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Implementation of a clinical pharmacokinetics unit in a third-level hospital

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European Statement

Clinical Pharmacy Services

Author(s)

María Calvo Arbeloa, Ana Isabel Idoate Grijalba, Mónica Uxue Beunza Sola, Daniel Fresán Restituto, Regina Juanbeltz Zurbano, Diana Tejada Marín , Andrea Rodriguez Esquiroz, Maite Sarobe Carricas

Why was it done?

Patients with special characteristics show a great variability in pharmacokinetic and pharmacodynamics (PK/PD) parameters, which may influence the efficacy and safety of antibiotic therapy.

What was done?

A Clinical Unit of Pharmacokinetics was implemented in the Service of Pharmacy (PS) for therapeutic drug monitoring (TDM) in patients.

How was it done?

1. Selection of drugs to be monitored: Antimicrobials (Vancomycin, amikacin, linezolid and voriconazole), Immunosuppressants (tacrolimus), Antineoplastics (methotrexate) and digoxin.
2. Installation of the Abbottbase Pharmacokinetic System (Pks®) software.
3. Creation in the Computerised Clinical History (CCH) a sheet for collecting anthropometric and pharmacological data and pharmacokinetic interpretation of the results obtained.
4. Creation in CCH of a consultation option for clinicians to request monitoring from the PS.
5. Formative session for clinicians and nurses.

What has been achieved?

To begin with the unit, we selected three drugs: vancomycin, amikacin and voriconazole. The hospital pharmacist or the clinician chose the susceptible patients.
Between December 2021 and September 2022, 171 determinations were made in 73 patients: 134 (78.36%) for vancomycin, 24 (14.06%) for amikacin and 13 (7.60%) for voriconazole. Forty-six (63.01%) patients were men and the mean age was 56.58 (17-97) years- old. Eighteen (24.66%) patients were obese. The mean creatinine level was 0.82 (0.4-2.69) mg/ml and glomerular filtration according to the Cockcroft and Gault formula was 81.16 (23.68-161.98) ml/min/m².
For vancomycin, 45 (88.24%) patients started the treatment with a standard dose of 1000 mg every 12 hours. In first determinations, 27 (52.94%) were under-therapeutic and 20 (42.55%) were overdosed. After modifying the dosage regimen, 35 (74.47%) were in range, 3 (6.38%) under-therapeutic and 13 (27.66%) supra-therapeutic.
In case of amikacin, 17 (85%) patients started with a standard dose (1000 mg every 24 hours) achieving target levels only in one case. All were under-therapeutic. After modifying the dosage regimen, we achieved the objective in all of them.
For voriconazole 3 patients were monitored. In 10 (43.5%) determinations, a change in dosage regimen was suggested due to subtherapeutic levels. All (100%) of the recommendations given by the PS were accepted.

What next?

The implementation of the unit in our hospital shows the usefulness and the need to extend pharmacokinetic monitoring to other medical services and drugs.

Creation of an ‘Agrippal’ programme to fight against nosocomial flu

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European Statement

Introductory Statements and Governance

Author(s)

Alexandre Benaiche, Mickael Tachon, Nathalie Arnouts, Amandine Gradelle, Kadidja Gribi, Remi Parsy

Why was it done?

The ‘Agrippal’ programme was created to strengthen the anti-influenza herd immunity in our hospital and reduce the risk of nosocomial influenza. It was then necessary to improve both the vaccination rate of the staff and the inhabitants of the institution’s living area who were potential users. The vaccines were previously distributed in departments and injections made by the nursing staff without any traceability. The purpose was also to improve knowledge about anti-influenza vaccination among staff and users.

What was done?

Our Healthcare-Associated Infectious Risk Prevention Unit (made up of hygienist pharmacists and nurses) launched a programme to fight against nosocomial influenza in our institution in winter 2018 to promote vaccination among staff and users and inform them about vaccination inside and outside the hospital.

How was it done?

Information conferences were held inside and outside the walls of the hospital for staff and residents of the city thanks to a partnership with the municipality to finance these events and communicate about their occurrence. Information materials (flyers) have also been made available to departments and some key departments (Emergency, Consultations, Obstetrics) were encouraged to inform patients at risk and their families about the positive impact of vaccination with provision of Health Insurance reimbursement forms. Our Healthcare-Associated Infectious Risk Prevention Unit created a Mobile Vaccination Team to vaccinate staff directly in the departments and encourage those who have not been vaccinated to do so.

What has been achieved?

