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Towards e-documentation of clinical pharmacist interventions

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European Statement

Clinical Pharmacy Services

Author(s)

Andrea Bor, Nóra Gyimesi, Eszter Erika Nagy

Why was it done?

Intervention-oriented classification systems are helpful tools to document the CPIs in a structured manner. Our aim was to develop a clinical pharmacy platform in the e-documentation system at our institution. This CPI data enables healthcare providers to track medication history, and to systematically analyse the effectiveness and the pharmacoeconomic benefits.

What was done?

A pilot survey was conducted on the traumatology wards to analyse and describe our clinical pharmacist interventions (CPI) based on severity and clinical relevance.

How was it done?

Three clinical pharmacists collected data on the changes of drug therapy at two 31-bed traumatology wards during pre- and postoperative period. We adopted the CPI classification system to our daily practices. This is challenging since the narrow time frame between patient admission and discharge often limits the opportunity to provide clinical pharmacy services. Raw data was previously screened and classified into 5 categories, drug related problems (DRP), clinical pharmacist intervention (CPI), significance (S), outcome (O) and acceptance (A).

What has been achieved?

We have established a data collection process, which allows us to record CPIs in our daily clinical environment in an efficient manner.
The most significant DRPs were incorrect dosage regimen (n=47), untreated indication (n=28), contraindication (n=25), excessive dose (n=19), subtherapeutic dose (n=17), drug interaction (n=15), no indication (n=11), experiencing adverse drug reaction (n=8), failure of drug administration due to shortages (n=5).
CPIs were divided into four groups:
1. Pharmacokinetic cause (dose adjustment, changes of drug dosage regimen, drug discontinuation, drug switch, etc.)
2. Pharmacodynamic cause (adding new drug, drug switch, – discontinuation, etc.),
3. Providing drug information (patient education, new drug, changes of administration route, etc.) and
4. Miscellaneous.
Significance were categorised as major (e.g. oral anticoagulant – LMWH switch, postoperative opioid use), moderate (e.g. loop diuretics – ion supplementation), minor.
Outcomes were therapeutic success, prevention of potential harm (e.g. adverse drug reaction) or cost saving.
73% of the interventions were accepted, the rest were rejected for the first time, but nearly half of them were admitted after minor modifications.

What next?

This CPI platform should be shared in the national digital health system.

Design and dissemination of infographics to improve safety in drug handling

European Statement

Patient Safety and Quality Assurance

Author(s)

Paula Hernando Martínez, María Antonia Meroño Saura, Caridad Marti Gil, Lidia Martínez Valdevieso, Jaime Fernández-Bravo Rodrigo, Dolores Barreda Hernández

Why was it done?

There is a wide bibliography on how human errors related to drugs put the patient’s health at risk. Drug preparation and administration errors, dose calculation errors, lack of knowledge about drugs or interactions, to name but a few. There must be protocols to ensure that drugs are safe for patients, including procedures which professionals should fulfill in order to reduce those errors in processes and guarantee, in such cases, that they will not have adverse effects on patients.

What was done?

Development of infographics for assembling drugs which are susceptible to a higher rate of errors in their preparation and administration to hospitalized patients.

How was it done?

During September 2021, a working group was formed in the pharmacy department (PD). Through the nominal group technique, the design and content of drug infographics was proposed as a solution to the raised problem. Subsequently, a bibliographic research of susceptible drugs to human errors during administration or preparation and those which requiring special handling was reviewed through the list of high-alert medication from National Institute for the Safe Use of Medications website and NIOSH list of hazardous drugs. To this end, the PD databases were analysed, obtaining the drugs that required the greatest number of pharmacotherapeutic consultations made by nursing staff on drug administration and recommendations made during pharmaceutical validation.

What has been achieved?

An infographic model has been designed which includes the description of the drug (name of drug, excipients, dose, pharmaceutical form, dosage regimen, route of administration, concentration), the preparation and administration protocol (reconstitution, dilution, infusion rate, premedication), observations (maximum doses, conditioning, incompatibilities, alerts) and storage conditions (conservation and stability). Infographics on dantrolene, intravenous phenytoin solution, intravenous nimodipine solution and potassium chloride solutions are currently being distributed. These documents are available at the nursing controls and on the hospital’s internal website.

What next?

To increase the availability of drug’s infographics and to update those that have already been developed when necessary. In addition, from the PD, the preparation of administration kits for the solicited drugs is proposed so as to ensure that all the necessary materials for the preparation and administration are included along with the corresponding drug and infographic.

Creating a standardized cisplatin hydration protocol

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European Statement

Patient Safety and Quality Assurance

Author(s)

Vera Pires, Maria Teixeira, António Gouveia

Why was it done?

