Medicine information helpline after hospitalization-a randomized trial: Impact on patient satisfaction, patient concerns about medicines and clinical outcome on patient safety.

BACKGROUND AND AIM: Hospitalization often leads to changes in patients' medicine which challenges a safe medication use after discharge. Medicine information helplines (MIHs) can be valuable for patients in overcoming these challenges. This study evaluates patient satisfaction with a newly established Danish hospital-based MIH for discharged patients. The MIH is operated by experienced pharmacists and a pharmacy technician, and the study explores how the service affects the patient's concerns and perception of safety in relation to their medication, followed by an assessment of the clinical impact of MIH on patient safety. METHOD: A randomized controlled study design was used in the present study. The study was registered at clinicaltrials.gov with the identification number NCT03829995. Participants were randomized 1:4 (50:200) into a control- and intervention group. Participants in the control group were offered standard care and those in the intervention group were offered access to the MIH. A telephone interview performed 2-4 weeks after discharge assessed patient satisfaction with the helpline and patient's feeling of safety in relation to medicine use (primary outcome). Data were analyzed using a Mann-Whitney U test. After case handling of each enquiry to the MIH, the cases were assessed with regard to medication-related problems (MRPs) and clinical impact of the MIH service was assessed (primary outcome). RESULTS: A total of 250 participants were included in the study and 152 participated in the telephone interviews (33 control and 119 intervention). Thirty-seven questions were enquired by 26 participants to the MIH. Of these, 8 were requested before the telephone interviews and these patients all expressed a high satisfaction with the MIH (score 4.57 +/- 0.73 on a 5-point scale). Most patients offered access to the MIH expressed that it increased the sense of safety in relation to their medicines (79%). However, comparing the control- and intervention group with regard to patient concerns and feeling of safety in relation to medicine use no differences were found. Evaluation of the enquiries revealed at least one MRP per enquiry, and in most cases the advice given were assessed to have a high- or moderate clinical significance. CONCLUSION: The MIH was appreciated by the participants, indicating that the MIH could be a valuable service for discharged patients in improving the sense of safety in relation to medication and alleviating MRPs. Providing easy access for patients to medicine information may contribute to patient safe medicine use after discharge.

Evaluation of the establishment of a national task force - A systematic measure to manage critical drug shortages in hospitals.

Introduction: Drug shortages (DSs) have become a well-known challenge in health care, and serious patient safety consequences, such as medication errors and adverse patient outcomes are reported. To meet these challenges, a national task force was established to manage and minimize the impact of critical DSs' on hospitals in Denmark. Objective: To evaluate the establishment of the National Task Force for Critical Drug Shortages (NTF) in terms of quality, patient safety, and resources from different actor perspectives related to critical DS management in Danish hospitals. Methods: Five online focus group interviews were held with participants representing different actor perspectives, all of whom were involved in managing DSs. They represent actors from 1) the NTF; 2) hospital pharmacists not involved in the NTF but who manage DSs locally and/or regionally; 3) the procurement departments of hospital pharmacies; 4) pharmacy technicians performing clinical pharmacy services at a patient level, and 5) the procurement and supply unit at Amgros. Results: The thematic analysis revealed four major themes: 1) centralized management of critical DSs is predominantly considered to be positive, 2) collaboration and professional discussion across actors and actor levels, 3) mixed attitudes toward the current communication platforms and format, and 4) short supply of time. Conclusion: The NTF ensures a consistent and qualified management of critical DSs. The NTF ensures the evaluation of different patient safety aspects related to identification of a suitable alternative. Challenges with the communication platform and transparency of the process from the NTF toward hospital pharmacy were mentioned but overall, the NTF contributes to a successful use of resources in health care.

Drug shortages in hospitals: Actors' perspectives.

BACKGROUND: Despite an increasing focus on drug shortages, no standardized global definition of a drug shortage seems to exist. This raises the question of whether healthcare actors are discussing the same phenomenon, which may influence their actions when managing, solving and preventing drug shortages. Further, the literature reports a lack of national contingency plans for managing drug shortages in hospitals. OBJECTIVE: To explore national-level communication, decision-making and collaboration on drug shortage management carried out in Denmark by secondary healthcare actors. METHODS: Seven semi-structured interviews were conducted with actor representatives from Amgros, the procurement department of the hospital pharmacy in the Capital Region of Denmark, two medicine suppliers, two pharmaceutical wholesalers and distributors, and the Danish Medicines Agency. Data was analyzed using a social constructivist approach. RESULTS: No common definition of a drug shortage exists among the actors, but referential definitions related to "contract" and delivered "as expected" were identified. Additionally, actors initiate drug shortage procedures differently, and, as efforts are minimally coordinated, the work procedures are often needlessly duplicated. Further, discrepancies in available drug shortage information arise, as information is distributed through different electronic systems, unavailable to all actors. Besides, Amgros (a national organization responsible for tendering and procuring medicines in hospitals) and the procurement department of the hospital pharmacy in the Capital Region of Denmark make joint decisions regarding the choice of alternative drugs. However, the study found that actors had diverse collaborative relationships, especially those with the Danish Medicines Agency, and that these were limited to contact regarding medicine regulations and unlicensed medicine. CONCLUSION: The study provided insight into national-level communication, decision-making and collaboration on drug shortage management by different actors in hospitals. This knowledge is useful in the development of a national contingency plan for drug shortage management.

