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GUIDE TO SUPPORT THE VALIDATION OF PHARMACOLOGICAL TREATMENT IN LUNG TRANSPLANTATION

European Statement

Clinical Pharmacy Services

Author(s)

ANA SANGRADOR, MARIA RIOJA, VICTOR MORA, MARTA VALERO

Why was it done?

reduce the variability of the process, standardize decisions, reduce medication errors, and quantify and measure results, among pharmacists who care for lung transplant patients in the hospital.

What was done?

Prepare a guide to support the pharmaceutical validation of treatment in lung transplantation

How was it done?

The circuit that has served as the script to develop the guide has been the Manual for the Preparation of Clinical Practice Guidelines in the Spain National Health System.

• Initial meeting of pharmacists with the LTx team: presentation of the need and definition of the desirable contents according to the proposals of pharmacists and pulmonologists.
• Task assignment meeting among participating pharmacists.
• Subsequent pharmacist-pulmonologist meetings to outline the aspects that could generate more doubts and controversies.
• Inclusion of the pharmacist in the TX team, to know in situ all the phases of the TX process (from the visit during the pre-TX study, going through the surgery and its subsequent recovery stage in the plant, until the subsequent follow-up in consultations).
• Put in common of the elaborated contents.
• Review by the multidisciplinary team of Ltx.
• Publication of the guide.

What has been achieved?

• Introduction to lung transplantation (LTx): idiosyncrasies of it and transplanted patients, inclusion on the waiting list, common diseases that lead to LTx.
• Most common pretransplant Disease : cystic fibrosis, autoimmune diseases, occupational diseases, obstructive diseases, etc …
• Reference laboratory values and most common deviations in LTx.
• Clinical pharmacokinetics: immunosuppressants and other drugs monitored.
• Clinical immunology of LTx.
• Pharmacology of LTx: Immunosuppression (induction and long-term), antibacterial, antiviral and antifungal infectious prophylaxis, pain treatment, prevention of osteoporosis and treatment of the most common comorbidities in post-PTx: arterial hypertension, supraventricular fibrillation, hyperglycemia and post-transplant dyslipidaemia.
• Inclusion of current pharmacological treatment protocols: initial and subsequent treatment of LTx, cytomegalovirus infection according to the donor-recipient pairing, humoral and cellular rejection, anticoagulation and osteoporosis.
• Treatment validation criteria.
• Drug-drug and drug-food interactions with clinical significance.
• Most common chronological complications in post-LTx.
• Nutrition in the post-LTx.
• Reconciliation of medication.
• Information on medicines and healthy lifestyle habits.
• Usual documentation: informed consents, uses outside the technical data sheet, etc …

What next?

This guide will help to other pharmacist.

Structured implementation to secure rapid and efficient changes of medicines: a national workflow

European Statement

Introductory Statements and Governance

Author(s)

Mikala Vasehus Holck, Jette Østergaard Rathe

Why was it done?

The role of the National Medicines Council (NMC) is to provide guidance about new medicines for use in the public hospital sector.

Recommendations from the NMC must be implemented at hospitals. Implementation of changes of medicines requires preparation and collaboration and involves numerous stakeholders, e.g. drug and therapeutic committees, hospital pharmacies, clinicians, and the national supply organization (NSO) to public hospitals. Knowledge sharing is crucial to ensure efficient implementation.

We needed a workflow focusing on knowledge sharing at national level, and thus we introduced the structured implementation workflow in September 2019.

What was done?

We have established a structured implementation workflow focusing on knowledge sharing. The workflow ensures rapid and efficient implementation of changes of medicines, and a more aligned treatment at national level.

How was it done?

To ensure knowledge sharing through the workflow, we developed:

– Implementation memo: Summarizes NMC recommendations and treatment guidelines, with information about current and upcoming tendering procedures and prices. The memo is shared with the stakeholders.

– Implementation group: The group is a mix of people with a direct connection to the implementation workflow. The group ensures that implementation of the recommendations from the NMC is regularly discussed and assessed.

– Implementation site: An intranet for the NSO and hospital pharmacies to share information and material related to the implementation of changes of medicines.

– A system to ensure that essential stakeholders receive the same information.

What has been achieved?

The structured implementation workflow has been a success and is now an integrated part of implementation. Evaluation shows that the workflow with knowledge sharing between relevant stakeholders is essential for effective implementation of changes of medicines, and it identifies discrepancies at national level.

What next?

The structured workflow is an integral part of managing the national implementation, and the workflow and outcomes will continue to undergo evaluation.