Cisplatin is a cytotoxic agent used in CT regimens in ST. (1) Nephrotoxicity is the main toxicity, and hydration is always indicated to prevent kidney damage. [1,2] In 2018, when we computerized the ST’s CT protocols, we verified the existence of variations in CH protocols. According to the bibliography, this lack of standardization could lead to sub-optimal treatment of patients, errors and unnecessary use of resources. [1,3] Thus, it was necessary to develop a standardized hydration protocol designed by pharmacists with the collaboration of oncologists.

What was done?

Standardize the cisplatin-based hydration (CH) protocols used in the solid tumors (ST) chemotherapy (CT) regimens in adults in our institution.

How was it done?

Audit of CH protocols used in ST in adults in our institution and literature review to build a standardized evidence-based protocol.

What has been achieved?

We gathered 31 CT regimens with cisplatin. Verified the existence of variations in the volume of hydration (VH) before and after cisplatin, in the volumes of drug dilution, perfusion time, in the use of oral hydration (OH) and in ionic supplementation. We found that all of them were indicated to perform cisplatin only “if urine output >100ml/min”, use of mannitol before cisplatin and furosemide in SOS. Through the consulted bibliography, 4 regimens were made and implemented in 2019, according to the dosage of cisplatin: HC1< 40mg/m2 (Hday) and HC21000ml, and mannitol is only administered if cisplatin ≥60 mg/m2 (RCM). All protocols have magnesium and potassium supplementation.

What next?

Thus, despite the lack of consensus in the bibliography, a standardized protocol was created based on the evidence and clinical practice of our Institution. It is our intention to assess the impact of this intervention, from the perspective of the patient and the Institution.

Evaluation of pharmaceutical interventions documented by a pharmacy technician: where do pharmacy technicians have the biggest impact to avoid drug-related problems?

European Statement

Clinical Pharmacy Services

Author(s)

Ruth Borchers, Linda Krampe, Andreas Fischer, Christian Thomas, Holger Knoth

Why was it done?

The aim of this study was to identify the clinical pharmacy services where the integrating of pharmacy technicians have the biggest impact to avoid drug-related problems.

What was done?

In the field of clinical pharmacy services there are activities that are suitable for pharmacy technicians under the supervision of a pharmacist. At the university hospital in Dresden one full-time pharmacist and one half-time pharmacy technician (4h/d) are looking after 80 beds in the department of urology. The main tasks of the pharmacy technician are medication reconciliation as well as clinical prioritisation by using guidelines to identify patients who are at high risk of drug-related problems.

How was it done?

Since 2019 the pharmacy technician is recording the interventions in a categorical excel sheet, there are two documentation weeks per quarter. The categories are drug name, short description of the drug related problem, intervention, classification (dose-related problems, consultation of general practitioner, consultation of patient, electronic prescription, other drug-related problems after discussion with the pharmacist, drug substitution).

What has been achieved?

During 22 documentation weeks from 01/2019 till 09/2020 the pharmacy technician documented 468 interventions. The main interventions are drug substitution on admission considering local guidelines (n=181; 39%), consultation of the general practitioner because of identified discrepancies on the medicine lists (n=138; 29%) and consultation of patients because of identified discrepancies (n=78; 17%). Dose-related interventions and other drug-related problems are detected by the pharmacy technician and discussed with doctors under the supervision of the pharmacist (n=49; 10%).

What next?

Especially in the field of medication reconciliation trained pharmacy technicians can be suitable to prevent drug-related problems. The consultation of general practitioners and patients because of identified discrepancies on the medication lists are time-intensive and probably would not happen in the same way without integration of the pharmacy technician. The drug substitution in consideration of local guidelines and the preparation of the electronic prescription lead to fewer queries from nurses or doctors.
Further research should focus on the quality of pharmaceutical interventions conducted by pharmacy technicians under the supervision of pharmacists.

Pharmaceutical care to Pediatric Home Health Care

European Statement

Clinical Pharmacy Services

Why was it done?

Home Health Care is a new emerging model of health care, with a great impact on pediatrics.
Pharmaceutical care is relevant in these population because:

•The pediatric patient,for many reasons, involves difficulties in the use of medications (adaptation of pharmaceutical forms, preparation of magistral formula, off-label use, need for calculations, etc.).
•Health education is esencial to family/primary caregiver of patients admitted at home

What was done?

Reciently a pharmacist has joined to multidisciplinary Home Health Care team.

How was it done?

