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Rethinking pharmacy and therapeutics committee procedures to achieve the efficiency required to overcome hospital complexity

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European Statement

Clinical Pharmacy Services

Author(s)

Sara Rodrigues, Sofia Pinheiro, Vandewalle Björn, Paulo Martins, Sofia Ferreira, Paulo Pereria, Jorge Félix

Why was it done?

Shared decision-making between pharmacists and physicians is key to PTC functioning and efficiency. Responsibilities include managing policies and procedures for appropriate use of high quality and cost-effective health technologies at hospitals. PTC performance is paramount to overall hospital efficiency.

What was done?

This project seeks to assess and redesign (optimize) existing Pharmacy and Therapeutics Committees (PTC) procedures within a University Hospital Centre (UHC – six public hospitals). The goal is to enable sound decision-making that significantly contributes to UHC key performance indicators, all while ensuring timely patient access to effective medication.

How was it done?

The project comprises four phases: (1) gathering feedback from stakeholders (PTC members; hospital service/pharmaceutical department directors) regarding their current involvement in PTC information flows, procedures, and decision-making; (2) developing a value-based criteria-matrix, across stakeholders, in a multiple-criteria decision analysis context, to guide future PTC decision-making; (3) rethinking PTC procedures and information flows; (4) assessing the effectiveness of the redesigned PTC model after 12 months. First phase included: a Likert-scale based survey1 for PTC members to evaluate their involvement in activities described in the internal PTC regulation, and a semi-structured interview-based survey2 for all stakeholders to characterize existing information flows and PTC mediated decision-making processes.

What has been achieved?

First phase: eight of 10 PTC members participated in survey1. Activities with 100% engagement of PTC members: prescription reviews; coordination with National PTC; monitoring of medicine utilization, antibiotics resistance and safety; advise the UHC management board. Activities with major non-engagement: monitoring/reporting of complementary diagnostics prescription (87.5%); medication therapy management programs (62.5%); National pharmacovigilance system activities (62.5%); therapy cost assessment (50%). In survey2 (n=14) authorization process for medicines utilization was accurately characterized, clearly identifying responsibilities for all clinical and pharmaceutical departments. Heterogeneity exists between urgent and non-urgent utilization requests. PTC members and pharmacy departments were more likely to use electronic platforms than clinical departments.

What next?

Next phases are under way to better support current competencies, information flows, procedures, and the shared decision-making processes offering an opportunity to rethink the PTC procedures in the University Hospital Centre and leverage efficiency over hospital complexity.

THE ROLE OF DNA SEQUENCING AND MOLECULAR TUMOR BOARD COUNSELLING IN THE SELECTION OF THE MOST APPROPRIATED THERAPY IN ONCOLOGY

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European Statement

Clinical Pharmacy Services

Author(s)

Marta Anghilieri, Francesco Guidoni, Vito Ladisa

Why was it done?

The new DNA sequencing techniques, globally defined “Next Generation Sequencing (NGS)”, allow the parallel sequencing of many samples producing in short times a big amount of data. To enable comprehensive analysis of the data and develop new specific and clinically useful therapies, we have introduced the approach of evaluating the data by the MTB, which includes pharmacists as experts in drugs and their use.

What was done?

Hospital Pharmacists (HPs) are integrated into the Molecular Tumour Board (MTB), a multidisciplinary group, to select the most appropriated therapy for oncology patients, ensure and facilitate patient access, and demonstrate therapeutic appropriateness found by MTB analisys.

How was it done?

MTB members, including HPs, perform DNA sequencing on each patient using NGS to identify known/unknown alterations. These data are entered into a database available to all MTB members and are the basic tool for selecting potential target therapy. The MTB meets once a week to discuss and integrate the observed DNA alterations with the patient’s clinical history. In this way, the most appropriate target therapy for the patient can ultimately be selected. The HPs then provide the patient with access to medications.

What has been achieved?

In this study, 208 patients affected by Non-Small Cell Lung Cancer were evaluated. DNA sequencing of patients identify 117 altered genes. After an extensive literature search, 15 genes were highlighted as potential targets for available drugs. They marked 116 patients potentially tractable with target therapy, of which 47 patients were candidates to a target therapy already in clinical practice and 69 to a target therapy not in clinical practice. Comparing the two groups, among candidates for drugs in clinical practice, treatment was started in 65% and continued in 53%; among those treated with drugs not in clinical practice, treatment was started in 23% and continued in 69%.

What next?

