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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.

WEB DIALOGUE: ONE MORE STEP IN TELEPHARMACY

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European Statement

Introductory Statements and Governance

Author(s)

ARDIZONE BEATRIZ, MARTA HERNÁNDEZ SEGURADO, MARÍA FORTE PÉREZ-MINAYO, LAURA GARCÍA JIMÉNEZ, ELENA TORTAJADA ESTEBAN, ANA CORDERO GUIJARRO, NATALIA BARRERAS RUIZ, LAURA JIMÉNEZ NAVARRO, JAVIER BÉCARES MARTÍNEZ

Why was it done?

First, we had a high number of patient inquiries by phone and by email. Furthermore, patient queries related with their treatment and their resolution were not recorded in the electronic clinical history. Finally, we needed a communication platform that would guarantee personal data privacy.

What was done?

In collaboration with the IT department, we developed a software tool called “Web Dialogue” within the e-health portal of our institution. This tool allows the patients to communicate with the pharmacist using a chat box where they can write queries about drug interactions, adverse effects and any questions about the hospital dispensing treatments, as well as other medications and herbal products. A pharmacist answers the queries within 24 hours, from Monday to Friday.

How was it done?

We asked the IT department to activate this tool for all active patients to whom we dispensed medication in our service (a total of 8000 patients). The development lasted 2 years (2017-2019), but it was not until March 2020, with the start of the COVID-19 pandemic, that the “Web Dialogue” began to be used by our patients more widely. We also made an informative video that was posted on the e-health portal in order to achieve a wider knowledge of this tool among patients. See link: https://www.youtube.com/watch?v=_Z9pd93sNY8

What has been achieved?

The median number of messages per month in 2020-2021 was 202 (IQR= 100,5; 468). At the beginning of the state of alarm in Spain there was a peak in the use of the “Web Dialogue”, mainly to query about how to access the medication (94% of the queries). Over the following months, the proportion of these consultations decreased and consultations regarding doubts about treatment, adverse effects and drug interactions increased. Furthermore, the Net Promoter Score (NPS), an indicator that allows us to measure the satisfaction of patients, shows that in the last year we have achieved, for the first time, a score over 60, which is considered excellent.

What next?

Some of our ideas for the future are: the possibility of selecting the type of inquiry and the interlocutor by the patient, creating algorithms for the automatic response of certain questions and carrying out Big Data research studies.

Role of Hospital Pharmacist in the compassionate use of Risdiplam since the submission to Ethics Committee to the therapy in patients affected by Spinal Muscular Atrophy: an example of close collaboration with the neuromuscular team.

European Statement

Introductory Statements and Governance

Author(s)

Anna Esposito, Claudia Panico , Loretta Cervi, Emilio Albamonte, Alice Zanolini, Valeria Sansone

Why was it done?

This allows a standardized and safe access to this therapeutic opportunity in close collaboration with the NT formed by child neurologist and neurologists.

What was done?

The hospital pharmacist (HP) supports the neuromuscular team (NT) in submitting the request to access compassionate use with Risdiplam in patients affected by spinal muscular atrophy (SMA). Risdiplam is an orally administered, survival motor neuron 2-directed RNA splicing modifer for the treatment of SMA.1 The HP is involved in Ethics Committee (EC) approval, is responsible for reconstituting and storage of oral solution and is also responsible of re-supply and pharmacovigilance surveillance. This allows a standardized and safe access to this therapeutic opportunity in close collaboration with the NT formed by child neurologist and neurologists.

How was it done?

HP is involved from the initial phases of the compassionate use of the drug. The NT that screens and enrolls the patients in the compassionate use program with Risdiplam by submitting a formal request to the EC. The teams of the EC, which includes the HP, evaluates the appropriateness and inclusion criteria for each patient. Once the patient is considered eligible, and treatment is approved, the HP receives the drug from Pharma, provides quality control and assigns the drug for each patient. HP prepares the oral solution and stores the products at 2-8°C until dispensing. After the initial dispensation it is the HP’s responsibility to work closely with the NT in order to maintain treatment over time, ensuring the right timing for re-supply of the drugs and medical devices.