Pharmaceutical Care consists on:

• Clinical and pharmacotherapeutic daily follow up

• Medication reconciliation for polymedicated patients, with narrow therapeutic range drugs, or chronic diseases (oncological, neurological…)

• Pharmaceutical validation, verifying: the indication, dosage, route of administration, drug interactions, adequacy of the dosage form to the patient’s situation

• Compounding sterile preparations at Pharmacy Service. It allows a longer storage period of them, so it will reduce nursing/medical visits to home in patients with stable health condition, so the unit can admitted more patients

• Active participation in multidisciplinary sessions to advise on pharmacological issues and ensure the maximum efficiency and safety of the treatments

• Dispensing weekly of prescribed medication

• Registration of pharmaceutical interventions and cost saving by compounding sterile preparations

What has been achieved?

The average of pharmaceutical interventions during six months were 17,5 per month, 90.7% were accepted. It means that 57,4% of admited patients to Pediatric Home Health Care Unit were done a pharmaceutical intervention.

The types of pharmaceutical interventions were: 35,3% for dosing of drugs, 27% for pharmacokinetic monitoring, 18% for medication use, 4% by prescription error, 4% for preparation and administration of drugs at home. Others were about monitoring side effects and medication acquisition.

Finally, 657 sterile preparations were compounding at Pharmacy Service, it has involved a cost saving of 5143€.

What next?

It is neccesary an individualized pharmaceutical care to chronic, polymedicated and pluripathological pediatric patient in Home Health Care Unit. It will be performed:

• Clinical and pharmacotherapeutic telematic follow up
• Telephone/telematic assistance with the pharmacist for any doubts about the use of drugs
• A personalized report with individualized recomendations about preparation, administration, manipulation, elimination and acquisition of drugs.

Distribution optimization of oral oncology therapy in the treatment of advanced renal cell carcinoma: between environmental impact and indirect costs

European Statement

Introductory Statements and Governance

Author(s)

Nicola Nigri, Maria Antonietta Calzola, Silvia Di Marco, Elisa Di Maio, Benedetta Fagotti, Martina Savoia, Luciana Negroni, Fausto Bartolini

Why was it done?

The 1st line treatment in RCC provides Pembrolizumab 200mg IV/21 days plus Axitinib (56cps/pack) P.O./BIS meaning two journeys. The PT and or CG have to come back to the hospital at different moments from the infusion date for 9 times/year, affecting negatively: the compliance, the IC, the patient’s follow-up and, the environmental impact.

What was done?

In Italy, the 1st line treatment of advanced renal cell carcinoma (RCC) involves 4791 new diagnoses/year. The most innovative therapies imply the association of intravenous therapy (IV) and oral chemotherapy.
In this case, the Hospital Pharmacist (HP) can assist the compliance and help to minimize the impact linked to indirect costs (IC), often unconsidered, through the reduction of the patient (PT) and or caregiver (CG) trips, improving also their quality of life. The HP can participate in decreasing the CO2 emissions that, in 70% of the cases, are generated by road transportations.

How was it done?

On the IV therapy day, is given to the patient, the oral treatment too (42cps), provided with the necessary documents.
To measure the IC has been considered the organizational costs to the PT and or CG. The time commitment was estimated, in the worst case, in a 2h return journey (150km) between the PT/CG location and the dispensation point. It has been considered 30min as the estimated time to park, arrival, waiting time in pharmacy, drug pick-up and back.
The average hourly earnings considered has been 13,6 €/h. The average diesel-engined utility car emits 95g/km of CO2 emissions.

What has been achieved?

Each avoided trip is 2h x 13,6€ = 34€ for missing productivity or 68€ if both are involved. The total IC avoided/year/PT is the number of avoided journeys/year x 34 = 306€ (612€ if both are involved).
The CO2 emissions are equal to 95g x 150km =14,25kg/distribution/PT, 128,25 kg/year/PT, equal almost to 2,3% of CO2 emission perceived in Italy, that, in the worst case, times the incident PTs/year that will become 614.000tonnes/year.

What next?

The HP shows, even more, its influence on more layers: clinic, economic, and environmental to benefit the patient, our NHS, and our planet, hoping in this approach in more combined therapies.

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.

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.

Possible interactions from COVID-19 drug employment: the Hospital Pharmacist’s intervention in a regional hospital

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European Statement

Patient Safety and Quality Assurance

Author(s)

Simone Leoni, Sabrina Guglielmi, Vincenzo Nicola Menditto, Adriana Pompilio, Francesca Vagnoni

Why was it done?

During the pandemic, almost all hospital departments were converted in COVID-19 wards and clinicians of several specializations were asked to work in. In a situation characterized by a great number of patients, mainly old and with several comorbidities, health professionals had to employ quickly drugs never used before and supported by limited scientific evidences. In this context the percentage of possible DDI rises out of proportion exposing patients to potential devastating consequences.