The staff flu vaccination rate increased sharply, from 19% and 17% respectively in 2016 and 2017 to 34% in 2018 and 39% in 2019. Among vaccinated staff, 25% in 2018 and 17% in 2019 were primary vaccinated. Although the impact of actions aimed at users is difficult to measure, the number of nosocomial flu has been reduced in our hospital from 3.14 per 10,000 days of hospitalisation in 2017 to 0.58 and 0.61 respectively in 2018 and 2019.

What next?

This initiative has made it possible to double the rate of vaccinated staff in our institution and strengthen patient protection by reducing the risk of nosocomial flu. It only required a period of consultation between different actors without creating additional financial and human resources.

Extensive renal pharmacotherapy course for hospital pharmacists

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European Statement

Clinical Pharmacy Services

Why was it done?

Kidney disease carries a significant worldwide health burden. In more the incidence of stage III chronic kidney disease in more than 9%. Many hospitals in Oman have special units of nephrology but clinical pharmacy services for these patients are almost none. It was important to upskill practicing pharmacists’ knowledge and skills to provide comprehensive pharmaceutical care for patients with renal diseases.

What was done?

An online 8-week course was developed by an experienced and certified renal clinical pharmacist with an aim of enhancing the knowledge and skills of pharmacists practising in primary, secondary and tertiary care hospitals in Oman. The course covered all the topics required to develop the skills of the pharmacists to enable them to deal with renal prescriptions and be able to intervene in any medication related problem in patients with kidney diseases. Before and after knowledge assessment was done for the participants to enable justify the benefits of the Course. Towards the end of the course a satisfaction survey was also completed by the participants to provide ensure achieving desired outcomes.

How was it done?

The course was hybrid and the beginning with some sessions carried out face-to-face and some online.
The course included topics such as acute kidney injury, chronic kidney disease, drug induced kidney diseases, medication management in renal replacement therapy and kidney disease complications. The course was interactive with case study discussions, question and answer sessions and some assignments done by the participants at home. The course was designed based on Kirkpatrick foundational principles with consideration of the four levels of learning.

What has been achieved?

Twenty pharmacists participated in the first cohort and 23 in the second cohort. The attendance was more than 90% throughout the course. The pharmacists were keen to learn and ask questions. There was a clear difference in knowledge before and after the course with only 19% of participants passing the pre-course assessment compared to more than 80% of participants passing the post-course assessment.

What next?

The course was highly appreciated by the participants and would run the course and regular intervals with considerations to applications from the Gulf region since they share similar practice and disease burden.

Development of a pharmacy-led technical assessment pathway for personal protective equipment

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European Statement

Selection, Procurement and Distribution

Author(s)

Rachel Huey, Catherine Goudy, Michael Scott

Why was it done?

The assessment process was developed in partnership with the Business Services Organisation Procurement and Logistics Service (BSOPaLS) and regional Infection Prevention and Control (IPC) colleagues in response to the outbreak of COVID-19 and escalating demand for PPE. In March 2020, early World Health Organization (WHO) guidance formed the basis of COVID-19 PPE ensemble recommendations. Prior to the COVID-19 pandemic, BSOPaLS procured such items from reputable market leaders. However, during this time of unprecedented demand on supply chains, there were many new manufacturers and suppliers with no previous experience of appropriate supply to healthcare. There were also many counterfeit goods being placed on the healthcare market.

What was done?

During the COVID-19 pandemic, the Medicines Optimisation Innovation Centre (MOIC) utilised pharmacist skills to undertake technical assessment of all Personal Protective Equipment (PPE) items procured for use across Health and Social Care Northern Ireland (HSCNI).

How was it done?

MOIC reviewed and validated all technical documentation associated with each PPE product to ensure that items procured were genuine, fit for purpose and met the relevant standards and regulations. Benchtop assessments were carried out by IPC colleagues and BSOPaLS carried out all procurement due diligence checks on potential suppliers. Early data from 1 April 2020 to 15 May 2020 showed that only 98 (16.5%) PPE offers reviewed met the required standard for approval, while 264 (44.6%) were rejected and a further 230 (38.9%) remained open. Some reasons for rejection included documentation deficiencies and misleading labelling.

What has been achieved?

This process resulted in procurement of only safe and effective products, putting safety of HSCNI staff and patients at the forefront. In addition, BSOPaLS worked closely with local manufacturers with no previous PPE experience, to establish more resilient supply chains for the future. Products manufactured locally were also assessed via this process, to ensure suitability for use within healthcare.

What next?

