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Author(s)

Giulia CANCELLIERI, Piera POLIDORI

Why was it done?

Hospital pharmacist provides all management of investigational medical product(IMP), i.e. its conservation, distribution, return and destruction. However, each clinical trial involves different methods of managing the drug: this can mislead the pharmacist who has to manage multiple trials at the same time. With the aim of minimizing errors that may arise from the simultaneous management of different clinical trials, we have developed a method to classify clinical protocols by “risk index”.

What was done?

With the aim of minimizing errors resulting from management of clinical trials in hospital pharmacy, we have developed a method to classify experimental protocols into low-moderate-high risk(risk index). For each of these categories, standard procedures were then outlined in order to minimize the occurrence of any errors.

How was it done?

In order to determine risk index(ρ) we have identified all risks related to IMP’s management: pharmacological risk(φ), dependent on pharmacological characteristics of IMP; technological risk(α), if drug should be compounding; risk related to number of patients enrolled(np); risk inherent to the protocol(π), i.e. whether protocol involves placebo, or randomization, etc. These risks were then related through the formula created by us, ρ=φ+(α*np)+π: protocols are defined low-risk if ρ<50, moderate-risk if 51<ρ151. For each risk index, standard procedures were outlined in order to minimize risks, i.e.(for high-risk) inclusion of at least four pharmacists in “Delegation of Responsibilities Log”; scheduling monthly meetings with trial’s Monitor; dispensing of IMP with supervision by at least two pharmacists; etc.

What has been achieved?

We applied this method to 45 active trials in our hospital. For 3/45(6,7%) protocols, φ>75 because IMPs are carcinogenic; instead, 26/45(57,8%) protocols, involve IMP’s compounding; finally 29/45(64,4%) protocols are randomized and 14/29(48,3%) of these involve use of placebo. By applying aforementioned formula, we found that 3/45(6,7%) protocols are low-risk, 32/45(71,1%) moderate-risk, 10/45(22,2%) high-risk. For these 10, standard procedures were applied, to improve the safety of patients enrolled in a clinical trial.

What next?

We promote use of this method in other clinical centers, because we believe it can be a valid tool for risk minimization. Finally, we hope that we will receive numerous feedback from these centers to further improve the proposed method.

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Author(s)

Carlos José Cortés Sánchez, Josefina Giménez Castellanos, Mónica Abdilla Bonías, Arantxa Valdivia Piqueres, José María Gómez Portolés, Irene Toledo Guasp, Eva García Cortés

Why was it done?

Proper use of antimicrobials is essential to ensure their efficacy and minimize the emergence of resistance. The evaluation of antibiotic prescription in a district hospital can provide information about clinical practice, adherence to local protocols, and the possibility of addressing antimicrobial resistance issues.

What was done?

Review the appropriateness of antibiotic prescription according to local guidelines and protocols.

How was it done?

This is 4-month prospective observational study(May to August 2023) in a district hospital. A daily list of admitted patients on antibiotic treatment was obtained through OrionClinic® electronic prescription. Each patient was reviewed and discussed for appropriateness with antimicrobial stewardship team in a Microsoft-TEAMS© chat. The following data were recorded: registration date, patient identification, hospitalization unit, microbiological culture, treatment modality (prophylaxis, empirical, or targeted) and appropriateness using a Microsoft FORMS©.
Descriptive analysis expressed as number and percentage and relationships derived from registration: percentage of patients by hospitalization unit, treatment modality, and appropriateness. Percentage of patients on empirical treatment with microbiological culture. And appropriateness according to treatment modality.

What has been achieved?

