May 01, 2012
By Rosaleen McLarney, B.Sc. Pharm, ACPR , Erin Cashin, BSP, ACPR , Richard Cashin, B.Sc.(Pharm), ACPR, PharmD , Celina Colegrave, BSP, ACPR, M.Sc. , Mabel Luscombe, RN, BSN
Unauthorized medication collections on inpatient units
Background: Unauthorized medication collections (UMCs) on inpatient (IP) units represent a potential source of medication errors. UMCs are collections of medications not approved for storage and immediate access on IP units. We sought to establish whether UMCs were present on IP units in a suburban acute care hospital and to document the characteristics of any UMCs found.
Methods: In this descriptive study, we searched all of the IP units in the hospital for unauthorized medications. We checked all medications found against current ward-stock lists to determine whether they were authorized, and we classified unauthorized medications into the following categories: high-alert, easily confused, expired and improperly stored medications, and controlled substances. All unauthorized medications found in various locations on a unit were considered one collection. We counted the number of unique products and total number of medications and calculated the total dollar value of the medications in each UMC.
Results: A UMC was found on each of the 17 IP units in the study hospital, resulting in a total of 656 unauthorized medications constituting 163 unique products. We documented high-alert, easily confused and expired medications and controlled substances. No unauthorized medications were improperly stored.
Discussion: Investigations are needed to determine why these UMCs exist and to formulate mechanisms to eliminate them. Knowing that UMCs may be present, nurses should search their workspace and remove any UMCs they find. They should also examine their nursing practice to determine if they are contributing to this unsafe practice.
Medication management systems in hospitals have been extensively studied to increase safety measures and prevent medication errors (Baker et al., 2004; Mansur, 2008; Phillips et al., 2001). The components of such systems include selection, prescribing, order transcription, order processing, preparation, dispensing, administration and monitoring (MacKinnon, 2007). Errors can occur at any step in the system, potentially affecting patient safety.
There are different types of drug distribution systems that hospitals may use to deliver medications to patients. The study hospital, a suburban acute care hospital with approximately 350 inpatient (IP) beds, uses a 24-hour-supply unit-dose dispensing system. Ward-stock supplies and a centralized night cupboard are maintained at the study hospital so that staff can access essential medications when the central pharmacy is closed, or for emergent situations. The pharmacy department, in collaboration with nursing staff, chooses the medications that will be available as ward stock or in the night cupboard based on the needs of the patient population and on patient safety requirements. Some of the factors that must be considered with respect to patient safety include the urgency of medication administration required, the safety profile of the medication, the likelihood that the medication might be easily confused with another medication already available and the likelihood that the medication might cause significant harm to patients if it is used incorrectly.
Not all medications are appropriate for storage on IP units; organizations such as the Institute for Safe Medication Practices (ISMP) provide recommendations about medications that require special attention because of patient safety concerns. ISMP has developed valuable medication safety tools, including ISMP’s List of Confused Drug Names, which lists medications with names that look or sound like those of other medications (Institute for Safe Medication Practices, 2009a), and ISMP’s List of High-Alert Medications, which lists medications that carry a high risk of causing injury when they are misused (Institute for Safe Medication Practices, 2009b). The study hospital has modified these tools and is using the modified versions in an effort to improve its medication management system.
Unfortunately, errors do occur within medication management systems for a variety of reasons. One area of potential error is the presence of unauthorized medication collections (UMCs), which are collections of any medications (including medications from other units or from patients’ homes) on IP units that have not been approved for storage and immediate access on the unit in question. UMCs can be considered a work-around of the medication management system; work-arounds are methods or processes that bypass an established system (Morath & Turnbull, 2005). Drawing medications from a UMC may result in the wrong medication or the wrong dose or strength of a medication being selected, or an expired or recalled medication being used; as well, medications in a UMC may be improperly stored. In essence, the presence of a UMC may result in patients receiving medications that have not been subjected to the safety precautions and verification procedures of a hospital’s medication management system.
Although it was believed that UMCs were present at the study hospital, this had not been confirmed before this study was conducted. Pharmacy staff had anecdotally reported removing UMCs from IP units and had expressed concern about their contents. In an effort to improve patient safety, our primary objective was to determine whether unauthorized medications were present on IP units.
This study involved a descriptive analysis of the unauthorized medications found on IP units in the study hospital in March 2010. All 17 IP units within the study hospital were examined: four general medicine units, one palliative care unit, three IP surgery units, three psychiatry units, two pediatric units, one maternity unit, two critical care units and one rehabilitation care unit. Outpatient areas, such as the emergency department, ambulatory clinics, day surgery unit, medical day room, dialysis unit and endoscopy unit, were excluded because they lacked designated medication rooms.
