Drug Shortages in Canada and Selected European Countries: A Cross-Sectional, Institution-Level Comparison.

BACKGROUND: Drug shortages represent a complex global problem affecting patients and health care professionals on a daily basis. OBJECTIVES: To identify, describe, and compare drug shortages in health care facilities in Canada and 4 European countries in early 2018. METHODS: A descriptive cross-sectional study was conducted in 1 hospital in each of 5 countries: Canada, France, Belgium, Spain, and Switzerland. Over a 4-week period, shortage data were collected daily by each hospital using a standardized grid and a standard process. RESULTS: From January 8 to February 2, 2018, there were a total of 84 shortages (median duration 32 days) in the Canadian hospital, 62 shortages (median duration 9 days) in the French hospital, 46 shortages (median duration 37 days) in the Belgian hospital, 28 shortages (median duration 25 days) in the Spanish hospital, and 98 shortages (median duration 68 days) in the Swiss hospital. The number of manufacturers implicated in the shortages was 28 for the Canadian hospital, 30 for the French hospital, 19 for the Belgian hospital, 16 for the Spanish hospital, and 42 for the Swiss hospital. Most of the shortages involved parenteral drugs, with both innovative and generic manufacturers being affected. Most therapeutic classes were affected by shortages to some extent, with the top 3 classes being anti-infective agents (accounting for 21.1% of shortages overall), central nervous system drugs (11.3%), and cardiovascular drugs (8.2%). CONCLUSIONS: Drug shortages occurred almost daily in all of the study hospitals. Across the 5 hospitals, the frequency of shortages varied by a factor of 3, which may imply similar variability at the national level. All stakeholders should work more diligently to prevent and manage drug shortages.

CONTEXTE: Les pénuries de médicaments représentent un problème mondial complexe qui touche quotidiennement les patients et les professionnels de la santé. OBJECTIFS: Recenser, décrire et comparer les pénuries de médicaments ayant eu lieu au début de 2018 dans des établissements de soins de santé du Canada et de quatre pays d'Europe. MÉTHODES: Une étude descriptive et transversale a été menée dans un hôpital de chacun des cinq pays suivants: le Canada, la France, la Belgique, l'Espagne et la Suisse. Sur une période de quatre semaines, chaque hôpital a recueilli quotidiennement les données sur les pénuries à l'aide d'une grille et d'un processus normalisés. RÉSULTATS: Pour la période allant du 8 janvier au 2 février 2018, on a recensé 84 pénuries (durée médiane de 32 jours) dans l'hôpital canadien, 62 pénuries (durée médiane de 9 jours) dans l'hôpital français, 46 pénuries (durée médiane de 37 jours) dans l'hôpital belge, 28 pénuries (durée médiane de 25 jours) dans l'hôpital espagnol et 98 pénuries (durée médiane de 68 jours) dans l'hôpital suisse. Vingt-huit (28) fabricants étaient impliqués dans les cas de pénuries dans l'hôpital canadien, 30 dans l'hôpital français, 19 dans l'hôpital belge, 16 dans l'hôpital espagnol et 42 dans l'hôpital suisse. La plupart des pénuries touchaient les médicaments parentéraux et mettaient en cause tant les fabricants de médicaments novateurs que ceux de médicaments génériques. Les pénuries ont affecté d'une manière ou d'une autre la plupart des classes de médicaments, mais les trois classes les plus touchées étaient les agents anti-infectieux (21,1 %) les médicaments agissant sur le système nerveux central (11,3 %) et les agents cardiovasculaires (8,2 %). CONCLUSIONS: Des pénuries survenaient presque quotidiennement dans chaque hôpital de l'étude. Dans l'ensemble des hôpitaux, la fréquence des pénuries variait selon un facteur de trois, ce qui pourrait se traduire par une variabilité semblable à l'échelle nationale. Toutes les parties prenantes doivent travailler avec plus d'ardeur à la prévention et à la gestion des pénuries de médicaments.

Accuracy of preparation of i.v. medication syringes for anesthesiology.

PURPOSE: The results of a study of the accuracy of i.v. medication preparation by anesthesiologists are presented. METHODS: The accuracy of syringe preparation was assessed by analyzing the contents of 500 unused syringes collected after adult and pediatric surgery procedures. The collected syringes contained various i.v. medication formulations representative of different preparation techniques: atracurium 1, 2.5, and 5 µg/mL and fentanyl 10, 20, 25, and 50 µg/mL, which required serial dilution after withdrawal of the drugs from ampuls; thiopental 5, 25, and 50 mg/mL, prepared by diluting reconstituted powdered drug from vials; and lidocaine 10-mg/mL solution, which was withdrawn directly from the ampul into a syringe. Variances between actual and labeled drug concentrations were determined via a validated ultraviolet-visible light spectro-photometry method. RESULTS: Overall, 29% of the evaluated syringes were found to contain drug concentrations outside the designated range of acceptability (±10% of the targeted concentration); 18% of preparations deviated from the declared dose by ±20%, 8% deviated by ±50%, and 4% deviated by ±100%. In one instance, the actual drug concentration was at variance with the labeled concentration by >100%. In 4% of cases (n = 20), discrepancies exceeded 100%, suggesting not just imprecision but errors in the preparation process, such as incorrect dilution calculations and selection of the wrong medication vial by the syringe preparer. CONCLUSION: Analysis of different i.v. formulations of four medications prepared in syringes by anesthesiologists revealed a high rate of discrepancies between ordered and actual drug concentrations, suggesting a need for increased institutional efforts to prevent errors during the preparation process.

Microbial contamination of syringes during preparation: the direct influence of environmental cleanliness and risk manipulations on end-product quality.

PURPOSE: The direct influence of environmental cleanliness and risk manipulations on prepared syringes was evaluated. METHODS: Media-fill testing was used to estimate potential microbial contamination. Syringes were prepared in three different environments using four different uncontrolled high-risk manipulations. The three environments included an International Organization for Standardization (ISO) class 5 horizontal laminar-airflow hood in an ISO class 6 cleanroom (in accordance with United States Pharmacopeia [USP] chapter 797), an ISO class 7 drug preparation area of an operating room, and an uncontrolled decentralized pharmacy in a ward. For each combination of environment and manipulation, 100 syringes were filled by a single operator. The four high-risk manipulations used included simple filling of syringes with trypticase soy broth, three-second contact by the ungloved fingers of the operator with the hub of the syringe, three-second contact between an object and the hub of the syringe, and exposure of the filled syringes to ambient air for 10 minutes. RESULTS: Of the 1500 syringes prepared in three different environments, none produced within the cleanroom contained microorganisms, 6% were contaminated in the operating room, and 16% were contaminated in the ward (p < 0.0001). Certain high-risk manipulations were associated with a significant increase in the contamination of the surrogate syringes, including exposure to nonsterile ambient air and nonsterile objects or fingers (p < 0.0001). CONCLUSION: High contamination rates were measured when the hub of syringes touched nonsterile environmental surfaces and fingers, whereas the drawn-air manipulation was associated with a lower risk of contamination. Working within a properly operating unidirectional airflow primary engineering control in an ISO class 5 cleanroom in accordance with USP chapter 797 requirements was demonstrated to be the best way to avoid bacterial or fungal contamination of injectable drugs directly resulting in patient infections.