Skip to content

Securing the management of experimental product in investigator services in case of non-nominative dispensing: a risk based approach

Pdf

PDF Icon

European Statement

Patient Safety and Quality Assurance

Author(s)

Mélanie Hinterlang, Mona Assefi, Pauline Glasman, Delphine Brugier, Meriem Charfi, Fanny Charbonnier-Beaupel, Marie Antignac, Carole Metz

Why was it done?

Clinical trials in critical care sometimes demand swift inclusion and administration, often occurring at any hour of the day or night. To enhance patient care, the experimental drug may be provided in a non-nominative manner directly from the pharmacy unit to the care unit for storage before any inclusion as a stock. This dispensing pathway is considered less secure than the conventional named dispensing but can be necessary. The objective of this risk analysis for this dispensing process was to identify the risks, determine the number of them with unacceptable criticality, and propose actions to reduce criticality of these risks.

What was done?

A risk analysis of non nominative dispensation of experimental drugs process was conducted to streamline, secure, optimize, and standardize this dispensing process.

How was it done?

Following a preliminary investigation, three pilot services were chosen: surgical intensive care, post-interventional recovery room (SSPI), and cardiology. The Failure Mode, Effects, and Criticality Analysis (FMECA) method was applied to the non-nominal dispensing circuit of experimental drugs from reception at the pharmacy unit to the administration of the drug to patient. Investigators, clinical research associates, nurse, and pharmacists participated.

What has been achieved?

Following the FMECA, 281 risks were identified. The majority were either acceptable (123 or 44%, 110 or 39%, 147 or 52%) or tolerable (139 or 49%, 148 or 53%, and 130 or 46%) for the intensive care, SSPI, and cardiology services, respectively. Unacceptable risks numbered 19 (7%), 23 (8%), and 4 (1%) for intensive care, SSPI, and cardiology services, respectively. The process identified as most critical for all three services was communication. After risk prioritization, a plan comprising 17 actions was implemented.

What next?

This risk analysis demonstrated that control over the non-nominal dispensing circuit is achievable. Once the actions are in place, a reduction in criticality is anticipated due to a decrease in the frequency. Theoretically unacceptable risks are now at 0%. In the long term, this project has the potential to participate to improve the care of patients enrolled in emergency clinical trials and boost research in the concerned units.

Development of a hospital pharmacist led re-evaluation of medication errors

Pdf

PDF Icon

European Statement

Patient Safety and Quality Assurance

Why was it done?

All errors, whether involving medication or not, are required to be reported and classified in the hospital reporting system. However, the system is poorly adapted for medication management and lacks the relevant terms. This results in the same type of error being classified in various ways, making systematic quality improvement difficult. A pilot study confirmed the system’s shortcomings, after which a new medication management process was developed and evaluated.

What was done?

The existing process for classifying medication errors was supplemented with a new process in which hospital pharmacists reclassified medication errors detected in the reporting system. The reclassification was based on a predefined medication management process.

How was it done?

A medication management process was developed in collaboration with specialist nurses and in accordance with applicable regulations and policies. The process consisted of the following activities: 1) Prescription, 2) Ordering/Delivery, 3) Storage/Narcotics Control, 4) Preparation, 5) Handover/Administration, 6) Medicines information in transitions of care, 7) Follow-up of treatment, and 8) Miscellaneous. The process was validated by having four hospital pharmacists independently classify 176 medication errors. Consistency in the assessment was evaluated, and the process was corrected as needed. All medication errors classified as medication-related in 2022 or containing the word “medication” in free text were thereafter exported from the reporting tool to Microsoft Excel and then into a data processing and performance monitoring tool for further analysis.

What has been achieved?

