Background: Informed consent forms (ICFs) are a mandatory prerequisite for participating in clinical trials. In pediatric studies, the ICF is generally signed by the child’s parents. The ICFs designed for clinical trials are often lengthy and complex to understand. We conducted this study to determine if a simplified ICF would improve parental understanding compared to a standard ICF. Methods: A single-centre, single-blind, randomized controlled trial featuring two fictitious ICFs took place in a tertiary Canadian mother and child university hospital. Parents of hospitalized children were assigned to read either a standard or simplified ICF. Parental comprehension was measured using the Modular Informed Consent Comprehension Assessment (MICCA) questionnaire. The primary outcome of this study was to assess the proportion of parents with a MICCA score of 75% or above. Results: One hundred and fifty participants answered the study questionnaires. The primary endpoint was reached by 55.7% of the participants who read the simplified ICF compared to 46.2% in the standard ICF group (p=0.303). The mean MICCA scores were 17.87 and 17.75 points, respectively (p=0.847). Themes that were poorly understood by both groups were the study procedures, the adverse effects, the other available treatment options as well as the main benefits and purpose of the study. Conclusion: This single centre, single-blind, randomized controlled study showed that the comprehension was similar between a simplified and a standard ICF. This suggests that using simplified ICFs does not improve nor impair parental comprehension. Therefore, a simplified ICF should be used as frequently as possible in pediatric research projects.

Contexte : Les programmes de soutien aux patients (PSP) visent à faciliter l’accès aux médicaments de spécialité, mais reposent notamment sur des formulaires souvent complexes, générant une charge administrative importante et limitant le temps clinique disponible. Peu de données décrivent leur forme et leur contenu.Objectif : Décrire la forme et le contenu des formulaires d’accès aux médicaments de spécialité (FAMS) disponibles au Québec.Méthodologie : Étude descriptive transversale incluant l’ensemble des formulaires disponibles sur la plateforme de l’Association québécoise des coordonnateurs d’accès aux médicaments en oncologie (AQCAMO, n=211) et les formulaires disponibles localement (n = 21). Après déduplication, 143 formulaires uniques ont été analysés selon leurs caractéristiques formelles (format, nombre de mots, nombre de pages) et leur contenu (informations patient, prescripteur, consentement, confidentialité, services).Résultats : Les formulaires comptaient en moyenne 1992 ± 1009 mots et 4,6 ± 1,8 pages. Tous requéraient des données identifiantes; 34,3 % demandaient le numéro de carte santé, 38,5 % les traitements antérieurs et 37,8 % des informations sur la progression de la maladie. La confidentialité était peu détaillée : seulement 1,4 % mentionnaient la durée de conservation des données et 17,5 % décrivaient les mesures de protection. Bien que 96,5% exigeaient une signature, seulement 25,9 % indiquaient la possibilité d’accéder au traitement sans recours au PSP.Conclusion : Les formulaires d’accès aux médicaments de spécialité présentent une forte hétérogénéité, une charge administrative notable et des lacunes en matière de transparence et de protection des données, soulignant la nécessité d’une harmonisation et d’une évaluation éthique.

BACKGROUND:Patient support programs (PSP) aim to facilitate access to specialty medications but rely heavily on often complex forms that create a significant administrative burden and reduce available clinical time. Few data describe their structure and content. OBJECTIVE:To describe the structure and content of specialty medication access forms (SMAFs) available in Québec. METHODS:A cross-sectional descriptive study including all forms available on the platform of the Association québécoise des coordonnateurs d'accès aux médicaments en oncologie (AQCAMO, n=211) and locally available forms (n=21). After deduplication, 143 unique forms were analyzed based on their formal characteristics (format, word count, number of pages) and content (patient information, prescriber information, consent, confidentiality, services). RESULTS:Forms contained an average of 1,992±1,009 words and 4.6±1.8 pages. All required identifying information; 34.3% requested the health insurance number, 38.5% prior treatments, and 37.8% information on disease progression. Confidentiality details were limited: only 1.4% mentioned data retention duration and 17.5% described data protection measures. Although 96.5% required a signature, only 25.9% indicated whether treatment access was possible without using the PSP. CONCLUSION:Medication access forms show substantial heterogeneity, significant administrative burden, and gaps in transparency and data protection, underscoring the need for harmonization and ethical review.

