospitalised patients compared to standard care. Patient's sense of medication safety, attitude to the provision of information, and to inpatient medication use were studied in both standard care and during POM use too. Method: In this nationwide intervention study perceived medication knowledge was assessed with a questionnaire pre and post implementing POM use. The questionnaire assessed perceived medication knowledge at admission and discharge, medication safety during hospitalisation, the provision of information during hospitalisation and at discharge, and inpatient medication use during hospitalisation. Patients' answers were categorised into positive and negative/neutral. The proportion of patients with adequate medication knowledge, in the standard care and POM use group at hospital admission and discharge, were calculated and compared with adjustment for potential confounders. Results: Among the 731 patients (393 received standard care and 338 POM) who completed the questionnaire (80.2%), POM use seemed to be positively associated with self-reported knowledge on how to use medication at discharge (adjusted OR: 3.22 [95% CI 2.01-5.16]). However, for the other two knowledge related statements POM use was not associated. Medication knowledge at admission was the most important variable associated with perceived medication knowledge at discharge. The majority perceived POM use to be safer (52.9% of standard care patients versus 74.0% POM users; P < 0.01), POM users knew better which medicines they still used during hospitalisation (85.8% versus 92.3% resp.; P = 0.01), and most patients preferred POM use regardless of having experienced it (68.2% versus 82.2% resp.; P < 0.01). Conclusion: POM use positively affects patient's medication knowledge about how to use medication and patients' perception of medication safety. With POM use more patients have a positive attitude towards the provision of information. The majority of patients prefer POM use. In conclusion, POM use seems a valuable intervention and requires further investigation.
MeSH term(s)	Hospitalization ; Hospitals ; Humans ; Patient Discharge ; Self Report ; Surveys and Questionnaires
Language	English
Publishing date	2022-03-30
Publishing country	England
Document type	Journal Article
ZDB-ID	2050434-2
ISSN	1472-6963 ; 1472-6963
ISSN (online)	1472-6963
ISSN	1472-6963
DOI	10.1186/s12913-022-07752-6
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Article ; Online: The Pharmacoeconomic Benefits of Pemetrexed Dose Individualization in Patients With Lung Cancer.

de Rouw, Nikki / de Boer, Merel / Boosman, René J / van den Heuvel, Michel M / Burger, David M / Lieverse, Joris E / Derijks, Hieronymus J / Frederix, Geert W J / Ter Heine, Rob

Clinical pharmacology and therapeutics

2022 Volume 111, Issue 5, Page(s) 1103–1110

Abstract: Neutropenia is a dose-related treatment-limiting and costly adverse event of pemetrexed. We postulate that individualized dosing reduces the incidence of neutropenia. The aims of this study were (i) to investigate the costs of pemetrexed-related ... ...

Abstract	Neutropenia is a dose-related treatment-limiting and costly adverse event of pemetrexed. We postulate that individualized dosing reduces the incidence of neutropenia. The aims of this study were (i) to investigate the costs of pemetrexed-related neutropenia and (ii) to determine the pharmacoeconomic benefits of individualized dosing of pemetrexed in terms of budget impact, yearly cost savings, and reduction in severe neutropenia. Retrospective data on the treatment of grade 3 or higher neutropenia during pemetrexed-based chemotherapy were collected from three Dutch hospitals to determine the mean healthcare consumption during a neutropenic episode. Subsequently, Monte Carlo simulations were performed using a validated pharmacokinetic/pharmacodynamic model to predict the neutropenia incidence during four cycles for standard dosing of pemetrexed and individualized dosing. The mean costs per neutropenia and the expected neutropenia incidence were combined to calculate the budget impact and cost savings. We found that the average costs per pemetrexed-associated neutropenic episode to be €1,490 (US $1,674). The neutropenia incidence for the standard and individualized pemetrexed dosing strategies were 12.7% and 9.9%, respectively. This resulted in total expected neutropenia-related costs of ~ €3.0 million (US $3.372 million) and €2.4 million (US $2.697 million), respectively. Taking the number of patients eligible for pemetrexed treatment into account, individualized dosing could result in saving €686,000 (US $770,995) on a yearly basis in the Netherlands alone. Individualized dosing of pemetrexed can decrease the incidence of neutropenia and thus result in a significant decrease in neutropenia-related costs and decreased risk of hospitalization or even death while maintaining therapeutic exposure.
MeSH term(s)	Antineoplastic Combined Chemotherapy Protocols ; Economics, Pharmaceutical ; Humans ; Lung Neoplasms/drug therapy ; Neutropenia/chemically induced ; Neutropenia/drug therapy ; Neutropenia/epidemiology ; Pemetrexed/adverse effects ; Retrospective Studies
Chemical Substances	Pemetrexed (04Q9AIZ7NO)
Language	English
Publishing date	2022-02-21
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.2529
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Article ; Online: Inhibition of CYP2D6 with low dose (5 mg) paroxetine in patients with high 10-hydroxynortriptyline serum levels-A prospective pharmacokinetic study.