A total of 172 patients were analysed, of which 83(48.25%) were surgical patients (orthopaedic surgery, general surgery, urology, gynaecology, otolaryngology), 64(37.2%) are from internal medicine,MIN, 17(9.9%) from intensive care unit,ICU, and 8(4.7%) from paediatrics,PED. Of the total of patients, 95(55.2%) had requested a microbiological culture. About 52(30.2%) patients were on prophylactic treatment, 103(59.9%) empirically, and 17(9.9%) on targeted treatment. In conclusion, 119(69.2%) antibiotic treatments were appropriate (prophylactic 26/50%, empiric 80/77.67% and targeted treatment 13/76.5%).
Breaking-down data by hospitalization unit and treatment, of the 83 surgical (49 prophylactic, 28 empirical, and 6 targeted) 47(56.6%) were appropriate. Among the 64 MIN patients(1 prophylactic, 56 empirical, and 7 targeted), 54(84.4%) were appropriate. In ICU of 17 patients(2 prophylactic, 12 empirical, and 3 targeted), 11(64.7%) were appropriate. In PED of 8 patients(7 empirical and 1 targeted), 7(87.5%) were appropriate. Of the total of patients on empirical treatment(103), in 28(27.2%) there isn’t microbiological sample.

What next?

This is a preliminary analysis of our hospital’s situation in order to assess where interventions are needed for those patients who are not appropriate. It also helps us identify the hospitalisation units in which it is more necessary to implement strategic non-imposing measures to improve antibiotic prescription.

Author(s)

Greta DUSABE, Jonathan DE GREGORI, Teo TODESCO, Vanessa GOMES, Hélène FEYEUX, Marine AGULLO, Cyril BORONAD

Why was it done?

Chronic Obstructive Pulmonary Disease (COPD) and asthma represent a significant public health issue. Medications are administered using inhaler devices (ID) that require prior demonstration to ensure their proper use. Incorrect usage of inhaler devices might have a major influence on the clinical effectiveness of the delivered drug.

What was done?

The goal of our study was to detect potential errors in the manipulation of inhaler devices (ID) and to provide patients with appropriate information on their correct use in order to improve medication management.

How was it done?

For this study, every hospitalised adult patient with an ongoing treatment with ID underwent a pharmaceutical interview during their hospitalisation.
This interview was done using a questionnaire assessing the patient’s knowledge of their medications and a 12-items evaluation grid covering every step of proper inhalation technique.

What has been achieved?

Between June and August 2023, 27 patients were interviewed: the average age was 73 years. 34 ID manipulations were observed. Dry powder inhalers were the most prescribed DIs (68%), followed by pressurized metered dose inhalers (23%) and soft mist inhaler (9%). For 10 DIs (29%), no explanation was given to the patient. Furthermore, inhaler technique instructions were provided by a pulmonologist (65%), general practitioner (23%), pharmacist (4%), nurse (4%) and therapeutic education program (4%). The interviews revealed that 71% of patients were not familiar with the prescribed molecules or their mechanism of action. Out of the 34 DI manipulations, only 15% were performed perfectly, and 27% were not executed properly. The steps of deep exhalation before inhalation and breath-holding after inhalation were not performed in 70% and 62% of observations, respectively. Finally, 50% of patients did not rinse their mouths after using inhaled corticosteroids.

What next?

This study has highlighted the improper use of DIs, which can lead to a loss of therapeutic effectiveness. Therefore, we have developed 9 information booklets on the correct use of the DIs that describe different handling procedures for proper inhalation. These booklets are provided at the end of the interview. Educating patients on the proper use of these inhalation devices during the initial prescription or dispensing should lead to an overall improvement in patient care.

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Author(s)

Esther Chamorro de Vega, Carmen Rodriguez Gonzalez, Belen Mayo Canaleja, María Pilar Montero Anton, Sergio Herrera Bermejo, Rosa Romero Jimenez, Vicente Escudero Vilaplana, Roberto Collado Borrell, Ana Herranz Alonso, María Sanjurjo Sáez

Why was it done?

