HERA – A NEW TOOL FOR THE QUALITATIVE AND PHARMACOECONOMICAL EVALUATION OF GENERIC DRUG PRODUCTS BEFORE CHANGING BRANDS (submitted in 2019)
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Steffen Amann, Rudolf Bernard, Georg Berndt , Meike Bindemann, Myga Brakebusch, Jörg Brüggmann, Frank Dörje, Miriam Gyalrong-Steur, Anita Kellermann, Markus Müller, Elfriede Nusser-Rothermundt, Rainer Riedel, Eva Tydecks
Why was it done?
Given rising cost-pressure and increasing numbers of supply shortages, changes between generics have become daily practice in hospital pharmacies. To ensure constant treatment quality and patient safety, the equivalence of a potential new product with the current one must be guaranteed before changing brands. So far there has been no transparent, standardised tool for the comparison of generics workable in everyday clinical practice. Developing such a tool was our project’s aim.
What was done?
We developed an Excel-based tool for the qualitative and pharmacoeconomical evaluation of generics before changing brands (aut-idem substitution) in hospitals.
How was it done?
A working-group of pharmacists from seven hospitals developed the “HERA” tool (HTA-evaluation of geneReric phArmaceuticals). Starting from a base version, 22 generic products were assessed with the tool during five evaluation rounds. Based on these results the instrument was gradually refined. Within HERA‘s Excel matrix a potentially to-be-used generic is compared with the current one. The economic evaluation is based on unit prices and prescription volumes, but also includes process costs associated with the product change. The assessment of pharmaceutical quality is based on 34 criteria from six areas (licensed uses, drug substance, dosage form and excipients, handling, safe design, packaging and storage). The objective quality evaluation is complemented by the assessment of hospital-specific features. Complex substitutions – e.g. associated with a handling change – require involvement of the medical staff using the product. The purchasing decision is taken based on the synopsis of pharmaceutical quality and economic evaluation.
What has been achieved?
The standardised evaluation of product differences before substitutions allows for the early identification of potential problems of brand changes and helps avoiding them for the benefit of patient safety. HERA also guarantees reproducibility and transparent, QM-compliant documentation of product changes. The pharmacies of our purchasing group now routinely use HERA for the assessment of generics before intended brand substitutions. Each evaluation is conducted in one pharmacy and shared with the others via data-cloud.
What next?
We have published a paper on HERA and presented it at the German Hospital Pharmacists congress in 2018. Our aim is to create a network of colleagues with shared access to all colleagues’ HERA product evaluations to reduce the workload for the individual pharmacies.
IMPLEMENTATION OF A MEDICATION SAFETY AGENDA AT TWO HOSPITAL SITES IN RESPONSE TO WORLD HEALTH ORGANISATION (WHO) PATIENT SAFETY CHALLENGE ‘MEDICATION WITHOUT HARM’ (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Meenal Patel, Sheena Patel, Peta Longstaff
Why was it done?
• Initiative introduced and on-going since 2017
• To increase and embed medication safety awareness
• To address under-reporting of medication-related incidents, with feedback
• To embed medication safety in education programmes and clinical practice
What was done?
A local medication safety agenda implemented across two hospital sites in response to World Health Organisation (WHO) patient safety challenge ‘Medication without Harm’.
How was it done?
• Medication safety group (MSG) introduced with local strategy, involving junior medical staff for frontline feedback • Medication safety metrics changed to allow benchmarking with peers as per NHS Improvement’s Model Hospital data • ‘Plan, Do, Study, Act’ model applied to improve transfer of care from hospital to rehabilitation unit following external incidents • Monthly analysis of incidents with harm, exploring reasons for under-reporting • Optimisation of incident reporting system to improve staff feedback following investigations • Near miss error log introduced in pharmacy with shared learning • Mitigation of medication-related risks e.g. medications safe storage action plan • Medication safety bulletins, patient safety newsletters and top tips guide introduced covering focal themes • ‘Safe prescribing’ mandatory induction training for junior doctors to support prescribing of high risk medicines and compliance to patient safety alerts • Hospital-wide education on lessons learnt from incidents • Medication safety resources for staff to access • Nursing quality round on medication safety • Electronic missed doses realtime report developed to tackle omitted/delayed critical medication doses • Medication safety awareness (MSA) week held to increase awareness on focal themes
What has been achieved?
