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1. Product Care & Daily Practise

Author

van Riet-Nales, Diana, Sinclair, Anthony, Le Brun, Paul, editor, Crauste-Manciet, Sylvie, editor, Krämer, Irene, editor, Smith, Julian, editor, and Woerdenbag, Herman, editor

Published
2023
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2. Association between culture and the preference for, and perceptions of, 11 routes of medicine administration: A survey in 21 countries and regions

Author

Murdan, Sudaxshina, Wei, Li, van Riet-Nales, Diana A., Gurmu, Abyot Endale, Usifoh, Stella Folajole, Tăerel, Adriana-Elena, Yıldız-Peköz, Ayca, Krajnović, Dušanka, Azzopardi, Lilian M., Brock, Tina, Fernandes, Ana I., dos Santos, André Luis Souza, Anto, Berko Panyin, Vallet, Thibault, Lee, Eunkyung Euni, Jeong, Kyeong Hye, Akel, Marwan, Tam, Eliza, Volmer, Daisy, Douss, Tawfik, Shukla, Sharvari, Yamamura, Shigeo, Lou, Xiaoe, van Riet, Bauke H.G., Usifoh, Cyril O., Duwiejua, Mahama, Ruiz, Fabrice, and Furnham, Adrian

Published
2023
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13. Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population.

Author

van Riet‐Nales, Diana A., van den Bemt, Bart, van Bodegom, David, Cerreta, Francesca, Dooley, Brian, Eggenschwyler, Doris, Hirschlérova, Blanka, Jansen, Paul A. F., Karapinar‐Çarkit, Fatma, Moran, Abigail, Span, Jan, Stegemann, Sven, and Sundberg, Katarina

Subjects
*OLDER patients, *OLDER people, *MEDICAL personnel, *POPULATION aging, *DRUG laws, *DRUGS
Abstract

Older people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation. The paper intends to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics include patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper is directed at older people and the pharmaceutical industry, the reflections are also relevant to younger patients with similar disease‐related needs and of value to other stakeholders parties, e.g., healthcare professionals, academics, patients and caregivers, as the paper makes clear what can be expected from industry and where collaborative work is needed. This commentary provides an overview of the different steps in the development of the reflection paper, discusses points considered most controversial and/or subject to (multidisciplinary) expert discussions and indicates their value for real world clinical practice. [ABSTRACT FROM AUTHOR]

Published
2022
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15. Developing patient centric medicines for older people: reflections from the draft EMA paper on the pharmaceutical development of medicines for use in the older population

Author

van Riet-Nales, Diana A, Sundberg, Katarina, de Boer, Anthonius, Hirschlérova, Blanka, Afd Pharmacoepi & Clinical Pharmacology, and Pharmacoepidemiology and Clinical Pharmacology

Subjects
aged 80 and over [MeSH], regulations, European Medicines Agency (EMA), drug delivery, public health, Taverne, health policy, clinical pharmacology, technology pharmaceutical [MeSH], drug regulation, medication safety, medication errors [MeSH], drug development
Abstract

Increased global longevity requires a re-evaluation of current structures in society to adapt to the consequential demographic shift. As (very) old people are prone to impaired human organ and body functions resulting in e.g. multimorbidity, polypharmacy, hospitalisation, and problems in medication management, it is increasingly acknowledged that re-evaluations should include the suitability of pharmaceutical patient care as one of the cornerstones of public health. Following the 2011 European Medicines Agency (EMA) "Geriatric Strategy", in 2017, the EMA published the draft "Reflection paper on the pharmaceutical development of medicines for use in the older population". The draft paper was opened for public consultation and specific attention and feedback (either supportive or with a proposal for revision) was asked on three design aspects: tablet breaking, drug administration through enteral feeding tubes and medication management. Following publication, the draft paper was presented at two public conferences attended by participants from different disciplines. This manuscript is intended to draw the attention of different stakeholder parties on the urgency to collaborate on the emerging issues arising from increasing longevity and multimorbidity, and especially those associated with pharmaceutical patient care and the drug product design, including the need for collaborative research into existing or emerging knowledge gaps. The manuscript focuses on the three aforementioned aspects of pharmaceutical development (tablet breaking, drug administration through enteral feeding tubes and medication management) as these highly relate to medication safety and efficacy and constitute persistent and typical challenges for older people, caregivers and healthcare professionals in daily clinical practice.

