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Author(s)

Moisés Couñago-Fernández, Marisol Samartín-Ucha, Ana María Regueira-Arcay, Sonia González-Costas, María Alfonsín-Lara, Paula Prado-Montes, Iván Agra-Blanco, Elena Cerdeira-Regueira, Noemí Martínez-López de Castro

Why was it done?

When a new pharmaceutical product should be introduced in a hospital, a multitude of factors must be considered in order to choose a specific brand. A lack of uniformity in the criteria for the selection of new medicines has been detected. To avoid selection errors or arbitrary decisions, a selection structured algorithm was developed using quality tools according to management quality system ISO 9001-2015.

What was done?

To ensure that the process of selecting from several pharmaceutical companies fulfil the requirements of quality and lower cost, a decision-making process for these purchases was designed, through a structured method for the evaluation of new pharmaceutical products based on standardised evaluation criteria.

How was it done?

A multidisciplinary group was created focused on making decisions about criteria. All stakeholders were represented (management pharmacist, quality experts, management assistant and pharmacy director). Also, a survey was given to different specialist pharmacists to complete the criteria. Second, criteria were categorised according to their importance or potential impact in pharmacy practice or patient.

What has been achieved?

The algorithm took into account aspects related to: a)pharmaceutical company and b)aspects related to the pharmaceutical product. Each of these aspects is valued as a percentage.

a)Pharmaceutical company: 40% of the score was based on not having a repeated history of stock-outs, 45% on the evaluation of the provider according to an internal file based on incidences registered, and 15% if the provider was already a known supplier.

b)Pharmaceutical product: 50% was based on the cost of the medicine, 15% unit dose presentation (if applicable), 10% expiry conditions of the medicine, 5% allergens, 5% if it was presented in a pre-filled pen (if applicable), 5% if it could be stored at room temperature, 5% if the drug is supplied in diluted vials (in the case of parenteral medicines) and 5% if it had all the possible indications in the technical data sheet.

This methodology has been used successfully in recent months with the pharmaceutical supplier changes of abiraterone and sugammadex.

What next?

This tool will be used for all changes of medicine brands and new drugs purchased in the hospital, enabling uniformity in the purchasing process for all new drugs.

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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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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.

Author(s)

Lorenzo Di Spazio, Daniele Mengato, Andrea Ossato, Vera Damuzzo, Marco Chiumente, Giulia Dusi, Sabrina Trippoli, Andrea Messori, Maria Cecilia Giron, Maria Chiara Silvani, Francesca Venturini

Why was it done?

Pharmacist’s activities on MDs are mainly linked to governance, management and vigilance but little to clinical pharmacy practice. In order to study and develop interventions aimed at optimizing the use and compliance of medical devices on patients, a national survey was conducted to identify the clinical pharmacy experiences already consolidated in this field.

What was done?

Clinical pharmacy activities that demand specialized expertise in medical devices (MD) constitute a relatively uncharted territory for hospital pharmacists. Our aim, through a nationwide survey, was to delineate the clinical responsibilities overseen and handled by hospital pharmacists that necessitate a specific focus on MDs.

How was it done?

A 54-question survey, available from 1 October 2022 to 31 December 2022, was created by a pool of experts from an Italian scientific society (Italian Society of Clinical Pharmacy and Therapeutics – SIFaCT) and shared through Google Forms. The questions, divided into six sections, were related to five clinical areas defined by the working group: surgery room (SR), wound care (WC), vascular access management (VAM), patient education on diabetes treatment technologies (DTT) and MD in oncology and artificial nutrition (ON).
The questionnaire allowed us to define the state-of-the-art of clinical pharmacy on MDs, highlighting the activities and training needs of the participants.

What has been achieved?

We received 142 responses. In particular, emerged that 42% of participants adopted standard kits in the SR and 76% of them declared the pharmacist involvement.
A specific team for WC was created for 35% of participants, with the involvement of the pharmacist in 90% of cases, in particular as consultant role in 22%.
37% of participants declared the presence of a team dedicated to VAM, with the involvement of the pharmacist in 40% of cases and patient counselling in 9%. Finally, in DTT and ON the pharmacist was involved in 8% and 10% of the responses, respectively.

What next?

This first national survey shows that the pharmacist is often involved in multidisciplinary groups in the five analyzed areas, but less involved in patient’s counselling probably due to the sub-optimal training in the field of MDs. Indeed, almost all the participants declared the need to improve their knowledge in this field and create a network among colleagues.

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Author(s)

Beatriz Somoza-Fernández, Vicente Escudero-Vilaplana, Cristina Ortega-Navarro, Ana de Lorenzo-Pinto, Ana Herranz-Alonso, María Sanjurjo-Sáez

Why was it done?

HH units have experienced an extraordinary period of growth over the past few years and are already considered the preferred option of care model for most patients. However, its full potential is actually limited by some challenges both demanding and ripe with opportunities for pharmacy engagement, such as patient clinical complexity (usually elderly and chronic patients at greater risk of poor adherence and suffering from medication errors) and lack of medical staff physically available for monitoring patients’ evolution.

What was done?

We developed and implemented a comprehensive pharmaceutical care programme in a home hospitalisation (HH) unit.

