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Article ; Online: How Granular Can a Dose Form Be Described? Considering EDQM Standard Terms for a Global Terminology

Robert H. Vander Stichele / Joseph Roumier / Dirk van Nimwegen

Applied Sciences, Vol 12, Iss 4337, p

2022 Volume 4337

Abstract: The aim was (1) to analyse the features of the EDQM terminology, (2) to formulate proposals for minor changes and (3) to create a small ontology of dose forms, based on characteristics of EDQM, and suitable for alignment with other dose form ... ...

Abstract	The aim was (1) to analyse the features of the EDQM terminology, (2) to formulate proposals for minor changes and (3) to create a small ontology of dose forms, based on characteristics of EDQM, and suitable for alignment with other dose form terminologies. The 428 Pharmaceutical Dose Forms (PDF) (“human and veterinary” only) were extracted from the EDQM Standard Terms database. A quantitative and qualitative analysis of the textual definitions of the terms was conducted. Through an analysis of unique combinations of different sets of descriptors and characteristics, a small ontology was built in three levels. For the 143 transformable PDFs, the administrable dose form was made explicit, with 121 requiring only one transformation and 22 multiple transformations, of which 10 include “no transformation”. Different levels of aggregations of the 428 PDFs were tested in 4 analyses, ranging from 206 to 383 unique combinations. An ontology in Webprotégé was created of 22 higher-level concepts (based on the intended site characteristics) and 69 intermediate-level terms (newly created) to accommodate the 428 PDFs of EDQM. EDQM Dose Form terminology is suitable terminology in terms of granularity, for defining dose forms of medicinal products, to enable fair comparison of similar medicinal products, and global identification of medicinal products (IDMP). Recommendations for minor improvements and a simple ontology for dose forms are proposed.
Keywords	dose forms ; ISO/CEN standards ; EDQM ; standardisation ; terminology ; ontology ; Technology ; T ; Engineering (General). Civil engineering (General) ; TA1-2040 ; Biology (General) ; QH301-705.5 ; Physics ; QC1-999 ; Chemistry ; QD1-999
Language	English
Publishing date	2022-04-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: How to ensure we can track and trace global use of COVID-19 vaccines?

Vander Stichele, Robert H / Hay, Christian / Fladvad, Malin / Sturkenboom, Miriam C J M / Chen, Robert T

Vaccine

2020 Volume 39, Issue 2, Page(s) 176–179

MeSH term(s)	COVID-19 ; COVID-19 Vaccines ; Humans ; Reference Standards ; SARS-CoV-2 ; Viral Vaccines
Chemical Substances	COVID-19 Vaccines ; Viral Vaccines
Language	English
Publishing date	2020-11-24
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2020.11.055
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Article ; Online: Healthy aging in Finland: patients adhere well to chronic statin therapy and their doctors to the guidelines.

Vander Stichele, Robert H / Van Camp, Yoleen

Cardiovascular drugs and therapy

2014 Volume 28, Issue 3, Page(s) 209–210

MeSH term(s)	Cardiovascular Diseases/drug therapy ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Male ; Medication Adherence
Chemical Substances	Hydroxymethylglutaryl-CoA Reductase Inhibitors
Language	English
Publishing date	2014-06
Publishing country	United States
Document type	Comment ; Editorial
ZDB-ID	639068-7
ISSN	1573-7241 ; 0920-3206
ISSN (online)	1573-7241
ISSN	0920-3206
DOI	10.1007/s10557-014-6526-9
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Article ; Online: Systematic review of anticholinergic risk scales in older adults.

Durán, Carlos E / Azermai, Majda / Vander Stichele, Robert H

European journal of clinical pharmacology

2013 Volume 69, Issue 7, Page(s) 1485–1496

Abstract: Background: Anticholinergic drugs are often involved in explicit criteria for inappropriate prescribing in older adults. Several scales were developed for screening of anticholinergic drugs and estimation of the anticholinergic burden. However, ... ...

