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Author(s)

Isabelle Sommer, David Palmero, Céline Julie Fischer-Fumeaux, Lydie Beauport, Vincent Adamo, Hervé Schwebel, Pascal Bonnabry, Lucie Bouchoud, Farshid Sadeghipour

Why was it done?

PN can be composed of about 50 different ingredients, whereof the majority are amino acids (AA). Therefore, PN represents a complex and high-risk fabrication. ME are often related to PN and may include prescription, transcription, preparation, and administration errors. As the treatment with PN is indispensable for a good cerebral and neurologic development as well as a postnatal weight gain, ME can result in growth retardation, developmental disturbances, and infections.
This project was performed with the aim to reduce ME having an impact on vulnerable newborns and to improve the security and quality of their nutritional treatment.

What was done?

A standardized pediatric parenteral nutrition (PN) solution for the first days of life of newborn infants has been developed. An industrial partner manufactures the ready-to-use double-chamber bag which is available 24/7 and of high-quality allowing a secured administration as well as a reduction of medication errors (ME).

How was it done?

A working group composed of pharmacists, clinicians, neonatologists, and industrials developed a PN solution for the first days of life of newborn infants conforming to the needs of two different neonatal services. An applied standardized PN and the ESPGHAN guidelines haven been used as references. The feasibility of an industrial production of double-chamber bags has been evaluated and implemented.

What has been achieved?

The developed PN solution has been formulated for a peripheral venous administration with an osmolarity under 900 mOsm/L to allow a wider range of application. The production of double-chamber bags has been chosen to increase the stability and shelf-life. The first compartment contains an AA admixture and the second compartment contains glucose and electrolytes (sodium, calcium, organic phosphate). This solution is initially produced by the service of pharmacy and afterwards by the industrial partner. The standardized PN bag has been implemented successfully on the neonatal ward in March 2019. Since then, almost 1800 standardized bags have been used (appr. 90 bags/month), resulting in a reduction of individual on-ward PN preparations of nearly 80%.

What next?

Further standardized PN for newborn infants need to be developed to allow a safe nutritional treatment. On-ward PN preparations must be prohibited to prevent undetectable preparation errors.

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Author(s)

Bastian Mende, Irene Krämer, Jannik Almasi, Christoph Klaas, Bernhard Rainer Kujau, Swantje Eisend, Herwig Heindl, Jacopo Raffaelli, Jochen Schnurrer

Why was it done?

During a two-day meeting in September 2018, the German community of APOTECAchemo users and technology experts developed Best Practices for the optimal implementation and subsequent application of APOTECAchemo technology in pharmacy based aseptic preparation of ready-to-administer antineoplastic medicinal products.

What was done?

Robotic systems, designed for the aseptic preparation of ready-to-administer parenterals in hospital pharmacies, should facilitate a fully integrated workflow and a process organization interconnecting the automated and manual preparation. Despite some differences between the hospital pharmacies, the definition of standards and Best Practices for the automated compounding of cytotoxic preparations facilitates the implementation of the technology in different hospital pharmacies.

How was it done?

Prior to the meeting of the user group a survey with 24 statements for the implementation and use of the APOTECAchemo technology was sent to the German APOTECAchemo users. The 24 Best Practices were assigned to 4 categories: Workflow & Organization, Production, Roles & Responsibilities and Quality & Process Control. The survey participants evaluated the proposed Best Practices in view of the practicability in German hospital pharmacies. During the meeting, results of the survey were consented or adapted and additional best practices were defined.

What has been achieved?

The German user group defined the Best practices for the implementation and use of APOTECAchemo technology. The most relevant result for each of the four categories is:
• Workflow and Organisation: The automated preparation should reduce the daily workload of manual preparation and minimize potential errors.
• Production: Optimum interconnection between technicians and the robot will increase the efficiency.
• Role and responsibilities: Pharmacists are responsible for the design of the automated production workflow, while technicians become the manager of the automated compounding process
• Quality & Process Control: Microbiological controls must be performed during manual and automated production

What next?

