dr. Sabine Straus

Search results

• 2024

  COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance

  Gordillo-Marañón, M., Szmigiel, A., Yalmanová, V., Caplanusi, I., Genov, G., Olsen, D. B. & Straus, S., Aug 2024, In: Drug Safety. 47, 8, p. 783-798 16 p.

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  • COVID-19 Vaccine 100%
  • Menorrhagia 100%
  • Vaccination Policy 40%
  • Menstruation Disorder 40%
  • Adverse Drug Reaction 20%
  2 Citations (Scopus)

  1 Downloads (Pure)

• Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines: Lessons Learnt and Recommendations

  Goedecke, T., Martirosyan, L., Gault, N., Seifert, K., Morales, D., Bahri, P., Strassmann, V., Huber, M. & Straus, S., Aug 2024, In: Pharmacoepidemiology and Drug Safety. 33, 8, e5874.

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  • Drugs 100%
  • Administrative Structure 100%
  • European Community 100%
  • Decision Making 100%
  • Pharmacovigilance 100%
  1 Citation (Scopus)

  12 Downloads (Pure)

• Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases

  Prilla, S., Groeneveld, S., Pacurariu, A., Restrepo-Mendez, M. C., Verpillat, P., Torre, C., Gartner, C., Mol, P. G. M., Naumann-Winter, F., Breen, K. C., Gault, N., Gross-Martirosyan, L., Benchetrit, S., Aylward, B., Stoyanova-Beninska, V., O'Donovan, M., Straus, S., Kjaer, J. & Arlett, P., 4 Jul 2024, (E-pub ahead of print) In: Clinical Pharmacology & Therapeutics. 10 p.

  Research output: Contribution to journal › Review article › Academic › peer-review

  Open Access

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  • Decision Making 100%
  • Medicine 100%
  • Clinical Trial 100%
  • Prevalence 100%
  • Drug Utilization 50%
  1 Citation (Scopus)

  13 Downloads (Pure)
• 2023

  Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

  Essink, S. C. M., Zomerdijk, I. M., Straus, S. M. J. M., Gardarsdottir, H. & De Bruin, M. L., Oct 2023, In: Drug Safety. 46, 10, p. 1007-1020 14 p.

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  • Pharmacovigilance 100%
  • Cohort Study 33%
  • Cross-Sectional Study 33%
  19 Downloads (Pure)
• 2021

  Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU: An Explorative Study on Relevant Factors

  Hoeve, C., de Vries, E., Mol, P., Sturkenboom, M. & Straus, S., 2021, In: Drug Safety. 44, 1, p. 73-82 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  • Risk Factor 100%
  • Health Care Personnel 100%
  • Medication Error 100%
  • Europeans 50%
  • Descriptive Study 50%
  2 Citations (Scopus)

  15 Downloads (Pure)

• Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe

  Francisca, R., Baba, E., Hoeve, C., Zomerdijk, I., Sturkenboom, M. & Straus, S., 2021, In: Drug Safety. 44, 1, p. 63-72 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

  • Europeans 100%
  • Confidence Interval 100%
  • Life Cycle 100%
  • Medicine 100%
  • Cohort Study 100%
  7 Citations (Scopus)
• 2020

  Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union

  Hoeve, C., Francisca, R., Zomerdijk, I., Sturkenboom, M. & Straus, S., 2020, In: Drug Safety. 43, p. 45-55 11 p.

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  12 Citations (Scopus)

  19 Downloads (Pure)

• Fatal outcomes following immunization errors as reported to the EudraVigilance: A case series

  Hoeve, C., Gadroen, K., Kwa, M., Haren, A., Sturkenboom, M. & Straus, S., 2020, In: Vaccine. 38, p. 3086-3095 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

  File
  4 Citations (Scopus)

  25 Downloads (Pure)
• 2018

  Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?

  Pacurariu, A., Hoeve, C., Arlett, P., Genov, G., Slattery, J., Sturkenboom, M. & Straus, S., 2018, In: Pharmacoepidemiology and Drug Safety. 27, 2, p. 168-173 6 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  5 Citations (Scopus)

• Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures

  Francisca, R., Zomerdijk, I., Sturkenboom, M. & Straus, S., 2018, In: Expert Opinion on Drug Safety. 17, 10, p. 975-982 8 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  7 Citations (Scopus)

• Spontaneous reports of vaccination errors in the European regulatory database EudraVigilance: A descriptive study

  Hoeve, C., van Haren, A., Sturkenboom, M. & Straus, S., 2018, In: Vaccine. 36, 52, p. 7956-7964 9 p.

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  11 Citations (Scopus)

  21 Downloads (Pure)

• Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs

  Mazzaglia, G., Straus, S., Arlett, P., de Silva, D., Janssen, H., Raine, J. & Alteri, E., 2018, In: Drug Safety. 41, 2, p. 191-202 12 p.

