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. 2024 Jul 16;16(7):e64653.
doi: 10.7759/cureus.64653. eCollection 2024 Jul.

Evaluation of the Effectiveness of the Adverse Drug Reaction Alert Card System in Preventing the Recurrence of Adverse Drug Reactions

Sarita Mulkalwar  1 , Shantanu Chitale  1 , Prachi Dandage  1 , Shraddha Bapat  1 , Abhijeet V Tilak  1 , Sayali Patil  2
Affiliations

Evaluation of the Effectiveness of the Adverse Drug Reaction Alert Card System in Preventing the Recurrence of Adverse Drug Reactions

Sarita Mulkalwar et al. Cureus. .

Abstract

Introduction Adverse drug reactions (ADRs) are among the leading causes of morbidity and mortality. It causes a significant prolongation of hospital stays, leading to an increased economic and infrastructural burden on the healthcare system. Thus, primary prevention will help in preventing recurrent ADRs. People are often unable to state whether they have suffered an ADR from a medicine or not. The patients also find it difficult to recall the offending drug. They seldom seem to carry any information that would warn others of their reactions. Thus, there was a need to introduce the ADR Alert Card. A pilot study was first conducted in 2018 to assess the feasibility of this card. All patients suffering from an ADR were thus provided an alert card. Following its implementation, there was a general acceptability regarding the potential of this card in ADR recurrence prevention among healthcare professionals (HCPs). Therefore, there is a need to assess the effectiveness of this card for ADR recurrence prevention. Objective This study aims to estimate the percentage of people who have shown the ADR Alert Card to their HCPs and benefited from it. Methods This was a prospective observational study, which was conducted at Dr. D. Y. Patil Medical College, Pune, from November 2022 to May 2024 and received approval from the Institutional Ethics Committee (IEC) before its initiation. All the patients who faced an ADR were given an ADR Alert Card by their HCP. All the patients to whom their HCP had given the card were part of this study. Any patient who suffered an ADR due to overdosage of medication was excluded from the study. After screening for inclusion and exclusion criteria, the data were analyzed using MS Excel (Microsoft Corporation, Redmond, Washington). A questionnaire was validated by professors in pharmacology, medicine, and community medicine. The patients were contacted through telephone conversations and provided with this questionnaire. They were asked questions regarding the ease of carrying the card, the benefit it provided them, whether they had shown it to their HCP, whether it helped them in an emergency, and their willingness to link it digitally. Their responses were recorded in Google Forms, and pie charts were generated. Results All 110 patients (100%) agreed that the ADR Alert Card was beneficial. Most (99, 90%) patients had shown the card to their HCP at their subsequent visit. The card helped 107 (97%) patients to describe their medical history easily. All the patients (110, 100%) agreed that carrying the card was easy, and most patients (95, 86%) agreed to recommend using the card to others. Additionally, most patients (79, 72%) were willing to link their card to their National Health ID. However, a small proportion of patients (28, ~25%) were skeptical whether they would link the card to the National Health ID or not. The card had helped 28 (25%) patients in an emergency. Approximately 11 (10%) patients had reported an ADR to the regulatory authority. Conclusion The patients welcomed this new concept to be inculcated in their daily lives as an effective means to enhance their healthcare. This study evaluates the number of patients who actually benefitted from using this card. It encourages patients to participate actively in their own healthcare. In an emergency situation, it proves to be a source of important health information. This study could lay the foundation for further research to prevent recurrent ADRs.

Keywords: adr monitoring; adr recurrence prevention; adverse drug reaction alert card; adverse drug reaction reporting; adverse drug reactions (adr); healthcare professionals (hcp).

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Conflict of interest statement

Human subjects: Consent was obtained or waived by all participants in this study. Institutional Ethics Sub-Committee issued approval IESC/PGS/2022/201. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: Dr. Sarita Mulkalwar declare(s) a grant from Dr. D. Y. Patil Medical College, Hospital & Research Centre, Pimpri, Pune, India. This grant was given for printing the ADR Alert Cards. Intellectual property info: Dr. Sarita Mulkalwar has the copyright certificate for the ADR Alert Card from the Copyright Office, Government of India (Registration No. L-111544/2022, dated 31/01/2022). Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1. The front and back views of the ADR Alert Card
ADR: adverse drug reaction; PvPI: Pharmacovigilance Programme of India
Figure 2
Figure 2. Permission request to use the ADR Alert Card (Copyright Form)
ADR: adverse drug reaction
Figure 3
Figure 3. Instructions to HCPs regarding the use of the ADR Alert Card
ADR: adverse drug reaction; HCPs: healthcare professionals; AMC: ADR Monitoring Centre
See this image and copyright information in PMC

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