The workflow provides the basis for knowledge sharing and can easily be transferred to other healthcare settings.

Illustrating the role of the Diabetes Specialist Pharmacist in an acute hospital

European Statement

Clinical Pharmacy Services

Author(s)

Laura O’Donnell, Barry Keenan, Laura Loughran, Edel Davidson, Rosemary Donnelly, Sarah McGinnity

Why was it done?

In 2020, it was identified that diabetes specialist pharmacists working within diabetes inpatient teams were able to provide safe, effective and patient-centred care. However, it was equally identified that there was a lack of awareness of these new roles and their potential impact on care improvement. This is a major barrier to ensuring that specialist pharmacists become an integral part of diabetes inpatient teams.

What was done?

Diabetes specialist pharmacists from across Northern Ireland collaborated to define their role, and communicated their scope of practice in improving patient care as an infographic.

How was it done?

Acute hospital trusts in Northern Ireland were allocated temporary funding to demonstrate the benefits of a diabetes specialist pharmacist. There were localised differences in services provided according to the experience, and competence of the individual pharmacist, however as a team, pharmacists across Northern Ireland collaborated to help establish, develop and define the role. Work was mapped to the four guiding principles for medicines optimisation from the Royal Pharmaceutical Society Good Practice Guidance (2013). The comprehensive worklist was then transformed into an infographic to give a quick, visual and easy to understand illustration of the role.

What has been achieved?

The infographic is a unique tool to share the vision of what can be achieved by diabetes specialist inpatient pharmacists, and promotes clinical pharmacy services. The work was used to develop a business case for permanent funding, and is being used to inform a wider diabetes workforce planning strategy within Northern Ireland.

What next?

It is hoped that sharing this work will help inform and inspire teams who would like to incorporate a diabetes specialist pharmacist into their diabetes inpatient team, and provide a roadmap for those who are developing and establishing the role in their own hospital.
Next steps involve expanding the remit to include the other roles in which a diabetes specialist pharmacist can enhance care, for example outpatient clinics, and links with primary and intermediate care, to fully illustrate the role.

Clinical impact assessment of pharmaceutical intervention during pharmaceutical consultation of oral therapy-treated cancer patients

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European Statement

Clinical Pharmacy Services

Author(s)

Justine Touchard, Elisabeth Angelier, Isabelle Ferry, Marion Lafay, Jean-Stéphane Giraud, Caroline Giard, Mallory Friou, Laurence Escalup, Thomas Genevée

Why was it done?

For more than 15 years, within the Institut Curie, a pharmaceutical consultation (PC) has been offered to patients undergoing anticancer oral therapy, in addition to a medical announcement consultation and a nurse consultation. The pharmacist secures and optimises drug management through a pharmaceutical analysis of the prescription, an explanation to the patient of drug intake and management of the main side effects.

What was done?

The aim is to assess the Clinical Impact (CI) of Pharmaceutical Interventions (PI).

How was it done?

From 1 January 2020 to 17 March 2020, two types of PI could be collected during each PC. One concerned the prescriber and problems of prescription, while the other concerned patients. Patients could misunderstand some of the information explained by their oncologist. The evaluation of the CI of these PI has been documented by an oncologist based on the Cléo scale v3, validated by a French learned society, Société Française de Pharmacie Clinique. CI of each PI was classified as harmful , null, minor, moderate, major, vital, and not determined.

What has been achieved?

140 PC were carried out. 95% of patients were female and mean age was 62 (±13.73) years. 66 PI were recorded. 39 PI with the prescriber were identified. We noted, among others, 8 risks of possible drug interaction, 9 lacks of prescriptions of support treatment, 3 lacks of drug intake advice and 3 lacks of prescription for blood monitoring.
27 PI with the patient were identified and 21 were relevant. We noted that 7 patients misunderstood drug intake, 5 patients did not know that the previous treatment should have been interrupted, 5 patients misunderstood the monitoring and 4 others were not aware of possible side effects related to their treatment.
The CI was assessed for 83% (n=55) of PI. CI was considered to be minor for 20%, moderate for 53%, major for 14% and vital for 13%. Two prescription errors were associated with vital CI. The first referred to a risk of drug interaction between a proton pump inhibitor and capecitabine. The other error was the risk of loperamide overdosage.

What next?

PC help secure medical care of patients. These results will be presented to our oncologists to improve medical practices.

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.

