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3. Association of busulfan exposure and outcomes after HCT for patients with an inborn error of immunity

Author

Bognàr, Tim, Garcia-Rosa, Moises, Lalmohamed, Arief, Güngör, Tayfun, Hauri-Hohl, Mathias, Prockop, Susan, Oram, Layne, Pai, Sung-Yun, Brooks, Jordan, Savic, Rada M., Dvorak, Christopher C., Long-Boyle, Janel R., Krajinovic, Maja, Bittencourt, Henrique, Teyssier, Anne-Charlotte, Théorêt, Yves, Martinez, Cary, Egberts, Toine C. G., Morales, Erin, Slatter, Mary, Cuvelier, Geoffrey D. E., Chiesa, Robert, Wynn, Robert F., Coussons, Mary, Cicalese, Maria P., Ansari, Marc, Long, Susan E., Ebens, Christen L., Lust, Hannah, Chaudhury, Sonali, Nath, Christa E., Shaw, Peter J., Keogh, Steven J., van der Stoep, M. Y. Eileen C., Bredius, Robbert, Lindemans, Caroline A., Boelens, Jaap-Jan, and Bartelink, Imke H.

Published
2024
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4. Detectability of Medication Errors With a STOPP/START-Based Medication Review in Older People Prior to a Potentially Preventable Drug-Related Hospital Admission

Author

Sallevelt, Bastiaan T. G. M., Egberts, Toine C. G., Huibers, Corlina J. A., Ietswaart, Jimmy, Drenth-van Maanen, A. Clara, Jennings, Emma, O’Mahony, Cian, Jungo, Katharina Tabea, Feller, Martin, Rodondi, Nicolas, Sibille, François-Xavier, Spinewine, Anne, van Puijenbroek, Eugène P., Wilting, Ingeborg, and Knol, Wilma

Published
2022
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7. Frequency and Acceptance of Clinical Decision Support System-Generated STOPP/START Signals for Hospitalised Older Patients with Polypharmacy and Multimorbidity

Author

Sallevelt, Bastiaan T. G. M., Huibers, Corlina J. A., Heij, Jody M. J. Op, Egberts, Toine C. G., van Puijenbroek, Eugène P., Shen, Zhengru, Spruit, Marco R., Jungo, Katharina Tabea, Rodondi, Nicolas, Dalleur, Olivia, Spinewine, Anne, Jennings, Emma, O’Mahony, Denis, Wilting, Ingeborg, and Knol, Wilma

Published
2022
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9. Tacrolimus Variability and Clinical Outcomes in the Early Post-lung Transplantation Period: Oral Versus Continuous Intravenous Administration

Author

Apotheek O&O&O, Apotheek Klinische Farmacie, Longziekten, Infection & Immunity, Apotheek Opleiding, Medische Staf Intensive Care, NVIC bedrijfsvoering, Brain, Apotheek Onderzoek, Regenerative Medicine and Stem Cells, van Dommelen, Julia E M, Grootjans, Heleen, Uijtendaal, Esther V, Ruigrok, Dieuwertje, Luijk, Bart, van Luin, Matthijs, Bult, Wouter, de Lange, Dylan W, Kusadasi, Nuray, Droogh, Joep M, Egberts, Toine C G, Verschuuren, Erik A M, Sikma, Maaike A, Apotheek O&O&O, Apotheek Klinische Farmacie, Longziekten, Infection & Immunity, Apotheek Opleiding, Medische Staf Intensive Care, NVIC bedrijfsvoering, Brain, Apotheek Onderzoek, Regenerative Medicine and Stem Cells, van Dommelen, Julia E M, Grootjans, Heleen, Uijtendaal, Esther V, Ruigrok, Dieuwertje, Luijk, Bart, van Luin, Matthijs, Bult, Wouter, de Lange, Dylan W, Kusadasi, Nuray, Droogh, Joep M, Egberts, Toine C G, Verschuuren, Erik A M, and Sikma, Maaike A