The inclusion of HPs in MTB allows for more deliberate use and better selection of drugs. HPs provide valid support to select drugs and facilitate access to them: HPs individualise the applicable therapy for a larger number of patients through MTB, they analyse the therapeutic outcome (MTB-selected therapy has a bigger chance to last longer) and the cost impact on the NHS.

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.

Structured implementation to secure rapid and efficient changes of medicines: a national workflow

European Statement

Introductory Statements and Governance

Author(s)

Mikala Vasehus Holck, Jette Østergaard Rathe

Why was it done?

The role of the National Medicines Council (NMC) is to provide guidance about new medicines for use in the public hospital sector.

Recommendations from the NMC must be implemented at hospitals. Implementation of changes of medicines requires preparation and collaboration and involves numerous stakeholders, e.g. drug and therapeutic committees, hospital pharmacies, clinicians, and the national supply organization (NSO) to public hospitals. Knowledge sharing is crucial to ensure efficient implementation.

We needed a workflow focusing on knowledge sharing at national level, and thus we introduced the structured implementation workflow in September 2019.

What was done?

We have established a structured implementation workflow focusing on knowledge sharing. The workflow ensures rapid and efficient implementation of changes of medicines, and a more aligned treatment at national level.

How was it done?

To ensure knowledge sharing through the workflow, we developed:

– Implementation memo: Summarizes NMC recommendations and treatment guidelines, with information about current and upcoming tendering procedures and prices. The memo is shared with the stakeholders.

– Implementation group: The group is a mix of people with a direct connection to the implementation workflow. The group ensures that implementation of the recommendations from the NMC is regularly discussed and assessed.

– Implementation site: An intranet for the NSO and hospital pharmacies to share information and material related to the implementation of changes of medicines.

– A system to ensure that essential stakeholders receive the same information.

What has been achieved?

The structured implementation workflow has been a success and is now an integrated part of implementation. Evaluation shows that the workflow with knowledge sharing between relevant stakeholders is essential for effective implementation of changes of medicines, and it identifies discrepancies at national level.

What next?

The structured workflow is an integral part of managing the national implementation, and the workflow and outcomes will continue to undergo evaluation.

The workflow provides the basis for knowledge sharing and can easily be transferred to other healthcare settings.

USE OF LINKED DATA SOURCES IN DYNAMIC DASHBOARDS TO VISUALISE HOSPITAL PRACTICE DIFFERENCES IN MEDICATION USE AND OUTCOMES

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European Statement

Patient Safety and Quality Assurance

Author(s)

Rawa Ismail, Jesper van Breeschoten, Michel Wouters, Anthonius de Boer, Alfonsus van den Eertwegh, Maaike van Dartel, Caspar van Loosen, Doranne Hilarius

Why was it done?

Most drugs obtain approval based on limited numbers of highly selected patients and mostly surrogate outcomes. Little is known on hospital variation on the use of new treatments in daily clinical practice. Benchmark information can be used to limit between hospital variation and provides real world evidence on the value of these treatments.

What was done?

In the Dutch Institute for Clinical Auditing (DICA) medicines project, administrative data on the use of expensive drugs from hospital pharmacies were linked to clinical data from national quality registries and hospital declaration data. Data were visualised in six dynamic dashboards (lung cancer, breast cancer, rheumatic disorders, colorectal cancers, gynaecological cancers and metastatic melanoma), leading to insight into expensive drugs use and clinical outcomes in real-world practice.

How was it done?

The three data sources were linked using patient-specific data and provide real-world insights in anti-cancer drug use and outcomes. After linkage, data were validated by individual sessions with hospital pharmacists and medical specialists.

What has been achieved?

Hospital pharmacists and medical specialists gained insight into expensive drugs use and treatment patterns in patient groups, compared to other hospitals. The dashboards also contain information on outcomes such as toxicity, emergency admissions, time-to-next treatment and users receive signals when their use of expensive medicines deviates from the benchmark. An example of the information provided by the dashboards was the number of stage IV non-small cell lung cancer patients treated with only one or two gifts of pembrolizumab. All hospitals received a report on this subpopulation to improve their treatment approach. Other findings were differences in the adjuvant treatment of stage III colon carcinoma patients and the treatment duration of trastuzumab/pertuzumab as adjuvant treatment in breast cancer patients.

What next?

The DICA medicines project is an example of good practice as it reuses available data sources without any additional registration burden. In the future, the dashboards will be extended with survival data and PROMs data. The focus of the program in the next year will be to include all hospitals in the Netherlands and to extend the dashboards with more features.