The profile of patients receiving antiretroviral therapy (ART) has changed. Patients are more active, autonomous and have greater information and communication needs.
Mobile health, especially apps, can help to healthcare professionals to optimize pharmacotherapeutic follow-up and provide patients greater autonomy facilitating communication with healthcare professionals and contributing to the humanization of their care.
Through this application we seek to achieve the following objectives:
– Allow patients to participate in their illness and/or treatment, promoting their compliance and safety and communication with the healthcare professional.
– Strengthen pharmacotherapeutic monitoring of patients receiving ART, avoiding visits to the emergency room and hospital consultations.
– Generate pioneering evidence on the impact of mobile applications on the pharmacotherapeutic monitoring of patients on ART.

What was done?

FarMCuida® is a mobile application designed for a closer and better pharmacotherapeutic monitorization of patients on antiretroviral therapy (ART). Through this app the patient can actively participate in his or her disease and treatment.

How was it done?

A multidisciplinary group was created to design and develop an app called FarMCuida® for patients on ART in a tertiary hospital. Once the app was designed and developed, we offered the app to patients starting or undergoing ART. Identification and inclusion of candidate patients was performed in the Pharmaceutical Care Consultation of the Pharmacy Service. The pharmacists responsible for the Infectious Diseases area performed real-time pharmacotherapeutic follow-up of the patients.
Records of adverse effect (AE) and Safety-related messages received (Adverse effects, interactions, drug administration) can be analyzed. All data can be exported from FarmCuida®. Informed consent is requested from all the patients included.

What has been achieved?

FarMCuida® was designed as a digital health mobile application that allows our patients to participate in their disease and/or treatment, promoting treatment safety, as well as making available a source of information and bidirectional communication, in real-time, between patients and healthcare professionals.
During a period of 13 months, a total of 152 patients were included in FarMCuida®. Seventy-two percent of the patients were diagnosed with HIV infection while 27.6% of them were included in the HIV pre-exposure prophylaxis programme.
In AE module, 58 adverse events (AEs) were registered. Twenty-two percent of the patients registered at least one AE.
Thirty-two percent of patients used the Messages module to communicate with healthcare professionals.
One hundred and twenty-six telematic consultations were carried out. Two hundred and five messages were exchanged between the patient and the pharmacist.
Forty-three percent of the consultations corresponded to doubts about interactions: 66.7% interactions with other drugs, 28.5% with herbal products and 4.8% with vitamin supplements. Three type D interactions and one type X interaction were identified.
In addition, 11% of the consultations corresponded to doubts about the administration of ART while 5.2% were related to adverse effects experienced by the patient.
At least three visits to the emergency department were avoided, resulting in health care and economic savings for the health system.

What next?

Based on the limited studies on the impact of mobile applications on the pharmacotherapeutic follow-up of patients, the results obtained will allow us to generate evidence in this regard. It is worth highlighting the flexibility of FarMCuida® design, being easily adaptable to different pathologies and hospital centres.

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Author(s)

Sabrina Trivellato, Daniele Mengato, Francesca Venturini

Why was it done?

Bulevirtide, available in Italy since June 2023, is the sole approved drug for treating long-term HDV. It represents a precious clinical opportunity but its technical features make it a complex therapeutic regimen to handle. It is commercially available as a powder for injection that needs daily reconstitution before subcutaneous use, has strict storage requirements (+2/+8°C), and requires familiarity with needles and syringes. As home therapy, this is the responsibility of the patient, who will therefore need to be enrolled in a PEP to ensure compliance.

What was done?

A Patient Education Programme (PEP) was implemented to support patients diagnosed with hepatitis delta virus (HDV) being compliant to a complex therapeutic chronic regimen.

How was it done?

In July 2023, a specific pharmacist-led PEP (named “EXPLAIN”) was defined. It consists of two phases: education & training; follow-up & assistance. After clinical examination, patients were received by pharmacists and introduced to the therapy thanks to a simulation kit. Posology, storage conditions and special warnings were described and the drug together with the administration kit was delivered. During the follow-up phase the pharmacist was focused on proofing medication adherence, discussing with the patient about any problems or ADRs and drug refilling. Quality of Life (QoL, measured through EuroQoL5) was adopted as an effectiveness outcome. Evaluation feedback on the service was requested as well.