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  27 Citations (Scopus)

  17 Downloads (Pure)
• 2017

  Baseline incidence of intussusception in early childhood before rotavirus vaccine introduction, the Netherlands, January 2008 to December 2012

  Gadroen, K., Kemmeren, J., Bruijning-Verhagen, P., Straus, S., Weibel, D., de Melker, H. & Sturkenboom, M., 2017, In: Eurosurveillance. 22, 25, p. 20-26 7 p., 30556.

  Research output: Contribution to journal › Article › Academic

  Open Access

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  9 Citations (Scopus)

  10 Downloads (Pure)

• Decision making in drug safety-a literature review of criteria used to prioritize newly detected safety issues

  Pacurariu, A., Coloma, P., Gross-Martirosyan, L., Sturkenboom, M. & Straus, S., 2017, In: Pharmacoepidemiology and Drug Safety. 26, 3, p. 327-334 8 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  6 Citations (Scopus)
• 2016

  Patterns of spontaneous reports on narcolepsy following administration of pandemic influenza vaccine; a case series of individual case safety reports in Eudravigilance

  Gadroen, K., Straus, S., Pacurariu, A., Weibel, D., Kurz, X. & Sturkenboom, M., 2016, In: Vaccine. 34, 41, p. 4892-4897 6 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  8 Citations (Scopus)

• The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study

  Vermeer, N., Ebbers, H., Straus, S., Leufkens, H., Egberts, T. & Bruin, M., 2016, In: Pharmacoepidemiology and Drug Safety. 25, 3, p. 297-306 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  9 Citations (Scopus)

• Using Prescription Patterns in Primary Care to Derive New Quality Indicators for Childhood Community Antibiotic Prescribing

  Bie, S., Kaguelidou, F., Verhamme, K., de Ridder, M., Picelli, G., Straus, S., Giaquinto, C., Stricker, B., Bielicki, J., Sharland, M. & Sturkenboom, M., 2016, In: Pediatric Infectious Disease Journal. 35, 12, p. 1317-1323 7 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  51 Citations (Scopus)
• 2015

  Dispensing of potentially teratogenic drugs before conception and during pregnancy: a population-based study

  Zomerdijk, I., Ruiter, R., Houweling, L., Herings, R., Straus, S. & Stricker, B., 2015, In: Bjog-An International Journal of Obstetrics and Gynaecology. 122, 8, p. 1119-1129 11 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  22 Citations (Scopus)

• Drug-Induced Progressive Multifocal Leukoencephalopathy: Lessons Learned From Contrasting Natalizumab and Rituximab

  Vermeer, N., Straus, S., Mantel-Teeuwisse, A., Hidalgo-Simon, A., Egberts, A., Leufkens, H. & de Bruin, M., 2015, In: Clinical Pharmacology & Therapeutics. 98, 5, p. 542-550 9 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  21 Citations (Scopus)

• Evaluating performance of electronic healthcare records and spontaneous reporting data in drug safety signal detection

  Patadia, V., Schuemie, M., Coloma, P., Herings, R., Lei, J., Straus, S., Sturkenboom, M. & Trifiro, G., 2015, In: International Journal of Clinical Pharmacy. 37, 1, p. 94-104 11 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  27 Citations (Scopus)

• Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project

  Bie, S., Ferrajolo, C., Straus, S., Verhamme, K., Bonhoeffer, J., Wong, I. & Sturkenboom, M., 2015, In: PLoS One (print). 10, 6

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  29 Citations (Scopus)

  11 Downloads (Pure)

• Pregnancy prevention programme insufficiently complied with: women who used idotretinoin sometimes get pregnant

  Zomerdijk, I., Ruiter, R., Houweling, L., Herings, R., Sturkenboom, M., Straus, S. & Stricker, B., 2015, In: Pharmaceutisch Weekblad. 150, 13, p. 12-15 4 p.

  Research output: Contribution to journal › Article › Professional

• The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study

  Bie, S., Coloma, P., Ferrajolo, C., Verhamme, K., Trifiro, G., Schuemie, M., Straus, S., Gini, R., Herings, R., Mazzaglia, G., Picelli, G., Ghirardi, A., Pedersen, L., Stricker, B., Lei, J. & Sturkenboom, M., 2015, In: British Journal of Clinical Pharmacology. 80, 2, p. 304-314 11 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  22 Citations (Scopus)

• Traceability of biologicals: present challenges in pharmacovigilance

  Vermeer, N., Spierings, I., Mantel-Teeuwisse, A., Straus, S., Giezen, T., Leufkens, H., Egberts, T. & de Bruin, M., 2015, In: Expert Opinion on Drug Safety. 14, 1, p. 63-72 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  42 Citations (Scopus)

