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The pharmaceutical approach to the processing of donor human milk in a human milk bank

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European Statement

Production and Compounding

Author(s)

Susana Fraga, Cláudia Cunha, Susana Pissarra , Carla Sampaio, Diana Silva, Pedro Soares, Teresa Soares, Renata Barbosa

Why was it done?

Human milk banks (HMBs) must use rigorous quality assurance practices to protect infants and milk processing, and post-pasteurization procedures are important in maintaining high-quality breast milk and safeguarding its quality.
The compounding pharmacist has all the knowledge and experience needed to implement processing circuits based on good handling practices and sterile technique, combined with quality assurance procedures to ensure their safety.

What was done?

Pharmacy implementation of the Donor Human Milk (DHM) processing circuit (by pasteurization) and conditions.

How was it done?

Bibliographical research and critical analysis of the functioning of HMB worldwide, with multidisciplinary meetings to define the best and most secure quality practices.
Equipment choice, in accordance with recommendations and assessment of their technical requirements.
Adaptation of the informatic medical integrated system to the DHM prescription, processing, quality control and dispensing circuit.
Design of the DHM circuit based on good practices for the safe use of products of human origin and on a robust quality assurance plan.

What has been achieved?

A DHM circuit was put into practice, with pharmacist intervention in DHM processing, quality control, and batch release.
Procedures for aseptic handling, quality control with check points and risk analysis, packaging, and labelling of DHM were outlined.
Work instructions were also established for handling equipment (pasteuriser, bottle sealer, laminar flow chamber) as well as procedures for cleaning facilities and material/equipment, with training sessions for the professionals involved.
The multidisciplinary circuit was adapted to the organisational management of the Neonatal Intensive Care Unit (NICU), HMB, and Pharmaceutical Services, certified on 18 April 2023 according to ISO 9001:2015 recommendations.
Guidelines for the correct use of equipment in accordance with its recommendations and technical requirements were established.

What next?

Opening more HMB worldwide is an inevitability. Prevailing know how at the level of hospital pharmacies represent several advantages to these projects, based on experience and expertise in manipulating biological products and maintaining a controlled circuit based on safety and quality standards.

Securing the care pathway of patients in the new experimentation of medical cannabis through pharmaceutical interviews

European Statement

Clinical Pharmacy Services

Author(s)

Marie Guedon, Maëliss Laurent, Thibault Vallecillo, Catherine Mennesson, Mélanie Jennesson Lyver, Dominique Hettler, Céline Mongaret

Why was it done?

In March 2021, the “Agence Nationale de Sécurité du Médicament” initiated an experiment to evaluate the relevance and feasibility of the availability of MC as a narcotic drug, in France. In our hospital, we included children to treat drug-resistant epilepsy, and performed a dispensing process to secure the patient care pathway and strengthen collaboration between hospital pharmacists and primary care professional.

What was done?

The aim of this study is to secure the care pathway of patients included in a national experimentation of medical cannabis (MC) by developing pharmaceutical interviews. Thus, to optimize the continuity of patient care, a pharmaceutical report was developed, and addressed to the community pharmacists of the patient.

How was it done?

A working group was created including clinical pharmacists, a neuropediatrician and a coordination nurse. During medical consultations, pharmaceutical interviews were conducted and led to pharmaceutic reports, sent to the community pharmacies of the patients. In order to evaluate this report, a satisfaction survey was carried out.

What has been achieved?

During the first six months of the experimentation, three children were included. The clinical pharmacist team (two senior pharmacists and two pharmacy residents) performed ten dispensing processes. During the eight pharmaceutical interviews, four pharmaceutical interventions were performed. Firstly, the interaction between clobazam and MC (noticed in one patient) required a dosage adjustment. Then, the association between MC and hepatotoxic drugs (found in two patients) requires hepatic monitoring. A pharmacovigilance statement was also drafted to report side effects (digestive disorders). The satisfaction survey of community pharmacists showed that the transmitted information, mostly related to the medication review, was considered as useful for the community pharmacies of the patients. This data helped to guide the pharmaceutical interviews during their dispensing process.

What next?

Pharmaceutical interviews and their reports lead to secure the patient care pathway and improve the communication amongst health care professionals. Those measures provide an optimal case management and avoid therapeutic breakdown. Nevertheless, difficulties have been reported, mostly due to delay in the supply chain of the community pharmacies. Therefore, this system requires some adjustments before it can be applied on a larger scale. One of the suggestions is a provisional calendar of consultations and dispensations.

COVID-19: Guidelines for Infection Prevention and Control in a Hospital Pharmacy According to ISO 9001:2015

European Statement

Patient Safety and Quality Assurance

Author(s)

SUSANA SANCHEZ SUAREZ, JOSE ANTONIO VINAGRE ROMERO, MARIA ISABEL BARCIA MARTIN, CAROLINA AGUILAR GUISADO, MERCEDES GARCIA GIMENO

Why was it done?