A UMC was defined as a collection of medications not approved for storage and immediate access on a particular IP unit. For example, these collections might include medications supplied by the pharmacy department for an inpatient who had since been discharged or an inpatient’s home medications that were not returned to the patient or disposed of by the pharmacy department when the patient was discharged. All unauthorized medications found in various locations on a unit were considered one collection. IP units were defined as areas within the hospital where health-care professionals provide care to admitted patients.
The secondary objectives of the study were (1) to identify the name, strength and number of controlled substances and high-alert, easily confused, expired and improperly stored medications found in UMCs, (2) to determine the number of IP units with UMCs and (3) to calculate the total dollar value of the medications in each UMC.
Approximately one month before data collection, the investigators (a registered nurse, a clinical quality consultant and three pharmacists) e-mailed a memo to the nursing managers of the 17 IP units with a request that the memo be distributed to staff. The memo indicated that the goal of the study was to determine whether UMCs were present on IP units and briefly described the study methodology. No direction was given concerning the removal of unauthorized medications. In an effort to minimize the potential for bias and the risk that someone might tamper with the UMCs, the investigators did not disclose the day or time the data would be collected.
On the day of data collection, three of the investigators (the RN, the clinical quality consultant and one of the pharmacists) visited each of the IP units in turn. Before starting to search for unauthorized medications, they reminded the nursing manager or delegate (e.g., charge nurse) of the purpose of the study. The nursing manager or delegate did not accompany them on their search. The investigators searched medication rooms, including all of the cupboards, drawers and fridges in these rooms, and medication carts. Medications that were found were checked by the three investigators against the current ward-stock list. If a medication was not approved for storage on that particular IP unit, it was determined to be part of a UMC. When unauthorized medications or groups of unauthorized medications were found, the nursing manager or delegate was notified, and his or her permission was sought to photograph them. The photographs were taken to document the various ways in which UMCs are stored and for future educational opportunities. No patient, staff or IP unit identifiers were included in the photographs. If the investigators did not find any unauthorized medications, they asked the nursing manager or delegate whether any were present on the unit and, if so, to show them to the investigators. The investigators approached the nursing managers or delegates for this step because it was felt they would be aware of practices used by their staff, and the investigators wanted to avoid disturbing front-line staff involved in patient care.
All unauthorized medications identified as such on an IP unit were included in the study. All unauthorized medications found on a given unit (e.g., multiple groups of medications) were analyzed as a single collection. They were placed in a study bag labelled to conceal the identity of the IP unit and removed from the unit. The investigator (a pharmacist) who analyzed the contents of each bag after it was removed was not blinded to the identity of the unit; however, the identity of each unit was kept confidential for the purpose of data presentation. All IP units were visited on the same day.
Descriptive statistics were used for data analysis and no comparisons between IP units were performed. Each unit was coded with a study letter for blinding, and Microsoft Excel was used to document the name, strength, number and value of each unauthorized medication. Medications were then classified into the following categories: high-alert, easily confused, expired and improperly stored medications, and controlled substances. High-alert medications and easily confused medications were identified through the ISMP medication safety lists as well as the study hospital’s modified versions of these lists. If a medication was included in either the ISMP version or the study hospital version of the high-alert list or easily confused medication list, it was classified as a high-alert or easily confused medication respectively. The number of unique products and the total number of medications were summed. We considered different strengths of the same drug as different products. For example, 10 metoprolol 50 mg tablets, 20 metformin 500 mg tablets, and 30 metformin 850 mg tablets were counted as three products and 60 medications. The total value of each UMC was calculated on the basis of McKesson Canada’s wholesale drug pricing as of March 2010.
Ethics approval was granted by the Community Research Ethics Board of Alberta in November 2009. No financial support was provided by any funding agency or commercial sponsor. Alberta Health Services Central Zone provided some of the information used in this study; however, it expresses no opinion on the interpretation and conclusions in this article.
Unauthorized medications were found on all 17 IP units. Overall, 656 medications, consisting of 163 different products, were found. The size of the UMCs varied; the smallest collection contained two medications, whereas the largest collection contained 170 medications (Fig. 1). Easily confused medications were the most frequently collected type of unauthorized medication, followed by high-alert medications, controlled substances and expired medications; no improperly stored medications were found. Table 1 summarizes the contents of the UMCs. The analysis that took place after the bags of unauthorized medications were removed from the IP units confirmed that all of the medications found were in fact unauthorized; therefore, all of the collected medications were included in the study and none was returned to the unit from which they had been taken after the study was completed.
Two of the 17 IP units had medications stored in a container within the medication room, separate from ward stock. One such container held over 80 medications, eight of which were high-alert medications and 20 of which were easily confused medications. The other 15 IP units had medications dispersed among their ward stock in cupboards, drawers (including drawers labelled for other medications) and medication carts within their medication room.
After the study was completed, one IP unit was found to have not fully disclosed the extent of its UMC, as a container with 104 medications was found by non-study pharmacy staff. These medications were not included in the data analysis.