Abstract	Background: Anticholinergic drugs are often involved in explicit criteria for inappropriate prescribing in older adults. Several scales were developed for screening of anticholinergic drugs and estimation of the anticholinergic burden. However, variation exists in scale development, in the selection of anticholinergic drugs, and the evaluation of their anticholinergic load. This study aims to systematically review existing anticholinergic risk scales, and to develop a uniform list of anticholinergic drugs differentiating for anticholinergic potency. Methods: We performed a systematic search in MEDLINE. Studies were included if provided (1) a finite list of anticholinergic drugs; (2) a grading score of anticholinergic potency and, (3) a validation in a clinical or experimental setting. We listed anticholinergic drugs for which there was agreement in the different scales. In case of discrepancies between scores we used a reputed reference source (Martindale: The Complete Drug Reference®) to take a final decision about the anticholinergic activity of the drug. Results: We included seven risk scales, and evaluated 225 different drugs. Hundred drugs were listed as having clinically relevant anticholinergic properties (47 high potency and 53 low potency), to be included in screening software for anticholinergic burden. Conclusion: Considerable variation exists among anticholinergic risk scales, in terms of selection of specific drugs, as well as of grading of anticholinergic potency. Our selection of 100 drugs with clinically relevant anticholinergic properties needs to be supplemented with validated information on dosing and route of administration for a full estimation of the anticholinergic burden in poly-medicated older adults.
MeSH term(s)	Aging ; Cholinergic Antagonists/adverse effects ; Cholinergic Antagonists/classification ; Cholinergic Antagonists/therapeutic use ; Databases, Pharmaceutical ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Pharmaceutical Preparations/classification ; Pharmacovigilance ; Polypharmacy ; Risk
Chemical Substances	Cholinergic Antagonists ; Pharmaceutical Preparations
Language	English
Publishing date	2013-03-26
Publishing country	Germany
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ZDB-ID	121960-1
ISSN	1432-1041 ; 0031-6970
ISSN (online)	1432-1041
ISSN	0031-6970
DOI	10.1007/s00228-013-1499-3
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Article ; Online: International recommendations for an effective control of head louse infestations.

Mumcuoglu, Kosta Y / Pollack, Richard J / Reed, David L / Barker, Stephen C / Gordon, Shirley / Toloza, Ariel C / Picollo, Maria I / Taylan-Ozkan, Aysegul / Chosidow, Olivier / Habedank, Birgit / Ibarra, Joanna / Meinking, Terri L / Vander Stichele, Robert H

International journal of dermatology

2020 Volume 60, Issue 3, Page(s) 272–280

Abstract: Head louse infestations continue to be a concern of public health in most countries, including the most developed ones. The present recommendations are intended to inform and stress the role and impact of the different authorities, institutions, industry, ...

Abstract	Head louse infestations continue to be a concern of public health in most countries, including the most developed ones. The present recommendations are intended to inform and stress the role and impact of the different authorities, institutions, industry, and the public in the control of head lice in order to reduce the prevalence of this parasite. We encourage health authorities to pursue more effective methods to correctly identify such infestations, and evaluate existing and new pediculicides, medical devices, louse repellents, and louse- and nit-removal remedies. Pediculicides and medical devices must have verifiable claims in the instructions for use and should be tested periodically to document current levels of resistance by lice to the active ingredients and to the formulated products. Where the prevalence of lice is claimed to be epidemic, children should be periodically evaluated objectively to document the actual level of prevalence. Continuing education for health providers and the general population promises to correct misinformation regarding the biology, prevention, and management of lice. Parents should regularly inspect their children for head lice and treat as necessary. Health authorities are encouraged to eliminate policies and practices that rely upon school exclusion as a means to reduce incidence and prevalence, e.g., the 'no-nit' policy which lacks scientific justification, and are counterproductive to the health and welfare of children.
MeSH term(s)	Animals ; Child ; Humans ; Lice Infestations/diagnosis ; Lice Infestations/drug therapy ; Lice Infestations/epidemiology ; Pediculus ; Prevalence ; Public Health ; Scalp Dermatoses/diagnosis ; Scalp Dermatoses/epidemiology ; Scalp Dermatoses/prevention & control ; Schools
Language	English
Publishing date	2020-08-07
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	412254-9
ISSN	1365-4632 ; 0011-9059 ; 1461-1244
ISSN (online)	1365-4632
ISSN	0011-9059 ; 1461-1244
DOI	10.1111/ijd.15096
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Article ; Online: The impact of chronic benzodiazepine use on cognitive evolution in nursing home residents.