The best practices defined by the German APOTECAchemo Community support experienced users and are especially useful for hospital pharmacies newly implementing the technology.

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Author(s)

VIDAL CARLOS

Why was it done?

The publication of NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings established that crushing tablets or making solutions
from them means an unasceptable risk at hospitals.

In adtition to this, USP 800 and Directive 2004/37/EC of the European Parliament on the protection of workers from the risks related to exposure to carcinogens or mutagens at work , impose the use of closed system devices and a plastic pouch to contain any dust or particles generated in these operations.

Conversely, there is no closed system device to crush, disperse and administer safely .

What was done?

We developed a new medical device to protect caregivers from exposure risk derived from crushing and dispersing in water hazardous drugs tablets.

How was it done?

We designed a new medical devide by combining existing issues so as to develop a workable solution that could overcome this safety problem and ensure the compliance with occupational regulations , and ensure a complete dosage.

What has been achieved?

We patented a new medical device that will allow a safe administration reducing exposure risk and environmental pollution at : pharmacy departments ( cross contamination in cabinets ) , nursery units and even at patient´s homes to protect caregivers and relatives.

Its design and simplicity of operation will favor its universalization.

This is an initiative of a hospital pharmacist to solve a daily problem and an example of the our potential in healthcare innovation.

What next?

The commercialization of this medical device will fulfill an unmet need in our daily practice at helathcare facilities and patients homes

Author(s)

Joanne Rhodes, Chris Bidad

Why was it done?

There was concern that there was a risk of reconstitution errors, missed doses or variation in dosing intervals which could impact on treatment efficacy and patient safety due to:
• a sudden increase in demand for IV antibiotics,
• depleted numbers of front-line nursing staff, and
• nurses being deployed to unfamiliar clinical environments and encumbered by PPE.
The emergency IV antibiotic reconstitution service was designed to mitigate these risks.

What was done?

In the absence of aseptic dispensing facilities an emergency intravenous (IV) antibiotic reconstitution service was set up in a laminar flow operating theatre. Nurses who could not work in a patient-facing role during the pandemic prepared ready-to-use infusions under the direct supervision of a pharmacist.

How was it done?

It was determined that a manufacturer’s licence was not required under part one, section three of the Human Medicines Regulations 2012 providing strict criteria were adhered to. Stability data was collated for the most frequently used IV antibiotics. Even where stability data supported a longer period, a maximum expiry of 24 hours after preparation was assigned. Processes were designed to adhere as closely as possible to the GMP principles described within The Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017. Specially tailored IV reconstitution training was delivered to the nurses.

What has been achieved?

Over a period of 4 weeks at the peak of the pandemic 1000 doses of IV antibiotics were prepared and supplied, enabling ward-based nurses to focus directly on patients. There were no reports of any incidents of delayed or missed doses, or administration errors relating to IV antibiotics supplied to the wards involved during this period. The time saved on the wards was equivalent to having 3 additional nurses on the wards each day.

What next?

With a reduction in the number of COVID-19 positive patients now presenting to the hospital the service has been paused but placed on standby so that it can be resumed in the event of a second wave. Work is underway to determine if there would be value in the team preparing a wider range of products, particularly those which may be of particular use in critical care areas such as sedatives and inotropes.

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Author(s)

Lucía Rubio , Mónica Montero

Why was it done?

Hospital Pharmacy Services staff may be exposed to hazardous substances, involving a risk to health. For this reason, is important to identify these substances and measures must be taken to ensure maximum safety for the staff at work. We decided to review the topic when we saw in the Technical Document on Prevention Measures for the Preparation and Administration of Dangerous Drugs, published by the National Institute for Safety and Hygiene at Work (INSHT) there are no specific recommendations for protection of raw materials used in magistral formulas; it only refers to dangerous drugs.

What was done?

Identify health problems involved in handling raw materials that we use in the preparation of magistral formulations. Define personal protective equipment and installations necessary for handling.
Improve work safety of area’s staff.

How was it done?