Limited data exist on pharmaceutical product use by infants, although available data suggests higher prevalence of use among children under 12 months of age. We conducted a descriptive study of 3050 infants recruited in the CHILD Cohort Study, a prospective, multicenter, longitudinal cohort following children from pregnancy through childhood. Parents were surveyed for use of prescription and over-the-counter drugs, and natural health products (NHPs, including homeopathic products and vitamins) at 3, 6, and 12 months after delivery. By one year of age, 96.0% of children had taken at least one pharmaceutical product. Among 307 reported products, 32 were given to at least 1% of cohort infants. Vitamin D, acetaminophen, ibuprofen, topical hydrocortisone, amoxicillin, and nystatin were the most common medications and natural health products (NHPs) received, with 8/32 of the most frequently used products being NHPs. Overall, 14.7% of pharmaceutical products administered to children were off-label and 35.8% were NHPs or products without a Drug Identification Number (DIN). The use of over-the-counter medications and NHPs is common and off-label use of drugs is frequent, even in the first year of life. This study highlights the importance of conducting studies on medication use in infants, and of infant medication use monitoring by healthcare providers.

Background: In 2015, commercial pediatric digoxin injection 0.05 mg/mL was discontinued, leaving only one adult concentration (0.25 mg/mL) for injection on the Canadian market. No published studies have documented the chemical stability over a long period of time of a diluted solution of digoxin for injection. Objective: The aim of this study was to assess the chemical stability of 2 digoxin injection formulations 0.05 mg/mL diluted in 2 vehicles stored at 5°C or a 25°C. Methods: The compounded solution of digoxin 0.05 mg/mL for injection was prepared with digoxin 0.25 mg/mL after dilution in 2 different vehicles, normal saline, and a compounding of the commercial vehicle. Half of the compounding products were stored in 2 mL transparent glass vials at 25°C and the other half at 5°C. Chemical stability was evaluated by HPLC-UV analysis on days 0, 14, 30, 60, 90, 120, 150, 180 for each temperature conditions. In addition, samples were tested for organoleptic change, presence of particular matter as well as sterility. Results: For all tested preparations, the concentration of digoxin remained above 90.0% of the initial concentration throughout the 180-day study. Furthermore, no organoleptic change was observed; particulate matter assessment was in acceptable range; and sterility specifications were met. Conclusions: Digoxin 0.05 mg/mL obtained with a dilution of digoxin 0.25 mg/mL by normal saline or a copy of the commercial vehicle remained stable for at least 180 days at 5°C and 25°C.

Abstract Background Bronchiolitis is the primary cause of hospitalization in children during the first year of life. Respiratory support and hydration are the two pillars of management. Practice guidelines for bronchiolitis (NICE and CPS) recommend nasogastric (NG) hydration before intravenous (IV) fluids if oral hydration cannot be maintained. However, IV hydration remains the primary mode of hydration at our tertiary care pediatric centre. Objectives This is a resource stewardship project aiming to evaluate the baseline use of IV versus NG hydration in children 0-15 months hospitalized for bronchiolitis and requiring supplemental hydration. The secondary objective is to evaluate potential barriers to NG hydration for these children. Design/Methods Data was collected retrospectively for the 2017-2018 bronchiolitis season. A survey was sent to all the pediatric emergency (ED) physicians and nurses, pediatric hospitalists, ED fellows, pediatric residents and ward nurses. Results Among eligible patients (n=95), IV hydration was prescribed 52% of the time, compared to 48% NG hydration. Ninety-six percent (47/49) of IV hydration was initiated in the ED, while only 4% (2/49) was initiated on the ward. Among patients who began receiving hydration in the ED (80/95, or 84%), 41% (33/80) were hydrated via NG and 59% (47/80) by IV. In the survey, while 92% (57/62) of responding physicians claimed to be aware of national guidelines for bronchiolitis, only 67% (42/62) said that NG was the recommended mode of hydration. Among ED practitioners, 56% (19/34) were up-to-date on the recommendation. Two-thirds of all respondents (physicians and nurses) felt that NG hydration would be more acceptable to parents. Among nurses, 84% (38/45) felt that IV installation was a longer procedure to complete. Despite the existence of a local order set indicating NG hydration as the preferred hydration method, only 64% (40/62) of physicians were aware of its existence, and only 23% of these (9/40) actually use the guideline. Main reasons of disuse included forgetting the guideline exists and it not being easily available. In contrast, 93% of nurses were aware of the local guideline. Conclusion Intravenous hydration is overused among patients hospitalized with bronchiolitis at our centre, and the ED is the main setting where this occurs. There is a discrepancy between physicians’ theoretical knowledge of hydration guidelines and the application of these in reality. Barriers to the use of NG hydration can be amenable to a quality improvement (QI) intervention targeting improved knowledge and use of our local guideline, and this will be our focus going forward.

