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COVID-19: Guidelines for Infection Prevention and Control in a Hospital Pharmacy According to ISO 9001:2015

European Statement

Patient Safety and Quality Assurance

Author(s)

SUSANA SANCHEZ SUAREZ, JOSE ANTONIO VINAGRE ROMERO, MARIA ISABEL BARCIA MARTIN, CAROLINA AGUILAR GUISADO, MERCEDES GARCIA GIMENO

Why was it done?

To keep occupational health and safety during a crisis in which healthcare settings were overloaded and facing a critical shortage of skilled professionals, due to sick leaves (2,75% of total cases), and for the need to maintain high quality of care processes. These were a big challenge that required to adapt operating procedures. In addition, and due to the effect of COVID-19 on the general population (overall incidence rate of 10.596 per 100,000 people) and in healthcare systems, the Spanish Ministry of Health (SMH) issued a technical document establishing a series of recommendations for COVID-19 infection prevention and control in patients medical assistance. This practice was designed to bring together national guidelines from the SMH that aimed to reduce COVID-19 impact, both in healthcare workers and general population, and meet ISO 9001:2015 requirements in SOP of a HP within a general hospital

What was done?

In order to ensure safe systems of work (SSoW) in the hospital pharmacy (HP) during the COVID-19 pandemic, specific operating procedures (SOP) were adopted in order to prevent the risk of contagion in daily operations for both patients and staff, according to the norm ISO 9001:2015

How was it done?

Four critical areas were identified according to risk management: High-risk areas: Preparation Area (PA) and Outpatient Dispensing Area (ODA); medium-risk area: Pharmacy Administration Area (PAA) and Inpatient Dispensing Area (IDA). Some SOPs were developed within these areas: Autologous serum eye drops preparation in the PA, pharmaceutical care and medication dispensing in the ODA, pharmacy receiving in the PAA and medicines return from COVID-19 areas. Different circuits were implemented for users and professionals, as well as general information and procedures directed at patients and personnel, to prevent infection. The individual protection equipment required in each SOP/area was also established

What has been achieved?

No COVID-19 case has been reported due to patient-professional interactions or working location and tasks. All operating procedures have been revised to fully comply with SMH guidelines and ISO 9001: 2015 requirements mitigating risks and maximizing performance in such critical circumstances

What next?

Adapting SOP to any infectious disease outbreak that may occur in the future and establishing early-detection mechanisms

A novel method to decline the number of inappropriate penicillin allergy alerts in electronic prescription systems

European Statement

Patient Safety and Quality Assurance

Author(s)

Saskia Coenradie, Hans Groot, de, Amy Rieborn, Erna Groot, de, Martti Visbeek, Denise Abswoude, Christian Alderweireld, Annegien Kenter

Why was it done?

Allergies for drugs and especially allergies for antibiotics of the penicillin group are common questions in electronic patient data systems (EPDS) in hospitals. In many cases the verification of an allergy is seldom a thorough process and so many inappropriate penicillin allergies are recorded in EPDS. Literature reports that only 10% of recorded allegies are appropiate. This has a detrimental effect when infections occur and patients have to be treated with antibiotics. When a penicillin allergy is recorded in the EPDS a warning not to prescribe any antibiotic from the penicillin group is given. In most cases the physician has to choose another antibiotic that is normally not first choice. This can have worse patient outcomes. We conducted a feasibility study to investigate if a reported penicillin allergy in a patient’s record was appropriate or not using a standard allergy algorithm consisting of 10 questions with YES or NO as answers.

What was done?

A novel method is tested to decline the number of inappropriate alerts for penicillin allergy in our electronic patient data system

How was it done?

When the reported allergy in a patients record popped up in our EPDS, a pharmacy technician was asked to have a medication – and allergy verification conversation with the patient. Only patients that were admitted to the emergency ward or the acute admittance ward of our hospital were included to test this method on feasibility. The feasibility study started in March 2021 after permission from our board of directors and after a declaration of our medical ethics committee stated that no judgement of this committee was neccessary. We started on the emergency ward in March 2021. Because of slow inclusions we decided in september 2021 that another ward needed to be included in this feasibility study to achieve the number needed to prove this method feasible (80 patients). Statistical analysis was done using IBM SPSS statistics,(vs 25) and the primary outcome was the total number and percentage of inappropriate penicilline allergies.

What has been achieved?