Published
2024

10. Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project

Author

Apotheek Onderzoek, Infection & Immunity, Regenerative Medicine and Stem Cells, van Rijt-Weetink, Yrea R J, Egberts, Toine C G, van Hunsel, Florence P A M, Lewis, David J, Yates, Laura M, Winterfeld, Ursula, van Puijenbroek, Eugène P, Apotheek Onderzoek, Infection & Immunity, Regenerative Medicine and Stem Cells, van Rijt-Weetink, Yrea R J, Egberts, Toine C G, van Hunsel, Florence P A M, Lewis, David J, Yates, Laura M, Winterfeld, Ursula, and van Puijenbroek, Eugène P

Published
2024

11. Tacrolimus Variability and Clinical Outcomes in the Early Post-lung Transplantation Period: Oral Versus Continuous Intravenous Administration

Author

Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, van Dommelen, Julia E M, Grootjans, Heleen, Uijtendaal, Esther V, Ruigrok, Dieuwertje, Luijk, Bart, van Luin, Matthijs, Bult, Wouter, de Lange, Dylan W, Kusadasi, Nuray, Droogh, Joep M, Egberts, Toine C G, Verschuuren, Erik A M, Sikma, Maaike A, Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, van Dommelen, Julia E M, Grootjans, Heleen, Uijtendaal, Esther V, Ruigrok, Dieuwertje, Luijk, Bart, van Luin, Matthijs, Bult, Wouter, de Lange, Dylan W, Kusadasi, Nuray, Droogh, Joep M, Egberts, Toine C G, Verschuuren, Erik A M, and Sikma, Maaike A

Published
2024

12. Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project

Author

Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, Rijt-Weetink, Yrea R. J. van, Egberts, Toine C. G., Hunsel, Florence P. A. M. van, Lewis, David J., Yates, Laura M., Winterfeld, Ursula, Puijenbroek, Eugène P. van, Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, Rijt-Weetink, Yrea R. J. van, Egberts, Toine C. G., Hunsel, Florence P. A. M. van, Lewis, David J., Yates, Laura M., Winterfeld, Ursula, and Puijenbroek, Eugène P. van

Published
2024

13. Intranasal vitamin B12 administration in elderly patients: A randomized controlled comparison of two dosage regimens.

Author

Tillemans, Monique P. H., Giezen, Thijs J., Egberts, Toine C. G., Hooijberg, Jan H., and Kalisvaart, Kees J.

Subjects
VITAMIN B12 deficiency, OLDER patients, OLDER people, INTRAMUSCULAR injections, METHYLMALONIC acid
Abstract

Aim: Vitamin B12 deficiency is common in the elderly population. Standard treatment via intramuscular injections, however, has several disadvantages. Safer and more convenient dosage forms such as intranasal are therefore being explored. This study compares the effects of two intranasal vitamin B12 dosage regimens in elderly vitamin B12‐deficient patients. Methods: Sixty patients ≥65 years were randomly assigned to either a loading dose (daily administration for 14 days followed by weekly administration) or a no loading dose (administration every 3 days) regimen for 90 days. Each dose contained 1000 μg cobalamin. Total vitamin B12, holotranscoblamin (holoTC), methylmalonic acid (MMA) and total homocysteine (tHcy) levels in serum were measured on days 0, 7, 14, 30, 60 and 90. Results: Both dosage regimens resulted in a rapid increase of vitamin B12 and holoTC concentrations and normalization of initial high, MMA and tHcy concentrations. The loading dose regimen resulted in the fastest and greatest increase to a median vitamin B12 of 1090 pmol/L (reference 350‐650 pmol/L) concentration after 14 days. Following weekly administration, B12 rapidly decreased to a median concentration of 530 pmol/L after 90 days. The no loading dose regimen resulted in a steady increase to a median vitamin B12 of 717 pmol/L after 90 days. Conclusions: Intranasal vitamin B12 administration is an effective and suitable way to replenish and sustain vitamin B12 levels in elderly patients. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Leftover of Amoxicillin Suspension After Use by Children in the Netherlands.

