Dosage form suitability in vulnerable populations: A focus on paracetamol acceptability from infants to centenarians.


Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2019
Historique:
received: 31 10 2018
accepted: 04 08 2019
entrez: 21 8 2019
pubmed: 21 8 2019
medline: 3 4 2020
Statut: epublish

Résumé

Medicine acceptability is a multi-faceted concept driven by both product and user characteristics. Although a key factor for treatment effectiveness, especially in vulnerable populations, knowledge of those medicine features that best promote individual user acceptability remains fragmented. Focusing on paracetamol, this study has explored the appropriateness of pharmaceutical products in different dosage forms to achieve adequate patient acceptability from infants to centenarians. This observational, multicentre, prospective study was carried out in 10 hospitals, 8 nursing homes and over 150 community dispensaries. Observers reported several behaviours/events evaluating acceptability for 1016 different pharmaceutical product uses in paediatrics (<18y.) and 1288 in the elderly (≥65y.). Using mapping and clustering, a multivariate approach offered an intelligible reference framework for each population, providing comprehensive scores: positively or negatively accepted. Among all the evaluations supporting the acceptability reference frameworks, there were 502 reports on paracetamol products intake. Herein we focused on the 5 products with ≥30 evaluations. Although oral suspension and powder for oral solution were positively-accepted in the paediatric group, the powder had a higher rate of negative patient reaction (p<0.001). Of those that received this formulation, 72% were ≤8y., and therefore suitable to receive the better accepted oral suspension. In the elderly, patients with swallowing disorders were preferentially treated with such powders (p<0.001), which were less often fully taken than orally disintegrating tablets (p<0.001). Even in those patients ≥90y., capsule formulations appeared to be the best accepted product in patients without swallowing alterations, and thus could be a suitable alternative to the powder in this population. By better integrating patient characteristics when choosing dosage forms, clinicians and caregivers may improve treatment acceptability and adherence. Moreover, hospitals and healthcare institutions could optimise purchasing to best suit their local population, disseminating information to help staff align specific dosage forms to targeted patients.

Identifiants

pubmed: 31430323
doi: 10.1371/journal.pone.0221261
pii: PONE-D-18-28685
pmc: PMC6701828
doi:

Substances chimiques

Dosage Forms 0
Acetaminophen 362O9ITL9D

Types de publication

Journal Article Multicenter Study Observational Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0221261

Déclaration de conflit d'intérêts

The authors have read the journal’s policy and the authors of this paper have the following competing interests: FR and TV are paid employees of ClinSearch. This alters our adherence to PLOS ONE policies on sharing data and materials. Please see the Data Availability statement for further information. There are no patents, products in development or marketed products to declare.

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Auteurs

Fabrice Ruiz (F)

ClinSearch, Malakoff, France.

Thibault Vallet (T)

ClinSearch, Malakoff, France.

Amélie Dufaÿ Wojcicki (A)

Département innovation pharmaceutique, Agence Générale des Équipements et Produits de Santé (AGEPS), Assistance Publique des Hôpitaux de Paris (AP-HP), Paris, France.

Émilie Belissa (É)

Département innovation pharmaceutique, Agence Générale des Équipements et Produits de Santé (AGEPS), Assistance Publique des Hôpitaux de Paris (AP-HP), Paris, France.

Jean-Eudes Fontan (JE)

Hôpital Jean Verdier, Groupe Hospitalier Universitaire Paris Seine-Saint-Denis, Assistance Publique des Hôpitaux de Paris (AP-HP), Bondy, France.

Loïc de Pontual (L)

Hôpital Jean Verdier, Groupe Hospitalier Universitaire Paris Seine-Saint-Denis, Assistance Publique des Hôpitaux de Paris (AP-HP), Bondy, France.

Sylvie Nathanson (S)

Centre Hospitalier de Versailles - André Mignot, Le Chesnay, France.

Alain Chevallier (A)

Hôpital Broca, Groupe Hospitalier Universitaire Paris Centre, Assistance Publique des Hôpitaux de Paris (AP-HP), Paris, France.

Sandra Laribe-Caget (S)

Hôpital Rothschild, Groupe Hospitalier Universitaire Est Parisien, Assistance Publique des Hôpitaux de Paris (AP-HP), Paris, France.

Vincent Boudy (V)

Département innovation pharmaceutique, Agence Générale des Équipements et Produits de Santé (AGEPS), Assistance Publique des Hôpitaux de Paris (AP-HP), Paris, France.
Université Paris Descartes, Paris, France.

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