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Author(s)

M. Echávarri de Miguel, C. Varela Guisasola, A. Sánchez Alonso, A. Abril Cabero, E. Nieto Martil, A. Merino Pardo, E. Algarra Sánchez, B. Riva de la Hoz, B. Márquez Arce, B. Leal Pino, M. Pozas del Río

Why was it done?

Lactose used as a pharmaceutical excipient is generally obtained from skimmed milk and purified to remove milk proteins. Pharmacopoeias specify that lactose must be free from protein contaminants; hence, it has been considered safe for patients with cow’s milk protein allergy (CMPA). However, in severe allergies, medicines containing natural lactose should be avoided due to the potential risk of protein contamination. Although rare, cases of anaphylaxis from contaminant milk proteins have been reported, particularly with dry-powder inhalers, injectables, and vaccines.

This initiative arose after a suspected allergic reaction in a patient with severe CMPA following administration of an injectable containing lactose as an excipient. Given limited evidence and lack of transparency about lactose origin, an internal guideline was developed to enhance patient safety.

What was done?

An internal hospital guideline was developed and implemented to verify the origin—natural or synthetic—of lactose used as an excipient in medicines. The guideline was created through systematic screening assisted by artificial intelligence, followed by verification with manufacturers.

How was it done?

With ChatGPT support, a Python-based code was created to analyse 3,278 pharmaceutical specialties for the presence of lactose. Manual validation of 360 medicines (95% confidence level, ±5% margin of error) confirmed the method’s reliability. The most dispensed medicines and all intravenous formulations, vaccines, and inhalers were reviewed due to higher risk described in literature. Manufacturers were contacted to determine whether lactose was natural or synthetic. Main challenges included delayed responses and limited data due to confidentiality.

What has been achieved?

Of the 3,278 medicines analysed, 350 contained lactose or mentioned it in their product information, 1,522 did not, and 1,406 were inactive codes. Lactose origin was investigated for 152 products from 58 manufacturers, with responses in 92 cases (60.5%). Only five (5.4%) contained synthetic lactose. High-risk medicines included one inhaler and eight injectables (two vaccines) with natural lactose. Manual validation showed 100% concordance with automated results.

What next?

Next steps include expanding data to over 350 confirmed medicines, publishing results for open access, and developing an app for healthcare professionals. Integration into prescribing and dispensing systems is planned to generate automatic alerts for patients with severe CMPA.

Pdf

Author(s)

Muñoz Cid, CL; Sierra Torres, MI; Sánchez Martín, A; Martín Roldán, A; González Sánchez, B

Why was it done?

A procedure was designed for the registration of drug allergies of patients admitted to the hospital in the electronic prescription program by reviewing the digital medical record.

What was done?

Several issues lead to the need of this development:
-Lack of integration of allergy information from computerized history and electronic prescribing.
-To facilitate the appropriate triggering of alerts, correct allergy terminology, coded properly, and captured in a standard location
-Variability in the recording of this information at the different levels of healthcare (primary care and hospitalized).
-Difficulty in accessing information on drug allergies when prescribing and validating medical treatments.
-To improve Patient safety, there is a high risk of serious adverse events if the patient receives a drug to which he/she is allergic.

How was it done?

-Review of allergy documentation (free text), including a more detailed specification and characterization of the patient´s allergies to coded properly (allergy to medicines or therapeutic groups, contraindications, intolerances).
-Validation and configuration of the alert system stratifying risk by means of different colors of according to the information from the clinical history.
-Development of an algorithm to evaluate how to register each allergy depending on every different situation.
-Elaboration of a procedure to alert management and incorporation into the electronic prescription program.
-Dissemination of the procedure and awareness-raising of the need for proper recording.

What has been achieved?

-Preventing medication errors related to drug allergies and ensuring patient safety.
– Improving access to all allergy information for all healthcare professionals involved in the prescription and validation of medication.
– To have a standardized methodology for recording and coding allergies.
– Integrating medical record information into the electronic prescription system.
– Setting-up an effective alert system to avoid allergy errors in the e-prescribing system.

What next?

We have achieved the implementation in the Pharmacy Service of our hospital, but it has already been taken to the safety committee in order to extend this practice to all the services of our hospital and we are working on the formation of a working group within the Patient Safety Commission. We are considering extending this procedure to primary care in order to address this problem from all healthcare areas.

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.