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A prospective observational study of medication prescribing errors in an Emergency Department.

European Statement

Patient Safety and Quality Assurance

Author(s)

Carmen Ortí Juan, Cristina Toro Blanch, Maria Àngels Gispert Ametller, Ana Perez Plasencia, Cristina Lecha Ochoa, Anna Dordà Benito, Rosa Sacrest Güell

Why was it done?

Prescribing errors (PE) are an important cause of medication-related adverse events in the Emergency Departments (ED) but limited data are available in ED with electronic prescribing and administration (ePA) systems. Knowing the frequency and types of PE can help healthcare professionals to prevent and reduce the risk of them occurring.

What was done?

To determine the rate of PE in the ED, to classify incident types and to identify critical points where measures should be implemented to improve patient safety.

How was it done?

Prospective, observational and cross-sectional study in an ED with ePA system during 6 working days (May-June 2021). The inclusion criteria were patients stayed more than 8 hours in the ED and all patients awaiting hospitalization. Prescriptions were analyzed by a multidisciplinary team made up of two pharmacists, an emergency physician and the person in charge of the hospital’s medication errors committee. PE were reported to the hospital’s patient safety-related incident notification system.

What has been achieved?

Of the 65 prescriptions revised during the study period, PE were reported in 84 cases and 15 situations with the capacity to cause errors were detected. The average age of patients was 67 ± (SD=17,9) years and each prescription had an average of 8.4 medications. The rate of PE was 1.52 errors per patient, being higher in less severe patients than monitored patients (1.09 vs 2.0 PE per patient, respectively). The most common types of EP were omission of the usual medication (60.7%), wrong dose (15.5%), wrong frequency (7.1%) and drug is not indicated (7.1%). No adverse reactions related to EP were detected. According to the Spanish consensus about Medication Reconciliation in Emergency Units, 47.1% of omissions of usual medication were drugs that should be reconciled during the first 4 hours in the ED. The results of the study and the importance of medication reconciliation are highlighted in a session in the ED.

What next?

The PE rate in the ED was 1.52 per patient and the main type was omission of the usual medication. A cross sectional study will be made in the future and compared to the current one to establish the impact of the implemented measures on the PE rate.

Proactive pharmacovigilance program of Covid-19 vaccination in haemodialysis centers

European Statement

Patient Safety and Quality Assurance

Author(s)

Carla Pinto, João Godinho, Luzia Fernandes, Patricia Vieira, Isabel Ferreira, Inês Sousa, Carolina Vieira, Ana Sardinha

Why was it done?

To promote a more effective notification process than the spontaneous reporting of suspected adverse drug reactions and contribute to the knowledge of the safety profile of medicines.
Covid-19 vaccines are medicines under additional monitoring, labelled with a black inverted triangle and expected to play a major role in the control of COVID-19 pandemic due to SARS-Cov2 virus.
This new medicine was administrated in a short time period and simultaneously to a large number of individuals in the beginning of vaccination period in Portugal (January 2021), to patients and healthcare professionals of our haemodialysis centers.

What was done?

Development and implementation of a proactive pharmacovigilance program to identify suspected adverse drug reactions (ADRs) to a covid-19 vaccine administration in haemodialysis centers patients and healthcare professionals.

How was it done?

Maintaining spontaneous report for immediate suspected ADRs, pharmaceutical services developed a form to collect suspected ADRs in the following 7 days after each dose administration. It was applied to each vaccinated exactly 7 days after the administration of each dose. To simplify its filling and application, overcoming workload and lack of resources in this pandemic setting, information was displayed with check mark boxes, including the list of described ADRs sorted by frequency, duration intervals and blank space for unexpected reactions.
Due to the large amount and variability of individuals and centers, the form was distributed in paper and online formats and applied to vaccinated patients by doctors or nurses.
Pharmacists validated the forms to notify the national pharmacovigilance system for serious or unexpected ADRs.

What has been achieved?

From the 9469 covid-19 vaccine administrations we obtained 6962 filled forms (74% of vaccinations) from which 38% (2666 forms) had suspected ADRs. 2nd dose had a lower participation rate of about 10%. These participation rates where due to no filled forms in cases of no symptoms.

What next?

Apply this proactive pharmacovigilance model in the integration in the institution of future medicines under additional monitoring will allow better knowledge of occurrence of adverse reactions, improving safety of medicines.
For the best outcomes program must be adapted to each medicine’s specification, considering even simpler tools to obtain information when there are no symptoms to report.

Improving the quality of ADR reporting

European Statement

Patient Safety and Quality Assurance

Author(s)

Sophia Elizabeth Campbell Davies, Elena Galfrascoli, Tommaso Saporito, Gaetana Muserra

Why was it done?

Spontaneous reporting is an important tool for the surveillance of drug safety. However, the number of reported ADRs by Hospital healthcare workers and patients was below the gold standard (300 reports/year). Since under-reporting is a major limitation of any Pharmacovigilance system, the causes were analysed by the Pharmacy and a number of actions were put into place.

What was done?

Active strategies were implemented by Pharmacists within the Hospital to raise awareness and encourage appropriate detection and reporting of Adverse Drug Reactions (ADRs).

How was it done?

Different active strategies have been implemented in the Hospital to increase the number of ADR reports:
-Training and educational programs for all healthcare professionals in order to create awareness within the Hospital of the importance of ADR reporting;
-Periodic ADR feedback reports to doctors;
-Guidelines for monitoring, detecting, preventing and reporting ADRs;
-Participation of Clinical Pharmacists in different ward teams (Internal Medicine, Diabetology, Oncology, Paediatrics, Emergency Room, Surgery) allowing Pharmacists to act immediately on problem recognition;
-Counseling patients when drugs are dispensed at the Hospital Pharmacy and providing them with “Patient Information Leaflets” containing adherence and ADR diaries. The monitoring tool has been shown to be a crucial element in raising awareness about compliance and ADRs in patients.
A successful example has been obtained with DAA treatment in HCV patients showing a 63% compliance to the monitoring tool.

What has been achieved?

A significant increase has been observed in ADR reporting in the Hospital. Projects implemented by the Pharmacy have almost trebled the number of reports. There has also been an increase in the number of reported severe ADRs.

What next?

Implementation of different approaches has significantly changed the scenario of ADR reporting in our Hospital. The strategies could be transferred into other healthcare settings by identifying the causes of underreporting ADRs and applying similar strategies both in the Pharmacy and in the ward settings.

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