What has been achieved?

There are currently 30 patients on therapy and they are monitored to ensure re-supply and reporting of any adverse events. Home delivery procedure was implemented in agreement with EC in cases where outpatient dispensing was difficult, especially due to logistical difficulties caused by the Covid-19 pandemic, if clinical conditions were stable. In addition, a strong collaboration between the HP and NT was implemented in order to provide access to an increasing number of patients.

What next?

Risdiplam has recently been approved and the HP is involved in the procurement and maintenance of ongoing therapies and ensures supply to new patients. The drug is under negotiation and HP will be involved in contracting procedures based on the expected number of patients and definitive inclusion criteria to access the drug

LEARNING FROM SARS-CoV-2 EXPERIENCE TO FACE FUTURE EMERGENCIES: ELABORATION OF A HOSPITAL PHARMACY EMERGENCY PREPAREDNESS PLAN

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European Statement

Introductory Statements and Governance

Author(s)

Edoardo Calzavara, Elena Galfrascoli, Stefania Vimercati, Lorenzo Gambitta

Why was it done?

The discovering of Coronavirus disease in 2019 and the subsequent outbreak in many countries and regions constituted in the first 5 months of 2020 a prominent issue worldwide: hospital pharmacists as well as other health care personnel were hit by pandemic emergency and faced a great challenge. We as hospital pharmacists had to cope with shortage of drugs, disinfectants, test and reagents, Intensive Care Unit medical devices, personal protective equipment. For this reason, we needed to start interventions to meet the needs of the front-line medical and nurse staff.

What was done?

We decided to start a self-auditing process, we aimed to realize an emergency preparedness plan and a procedure, created from our experience, which will be helpful to face future emergencies.

How was it done?

The starting point was our Hospital Pharmacy process map, which identifies all pharmacy activities. For each one, actions taken during the emergency were described. Regulations at local and national level were analysed together with literature and international statements about hospital pharmacist role during health emergency.

What has been achieved?

We developed a process map in which we split up pharmacy activities into five big areas:

1. DIRECTION AND COORDINATION: team communication, role and responsibilities definition (“role mapping”); multidisciplinary external communication with hospital management facilities;

2. LOGISTICS AND ADMINISTRATION (Purchase, management and distribution of medical products): an inventory of drugs, medical devices and diagnostics was created, especially for the ones essential to challenge SARS-CoV-2 health emergency;

3. RESEARCH, GALENIC, “PATIENT CARE”: therapeutic protocols, galenic preparation, studies, home-therapies distribution and communication with patients;

4. PHARMACOVIGILANCE: close monitoring of potential Adverse Drug Reactions (ADRs);

5. REGULATIONS AND LEGISLATION: Updating and intra-hospital divulgation.

From this emergency process we created an emergency preparedness plan and an internal procedure, in which, for every activity area, we assigned specific roles and responsibilities and set operating instructions.

What next?

The emergency preparedness plan developed from our experience during SARS-CoV-2 emergency, will allow hospital pharmacists to anticipate, plan, and prepare strategies in case of future health emergencies, due to biologic infective agents. Our and other Hospital Pharmacies will be able to overcome priority drugs shortages, to set a drug home delivery service, to offer extemporary solutions, communicate and inform patients.

Implementation of pharmacological consultation as part of geriatric trauma treatment

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European Statement

Introductory Statements and Governance

Author(s)

Tanja Schicksnus

Why was it done?

The team of the geriatric trauma center consists of an orthopedic surgeon, geriatrician, nurse, physiotherapist, occupational therapist and a discharge management and diabetic nutrition expert according to the German society for orthopedic surgery (DGU) and now also a pharmacist who performs risk screening for drug-related problems such as fall, dizziness, cognitive impairment, conspicuous laboratory values, lack of appetite, etc. immediately after admission, in order to optimize drug therapy.

What was done?

The geriatric trauma center aims to provide geriatric patients with the best possible peri- and post-operative care after a fall with a fracture so that they resume their usual life and environment after the hospital stay. The pharmacist joined the interdisciplinary team with the aim of a medication review for the often multi-morbid and multi-prescription patients.