PHARMACEUTICAL INTERVENTIONS IN PARENTERAL NUTRITION: METHODOLOGY AND RESULTS (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

Teresa Cabeças, Sara Franco, Rita Oliveira, Maria Pereira

Why was it done?

PN is an alternative or complement in patients whose oral and/or enteral nutritional intake is inadequate/unsafe or whenever the digestive tract is not functioning or this route is contraindicated. Success in choosing the most appropriate PN depends on a specialised multidisciplinary team that can provide nutritional support that results in improved clinical outcomes and patient safety. With the decision flowchart (designed in January 2019), the hospital clinical pharmacist intervenes in the calculation of the patient’s nutritional needs and, consequently, in the counselling of the most appropriate PN bag and clinical and biochemical monitoring of the patient.

What was done?

Definition and implementation of action methodology, in a form of flow chart, for patients in need of parenteral nutrition (PN).

How was it done?

Implementation of the following therapeutic decision methodology: 1. Validation of parenteral support nutritional option according to decision flowchart; 2. Filling out a patient’s nutritional needs spreadsheet −anthropometric assessment; biochemical data; calculation of protein requirements; calculation of non-protein energy needs; calculation of total energy requirements; choosing the appropriate volume; validation of the route of administration; 3. Selection of the most suitable PN bag from the Hospital Formulary (preferably after ionic corrections); 4. PN bag suggestion to the prescribing physician; 5. Acceptance and alteration (or not) by the prescribing physician; 6. Clinical and biochemical monitoring of the patient; 7. Optimisation of nutritional therapy when applicable.

What has been achieved?

From January to August 2019 the Pharmaceutical Services intervened in all 21 PN prescriptions. In this universe, 15 were in the context of gastroenterology surgery, 5 due to infection and 1 due to non-gastrointestinal cancer disease. The intervention was not accepted in only 5 cases.

What next?

Clinical pharmacists play a key role in supporting the prescription of PN. The future is challenging, particularly in assessing patients’ outcomes and quality of life, as well as the economic and financial dimension. It will also be essential to create a Clinical Nutrition Commission that covers PN, enteral and oral feeding.

DESIGN OF AN ANTI-HAEMORRHAGIC AGENTS PROTOCOL FOR AN INTENSIVE CARE UNIT (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

Mercedes Gómez-Delgado, Marta Valera-Rubio, Margarita Carballo-Ruiz, José Luis Ortiz-Latorre, Isabel Moya-Carmona

Why was it done?

Blood coagulation factors and their adequate use can be of particular importance in the treatment of massive haemorrhage, especially in the ICU. This initiative was taken in order to improve uptake and to avoid errors in the administration, which can be difficult in emergency situations.

What was done?

To define an emergency procedure that ensures correct management in cases of massive bleeding in an intensive care unit (ICU).

How was it done?

The development of drug use protocols for emergency situations is a simple task that facilitates health workers to manage them. Prioritising the drugs to be included in a protocol by a previous survey in a multidisciplinary setting is important to consider the different points of view. We carried out a review of the pharmacy service to the ICU needs of antihaemorrhagic drugs. ICU staff (doctors and nurses) were informed to reach an agreement about eligible drugs for being included in the protocol. ICU staff requested the inclusion of four drugs in the protocol according to the prevalence of use and the difficulty of administration: human fibrinogen, tranexamic acid, eptacog alfa and human prothrombin complex. We created a protocol with four information sheets, one of each drug, made of schematic information about: 1. Physical location (fridge or room temperature, number of shelf) and minimum safety stock (3 units of human fibrinogen, 4 units of tranexamic acid and 3 units of human prothrombin complex). 2. Indications and dosage according to the clinical situation and the patient characteristics (dosage adjustment according to renal or hepatic impairment, weight or age when applicable). 3. Recommendations for intravenous administration (flow rate, bolus, loading dose, dilution, mixture stability).

What has been achieved?

Mapping the information and dividing it into sections is essential for its rapid understanding in a high-stress work environment. The implementation of this protocol was well embraced by all the staff involved, since it allowed a more efficient health care circuit for the ICU staff. It also optimises the consumption of this type of more monitored drugs.

What next?

We will monitor the compliance with this protocol, as well as possible updates that may be beneficial for a better understanding of the forms of administration.

