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
Pdf
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
Pdf
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.
HANDLING OF HAZARDOUS DRUGS IN HEALTHCARE SETTINGS – HAZARD EVALUATION AND PROTECTIVE MEASURES RELATED TO EXPOSURE LEVELS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Falko Schüllner, Martina Jeske, Martin Munz, Sabine Bischinger, Anna Reich
Why was it done?
The right handling of hazardous drugs in healthcare settings is essential to ensure occupational safety and health as the use and number of these potent drugs increase. In the last decades, protection at the workplace has become more important and several organizations analyze substances for this very reason. Although the antineoplastic drugs remain the principal focus, other drugs may also be considered hazardous because they are potent or cause irreversible effects.
What was done?
In this study drugs used in the University Hospital considered hazardous and to describe potential exposure values were evaluated in connection with exposure limits. A health risk assessment was conducted regarding protective measures related to exposure levels.
How was it done?
The National Institute for Occupational Safety and Health (NIOSH) assumes five categorizations with hazardous potential. According to their ATC-Code, substances from this categorization were listed. Findings of the European Chemicals Agency (C&L inventory), European Directorate for the Quality of Medicines & HealthCare, manufacturer’s guidance, European public assessment report, and safety data sheets were compared with categorization from the International Agency for Research on Cancer, NIOSH, Food and Drug Administration pregnancy categories, and publications from the German Berufsgenossenschaft für Gesundheit und Wohlfahrtspflege. The topic of exposure was divided into a determination of exposure limits in safety data sheets or in the “Grenzwerteverordnung” and into published information regarding exposure in healthcare settings. Monoclonal antibodies were examined separately. For risk assessment purposes, Stoffenmanager and other relevant tools were used.
What has been achieved?
717 substances were analyzed. 461 of them showed at least one probable hazardous or hazardous characteristic. It was possible to establish 177 threshold values, 124 for hazardous substances. The range of threshold values for the criterion “hazardous” was 0,015 μg/m3 – 10 mg/m3. Further research yielded a few public health publications referring to exposure values.It is hardly possible to quickly obtain information on the hazard potential of drugs, but C&L inventory has shown good results . Beside, there is a lack of data on exposure limit values, which is due to the difficulty in providing safety data sheets from manufacturers. As a result, exposure tools are not readily available for use by healthcare workers.
What next?
In an ongoing process every new drug will be evaluated towards the hazardous properties respectively associated exposure limits and communicated to the health care workers in the institution.
IMPLEMENTATION DESIGN OF A SECURITY STRATEGY IN THE HANDLING OF HAZARDOUS DRUGS IN A SOCIAL HEALTH CENTRE
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
CRISTINA MORA HERRERA, VICTORIA VAZQUEZ VELA
Why was it done?
Occupational exposure to HD can cause health damage to exposed healthcare professionals, so protective measures must be taken
What was done?
The hazardousness of drugs can cause damage due to exposure in healthcare workers from Social Health Centers (CSS). As an objective, the design of a security strategy in the handling of hazardous drugs (HD) was proposed with the elaboration of a safety working procedure (SWP) and preventive measures. In addition, the HDs were identified, with proposals for alternatives and recommendations for handling and administration were released.
How was it done?
Observational cross-sectional study to identify employment MPs in a public CSS. The demographic characteristics of the patients and their Pharmacotherapeutic prescription were recorded. A total of 107 residents were included, with a mean age of 78.9 years and 59.8% (64) men. The average stay in the center was 7.4 years (1-27). Regarding functional capacity, 53.3% were considered assisted, 89% of them with grade III -II assessment, that is, large dependents and severe dependents. Of the valid group (46.7%), 70% belonged to socially excluded. The most prevalent pathologies in the center are vascular, neurodegenerative, osteomuscular and respiratory. The mean number of medications per patient was 4.8. Only 6 patients did not receive Pharmacological treatment.
The design of the security strategy was structured in 3 phases; 1st)Elaboration of an SWP with assignment of functions/responsibilities, preventive measures to be adopted in the handling of HDs, description of the circuit and quality indicators of the strategic procedure; 2nd)Carrying out a descriptive observational cross-sectional study to identify the HDs used. The list of active principles (AP) included “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014” was compared with those included in the GFT of the center; 3rd)Releasing of recommendations through information sessions/ workshops for healthcare professionals.
What has been achieved?
An effective and safe employment system/circuit is established in the SWP, with relative preventive measures to control associated risks that may occur in handling and/or administration. 22 HDs were identified. A safer alternative was proposed for 9. Recommendations for the handling of HDs, associated risks and proper use of PPE were disseminated through 2 training sessions.
What next?
The identification of hazardous drugs and communication of improvement actions made it possible to implement a standard work procedure guaranteed safety in handling, and to provide an adequate means to avoid exposure due to healthcare workers.
HOME DELIVERY SERVICE DURING COVID-19 PANDEMIC TO RHEUMATOLOGIC DISORDERS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Ana Pelaez Bejarano, Maria de las Aguas Robustillo Cortes, Pilar Villar Santos, Olalla Montero Pérez, Ignacio Garcia Gimenez
Why was it done?
Rheumatologic disorders carry increased risk of infection compared with the general population, so facilitate access to hospital medications is of vital importance.
What was done?
On 14 March 2020, the Spanish government declared a state of alarm to deal with the spread of COVID-19. Medication dispensing protocols were immediately established to deliver drugs to patients who could not come in person to the hospital pharmacy department. These measures were designed to benefit citizens who, due to age or physical fragility, were more vulnerable to contagion. We had the collaboration of community pharmacies actively practicing during the COVID-19 pandemic and a logistics service, with no extra cost to the public healthcare system.
How was it done?
Between 30 March and 1 September 2020, a circuit was designed as follows: First, patient request the delivery service in the community pharmacy of their choice, which sending the request of each patient to college of pharmacists. Later, this institution sending of applications received from all pharmacies to hospital pharmacy. Here, the hospital pharmacist reviewed the patient’s electronic medical record, checking that the medication requested was appropriate, modifying it if deemed necessary (change of drug, dose, and so on). A pharmaceutical cooperative sending antirheumatic drugs to the community pharmacies. Finally, the community pharmacist who received the package checked the medication and, with the patient, reviewed and reinforced the information on the treatment.
What has been achieved?
587 patients were included: 211 rheumatoid arthritis, 173 psoriatic arthritis, 121 psoriasis and 82 ankylosing spondylitis. The delivery service enabled us to provide antirheumatic drugs to patients in their immediate environment through a service that was free for both the patient and the hospital pharmacy service. This contributes to guaranteeing the achievement of the pharmacotherapeutic objectives established for these patients.
What next?
Further action is needed to identify which groups of patients require more intensive pharmaceutical care and, therefore, who could benefit most from telepharmacy, and not only the delivery service.