Up till October 2021 29 patients were included in this feasibility study. Most of them had an inappropriate record of penicllin allergy after a pharmacy technician had a medication- and allergy-verfication conversation using the standard algorithm. We will continue with this feasibility study until 80 patients have been included and our statistical analysis can be done appropriately.

What next?

Continue with inclusions until the number needed to statistical analysis has been reached (80 patients). We will then perform our statistical analysis and hope to report back to you at the 27th EAHP congress in 2023 that this method is effective and reproducible. And most importantly, decreases the number of inappropriate penicillin allergy records in hospitals. We are confident that with this method we create a tool to decrease the number of inappropriate allergy records in our electronic prescription system in our hospital.

Deprescribing interventions performed by hospital pharmacists reduce potentially inappropriate medication at hospital discharge

European Statement

Patient Safety and Quality Assurance

Author(s)

Alba Martin Val, Adrià Vilariño Seijas, Arantxa Arias Martínez, Anna Terricabras Mas, Andrea Bocos Baela , Maite Bosch Peligero, Carles Quiñones Ribas

Why was it done?

In CCPs the efficacy and safety of many drugs are unknown or questionable, in fact, medication may be the cause for side effects. Deprescribing is aimed to reduce the use of potentially inappropriate medications (PIMs) and improve patient outcomes. Pharmacist deprescribing interventions may contribute to reassess prescriptions and withdraw those with a negative risk/benefit balance.

What was done?

To analyze the pharmacist deprescribing interventions in complex chronic patients (CCPs) performed in hospital and primary care.

How was it done?

This prospective study was carried out in a tertiary hospital between February and March 2021. CCPs whom medication was reconciliated at hospital discharge were included and the pharmacist interventions (PIs) performed were analyzed. After hospital discharge, the acceptance of the PIs was verified and were notified to the primary care physician in case of not being accepted in hospital setting. Drugs involved in PIs were classified according to the therapeutic group established by the Anatomical Therapeutic Chemical classification and high-risk medication was quantified using the Institute for Safe Medication Practices classification for chronic patients. Deprescribing interventions were classified according to the Less-Chron criteria and other medication-related problems were also quantified.

What has been achieved?

Among the 55 patients included, 55% were female, the mean age was 83 years and the mean of medication per patient was 13. A total of 111 PIs were performed, 44% (n = 49) were deprescribing interventions and 56% (n = 63) other problems related to medication. Fifty-five per cent of patients presented 1 or more PIMs, and a mean of approximately 1 PIMs per patient was reported. The most frequent therapeutic groups involved in PIs were cardiovascular system (34.2%), nervous system (29.7%) and alimentary tract and metabolism medication (13.5%). High-risk medication represented 41% of all PIs. The most frequent deprescribing interventions were associated to blood pressure treatment (30.6%), benzodiazepines (24.4%) and statins (12%). The 65% of deprescribing interventions were accepted among hospital and primary care settings.

What next?

Deprescribing interventions supported by hospital pharmacists reduce potentially inappropriate medications, however, deprescribing practice is still limited in hospital and primary care.

Benefits beyond the EU Falsified Medicines Directive – The hospital setting

European Statement

Patient Safety and Quality Assurance

Why was it done?

The purpose of the report was to investigate and share what benefit opportunities exist because of the introduction of the EU FMD barcode.

What was done?

EFPIA, the industry association, commissioned a report to investigate what benefits had occurred in the hospital setting, following the introduction of the EU Falsified Medicines Directive (EU FMD).

www.be4ward.com/benefits-beyond-eu-falsified-medicines-directive/

How was it done?

The author worked directly with Guy’s and St Thomas’ NHS Foundation Trust in the UK and AZ Sint-Maarten in Belgium. In addition, he reviewed various relevant case studies and publications.

What has been achieved?

The report demonstrates benefits exist at all points in the hospital supply chain, where packs are handled, stored and processed. Opportunities also exist to web enable the product to provide digital content and services to healthcare providers and patients.

The introduction of standardised barcodes and product identification enables hospitals to leverage benefits opportunities which were difficult to realise before this level of harmonisation and barcoding prevalence.

• The costs of operating the EU FMD can be minimised, integrating with normal operations and leveraging the use of conveyor systems and robotics are successfully reducing the workload impact by up to an expected 80%.

• Barcodes and product identification brings impressive financial benefits to those hospitals which leverage them. In one hospital they were able to save £4 million through the reduction of over ordering products. In another, the improved accuracy and speed in the recharging of procedures identified £840K in lost revenues in a single year.