• Understanding drug preferences, different perspectives

  Mol, P., Arnardottir, A., Straus, S., de Graeff, P., Haaijer-Ruskamp, F., Quik, E., Krabbe, P. & Denig, P., 2015, In: British Journal of Clinical Pharmacology. 79, 6, p. 978-987 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  14 Citations (Scopus)

• Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection

  Pacurariu, A., Straus, S., Trifiro, G., Schuemie, M., Gini, R., Herings, R., Mazzaglia, G., Picelli, G., Scotti, L., Pedersen, L., Arlett, P., Lei, J., Sturkenboom, M. & Coloma, P., 2015, In: Drug Safety. 38, 12, p. 1201-1210 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  49 Citations (Scopus)

  16 Downloads (Pure)
• 2014

  A comparison of pregnancy prevention programmes in Europe

  Crijns, I., Zomerdijk, I., Sturkenboom, M., Berg, L. & Straus, S., 2014, In: Expert Opinion on Drug Safety. 13, 4, p. 411-420 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  7 Citations (Scopus)

• A Description of Signals During the First 18 Months of the EMA Pharmacovigilance Risk Assessment Committee

  Pacurariu, A., Coloma, P., van Haren, A., Genov, G., Sturkenboom, M. & Straus, S., 2014, In: Drug Safety. 37, 12, p. 1059-1066 8 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  42 Citations (Scopus)

• Adherence to Renal Function Monitoring Guidelines in Patients Starting Antihypertensive Therapy with Diuretics and RAAS Inhibitors: A Retrospective Cohort Study

  Blijderveen, N., Straus, S., de Ridder, M., Stricker, B., Sturkenboom, M. & Verhamme, K., 2014, In: Drug Safety. 37, 5, p. 369-377 9 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  7 Citations (Scopus)

• A population-based study on the prevalence and incidence of chronic kidney disease in the Netherlands

  Blijderveen, N., Straus, S., Zietse, R., Stricker, B., Sturkenboom, M. & Verhamme, K., 2014, In: International Urology and Nephrology. 46, 3, p. 583-592 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  36 Citations (Scopus)

• Isotretinoin exposure during pregnancy: a population-based study in The Netherlands

  Zomerdijk, I., Ruiter, R., Houweling, L., Herings, R., Sturkenboom, M., Straus, S. & Stricker, B., 2014, In: BMJ Open Gastroenterology. 4, 11

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  36 Citations (Scopus)

  12 Downloads (Pure)

• Long-term use of 5 alpha-reductase inhibitors and the risk of male breast cancer

  Duijnhoven, R., Straus, S., Souverein, P., Boer, A., Bosch, R., Hoes, A. & de Bruin, M., 2014, In: Cancer Causes & Control. 25, 11, p. 1577-1582 6 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  28 Citations (Scopus)

• Risk Management Plans as a Tool for Proactive Pharmacovigilance: A Cohort Study of Newly Approved Drugs in Europe

  Vermeer, N., Duijnhoven, R., Straus, S., Mantel-Teeuwisse, A., Arlett, P., Egberts, A., Leufkens, H. & de Bruin, M., 2014, In: Clinical Pharmacology & Therapeutics. 96, 6, p. 723-731 9 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  22 Citations (Scopus)

• Risk of Hyponatremia with Diuretics: Chlorthalidone versus Hydrochlorothiazide

  Blijderveen, N., Straus, S., Rodenburg, E., Zietse, R., Stricker, B., Sturkenboom, M. & Verhamme, K., 2014, In: American Journal of Medicine. 127, 8, p. 763-771 9 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  35 Citations (Scopus)
• 2013

  Additional risk minimisation measures in the EU- are they eligible for assessment?

  Zomerdijk, I., Trifiro, G., Sayed-Tabatabaei, F., Sturkenboom, M. & Straus, S., 2013, In: Pharmacoepidemiology and Drug Safety. 22, 10, p. 1046-1053 8 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  20 Citations (Scopus)

• Healthcare professional surveys to investigate the implementation of the isotretinoin Pregnancy Prevention Programme: a descriptive study

  Crijns, I., Mantel-Teeuwisse, A., Bloemberg, R., Pinas, E., Straus, S. & Berg, L., 2013, In: Expert Opinion on Drug Safety. 12, 1, p. 29-38 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  18 Citations (Scopus)

• Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

  Duijnhoven, R., Straus, S., Raine, J., den Boer, A., Hoes, A. & de Bruin, M., 2013, In: PLoS Medicine (print). 10, 3

  Research output: Contribution to journal › Article › Academic › peer-review

  Open Access

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  69 Citations (Scopus)