A total of 756 medication errors were identified in the reporting tool, distributed across 65 different activities. Hospital pharmacists identified an additional 305 errors through free-text searches that had not been reported as medication-related. A total of 1,061 medication errors (756+305) were reclassified and grouped into eight activities. The highest risk of errors was associated with the preparation (19%), followed by storage/narcotics control (18%), and prescription (17%). The new process, involving hospital pharmacists in classification, creates conditions for a more systematic approach to medication errors. The pilot project was presented at the hospital’s themed day for World Patient Safety Day 2022.

What next?

Discussions have been initiated with system developers to improve the reporting tool. Discussions with hospital management will be initiated with the goal of creating a structure in which hospital pharmacists have an active role in the hospital’s work on patient safety related to medication.

90% reduction of medication waste by reusing returned medication from medical wards

Pdf

PDF Icon

European Statement

Selection, Procurement and Distribution

Author(s)

Douwe van der Meer, Peder Nygard

Why was it done?

In our hospital 30% of the daily distributed medication for individual patients was not administered. Reasons for not administering were for example lack of need because of patients clinical performance, discontinuation of prescriptions or early discharge. Because of safety concerns, like mix-ups, our standard procedure was to discard all returned medication. This resulted in a waste of about 220.000 pills annually.

What was done?

We reduced medicine waste by 90% by reusing returned medication from our medical wards. With this result we made an important step for our hospital to meet the national sustainability goals in the Dutch ‘Healthcare Green Deal (3.0)’.

How was it done?

Reusing returned medication brings multiple safety concerns. By performing a prospective risk analysis we identified three major risks: mix-ups, expired medication and accepting non-qualitative packages (like slightly opened blisters or incomplete labels). With these risks identified we redefined our distribution process on four key elements: 1) Every medication has a barcode on unit level and if not, is labelled by our team through duplicating the ‘Falsified Medicine Directive’-barcodes to small 2D barcode labels which includes expiration date. 2) All returned medication is checked by a pharmacy employee on major quality aspects. 3) Returned medication is placed in a separate ‘return-box’ in front of the original stock inside the distribution cabinet. 4) Expiration dates are checked more frequently and are checked upon distribution and administration through barcode scanning.

What has been achieved?

The new distribution process was implemented in all of our eight distribution cabinets and resulted in saving 90% of the returned medication; witch amount to 200.000 pills and 70.000 euro savings annually. On average we work with 6 employees daily, who need 15 minutes extra per person per day to process returned medication.

What next?

Our goal is to save all returned medication that meets our quality standards. 5% of the returns that are not reused are medicines not included in the assortments of the specific distribution cabinet, so extra logistic and administrative steps are needed to place them back in the pharmacy stock. We are exploring new ways to make this next step in reducing medication waste further.

Development of a telepharmacy and drug delivery programme

European Statement

Clinical Pharmacy Services

Author(s)

Maria Gregori, Eva Legido, Marta Bellver, Inmaculada Seguí, Amando Mengual, Jose Manuel Ventura

Why was it done?

In Spain hospital pharmacy services dispense specific medications to outpatients. Nevertheless, some patients have difficulties in getting to the hospital due to disabilities, displacement problems or work reconciliation. In this sense, the objectives of the programme were as follows: Improve patient access to healthcare professionals and reduce visits to the hospital. Promote patient autonomy, responsibility, and participation in decision making regarding pharmaceutical care and dispensing of medicines. Increase patient satisfaction with the healthcare provided. To expand the portfolio of services of the OPCUs. Promote the integration and continuity of pharmaceutical care between the OPCU and CP.

What was done?

Implementation of a programme in the Outpatient Pharmaceutical Care Unit (OPCU) that includes telematic pharmaceutical care (telepharmacy) as well as the dispensing of hospital medications in proximity through our health structures (primary care centres) or community pharmacy (CP).

How was it done?

We took the following steps:
– Establish inclusion and prioritisation criteria for the selection of patients who are candidates to participate in the telematic pharmaceutical care and proximity dispensing programme.
– Establish the procedures for the development of telematic pharmacotherapeutic follow-up: telephone consultation at the beginning of inclusion and successive ones prior to each dispensation.
– Establish the processes, procedures, and resources for the performance of drug dispensing in CP.
– Coordination of all participants in the process.
– Establish indicators and variables to measure and improve the results obtained.
– Guarantee patients’ rights in terms of confidentiality, authorisation, and information.