• Multidisciplinary MSG with assurance on meeting WHO global challenge. • Monthly analysis of medication safety data to allow learning, collaboration and benchmarking against peers. • Positive staff feedback on bulletins/newsletters with staff involvement/engagement. • Training programmes embedded with safe prescribing education. • Improved hospital safety metrics: Following MSA week, a 5% and 21% increase in medication-related incident reporting occurred at each site which has been sustained. Reporting rates doubled at one site following success of MSA week. • In 2018-19, local target achieved for reported medication-related incidents per 100,000 finished consultant episodes and medication-related incidents with harm
What next?
• Collaborative multidisciplinary working raising the profile of pharmacists acting as medication safety officers
• Implementing medication safety measures from NHS Patient Safety Strategy 2019
• Initiatives for safer culture, safer systems and safer patients
IMPLEMENTING THE PRODUCTION OF STERILISED SYRINGES IN THE HOSPITAL: IMPROVING MEDICATION SAFETY AND SAVING HEALTHCARE COSTS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Karin Larmene-Beld, Rommert Wijnsma, Gerrit de Weerd, Maarten Postma, Erik Frijlink, Katja Taxis
Why was it done?
Medication administration errors are common in hospital practice. Meta-analyses suggest that about 10% of administrations are erroneous, with much higher error rates occurring during intravenous drug administrations. It has been demonstrated that 21% of the errors can be eliminated when prepared syringes are used. Many countries struggle with the problem of optimising the process of safe parenteral medication in hospitals. Different guidelines across countries outline how preparation of parenteral medication in the clinical environment should be done. Recently the Council of Europe published a resolution about preparation of medication which encourage the supply of ready-to-administer products by the pharmacy. Moving the activities of preparation of medication from the clinical environment to the pharmacy requires investments in pharmacy equipment but will result in efficacy, better quality and reduction in preparation medication errors in the hospital.
What was done?
Development and implementation of sterilisable plastic syringes produced in the hospital pharmacy for large-scale production of ready-to-administer products.
How was it done?
A new development in this area are ready-to-administer pre-filled sterilised syringes (PFSS) produced by the pharmacy. PFSS are produced on stock under GMP conditions by the hospital pharmacy using (semi) automatic filling and closing machines whereby quality and safety are embedded in the whole process of manufacturing. A total cost of ownership analysis is performed showing PFSS prepared in the hospital pharmacy yielded cost savings compared to conventional preparation on the ward. The process of production, filling, closing and sterilisation has been validated using newly acquired equipment. With the introduction of the cyclic olefin polymer (COP) syringes a new type of primary container is implemented in the pharmacy. To ensure patient safety and product quality a science- and risk-based strategy has been developed for testing extractables and leachables to qualify the new container as primary packaging material.
What has been achieved?
Introducing PFSS is cost saving for the healthcare system:– COP syringes are suitable as primary packaging material; –enhancement styles for better readability of labels are established; and – already, 15 products are validated and available for use in the hospital.
1. KHM Larmené-Beld KHM, Touwen-Spronk J, Luttjeboer J, et al. A cost minimization analysis of ready-to-administer pre-filled sterilized syringes in a Dutch hospital.. Submitted for publication in Clinical Therapeutics.
2. Larmené-Beld K, Kuiper A, van Berkel S, et al. A science- and risk-based strategy to qualify sterilized prefilled syringes as primary packaging material in a hospital pharmacy. Abstract submitted for 24th EAHP Congress.
3. Larmené-Beld KHM, Kim Alting E, Taxis K. A systematic literature review on strategies to avoid look-alike errors of labels. Eur J Clin Pharmacol 2018 74:985–93.
What next?
Introducing more drugs as ready-to-administer products. Optimising the label of ready-to-administer syringes to avoid look-alike errors based on the results of the review.
BIG ECONOMIC GAIN IN IMPLEMENTING NATIONAL TREATMENT GUIDELINES FOR WET AGE-RELATED MACULAR DEGENERATION, DIABETIC MACULAR OEDEMA AND RETINAL VEIN OCCLUSION
Pdf
European Statement
Selection, Procurement and Distribution
Why was it done?