Author

Sadreghaemy, Milad, Gamba, Magdalena A., Bloem, Lourens T., and Egberts, Toine C. G.

Abstract

Purpose: In clinical practice, a discrepancy may exist between the prescribed amount of a drug and the commercially available pack sizes in the pharmacy, potentially contributing to drug waste. This study aimed—as an example of this phenomena—to quantify leftover of amoxicillin suspension prescribed to children, due to discrepancies between physician‐prescribed and pharmacy‐dispensed amounts. Methods: We performed a retrospective cohort study including amoxicillin suspension dispensations for patients aged 0–12 years between 2017 and 2019 utilizing the Dutch PHARMO database. Leftover amount of amoxicillin was estimated by assessing the discrepancy between the prescribed and dispensed amounts. Extrapolated amoxicillin weight and economic spillage estimates for the Netherlands were determined. The impact of two theoretical interventions on leftover amount was assessed: (1) introducing vials with half the volume of the current 100 and 30 mL vials and (2) a combination of the first intervention with a maximum of 10% round‐down by the dispensing pharmacy of the prescribed dose. Results: We included 79 512 amoxicillin suspension dispensations for 62 252 patients. The mean leftover amount of amoxicillin suspension per dispensing was 27%. The yearly amount of amoxicillin leftover was 49.8 kg in the study cohort, equivalent to yearly 633 kg and €621 000 when extrapolated to the Netherlands. Employing the first theoretical intervention reduced the mean leftover per dispensing to 20%, reducing the yearly leftover to 31.6 kg amoxicillin in the study cohort, and to 400 kg and €400 000 extrapolated. The second theoretical intervention further reduced leftover to 17%, reducing the yearly leftover to 24.3 kg amoxicillin in the study cohort, and to 300 kg and €300 000 extrapolated. Conclusion: Approximately a quarter of amoxicillin suspension remains as leftover per dispensing. Applying different theoretical intervention shows the potential for a significant reduction of amoxicillin leftover. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Combining text mining with clinical decision support in clinical practice: a scoping review

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, van de Burgt, Britt W M, Wasylewicz, Arthur T M, Dullemond, Bjorn, Grouls, Rene J E, Egberts, Toine C G, Bouwman, Arthur, Korsten, Erik M M, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, van de Burgt, Britt W M, Wasylewicz, Arthur T M, Dullemond, Bjorn, Grouls, Rene J E, Egberts, Toine C G, Bouwman, Arthur, and Korsten, Erik M M

Published
2023

22. Association between Genetic Variants and Peripheral Neuropathy in Patients with NSCLC Treated with First-Line Platinum-Based Therapy

Author

Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, de Jong, Corine, Herder, Gerarda J M, van Haarlem, Simone W A, van der Meer, Femke S, van Lindert, Anne S R, Ten Heuvel, Alexandra, Brouwer, Jan, Egberts, Toine C G, Deneer, Vera H M, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, de Jong, Corine, Herder, Gerarda J M, van Haarlem, Simone W A, van der Meer, Femke S, van Lindert, Anne S R, Ten Heuvel, Alexandra, Brouwer, Jan, Egberts, Toine C G, and Deneer, Vera H M

Published
2023

23. Drug waste of ready-to-administer syringes in the intensive care unit: Aseptically prepared syringes versus prefilled sterilized syringes

Author

Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, van Gelder, Thomas G, Lalmohamed, Arief, Dorst-Mooiman, Kim D, Dekker, Jan C, Schinkel, Marcel J, Sikma, Maaike A, Uijtendaal, Esther V, Egberts, Toine C G, Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, van Gelder, Thomas G, Lalmohamed, Arief, Dorst-Mooiman, Kim D, Dekker, Jan C, Schinkel, Marcel J, Sikma, Maaike A, Uijtendaal, Esther V, and Egberts, Toine C G

Published
2023

24. The efficacy of the entire-vial dosing of emicizumab: Real-world evidence on plasma concentrations, bleeds, and drug waste

