BACKGROUND: A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Due to the high level of complexity in care, the severity of the patient’s condition, any underlying diseases, and the need to provide life-sustaining therapy, patients in intensive care units (ICUs) are most susceptible to exposure to incidents. High-risk (HR) medications in particular are linked to medication errors that result in severe harm, protracted hospital stays, or even fatalities. Due to lack of studies regarding reporting of medication errors in India, we aim to understand the causes and incidence of medication errors in critical care system and to reduce them through development of various suitable strategies. We plan to carefully audit the ICUs in order to identify the reasons for medication errors specially with high-risk medications, thereafter, conduct interviews with the stakeholders and develop relevant strategies which can be easily implemented in our healthcare system to reduce the chances of medication errors.

 OBJECTIVES: 1) To study the incidence, severity, outcomes, and various factors influencing the medication errors in ICU settings.

 2)Development of strategies to overcome the medication errors through qualitative interview of various stake holders.

3)Implementation and evaluation of strategies in ICU settings through pre and post interventional assessment.

 METHOD:

Inclusion and exclusion criteria:

For Patients

Inclusion criteria: Cases involving high risk medications in critical care unit. 

Only seriously ill patients will be enrolled.

Exclusion criteria: Cases not involving high risk medications and who are not willing to participate.

 For Stakeholders

Inclusion criteria: Physicians, nurses, PG students and other staff working in critical care settings.

Exclusion criteria: Physicians and nurses not working in critical care settings and not willing to participate.

Development of strategies to overcome the medication errors through qualitative interview of various stake holders, implementation, and evaluation of these strategies in the ICU settings. Detailed explanation of the process is given below. This is an interventional study which will be done for physicians and health care staff involved in critical care settings to assess the potential medication errors occurring in patients taking high risk medications.

PHASE 1: Auditing (Pre assessment): After ethical committee approval, patients who are admitted in critical care settings will be observed. Based on the inclusion and exclusion criteria, study will be explained to the patient representatives and consent will be obtained, reconsenting will be done with the patient once he is conscious. Once the patient is enrolled into the study, he will be followed from the day of admission to the day of  discharge. Observing and conducting audits of prescription and medication administration chart will be done for a period of 6 months. All the data will be collected with respect to the medication errors including administration errors, transcription errors and prescription errors in a pre-designed checklist. The outcomes measured will be types of medication errors, adverse events, length of hospital stay and mortality. Based on the collected data, medication error will be classified into different categories and correlate the factors affecting the medication errors. The data collected will be used to understand the practice and barriers related to the medication errors in critical care setting.

Our study focuses only on the medication errors that occur in relation to High risk medications. High risk medicines are those medicines that have a high risk of causing significant patient harm or death when used in error. Although errors may or may not be more common than with other medicines, the consequences of errors with these medicines can be more devastating.

 PHASE 2: Interview of stakeholders: Conducting one-on-one in depth semi structured qualitative interview from various stakeholders including physicians and nurses by using an interview guide developed based on literature review, prospective audit, and expert opinion. The stakeholders will be recruited based on the purposive sampling method. The focus of this interview is to understand the perspective of stakeholders on the different aspects like concern, need and ways to minimize the occurrence of medication errors. The interviews will be audio recorded based on their consent. The audio recordings will be transcribed verbatim and NVivo software will be used to manage the data.

 PHASE 3: Development of strategies and educational model (Post assessment): It is an educational interventional study with pre and post assessment. Based on the audits and interviews performed during phase 1, different strategies and education model will be developed to train the healthcare professionals including nurses, PG students, emergency doctors and other ICU staff. Once the model has been developed, it will be validated with the help of the experts using the proper checklist. The validated model will be submitted to the IEC before implementation.

 IMPLEMENTATION

A one-day workshop will be conducted separately for nurses, PG students, emergency doctors and other ICU staff to create awareness regarding the medication errors. The developed model will be delivered by the expert physician through the workshop to the healthcare professionals in all ICUs after taking their consent. 

The strategies developed will be implemented along with the education simultaneously. Up to a period of 6 months, all the medication errors will be assessed and compared with the phase 1 results. Informed consent will be taken first from the legally authorized representative and later reconsenting will be done when the patient is conscious.

 The change of practice will be followed for a duration of 6 months from the day of workshop in all the patients who are seriously ill and are admitted to the ICU during that period. The outcome will be assessed in terms of percentage of decrease in the medication errors compared to the pre assessment conducted in phase 1.

 OUTCOME:

The study will be helpful to identify the suitable strategy which can be implemented throughout the hospital effectively to reduce all the medication errors including administration errors, transcription errors and prescription errors. The outcomes measured in terms of percentage of types of medication errors, adverse events, length of hospital stay and mortality.