ANALYSIS OF DISCREPANCIES BETWEEN DATABASES OF DRUG-PLANT INTERACTIONS: A NEW TOOL THAT FACILITATES DAILY DECISION MAKING

European Statement

Clinical Pharmacy Services

Author(s)

Belén Serna Serrano, Victoria Lerma Gaude, Ana Valladolid Walsh, Cristina Del Pozo Carlavilla, Juan Manuel Collado Sanz, Héctor Alabort Ayllón, Eduardo Tébar Martínez, Andrea Drozdz Vergara

Why was it done?

In the pharmacist-patient clinical interview (CI), DP-I revision is frequent due to consumption increase of phytotherapy in recent years. The aim of the initiative was to study the degree of discrepancy (DD) based on the severity criteria (SC) found about the recommendations on the management of DP-I. Nowadays there are multiple databases with lack of unification. Patients diagnosed of Multiple Sclerosis (MS) are frequently interviewed by the pharmacist and they often take herbal medicines (HM).

What was done?

We unified the information collected from the commonly consulted databases of drug-plant interactions (DP-I) whose information could be scarce or contradictory, by creating a tool based on the most consulted plants in our clinical practice (CP).

How was it done?

To create our own DP-I tool, the sources consulted were:
– Our own plant database based on CP. A total of 56 plants.
– Six official databases of DP-I: (A)-Phytotherapy official monographs, (B)-MedInteract®, (C)-Micromedex®, (D)-UpToDate-Lexicomp® (E)-Medscape®.

In order to unify the DP-I information consulted and to be able to identify the DD (0 to 2), the SC for all databases were unified in 3 levels: if the database had 5 levels (1=1-2; 2=3-4; 3=5) or 4 levels (1=1-2; 2=3; 3=4). In first place we decided to test this tool with a small sample size of drugs (6 drugs commonly used for the treatment of MS) to check whether the discrepancy between the databases usually consulted was significant or not.

What has been achieved?

Finally, 6 DP-I were detected with Hypericum perforatum (HP) and Echinacea angustifolia (EA):

The DD seems to be similar between A-B databases and greater respect to the rest of them. Depending on the database consulted the pharmacist’s performance could change and consequently, pharmaceutical care may be affected. Since this tool was implemented in our CP, none of our MS patients have taken HP or EA, therefore, it has not been necessary to modify their treatment because of DP-I.

What next?

This tool could speed up the pharmacological review of possible DP-I and improve decision-making for the care of MS patients. Our next step is to increase the sample of analysed drugs commonly used in other pathologies, such as antiretroviral drugs.

Partnership of Specialist Nurse and Specialist Pharmacist roles improves quality of care of IBD patients

European Statement

Clinical Pharmacy Services

Author(s)

Fernando Fuertes

Why was it done?

Monitoring of patients on immunomodulators increases the workload of consultants in gastroenterology outpatient clinics. Pharmacist-led monitoring clinics reduces the number of patients who had to discontinue treatment due to myelosuppression, optimises dosage by therapeutic drug monitoring (TDM), and increases adherence to blood monitoring.

What was done?

A creation of a outpatient pharmacist-led Inflammatory Bowel Diseases (IBD) clinic to monitor and optimised immunomodulators and biologic therapy. The role of the specialist pharmacist has added value and clinical oversight to the care of IBD patients as treatment with biologic therapy has become more prevalent. In addition, the pharmacist routinely participate in IBD multidisciplinary team meetings to help with decision-making and treatment optimisation.

How was it done?

The Department of Gastroenterology at Barnsley Hospital, developed the twin roles of a Specialist Gastroenterology Pharmacist and an IBD Specialist Nurse/Non-medical endoscopist in 2012 to augment IBD care. Both roles require accreditation for independent prescribing. The pharmacist has responsibility for therapeutic drug monitoring, the prescription of biologic treatment following induction and immunosuppressants, participate at MDT, patient support and patient education. The nurse oversees the clinical and endoscopic surveillance of patients including the running of the IBD telephone helpline service

What has been achieved?

Robust clinical, biochemical and endoscopic surveillance is crucial for the delivery of effective treatments and quality of care in IBD. Telemedicine and virtual clinics have become part of our mainstream clinical practice to allow our IBD patients rapid access to healthcare services, pathway-driven treatment decision-making processes and endoscopy. IBD specialist Nurse and pharmacist clinics allow efficient management of the Gastroenterology workload and show extremely high levels of patient acceptability and satisfaction.

What next?