Author

Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, Donners, Anouk A M T, van der Zwet, Konrad, Rademaker, Carin M A, Egberts, Toine C G, Schutgens, Roger E G, Fischer, Kathelijn, Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, Donners, Anouk A M T, van der Zwet, Konrad, Rademaker, Carin M A, Egberts, Toine C G, Schutgens, Roger E G, and Fischer, Kathelijn

Published
2023

25. Discontinuation of infliximab treatment in patients with inflammatory bowel disease who retransitioned to originator and those who remained on biosimilar

Author

Apotheek O&O&O, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, Apotheek Onderzoek, Meijboom, Rosanne W, Gardarsdottir, Helga, Becker, Matthijs L, Movig, Kris L L, Kuijvenhoven, Johan, Egberts, Toine C G, Giezen, Thijs J, Apotheek O&O&O, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, Apotheek Onderzoek, Meijboom, Rosanne W, Gardarsdottir, Helga, Becker, Matthijs L, Movig, Kris L L, Kuijvenhoven, Johan, Egberts, Toine C G, and Giezen, Thijs J

Published
2023

26. Association between Genetic Variants and Peripheral Neuropathy in Patients with NSCLC Treated with First-Line Platinum-Based Therapy

Author

Apotheek Onderzoek, Cancer, Arts Assistenten Longziekten, Longziekten, Infection & Immunity, Apotheek Klinische Farmacie, de Jong, Corine, Herder, Gerarda J M, van Haarlem, Simone W A, van der Meer, Femke S, van Lindert, Anne S R, Ten Heuvel, Alexandra, Brouwer, Jan, Egberts, Toine C G, Deneer, Vera H M, Apotheek Onderzoek, Cancer, Arts Assistenten Longziekten, Longziekten, Infection & Immunity, Apotheek Klinische Farmacie, de Jong, Corine, Herder, Gerarda J M, van Haarlem, Simone W A, van der Meer, Femke S, van Lindert, Anne S R, Ten Heuvel, Alexandra, Brouwer, Jan, Egberts, Toine C G, and Deneer, Vera H M

Published
2023

27. Combining text mining with clinical decision support in clinical practice: a scoping review

Author

Apotheek Klinische Farmacie, Apotheek Onderzoek, van de Burgt, Britt W M, Wasylewicz, Arthur T M, Dullemond, Bjorn, Grouls, Rene J E, Egberts, Toine C G, Bouwman, Arthur, Korsten, Erik M M, Apotheek Klinische Farmacie, Apotheek Onderzoek, van de Burgt, Britt W M, Wasylewicz, Arthur T M, Dullemond, Bjorn, Grouls, Rene J E, Egberts, Toine C G, Bouwman, Arthur, and Korsten, Erik M M

Published
2023

28. Discontinuation of infliximab treatment in patients with inflammatory bowel disease who retransitioned to originator and those who remained on biosimilar

Author

Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, PECP - Centre for Pharmacoepidemiology, Meijboom, Rosanne W, Gardarsdottir, Helga, Becker, Matthijs L, Movig, Kris L L, Kuijvenhoven, Johan, Egberts, Toine C G, Giezen, Thijs J, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, PECP - Centre for Pharmacoepidemiology, Meijboom, Rosanne W, Gardarsdottir, Helga, Becker, Matthijs L, Movig, Kris L L, Kuijvenhoven, Johan, Egberts, Toine C G, and Giezen, Thijs J

Published
2023

30. Structured Medication Review to Improve Pharmacotherapy in People with Intellectual Disability and Behavioural Problems

Author

Scheifes, Arlette, Egberts, Toine C. G., and Stolker, Joost Jan

Abstract

Background: Polypharmacy and chronic drug use are common in people with intellectual disability and behavioural problems, although evidence of effectiveness and safety in this population is lacking. This study examined the effects of a structured medication review and aimed to improve pharmacotherapy in inpatients with intellectual disability. Methods: In a treatment facility for people with mild to borderline intellectual disability and severe behavioural problems, a structured medication review was performed. Prevalence and type of drug-related problems (DRPs) and of the recommended and executed actions were calculated. Results: In a total of 55 patients with intellectual disability and behavioural problems, 284 medications were prescribed, in which a DRP was seen in 106 (34%). No indication/unclear indication was the most prevalent DRP (70). Almost 60% of the recommended actions were also executed. Conclusions: This high prevalence of DRPs is worrying. The structured medication review is a valuable instrument to optimize pharmacotherapy and to support psychiatrists in adequate prescribing of both psychotropic and somatic drugs.