THE PHARMACIST IN THE LUNG CANCER MULTIDISCIPLINARY TEAM

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European Statement

Clinical Pharmacy Services

Author(s)

Ana Soares, Armando Alcobia

Why was it done?

Several clinical practice guidelines for LC recommend that multidisciplinary teams should be used to plan patients’ treatment. The evolution of thoracic oncology, namely the increasing knowledge of the diverse histologic and molecular phenotypes in non-small cell LC, has been driven to more complex treatment algorithms in recent years. This complexity increases the need for a multidisciplinary approach in therapeutic decision-making, which must be individualised and based on the best information available. The pharmacist’s inclusion in the multidisciplinary team is essential and was formerly proposed by the Pneumology Director to the Hospital Administration Board.

What was done?

A hospital pharmacist is a permanent member of the lung cancer (LC) multidisciplinary team, which has met weekly since January 2016, to plan the management and treatment of LC patients in our hospital. The pharmacist brings updated information about the efficacy and safety of drug treatments, its cost-effectiveness and its availability. The pharmacist improves communication with the Pharmacy and Therapeutic Committee.

How was it done?

The multidisciplinary team meets weekly to discuss the diagnosis and treatment options of LC patients, and includes a dedicated group of professionals: pulmonary oncologists, a thoracic surgeon, a radiation oncologist, a radiologist, a pathologist, a nuclear medicine specialist, a hospital pharmacist, a palliative care physician and an oncology nurse.

What has been achieved?

About 240 cases, corresponding to 200 patients were discussed per year. An average of 110 solicitations to the Pharmacy and Therapeutic Committee were made. The multidisciplinary team grants a systematic approach to diagnosis and therapeutics, in compliance with evidence-based guidelines, improves communication and coordination between professionals and short waiting times for the patient.

What next?

The next step is to systematise real-world data collecting, from the patients treated, to better understanding the effectiveness of treatment options and the real impact of the multidisciplinary team in patient outcome, ideally, extending it onto a national level.

IMPLEMENTATION OF THE FIRST MEDICINES INFORMATION SERVICE IN BELGIUM

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European Statement

Clinical Pharmacy Services

Author(s)

Elise Deyaert, Hilde Collier, Pieter-Jan Cortoos, Claudine Ligneel

Why was it done?

Medication errors are often caused by insufficient knowledge among healthcare professionals. Given limited clinical pharmacists’ presence on Belgian hospital wards, a pharmacy-led MIS can efficiently provide fast, accurate and objective medication-related information.

What was done?

We implemented the first Belgian Medicines Information Service (MIS) in our university hospital. In several countries, a MIS is common in most hospitals but until our project, no such MIS was available
in Belgian hospitals.

How was it done?

Best practices were researched through literature review and site visit at Charing Cross Hospital (London, UK). Secondly, in order to customize activities, all nurses and physicians were surveyed on medicines information needs. Our MIS was set up to centrally (1 dedicated pharmacist, phone number and e-mail address) receive medication-related questions from healthcare workers with the option to request additional clinical-pharmaceutical interventions (e.g. drug review). Implementation was accompanied by mailings, posters, business cards and presentations. All enquiries were registered in the MiDatabank® (UKMi National Medicines Information) and evaluated after 4 months, together with user satisfaction.

What has been achieved?

221 respondents (113 physicians, 103 nursing) to our survey found ‘drug administration/dosing’ (79.7%), interactions (69.6%) and ‘tablet crushing’ (49.7%) major problematic topics. Physicians rated the MIS to be useful for drug review, counselling and interactions while nursing preferred support on drug administration and tablet crushing. 96.8% intended to use the MIS.
Between 09/01 and 09/05/2017, our MIS received 247 enquiries (45.5% residents, 34.0% nursing, 13.8% clinical staff). Drug administration/dose-related questions (43.3%) was the most important category, followed by drug choice/indication (10.5%) and interactions (9.7%). 80.2% were answered within 1 hour (median: 11min). 81% of users mentioned the MIS improving their knowledge, with 59% and 56% reporting positive patient outcomes and time savings. Our MIS scored high on accessibility, timeliness, comprehensiveness and quality (average 4.34, 4.29, 4.42 and 4.47 on 5-point scale). MIS activity corresponded to 0.4FTE pharmacist with an average cost of €15.4/enquiry.

What next?

Our project shows that fast and reliable medication-related information is greatly needed. For the future, this service should be organized with other hospitals as to optimally use resources, share information and increase expertise. Also providing such service to primary care and patients will have be explored.

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