To keep occupational health and safety during a crisis in which healthcare settings were overloaded and facing a critical shortage of skilled professionals, due to sick leaves (2,75% of total cases), and for the need to maintain high quality of care processes. These were a big challenge that required to adapt operating procedures. In addition, and due to the effect of COVID-19 on the general population (overall incidence rate of 10.596 per 100,000 people) and in healthcare systems, the Spanish Ministry of Health (SMH) issued a technical document establishing a series of recommendations for COVID-19 infection prevention and control in patients medical assistance. This practice was designed to bring together national guidelines from the SMH that aimed to reduce COVID-19 impact, both in healthcare workers and general population, and meet ISO 9001:2015 requirements in SOP of a HP within a general hospital

What was done?

In order to ensure safe systems of work (SSoW) in the hospital pharmacy (HP) during the COVID-19 pandemic, specific operating procedures (SOP) were adopted in order to prevent the risk of contagion in daily operations for both patients and staff, according to the norm ISO 9001:2015

How was it done?

Four critical areas were identified according to risk management: High-risk areas: Preparation Area (PA) and Outpatient Dispensing Area (ODA); medium-risk area: Pharmacy Administration Area (PAA) and Inpatient Dispensing Area (IDA). Some SOPs were developed within these areas: Autologous serum eye drops preparation in the PA, pharmaceutical care and medication dispensing in the ODA, pharmacy receiving in the PAA and medicines return from COVID-19 areas. Different circuits were implemented for users and professionals, as well as general information and procedures directed at patients and personnel, to prevent infection. The individual protection equipment required in each SOP/area was also established

What has been achieved?

No COVID-19 case has been reported due to patient-professional interactions or working location and tasks. All operating procedures have been revised to fully comply with SMH guidelines and ISO 9001: 2015 requirements mitigating risks and maximizing performance in such critical circumstances

What next?

Adapting SOP to any infectious disease outbreak that may occur in the future and establishing early-detection mechanisms

A PROTOCOL FOR PLACEMENT AND REMOVAL OF PERSONAL PROTECTIVE EQUIPMENT IN A POSSIBLE CASE OF CORONAVIRUS SARS-CoV-2

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European Statement

Selection, Procurement and Distribution

Author(s)

Rebeca Iglesias-Barreira, Emilio Rubén Pego-Pérez, Carlos Sandoval-Aquino, Cristina López-Pardo y Pardo, Maria Jesús Rodríguez-Gay

Why was it done?

To guarantee workers safety as well as optimize the use of PPE in the hospital.

What was done?

To develop a protocol for placement and removal of personal protective equipment (PPE), established for contact with possible or confirmed coronavirus SARS-CoV-2 infected patients, taking into account the medical devices (MD) available during the pandemic. Alternatives and strategies were also proposed for resources optimization. Final protocol resulted from a multidisciplinary team work (Hospital Pharmacy Service team and Emergency Service workers). It was finally revised and approved by the Medical and Quality Direction.

How was it done?

1)A systematic bibliographic review was made, for articles selection on the placement / removal of PPE. Technical specifications of the available MD and the sanitary recommendations of the competent organitations were reviewed.
2)Establishment of PPE components, and the order of placement and removal:
a. PPE placement:1-Wash hands (WH).2-Place shims.3-WH.4-Put on the first pair of gloves.5-Put on FFP2 mask.6-Wear waterproof protective overalls from the feet.7-Place garbage bags on feet and adjust them on legs.8-Wash gloves with a hydroalcoholic solution (HS).9-Put on second pair of gloves.10-Put on a standard/reinforced surgical gown.11-Wash HS.12-Put on surgical mask.13-Put on disposable gown.14-Put on third pair of gloves.15-Put on face protection screen. 16-Put on surgical cap and fit it over a face shield.
b. PPE removal: a) Before leaving the isolation room: 1-Remove and discard bags from both feet.2-Remove and discard disposable gown.3-Remove and discard the outermost gloves. b) Outside the isolation room: 1-Wash HS.2-Remove surgical cap and screen (reserve screen).3-Remove and discard surgical mask.4-Wash HS.5-Remove the standard/reinforced surgical gown and reserve it.6-Remove second pair of gloves.7-Wash HS.c) Before entering the clean area:1-Remove shoes.2-Remove third pair of gloves.d)Go to the clean area:1-Disinfect footwear.2-Wash HS.3-Remove monkey and if necessary reserve it. 4-Wash HS.5-Remove FFP2 mask and reserve it if necessary.6-WH.
c. A team member read and check all steps carried out during the all steps procedure.

What has been achieved?

The protocol was followed by 54 (100%) workers. Since its implantation, on March 16 th, only the 3,7% (n=2) of workers were infected by SARS-CoV-2.

What next?

The protocol is under constant revision and modification to adapt it to the available MD in every moment.

National monitor for the quality of medication surveillance

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European Statement

Patient Safety and Quality Assurance

Why was it done?

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What was done?

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How was it done?

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What has been achieved?

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What next?

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