Resume Objectifs : Dresser un etat des lieux des pratiques du bilan comparatif des medicaments dans les hopitaux du Quebec en 2016 et obtenir au moyen d’un sondage l’avis des pharmaciens sur l’etat actuel et son evolution. Mise en contexte : Les pratiques heterogenes entourant la conciliation medicamenteuse contribuent a reduire la conformite des pratiques par rapport a celles attendues. Malgre les nombreuses etudes publiees, il n’existe pas de portrait reel des pratiques actuelles au Quebec. Resultats : Vingt-huit chefs de departement ont repondu a l’enquete (taux de participation de 82 %). La plupart du temps, le pharmacien participe a la realisation du meilleur schema therapeutique possible, en revanche, les medecins semblent moins s’y investir. Les infirmieres et les assistants techniques en pharmacie ont des reponses mitigees sur leur role. Au conge des usagers, 59 % des repondants affirment que le pharmacien participe au bilan comparatif des medicaments en preparant ou en validant les ordonnances. Cela represente un pourcentage d’ordonnances de depart validees variant entre 2 et 100 %. Conclusion : Cette etude descriptive fait le point sur les pratiques entourant le bilan comparatif des medicaments dans les etablissements de sante du Quebec. Un tel bilan implique plusieurs intervenants, en particulier les pharmaciens, les infirmieres, les assistants techniques et les medecins. L’utilisation d’outils tres divers entraine un manque d’uniformite de cette demarche dans le reseau. L’information decoulant du processus de prescription medicamenteuse semble essentielle pour assurer l’optimisation du processus de conciliation. Abstract Objectives: To provide an overview of medication reconciliation practices in Quebec hospitals in 2016 and to obtain, by means of a survey, pharmacists’ opinions regarding the current state and the evolution of medication reconciliation. Background: The heterogeneity of practices surrounding medication reconciliation contribute to reducing their compliance with the expected practices. Despite the numerous published studies, there is no actual description of the current practices in Quebec. Results: Twenty-eight department heads responded to the survey (participation rate: 82 %). Most often, pharmacists participate in providing the best possible therapeutic regimen, but physicians seem to get less involved. Nurses and pharmacy technical assistants gave mitigated responses regarding their role. Fifty-nine percent of the respondents indicated that the pharmacist participates in medication reconciliation at patient discharge by preparing or verifying the prescriptions, the proportion of discharge prescriptions verified ranging from 2 to 100 %. Conclusion: This descriptive study explores the practices surrounding medication reconciliation in Quebec’s health-care facilities. Medication reconciliation involves several health professionals, notably, pharmacists, nurses, pharmacy technical assistants and physicians. The use of a wide array of tools leads to a lack of uniformity in medication reconciliation in the health-care system. The information from the medication prescribing process seems essential for ensuring the optimization of the reconciliation process.