Scanning barcodes, is being used to deliver value across all three of the benefit opportunity areas: Improved Patient Safety, Enhanced Clinical Effectiveness and Operational Efficiencies. It is possible to offset the costs of EU FMD implementation and operation through the additional benefits.

What next?

Share the report findings to enable hospitals to leverage the opportunities of the EU FMD barcode.

How to become a resilient chemotherapy preparation unit?

European Statement

Patient Safety and Quality Assurance

Author(s)

Victorine MOUCHEL, Romy LINOSSIER, Chloé FERCOCQ, Jean-Luc PONS, Lucie BAILLET

Why was it done?

Injectable anti-cancer drugs are critical drugs and production disruption would result in discontinuity of care. Moreover, 60% of the production is dedicated to external clients as part of outsourcing contracts. To strengthen client’s confidence, we achieved the ISO 9001 certification in 2019. Implementing a BCMS is part of the overall quality and resilience process.

What was done?

In our hospital centre, production of injectable anti-cancer drugs is centralised in a chemotherapy preparation unit. Within the unit, we decided to implement a business continuity management system (BCMS). Therefore, we established and validated a business continuity plan (BCP) to face a production disruption and continue the delivery of products.

How was it done?

We followed the ISO 22301:2019 standard methodology. First, we performed the risk assessment as described by the ISO 22300: 2018 standard. A multidisciplinary working group (pharmacists, pharmacy technician, quality engineer) identified and analysed the risks likely to threaten the unit’s business continuity (BC). Risks were rated in term of criticality (Cr) from 1 to 4 and risks with Cr ≥ 3 were considered as priority risks. Then, a business impact analysis was led by the pharmacists and validated by the department chief. Strategies were set to face priority risks in accordance with the BC objectives. Finally, we documented the BCP and validated it thanks to tests followed by debriefing.

What has been achieved?

The risk assessment highlighted 23 risks and 13 of them (57%) were rated as priority risks. Most of the risks revolve around unavailability of production equipment or premises (fire, flood, natural disaster). The treatment of 7 of these risks was included in the action plan for 2021. Three strategies were documented to treat these risks: extended opening hours of the unit, closed system transfer device used in a contaminated isolator and production relocation in two other centres. Five tests were conducted to check necessary procedures and devices to use these strategies (closed system transfer device, remote access, transportation). Tests will be repeated yearly to maintain the BCP.

What next?

In conclusion, implementing a BCMS represents a continual improvement approach that will improve the unit’s ability to cope with a crisis in an appropriate way.

Evaluation of pre-splenectomy vaccination compliance in a large London teaching hospital.

European Statement

Patient Safety and Quality Assurance

Why was it done?

Due to the increased risk of infection to asplenic patients by encapsulated bacteria, national guidance states the following vaccinations should be administered at least two weeks prior to elective splenectomy: influenza, meningococcal (meningitis B and meningitis ACWY), Neisseria meningitides group B, and pneumococcal. Anecdotally this does not happen, resulting in administration in the hospital setting. This adds complication to the discharge process and leaves the patient with follow-up to arrange at home, whilst also having a cost burden to the hospital.

What was done?

An audit was carried out to assess compliance with national guidance on administration of vaccinations in primary care prior to elective splenectomy.

How was it done?

A report was run to generate a list of all patients who underwent a splenectomy over a 5-year period between 2015 and 2020. The records of patients admitted for elective splenectomy were investigated. It was ascertained whether medication and vaccination histories had been completed by pharmacy, whether vaccinations were given whilst in the secondary care setting, and whether the appropriate follow-up information was given to the general practitioner (GP) on discharge.

What has been achieved?

Only 6% of patients admitted for elective splenectomies across the 5-year period had received the required vaccinations in primary care prior to admission. If not administered by their GP prior to admission, only 69% of patients received the required vaccinations following splenectomy before discharge from hospital. Inclusion of the required information regarding long-term management in the discharge notification was completed in 76% of cases. Often this was included by the screening pharmacist in the pharmacy section of the discharge summary, where this was omitted by the discharging doctor. These results were submitted to the quality improvement team with recommendations to improve future practice.

What next?

This audit highlighted the need for a substantial improvement in communication between hospital and GP settings, utilising the new electronic era. In the hospital setting, poster reminders and regular teaching sessions for new and regular staff on the importance of these vaccinations will be implemented. Re-audit should then take place, with an additional component looking at communication processes and implementation by GPs of suggestions made on discharge.