Bourgeois, Jolyce / Elseviers, Monique M / Van Bortel, Luc / Petrovic, Mirko / Vander Stichele, Robert H

Human psychopharmacology

2015 Volume 30, Issue 2, Page(s) 85–93

Abstract: Objective: Chronic use of benzodiazepines and Z-drugs (BZD/Zs) has been linked to cognitive decline. In this one-year prospective cohort study, we explored the impact of chronic BZD/Z use on cognitive decline compared to nonusers.: Methods: In ... ...

Abstract	Objective: Chronic use of benzodiazepines and Z-drugs (BZD/Zs) has been linked to cognitive decline. In this one-year prospective cohort study, we explored the impact of chronic BZD/Z use on cognitive decline compared to nonusers. Methods: In cognitively capable BZD/Z users and nonusers in 10 Belgian nursing homes, we investigated cognition with the MiniMentalStateExamination(MMSE) at baseline and one year. A decrease of ≥ 4 points on the MMSE (clinically relevant decrease) was used in multiple logistic regression. We collected baseline demographics, functional, psychometric and social characteristics potentially influencing cognition. Results: In both the 131 BZD/Z users and 95 nonusers, the cognition decreased significantly over time, but without significant difference between the groups. Clinically relevant decrease was present in 34% BZD/Z users and 27% nonusers (NS). Controlled for age, gender, education and BZD/Z use, the significant risk factors for clinically relevant cognitive decline were depression, hearing and functional impairment. Frequent reading was associated with less MMSE decrease. Our findings could not demonstrate with statistical significance that BZD/Z use was associated with fast cognitive decline. The risk factors for fast decline were depression, hearing and functional impairment, and the absence of a reading attitude. In addition, BZD/Z use and depression were associated, indicating a complex relationship.
MeSH term(s)	Aged ; Aged, 80 and over ; Belgium ; Benzodiazepines/adverse effects ; Cognition Disorders/chemically induced ; Cohort Studies ; Female ; Humans ; Hypnotics and Sedatives/adverse effects ; Male ; Middle Aged ; Neuropsychological Tests ; Nursing Homes ; Psychiatric Status Rating Scales ; Psychometrics ; Risk Factors ; Sleep Wake Disorders/drug therapy ; Statistics, Nonparametric
Chemical Substances	Hypnotics and Sedatives ; Benzodiazepines (12794-10-4)
Language	English
Publishing date	2015-03
Publishing country	England
Document type	Journal Article
ZDB-ID	632931-7
ISSN	1099-1077 ; 0885-6222
ISSN (online)	1099-1077
ISSN	0885-6222
DOI	10.1002/hup.2456
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Article ; Online: Awareness of dementia by family carers of nursing home residents dying with dementia: a post-death study.

Penders, Yolanda W H / Albers, Gwenda / Deliens, Luc / Vander Stichele, Robert / Van den Block, Lieve

Palliative medicine

2015 Volume 29, Issue 1, Page(s) 38–47

Abstract: Background: High-quality palliative care for people with dementia should be patient-centered, family-focused, and include well-informed and shared decision-making, as affirmed in a recent white paper on dementia from the European Association for ... ...