We have to update raw materials discharged in 2018 in the Pharmacy Service.
The safety data sheets were reviewed in the National Institute for Occupational Safety and Health, paying special attention to dangerous identification and exposure controls/individual protection sections. In this database there is not all the information, so we have to use data sheets of our supplier.
We studied Regulation (EU) Nº 1272/2008 on classification, labelling and packaging of substances and mixtures to determined 3 variables: health dangerous, using hazard class like REPR B, MUTA 2 and STORE RE 1; personal protective equipment and installations must be used in handling of our raw materials.

What has been achieved?

We obtained a list of 20 raw materials. 40% of raw materials aren´t considered hazardous.
Of 60% that are classified as hazardous, they were divided into 2 levels: the first, with categories such as serious eye injuries, skin disorders, respiratory tract irritation or toxicity if swallowed; it includes 75% of raw materials. The second level, which includes the rest of products considered hazardous (25%), is associated with 3 categories: REPR B or possible carcinogenicity, that influence the fertility and development of the fetus; MUTA 2 or genetic defects, that are associated with germ cell or mutations; and STORE RE 1 that can cause damage to organs after prolonged or repeated exposure. For 40% of raw materials there are no specific recommendations about using personal protective equipment. With 60% it is recommended to use self-filtering masks for particles, protective gloves and glasses. For 16% of materials, protective clothing against chemicals is required too. In 65% of raw materials, no specific installation is required to handle them. However, for 25% it is recommended to have well-ventilated areas and with 10% a chemical smoke cabin.

What next?

Most of raw materials we use to make magistral formulations are considered hazardous according to Regulation (EU) nª1272/2008. For this reason, we developed a protocol that included individual protection measures and laboratory equipment necessary to handle such raw materials. So it is possible to normalise the preparation of magistral formulations guaranteeing the safety of the area’s staff. We have devised a plan for review and update of the protocol, following current regulations.

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Author(s)

Mª Antonia Meroño-Saura, María López-Morte, Taida Rodríguez-Martínez, Pilar Pacheco-López, Consuelo García-Motos

Why was it done?

The publication of the NIOSH list and its application by INSHT in Spain has changed the concept of “Hazardous drug” in terms of its handling and administration, as well as personnel training involved in its management.

What was done?

The main objective is to label every drug considered “Hazardous” and to review the medication included in the Emergency Department kit in a tertiary hospital.

How was it done?

Literature about Hazardous drugs was reviewed. All the drugs included in the Emergency Department kit belonging were identified and classified according to their level published in the NIOSH list. A kit’s review was carried out on site, as well as a Hazardous drugs’ categorisation by adequate labels.

What has been achieved?

6 out of 239 drugs included in the emergency kit were labelled as Hazardous drugs, and could be found in 9 different presentations. Regarding its risk level according to the NIOSH list; chloramphenicol, risperidone and all different presentations of phenytoin were classified as level 2. Acenocoumarol, colchicine/dicycloverine and all different presentations of valproic acid were classified as level 3.
The following incidents were detected;
– Lack of identification: 8 out of the total number of drugs presented identification errors.
– Location error: 4 out of the total number of drugs were not well located.
– Photosensitive: 56 out of the total drugs were photosensitive, of which 11 were not correctly identified or stored.
– Expired drugs: 12 drugs, whose total stock was 399 units. 51 out of the total amount were expired.
After this review, the following measures were carried out:
– Orange labelling for Hazardous drugs’ identification, regardless of their risk level.
– Misidentified drugs were re-labelled, and those that were misplaced were placed in their assigned spot.
– Photosensitive drugs were correctly identified by blue labels and properly preserved.
– Expired drugs were withdrawn.

What next?

Simplifying Hazardous drugs’ identification by a categorisation following a colour code could lead to a safer manipulation by the professionals. During the review of the kit, several incidents were detected and sorted out, which avoided possible medication-related errors. Therefore, it is necessary to establish several control measures in emergency kits in order to avoid errors and improve the safety in the use of drugs.

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Author(s)

MARIA MUROS ORTEGA, INMACULADA SANCHEZ MARTINEZ, ARANTXA ANDUJAR MATEOS, ISABEL ALARCON FUENTES, FRANSCISCO VALIENTE BORREGO, ANGELA SANCHEZ , ASUNCION SARABIA, ANTONIA RODRIGUEZ, NURIA LUCAS VILLA

Why was it done?