How was it done?

After the patient has been assigned to geriatric complex therapy according to the DGU criteria, the doctor requests a pharmacological consultation for this patient via the digital patient record. The pharmacist carries out a medication analysis with information from the record as well as bed side visits focusing on possible medication based problems.
Results are stored in the consultation report, serving as documentation and as basis for later evaluation. Important information for immediate implementation is highlighted in the digital file and transmitted to the attending physician by telephone.
Once a week, the entire team meets, with the scope for each patient being: What are the remaining problems? How can these be solved (interdisciplinary)?

What has been achieved?

During four months, medication reviews were carried out for about 100 patients. In the areas of bleeding risk, anticholinergic adverse events, antibiotics, malnutrition, dose adjustments and medicines inappropriate for geriatric patients, for one third of patients corrections led to an improvement in patients. For nearly 10% of patients also a prescription cascade was resolved and some medical device training has increased drug therapy safety.

What next?

Future benefit evaluation will be carried out based on resumption of patients due to a fall, in the categories: Time until next hospital admission, reason for next admission, adoption of optimized medication plan.

THE ADDITION OF A COST ANALYSIS CHANGES THE OUTCOME OF A TENDER (submitted in 2019)

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European Statement

Introductory Statements and Governance

Author(s)

Camilla Munk Mikkelsen

Why was it done?

Including a CA in the evaluation is time-consuming and I wanted to evaluate whether the obtained drug recommendation was different from the result we could have achieved without the inclusion of a CA. The CA process includes data collection from clinicians within resource consumption per drug, including the costs of time usage of physician, nurse and patient, transportation expenses, monitoring costs, blood tests, co-medicine, utensils, shipping and hospital facilities. When a CA is included it is possible to take the derived costs associated with treatment of different drug dispensing forms and specific costs of treatment with various analogue drugs into account to achieve a recommendation upon the lowest total price including the tender price and the derived costs associated with the treatment.

What was done?

Tenders are made on ATC-level 5, but clinically equivalent therapeutic areas are evaluated on ATC-level 4. The analogue competition is an important strategic tool when conducting tenders and elaborating national recommendations on therapeutic areas (TA). Since 2017 the evaluation of TA has been based on a clinical evaluation, an economic evaluation and a tender. Previously the call for tenders was based on clinical evidence only. To evaluate whether the addition of a cost analysis (CA) to a tender evaluation would alter the drug recommendation of TA, a re-evaluation of the processed TA, evaluated from October 2018 until October 2019, was made on multiple sclerosis, rheumatoid arthritis and severe asthma.

How was it done?

The drug recommendations on TA made in the period was re-evaluated. Results from the cases with multiple sclerosis, rheumatoid arthritis and severe asthma were evaluated on clinical evaluation, tender price and finally with or without the CA.

What has been achieved?

From October 2018 to October 2019 three TA have ended the evaluation process. The recommendation of severe asthma had a similar outcome regardless of the process used. For multiple sclerosis and rheumatoid arthritis, the CA altered the drug recommendations.

What next?

In order to balance resource consumption on performing CA and the economic impact on the outcome, the plan is to identify TA where it isn’t meaningful to conduct a cost analysis. In all other areas a CA will be included in the standard procedures.

FOUR YEARS OF A REGIONAL MEDICINES OPTIMISATION INNOVATION CENTRE – WHAT HAS BEEN ACHIEVED? (submitted in 2019)

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European Statement

Introductory Statements and Governance

Author(s)

Michael Scott, Glenda Fleming, Catherine Harrison

Why was it done?

There is a wide recognition that there are significant issues with regard to the issue of medicines, such as the fact that 30−50% of medicines are not taken as required. Thus the DoH decided to set up MOIC as a vehicle to focus activities in order to address this issue and optimise medicines use.

What was done?

A Regional Medicines Optimisation Innovation Centre (MOIC) was set up in 2015 by the Department of Health (DoH) in Northern Ireland as a key enabler for the Government policy document namely the Medicines Optimisation Quality Framework.