Published
2016
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35. Recommendations on TNFα inhibitor biosimilar use in clinical practice: a comparison of European gastroenterology IBD guidance

Author

Meijboom, Rosanne W, Barbier, Liese, Druedahl, Louise C, Sarnola, Kati, Tolonen, Hanna M, Gardarsdottir, Helga, Egberts, Toine C G, and Giezen, Thijs J

Subjects
Pharmacology, Clinical Biochemistry, Drug Discovery
Abstract

Professional associations publish guidance advising gastroenterologists on prescribing biosimilars; however, guidelines differ between countries and change over time. This study aimed to map the presence and content of guidance from European gastroenterology associations on TNFα inhibitor biosimilar use and its development over time. Guidelines on biosimilar prescribing from national gastroenterology associations in the European Economic Area (EEA) partnered with the European Crohn’s and Colitis Organization (ECCO) were collected. Treatment guidelines and biosimilar position papers from 2010 to 2022 were included. Data were extracted using a template. 26 of 30 EEA countries have an ECCO-partnered gastroenterology association, of which 14 (53.8%) had national guidelines addressing biosimilars, four (15.4%) followed ECCO’s position, and three (11.6%) had treatment guidelines without mentioning biosimilars. From five countries (19.2%) no guidelines were retrieved. Among 18 countries with guidance, 14 (77.8%) associations endorsed initiating biological treatment with biosimilars, and 13 (72.2%) endorsed transitioning from originator to biosimilar. Nine associations published multiple guidelines over time addressing biosimilars; overall, their positions became more encouraging. The majority of gastroenterology associations endorsed biosimilar use. The lack of (up-to-date) guidelines for some associations indicates an area of improvement to support biosimilar use in clinical practice.

Published
2023
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36. The association between skeletal muscle measures and chemotherapy‐induced toxicity in non‐small cell lung cancer patients

Author

de Jong, Corine, Chargi, Najiba, Herder, Gerarda J M, van Haarlem, Simone W A, van der Meer, Femke, van Lindert, Anne S R, Ten Heuvel, Alexandra, Brouwer, Jan, de Jong, Pim A, Devriese, Lot A, Huitema, Alwin D R, Egberts, Toine C G, de Bree, Remco, Deneer, Vera H M, Pharmacoepidemiology and Clinical Pharmacology, and Afd Pharmacoepi & Clinical Pharmacology

Subjects
Male, Lung Neoplasms, Antineoplastic Agents, Middle Aged, Body composition, Chemotherapy-induced toxicity, Skeletal muscle mass, Non-small cell lung cancer, Carcinoma, Non-Small-Cell Lung, Physiology (medical), Humans, Female, Orthopedics and Sports Medicine, Prospective Studies, Muscle, Skeletal, Platinum-based chemotherapy, Follow-Up Studies
Abstract