What has been achieved?

From January 2022 to August 2023, a total of 376 patients have been included in the programme, which translates to 2,041 telephone consultations and 2,306 dispensations of medication from hospital to CPs or primary care centres. A total of 36 incidences were resolved.
Of these patients, 68% were included because of having reduced mobility or dependence, 18% due to work-life balance, and 14% due to distance or problems getting to the hospital.

What next?

– Inclusion of at least 15-20% of patients from face-to-face modality to telepharmacy and proximity program.
– Evaluate indicators and detect opportunities for improvement in the processes.
– Determination of patient reported outcomes.

Establishing a medicine donation circuit for non-governmental organisations at a pharmaceutical service in the Basque country (Spain)

Pdf

PDF Icon

European Statement

Selection, Procurement and Distribution

Author(s)

Ariadna Martin Torrente , Itziar Palacios Zabalza, María Olatz Ibarra Barrueta, Maialen Palacios Filardo, Garazi Miron Elorriaga

Why was it done?

To optimise the functioning and the management of the procedures and an accessible and effective communication system in the PS. Moreover, the quality of the shipment is guaranteed all the time. The development of a circuit has allowed being faster and more efficient during its preparation than before.

What was done?

Establishing the circuit of execution, preparation, distribution, and delivery of medicine to Non-Governmental Organisations (NGO) from the Pharmaceutical Service (PS) of a tertiary hospital in the Basque Country (Spain). The circuit has been designed taking into account the criteria in a context of humanitarian donations, published and updated by the Spanish Agency of Drugs and Sanitary Products (AEMPS) on 16 March 2022

How was it done?

Since it has been included in the daily activity of the service it has cause and increase its amount of work, hence, daily routine tasks have been slowed down, given the increase of petitions the hospital has had during last year. However, its creation has allowed being faster and more efficient during its preparation.
The circuit begins with the request of NGO, which has to be authorised by the hospital’s directory. Then, in the procedure participate pharmacists; pharmacy technicians and office clerks who prepare the donation rely on the personalised list that the donation has created. Once, the necessary documents are filled out and they are sent to the AEMPS.

What has been achieved?

From November 2021 to September 2022, 7 donations have been carried out; these contained 100 active ingredients, concretely 15.198 units. We could find most of them in the WHO model lists of essential medicines. The NGO’s destinations have been Guatemala, Romania, Ukraine and Senegal. The medications sent most according to the ATC classification were 21% anti-infective medicines, 17% cardiovascular, 13% nervous system, 12% systemic hormonal preparations and 3% alimentary tract and metabolism.

What next?

The project is easily enforceable in any Spanish PS that is willing to process a donation at any given occasion. Some of our ideas for the future are the creation of a standard list including common medications, avoiding personalised lists, in addition to connect it to our internal programme to be faster when preparing the donation.

IMPLEMENTATION OF A NEW MODEL OF MEDICATION DELIVERY AND CLINICAL PHARMACY FOLLOW-UP IN A TERTIARY HOSPITAL

Pdf

PDF Icon

European Statement

Clinical Pharmacy Services

Why was it done?

Due to the COVID-19 lockdown, many patients could not attend to hospital pharmacy for medication supply. To ensure treatment effectiveness, tolerance and therapeutic adherence, we developed this new model of medication dispensing as well as additional routes of patient follow-up, such as the use of mobile Health (mHealth).

What was done?

In 2024/03 we started to approach hospital medication (mainly onco-haematology oral treatments, subcutaneous monoclonal antibodies and clotting factors) to the patient’s home. We developed an alternative model of medication supply through the collaboration with community pharmacies (CPs) and a logistics partner.

How was it done?