How was it done?

The DoH requested the Northern Health and Social Care Trust to locate the centre within the Trust based on the fact that there had been a long standing academic practice centre with the School of Pharmacy at Queens University of Belfast. Barriers that had to be addressed were highlighting the regional nature of the centre, to get engagement with all sectors of the service and building relationships with other key organisations, including the private sector. Initial core funding was provided by the DoH.

What has been achieved?

MOIC has successfully evaluated improved systems with regard to hospital pharmacy such as doctor-light discharge (90 minutes faster), post-discharge telephone follow-up (30 day readmission rate reduced by 9.9%), and medicines optimisation in older people service in care home settings (reduced Emergency Department attendances and medicines costs). In addition MOIC has been successful in 3 EU funding bids relating to medicines optimisation and has published over 30 papers. It has also been accredited as a Statement Implementation Learning Collaborative Centre (SILCC) site and also a Centre of Excellence by the Spanish Hospital Pharmacists Association. MOIC has also successfully worked with the private sector including pharmaceutical, device and technology companies. It has also been accredited as a knowledge provided by Invest NI.

What next?

MOIC has delivered on its key initial objectives, related to medicines optimisation with good collaborative work across health, academia and commercial organisations, in the UK and Europe. It will have a key role in meeting the WHO Global Challenge of reducing medication-related harm by 50% by 2023 for the region and further optimising medicines systems.

This approach with government policy support could be relatively easily established in any other region.

SOFTWARE TOOL DEVELOPMENT FOR THE ASSISTANCE OF HOSPITAL PHARMACISTS IN MEDICINES’ SHORTAGES MANAGEMENT (submitted in 2019)

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European Statement

Introductory Statements and Governance

Author(s)

Eleni Rinaki, Marinos Petrongonas, Maria Fragiadaki, Leonidas Tzimis

Why was it done?

MSs are a frequent problem in our hospital. In a study carried out in 2018, we investigated reported shortages during one year and found that 56% of cases of unsatisfied wards’ requests were due to failure of pharmacy’s procedures to restore availability. In 70% of these cases, time to re-stock was more than 4 days and strong involvement of HPs in following up and taking measures was required. The purpose of this tool is to bring together all relevant information of shortages, aiming to improve hospital pharmacy’s response as well as following-up MSs for further investigation or research.

What was done?

A new software module in Hospital Information System (HIS) for monitoring medicines’ shortages (MSs) was conceived by hospital pharmacists (HPs), and it was designed, developed and integrated to the ICT system. This module helps HPs easily track which medicines were totally or partially substituted due to insufficient quantities and gives additional information (such as residual quantity of a medicine on prescription date, on inspection date, pending orders, known shortage) needed for managing MSs. In this tool, MSs and relevant information, such as causes, measures to re-stock and shortage’s impact, can be entered, centrally managed and regularly reported.

How was it done?

Implementation of the module in ICT system was made at zero cost by the ICT service provider, following technical specifications designed by HPs. The final product was multi-checked by HPs during development and all technical problems have been resolved accordingly.

What has been achieved?

• Quick intervention of HPs to restore medicines availability is feasible. • We can now have precise and easier follow up, with less human resources required. • MSs are collected, registered and easily utilised to draw conclusions. • HPs’ interventions to deal with MSs are easier to evaluate

What next?

ICT tools’ development is very important in facilitating hospital pharmacy’s practice, especially when human recourses are restricted. These software modules can be easily incorporated in every HIS. Pharmacists are competent and should have a central role in designing such tools. We are planning to evaluate our new MSs management procedure; in the long run, incorporating in this tool a risk assessment algorithm will be an asset.

ANTIMICROBIAL STEWARDSHIP: WHAT IF EVERYTHING IS ON YOUR SCREEN? (submitted in 2019)

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European Statement

Introductory Statements and Governance

Author(s)

Marinos Petrongonas, Maria Fragiadaki, Eleni Rinaki, Leonidas Tzimis

Why was it done?