BACKGROUND: Chemotherapy-induced toxicities frequently occur in non-small cell lung cancer (NSCLC) patients treated with platinum-based chemotherapy. Low skeletal muscle mass (SMM) has been associated with a higher incidence of toxicities for several types of cancers and cytostatics. The aim of this study was to evaluate the association between skeletal muscle measures and chemotherapy-induced toxicity in a large cohort of NSCLC patients. METHODS: A multicentre prospective follow-up study (PGxLUNG, NTR number NL5373610015) in NSCLC patients was conducted. Included were patients diagnosed with NSCLC (stage II-IV) treated with first-line platinum-based (cisplatin or carboplatin) chemotherapy of whom pretreatment imaging was available. Skeletal muscle area (SMA) segmentation was performed on abdominal imaging at the level of the third lumbar vertebra (L3). SMA at the level of L3 was corrected for squared height (m2 ) to yield the lumbar skeletal muscle mass index (LSMI). Skeletal muscle density (SMD) was calculated as the mean Hounsfield Unit (HU) of the segmented SMA. SMM and SMD were categorized as low, intermediate, and high, based on LSMI and mean HU tertiles, respectively. Chemotherapy-induced toxicity was scored using CTCAE v4.03 and categorized into haematological (anaemia, leukocytopenia, neutropenia, and thrombocytopenia), non-haematological (nephrotoxicity, neurotoxicity, and esophagitis), and dose-limiting toxicity (DLT) (treatment switch, delay, de-escalation, discontinuation, or hospitalization). The relationship between SMM, SMD, and toxicities was assessed with logistic regression modelling taking into account potential confounders like gender and body mass index (BMI). RESULTS: In total, 297 patients (male n = 167, median age 64 years) were included. Haematological toxicity grade 3/4 was experienced in 36.6% (n = 108) of the patients, 24.6% (n = 73) experienced any non-haematological toxicity grade ≥2, and 55.6% (n = 165) any DLT. Multivariate logistic regression analysis showed that low SMM (ORadj 2.41, 95% CI 1.31-4.45, P = 0.005) and age at diagnosis >65 years (ORadj 1.76, 95% CI 1.07-2.90, P = 0.025) were statistically significantly associated with overall haematological toxicity grade 3/4. No statistically significant associations were found between low SMM or low SMD and non-haematological toxicities. Low SMM (ORadj 2.23, 95% CI 1.23-4.04, P = 0.008) and high SMD (ORadj 0.41, 95% CI 0.23-0.74, P = 0.003) were statistically significantly associated with a higher respectively lower risk of DLT. CONCLUSIONS: Non-small cell lung cancer patients with pretreatment low SMM are at significant higher risk for haematological toxicities grade 3/4 and DLT. NSCLC patients with high SMD are at significant lower risk for DLT. Further studies should be aimed to investigate whether platinum dosing based on skeletal muscle measurements and/or improvement of pretreatment SMM/SMD could reduce the risk of toxicity without compromising efficacy.

Published
2022

44. Impulse control disorders associated with dopaminergic drugs: A disproportionality analysis using vigibase

Author

De Wit, Laura E, Wilting, Ingeborg, Souverein, Patrick C, van der Pol, Peggy, Egberts, Toine C G, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, and Pharmacoepidemiology and Clinical Pharmacology

Subjects
Pharmacology, Drug-Related Side Effects and Adverse Reactions, Dopamine Agents, Clinical Neurology, Adverse drug reactions, Parkinson Disease, Impulse control disorders, Disruptive, Impulse Control, and Conduct Disorders, Pharmacovigilance, Psychiatry and Mental health, Pramipexole, Neurology, Dopamine Agonists, Humans, Pharmacology (medical), Neurology (clinical), Disproportionality analysis, Biological Psychiatry, Dopaminergic drugs
Abstract

BACKGROUND: Dopamine receptor agonist drugs, which are used, for example, to treat Parkinson's disease (PD), increase the risk for impulse control disorders (ICDs), potentially resulting in devastating psychosocial consequences. It is unknown whether other drugs with dopaminergic properties also increase the risk for ICDs. This study assesses the disproportionality of reporting ICDs between drugs with dopaminergic properties and selected non-dopaminergic drugs. METHODS: A case/non-case disproportionality analysis was performed, using data from VigiBase (1968-2020). Reports on ICDs as suspected adverse drug reactions (ADRs) were cases (n=852), and those with ADRs other than ICDs were non-cases (n=281,720). Relative reporting frequencies were expressed as adjusted reporting odds ratios (aRORs). Within the dopamine receptor agonists, the relationship between reporting odds ratios and dopamine receptor occupancy was explored. RESULTS: A high disproportionality was found for reporting ICDs for all dopaminergic drugs (aROR 20.4 [95% CI 17.4-24.1]) compared to non-dopaminergic drugs. In pharmacotherapeutic subgroups, a high disproportionality was found for primary dopaminergic agents used in PD (aROR 52.1 [95% CI 44.1-61.5]), and to a lesser extent for ADHD psychostimulants and antidepressants (aROR 5.8 [95% 4.1-8.3] and aROR 3.9 [95% CI 2.9-5.6], respectively). There was no difference in reporting by consumers and healthcare professionals. The highest disproportionality was found for the dopamine receptor agonists pramipexole and ropinirole. CONCLUSIONS: A signal of disproportion in ICD occurrence was found among all investigated drugs with dopaminergic properties, highlighting the importance of counselling and monitoring for ICDs when prescribing dopaminergic drugs.