Resume Objectif : Cette etude a pour objectif principal l’evaluation de la conformite des meilleurs schemas therapeutiques possibles a l’admission, realises a l’urgence et dans les autres unites de soins. Son objectif secondaire vise l’evaluation de la qualite des meilleurs schemas therapeutiques possibles basee sur la comparaison de l’information recueillie dans le formulaire rempli a l’urgence et dans les unites de soins dans les notes medicales d’admission. Mise en contexte : Depuis 2006, la realisation du bilan comparatif des medicaments aux points de transition des soins est une pratique organisationnelle requise par Agrement Canada. Il s’agit d’une etude descriptive retrospective. L’etude a ete menee au Centre hospitalier universitaire Sainte-Justine et approuvee par le Comite d’ethique de la recherche de l’etablissement. Resultats : Au total, 100 patients ont ete inclus dans l’etude, 22 patientes adultes du service d’obstetrique gynecologie (âge moyen : 32 ans) et 78 enfants (âge moyen : 5,7 ans). L’evaluation a porte sur l’analyse des 145 formulaires du meilleur schema possible contenus dans les 100 dossiers medicaux dont, 60 rediges a l’urgence et 85 rediges dans les services. Les taux de presence du formulaire du meilleur schema therapeutique possible etaient tres eleves pour tous les patients (94 %, 94/100), qu’ils aient ete admis en passant par l’urgence (96 %, 68/71) ou directement a l’etage (90 %, 26/29). Conclusion : Malgre la presence importante du meilleur schema therapeutique possible dans les dossiers medicaux, toutes les sections du formulaire ne sont pas remplies lors de sa redaction. Si ces donnees demontrent l’adoption croissante du meilleur schema therapeutique possible, force est de constater que son utilisation n’est pas encore optimale. Abstract Objective: The primary objective was to assess best possible medication history compliance at admission in the emergency department and the other care units. The secondary objective was to assess best possible medication history quality by comparing the information gathered on the form in the emergency department and the other care units, and the admission medical notes. Background: Medication reconciliation at care transition points has been an Accreditation Canada-required organizational practice since 2006. This was a retrospective descriptive study conducted at the Centre hospitalier universitaire Sainte-Justine with its research ethics board’s approval. Results: A total of 100 patients were included in the study: 22 adult obstetrics/gynecology patients (mean age: 32.0 years) and 78 children (mean age: 5.7 years). From the 100 charts analyzed, 60 best possible medication histories from the emergency department and 85 best possible medication histories from the other departments were evaluated. The best possible medication history presence rates were very high for all the patients (94%, 94/100), whether they had been admitted through the emergency department (96%, 68/71) or directly to a ward (90%, 26/29). Conclusion: Despite a high best possible medication history presence rate in the charts, not all sections of the form are completed when it is filled out. Although these data show an increasing uptake of the use of the best possible medication history, its use is still not optimal.

In early 2015, the paediatric formulation of injectable digoxin (50 μg/mL) was discontinued in Canada. The only remaining injectable formulation is five times more concentrated. This recent event has major implications for paediatric hospitals all over the country. The use of a more concentrated formulation is of particular concern in low-weight infants because the required volumes of digoxin are almost impossible to draw precisely. Such a situation is problematic because of the narrow therapeutic index of digoxin. There are different ways to deal with this inconvenient situation; however, none is as efficient or safe for infants as the discontinued formulation. The authors believe it remains imperative that patients requiring intravenous digoxin be treated with the safest and most efficient formulation possible, regardless of their age or size.

OBJECTIVES: To describe the knowledge, beliefs and attitudes of Quebec's pharmacists towards immunization and determine their perceived barriers to pharmacist-led immunization.METHODS: The current study was a descriptive survey of pharmacists working in a community setting in Quebec. Pharmacists were randomly chosen from a list of Quebec's community pharmacies and were contacted by phone from January 17 to 25, 2013. Participating pharmacists were given a web link to the online questionnaire. An e-mail reminder was sent 5-7 days after the first contact.RESULTS: A total of 201 community pharmacists were contacted during the study period, and 115 answered the survey, generating a 57% response rate. The vast majority of respondents answered that vaccines have more benefits than adverse effects. Approximately 52% answered that pharmacists should be able to prescribe and administer vaccines, pending a legislative change. These pharmacists were more interested in administering travel (92%), flu (88%) and pandemic (85%) vaccines than regularly scheduled vaccines for adults (65%) or children (18%). Leading barriers to pharmacist-led immunization were lack of time (90%) and training (92%), and the most common factors that would help its implementation were increased immunization training (95%) and adequate remuneration (92%).CONCLUSION: These findings should push for a renewed discussion about the role of pharmacists as immunization agents in Canadian provinces where pharmacists do not have the right to administer vaccines.

Objectif : L’objectif de cet article est de décrire une méthode pour la mise à niveau des soins pharmaceutiques en établissement de santé. Méthode : Il s’agit d’une étude descriptive des soins pharmaceutiques pratiqués en immunisation au sein d’un établissement mère-enfant de 500 lits (Montréal, Canada). La démarche proposée comporte trois étapes : une revue de la documentation, une description du profil de l’activité et une description de la mise à jour du niveau de pratique du pharmacien en immunisation. Résultats : La revue de la documentation a permis de recenser 19 articles. Nous ne recensons aucune activité pharmaceutique spécifique reposant sur des données de très bonne qualité (A). Nous recensons huit activités pharmaceutiques reposant sur des données de bonne qualité (B) ou comportant un niveau de preuve insuffisant (D). Une revue de l’activité pharmaceutique en 2013-2014, a permis de comptabiliser une dépense annuelle en vaccins de 4 227 dollars canadiens, pour une dépense annuelle en médicaments de 27 633 944 dollars canadiens, et un total de 9 254 doses de produits immunisants prescrits chez 3 544 patients. La mise à jour envisagée de l’activité d’immunisation inclut notamment un bilan comparatif ciblant les besoins en immunisation, la consultation systématique des dossiers pharmacologiques des patients hospitalisés depuis plus d’un mois afin de s’assurer l’adhésion au Protocole d’immunisation du Québec, la déclaration systématique des effets indésirables vaccinaux, l’implantation de notices d’informations sur les nouveautés vaccinales. Conclusion : Il existe peu de données sur les retombées de l’activité pharmaceutique en immunisation. Cette étude décrit une démarche de mise à niveau en immunisation.