Implementation of antimicrobial stewardship programmes in hospitals is part of the national strategy to promote prudent use of antimicrobials. As HPs chair stewardship teams, they are responsible for assessing prescription and monitoring antimicrobial use. Designing and developing automated informative tools facilitates HPs in their role.

What was done?

Hospital pharmacists (HPs) designed and developed software tools to support the antibiotic stewardship team’s work. Particular developments were: a) Α PC application (GrAD_calc), in Microsoft Excel, to calculate antimicrobial consumption, instead of ABC_calc tool. GrAD_calc takes advantage of the unique codes for each branded product and transforms aggregated data, provided by the Hospital Information System (HIS), into antibiotic consumption in DDDs/100 occupied bed-days. Results are presented in charts and figures, in a format that enables ease of comparative monitoring over time. b) Necessary indexes of the above calculator and documentation needed as justification for restricted antimicrobials dispensing have been integrated into the HIS; in result, data for national surveillance programme for antimicrobial consumption are automatically exported. Useful information for pre- and post-prescription review, like demographics, indication(s), co-morbidities, current and previous treatments, microbiology tests’ results, susceptibility reports, is available and easily accessible to prescribers, HPs, and infection disease specialists.

How was it done?

HPs created GrAD_calc on their own resources, while changes in HIS were made by ICT service provider, following technical specifications described by HPs. A number of technical problems have been resolved with the contribution of HPs.

What has been achieved?

• Monitoring of antimicrobial use by pharmacy is quicker and effortless. • Handwritten documentation included in restricted antimicrobials’ prescriptions has been replaced by an electronic decision support system, as tool to improve antimicrobial prescribing and stewardship. • Useful information from patient’s medical record is directly available to HPs and physicians, and facilitates hospital’s policy for assessing antimicrobial prescriptions. • Data, like indication, medicine, dosage scheme, microbiology results and susceptibility reports, are recorded electronically and update patients’ pharmaceutical records, permitting further use for pharmaco-epidemiology studies. 

What next?

Next challenge is wide use of tools developed, to optimise pharmaceutical services provided and dispense restricted antibiotics only when accordingly justified. GrAD_calc is applicable in hospital setting and HIS’s tool is incorporated and can be used by all regional hospitals.

OPTIMISATION OF CANCER CARE PATHWAY OF SCHEDULED PATIENTS WHEN OUTSOURCING CHEMO SUPPLY (submitted in 2019)

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European Statement

Introductory Statements and Governance

Author(s)

Charlotte Chatain, Orane Gleizes, Séverine Barbault-Foucher, Sophie Barthier, André Rieutord, Niccolo Curatolo

Why was it done?

The production of chemotherapy of our hospital will be outsourced by September 2019. This is going to lead to new constraints including anticipated production before patients are admitted to the clinical ward.

What was done?

The clinical pathway of scheduled patients receiving chemotherapy in the main full hospitalization unit of the hospital was optimised.

How was it done?

The clinical pathway of scheduled patients was mapped to describe each step and validated by all the concerned health professionals. Data were collected between October and December 2017 to monitor the percentage of anticipated orders by physicians for chemotherapy production (also called “OK production”). Critical steps and/or bottlenecks were identified. Brainstorming workshops were set to identify areas of improvement with pharmacists, physicians, nurses and secretaries. Finally, the proposals made were implemented.

What has been achieved?

Two critical steps have been identified in this pathway: the receipt of the biological test results by the secretary and the “OK production” given by the physician. It has been decided for the secretary to call patients 72 hours (instead of 24 hours) before to remind them to do their biological test in the medical laboratory. An electronic and standardised prescription with the specific date for the biological test has also been created. In addition, a follow-up form was completed by pharmacists to secure all the critical steps and remind secretaries when they had to call patients and remind physicians when they had to give the “OK production”. Over a two months period, “OK production” given 24−48 hours before the admission increased from 18% to 40% (n= 15 patients).

What next?

These clinical pathway improvements allowed a better anticipation. The process-oriented approach used to identify solutions was very fruitful and led to collaborative solutions likely to be applied and accepted by both clinical ward and pharmacy. This method could be applied to improve other types of processes in our hospital.