Condylomata acuminata or genital warts are produced by human papillomavirus (HPV). They are considered one of the most common sexually transmitted diseases that must be treated on an individual basis. Imiquimod increases the local immune response mediated by interferon and other cytokines; it is marketed as a 5% cream for topical administration 3 times a week, for a maximum of 16 weeks.

What was done?

The aim of the study is to describe the formulation and results obtained after treatment with imiquimod suppositories manufactured by the Pharmacy Hospital Service.

How was it done?

Suppositories of imiquimod 6.25mg were prepared from Aldara® 5% cream sachets; stearic mass was used as excipient to convey the active principle adding about 2.2g/suppository and molds of 2g for its preparation. The bain-marie was used for fusion and mixing the components. A sterile gauze was included to facilitate extraction if there was anal irritation. The established shelf life was 6 months between 2−8ºC. Suppositories were dispensed individually wrapped in aluminium foil and protected from light added a diptych of information to the patient.

What has been achieved?

The case of a 33-year-old male, VHP 6 positive, with anal condylomatosis and high-grade epithelial dysplasia, most of which had been resected and burned previously without satisfactory results. Imiquimod was added as an adjuvant treatment in suppositories for administration three days a week at night. Twelve suppositories were dispensed each month, and the duration of treatment was 2 months. During treatment the patient reported good tolerance, no itching, no pain in the area of administration. One month after finishing the treatment, no new macroscopic lesions were observed, nor recurrence of previous ones in anoscopic examination.

What next?

The contribution of the Pharmacy Service through the development of imiquimod suppositories has facilitated the achievement of early health results in a complex treatment pathology, allowing rectal administration through suppositories made from a specialty marketed in envelopes for topical use and reducing the duration of treatment to 8 weeks, with very good tolerance on the part of the patient.
References:
1. Bastida C et al. Formulation of imiquimod suppositories for the treatment of intra-anal neoplasms by human papillomavirus. 57th SEFH Congress.
2. PNT elaboration of the Reina Sofía General University Hospital.
3. Lacey C et al. 2012 European guideline for the management of anogenital warts. J Eur Acad Dermatol Venereol 2013 Mar;27(3):e263-70.
4. AEPCC-Guide: Condylomata acuminata. AEPCC Publications, November 2015.

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Author(s)

Marijana Fortuna, Petra Tavčar, Jure Dolenc, Monika Sonc

Why was it done?

To support us in understanding our role in the preparation of chemotherapy products. To prevent the risk of harm to patients. Recognise prescribed error in pre-documented chemotherapy protocols

What was done?

Cytostatics are carcinogenic, mutagenic and teratogenic drugs. Handling requires a number of organisational and technical systems. All products should be safely and accurately prepared with special care to ensure the highest possible product quality, correct dose, the right patient, the right medicine, the right carrier solutions and right administration, without microbiological and particle contamination. The prescription and preparation of cytostatic drugs must be closely monitored. The most important factor in achieving this is the constant training of pharmacists in pharmaceutical techniques.

How was it done?

This year started with monthly reviews and training in the following subjects by using a written algorithm. Risk to product: Drugs reconstitution negative pressure isolators, leakage/damage or defects of vials, particles, transport and storage. Risk to patient: Incorrect calculations, microbiological contamination, incorrect administration, extravasation, incorrect administration route, incorrect labelling. Risk to operators: Contamination, toxicity, equipment, gloves, cleaning, occupational exposure. All checks have been made throughout the whole of preparation process, adhering to standard operating procedures (SOP-s).

What has been achieved?

We concluded that continuing education by using a writhen algorithm is useful practice. It helps prevent automatic work, remind us to check each step in process and know how to recognise errors in chemotherapy prescriptions and preparation. In 25 cases of prescribed chemotherapy, intervention of a pharmacist was required. In 5 cases of chemotherapy preparation, pharmaceutical techniques have detected a discrepancy in the prescribed therapy.