Aim: This article describes an approach to upgrading pharmaceutical care in healthcare facilities.Methods: This is a descriptive study supporting the upgrade of pharmaceutical care in the field of immunization [blinded for review], in a 500-bed mother-child university hospital. Our approach consisted of 3 steps: (1) a review of the literature, (2) a description of the profile of the sector and (3) a description of upgrading of pharmacists' practices in immunization.Results: A total of 19 articles were reviewed. No specific pharmaceutical activity based on very good quality data was identified (A).However, eight pharmaceutical activities based on good quality data (B) or with an insufficient level of proof (D) related to immunization practices were identified. A review of pharmaceutical activities (2013-2014) accounted for an annual expenditure of $ CAN 4,227 for vaccines compared to $ SCAN 27,633,944 for all drugs. A total of 9,254 doses of vaccines were prescribed for 3,544 patients. The planned revision of immunization activities includes a medication reconciliation process targeting immunization requirements, systematic consultation of pharmacy dispensing records for patients hospitalized for more than one month to ensure adherence to the Quebec Immunization Protocol, systematic reporting of vaccine adverse reactions, and implementation of information reviews about new vaccines.Conclusion: Few data are available concerning the impact of pharmacists in immunization. This descriptive study proposes a number of steps designed to upgrade pharmaceutical practices in a university hospital.

e bilan comparatif des medicaments (BCM) est un processusstructure au cours duquel les professionnels de la sante travaillent en partenariat avec les patients, les familles et lessoignants pour assurer la transmission d’une information exacteet complete sur les medicaments aux points de transition dessoins du patient (c.-a-d. admission, transfert et conge). Le processus englobe la production d’une liste complete de tous lesmedicaments que le patient prenait avant l’admission, c’est-a-dire le meilleur schema therapeutique possible. Cette liste estetablie grâce a diverses sources et comprend des renseignementssur les medicaments d’ordonnance, les medicaments en ventelibre, les vitamines et supplements, ainsi que le nom du medica-ment, la dose, la frequence et la voie d’administration. Touteanomalie relevee entre ce qui est prescrit au patient et ce qu'ilprend en realite sera signalee au fournisseur de soins pour etrecorrigee.L’etablissement d’un plan ecrit pour instaurer le BCMpartout dans l’organisme de soins est un test de conformiteetabli dans l’intitule de la Pratique organisationnelle requise parAgrement Canada

ObjectivesThe objective of this study was to evaluate the quality of medication information available in medical charts before and after the implementation of a medication reconciliation form.Patients and methodsThis study is a retrospective chart review of patients under 18 years who were taking two medications or more at home and were admitted to a paediatric hospital for more than 24 hours and discharged from a general paediatrics, infectious disease, gastroenterology or pneumology ward over two 20-week periods (pre- and post-implementation). Each week, 10 medical records were randomly chosen and reviewed. The quality of the medication information was measured on admission (dose, route of administration and frequency) and on discharge (dose, route of administration, frequency and duration of treatment). The proportion of medications that fully met these criteria was compared between the groups using the chi-squared test.ResultsInformation was analysed for a total of 3275 medications in the pre-implementation group, vs. 3240 medications in the post-implementation group. Baseline characteristics were similar in both groups. On admission, the quality of medication information was comparable between the pre- and post-implementation groups (29.1 vs. 29.3%, respectively; P = 0.86). However, on discharge, an improvement in the quality of information was observed in the post-implementation group (51.7 vs. 65.2%; P < 0.001).ConclusionOur study demonstrated that the forms used in the reconciliation process, in particular the discharge prescription, could increase the quality of the information related to drug use in medical charts. We believe that medication reconciliation forms should be widely used by all the health care professional teams involved in the drug history or prescription process.