Published
2022

45. Association Between the Magnitude of Intravenous Busulfan Exposure and Development of Hepatic Veno-Occlusive Disease in Children and Young Adults Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation

Author

Bognàr, Tim, Bartelink, Imke H, Egberts, Toine C G, Rademaker, Carin M A, Versluys, A Birgitta, Slatter, Mary A, Kletzel, Morris, Nath, Christa E, Cuvelier, Geoffrey D E, Savic, Rada M, Dvorak, Christopher, Long-Boyle, Janel R, Cowan, Morton J, Bittencourt, Henrique, Bredius, Robbert G M, Güngör, Tayfun, Shaw, Peter J, Ansari, Marc, Hassan, Moustapha, Krajinovic, Maja, Hempel, Georg, Marktel, Sarah, Chiesa, Robert, Théoret, Yves, Lund, Troy, Orchard, Paul J, Wynn, Robert F, Boelens, Jaap Jan, Lalmohamed, Arief, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Clinical pharmacology and pharmacy, and CCA - Cancer Treatment and quality of life

Subjects
Medicine(all), Transplantation, Transplantation Conditioning, Hematopoietic cell transplantation, Sinusoidal obstruction syndrome, Veno-occlusive disease, Hematopoietic Stem Cell Transplantation, Hepatic Veno-Occlusive Disease, Hematopoietic cell, Hematology, Cell Biology, Young Adult, Humans, Immunology and Allergy, Molecular Medicine, Administration, Intravenous, Busulfan exposure, Child, Busulfan
Abstract

Intravenous busulfan is widely used as part of myeloablative conditioning regimens in children and young adults undergoing allogeneic hematopoietic cell transplantation (HCT). Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a serious clinical problem observed with busulfan-based conditioning HCT. The development of VOD/SOS may be associated with busulfan exposure. Getting more insight into the association between busulfan exposure and the development of VOD/SOS enables further optimization of dos-ing and treatment strategies. The objective of this study was to assess the association between the magnitude of busulfan exposure and the occurrence of VOD/SOS in children and young adults undergoing myeloablative con-ditioning with a busulfan-containing regimen before allogeneic HCT. In this observational study we included all patients who underwent allogeneic HCT with intravenous busulfan as part of the conditioning regimen at 15 pediatric transplantation centers between 2000 and 2015. The endpoint was the development of VOD/SOS. The magnitude of busulfan exposure was estimated using nonlinear mixed effect modeling and expressed as the maximal concentration (Cmax; day 1 and day 1 to 4 Cmax), cumulative area under the curve (AUC; day 1, high-est 1-day AUC in 4 days, and 4-day cumulative AUC), cumulative time above a concentration of 300 mg/L, and clearance on day 1. A total of 88 out of 697 patients (12.6%) developed VOD/SOS. The number of alkylators in the conditioning regimen was a strong effect modifier; therefore we stratified the regression analysis for the number of alkylators. For patients receiving only busulfan as one alkylator (36.3%, n = 253), cumulative busulfan exposure (>78 mg x h/L) was associated with increased VOD/SOS risk (12.6% versus 4.7%; odds ratio [OR] = 2.95, 95% confidence interval [CI] 1.13 to 7.66). For individuals receiving busulfan with one or two addi-tional alkylators (63.7%, n = 444), cumulative busulfan exposure (78 mg x h/L) did not further increase the risk of VOD/SOS (15.4% versus 15.2%; OR = 1.03, 95% CI 0.61 to 1.75). The effect of the magnitude of busulfan exposure on VOD/SOS risk in children and young adults undergoing HCT is dependent on the number of alkylators. In patients receiving busulfan as the only alkylator, higher cumulative busulfan exposure increased the risk of VOD/SOS, whereas in those receiving multiple alkylators, the magnitude of busulfan expo-sure did not further increase this risk. (c) 2022 The American Society for Transplantation and Cellular Therapy. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

