Stability of Compounded Digoxin Solution 0.05 mg/mL for Injection.

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.

Discontinuation of paediatric injectable digoxin: A loss for optimal drug therapy in children.

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.

Au début de 2015, la formulation pédiatrique de digoxine injectable (50 µg/mL) a été retirée du marché canadien. La seule formulation injectable restante est cinq fois plus concentrée. Cet événement récent entraîne des changements de pratique majeurs dans les hôpitaux pédiatriques du pays. L'utilisation d'une formulation plus concentrée est particulièrement inquiétante chez les nourrissons de petits poids, car il est pratiquement impossible de prélever les volumes adéquats de digoxine avec précision. Une telle situation pose problème en raison de l'index thérapeutique étroit de la digoxine. Il y a plusieurs façons de pallier cet inconvénient, mais aucune n'est aussi efficace ni aussi sécuritaire pour les nourrissons que la formulation abolie. Les auteurs trouvent impératif de fournir aux patients qui ont besoin de digoxine intraveineuse la formulation la plus sécuritaire et la plus efficace possible, quel que soit leur âge ou leur taille.

[Approach to upgrading pharmaceutical care: the example of immunization]. / Démarche pour la mise à niveau de soins pharmaceutiques en établissement de santé: l'exemple de l'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.

From Prescription Drugs to Natural Health Products: Medication Use in Canadian Infants.

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.

Medication errors room: a simulation to assess the medical, nursing and pharmacy staffs' ability to identify errors related to the medication-use system.

RATIONALE, AIMS AND OBJECTIVES: The medication-use system in hospitals is very complex. To improve the health professionals' awareness of the risks of errors related to the medication-use system, a simulation of medication errors was created. The main objective was to assess the medical, nursing and pharmacy staffs' ability to identify errors related to the medication-use system using a simulation. The secondary objective was to assess their level of satisfaction. METHOD: This descriptive cross-sectional study was conducted in a 500-bed mother-and-child university hospital. A multidisciplinary group set up 30 situations and replicated a patient room and a care unit pharmacy. All hospital staff, including nurses, physicians, pharmacists and pharmacy technicians, was invited. Participants had to detect if a situation contained an error and fill out a response grid. They also answered a satisfaction survey. RESULTS: The simulation was held during 100 hours. A total of 230 professionals visited the simulation, 207 handed in a response grid and 136 answered the satisfaction survey. The participants' overall rate of correct answers was 67.5% ± 13.3% (4073/6036). Among the least detected errors were situations involving a Y-site infusion incompatibility, an oral syringe preparation and the patient's identification. Participants mainly considered the simulation as effective in identifying incorrect practices (132/136, 97.8%) and relevant to their practice (129/136, 95.6%). Most of them (114/136; 84.4%) intended to change their practices in view of their exposure to the simulation. CONCLUSIONS: We implemented a realistic medication-use system errors simulation in a mother-child hospital, with a wide audience. This simulation was an effective, relevant and innovative tool to raise the health care professionals' awareness of critical processes.

Community pharmacists' knowledge, beliefs and attitudes towards immunization in Quebec.

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.

A medication reconciliation form and its impact on the medical record in a paediatric hospital.

OBJECTIVES: The 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 METHODS: This 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. RESULTS: Information 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). CONCLUSION: Our 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.