The consumption of medicine for the treatment of wAMD, DME and RVO is increasing. The medicines used are in the top five of the most expensive drugs in Denmark. With the prospect of more patients, greater costs and the introduction of new drugs in the field, there was a need to develop a national treatment guideline.
What was done?
An expert committee prepared a national treatment guideline including a clinical medicine comparison report for the treatment of wet age-related macular degeneration (wAMD), diabetic macular oedema (DME) and retinal vein occlusion (RVO). The aim was to create uniform treatment across the country and to trigger competition between medicines in the hope of achieving lower prices.
How was it done?
An expert committee consisting of physicians, clinical pharmacist, clinical pharmacologist and medicine procurement pharmacist was appointed. The committee prepared a national treatment guideline including a clinical medicine comparison report based on existing clinical evidence and Danish practice. The committee reached the conclusion that the anti-vascular endothelial growth factor (VEGF) drugs ranibizumab and aflibercept are ranked equally in terms of effect and side effects. The choice of anti-VEGF should be determined solely by price and dosage. A tender was prepared in alignment with the guidelines. This result led to the development of a medicine recommendation, which was passed onto hospital pharmacies, clinical pharmacists and physicians to ensure implementation in the clinic. Feedback from the clinics concerning estimated consumption was forwarded to the drug suppliers and was continuously monitored by the procurement pharmacist to ensure compliance at the clinics.
What has been achieved?
The clinicians switched patients to the new first-line choice. The market share of first-line treatment was 89% compared to 25% before the guideline. Two tenders were published based on the guideline. The first resulted in a price reduction of 28%, the second a reduction of 54%. Total actual savings in the first tender (based on a 31-month contract period) was €38m. In the second tender (based on the first 12 months of the contract period) was €35m.
What next?
New medicines are expected to be approved in the near future. We will continue to use and develop national treatment guidelines in combination with tender procedures and proper implementation of guidelines to obtain better and cheaper treatment options for patients.
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.
A SET OF QUALITY IMPROVEMENT INTERVENTIONS TO INCREASE THE PERCENTAGE OF STAT IV MEDICINES, MEETING THE GOAL OF BEING READY WITHIN 30 MINUTES
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
MELINDA LITAO, HANY ELATROUSH , KHATHLEEN ESER, ARWA AFANA, AHMED BAIBRAHIM, JAYSON DE JUZMAN, BAYAN RAMBO, DERI PASCUAL, MA ENCARNACION DELOS ANGELES, MANAL SALLAM, MALIK KHUWAJA
Why was it done?
STAT orders have always been a priority, however there are some areas which require some modification in the workflow to attain higher efficiency and to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.
What was done?
A set of quality improvement interventions to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.
How was it done?
This was a pre-post study in a government hospital between January and September 2018. LEAN and FOCUS-PDCA models were implemented to design the process of improvement. A medication-tracking system (MedBoard) was used to collect the data to measure the number of STAT IV medicines ready within 30 minutes. Data was also collected from the number of phone calls and faxes received from the day procedure unit (DPU) and home health care unit (HHC).
What has been achieved?
The cumulative data showed an increase in the percentage of STAT IV medicines being ready by 7%, equivalent to 707 orders per month (90% vs 97%), a reduction in the number of phone calls by 87.5% (48 vs six calls per day) and fax by 100% from the DPU and HHC units, which means that implementing the set of interventions were associated with an increase in percentage of STAT IV medicines being ready within 30 minutes. Additionally, there was a significant decrease in the number of phone calls and faxes, which allowed pharmacists to focus more on STAT IV orders.
What next?
Since the hospital pharmacy receives numerous orders on a day-to-day basis, this will facilitate prioritisation during the entire process. This aligns with the hospital goal of attaining ‘zero harm’, and is therefore a good example of good practice in a hospital setting. The use of Medboard in tracking medications and monitoring performance can be applied to allow any healthcare setting to ensure that goals are reached, and performance is maintained at the highest level. Designing a list of eligible medications that can be ordered as STAT can be used as a guide to avoid the abuse of STAT orders and can help in prioritising order preparation in the STAT IV room.