Jessurun, Naomi T / Vermeulen Windsant, Annemieke / Mikes, Oenone / van Puijenbroek, Eugène P / van Marum, Rob J / Grootens, Koen / Derijks, Hieronymus J

British journal of clinical pharmacology

2020 Volume 87, Issue 3, Page(s) 1529–1532

Abstract: The antidepressant nortriptyline is metabolized by cytochrome P450 2D6 (CYP2D6) to the less active and more cardiotoxic drug metabolite, 10-hydroxynortriptyline. High serum levels of this metabolite (>200 μg/L) may lead to withdrawal of nortriptyline ... ...

Abstract	The antidepressant nortriptyline is metabolized by cytochrome P450 2D6 (CYP2D6) to the less active and more cardiotoxic drug metabolite, 10-hydroxynortriptyline. High serum levels of this metabolite (>200 μg/L) may lead to withdrawal of nortriptyline therapy. Adding CYP2D6 inhibitors reduce the metabolic activity of CYP2D6 (phenoconversion) and so decrease the forming of hydroxynortriptyline. In this study, 5 mg paroxetine is administered to patients with high hydroxynortriptyline concentrations (>200 μg/L). The shift in number of patients to therapeutic nortriptyline (50-150 μg/L) and safe hydroxynortriptyline (<200 μg/L) concentrations, and the degree of phenoconversion, expressed as the change in ratio nortriptyline/hydroxynortriptyline concentrations before and after paroxetine addition, are prospectively observed and described. After paroxetine addition, 12 patients (80%) had therapeutic nortriptyline and safe hydroxynortriptyline concentrations. Hydroxynortriptyline concentrations decreased in all patients. The average nortriptyline/hydroxynortriptyline concentrations ratio increased from 0.32 to 0.59. This study shows that 5 mg paroxetine addition is able to lower high hydroxynortriptyline serum levels to safe ranges.
MeSH term(s)	Cytochrome P-450 CYP2D6/genetics ; Cytochrome P-450 CYP2D6 Inhibitors ; Humans ; Nortriptyline/analogs & derivatives ; Paroxetine/adverse effects ; Prospective Studies
Chemical Substances	Cytochrome P-450 CYP2D6 Inhibitors ; 10-hydroxynortriptyline (1156-99-6) ; Paroxetine (41VRH5220H) ; Nortriptyline (BL03SY4LXB) ; Cytochrome P-450 CYP2D6 (EC 1.14.14.1)
Language	English
Publishing date	2020-07-14
Publishing country	England
Document type	Journal Article
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.14455
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Article ; Online: Renal function-based versus standard dosing of pemetrexed: a randomized controlled trial

de Rouw, Nikki / Boosman, René J. / Burgers, Jacobus A. / Huitema, Alwin D. R. / Dingemans, Anne-Marie C. / Derijks, Hieronymus. J. / Burger, David M. / Piet, Berber / Hendriks, Lizza E. L. / Biesma, Bonne / Pruis, Melinda A. / Dumoulin, Daphne W. / Croes, Sander / Mathijssen, Ron H. J. / van den Heuvel, Michel M. / ter Heine, Rob

Cancer Chemother Pharmacol. 2023 Jan., v. 91, no. 1, p. 33-42

2023 , Page(s) 33–42

Abstract: PURPOSE: Pemetrexed is a chemotherapeutic drug in the treatment of non-small cell lung cancer and mesothelioma. Optimized dosing of pemetrexed based on renal function instead of body surface area (BSA) is hypothesized to reduce pharmacokinetic ... ...

Abstract	PURPOSE: Pemetrexed is a chemotherapeutic drug in the treatment of non-small cell lung cancer and mesothelioma. Optimized dosing of pemetrexed based on renal function instead of body surface area (BSA) is hypothesized to reduce pharmacokinetic variability in systemic exposure and could therefore improve treatment outcomes. The aim of this study is to compare optimized dosing to standard BSA-based dosing. METHODS: A multicenter randomized (1:1) controlled trial was performed to assess superiority of optimized dosing versus BSA-based dosing in patients who were eligible for pemetrexed-based chemotherapy. The individual exposure to pemetrexed in terms of area under the concentration–time curve (AUC) was determined. The fraction of patients attaining to a predefined typical target AUC (164 mg × h/L ± 25%) was calculated. RESULTS: A total of 81 patients were included. Target attainment was not statistically significant different between both arms (89% vs. 84% (p = 0.505)). The AUC of pemetrexed was similar between the optimized dosing arm (n = 37) and the standard of care arm (n = 44) (155 mg × h/L vs 160 mg × h/L (p = 0.436). CONCLUSION: We could not show superiority of optimized dosing of pemetrexed in patients with an adequate renal function does not show added value on the attainment of a pharmacokinetic endpoint, safety, nor QoL compared to standard of care dosing. CLINICAL TRIAL NUMBER: Clinicaltrials.gov identifier: NCT03655821
Keywords	drug therapy ; drugs ; lung neoplasms ; mesothelioma ; pharmacokinetics ; randomized clinical trials ; renal function ; surface area
Language	English
Dates of publication	2023-01
Size	p. 33-42
Publishing place	Springer Berlin Heidelberg
Document type	Article ; Online
ZDB-ID	6820-2
ISSN	1432-0843 ; 0344-5704 ; 0943-9404
ISSN (online)	1432-0843
ISSN	0344-5704 ; 0943-9404
DOI	10.1007/s00280-022-04489-1
Database	NAL-Catalogue (AGRICOLA)

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