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The design and implementation of a crushability algorithm: first experiences of a pharmacist-lead medication review in patients with swallowing difficulties

European Statement

Clinical Pharmacy Services

Author(s)

Nicolas Sagaria, Daniele Mengato

Why was it done?

Dysphagia is a swallowing disorder more common in the elderly. The pharmaceutical market is not always able to meet the needs of dysphagic patients and manipulation of a medication is sometimes the only possible way to ensure its administration. This activity is often delegated to nurses or other professionals without the necessary education.

What was done?

The manipulation of solid oral pharmaceutical forms, such as tablets or capsules, is such a common act that it is sometimes regarded superficially. In order to guide the clinical pharmacist in assessing the crushability of a tablet, we designed, and validated through an on-field application, a decision-making algorithm.

How was it done?

The first two steps of the algorithm help, respectively, to understand whether there are clear indications in the summary of product characteristics on how to manipulate the drug and/or whether there are alternatives on the market, other than the solid oral, suitable for administration to the dysphagic patient. When neither of these steps is feasible, the pharmacist is guided towards direct manipulation of the drug, supported by evidence in literature and study of excipients. If a solution cannot be found, the physician should be advised to consider a switch or a discontinuation of therapy. Finally, we tested the algorithm by including it in a medication review form in a otolaryngology-ENT department, where the incidence of dysphagic patients was higher.

What has been achieved?

In the second half of 2020, we analyzed 45 medrev forms filled out in the ENT-department. Each form contained an average of 2.8 drugs to be re-analyzed for the dysphagic patient. We applied our algorithm to a total of 123 drugs. For 101 (82%) of these, we provided precise information on the correct way to administer and manipulate the drug. For only 22 drugs, a discussion with the prescriber was necessary to identify an alternative. In this way we have improved patients’ and operators’ safety.

What next?

In the near future we will expand our test to other departments, not only surgical, and try to minimise the rate of drugs for which we could not provide information on manipulation. In addition, we are planning to develop a software to simplify the process.

RESOURCES OPTIMISATION OF LOPINAVIR/RITONAVIR IN THE SANITARY EMERGENCY DUE TO SARS-CoV-2 IN A THIRD-LEVEL HOSPITAL IN THE ULTRA-PERIPHERY

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European Statement

Selection, Procurement and Distribution

Author(s)

Lierni Goitia Barrenetxea, Natalia Toledo Noda, Moisés Pérez León, Victoria Morales León

Why was it done?

Lopinavir/ritonavir is a HIV-1 and HIV-2 proteases inhibitor indicated for HIV. It was used in patients with a positive SARS-CoV-2 test after being recommended by the Chinese health authorities. The hospital protocol guideline was: 400/100mg every 12 hours orally. It was presented in both tablets and oral solution, which was reserved for patients intubated in the ICU and those who were not able to take tablets.

What was done?

Optimizing the use of lopinavir/ritonavir solution during the state of sanitary emergency.

How was it done?

Descriptive study of resources optimization for lopinavir/ritonavir and actions carried out to ensure the availability of the antiviral in intubated SARS-CoV-2 positive patients. Preparation and stability data were obtained from official sources (Spanish Agency for Medicines and Health Products) and from the Spanish Society of Hospital Pharmacy.

What has been achieved?

The Pharmacy Service designed a protocol to repackage lopinavir/ritonavir 80/20mg/mL solution in syringes containing the exact amount for a single dose (400/100mg in 5ml), for single use. The solution is formulated on an alcoholic basis and there is an interaction with the polyurethane nasogastric tube because the polyurethane absorbs alcohol causing the catheter to swell and deteriorate, which is why, other services were notified to use polyvinyl chloride catheters or silicone. Likewise, the syringes used to repackage the solution were exclusive for oral administration used in pediatrics, with the aim of reducing medication administration errors, since it is not possible to connect parenteral injection needles with them. These measures were intended to make the dispensing system as efficient as possible, as once the drug entered a unit with patients with a positive test, it was contaminated, therefore it could not be reused. Additionally, the fact that the hospital is located on an island made it even more difficult to acquire the medicine, given the supply problems nationwide, the great restriction of air and maritime traffic and loan limitations from other hospitals.

What next?

The measures adopted managed to ensure the availability of lopinavir/ritonavir solution in all admitted patients, optimizing the scarce availability of a solution medication whose presentation is formulated in multidose containers. By adding the use of syringes for exclusive oral use, administration errors were prevented.

HAZARDOUS DRUG ENTERAL DEVICE

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European Statement

Production and Compounding

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

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