INTEGRATION OF THE CLINICAL PHARMACIST IN A MULTIDISCIPLINARY TEAM IN A BURNS UNIT
European Statement
Clinical Pharmacy Services
Author(s)
Ángel Guillermo Arévalo Bernabé, Pilar Lalueza Broto, Jordi Serracanta Doménech, Jacinto Caparrós Baena, José Manuel Collado Delfa, Jordi Aguilera Sáez, Romy Rossich Verdés, Pablo Sánchez Sancho, Juan Carlos Juárez Giménez, Maria Queralt Gorgas Torné
Why was it done?
The burns unit of a third-level hospital includes a patient’s great heterogeneity depending on his population group and his clinical condition (extension, degree and depth of his burns, etiological agent of the burns and associated comorbidities), which makes the managing of these patients complex and they need multidisciplinary solutions. In addition, extensive burns provoke physiopatological alterations that involve changes in the pharmacokinetical and the pharmacodynamical modelling of some drugs. The knowledge that the pharmacist has about the changes that take place in vascular dynamics, the clearance and the distribution volume of the drugs, and the degree of union from these to plasmatic proteins, makes his active participation in the care of the burns patient, and in the optimisation of his pharmacotherapeutic plan, very interesting.
What was done?
The integration of the pharmacist into a multidisciplinary group of assistance to the burns patient constituted as the Managing Committee of Cases and was integrated by plastic surgery, intensive medicine, intensive paediatric medicine, preventive medicine, infectious diseases, psychiatry, psychology, social work and infirmary, as well as pharmacy.
How was it done?
A protocol was devised that standardises and systematises the review of the pharmacotherapeutic plan of all patients in the burns unit, including burn critical and paediatric. Also, there is included a model of record and codificate of pharmaceutical interventions. The multidisciplinary group meets weekly and every patient is analysed from all clinical points of view, the pharmacist intervening in relation to the pharmacotherapeutic and nutritional plan.
What has been achieved?
The active integration of the pharmacist has been achieved in the clinical group of assistance to the burns patient. In addition, there has been created a collaborative attitude that has benefited joint projects of investigation. The degree of acceptance of the offers of modification that the pharmacist realises is 90%.
What next?
The following step must be, depending on the obtained results, to establish improvement assistance measures, including the accomplishment of protocols and the development of investigation projects that help to generate knowledge about the use of some drugs in burns patients, such as immunoglobulin or proteolitic enzymes for the extraction of bed sores.
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.
HOW TO HANDLE ACTIVE AND PLACEBO DRUGS FOR A CLINICAL TRIAL IN THE PRODUCTION SYSTEM CATO IN ORDER TO SECURE THE BLIND AND TO ENSURE THE EXACT SAME PREPARATION OF ACTIVE AND PLACEBO PRODUCTS
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European Statement
Production and Compounding
Author(s)
Kirsten Lykke Vorbeck
Why was it done?
When preparing treatments for blinded clinical trials it is very important to make sure that it is not possible to distinguish between the active and the placebo dose, as this may lead to unblinding of the treatment and thus jeopardise the results of the trial.
What was done?
The purpose was to find solutions for how to handle active and placebo drugs in the production system CATO to ensure they would end up being identical when prepared.
How was it done?
Before preparing a drug using CATO the drug must be registered in the system with all of its data. It is not possible to have two different sets of data for one drug. CATO records detailed documentation of what is being done during preparation and it is not possible to pretend to pick one drug and then grab another instead. Also, the label is printed automatically so it will show exactly what was prepared. We decide on a common name for the active/placebo and register both of these in the system under that name so that they will be prepared in exactly the same way and appear identical on the label but are still distinguishable in the batch documentation. We name the drug ‘Protocol name Active substance/placebo’ and register the stock of both active drug and the sodium chloride solution that is used as placebo under that name. We will also stock vials of NaCl for this purpose next to the drug it is being placebo for, and NaCl can be prepared pretending it has the density of the drug. CATO will think they are the same drug but they have been registered with their very different batch numbers, maybe with a NaCl after the number of that, so it is always possible to see what was actually being prepared.
What has been achieved?
Our doses of active and placebo are indistinguishable. Labels are the same and, for example, withdrawal into a syringe and insertion of a needle into the port of the infusion bag will be done in the same way.
What next?
These very simple routines can be used anywhere for the preparation with CATO and possibly also with other systems.
COMPREHENSIVE SMOKING CESSATION PROGRAMME RUN BY CLINICAL PHARMACIST IN COLLABORATION WITH THE ADDICTOLOGY DEPARTMENT
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Mathilde ROCHE, Niccolo CURATOLO, Marion ADLER, José POLO DEVOTO, André RIEUTORD
Why was it done?