  16 Downloads (Pure)

• Overanticoagulation is associated with renal function decline

  Blijderveen, N., Verhamme, K., Zietse, R., Visser, L., Romio, S., Buhre, P., Sturkenboom, M., Hofman, B., Straus, S. & Stricker, B., 2013, In: Journal of Nephrology. 26, 4, p. 691-698 8 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  8 Citations (Scopus)

• Post-Approval Safety Issues with Innovative Drugs: A European Cohort Study

  Mol, P., Arnardottir, A., Motola, D., Vrijlandt, P., Duijnhoven, R., Haaijer-Ruskamp, F., de Graeff, P., Denig, P. & Straus, S., 2013, In: Drug Safety. 36, 11, p. 1105-1115 11 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  27 Citations (Scopus)

• The Additional Value of an E-Mail to Inform Healthcare Professionals of a Drug Safety Issue: A Randomized Controlled Trial in the Netherlands

  Piening, S., de Graeff, P., Straus, S., Haaijer-Ruskamp, F. & Mol, P., 2013, In: Drug Safety. 36, 9, p. 723-731 9 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  19 Citations (Scopus)

• Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases

  Vermeer, N., Straus, S., Mantel-Teeuwisse, A., Domergue, F., Egberts, T., Leufkens, H. & de Bruin, M., 2013, In: Drug Safety. 36, 8, p. 617-625 9 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  65 Citations (Scopus)

• When Direct Health-Care Professional Communications Have an Impact on Inappropriate and Unsafe Use of Medicines

  Reber, K., Piening, S., Wieringa, J., Straus, S., Raine, J., de Graeff', P., Haaijer-Ruskamp, F. & Mol, P., 2013, In: Clinical Pharmacology & Therapeutics. 93, 4, p. 360-365 6 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  33 Citations (Scopus)
• 2012

  Concomitant Use of Contraceptives and Potentially Teratogenic Medicinal Products-Results From a Study Using Pharmacy Dispensing Data in the Netherlands

  Ruiter, R., Teichert, M., Straus, S., Stricker, B. & Visser, L., 2012, In: Reproductive Sciences. 19, 9, p. 987-994 8 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  4 Citations (Scopus)

• Healthcare Professionals' Self-Reported Experiences and Preferences Related to Direct Healthcare Professional Communications A Survey Conducted in the Netherlands

  Piening, S., Haaijer-Ruskamp, F., de Graeff, P., Straus, S. & Mol, P., 2012, In: Drug Safety. 35, 11, p. 1061-1072 12 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  33 Citations (Scopus)

• Impact of Safety-Related Regulatory Action on Clinical Practice A Systematic Review

  Piening, S., Haaijer-Ruskamp, F., de Vries, J., van der Elst, M., de Graeff, P., Straus, S. & Mol, P., 2012, In: Drug Safety. 35, 5, p. 373-385 13 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  82 Citations (Scopus)

• Impact of Safety-Related Regulatory Action on Drug Use in Ambulatory Care in the Netherlands

  Piening, S., Reber, K., Wieringa, J., Straus, S., de Graeff, P., Haaijer-Ruskamp, F. & Mol, P., 2012, In: Clinical Pharmacology & Therapeutics. 91, 5, p. 838-845 8 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  29 Citations (Scopus)

• Lower Risk of Cancer in Patients on Metformin in Comparison With Those on Sulfonylurea Derivatives Results from a large population-based follow-up study

  Ruiter, R., Visser, L., van Herk-Sukel, M., Coebergh, J. W., Haak, H., Geelhoed-Duijvestijn, P., Straus, S., Herings, R. & Stricker, B., 2012, In: Diabetes Care. 35, 1, p. 119-124 6 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  207 Citations (Scopus)

• Prescribing of Rosiglitazone and Pioglitazone Following Safety Signals Analysis of Trends in Dispensing Patterns in the Netherlands from 1998 to 2008

  Ruiter, R., Visser, L., van Herk-Sukel, M., Geelhoed-Duijvestijn, P., Bie, S., Straus, S., Mol, P., Romio, S., Herings, R. & Stricker, B., 2012, In: Drug Safety. 35, 6, p. 471-480 10 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  35 Citations (Scopus)

• Reasons for and Time to Discontinuation of Rimonabant Therapy A Modified Prescription-Event Monitoring Study

  Willemen, M., Mantel-Teeuwisse, A., Buggy, Y., Layton, D., Straus, S., Leufkens, H. & Egberts, T., 2012, In: Drug Safety. 35, 12, p. 1147-1158 12 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  7 Citations (Scopus)

• Risk Minimization Activities of Centrally Authorized Products in the EU A Descriptive Study

  Zomerdijk, I., Sayed-Tabatabaei, F., Trifiro, G., Blackburn, S., Sturkenboom, M. & Straus, S., 2012, In: Drug Safety. 35, 4, p. 299-314 16 p.

  Research output: Contribution to journal › Article › Academic › peer-review
  30 Citations (Scopus)