Time spent by hospital personnel on drug changes: A time and motion study from an in-and outpatient hospital setting.

INTRODUCTION: Medicines used at Danish public hospitals are purchased through tendering. Together with drug shortage, tendering result in drug changes, known to compromise patient safety, increase medicine errors and to be resource demanding for healthcare personnel. Details on actual resources required in the clinic setting to manage drug changes are unknown. The aim of the study is to explore time spend by hospital personnel in a drug change situation when dispensing medicine to in- and outpatients in a hospital setting in the Capital Region of Denmark. METHOD: A time and motion study, using direct observation combined with time-registration tools, such as eye-tracking, video recording and manual time tracking. Data were obtained from observing nurses and social and health care assistants with dispensing authority while dispensing or extraditing medicine before and after the implementation of drug changes in two clinical setting; a cardiology ward and a rheumatology outpatient clinic. RESULTS: Hospital personnel at the cardiology inpatient ward spent 20.5 seconds on dispensing a drug, which was increased up to 28.4 seconds by drug changes. At the rheumatology outpatient clinic, time to extradite medicine increased from 8 minutes and 6 seconds to 15 minutes and 36 seconds by drug changes due to tender. Similarly, drug changes due to drug shortage prolonged the extradition time to 16 minutes and 54 seconds. Statistical analysis reveal that drug changes impose a significant increase in time to dispense a drug for both in- and outpatients. CONCLUSION: Clinical hospital personnel spent significantly longer time on drug change situations in the dispensing of medicine to in- and outpatients in a hospitals. This study emphasizes that implementing drug changes do require extra time, thus, the hospital management should encounter this and ensure that additional time is available for the hospital personnel to ensure a safe drug dispensing process.

Prospective risk assessments of patient safety events related to drug shortages in hospitals: Three actor-level perspectives.

Background: The increasing number of drug shortages (DSs) worldwide calls for more proactive solutions to prevent the negative impacts of DSs on patient care. Such solutions require in-depth knowledge about potential patient safety risks related to DSs, the processes of recognizing and managing DSs, the contextual setting in which DSs occur, and the actors involved. Objective: The aim of the study is to use prospective risk assessment to identify patient safety risks in hospitals associated with the management of DSs among actors at national, regional and local level in Denmark. Methods: Healthcare Failure Mode and Effect Analysis (HFMEA) was employed in composition with elements from the Systematic Human Error Reduction and Prediction Approach (SHERPA) and the Systems-Theoretic Accident Model and Processes (STAMP). Potential risks related to DS management across three actor levels (national, regional and local) in the Danish healthcare system were described. Each actor level consisted of six participants that were identified using a purposive sampling strategy. Processes and sub-processes related to managing critical DSs were outlined and the actors identified, prioritized and rated potential failure modes, causes and consequences related to the processes. Recommendations to mitigate failures were proposed for high risk failures modes. Results: Overall, a total of 167 failure modes were identified across the three actor levels. At the national level, the process of DS management consisted of 17 sub-processes, from which 71 failure modes were identified. Nine of them were rated as high risk. At regional level, 7 sub-processes and 33 failure modes were identified, of which 9 were rated as high risk. At local level, 14 sub-processes and 63 failure modes were identified, of which 32 were rated as high risk. The high-risk failures were related to a lack of IT support in the medication modules, underestimation of patient safety aspects, and insufficient personnel training and patient information. Conclusion: Exploring DS management failure modes across actor levels provided an overview of interrelated failures. Potential solutions related to high risk failures were developed to ensure that actors ensure patient safety related to DS in healthcare.

Drug change: 'a hassle like no other'. An in-depth investigation using the Danish patient safety database and focus group interviews with Danish hospital personnel.

BACKGROUND: Drug change (DC) is a common challenge in Danish hospitals. It affects the work of hospital personnel and has potentially serious patient safety consequences. Focus on medication safety is becoming increasingly important in the prevention of adverse events. The aim of this study is to identify and describe patient safety challenges related to DCs, and to explore potential facilitators to improve patient safety in the medication process in Danish hospital setting. METHOD: Two qualitative methods were combined. Data were obtained from the Danish Patient Safety Database (DPSD) containing incidents reports of adverse events related to DCs. Additionally, five semi-structured focus group interviews with hospital personnel (doctors, nurses, pharmacists and pharmacy technicians) from the five regions of Denmark were held. RESULTS: The DPSD search identified 88 incidents related to DCs due to tender or drug shortage. The incidents were linked to prescribing errors, incorrect dose being dispensed/administered, and delayed/omitted treatment. Four themes from the interviews emerged: (1) challenges related to the drug itself; (2) situational challenges; (3) challenges related to the organization/IT systems/personnel; (4) facilitators/measures to ensure patient safety. CONCLUSION: DC is as a complex challenge, especially related to drug shortage. The results allow for a deeper understanding of the challenges and possible facilitators of DCs on the individual and organizational level. Pharmacy personnel were identified to play a key role in ensuring patient safety of DCs in hospitals. Indeed, this emphasizes that pharmacy personnel should be engaged in developing patient safety strategies and support hospital personnel around drug changes.