Clinical impact assessment of pharmaceutical intervention during pharmaceutical consultation of oral therapy-treated cancer patients
Pdf
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.
DEVELOPMENT AND IMPLEMENTATION OF A CAR-T CELL THERAPY PROGRAM IN ADULTS
European Statement
Clinical Pharmacy Services
Author(s)
Natalia Toledo Noda, Víctor Quesada Marqués, María Leonor Oliva Hernández, Nayra Sangil Monroy, Marta María Piñero González, María Victoria Morales León
Why was it done?
The implementation would allow access to this novel therapy to patients who have already exhausted all lines of treatment. The Ministry of Health decides to establish an administration point in the hospital, since due to its geographical location (European ultra-periphery) it would avoid the transfer of patients to other reference centers.
What was done?
Development and implementation of a CAR-T cell therapy administration program in adults.
How was it done?
In November 2018, the Ministry of Health authorized the center to use CAR-T treatment in adult patients with relapsed or refractory diffuse large B-cell lymphoma or with B-cell acute lymphoblastic leukemia. The hospital was prepared to meet specific quality criteria (JACIE Accreditation). Interhospital protocols were developed for the referral, transport, and study of candidate patients from other centers.
What has been achieved?
1. A multidisciplinary team was created made up of professionals from Hematology, Intensive Care Medicine, Neurology and Pharmacy Services, with the aim of assessing candidate patients. A qualified team oversees the clinical management, follow-up, analysis of adverse effects and results obtained.
2. The professionals involved were trained to ensure safe administration and to identify and treat possible complications.
3. Due to the special storage conditions of the drug, a circuit was established. It is storage in the Hematology Service under the supervision of the hospital pharmacist specialized in onco-hematology.
4. One of the most frequent complications of the therapy is cytokine release syndrome. Depending on the gravity, drugs such as tocilizumab should be given as soon as possible. To ensure its availability, the Pharmacy Service permanently reserves two doses. At the time of performing a CAR-T, the automated dispensing system of the hematology ward is provided with the first dose, along with a preparation sheet and its corresponding label in order not to delay its administration. The second dose remains in the Pharmacy Service.
To date, 8 infusions have been made. 100% of the patients had diffuse large B-cell non-Hodgkin lymphoma.
What next?
Facilitate access to this therapy to more patients. Generate data that support its efficacy and safety in real life.
Obtain the accreditation of the center to use the new therapies authorized by the European Medicines Agency.
Role of Hospital Pharmacist in the compassionate use of Risdiplam since the submission to Ethics Committee to the therapy in patients affected by Spinal Muscular Atrophy: an example of close collaboration with the neuromuscular team.
European Statement
Introductory Statements and Governance
Author(s)
Anna Esposito, Claudia Panico , Loretta Cervi, Emilio Albamonte, Alice Zanolini, Valeria Sansone
Why was it done?
This allows a standardized and safe access to this therapeutic opportunity in close collaboration with the NT formed by child neurologist and neurologists.
What was done?
The hospital pharmacist (HP) supports the neuromuscular team (NT) in submitting the request to access compassionate use with Risdiplam in patients affected by spinal muscular atrophy (SMA). Risdiplam is an orally administered, survival motor neuron 2-directed RNA splicing modifer for the treatment of SMA.1 The HP is involved in Ethics Committee (EC) approval, is responsible for reconstituting and storage of oral solution and is also responsible of re-supply and pharmacovigilance surveillance. This allows a standardized and safe access to this therapeutic opportunity in close collaboration with the NT formed by child neurologist and neurologists.
How was it done?
HP is involved from the initial phases of the compassionate use of the drug. The NT that screens and enrolls the patients in the compassionate use program with Risdiplam by submitting a formal request to the EC. The teams of the EC, which includes the HP, evaluates the appropriateness and inclusion criteria for each patient. Once the patient is considered eligible, and treatment is approved, the HP receives the drug from Pharma, provides quality control and assigns the drug for each patient. HP prepares the oral solution and stores the products at 2-8°C until dispensing. After the initial dispensation it is the HP’s responsibility to work closely with the NT in order to maintain treatment over time, ensuring the right timing for re-supply of the drugs and medical devices.
What has been achieved?
There are currently 30 patients on therapy and they are monitored to ensure re-supply and reporting of any adverse events. Home delivery procedure was implemented in agreement with EC in cases where outpatient dispensing was difficult, especially due to logistical difficulties caused by the Covid-19 pandemic, if clinical conditions were stable. In addition, a strong collaboration between the HP and NT was implemented in order to provide access to an increasing number of patients.
What next?
Risdiplam has recently been approved and the HP is involved in the procurement and maintenance of ongoing therapies and ensures supply to new patients. The drug is under negotiation and HP will be involved in contracting procedures based on the expected number of patients and definitive inclusion criteria to access the drug
TELEPHARMACY PROGRAMME IN CHRONIC NEUROLOGICAL PATIENTS DURING THE COVID PANDEMIC
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
ROSARIO MORA-SANTIAGO, JOSE-LUIS ORTIZ-LATORRE, ELENA SANCHEZ-YANEZ, ANGEL JURADO-ROMERO, ISABEL MOYA-CARMONA
Why was it done?
During the health alert caused by Covid-19, home delivery was quickly implemented in our country to reduce attendance at the Hospital Pharmacy Service (HPS) to obtain their medications.
In our HPS we transform home delivery into telepharmacy program (TP) with chronic neurological patients, who suffering pathologies that decrease their autonomy, with the purpose to optimize clinical outcomes and reduce the risk of contagion.
What was done?
The main purpose was to design a telepharmacy program (TP) undertstood as the provision of pharmaceutical care by pharmacists through the use of telecommunications to patients located at a distance. Telepharmacy services include patient follow-up and clinical service delivery. In our case, home delivery is also included.
How was it done?
We design the TP stratifying stable chronic patients (more than 6 months of treatment) by level of autonomy, physical distance to our Hospital and high risk (due to immunosuppressive treatment). Inclusion in the TP was proposed to patients with multiple sclerosis (MS) and aminotrophic lateral sclerosis (ALS).
Telepharmacy appointments were recorded and scheduled within the outpatient care activity, they were recorded in the patient’s medical history, as a pharmaceutical clinical follow-up, reviewing adherence, interactions and possible adverse events. Later, home delivery was made, through an external logistics company. Patients gave their consent to transfer personal data for home delivery.
Data collected were: sex and age, first or second line treatment in MS patients, pharmaceutical form (pill or syrup ) in ALS patients and number of total deliveries made.
What has been achieved?
We started on April 2020 with the program, six months later 56 patients were included, 48 with MS (total of MS patients attended by our HPS: 296) and 8 with ALS ( total of ALS patient attended by our HPS: 58). Median age: 45 years in MS group and 65 in ALS group. In MS group 37 patients received 1st line treatment and 10 second line. In ALS patients 6 received tablets and 2 syrup.
420 deliveries took place (average: 3,1 for patient).
What next?
The implementation of the TP was well accepted, avoiding longed displacement in patients with neurological pathologies. Our future target is to reach a greater number of patients that can be included in the program.