IBD is a life-long condition associated with considerable ongoing morbidity. Patient’s social and psychological wellbeing can be affected if the disease is poorly controlled. It is proven the specialist role of the pharmacist adds value to the gastroenterology teams and improves patient’s care. However, there is a need to standardise the specialist IBD pharmacist like in others specialities such as haemato-oncologist pharmacist or anticoagulation pharmacist. A Continuous Professional Development (CPD) course has been launched in partnership with the School of Pharmacy at the University of Bradford (United Kingdom) to initiate this goal. Further recognition and awareness of the role is required with our profession to achieve the goal and improve patients’ quality of care.

Impact of a specialist pharmacist on hepato-pancreatico-biliary (HpB) surgical ward rounds at a large tertiary liver centre.

European Statement

Clinical Pharmacy Services

Author(s)

Connor Thompson, Alison Orr

Why was it done?

Surgical patients are at risk of medication-related adverse events, with some of these patients having co-morbidities requiring long-term medications prior to surgery. Published data suggests pharmacist interventions can reduce adverse drug reactions (ADRs) and medication errors and reduce hospital length of stay.

What was done?

The effect of implementing a pharmacist into the HpB surgical ward round (WR) was unknown, this would also support ongoing service development projects in liver pharmacy on patient pathways.

This study aimed to establish the range and clinical impact of interventions made by the specialist pharmacist when attending HpB post-surgical WR as part of ongoing pharmacy engagement and service development.

How was it done?

A prospective study looking at interventions of a specialist pharmacist on WR over a one-month period, attending two WR per week. Review of all post-surgical HpB on an inpatient ward. All interventions collated and categorised based on commonality.

What has been achieved?

Over the course of data collection, the pharmacist reviewed 140 patients and made 477 interventions as part of the WR. This included 45 history medications being started, identification of 32 ADRs to current treatment, 16 instances of vancomycin dose adjustments, confirmation of anticoagulation for 17 patients and addition of 101 antibiotic stop dates contributing to better antimicrobial stewardship. There were also 70 instances of a nurse/doctor/patient requiring additional information on medication treatments.

What next?

This has highlighted the scale of interventions a pharmacist can make on a WR. Emphasising not only adjustment of medications but also the need for medication related information by healthcare professionals and patients alike.

Moving forward a pharmacist will attend at least two WR per week, with potential scope for support in pre-assessment and post-operative clinics to review weaning of analgesia and long-term management of pancreatic replacement for example.

With the recent announcement regarding new standards for the initial education and training of pharmacists in the UK, it would be valuable to assess the impact of a prescribing pharmacist on these WR.

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.

DEVELOPMENT AND IMPLEMENTATION OF A PRE-EXPOSURE HIV PROPHYLAXIS DISPENSATION PROGRAM

European Statement

Clinical Pharmacy Services

Author(s)

Natalia Toledo Noda, Víctor Quesada Marqués, Laura Majuelos Aicart, Milagros Varela González, Maria Victoria Morales León

Why was it done?

Despite advances in the control of HIV infection, the number of people who become infected annually in the island (European ultra-periphery region) remains high. The implementation of a PrEP dispensing program would prevent many of these infections since it is known that there is a high number of undiagnosed infected people. In addition, the implementation would allow legally access to this therapy, being an effective, cheap and easily to use therapy.

What was done?

Development and implementation of a medication dispensing program for HIV pre-exposure prophylaxis (PrEP) in adults.

How was it done?

In 2016, the European Medicines Agency authorized the indication of tenofovir disoproxil fumarate 245mg + emtricitabine 200mg as a preventive treatment. In December 2019 the Ministry of Health incorporated it into the National Health System for people who met certain minimum criteria. The hospital was formed since then with the aim of establishing a prescription and dispensing circuit.

What has been achieved?

The following circuit was established:
1. The primary care physician will screen candidates who want to apply to the program and request an initial study. If the candidate meets the criteria, he will consult the infectious diseases unit.
2. The unit value the entry into the program and carry out clinical follow-up. The request for outpatient dispensing is generated for the Pharmacy Service.
3. The Pharmacy Service informs about how to take the medication and its adverse effects. It is dispensed for a maximum period of 3 months. If any problem related to the drug or lack of adherence is detected, it will be communicated to the doctor.
4. A clinical and analytical follow-up is carried out every 3 months to assess the correct use of the medication as well as the appearance of safety problems (renal function and bone involvement). The continuity in the program is evaluated annually.

Since then, the Pharmacy Service has dispensed medication to 20 users and only one discontinued due to lack of adherence.

What next?

Achieve a reduction in the incidence of HIV, which for years has remained stable. Contribute to generate data that support the efficacy and safety of these therapies in real life. Avoid the illegal sale of these drugs.

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BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.