Value of Integrated Inventory Management and Automation Solution for Medical Devices and Supplies: a case study

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European Statement

Patient Safety and Quality Assurance

Author(s)

Serdar Kaya, Ulker Sener

Why was it done?

Despite medical devices and supplies are often high-cost products, they are often sub-optimally managed by hospitals. The objectives of the installation were the optimization and the automation of the inventory, and the charge management workflows, to comply with JCI (Joint Commission International) standards and address current challenges as safety, labor, stock-outs, space, costs and charges accountancy, traceability.

What was done?

An integrated Inventory Management and automation solution was implemented at Amerikan Hospital Istanbul (BD Pyxis™ SupplyStation™ system). 83 automated dispensing cabinets, a central management system, and a data analytics solution, are serving the 278-beds hospital.

How was it done?

The workflows for medical devices/supply inventory, and for patients charge management were mapped pre-installation and major challenges identified. Based on these needs, the decision to automate the hospital supply management was made. The cabinets were installed in the whole hospital but in particular in operating rooms, emergency rooms and intensive care units.

What has been achieved?

The impact of automation was measured one-month pre and one-month post installation, and five major areas of improvements have been identified:
1) Significant decrease in workload: -8% for nurses; -30% for charge secretaries
2) Missing charge rate reduced from 2.5% to 0.1%
3) Improved use of space and material organization
4) Inventory optimization: 0% stock-out, -16% expired items; – 45% on-hand inventory
5) Improved materials and patients’ safety, ensuring that supply were managed in the right way by the right staff. Patients are now protected by the risk of being provided with the wrong device.
All the nurses (n>50) were interviewed, reporting great satisfaction and ease of use with the new system. Furthermore, a positive return on investment was achieved in 4 years.

What next?

Due to legal regulations (MDR Regulation/ UDI Tracking requirements) the hospital is planning to leverage the automated system to achieve a full compliance and traceability of critical medical devices throughout their hospital.
The decision of investing in automation demonstrated important benefits in terms of safety and efficiency, with a positive impact on the hospital’s economy as well.

NEW DISPENSATION CIRCUIT TO MEDICAL DAY HOSPITAL TO REDUCE THE PATIENT’S EXPOSURE TO COVID-19.

European Statement

Patient Safety and Quality Assurance

Author(s)

PILAR PACHECO, MIGUEL ÁNGEL CARVAJAL, JAVIER IBAÑEZ, LYDIA FRUCTUOSO, PAULA TORRANO, MARIA HERNÁNDEZ, JUAN ANTONIO GUTIERREZ, JOAQUIN PLAZA

Why was it done?

Since the covid 19 pandemic, the hospital environment has become a place of risk, especially for the oncological and immuno-depressed patient, so it is important to reduce the exposure of the patient and the risk of covid19 infection.

What was done?

The pharmacy service (PS) has designed this new delivery circuit for supportive treatment (master suspension formula for mucositis and colony-stimulating factors) with the aim of reducing the risk of Covid-19 infection associated with the hospital environment.

How was it done?

The circuit and the main stages are:
1. The MDH orderly comes to the PS to deposit the medical prescriptions of the patients who are receiving treatment at that time.
2. The PT prepares the treatment of each patient, always checking that prescriptions and the date of the current day. If it is a continuation of treatment, the PT will verify that the same dose is maintained and will proceed to dispense the medication with the dispensing program. If it is a new treatment or a change in dose, the PT will notify the pharmacist so that he must validate the prescription first and then the PT can dispense it.
3. The prepared medication, together with its information sheet, is placed in bags that are identified with the patient’s name pending let the orderly come to remove them.

What has been achieved?

The circuit was implemented in January 2021, after analyzing the risks that excessive wandering around the hospital poses for immunosuppressed patients, including stays in the PS waiting room.

Since the implantation of the circuit, have been dispensed: 43 suspension formula for mucositis, 25 filgrastim, 12 darbepoetin and 11 pegfilgrastim. So far, the circuit has operated in a coordinated way, contributing to the improvement patient care, avoiding wandering through crowded areas, without giving up individualized care.

What next?

The fact of preventing patients from going to the pharmacy waiting room to withdraw their support treatment, which in most cases they carry continuously and know very well, supposes a decrease in hospital ambulation and thus reduces the risk of infection by covid 19.

STANDARDIZED ORDER SETS FOR ANTIBIOTICS IN THE EMERGENCY ROOM

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European Statement

Patient Safety and Quality Assurance

Author(s)

Natalia Toledo Noda, Víctor Quesada Marqués, Héctor Alonso Ramos, Moisés Pérez León, María Victoria Morales León

Why was it done?