This efficient assessment process has now been implemented into the PPE procurement pathway for all future HSCNI purchases, enabling the application of due diligence in a transparent, robust and evidence-based manner. Provided there is opportunity to develop an appropriate knowledge base of the relevant regulations and standards, this process is transferable across many healthcare organisations.

Pharmacist-led antimicrobial stewardship in the management of COVID-19 patients

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European Statement

Clinical Pharmacy Services

Author(s)

Nóra Gyimesi, Andrea Bor, Eszter Erika Nagy, András Süle

Why was it done?

Evidence suggests that the rate of bacterial co-infection among COVID-19-infected patients is low. However, routine use of antibiotics was common in the early stages of the treatment.

What was done?

Clinical pharmacist participated in the therapeutic decision making of COVID-19 patients treated in our institution in order to ensure the optimal choice of medicines with special regard to the use of antibiotics.

How was it done?

A daily therapeutic discussion was started in the quarantine department from 2021, with the participation of clinical pharmacists, during which all therapy initiation were consulted. The pharmacist was involved in the walk-arounds and reviewed the medication therapies of each patient daily. The clinical pharmacist advised on the starting, or, if it was considered unnecessary, the stopping of the antibiotic therapies, as well as the monitoring required. The choice and dosage of antibiotics were also consulted.

What has been achieved?

Of the 314 patients treated in the Quarantine Department of our institution between September 2020 and May 2021 104 (33%) received antibiotic therapy during treatment, with 73% of cases initiated within 72 hours of admission. In 68 cases, bacterial superinfection was the indication for antibiotic therapy, of which only 9 cases had radiologist-confirmed bacterial co-infection. The rate of antibiotic usage has decreased after the intervention was started. During the second wave of the coronavirus epidemic (until February 2021), 41% of patients received antibiotics, while during the third wave (from March 2021), 28% of patients.

What next?

The pharmacist involvment, along with increasing experience and evidence for the clinical management of COVID-19, have moderated antibiotic use, however antibiotic overuse is still significant. Our Department of Pharmacy developed a local COVID-19 treatment guideline with emphasis on antibiotic use requirements. The education and promotion of this guideline will be undertaken by clinical pharmacists. Multidisciplinary therapeutic decision-making and strengthening of antibiotic stewardship programs are necessary for proper antibiotic use practices in the treatment of coronavirus patients.

INTRODUCTION OF REGULATORY AND HEALTH WATCH IN THE CLINICAL TRIALS AREA

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European Statement

Patient Safety and Quality Assurance

Author(s)

Diane Le

Why was it done?

When the case for a study sponsored by the hospital has been filed a few months ago, the national agency authorizing trials raised the issue of health waltch, particularly the management of drug recalls. With the research department, which alerted us on the lack of resources for health alerts, and at the same time facing an international cease of some drugs, we set up a health alert and a regulatory watch system, to improve the quality of product and the patient’s safety.

What was done?

We set up a daily health and regulatory watch to stay abreast of any news. Regarding health watch, we included : studies for which the hospital is the sponsor ; studies for which the experimental treatments are not provided by the sponsor ; treatments used for adverse events and authorized by the sponsor.

How was it done?

Daily regulatory watch is carried out on the national legislation website with daily updates of national texts. If a new rule applies, it is written in a table to alert everyone.
Daily health watch is also carried out on the site of the national agency of drugs. Four types of information are recorded: drug shortages, alerts, recalls and releases.

What has been achieved?

Tables collecting those information are available on the pharmacy’s network so that anyone can read them, and can be shared with clinical research officers. To that day, some information has been collected due to a european legislation update on the clinical trials and has allowed us to anticipate what will change next year. We have not yet faced a drug recall but what has been done will allow us to react in the best way when this will happen.

What next?

The aim for carrying out regulatory and health watch is to allow us to quickly react and anticipate future problems, while keeping in mind the patient’s safety and the pharmacy practices improvement. This work was therefore completed with success, demonstrating the ability to react and the desire to deploy continuous improvement initiatives to strive for operational excellence and pharmaceutical. We now want to implement this work in the daily activity and extend it to other sectors.

Digitization: a key to improve health condition of patients with cancer disease

European Statement

Clinical Pharmacy Services

Why was it done?

the app was developed in order to improve therapeutic adherence, pharmacological counseling, management of adverse events and increase pharmacovigilance’s reports with higher data quality. The World Health Organization recognizes that 20% of health is due to medical care, 20-30% to lifestyle, while the remainder depends on the environmental, social, genetic and psychological conditions of the individual. The goal of this app is to improve patient’s therapeutic path at different levels and breaking down geographical barriers.