The collaboration with CPs was coordinated by the Barcelona College of Pharmacists, who developed a new digital platform to manage and track delivery orders. A pharmaceutical wholesaler delivered these medications to CPs in 48–72 hours. In case of requiring a faster dispensation, we used a logistics operator which guaranteed a delivery time to the patient’s home of 24 hours.
Considering that our hospital pharmacy attends more than 8,000 patients, we prioritised this service to those with a complex socio-functional situation or who lived far from the hospital.
Pharmacy technicians were the key managers in this process. Through a telephone interview, they detected possible medication related problems (adverse effects, administration errors, inadequate dose/route of administration/duration of therapy and lack of treatment adherence). They also checked for in-person medical appointments that could justify dispensing direct to the patient. If any incident was detected, the technician referred the case to the pharmacist for further assessment and resolution.
Additionally, for some health conditions (heart transplant, colorectal and breast cancer, haematopoietic stem cell transplant, chronic migraine or HIV infection), we developed a mHealth programme in which patients were empowered by using a smartphone and tablet app to promote self-care management and contact with their healthcare professionals.

What has been achieved?

In 2020, 4,793 shipments were made to 1,814 patients. This meant 12.4% of the total hospital pharmacy dispensations (N=38,527). Of these shipments, 61.0% went to CPs and 39.0% to patients at home. In 2021, there were 4,171 shipments to 1,248 patients, 90.0% of which were sent to CF, which implies a decrease of the shipments of 12.9% compared to the previous year.
In our setting, mean time of virtual dispensing was 10 minutes versus 3 minutes of in-person dispensing. This additional time was due to the preparation of drug shipments and tracked delivery orders. The assessment of this model was positive for both patients and pharmacy staff. However, it was not exempt from some incidents, such as delivery delays or errors in package identification.
As for telepharmacy follow-up, 257 patients are using mHealth applications. In 2021, they performed 4,387 consultations with the pharmaceutical team.

What next?

The COVID-19 pandemic forced us to rethink the care model for outpatient care in hospital pharmacy services. Our assessment is positive and we believe that this model should continue in the future for a selected group of patients.

Implementation of a telepharmacy service in outpatient’s pharmaceutical consultation

European Statement

Clinical Pharmacy Services

Author(s)

QUERALT LOPEZ NOGUERA, ÀNGELA CASTELLÓ NÒRIA, CRISTINA DIEZ VALLEJO, LAURA VIÑAS SAGUÉ, MARTA COMA PUNSET, SILVIA CABARROCAS DURAN, MIREIA VILA CURRIUS, ANNA DORDÀ BENITO, EDUARDO TEJEDOR TEJADA, CRISTINA TORO BLANCH, ROSA NURIA ALEIXANDRE CERAROLS, ROSA SACREST GÜELL

Why was it done?

The declaration of the state of emergency by SARS-CoV-2 pandemic on March of 2020 had an impact on hospital PC.
During that period, it was advised by Healthcare Authorisations to minimize the risk of infection or spread of SARS-CoV-2 in order to protect vulnerable groups. For that reason, it was not recommended to assist in the hospital if it was not necessary. This fact caused some organizational changes in OPC to adapt to the current situation.

What was done?

Our hospital Pharmacy Department created a telepharmacy service in outpatient’s pharmaceutical consultation (OPC) after state of emergency declaration by SARS-CoV-2. We created a standard operating procedure working together with communitarian pharmacists and the Region Pharmacist’s College. The main aim was to ensure pharmaceutical care (PC) quality in vulnerable patients and the correct medication distribution and conservation. Pharmaceutical care was developed by telephone call and medication was send to communitarian pharmacy.
A comprehensive analysis was made to concern the impact on drugs delivery selecting certified distribution company which ensured drug traceability, custody and conservation.

How was it done?