It has been observed that emergency physicians tend to prescribe higher doses of antibiotics even though a lower dose is enough for the most common pathologies. This implied a decrease in safety, a probable increase in bacterial resistance as well as an increase in cost.

What was done?

The dose of antibiotics that appeared by default in the pharmacological prescription program were adjusted with the aim of reducing overdose.

How was it done?

The most common pathologies in the emergency room were taken into account and the pharmacist, in agreement with the emergency physicians and following the Antimicrobial Stewardship Program, programmed those doses by default in the order set. For example, 1g of ceftriaxone once a day instead of 2g is enough for urinary tract infections and community-acquired pneumonia and 1 or 2 doses of oral phosphomycin are enough to treat non-complicated urinary tract infection. Regarding weight-adjusted antibiotics (for example amikacin), it was proposed that the dose corresponding to 65kg should appear by default in the program, which is the average weight that our patients in the emergency room usually have. These measures were intended to make the prescription as safe as possible.

What has been achieved?

The measures adopted by the Pharmacy Service achieved a drastic reduction in the overdose of antibiotics. The potential for medication errors was decreased and, therefore, patient safety improved. Unnecessary calls to prescribers for clarifications and questions about orders were also avoided. In economic terms, it has been possible to save almost 40% of the cost of treatment per patient. However, the aim of this measure was never resourcing optimization since most antibiotics used in the emergency room do not have a high cost.

What next?

In addition to the treatment protocols according to pathologies that are usually predefined in order sets, these actions carried out (not just in antibiotics) can be useful in emergency departments and for medical professionals who are not as used to prescribing medication. The use of well-designed order sets requires vigilance and a team approach because if they are not carefully designed, reviewed, and maintained to reflect evidence-based care, they may contribute to errors.

PROTOCOL OF ACTION AGAINST DRUGS SUSCEPTIBLE OF CONTACT WITH SUSPECT COVID-19 PATIENTS IN A PSYCHIATRIC HOSPITAL

European Statement

Patient Safety and Quality Assurance

Author(s)

JUAN MIGUEL PEÑALVER GONZALEZ, EVA MARIA ROBLES BLAZQUEZ, MARINA MARTINEZ DE GUZMAN

Why was it done?

The possibility of hospitalized patients with COVID-19 has required substantial changes in protocols and workflows, including those related to the use of medications.

What was done?

The objective is to develop an action protocol to be followed against drugs that may have been in contact with patients suspected of COVID-19 infection in our hospital.

How was it done?

1-Anticipation of risk of cross contamination: it must be ensured that the drugs of suspected COVID-19 patients are not handled together with the rest of the medication.
2-Decrease in traffic and limit cross contamination:
– Temporarily increase the stock of medicines in the medicine cabinets to decrease the frequency of restocking.
– Dispense only the medications necessary to minimize the volume of items returned to the Pharmacy.
– Store medications in multiple containers with fewer doses per container to minimize tactile contamination of the container when removing medications. To do this, after reviewing the inventory reports, drugs that are not used are withdrawn to make room for drugs with more movement.
– Do not use the same storage box for >1 drug, thus reducing cross contamination from other stocks.
3-Safe storage of critical items: place drugs with high demand, scarcity or that require stricter control in drawers with greater supervision and periodic inventory.
4-Security policy for returns: unused medications are placed in a plastic bag labeled with the date and sent to the Pharmacy, where they are stored in a safe place and separate from the rest of the medication. After at least 3 days, the viability of any possible SARS-CoV-2 virus will be eliminated from their surfaces (ISMP-N van Doremalen et al. 2020). It is not allowed to return multi-dose vials, single-dose or multi-dose formulations (creams, eye drops, syrups) of medications that have been in the room of the suspected COVID-19 patient.
5-When handling drugs in the plant, professionals should follow a “clean hands” approach, performing hand hygiene before and after accessing the drug.

What has been achieved?

An action protocol is agreed with the Nursing Directorate; it is pending approval in the next few days and the circuit will be simulated.
Limitations: After several months on alert for COVID-19, there have been no cases in our hospital. However, said action measures will be in force in any case of alert.

What next?

This circuit and measures are easily applicable to Pharmacy Services of other hospitals with a higher incidence of COVID-19 infection than ours.
Likewise, this protocol is valid for any other infectious agent that may appear in the future.