Published
2020

17. Developing patient centric medicines for older people: reflections from the draft EMA paper on the pharmaceutical development of medicines for use in the older population

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, van Riet-Nales, Diana A, Sundberg, Katarina, de Boer, Anthonius, Hirschlérova, Blanka, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, van Riet-Nales, Diana A, Sundberg, Katarina, de Boer, Anthonius, and Hirschlérova, Blanka

Published
2020

18. Opportunities for changes in the drug product design to enhance medication safety in older people: Evaluation of a national public portal for medication incidents

Author

MS Geriatrie, Circulatory Health, Karapinar-Çarkit, Fatma, van den Bemt, Patricia M.L.A., Sadik, Mariam, van Soest, Brigit, Knol, Wilma, van Hunsel, Florence, van Riet-Nales, Diana A., MS Geriatrie, Circulatory Health, Karapinar-Çarkit, Fatma, van den Bemt, Patricia M.L.A., Sadik, Mariam, van Soest, Brigit, Knol, Wilma, van Hunsel, Florence, and van Riet-Nales, Diana A.

Published
2020

23. Actual versus recommended storage temperatures of oral anticancer medicines at patients' homes

Author

Vlieland, Nicolaas D, van den Bemt, B, van Riet-Nales, Diana A, Bouvy, M L, Egberts, Toine, Gardarsdottir, H, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, RS: Carim - V01 Vascular complications of diabetes and metabolic syndrome, and Clinical Pharmacy

Subjects
Male, home storage conditions, medicine.medical_specialty, Oral anticancer drugs, Drug Storage, Pharmacy, Antineoplastic Agents, Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18], 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, 0302 clinical medicine, Primary outcome, MEDICATION, Internal medicine, Product Label, Health care, Antineoplastic Agents/chemistry, Journal Article, Medicine, Humans, Pharmacology (medical), Comparative Study, Hospital pharmacy, Summary of Product Characteristics, Drug packaging, Drug Packaging, Aged, Drug Storage/methods, Adult patients, business.industry, Temperature, Original Articles, Middle Aged, Oncology, 030220 oncology & carcinogenesis, Female, business, redispensing, 030215 immunology
Abstract

Background Substantial quantities of unused medicines are returned by patients to the pharmacy each year. Redispensing these medicines would reduce medicinal waste and health care costs. However, it is not known if medicines are stored by patients as recommended in the product label. Inadequate storage may negatively affect the medicine and reduce clinical efficacy whilst increasing the risk for side effects. Objective To investigate the proportion of patients storing oral anticancer medicines according to the temperature instructions in the product label. Methods Consenting adult patients from six Dutch outpatient hospital pharmacies were included in this study if they used an oral anticancer medicine during February 2014 – January 2015. Home storage temperatures were assessed by inclusion of a temperature logger in the original cancer medicines packaging. The primary outcome was the proportion of patients storing oral anticancer medicines as specified in the Summary of Product Characteristics, either by recalculating the observed temperature fluctuations to a single mean kinetic temperature or by following the temperature instructions taking into account a consecutive 24-h tolerance period. Results Ninety (81.1%) of the 111 included patients (47.8% female, mean age 65.2 (SD: 11.1)) returned their temperature loggers to the pharmacy. None of the patients stored oral anticancer medicines at a mean kinetic temperature above 25℃, one patient stored a medicine requiring storage below 25℃ longer than 24 h above 25℃. None of the patients using medicines requiring storage below 30℃ kept their medicine above 30℃ for a consecutive period of 24 h or longer. Conclusion The majority of patients using oral anticancer medicines store their medicines according to the temperature requirements on the product label claim. Based on our results, most oral anticancer medicines will not be negatively affected by temperature conditions at patients’ homes for a maximum of three months and are likely to be suitable for redispensing.