What was done?

the Sars-cov-2 pandemic entailed a lot of new challenges for the Hospital pharmacist . As the scenario was completely new, it was developed an app to better manage patients with cancer disease treated with oral chemotherapy.

How was it done?

Patient has been divided into two groups, of which only one group use the app to manage the therapy. The primary endpoint was the improvement of therapeutic adherence, while the secondary endpoints are: improve in the quality of patient life (HRQoL), increase pharmacovigilance’s reports and avoid therapeutic errors.

What has been achieved?

The continuous dialogue between patients and hospital pharmacist througt system’s online messaging app improved the management of patients needed and reduce drug interactions. Digital management led to a 56% increase of pharmacovigilance reports. It was also detected a reduction in overall costs and patient uneasiness.

What next?

the health system has to be reorganized around patient’s needed, by promoting the use of more and more homogeneous, safe, transparent and accessible technologies.
Regulatory authorities should accelerate the adoption of digital solution. In this new framework hospital pharmacist will play a key role in the development of value based medicine and in the process of treatment humanization as a patient’s landmark person too.

DESIGNING A PROTOCOL TO IDENTIFY AND IMPROVE ADHERENCE IN PATIENTS WITH ANTIRETROVIRAL THERAPY IN THE HOSPITAL SETTINGS.

European Statement

Clinical Pharmacy Services

Author(s)

Luis Díaz Suárez, Elena Sánchez-Yanez , Raquel López Escoz, Mercedes Gómez Delgado, Nuria Martínez Casanova, Isabel Moya Carmona

Why was it done?

The hospital pharmacist plays a role obtaining therapeutic success by improving the adherence. Our unit attends around 1900 HIV patients, so the interventions we make to improve adherence will have a positive impact on patients and community.

What was done?

The Pharmacy Service has developed a protocol for the identification of non-adherent HIV patients to treatment along with the pharmaceutical attendance strategies designed to improve the adherence to ART.

How was it done?

The protocol was drawn up with the recommendations of the National AIDS Plan(PNS), the Spanish Society of Hospital Pharmacy(SEFH) and the AIDS Study Group(GeSIDA). Thus, we wanted to provide a multidisciplinary approach for non-adherent patients. The relevant aspects of the protocol are described below:

1.-Identification of patients: Technical staff and pharmacists identify patients with poor adherence through dispensing records, a history of previous voluntary abandonment of ART or the presence of risk factors for poor adherence to ART.

2.-Pharmaceutical attendance following the CMO model.

· Data such as viral load, CD4, prescribed ART, pharmacotherapeutic complex index, home medication, polypharmacy, pluripathology and risk factor have
been collected. Adherence was calculated using dispensing records and adherence questionnaire(SMAQ).

· Health education and motivational interviewing.

· Personalised planning of patient care following face-to-face and non-face-to-face programs. Every 6months adherence will be re-evaluated to assess the
success of the pharmaceutical care offered.

What has been achieved?

The protocol was implemented in March-2021, and to date, 68patients have been included. 73.5%(n=50) of them have been followed for more than 6 months. 88% of whom(n=44) improved their adherence to both ART, all of them achieving an undetectable viral load and an elevation of the CD4 count.

What next?

Our desire is to continue detecting patients and to contribute to the improvement of the adherence to their treatment. We are aware of the challenge that lies ahead in the near future, as the progressive ageing of the HIV population means an increase in associated comorbidities and polypharmacy, which may have a negative impact on the adherence.

Implementation of an Antibiotic Stewardship Program in Primary Care

European Statement

Clinical Pharmacy Services

Author(s)

CLARA NOTARIO DONGIL, ALEJANDRO MARCOS DE LA TORRE, MARÍA CARMEN CONDE GARCÍA, MARÍA MAR ALAÑÓN PARDO, BEATRIZ PROY VEGA, NATALIA ANDRÉS NAVARRO

Why was it done?

Most of the cultures performed in outpatients were not reviewed or were reviewed too late. An early detection for an adequate control of multidrug-resistant bacteria and the setting of a targeted antibiotic treatment, in case of being necessary, was the aim of this project. Hence basis for the implementation of an ASP is laid down, giving also advice to medical staff regarding appropriate antibiotic treatments.

What was done?

Multiresistant bacteria containment is a public health priority. Antibiotic Stewardship Programs (ASPs) can help to enhance patient outcomes by improving antibiotic prescribing. ASPs are common in hospitals, but are not usually available in primary care.