In 2020, approximately 60 patients per day used to attend in OPC. According to the large number of patients, we defined which patients could take advantage of this programme. The selection criteria were adherent patients with pulmonary pathologies (cystic fibrosis, asthma, bronchiectasis, etc.), multiple sclerosis, amyotrophic lateral sclerosis, reduced mobility or patients over 65 years old who lived in more than 30km closed to the hospital or without any family member that could come.
In order to ensure the process traceability, an informatics tool has been created by Region Pharmacist’s College. Pharmacy Department, community pharmacy and the distribution company assumed all expenses.

What has been achieved?

369 of 2.346 patients were included in our telepharmacy service during the state of emergency. There was high level of acceptance by all patients. Only low-risk patients or patients who had an on-site doctor visit were attends in OPC. Nowadays, 196 patients still benefit from the initiative.

What next?

Telepharmacy program avoids patient’s displacements that are particularly susceptible to COVID-19 negatives effects. Moreover, it guarantees PC quality, patient’s adherence, process traceability and correct medication conservation from hospital to patient’s home.

Do we provide patients with sufficient information for the safe use of thermolabile medicines?

European Statement

Clinical Pharmacy Services

Author(s)

Miguel Angel Carvajal-Sanchez, Josefa Leon-Villar, Pilar Pacheco-Lopez, Javier Ibañez-Caturla, Paula Torrano-Belmonte, Lydia Fructuoso-Gonzalez, Juan Antonio Gutierrez-Sanchez, Maria Hernandez-Sanchez

Why was it done?

In recent years, we have witnessed a significant increase in the number of thermolabile pharmaceutical specialities, which makes it necessary to keep strict control of the storage temperature from manufacture to administration.

In this context, patient education is a fundamental step in ensuring that these medicines are administered effectively and safely.

What was done?

A study was carried out to determine the quality of the information provided by Hospital Pharmacy Service (HPS) professionals to patients regarding the storage of thermolabile medicines (TM) at home.

After analysing the variability of the results, we established in a protocolised manner the necessary and sufficient information items to be included in the pharmaceutical advice to patients regarding the storage of this type of medicines.

How was it done?

A random selection of 28 HPS professionals (13 nurses, 10 specialist pharmacists and 5 resident pharmacists) was made. Each participant, in isolation and individually, made a selection of criteria to be contained in the patient information regarding the transport and storage of TM.

The results obtained were:

General information:

o Informing that it is a TM: 89.28%.

o Telephone number for incidents: 10.71%.

o Keep out of the reach of children: 3.57%.

o Return if discontinuation of treatment: 3.57%.

Storage:

o Specify location in refrigerator: door/indoor distinction 28.57%; Avoid contact with walls: 28.57%; specific place in refrigerator 3.57%.

o Do not store next to food: 17.85%.

o Refrigerator/freezer distinction: 10.71%.

Transport:

o Recommendations for correct transport: 50%.

o Time elapsed from dispensing to refrigerator storage: 39.29%.

Administration:

o Tempering prior to administration (when necessary): 39.28%.

o Visual inspection: 7.14%.

o Check expiry date: 7.14%.

o Frecuency of administration: 3.57%.

What has been achieved?

Completion, standardisation and systematisation of the provision of information to patients on TM.

What next?

Training sessions will be given to all HPS professionals involved, including new recruits and pharmacy assistants. This is an initiative applicable to all HPS.

EXPANDING OPPORTUNITIES FOR PHARMACISTS IN ONCO-HEMATOLOGIC CLINICAL TRIALS: DESIGN AND IMPLEMENTATION OF THE OUTPATIENT SERVICE MODEL

European Statement

Clinical Pharmacy Services

Author(s)

Eugenia Serramontmany Morante, Patricia Garcia Ortega, Lorena Garcia Basas, Pablo Latorre Garcia, Pilar Rovira Torres, Laura Maños Pujol, Isabel Cidoncha Muñoz, M. Queralt Gorgas Torner

Why was it done?