What has been achieved?

Up to September 2023, 15 patients, with a mean QoL starting score of 72,5/100±15, are assisted by the EXPLAIN program. 12 of them already accessed the follow-up phase. A single episode of medium gravity ADR was reported, but it did not affect therapy continuation. Globally, an excellent reported medication adherence (98.5% of doses taken) was registered and the educational support of the pharmacist was considered to be “essential on positively approaching the medication”.

What next?

QoL, adherence and feedback on the received service have to be proofed after 6, 9 and 12 months as well, together with a regular viral load detection to confirm referred compliance. Although the EXPLAIN program has just started, it represents a promising PEP model to be adopted in the case of complex therapies, where continuity is crucial to ensure effectiveness and safety.

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Author(s)

Carmen Redondo Galán, Cristina Ortega Navarro, Ana de Lorenzo Pinto, Beatriz Torroba Sanz, Cecilia Martínez Fernández-Llamazares, Silvia Manrique Rodríguez, Álvaro Narrillos Moraza, Carmen Rodríguez González, Ana Herranz Alonso , María Sanjurjo Sáez

Why was it done?

Transitions of care put the patients at risk for medication error as a result of poor communication and information loss. Treatment beginnings, complex treatment and medication reconciliation errors are an important cause of morbidity and have a predominant role in chronic complex patients (CCP). In this sense, collaboration and effective communication between hospital and community pharmacy are considered essential elements to guarantee continuity of patient care, obtaining better health results in terms of safety, effectiveness and efficiency.

What was done?

Create and implement a collaborative network with direct communication between the Hospital Pharmacy Service of a tertiary hospital and the community pharmacies responsible for patient follow -up.

How was it done?

A multidisciplinary group of hospital pharmacists dedicated to different clinical areas was created: three pharmacists from the Emergency Department, two from the Paediatrics Department, one from the Neurology Department and one from the Outpatients area. They selected and contacted by telephone the 40 community pharmacies responsible for 25% of patient prescriptions in the area. Periodic meetings were scheduled and possible strategic lines of collaboration were shared. The following priority groups were identified: Group 1: CCP (paediatric patients and fragile elderly patients) and Group 2: patients treated in the hospital emergency department. We addressed logistical aspects (supplies and preparation of formulations), pharmacotherapeutic monitoring (adherence, adverse drug reactions and collaboration in the management of CCP). The main limitations were small population and short follow-up time.

What has been achieved?

From March 2023 to September 2023, the hospital Pharmacy Service has received 50 consultations on 45 patients from community pharmacies: 85% were classified as group 1 and 15% group 2. Pharmaceutical interventions were related to medical shortages (28%), reconciliation errors at discharge (22%), information about formulations (20%), information about new treatments (15%), prescribing errors (12%) and adverse drug reactions (3%). Community pharmacists appreciated accessibility and value of information provided by hospital pharmacists. 50% of patients avoided a hospital visit to solve their queries.

What next?

Our first results show the importance of pharmacist interventions with patients and other healthcare professionals.This collaborative network can be applicable to all services that work with community pharmacies to guarantee greater coordination and integration in the different healthcare settings.

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Author(s)

Eva Gomez-Costa, Purificacion Cid-Silva, Juan Luis Hurtado-Bouza, Laura Caeiro-Martinez , Pablo Feijoo-Vilanova, Andrea Luaces-Rodriguez, Sandra Rotea-Salvo, Alejandro Martinez-Pradeda , Maria Isabel Martin-Herranz

Why was it done?

The purpose is to identify deficiencies and improvement areas in the outpatient consultation area for evaluation and proposal of possible solutions.

What was done?

Implementation of an user satisfaction evaluation system for outpatient consultations at the Pharmacy Service of a tertiary-level hospital and initial results assessment.

How was it done?