How was it done?

The project was conceived by a multidisciplinary team (physicians, pharmacists, and nurses) that conducted a literature review and developed a new home medication management standardised operating procedure. The team worked in the design of a HH pharmaceutical care guideline and the implementation of an e-health care tool for remote patient monitoring.

What has been achieved?

1. HH pharmaceutical care guideline: it included the directions for the following measures: (1) a comprehensive pharmaceutical assessment and medication reconciliation, (2) standardised recommendations for optimising acute and chronic treatments at home, (3) daily interviews with patients or caregivers to explain medication changes, and (4) follow-up calls 7 days after discharge in order to assess medication adherence.
2. HH monitoring app: this new tool ensures pharmacotherapeutic monitoring by setting medication schedules and intake notifications. The platform includes a patient recording for vital signs, side effects, medication intake, and health status (functional status and quality of life). The system enables online access for pharmacists and physicians in real-time and continuous two-way communication.

What next?

Since our programme is easily applicable to any HH unit, we are working on implementing it in other hospitals in our country, in order to overcome HH medication management complexity nationally. We aim to conduct a multicentre study to evaluate its external validity in terms of increasing medication errors detected and optimising hospital resources.

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Why was it done?

This service emerged as a result of the COVID-19 pandemic, when the collection of hospital medication posed patients, many of whom were immunocompromised, at higher risk for COVID-19 and other infections, as they had to enter the hospital facilities. Over time, it was observed that this service was not only beneficial during periods of high SARS-CoV-2 transmission. RutiCar enabled medication pickup from the patient’s own private vehicle, avoiding necessity for parking as well as entering the hospital.

What was done?

In June 2021, the Pharmacy Department of Germans Trias i Pujol University Hospital(HUGTP) established an outpatient medication dispensing point located outside the hospital premises, “RutiCar”. This initiative facilitated patients in collecting their chronic treatments without entering the hospital, enabling direct access from their vehicles.

How was it done?

A new preparation and dispensing circuit was established. The patients specify their preferred date for medication pickup by telephone, e-mail or by a form after scanning a QR code. Pharmacy technicians undertake the responsibility of scheduling the appointment and preparing the medications one day prior to the designated dispensing day. The prepared medications are transported early in the morning to a temporary medication storage facility situated within the hospital’s parking area. Finally, the patient arrives at RutiCar at their scheduled appointment time and, without the need to exit their vehicle, collects their medication.

This service is aimed at patients with chronic treatments who have been on their medication for an extended period (>6 months) and show adherence. Pharmacists play an important role in this context, by ensuring that patients meet the criteria to initiate RutiCar service, reviewing treatments to validate their continuation and overseeing medication pickups to enhance patient adherence.

What has been achieved?

This service has led to an improvement in the medication dispensing process, assisting 10.46%(282) of the monthly average of patients who collect hospital medication(2695) and extending the hours for medication pickup, facilitating the work-life balance for patients and enhancing access to patients from remote areas.

What next?

In the future, improvements can be considered, such as implementing reminders for patients who have not yet scheduled their appointments and are projected to run out of medication soon, or automated appointment systems.

Author(s)

Ana Helena Ulbrich, Amanda Fonseca, Catherine Isoppo, Henrique Dias

Why was it done?

The motivation behind NoHarm stemmed from the time-consuming nature of the prescription review process, which required clinical pharmacists to assess not only drug interactions but also factors such as appropriateness, effectiveness, safety, adherence, and affordability of drug therapies. NoHarm was envisioned as a solution to systematize the workflow and provide cross-referencing of essential drug and inpatient information, thereby addressing these issues.

What was done?

The NoHarm initiative was developed to address challenges faced by clinical pharmacy teams during the prescription review process in a hospital setting. This open-source intelligent system was introduced to enhance the medication review process. The initiative was executed in a 420-bed public hospital in Brazil over a 17-month period to evaluate its impact on prescription reviews.

How was it done?

The implementation of NoHarm involved integrating the system with the hospital’s electronic health records to collect and compute all inpatient data. NoHarm utilized a drug knowledge base and intelligent algorithms to identify and alert healthcare professionals about inpatient risks. The algorithms were designed to cross-reference patient laboratory results with drug thresholds, adjust for liver and renal function, analyze drug usage patterns at the hospital, and extract patient risk factors from clinical notes, including diseases, adverse events, symptoms, and biometric data.

What has been achieved?

The number of medications assessed increased dramatically from 17,000 to 2,643,957 within the 17-month period, all while maintaining the same team size. Improved prescription review rates, rising from 65% to 94%, demonstrate the effectiveness of the system. Furthermore, these improvements in prescription reviews resulted in better clinical pharmacy services and contributed to reducing medication errors and associated risks in patient care at the hospital.

What next?

NoHarm is an open-source solution and an example of good practice in healthcare due to its achievements in streamlining prescription reviews and enhancing patient safety. Its successful implementation led to increased efficiency, higher prescription review rates, and substantial cost savings, showing its potential as a model for other healthcare settings. Its prospective global applicability makes it a solution to address medication errors and elevate the standard of care in healthcare institutions worldwide.