What was done?

During COVID-19 emergency we develop a quick reference tool for clinicians involved in first line assistance to patients. A table summarizing drug-drug interactions (DDI) of the most used therapies was created to allow professionals making the best pharmacological decision.

How was it done?

After a literature review using Micromedex and TERAP (Mario Negri Institute), we have created two table summarizing DDI of lopinavir/ritonavir (LR) and hydroxychloroquine (HC). Those drugs have been grouped according to pharmacological group and clinical relevance. The tables were provided to Infectious Disease, Intensive Care Unit and Emergency Medicine departments.

What has been achieved?

The tables showed 359 DDI for LR (67% contraindicated/severe, 12% major and 21% moderate) and 176 for HC (96% contraindicated/severe, 1% major and 3% moderate). Almost all contraindicated/severe interactions of HC were the same of LR and regarded: protein kinase inhibitors, beta2 agonists, macrolides and fluoroquinolones antibiotics, some antidepressants, phenothiazines, protease inhibitors and antiarrhythmics. Other LR severe interaction were: factor Xa inhibitors, statins and benzodiazepine derivates. Both LR and HC present moderate interactions with acid pump inhibitors, while LP interacts with Ca and vitamin K antagonists and antiepileptics.
Interactions mentioned have a great impact, since they concern drugs commonly used and hypertension, diabetes, respiratory system disease, cardiovascular disease are the most frequent comorbidities linked to COVID-19. Tables provided had a positive impact in avoiding DDI. Pharmacist was consulted for drug dosing and frequency adjustments. The intervention was fully accepted and extended to the rest of COVID-19 wards.

What next?

The project represents a good example of multidisciplinary collaboration able to improve safety and efficacy in pharmacological treatments. The added value of the Pharmacist and the simplicity of the tool make it useful and easy to extend to other healthcare settings.

MEDICATION MANAGEMENT OF COMBINATION THERAPY IVACAFTOR , TEZACAFTOR AND ELEXACAFTOR FOR CYSTIC FIBROSIS PATIENTS WITH THE F508del MUTATION BY THE HOSPITAL PHARMACY IN A CENTRAL GENERAL HOSPITAL

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European Statement

Clinical Pharmacy Services

Author(s)

DESPOINA MAKRIDAKI, KALLIOPI ALLAGIANNI, NIKOLAOS SKORDAS

Why was it done?

In our hospital is located the main CF Unit for Adults in the country. Ensuring that as many as possible young patients benefit from accessing the new and crucial treatment, even during COVID-19 period, reflects our commitment to improve patients’ outcomes and overall survival,

What was done?

A Phase 3, open-label clinical trial (CT) with 3 enrolled patients runs since April 2019 and two early access (EA) programs with 23 enrolled patients run since the end of July 2020 to permit the access of cystic fibrosis (CF) patients with the F508del mutation in the innovative combination therapy of ivacaftor, tezacaftor and elexacaftor (IVA/TEZA/ELEXA) in our hospital.

How was it done?

3 outpatients enrolled in the CT and procedures regarding the protocol have been followed strictly. Medication dispensing is conducted every 12 weeks.
In the EA procedure, 2 parallel programs have been approved by authorities, one for the homozygous including 19 patients and one for the heterozygous including 4 patients. Dispensing is programmed every 4 weeks, although an initial stock for 3 months was shipped to pharmacy.
The role of HPs was decisive for the quick start of the EA programs during COVID-19 period. Roadmap was designed at the beginning by HPs in collaboration with the physicians to accelerate approval and shipment procedures and also regarding licensing for each patient, drug receipt, storage, dispensing, accountability, electronic registry in designated EA platform and additional electronic recording and follow up in the electronic Pharmacy platform for both the IVA/TEZA/ELEXA and supporting therapies (e.g. inhaled antibiotics, a-dornase)
For 17 EA patients with chronic obstructive pulmonary disease in exacerbation, hospitalization before starting the IVA/TEZA/ELEXA therapy was necessary. HPs monitored closely their cartexes to avoid adverse reactions and delays in therapy.
HPs served all outpatients on personal afternoon appointments, to avoid overcrowding in the hospital during the pandemic.

What has been achieved?

Critically ill patients have been able to receive in priority the IVA/TEZA/ELEXA treatment, without cost, and valuable scientific experience has been gained.

What next?

EA programs have received 3 months extension until reimbursement negotiations are completed by authorities. In the meantime, we design a cost affordable procedure to ensure continuity of access for our patients.