Many smoking patients are not identified as smokers when admitted at the hospital, depriving them of any help to quit smoking. During medication reconciliation at admission (MR), the pharmacist is in a position to identify smoking patients and then offer a support programme.
What was done?
An integrated care model based on a smoking cessation programme was designed to assist smoking patients to quit tobacco. Pharmacy and addictology departments co-built and led the project. It was implemented and proposed to patients from May 2018 in three medical and surgical wards.
How was it done?
The project included five steps:
1. Training of one clinical pharmacist about smoking cessation by the addictology team.
2. Designing the process and developing tools used for a smoking cessation programme.
3. Implementing the programme.
4. Evaluating the pilot phase.
5. Developing a comprehensive training programme (including role-play sessions) for the pharmaceutical team.
The process counted six steps:
1. Smoking patients’ identification (MR, patient record, request from doctors). If the patient was polyaddicted, the addictology team was informed.
2. First patient visit: patient consent was collected, anamnesis related to tobacco and explanation about nicotine’s mechanisms and nicotine substitutes given. Appropriate nicotine substitutes were selected and tested with the patient.
3. Prescription and administration of nicotine substitutes.
4. Second patient visit (24 to 48 hours’ later): nicotine substitutes adjusted if needed.
5. Third patient visit if needed.
6. Discharge medication reconciliation.
What has been achieved?
During 4 months, 62 patients were identified as smokers during MR interviews. Twenty-seven per cent of the patients (n= 17) were sent to the addictology team because of polyaddiction, 39% (n=24) refused the programme and 34% (n=21) accepted to experience our support programme. Of these, 62% (n=13) either reduced or quit smoking during hospitalisation.
What next?
According to our encouraging preliminary results, this programme will continue to be carried on by the pharmaceutical team, while keeping a close link with the addictology team. We decided to call the patients one week and one month after discharge to better assess the performance of our smoking cessation programme.
IMPLEMENTATION OF A NEW CLINICAL PHARMACY SERVICE WITHIN A NEWLY LAUNCHED SURGICAL ADMISSIONS PROCESS
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Dora Mueller, Maria-Theresia Pichler, Karin Kirchdorfer, Kora Koch
Why was it done?
Prior to the implementation, insufficient time resources did not allow for clinical pharmacy services (CPS) on all surgical wards. Existing cover was not efficient or effective as drug-charts were often not available or patients discharged before pharmacy suggestions were implemented. The integration of the CPS into the centralised admission process instead of the wards resolved these shortcomings and facilitated pharmacy input to all surgical patients using this admission process.
What was done?
A central surgical admissions process was launched at a 450-bed teaching-hospital in April 2018 in which patients are seen five days before surgery by an interdisciplinary team. A new clinical pharmacy service (CPS) was implemented on-site to review patients’ medical history comprising three consecutive steps:
1. Medicines reconciliation is completed based on existing patient-consultation records.
2. Recommendations for switching drugs to the hospital formulary on admission are noted on the drug chart.
3. Medication review is carried out to improve inpatient medication safety, and changes are communicated to medical staff via e-consult.
How was it done?
This proactive concept highlighting the advantages of interdisciplinary CPS and reflecting international evidence (e.g. patient safety, patient care, workload reduction for medical and nursing staff) convinced hospital management of its need. Resource implications included allocation of a pharmacy office on-site, development of a standard operation procedure and support for interdisciplinary teamwork on-site.
What has been achieved?
Between April and September 2018, records of all patients using the new process (n = 1527) were reviewed by a clinical pharmacist. At least one drug-related recommendation was made for 38.6% (n = 589) of all patients taking medication. This development enhances the clinical pharmacy workforce at our hospital and contributes to the quality of the admission process. Feedback from medical and nursing staff, hospital and quality management was positive throughout. We observed an improved level of awareness, higher numbers of requests for other CPS and a better understanding of the clinical pharmacists’ role within the healthcare team.
What next?
This initiative reflects how CPS can be expanded and optimised by seizing the opportunity and using existing resources. This model may be adapted for other hospital inpatient settings.
USING AN ELECTRONIC ALGORITHM TO IDENTIFY THE MOST RELEVANT PATIENTS FOR MEDICATION REVIEW
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European Statement
Clinical Pharmacy Services
Author(s)
Charlotte Olesen
Why was it done?
In the Regional Hospital in Horsens, Central Denmark Region (covering 217,000 citizens) medication reviews by clinical pharmacists were performed on a few wards. Patients were selected to receive medication reviews on the basis of pre-defined criteria. The criteria were not evidence-based and were individual for each ward and pharmacist. This screening was time-consuming, as we screened every patient in the EPS to find relevant patients for medication review. Assuming that patients at high risk of medication errors will benefit most from medication reviews, we wanted to identify, using an evidence-based algorithm, these patients automatically across all wards at the hospital, thereby reducing resources during screening and allowing more time on the relevant patients.