The system was put into operation in January 2023 through a QR code placed in each consultation room and in the waiting areas accessible to all patients. The survey allows for differentiation between the different pharmacy service centers in the hospital, patient-caregiver patient category, age group, and whether it was the first consultation or an appointment for treatment continuation. Users can rate aspects related to information, waiting time from the appointment time to receiving attention, the professionalism of the staff, respect for privacy, pharmaceutical information about the treatment, and the facilities. This rating can be classified into: very good, good, bad, very bad, except for the waiting time: reasonable or excessive. Final question is an overall assessment of the service from 0 to 10. Survey allows for comments or suggestions.

What has been achieved?

A total of 86 surveys were conducted between January and September 2023. The majority were from users of the pharmacy service in the main building of the university hospital complex (82.6%). 10.6% were from first-time appointment and were mainly patients who answered (67.4%). Age groups: 65 years (12.8%). Regarding the evaluation, the results were: information about appointments, 51.8% very good; waiting time from the appointment time to receiving attention, 59.3% reasonable; professionalism of the staff, 59.3% very good; respect for privacy, 59.3% very good; pharmaceutical information about the treatment, 51.2% very good. The evaluation of facilities where pharmaceutical care is provided to the patient were: 33.7% bad and 9.3% very bad. The average score for the overall assessment was 6.7 points.

What next?

The evaluation of the information obtained from the surveys will serve as a basis for implementing corrective measures and possible improvements. The progressive increase in the number of survey will facilitate the detection of new issues and allow us to track changes in user satisfaction over time.

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Why was it done?

OAM are widely used in the treatment of solid tumors and are administered orally in cycles that require self-administration at home. However, dose adjustments and discontinuations often lead to leftover medication which is discarded as waste. Therefore, the increasing use of expensive OAM comes with the downside of a financial and environmental burden. To reduce this waste, returned OAM to the pharmacy could be considered for redispensing to other patients providing guaranteed quality.

What was done?

We defined quality criteria for redispensing of oral anticancer medicines (OAM) in our hospital pharmacy. These criteria were laid down in a Standard Operating Procedure (SOP) to assess the eligibility for redispensing of returned OAM. This SOP was implemented in daily pharmacy practice.

How was it done?

A systematic risk analysis was conducted to determine eligibility of OAM for redispensing taking relevant guidelines and product information into account. The defined quality criteria were translated into a SOP and implemented in daily pharmacy practice. Over a year period, the number of returned OAM accepted for redispensing was quantified, and the reduction in financial waste and environmental burden calculated.

What has been achieved?

From the systematic risk analysis, four categories of quality aspects were identified: product presentation suitability (stability characteristics, storage requirements), physical condition (unopened or opened secondary or primary packaging, visual appearance), authentication (Falsified Medicines Directive, confirmation of initial dispense, recall), and additional aspects (remaining shelf life, period of storage under uncontrolled conditions). The first category identified that in principle, 75% of the licenced OAM (n=..products) dispensed at our institute is eligible for redispensing. From all combined quality aspects, a flow chart was created according to which each individual returned OAM is assessed . During the study period, 10,415 OAM dose units out of 13,210 returns (79%) were accepted for redispensing. The total value of OAM accepted for redispensing was €483,301, accounting for 0.9% of the total value dispensed during this period. Furthermore, the potential reduction in environmental burden was estimated at 1132.1 g of potent active pharmaceutical ingredient.

What next?

We established an easily implementable, comprehensive quality assessment of returned OAM for redispensing. Wide implementation of this approach would result in serious OAM cost and waste reduction.

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Author(s)

Sergio Portillo-Haro, Aída Rueda-Naharro, María Martínez-Pérez, Manuela Martínez-Camacho, David García-Marco

Why was it done?