Published
2022

46. Frequency and Acceptance of Clinical Decision Support System-Generated STOPP/START Signals for Hospitalised Older Patients with Polypharmacy and Multimorbidity

Author

Afd Pharmacoepi & Clinical Pharmacology, Sub Natural Language Processing, Pharmacoepidemiology and Clinical Pharmacology, Sallevelt, Bastiaan T G M, Huibers, Corlina J A, Heij, Jody M J Op, Egberts, Toine C G, van Puijenbroek, Eugène P, Shen, Zhengru, Spruit, Marco R, Jungo, Katharina Tabea, Rodondi, Nicolas, Dalleur, Olivia, Spinewine, Anne, Jennings, Emma, O'Mahony, Denis, Wilting, Ingeborg, Knol, Wilma, Afd Pharmacoepi & Clinical Pharmacology, Sub Natural Language Processing, Pharmacoepidemiology and Clinical Pharmacology, Sallevelt, Bastiaan T G M, Huibers, Corlina J A, Heij, Jody M J Op, Egberts, Toine C G, van Puijenbroek, Eugène P, Shen, Zhengru, Spruit, Marco R, Jungo, Katharina Tabea, Rodondi, Nicolas, Dalleur, Olivia, Spinewine, Anne, Jennings, Emma, O'Mahony, Denis, Wilting, Ingeborg, and Knol, Wilma

Published
2022

47. Monitoring of Adverse Drug Reaction-Related Parameters in Children, Youth, and Young Adults Prescribed Antipsychotic Drugs by General Practitioners

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Minjon, Lenneke, van den Ban, Els, Bazelier, Marloes T, Lalmohamed, Arief, Egberts, Toine C G, Heerdink, Eibert R, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Minjon, Lenneke, van den Ban, Els, Bazelier, Marloes T, Lalmohamed, Arief, Egberts, Toine C G, and Heerdink, Eibert R

Published
2022

48. The effect of a decision support system on the incidence of prescription errors in a PICU

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Hashemi, Fatema, van Gelder, Thomas G, Bollen, Casper W, Liem, Yves T B, Egberts, Toine C G, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Hashemi, Fatema, van Gelder, Thomas G, Bollen, Casper W, Liem, Yves T B, and Egberts, Toine C G

Published
2022

49. Quantification of emicizumab by mass spectrometry in plasma of people with hemophilia A: A method validation study

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Donners, Anouk A. M. T., Gerencsér, László, Elst, Kim C. M. van der, Egberts, Toine C. G., Maat, Moniek P. M. de, Huisman, Albert, Urbanus, Rolf T., Amrani, Mohsin El, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Donners, Anouk A. M. T., Gerencsér, László, Elst, Kim C. M. van der, Egberts, Toine C. G., Maat, Moniek P. M. de, Huisman, Albert, Urbanus, Rolf T., and Amrani, Mohsin El

Published
2022

50. Impulse control disorders associated with dopaminergic drugs: A disproportionality analysis using vigibase

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, De Wit, Laura E, Wilting, Ingeborg, Souverein, Patrick C, van der Pol, Peggy, Egberts, Toine C G, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, De Wit, Laura E, Wilting, Ingeborg, Souverein, Patrick C, van der Pol, Peggy, and Egberts, Toine C G

Published
2022

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