PHARMACISTS ROLE IN THE DEVELOPMENT OF A THERAPEUTIC PATIENT EDUCATION (TPE) PROGRAM BASED ON THE DIRECT ACTING ANTIVIRALS (DAA) USED IN CHRONIC HEPATITIS C TREATMENT.
Pdf
European Statement
Clinical Pharmacy Services
Why was it done?
It is now usual to dispense hepatitis C DAA to outpatients, whose virological success rate is high in the general population. However, subpopulations are at risk of re-infection or noncompliance for which an individualized approach with TPE is required. Role of the pharmacist is to transmit skills for starting and to assist the patient during treatment. SE are sometimes more easily disclosed to pharmacist, thereby allowing to take them into account so that the treatment can be adapted until completion. TPE benefits for these subpopulations are expected in the short term with regards to compliance and empowering the patient during treatment and in the long term to eliminate risky practices and leaving additions.
What was done?
setting up and running TPE sessions for hepatitis C by pharmacists
How was it done?
Hepatology department, based on multidisciplinary team (hepatologist physicians, psychiatrists, addiction specialists, pharmacists, nurses and psychologists), developed a TPE program on viral hepatitis in april 2016. Following written consent, entry into the program was systematically offered to vulnerable patients (background of substance abuse, active alcohol consumption, risk of non-compliance).
Pharmacists were involved in individual sessions concomitantly to DAA dispensing, since the day when patient started TPE program. Pharmaceutical sessions aimed outpatients to acquire following competencies:
– DAA’s name, action mechanism,
– Terms of administration, what to do if forgotten,
– Side effects (SE) and their management,
– Drug interactions (adapted to outpatient treatment).
Pharmacists also answered to questions concerning the patient and monitored compliance and SE.
Interactive practical tools were developed: treatment logbook (also allowed evaluating objectives at each session), cards about known and preconceived SE, timetable for drug intake. Patients fulfilled a satisfaction survey at last session.
What has been achieved?
31 outpatients were included. Pharmacists conducted 65 sessions, 2 or 3 individual meetings per patient (one hour-long total per pharmaceutical session) depending on treatment length (8-24 weeks). 6 patients were still ongoing and 25 achieved the program. Among them, 12 had an undetectable viral load after 12 weeks (Sustained Virological Response 12) and 1 relapsed. 100% of goals were achieved as from the first pharmaceutical session. 100% of patients were satisfied about pharmaceutical session
What next?
Evaluation of program’s benefits in terms of virological success need to be continued.
OPIOID ROTATION IN PEDIATRICS: A CONVERSION CHART FOR CHILDREN OLDER THAN 1 YEAR
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Sabina Hiltbrunner, Dalibor Panis, Jörg Thomas, Eva Bergsträsser, Angela Caduff Good
Why was it done?
Opioids are widely used for acute pain management in pediatrics after surgery, for sedation on the intensive care unit, and chronic pain management in palliative care and many other conditions. In some patients, it is necessary to change the opioid during therapy, due to tolerance development or due to side effects. Although conversion tables for adults are well established, they are not readily available for pediatric use.
What was done?
To simplify the process of opioid rotation in pediatrics, an opioid conversion chart with easily memorable conversion factors was generated.
How was it done?
A literature search was performed to collect conversion factors and equivalent doses of opioids with different application routes. We searched specifically for conversion factors in pediatrics. Except for Oxycodone and Remifentanil, for all other opioids in our chart conversion factors for pediatric patients were found. Data for adults were used for these two substances. For all conversion factors experts confirmed their adequacy for clinical use in pediatrics. The conversion factors were rounded up to whole numbers, which was considered reasonably based on long-term experience in pediatric pain manage-ment.
What has been achieved?
This conversion chart is now part of a drug information document about opioid dosing in children older than 1 year in our hospital. For every substance, starting doses were set according to www.pediatric-dosages.ch and based on clinical experience. When necessary, details about the therapy with the indi-vidual substance were added. For illustration purposes, a sample calculation of the change from oral Morphine to oral Oxycodone was included.
The immature metabolism in children younger than 1 year makes the opioid action often unpredictable. Therefore we restrict the use of the chart for children older than 1 year and in younger children specialists in pain management should be consulted.
What next?