Currently, multi-resistant microorganisms are a huge global problem of Public Health. In addition, this problem will be bigger in the next decades. The main strategy to face this threat is improve the use of antibiotics. DADA was born with this purpose. The app lets the Pharmacy Department manage a sizable number of inpatients using the time to analyse the results obtained by DADA. In other words, we have improved the efficiency in our use of time.
How was it done?
The app was developed in July 2022, and since then it has been updated multiple times to adapt it to our needs and expectations and the changes in clinical guidelines. Every Monday and Thursday, the app is started up. The results are analysed carefully by a pharmacist and afterwards the conclusions are transmitted to an Infectious Diseases Medician, who decides if modify the treatment.

What was done?

In July 2022, Pharmacy Department designed an app easy to use and comfortable in order to detect active antibiotic treatments that might be de-escalated. This app, DADA (Automated Antibiotic De-escalation) is fed with data of antibiotic treatments and microbiological cultures. DADA reads and understands every gap of information, and finally search results between the active treatments comparing it with theorical de-escalation sequencies, designed by Infectious Diseases Commission in our hospital and based in local epidemiological guidelines. In this way, DADA works with automatic decision algorithms. In addition, DADA also provides alerts of active treatments for resistant microorganisms to that antibiotic.

How was it done?

The app was developed in July 2022, and since then it has been updated multiple times to adapt it to our needs and expectations and the changes in clinical guidelines. Every Monday and Thursday, the app is started up. The results are analyzed carefully by a pharmacist and afterwards the conclusions are transmited to an Infectious Diseases Medician, who decides if modify the treatment.

What has been achieved?

Since August 2022 to March 2023, using DADA, the Pharmacy Department has made 25 proposals of antibiotic de-escalation, and 11 proposals were accepted (44.0%) by Medicians. In addition, the Department made two proposals of change for resistance to that antibiotic, both accepted by Medicians. This app has improved efficiency of time in the clinical team.

What next?

The main outcome is to improve the confidence of Medicians in this tool, in order to increase the percentage of acceptance in the proposals. Furthermore, the app can be more complete and interprets data, such as analytics parameters. In the future, other hospitals might use this tool to analyse their patients or in outpatients treatments.

Why was it done?

Benzodiazepines and derivatives (BZD) are often prescribed over a long time period among the elderly for anti-anxiety and hypnotic purposes leading the eldery to become addicted to their treatment. However, on the long term, BZD are less effectives and may cause dependence and adverse effects (AE). It is necessary to reassess the treatment to avoid them.

What was done?

This study evaluates patients’ dependence on BZD and reassesses the treatment after explaining the AE to patients.

How was it done?

A questionnaire for patients taking BZD at home, were developed: at first, the questions were about the reason of hospitalization, BZD’s indications, initiation date, occurrence of AE and attempts to stop treatment.

Then, the ECAB dependence test (cognitive scale of attachment to BZD) was proposed.

Eventually, explanations about BZD long term AE and an information sheet were given to patients. A substitution with short half-life BZD, dosage reduction or treatment discontinuation was proposed to the patient in collaboration with the geriatrician.

What has been achieved?

The questionnaire was completed by 34 patients. Of these patients, 44.1% came for falls and/or confusions, 27 had one BZD at home and 7 had two. About the prescribed BZD, 80.5% were for hypnotic purpose, 19.5% for anti-anxiety purpose, and 9.8% had long half-lives (not recommended for elderly).

Of 41 BZD, 46.3% had been prescribed for over 10 years.

Amid the patients, 79.4% reported AE, including 21 fall cases, 11 confusion cases and 7 somnolence cases.

Only 13 patients tried to stop the treatment.

There are 18 patients with an ECAB score greater than or equal to 6 which indicates that they are dependent on BZD (sensitivity: 94%; specificity: 81%).

Eventually, after presenting BZD AE, 6 patients switched to a BZD with shorter half-life, 10 agreed dosage reduction and 4 agreed stopping the treatment. In total, a positive result was obtained in 58.8%.

What next?

BZD are still widely prescribed and very few are re-evaluated despite the risk of AE among the elderly (often poly-pathological and poly-medicated). Given the positive results after providing an information sheet on BZD AE, it would be interesting to extend this practice to the entire hospital.