Abstract	Background: High-quality palliative care for people with dementia should be patient-centered, family-focused, and include well-informed and shared decision-making, as affirmed in a recent white paper on dementia from the European Association for Palliative Care. Aim: To describe how often family carers of nursing home residents who died with dementia are aware that their relative has dementia, and study resident, family carer, and care characteristics associated with awareness. Design: Post-death study using random cluster sampling. Setting/participants: Structured questionnaires were completed by family carers, nursing staff, and general practitioners of deceased nursing home residents with dementia in Flanders, Belgium (2010). Results: Of 190 residents who died with dementia, 53.2% of family carers responded. In 28% of cases, family carers indicated they were unaware their relative had dementia. Awareness by family carers was related to more advanced stages of dementia 1 month before death (odds ratio = 5.4), with 48% of family carers being unaware when dementia was mild and 20% unaware when dementia was advanced. The longer the onset of dementia after admission to a nursing home, the less likely family carers were aware (odds ratio = 0.94). Conclusion: Family carers are often unaware that their relative has dementia, that is, in one-fourth of cases of dementia and one-fifth of advanced dementia, posing considerable challenges for optimal care provision and end-of-life decision-making. Considering that family carers of residents who develop dementia later after admission to a nursing home are less likely to be aware, there is room for improving communication strategies toward family carers of nursing home residents.
MeSH term(s)	Awareness ; Belgium/epidemiology ; Caregivers/psychology ; Cross-Sectional Studies ; Dementia/mortality ; Dementia/nursing ; Female ; Humans ; Male ; Middle Aged ; Nursing Homes ; Palliative Care ; Retrospective Studies ; Surveys and Questionnaires
Language	English
Publishing date	2015-01
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639247-7
ISSN	1477-030X ; 0269-2163
ISSN (online)	1477-030X
ISSN	0269-2163
DOI	10.1177/0269216314542261
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Article ; Online: Ex vivo effectiveness of French over-the-counter products against head lice (Pediculus humanus capitis De Geer, 1778).

Combescot-Lang, Catherine / Vander Stichele, Robert H / Toubate, Berthine / Veirron, Emilie / Mumcuoglu, Kosta Y

Parasitology research

2015 Volume 114, Issue 5, Page(s) 1779–1792

Abstract: Head lice infestation is still a public health problem worldwide, with an intracountry and intercountry prevalence variation of 0.7 to 59%. There is a large variety of over-the-counter anti-louse products, but their efficacy is not always well assessed. ... ...

Abstract	Head lice infestation is still a public health problem worldwide, with an intracountry and intercountry prevalence variation of 0.7 to 59%. There is a large variety of over-the-counter anti-louse products, but their efficacy is not always well assessed. Our objective was to test the pediculicidal and ovicidal efficacy of 21 over-the-counter head louse products, available in France during the period of 2008 to 2012. We tested children living in Tours City in central France and visiting preschools, primary schools, kindergarten, camps, and child care facilities, as well as children in their family houses, and were examined for the presence of lice. The products were collected from randomly selected pharmacies by covert investigators and then tested in the laboratory on an ex vivo sample of head lice and their eggs, collected from the hair of infested children. Living lice and unharmed eggs were collected from the scalps of 3-12 years old. The laboratory conditions for ex vivo testing mimicked the manufacturers' instructions for exposure time and application method. In 21 runs, 3919 living lice and 4321 undamaged living eggs were collected from the scalp of over 400 children. The 21 products were classified in three groups: 6 products in a group of potentially 100% pediculicidal activity and potentially 100% ovicidal activity, 8 products in a group of potentially 100% pediculicidal activity but insufficient ovicidal activity (including 2 products with claims of single application treatment), and 7 products in a group of insufficient pediculicidal activity and ovicidal activity. The pharmaceutical market for head lice products in France is swamped with poorly tested and ineffective products. Rigorous efficacy testing preregistration and periodic screening and testing of effectiveness in the post-registration period should be endorsed by the health authorities.
MeSH term(s)	Animals ; Antiparasitic Agents/pharmacology ; Female ; France ; Humans ; Insecticides/therapeutic use ; Ovum/drug effects ; Pediculus/drug effects
Chemical Substances	Antiparasitic Agents ; Insecticides
Language	English
Publishing date	2015-05
Publishing country	Germany
Document type	Journal Article
ZDB-ID	284966-5
ISSN	1432-1955 ; 0932-0113 ; 0044-3255
ISSN (online)	1432-1955
ISSN	0932-0113 ; 0044-3255
DOI	10.1007/s00436-015-4363-9
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Article ; Online: Reasons for End-of-Life Hospital Admissions: Results of a Survey Among Family Physicians.