Published
2019

26. Actual versus recommended storage temperatures of oral anticancer medicines at patients' homes

Author

Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Vlieland, Nicolaas D, van den Bemt, B, van Riet-Nales, Diana A, Bouvy, M L, Egberts, Toine, Gardarsdottir, H, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Vlieland, Nicolaas D, van den Bemt, B, van Riet-Nales, Diana A, Bouvy, M L, Egberts, Toine, and Gardarsdottir, H

Published
2019

27. Actual versus recommended storage temperatures of oral anticancer medicines at patients' homes

Author

Apotheek Onderzoek 1, Apotheek Onderzoek, Apotheek, Apotheek O&O&O, Vlieland, N D, van den Bemt, Bjf, van Riet-Nales, Diana A., Bouvy, Marcel L, Egberts, ACG, Gardarsdottir, H, Apotheek Onderzoek 1, Apotheek Onderzoek, Apotheek, Apotheek O&O&O, Vlieland, N D, van den Bemt, Bjf, van Riet-Nales, Diana A., Bouvy, Marcel L, Egberts, ACG, and Gardarsdottir, H

Published
2019

30. The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group

Author

Koziolek, Mirko, primary, Alcaro, Stefano, additional, Augustijns, Patrick, additional, Basit, Abdul W., additional, Grimm, Michael, additional, Hens, Bart, additional, Hoad, Caroline L., additional, Jedamzik, Philipp, additional, Madla, Christine M., additional, Maliepaard, Marc, additional, Marciani, Luca, additional, Maruca, Annalisa, additional, Parrott, Neil, additional, Pávek, Petr, additional, Porter, Christopher J.H., additional, Reppas, Christos, additional, van Riet-Nales, Diana, additional, Rubbens, Jari, additional, Statelova, Marina, additional, Trevaskis, Natalie L., additional, Valentová, Kateřina, additional, Vertzoni, Maria, additional, Čepo, Dubravka Vitali, additional, and Corsetti, Maura, additional

Published
2019
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31. Age-Related Medicine

Author

Wahlich, John, primary, Orlu, Mine, additional, Mair, Alpana, additional, Stegemann, Sven, additional, and van Riet-Nales, Diana, additional

Published
2019
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32. Paediatric Drug Development and Formulation Design—a European Perspective

Author

Apotheek, Circulatory Health, Apotheek Opleiding, van Riet-Nales, Diana A., Kozarewicz, Piotr, Aylward, Brian, de Vries, Rutger, Egberts, Toine C G, Rademaker, Carin M A, Schobben, Alfred F A M, Apotheek, Circulatory Health, Apotheek Opleiding, van Riet-Nales, Diana A., Kozarewicz, Piotr, Aylward, Brian, de Vries, Rutger, Egberts, Toine C G, Rademaker, Carin M A, and Schobben, Alfred F A M

Published
2017

33. Kindvriendelijke geneesmiddelen

Author

UMC Utrecht, Apotheek, Circulatory Health, Brain, Infection & Immunity, Child Health, Regenerative Medicine and Stem Cells, Apotheek Opleiding, van Riet-Nales, Diana, Schobben, Fred, Vromans, Herman, Egberts, Toine, Rademaker, Carin, UMC Utrecht, Apotheek, Circulatory Health, Brain, Infection & Immunity, Child Health, Regenerative Medicine and Stem Cells, Apotheek Opleiding, van Riet-Nales, Diana, Schobben, Fred, Vromans, Herman, Egberts, Toine, and Rademaker, Carin

Published
2017

36. Streven naar fundamentele kennis moet leidend zijn: Weinig onderzoek beschikbaar voor de ontwikkeling naar kindergeneesmiddelen

Author

Van Riet-Nales, Diana, Schobben, Alfred, Egberts, Toine, Rademaker, Karin, Sub Clinical Pharmacy, Pharmacoepi, and Pharmacoepidemiology and Clinical Pharmacology

Subjects
Pharmacology, Pharmacology (medical)
Abstract

Over de relatie tussen het farmaceutisch ontwerp van een geneesmiddel en de uitkomsten bij kinderen is weinig bekend. Uit onderzoek van de auteurs blijkt dat een 4 mm-tablet en een siroop(oplossing) de voorkeur hebben van kinderen. Dit is deel twee in een serie over kindvriendelijke geneesmiddelen, naar aanleiding van het promotieonderzoek van apotheker Diana van Riet.