Our opioid conversion chart, with easily memorable conversion factors and starting doses, supports all healthcare professionals in pediatric pain management and may also help to reduce critical incidences due to mistakes in calculation. This is the first time an opioid conversion chart is established for pediatric purpose. Its impact on patient safety has to be shown in the future.
DEVELOPMENT OF A COMPUTER APPLICATION TO REDUCE THE RISK OF ERRORS IN RECONSTITUTION OF CYTOTOXIC DRUGS
Pdf
European Statement
Production and Compounding
Why was it done?
The preparation of cytotoxic drugs perfusions can be accompanied by errors that can be fatal to some patients. Several methods were tested to minimise the risk of errors associated with reconstitution of cytotoxic perfusions (camera, HPLC, analytical balance, the presence of a second technician to monitor his colleague). All of these methods can be expensive and are not available to all hospital pharmacists.
What was done?
We present a simple and effective method that we have developed in our hospital to solve the problem of reconstitution errors.
How was it done?
Errors of cytotoxic drugs reconstitution can have catastrophic consequences for patients. Some studies have found that the incidence of major and minor errors were, respectively, 0.19% and 0.26%. Reconstitution control methods are numerous but not always accessible to all hospital pharmacists and preparers, particularly in developing countries.
This work involves the development of a computer application developed from an Open Source voice recognition software. The daily chemotherapy protocols are entered in the application that dictates to a technician the protocol prescribed by the physician, product by product, for all patients. The technician performs the cytotoxic preparations in the order in the centralised pharmaceutical unit for the preparation of cytotoxic drugs and he communicates with the application manually or by speaking.
The application begins with the patient’s ID, name and surname, the first drug, the dosage, the dilution solution and the volume of this solution. Then, it passes to the second product and so on. In the case of an observation, the application warns the technician to take this observation into account.
What has been achieved?
This application has helped provide better assistance to the technicians and pharmacists in the reconstitution of cytotoxic drugs, and no event or error has been detected to date.
What next?
To make a large number of reconstructions using this application to assess its effectiveness and install it in other hospitals who handle cytotoxic drugs.
PHARMACEUTICAL INITIATIVE FOR APPROPRIATE HANDLING WITH CYTOTOXIC DRUG ON NON-ONCOLOGY DEPARTMENT AT OUR CLINICAL HOSPITAL
Pdf
European Statement
Introductory Statements and Governance
Author(s)
T. DIMITROVSKA MANOJLOVIKJ
Why was it done?
To highlight the classification of this drug, its dangerous side effects even to those patients not receiving it, due to intoxication when handled inappropriate, and the precautions and measures that should be undertaken to minimise the risk/danger of occupational exposure and environmental pollution with inappropriate managing of the waste and spill.
What was done?
These 4 written statements were created: (1) Notification/instructions for handling cytotoxic agentS, (2) instructions for hygienic use of the toilets by patients receiving cytotoxic therapy and disposal of toxic waste on gynaecology and obstetrics wards, (3) instructions for a woman receiving methotrexate injection and (4) standard operating procedure for intramuscular application of methotrexate for nurses in the gynaecology-obstetric ward.
All statement were copied and disseminated to all departments on the ward. In November 2014 during verification of daily drug supplies to the gynaecology-obstetrics ward, I detected a package of methotrexate injections in the transporting container together with other drugs. I immediately contacted the head ward nurse and took control of the handling of the drugs on the ward, especially in the department for pathological pregnancy. The young departmental nurse responsible nurse was not aware of the classification of nethotrexate as a hazardous cytotoxic drug that should be handled with special care. Even though a drug is not given for cancer, it should still be treated as hazardous. Explanations were given to all those present at the time: nurses, gynaecologists and hygiene maintenance staff in the department.
How was it done?
Difficulties in persuading departmental staff of the occupational hazard, intoxication by other patients not receiving the drug and environmental pollution, particularly the danger of extravasation in this class of drugs when handled inappropriately, were overcome by repeating the explanations several times and disseminating the 4 statements.
What has been achieved?
Appropriate handling of cytotoxic drugs, improvement in patient care and protection from pollution of the environment.
What next?
Frequent controls on drug handling on all hospital wards for prevention of irregularities and to ensure safe medicines application.