Reyniers, Thijs / Deliens, Luc / Pasman, H Roeline / Vander Stichele, Robert / Sijnave, Bart / Cohen, Joachim / Houttekier, Dirk

Journal of pain and symptom management

2016 Volume 52, Issue 4, Page(s) 498–506

Abstract: Context: Although the acute hospital setting is not considered to be an ideal place of death, many people are admitted to hospital at the end of life.: Objectives: The present study aims to examine the reasons for hospital admissions that result in ... ...

Abstract	Context: Although the acute hospital setting is not considered to be an ideal place of death, many people are admitted to hospital at the end of life. Objectives: The present study aims to examine the reasons for hospital admissions that result in an expected death and the factors that play a role in the decision to admit to hospital. Methods: This was a survey among family physicians (FPs) about those of their patients who had died nonsuddenly in an acute university hospital setting in Belgium between January and August 2014. Questions were asked about the patient's health situation, care that the patient received before the admission, the circumstances of the hospital admission, the reasons necessitating the admission, and other factors that had played a role in the decision to admit the patient to hospital. Results: We received 245 completed questionnaires (response rate 70%), and 77% of those hospital deaths were considered to be nonsudden. FPs indicated that 55% of end-of-life hospitalizations were for palliative reasons and 26% curative or life-prolonging. Factors such as the patient feeling safer in hospital (35%) or family believing care to be better in hospital (54%) frequently played a role in the end-of-life hospitalization. When patients were admitted with a limited anticipated life expectancy, FPs were more likely to indicate that an inadequate caring capacity of the care setting had played a role in the admission. Conclusion: To reduce the number of hospital deaths, a combination of structural support for out-of-hospital end-of-life care and a more timely referral to out-of-hospital palliative care services may be needed.
Language	English
Publishing date	2016-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	639142-4
ISSN	1873-6513 ; 0885-3924
ISSN (online)	1873-6513
ISSN	0885-3924
DOI	10.1016/j.jpainsymman.2016.05.014
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Article ; Online: Appropriateness and avoidability of terminal hospital admissions: Results of a survey among family physicians.

Reyniers, Thijs / Deliens, Luc / Pasman, H Roeline W / Vander Stichele, Robert / Sijnave, Bart / Houttekier, Dirk / Cohen, Joachim

Palliative medicine

2016 Volume 31, Issue 5, Page(s) 456–464

Abstract: Background: Although the acute hospital setting is not considered to be an ideal place of death, many people are admitted to hospital at the end of life.: Aim: To examine what proportion of terminal hospital admissions among their patients family ... ...

Abstract	Background: Although the acute hospital setting is not considered to be an ideal place of death, many people are admitted to hospital at the end of life. Aim: To examine what proportion of terminal hospital admissions among their patients family physicians consider to have been avoidable and/or inappropriate; which patient, family physician and admission factors are associated with the perceived inappropriateness or avoidability of terminal hospital admissions; and which interventions could have prevented them, from the perspective of family physicians. Design: Survey among family physicians, linked to medical record data. Setting: Patients who had died non-suddenly in the acute hospital setting of a university hospital in Belgium between January and August 2014. Results: We received 245 completed questionnaires (response rate 70%) and 77% of those hospital deaths ( n = 189) were considered to be non-sudden. Almost 14% of all terminal hospital admissions were considered to be potentially inappropriate, almost 14% potentially avoidable and 8% both, according to family physicians. The terminal hospital admission was more likely to be considered potentially inappropriate or potentially avoidable for patients who had died of cancer, when the patient's life expectancy at the time of admission was limited, by family physicians who had had palliative care training at basic, postgraduate or post-academic level, and when the admission was initiated by the patient, partner or other family. Conclusion: Timely communication with the patient about their limited life expectancy and the provision of better support to family caregivers may be important strategies in reducing the number of hospital deaths.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Belgium ; Female ; Hospital Mortality ; Hospitalization/statistics & numerical data ; Humans ; Male ; Middle Aged ; Palliative Care/statistics & numerical data ; Patient Admission/statistics & numerical data ; Physicians, Family ; Surveys and Questionnaires ; Terminal Care/statistics & numerical data
Language	English
Publishing date	2016-07-12
Publishing country	England
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639247-7
ISSN	1477-030X ; 0269-2163
ISSN (online)	1477-030X
ISSN	0269-2163
DOI	10.1177/0269216316659211
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