How was it done?

1- A circuit between microbiology laboratory staff, preventive medicine and pharmacy service was done. The first two collaborated by presenting data from lab results.
2- Cultures of multidrug-resistant species of outpatients were included. Results were interpreted by a hospital pharmacist on a daily basis.
3- A circuit of telephone calls between pharmacy and primary care was settled in order to communicate high epidemiological impact species detected. Pharmacist collaborates by giving advice regarding the right drug, right dose and right time, only when antibiotic treatment was necessary. Reports were registered on the medical history.
4- Variables collected in database were: age, sex, institutionalized, antibiotics received, kidney disease, culture type, specie.

What has been achieved?

During five months, 52 patients were included (52% male, 48% female). Mean age: 68 years. 11% institutionalized patients. 31% presented kidney disease.
Urine culture (58%),skin culture (13%), bronchial/sputum culture (12%), stool culture (12%), , and other cultures (5%) were analysed. Multidrug-resistant species (spp) were: Klebsiella spp (34%); Pseudomonas spp (8%); Mycobacterium spp (6%); other spp (52%).
17 pharmacist interventions were carried out, all of them related to appropriated treatment. 2 patients were hospitalized in order to receive parenteral antibiotic.

What next?

Optimizing antibiotics use is important to effectively treat infections. Identifying species that generate therapeutic difficulties is essential. Pharmacist advice could reduce treatment failures applying efforts to improve antibiotic use, being link of union between hospital and primary care. Other activities such as providing training to medical staff or spread results regarding to the use of antibiotics will be critical for ASP development.

MEDICATION REGIMEN COMPLEXITY INDEX AMONG SOLID ORGAN TRANSPLANT PATIENTS

European Statement

Clinical Pharmacy Services

Author(s)

Andrea Costa-Navarro, Emilio Monte-Boquet, Mª Jesus Cuellar-Monreal, Ana Garcia-Robles, Eduardo Guerrero-Hurtado, Alejandra Ferrada-Gasco, Octavio Ballesta-Lopez, Andres Cruz-Sanchez, Jose Luis Poveda-Andres

Why was it done?

Complex medication regimens (MR) are associated with worse treatment adherence. The Medication Regimen Complexity Index (MRCI) is a validated tool used to quantify complexity of MR and it is the sum of the score in three sections: Dosage forms (A), dosing frequency (B) and additional directions (C).

What was done?

To assess the relative MR complexity among solid organ transplant patients (SOT; kidney, heart, lung and liver) in a tertiary hospital through the validated MRCI Spanish version.

How was it done?

Transplant patients who collected medication in the Hospital Pharmacy between January and March 2021 were selected. A total amount of 40 patients (ten per transplant) were chosen randomly through Excel®, and a macro with a template of MCRI was created. The qualitative variables were age, sex and type of transplant; the quantitative ones were months from transplant, total amount of medications, sections A, B, C and total MRCI. All prescribed medications documented in medical records at the hospital ambulatory clinics and the electronic medication list were included. Patients were excluded if they were followed-up in other hospitals, were exitus or MR dosage or frequency was missed/unclear. Subgroup analyses was made to assess MRCI among type of transplants through ANOVA. All data analysis were made with SPSS® version 23, with a <0,05 significance level and a confidence interval of 95%.

What has been achieved?

Sample median age was 56,6±14,7 years (95%CI:51,9-61,3), a 40%(16/40) were women, median of time from trasplant was 92,7±69,9 months (95%CI:70,4-115,0) and number of medications 11,1±4,6 (95%CI:9,6-12,6). Subgroup median MCRI were 23,3±10,2 (kidney; [95%CI:16,0-30,5]), 46,2±12,8 (lung; [95%CI:37,1-55,3]), 28,5±11,1 (heart; [95%CI:20,6-36,4]) and 18,7±5,4 (liver; [95%CI:14,8-22,5]). Section B was the most contributor to MCRI (16,6±8,2 [95%CI:14,0-19,2]), followed by C (6,6±4,3 [95%CI:5,2-7,9]) and A (5,7±3,7 [95%CI:4,5-6,9]). Tukey test showed a statistically significant MCRI in lung transplant with p<0,001 when compared to kidney and liver transplants, and p=0,002 compared to heart transplant.

What next?

Medication regiment of our sample was more complex in lung patients than in any other SOT, therefore these patients could benefit more pharmaceutical interventions. Further studies with bigger samples are required to confirm differences among kidney, liver and heart transplants.