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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.

PHARMACISTS IMPROVE DOCUMENTATION OF DRUG ALLERGIES

European Statement

Patient Safety and Quality Assurance

Author(s)

Mohammed Almeziny, Fahad Alkharji , Ali Alkhudair , Jameel Al Mutairi

Why was it done?

Poor allergies’ documentation may cause harm to the patients, if the concerned medication reaches them. The hospital is planning to implement a new Health Information System, which includes a Computerised Provider Order Entry. However, this is a long-term project, so in order to minimise that risk, the hospital administration gave the pharmacists the privilege to do so. The percentage of documented drug allergies was 14%. The issue of compliance from the medical, nursing and pharmacy staff was a major obstacle in allergies’ documentation. For that reason, the pharmaceutical services initiated an improvement project to enhance allergies’ documentation. it is the responsibility of the physician to document any allergy on the inpatient prescription form (IPPF). On the other hand, it is the responsibility of the nurse to ensure that all information is completed on the IPPF before it is sent to the pharmacy. The role of the pharmacist is to document the patient’s allergy in the pharmacy system.

What was done?

Increase the allergy documentation from 14% to 96%.

How was it done?

The FOCUS PDCA was adopted. Find: It was found that the compliance rate was not satisfactory. Patients might receive a medication that is known to cause an allergic reaction, because the allergy was not documented and communicated with other healthcare providers. Organise: The team consisted of all involved departments. Clarify: Some IPPF may not contain allergies and some pharmacy staff do not document the allergy in the pharmacy system. Understand: The factors that may influence the process were identified, although some healthcare professionals consider the documentation as a time-consuming process. The pharmacy system is an old system which does not support enforcing function. Select: The targeted outcome was 90% within 1 year of its inception, July 2017 to July 2018. Plan: All allergies MUST be assisted, and the pharmacy will act as the enforcing body. Do the plan: All pharmacists were reminded to enforce hospital policies by not accepting any incomplete prescription and document all drug allergies in the pharmacy system. Check: Statistics regarding compliance were presented in monthly meetings to highlight the challenges, difficulty or any serious issue. It is a proactive meeting and members can freely suggest any tools required to improve the situation.

What has been achieved?

There was a significant improvement from 14% to 96%.

What next?

Start e-prescription to enforce the documentation of allergies.

DEVELOPMENT OF A COMPUTER APPLICATION TO REDUCE THE RISK OF ERRORS IN RECONSTITUTION OF CYTOTOXIC DRUGS

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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

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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.

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