What was done?
An algorithm, to identify patients who would benefit most from a medication review, was developed using data from the Electronic Prescribing System (EPS). The system could produce a list of patients daily considered relevant for medication review.
How was it done?
MEdication RIsk Score (MERIS), a validated algorithm to identify patients in high risk of medication errors, was implemented using data from the EPS. Each hospitalised patient’s risk score was automatically calculated, and a list with risk scores was generated. Patients with highest risk were selected to receive a medication review by a clinical pharmacist. We validated the algorithm on two wards. The variables used in MERIS are reduced renal function, the total number of drugs and the risk of individual drugs to cause harm and interactions.
What has been achieved?
Instead of individual and time-consuming screening, electronic uniform screening has been implemented in our clinical pharmacy service. Our limited time is now used carrying out medication review on patients with the highest risk of medication errors instead of patients with less benefit.
What next?
The electronic version of MERIS is now used on two wards at our hospital. The next step is to include more wards so all patients with high-risk factors will receive a medication review from a clinical pharmacist. Furthermore, clinical pharmacists in other hospitals in the Central Denmark Region will also implement the electronic algorithm.
DRUG-FOOD INTERACTION GUIDE PREPARATION FOR OUTPATIENT CONSULTATION
European Statement
Patient Safety and Quality Assurance
Author(s)
Gregorio Romero Candel, Paula Ruiz Belda, Carmen Caballero Requejo, Maria Jesus Sanchez Cuenca, Jose Marco del Rio, Juilan Castillo Sanchez, Luna Carratala Herrera
Why was it done?
Some drugs dispensed in the outpatient office present interactions with food, leading to changes in their bioavailability. These changes which can result in a decrease in therapeutic activity or an increase in adverse effects, when dealing with narrow therapeutic margin drugs, may lead to alterations in their efficacy and/or toxicity. Developing the quick and accessible consultation table, we improved the quality and effectiveness of the treatment.
What was done?
Preparation of the drug and food interaction guide for outpatient consultations.
How was it done?
The technical specifications of all drugs that are dispensed in the hospital outpatient office were consulted, and the possible interactions with food of every one of them were analysed by consulting the following electronic databases: Technical sheet, Bot Plus, Micromedex, Pubmed, UpToDate and Online Medicine Information Centre of the AEMPS. A database was developed with drugs that presented some type of restriction with meals, designing a quick reference table for outpatient consultation.
What has been achieved?
One-hundred specialities were reviewed, of which 22 were to be taken without food, 43 with food and 35 could be taken with or without food. The information given to the patient was quick and efficient, improving the effectiveness and safety of the treatment.
What next?
Our goal is to continue developing tools that allow us to provide quality information to the patient, improving the effectiveness and safety of treatments.
DEVELOPMENT OF NEW PRODUCTION WHEN NEITHER PACKAGING NOR SOME OF THE RAW MATERIALS CONFORM TO EUROPEAN STANDARDS
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European Statement
Production and Compounding
Author(s)
Katrine Bødker Rubach-Larsen, Anne Rungø, Anette Eskildsen, Lone Skovhauge
Why was it done?
A research team at the MR Centre (MRC2) wished to set up the production of Pharmacy Kits, but had no prior experience of, or licence to, manufacture drugs. Thus, the hospital pharmacy was asked to participate in the development of such production.
What was done?
A new MR-scanning technology, hyperpolarisation, for the quantification of metabolic processes with an extremely high sensitivity enables physicians early detection of treatment effects in, for example, cancer and diabetes. A so-called Pharmacy Kit is used in the hyperpolarisation process and consists of a specially designed packaging with tubes, vessels and filters containing the contrast agent and buffer solutions. The objective for the hospital pharmacy1 was to manufacture Pharmacy Kits complying with Good Manufacturing Practice (GMP), though neither packaging nor two of the raw materials conformed to European standards.
How was it done?
The MRC research team presented the hospital pharmacy with the desired combination of compounds and the packaging required for Pharmacy Kit production. The task for the hospital pharmacy was then to set up a manufacturing process that met these requirements and complied with the guidelines for GMP. A production complying with GMP was developed in close collaboration with the MRC and an ongoing contact with the Danish Medicines Agency. During the process the hospital pharmacy carried out its own microbiology test in order to determine if, and for how long, the non-CE-marked packaging could store the contrast agent and buffer solutions. Risk assessment of the raw materials not found in the European Pharmacopeia were conducted. The method investigated by the MRC already takes place at a few other places in and outside of Europe. Experiences from these production sites were implemented and expanded with process optimisation, and specially designed equipment for the production.