The total value of all of the medications in the UMCs was $3,254.91. The most expensive UMC was $457.60 and the least expensive was $3.78. The mean value was $191.24 per IP unit.
This study demonstrates the widespread presence of unauthorized medications at IP units in the study hospital. The UMCs create hazards since there are no procedures to ensure the proper selection, procurement, preparation, dispensing and storage of unauthorized medications or the monitoring of expiration dates or recalls. In addition, the appropriateness and safety of the unauthorized medication for the patient is not assessed by a pharmacist before the medication is administered.
Poor design of work processes can lead to blocks in work flow and thus is a common cause of work-arounds. For example, delays in the distribution of medications from the pharmacy to the nursing unit have been associated with nurses borrowing medications intended for another patient to ensure that medications are administered at the appropriate time (Halbesleben, Wakefield, & Wakefield, 2008). UMCs provide nurses with another source of medications that can be borrowed.
Unauthorized medications were found in various areas in the medication rooms; in two IP units a large number of unauthorized medications had been stored in one container. Unauthorized medications were also found in medication cart drawers assigned for a specific ward-stock medication. An unorganized storage system such as this increases the potential that an incorrect medication may be selected. The potential for error was also clear when multiple formulations of lidocaine were found within the same drawer (see photo). Lidocaine is a high-alert medication and therefore carries a higher risk of harm. These examples demonstrate the potential for errors posed by UMCs, including the selection and administration of a wrong drug, dose or formulation.
As indicated in Table 1, eight expired medications were discovered on five of the 17 IP units. If an expired medication is administered to a patient, the therapeutic effect may be reduced as a result of product degradation (because of a chemical change in one of the ingredients, for instance). Although patient harm caused by use of an expired medication has rarely been documented, best practice is to not administer a medication after its expiration date. Medication recalls are another potential safety issue: removing recalled medications from hospital units is the responsibility of the pharmacy department, but the pharmacy department cannot manage UMCs, and harm may be caused if a recalled medication is administered to a patient.
Two of 17 IP units were found to have controlled substances; there is a potential risk for diversion since the contents of UMCs are not monitored. Health-care professionals who have easier access to controlled substances have been found to be more likely to misuse them (Booth et al., 2002; Cicero et al., 2011; Dabney, 2001; Trinkoff, Storr, & Wall, 1999).
Several of the UMCs contained not a large number of products but large amounts of a specific product (e.g., units A, H) (Fig. 1). An IP unit may store a specific medication for a variety of reasons, such as a high volume of usage by its patient population. These results demonstrate possible ward-stock needs that have not been addressed. Therefore, a potential way of reducing UMCs is to review the ward-stock lists regularly to ensure sufficient approved medications while maintaining patient safety.
The fact that a container with unauthorized medications on one of the IP units was not disclosed during the study highlights the need for future investigations to determine why UMCs are present. If there is a better understanding of why these collections exist, strategies such as targeted procedures and educational initiatives can be developed to address the problem.
This study has some limitations. Although 656 medications were found, this may be an under-representation of the actual number of medications stored in UMCs. Although the study timelines were not disclosed in the memo sent to nursing managers, UMCs may have been tampered with or removed after the memo was distributed. In the future, this may be avoided if the investigation were repeated on an ongoing basis, as staff may not bother removing unauthorized medications regularly. Notifying senior administrators in advance rather than nursing units would also mitigate this limitation.
The number of medications found in this study might also under-represent the true number if UMCs were stored in areas on IP units not examined by investigators (e.g., patient rooms), if some UMCs had been removed by non-study pharmacy staff before the study and if nursing managers or delegates did not find and report all of the UMCs.
Another limitation of this study is that it was conducted at a single hospital. UMCs should be investigated at other institutions to determine whether our results accurately reflect the scope of the UMC problem in health-care facilities.
This study did not examine why UMCs are present on IP units. We can hypothesize several reasons for these collections. First, IP unit staff may have believed that UMCs allow them to deliver medications more quickly to patients. Second, delays in approval by the pharmacy department to add a particular medication to an IP unit’s ward stock may have played a role. Third, hospital staff may not have been completely familiar with their unit’s ward-stock medication list and may have stored an unauthorized medication in the belief that it was ward stock. Fourth, staff may not have been aware of the process by which medications are added to ward stock, which includes the assessment of patient safety risk.
We see our study as a first step in the process of ensuring that UMCs are not stored on IP units. We hope that future studies will examine why staff create UMCs: the findings from such studies could be used to develop procedures to prevent UMCs from being created and to educate staff about the risks associated with these collections.
Since this study revealed that UMCs exist at the study hospital, thought should be given at the hospital and at other health-care facilities to instituting processes to routinely check for UMCs. Increasing staff awareness of the hazards associated with UMCs may also be helpful. These two efforts may help health-care facilities eliminate collections of unauthorized medications and thereby reduce the risk of patient harm.
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