The provision of outpatient oncology services by pharmacists is still limited, but it is an emerging role. It can add value while increasing the quality of patient care required, maximizing the likelihood of achieving positive outcomes and thus improving the patient’s quality of life. It is important to incorporate clinical pharmacists into outpatient clinics to ensure the safe use of investigational drugs and guarantee the best treatment for the patient.

What was done?

The oncology clinical trials pharmacy team initiated an outpatient clinic at a tertiary hospital. This enabled review of patients’ medications, monitoring of interactions, appropriate oral chemotherapy counseling, design of medication diaries and instructions, discussion of side effects, as well as other dietary and daily living recommendations.

How was it done?

A multidisciplinary team was formed: pharmacy, medical, nursing, ancillary and administrative staff, to discuss circuits and strategies to address outpatient pharmacy clinic.
The pharmaceutical care program was implemented gradually during 6 months, first in phase I, then phases II and III clinical trials.
Factors including appointment scheduling, patient prioritization, clinic room availability as well as detailed definition of pharmaceutical activity were discussed, in order to have a standard procedure for all patients included in a clinical trial.
The group continued to meet weekly to further discuss the progress of the pharmaceutical care program and any obstacles and unforeseen events.

What has been achieved?

Medication has been dispensed to 8447 patients in the outpatient pharmacy, of which 1172 patients have been attended by the clinical pharmacist during the first 8 months (January-August 2021) of the programme’s implementation.
Pharmaceutical care at the first day of treatment has been provided to 275 patients to explain how to take the treatment and resolve doubts. The concomitant medication of 312 patients has been reviewed for the screening and 425 telephone queries about concomitant medication have been resolved.

What next?

The evolutionary change in cancer care along with the increase in the number of clinical trials and its complexity will emphasize the need to include the oncology pharmacist in the cancer care team. The role of a clinical pharmacist is vital to ensure the safety and controlled use of the drug, ensuring the best possible outcomes.

Croatian hospital pharmacists managing earthquake(s) medical consequences during lockdown(s)

European Statement

Clinical Pharmacy Services

Author(s)

Mirna Momcilovic, Anita Simic, Petra Turcic

Why was it done?

Croatia was hit by 2 big earthquakes in 2020, both happened just right after 1st and 2nd lockdown due to high number of COVID-19 cases. Since most of the hospitals were strategically built on the hills, it was more destructive for them. It also hit a number of community pharmacies responsible for drugs supply to specific areas in the country. There was no electricity, no heating, no drugs supply, no fridge to store drugs, for days, so quick back-up plan was needed to provide minimal healthcare.

What was done?

Croatian hospital pharmacists organised a temporary pharmacy in a tent, filled it with drugs and medical products donated from community pharmacies, hospitals and wholesalers from Croatia and other European countries and started supplying patients with it.

How was it done?

It was modified way of dispensing, without prescription because there was no doctors and no place to prescribe it, based on patient’s medical documentation, if available, and patient’s medication history according to what patient said only. Pharmacists needed to use their knowledge about dosing, duration of action – difference between immediate release or modified release formulations, possibility of splitting tablets into equal parts to get the needed dose and, most important, substituting drugs from the same pharmacologic class (ex. switching from one inhaler for treatment of asthma containing ICS + LABA to another one that was available at the moment), taking into consideration patient’s needs and avoiding drug to drug interactions. Pharmacists provided patients with OTC drugs, free of charge, followed by an advice of how to use it. Non having prescription problem was solved afterwards by Croatian Health Insurance Fund. Also, all the supply of vaccine against COVID-19 available in Croatia at that point, was sent to an area hit by the earthquake. Vaccination was done by doctors, and pharmacists assisted by supplying them with all the equipment needed (needles, alcohol, cotton wool, etc.).

What has been achieved?

Patients were supplied by all the drugs/medical products needed in the first, critical week after an earthquake.

What next?

Following the Croatian example of handling an earthquake situation, there is an idea of organising a medical crisis team, would include pharmacist, in each European country.

×

EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.