What has been achieved?
Due to a strong inter-professional collaboration between the MRC and the hospital pharmacy and due to qualified risk assessments, it was possible to set up a production of Pharmacy Kits according to GMP.
What next?
When researchers contact hospital pharmacies with new ideas, we have to be willing to work with GMP in a different way by applying knowhow and risk assessments in order to ensure developments within the healthcare system.
1. Hospital Pharmacy Central Region, Production, Aarhus, Denmark.
2. MR Centre, Aarhus University Hospital, 8200 Aarhus N, Denmark
PREPARATION OF A CYTOSTATIC STABILITY GUIDE AFTER RECONSTITUTION AND DILUTION
European Statement
Patient Safety and Quality Assurance
Author(s)
Gregorio Romero Candel, Paula Ruiz Belda, Maria del Carmen Caballero Requejo, Maria Jesus Sanchez Cuenca, Jose Marco del Rio , Julian Castillo Sanchez, Luna Carratala Herrera
Why was it done?
In common clinical practice, the stability of medications is an area of interest to obtain maximum security and efficiency. After reconstitution and dilution, knowing the validity period is very important for the effectiveness and safety of the treatment, since it must be administered to the patient under the appropriate conditions. In recent years, a large number of high-impact cytostatic medicines with limited stability data have been registered and incorporated into clinical practice. Frequently, the stability data results are contradictory or insufficient. The main goal is to make a reliable quick guide of reference with the validity periods of the reconstituted and diluted active principles according to physicochemical stability, therefore increasing safety, reducing queries for these doubts and improving the management of unused remains that have high economic impact.
What was done?
A cytostatic stability guide after reconstitution and dilution has been made. The active principles and commercial presentations that are used in the intravenous mixtures area were reviewed.
How was it done?
The obtaining of the physical-chemical stability data has been done by reviewing the information available in Stabilis, Pubmed, Lexicomp and technical data sheets.
What has been achieved?
Fifty-four pharmaceutical specialities from 44 active principles, all in the cytostatic group, were checked. Tables of reference for the elaboration sites were made for consultation. It has reduced the number of consultations conducted and improved the time of preparation of these products. The rest of the elaborations for other administrations have been taken advantage of, making a better use of the pharmacotherapeutic resources.
What next?
The next step is to keep developing consultation tools that improve the safety and management of hospital drugs.
PROGRAMME OF PHARMACOTHERAPEUTIC BENEFIT TO THE SOCIO-SANITARY CENTRES OF A SPECIFIC HEALTH AREA THROUGH THE HOSPITAL PHARMACY SERVICE
European Statement
Clinical Pharmacy Services
Author(s)
Gregorio Romero Candel, Maria Jesus Sanchez Cuenca , Nieves Cano Cuenca, Jose Marco del Rio , Julian Castillo Sanchez, Luna Carratala Herrera
Why was it done?
The healthcare provided in the SSC is not fully integrated into the structures of the National Health System. These patients present a higher risk of adverse events related to pharmacotherapy, due to patient factors, with the treatment, the health system and the institutionalisation. The integral approach of the pharmaceutical benefit was necessary for improving the efficiency, safety, health and economic results due to the process using drugs and other health products in the SSC.
What was done?
A pharmacotherapeutic benefit model has been started through the hospital pharmacy to the Socio-Sanitary Centres (SSC) of our health area. A pharmacotherapeutic management system based on the evaluation and selection of drugs and diet therapy items has been established.
How was it done?
An adherence protocol was made to the hospital pharmacy service, with the benefits that were to be provided to them. A guide was prepared with drugs and nutritional supplements that were available to them according to the Pharmacotherapeutic Guide of the Hospital Pharmacy Service, thus guaranteeing the most efficient products. A request model of both drugs and dietotherapics was developed for the SSC, assigning each centre one day per month to request the order and another day of dispensation. Finally, a calendar of distribution routes for each SSC was prepared.
What has been achieved?
For 12 months, eight SSC have been assigned to this programme, with 538 patients. Twelve shipments have been made to each centre, which have been provided with a total of 682,484 units of 223 active ingredients. The dispensation in diet therapy contained 28,045 units of 13 specialties. It has been possible to improve the pharmacotherapeutic coverage of these patients and reduce the expenditure on drugs in the area through centralised supply.
What next?
Development of follow-up programmes for patients with high health or economic impact drugs. Also, the adherence of new SSC, as well as increasing the dispensing portfolio, and achieving the integration of information systems, to have a total traceability from the patient to the different assistance levels.