What next?

Regardless of experience at work, it is necessary to constantly repeat how to work properly, and awareness why we are doing this.

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Author(s)

Jane Francomb, Dirk Leutner

Why was it done?

Formularies for extemporaneous formulations of paediatric medicines of appropriate quality are currently available in some regions or countries, but no pan-European equivalent exists. Some formulations in use are not appropriate due to a lack of knowledge of best practices. The idea behind the new formulary is to collect, review and then select the most appropriate formulations currently used in Europe which meet today’s requirements.

What was done?

The European Paediatric Formulary was launched at the end of 2019. It is a freely available online publication for pharmacists and clinicians that is intended to provide guidance on the use and preparation of standardised paediatric medicines of an appropriate quality when a suitable licensed medicinal product is not available. The first two monographs and two explanatory texts of the European Paediatric Formulary have now been published by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

How was it done?

Criteria for selection and evaluation of formulations were developed by 2015. Since then the current work is carried out by the European Paediatric Formulary Working Party under the supervision of the European Pharmacopoeia Commission and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The EDQM provides the scientific secretariat. Monographs for development were prioritised based on patient need. Many formulations currently described in national formularies and other well-established formulations have been gathered from stakeholders throughout Europe. The information available for the most appropriate formulation was transferred into a common format with full quantitative composition details, extemporaneous preparation instructions, validated test methods for quality control and storage conditions.

What has been achieved?

Monographs for hydrochlorothiazide 0.5mg/mL oral solution and sotalol hydrochloride 20mg/mL oral solution were published at the end of 2019. These were accompanied by an introduction and general principles which describe the purpose and content of the European Paediatric Formulary.

What next?

Monographs for Azathioprine oral suspension, Chloral hydrate oral solution, Furosemide oral solution, Isoniazid oral solution, Omeprazole oral suspension and Ranitidine oral solution and a monograph on an oral vehicle are currently under development. Further prioritised items will subsequently be added. Draft monographs for public consultation and final texts will be made available on https://paedform.edqm.eu.

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Author(s)

Faten Ahmad Díaz, Eugenia Serramontmany Morante, Carla Esteban Sánchez, Pablo Latorre García, Montserrat Carreres-Prieto, Javier Martínez Casanova

Why was it done?

Different critical points were detected: 1) some OV dose prescription depends on tumor size, 2) special storage conditions, 3) special safety measures related to preparation to prevent cross-contamination and technician exposure, 4) special transport conditions in a safety container, and 5) safe administration. The increasing number of clinical trials with OV combined with the identified critical points implies a better coordination between the different departments involved.

What was done?

Development of a standardised working procedure for the safe handling considerations, storage requirements, and modes of administration of oncolytic viruses (OV) in patients with cancer.

How was it done?

Different meetings were arranged with a multidisciplinary team to standardise procedures, in order to avoid errors: 1. The pharmacist validates the prescription volume reflected on the certified sheet according to the tumour size. Then, a pharmacy technician is authorised to remove the vials from the freezer to start the preparation. 2. Special −80ºC freezer is needed to preserve the OV. 3. According to the preventive medicine service, OV must be prepared in biological safety cabinet class II (BSC) with personal protective equipment. At the end of preparation, the BSC must be cleaned with the OV appropriate disinfectant and ventilated for 1 hour before restarting to work again. So, the OV preparation was established at 7 a.m. in order to avoid cross-contamination with the chemotherapy (first preparation in the day). 4. Safety transport must be considered, so OV is packaged in a special hermetic box. 5. The majority of the OV preparations are administered intralesionally at the radiology room so safe administration is needed to avoid the room contamination.

What has been achieved?

By using these procedures, it is possible to work with a single BSC, avoiding delays in the administration of other therapies while reducing the risk of mistakes.

What next?

These types of therapies represent a novel therapeutic modality: their preparation, administration and handling requirements differ from current therapies; pharmacists have an important role in developing new procedures to incorporate them into clinical practice. This protocol may be useful to other centres due to the lack of experience and standardised guidelines to work with this type of therapy.