This descriptive observational study was conducted in an urban university hospital centre. The Centre Hospitalier Universitaire Sainte-Justine in Montreal, Quebec, has 500 mother—child beds in 2 locations (450 beds at the main site and 5 0 beds at a rehabilitation site). The study was carried out at the main site, which has 21 inpatient locations (which together had 18 324 admissions in 2006/2007) and 63 outpatient locations (which had 198 227 outpatient visits and 67580 emergency visits in 2006/2007). At the time of the study, which was conducted from October 18 to November 1, 2007, the institution had about 1000 nurses, about 350 physicians, and 34 pharmacists.
For the planned physical inventory of all drug samples available in the hospital, a data collection form was designed, which had the following variables: number of locations where drug samples were found, primary patient care activity performed at each location, number of storage areas in each location, type of storage, presence of a lock, location of the key (if a lock was present), medical specialty, number of physicians and nurses likely to use the samples, reasons given for handing out samples, presence of a designated person to manage the samples, physical inventory (i.e., for each distribution unit, the trade name, generic name, content or form, number of distribution units, number of doses per distribution unit, and expiration date), and declaration of samples to the pharmacy department.The risk management consultant contacted all of the unit heads or clinical administrative managers, identified from an administrative list of all sectors within the institution, by phone and e-mail during the study period, with a request to identify a suitable contact person for the inventory and to request access to the areas likely to contain drug samples. However, no advance notice was given of the study or the visits at each location.
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Two research assistants (G.S., L.T.), working independently, took the inventories during the day shift. On arrival in a health care unit, the research assistant asked the contact person (typically a nurse, clerk, or receptionist) to provide access to all storage areas likely to contain samples. The research assistant completed the data collection form by taking a physical inventory (on the basis of visual observation) and questioning the contact person. Any expired drug samples (with expiration dates of November 1, 2007, or earlier) were immediately removed and destroyed according to operational procedures. The proportion of distribution units that had been declared to the pharmacy department was determined with reference to declarations archived in the department. A distribution unit was deemed “compliant” if the unit, its lot number, and its expiration date were recorded in the declaration register. According to policies in effect since January 2004, the pharmaceutical sales representative must hand the requested stock to a physician or nurse. The physician, the nurse, or the pharmaceutical sales representative must then complete a paper declaration (with information such as the commercial name, drug strength, formulation, quantity given, expiration date, manufacturer’s name, and representative’s name), which is sent by fax or delivered by hand to the pharmacy department. Finally, the drug sample stock was compared with authorized floor stock of medications in the unit (drugs purchased and dispensed by the pharmacy department through floor stock policies and procedures).
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The data were entered into an Excel 2007 spreadsheet (Microsoft, Seattle, Washington), and descriptive statistics were calculated (average, standard deviation, median, minimum, and maximum). Data included the numbers of individual companies, generic entities, brands, distribution units, and doses; the total cost and cost per dose; and the proportions of expired distribution units and of distribution units not recorded on the local list by therapeutic class or location, as applicable. In the case of multidose formats, a scale was established to estimate the number of doses per format: 5 mL/dose for syrup, 1 g/dose for cream, and 1 mL/dose for lotion. The monetary value of the drug samples was calculated from prices on the October 2007 price list for insured drugs, prepared by the Regie de l’assurance maladie du Quebec (Quebec’s health insurance board). The distribution of the number of drug sample doses was compared with the number of doses of drug floor stock for each location. For drug floor stock, the estimated number of distribution doses was based on authorized quotas rather than physical inventory. The main products used as antiseptics or disinfectants (including isopropyl alcohol, ethyl alcohol, methyl alcohol, hydrogen peroxide, sodium hypochlorite, acetone, acetic acid, and all solutions containing chlorhexidine) were excluded from the drug floor stock. Staff from the pharmacy department were responsible for managing the drug floor stock, refilling the stock daily using a bar code system; therefore, the quotas established were assumed to be representative of usual stock levels.
Because this project involved quality and risk assessment, it was conducted under the auspices of the hospital’s Pharmacology Committee and the Professional Services Directorate.