Published
2015

42. Methods of administering oral formulations and child acceptability

Author

Sub Clinical Pharmacotherapy, Sub Clinical Pharmacy, Pharmacoepi, Pharmacoepidemiology and Clinical Pharmacology, van Riet-Nales, Diana A, Ferreira, José A, Schobben, Alfred F A M, de Neef, Barbara J, Egberts, Toine C G, Rademaker, Carin M A, Sub Clinical Pharmacotherapy, Sub Clinical Pharmacy, Pharmacoepi, Pharmacoepidemiology and Clinical Pharmacology, van Riet-Nales, Diana A, Ferreira, José A, Schobben, Alfred F A M, de Neef, Barbara J, Egberts, Toine C G, and Rademaker, Carin M A

Published
2015

46. Methods of administering oral formulations and child acceptability

Author

Apotheek, Apotheek Opleiding, Van Riet-Nales, Diana A., Ferreira, José A., Schobben, Alfred F A M, De Neef, Barbara J., Egberts, Toine C G, Rademaker, Carin M A, Apotheek, Apotheek Opleiding, Van Riet-Nales, Diana A., Ferreira, José A., Schobben, Alfred F A M, De Neef, Barbara J., Egberts, Toine C G, and Rademaker, Carin M A

Published
2015

47. The availability and age-appropriateness of medicines authorized for children in the Netherlands

Author

van Riet-Nales, Diana A, de Jager, Karin E, Schobben, Alfred FAM, Egberts, Toine CG, and Rademaker, Carin MA

Subjects
Health Knowledge, Attitudes, Practice, Adolescent, Pharmaceutical Preparations, Child, Preschool, Age Factors, Humans, Infant, Paediatric Clinical Pharmacology, Practice Patterns, Physicians', Child, Drug Approval, Netherlands
Abstract

To study the number of medicines and active chemical entities that are authorized and commercially available for children in the Netherlands and to evaluate the age-appropriateness of the available paediatric medicines.The availability of paediatric medicines and active chemical entities was studied with the help of a Dutch medicines database and the Summary of Product Characteristics. Medicines were categorized with respect to their route of administration, type of oral dosage form and therapeutic category. The age-appropriateness was assessed on three aspects: dose capability, suitability of the dosage form and inclusion of potentially harmful excipients.Three thousand five hundred and forty-two paediatric medicines containing 703 different active chemical entities were identified. This equalled half of all the medicines and chemical entities available for human use. The percentage of paediatric medicines increased with age and varied for the route of administration from 22% (dermal) to 81% (inhalation) and for the therapeutic category from 11% (uro-genital, sex hormones) to 89% (anti-parasites). The appropriateness of the paediatric medicines with respect to their authorization status, dose capability and dosage form increased with age from 27-88%. Fifty-two percent of all oral paediatric liquid formulations contained a potentially harmful excipient.This study confirms the limited availability of paediatric medicines for a broad range of therapeutic areas and shows that paediatric medicines may not be age-appropriate, even if authorized. While confirming the need for a legislative incentive, the results also provide baseline information for an estimation of the effect of the European Paediatric Regulation in the near future.

Published
2011

48. Oral medicines for children in the European paediatric investigation plans

Author

Sub Clinical Pharmacy, Pharmacoepi, Sub Clinical Pharmacotherapy, Pharmacoepidemiology and Clinical Pharmacology, van Riet-Nales, Diana A, Römkens, Erwin G A W, Saint-Raymond, Agnes, Kozarewicz, Piotr, Schobben, Alfred F A M, Egberts, Toine C G, Rademaker, Carin M A, Sub Clinical Pharmacy, Pharmacoepi, Sub Clinical Pharmacotherapy, Pharmacoepidemiology and Clinical Pharmacology, van Riet-Nales, Diana A, Römkens, Erwin G A W, Saint-Raymond, Agnes, Kozarewicz, Piotr, Schobben, Alfred F A M, Egberts, Toine C G, and Rademaker, Carin M A

Published
2014

49. Practical problems with medication use that older people experience: A qualitative study

Author

Sub Pharmacoepidemiology, UIPS - Utrecht Institute for Pharmaceutical Sciences, Sub Gen. Pharmacoepi and Clinical Pharm, Sub Clinical Pharmacy, Pharmacoepi, Pharmacoepidemiology and Clinical Pharmacology, Notenboom, Kim, Beers, Erna, Van Riet-Nales, Diana A., Egberts, Toine C G, Leufkens, Hubert G M, Jansen, Paul A F, Bouvy, Marcel L., Sub Pharmacoepidemiology, UIPS - Utrecht Institute for Pharmaceutical Sciences, Sub Gen. Pharmacoepi and Clinical Pharm, Sub Clinical Pharmacy, Pharmacoepi, Pharmacoepidemiology and Clinical Pharmacology, Notenboom, Kim, Beers, Erna, Van Riet-Nales, Diana A., Egberts, Toine C G, Leufkens, Hubert G M, Jansen, Paul A F, and Bouvy, Marcel L.

Published
2014

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