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How to cite this paper: Papoyan, T. (2023). Drug Safety: Challenges and Solutions. Messenger ofASUE, 2(14), 63-71. DOI: 10.52174/1829-0280_2023.2-63
Received: 18.05.2023. Revision: 24.05.2023. Accepted: 29.11.2023.
TATSHAT PAPOYAN
PhD Student of the Chair of Statistics at Armenian State University of Economics hups: orciil. org/0009-0002-8525-11 OX
DRUG SAFETY:
CHALLENGES AND SOLUTIONS
Drug safety is a significant healthcare problem with consequences for patient outcomes and quality of care (WHO, 2017). This particular report reviews the different facets of drug safety, in terms of the issues related to the production and distribution, the regulatory authority responsible for drug safety, ADR monitoring and security complaints. A literature review was performed to evaluate the present state of drug safety and to identify challenges and trends. The study also describes research activities. methodology, sources of data and analysis techniques. It is concluded that there are several challenges in drug safety assurance including an increase in counterfeit medicines, lack of regulatory oversight, lack of surveillance of negative effects of drugs on people. The article examines these solutions and challenges, like blockchain, improved accountability and transparency, and better reporting and monitoring of ADRs. The paper also discusses how the findings can contribute to the activities of providers, regulators, and policy makers, and calls for a concerted approach to drug safety problems from policymakers.
Keywords: drug safety, healthcare, regulatory compliance, side effects, counterfeit drugs, blockchain technology, collaborative approach.
JEL: I12, L56
DOI: 10.52174/1829-0280_2023.2-63
INTRODUCTION. A significant issue of medical care is drug safety due to its direct effect on individual and public health. The primary objective of drug
safety is to lessen the dangers of drug usage while maximizing the advantages (Institute of Medicine, 2006). Still, drug safety faces such challenges as counterfeit drugs, insufficient regulatory oversight, coupled with weak monitoring of ADRs (WHO, 2017). Negligent drug events could cause severe damage, high medical expenses and even death. As a result, comprehensive (Aronson, 2012) methods and interventions are required to lower the incidence of ADRs and enhance drug safety.
Recently, drug safety has seen considerable advancement because of technical developments, increased information availability and increased recognition of the need for pharmacovigilance (Davies and Rawlins, 2012). Pharmacovigilance is the science and practice of identifying, assessing, and preventing adverse drug reactions (ADRs), which are critical for human bodily wellbeing. It consists of data on drug safety coming from various sources such as manufacturers, patients, regulatory bodies and pharmaceutical companies (Pal et al., 2012).
The objective of the paper is to explain the current state of drug safety and outline a few approaches and strategies which support its improvement. In systematic evaluation of the literature, we will discuss the drug safety pillars: pharmacovigilance systems, electronic health record, data mining of medical records, blockchain technology, and social media data analysis. By comparing these approaches, we can find their potential, disadvantages and advantages for achieving effective drug safety.
Additionally, the issues and gaps found in existing drug safety methods are underreporting of ADRs, nonstandardization of reporting and information collection, and the increase of counterfeit drugs. Knowledge of these difficulties is crucial for the design of certain interventions and future research directions to solve these problems.
By reviewing the literature and offering the latest trends in drug safety analysis, this paper will contribute to the continuing efforts in enhancing patient safety and healthcare outcomes. Conclusions and recommendations drawn from this study can be used by physicians, researchers, regulatory agencies and policymakers to develop evidence-based recommendations to reduce medication - related risk and ensure drug safety in patient care. Lastly, the goal is to develop a continuously imptoving drug safety culture and patient satisfaction in healthcare environment worldwide.
LITERATURE REVIEW. Drug safety is a thorny issue for physicians, regulators and policymakers. Counterfeit drugs have been posing a significant risk to medication safety in recent years. Drugs which are purposely mislabeled or adulterated as fake medicines usually have inactive or incorrect ingredients (Khalid et al., 2021). This might result in severe health effects including treatment failure, drug overreaction and death. In the US, ADRs are believed to cause 100,000 deaths yearly (FDA, 2022). According to Abidi et al. (2021), the
global counterfeit drugs industry is valued at over USD seventy five billion. Up to 30% of medicines in developing nations are counterfeit (Rahman & Islam, 2020). Blockchain technology has been recommended to resolve this particular issue. Blockchain technology can enable a transparent and secure supply chain which could verify the authenticity and integrity of medicines, and, therefore, make counterfeit drugs harder to find.
Yet another hurdle to drug safety is insufficient regulatory oversight, which may result in the endorsement and selling of harmful drugs. Regulatory agencies such as the Food and Drug Administration (FDA) in the United States, help guarantee drug safety by enhancing accountability and transparency and by establishing greater security standards. However, some parts of the world still need increased regulatory oversight (Rahman & Islam, 2020). Restricted resources, political pressure and competing interests can restrict the efficacy of regulatory oversight. This may lead to drug approval delays, poor ADR monitoring and poor safety enforcement.
Additionally, inadequate monitoring of ADRs represents one more substantial problem of drug safety because of the possibility to postpone detection and reaction to safety issues (Lammers et al., 2017). ADRs are accidental, toxic drug reactions at physiological doses. These reactions might be moderate to severe and at times lethal. Based on WHO (WHO, 2017) over 1 in 10 hospitalized patients experiences an ADR. In 2021, (FDA, 2022; Announcement), over 1.5 million ADRs were reported to the FDA's Adverse Event Reporting System (AERS). (Nwosu, 2020). However, it has been revealed that just a tiny proportion of ADRs is reported to regulatory authorities (Ward et al., 2019). A Canadian study reported that just 5-10% of ADRs are reported to the appropriate regulatory authority (Ward et al., 2019). While ADRs can be reported to regulatory bodies and healthcare providers, underreporting of ADRs remains a major issue. This can delay the processes related to the recognition of safety issues and taking actions. Reporting and monitoring of ADRs can be enhanced using electronic health records along with other digital methods which help support the collection coupled with ADR information analysis (Bates et al. 2019).
RESEARCH METHODOLOGY. A systematic literature review was performed to provide the present drug safety situation. The assessment included academic articles, books, reports and associated publications from sources including PubMed, Scopus, Web of Science and Google Scholar. Key information from regulatory bodies, including the FDA and WHO, has also been discussed (Harpaz et al. 2012; Lammers et al., 2017; FDA, 2022; WHO (2017). The search strategy used a blend of keywords (drug safety, regulatory oversight, adverse drug reactions, healthcare providers and policymakers) for comprehensive coverage.
To narrow the review, the articles published in English between 2015 and 2022 were included. This particular timeframe was chosen to capture recent advances and developments in the area. Following preliminary review of relevant articles, 56 papers were chosen for additional evaluation.
Data analysis involved examining every article for emerging trends, issues and suggestions related to drug safety. Key themes and patterns were identified, and relevant data were extracted to summarize current drug safety status. The analysis consisted of pharmacovigilance systems, electronic medical record monitoring, data mining of medical records, social media and blockchain technology information.
This study will give a summary of existing information, future perspectives and promising strategies in drug safety. The paper will shed light on the subject matter and lay the basis for more investigation and development of policies for better drug safety and patient safety.
ANALYSIS. A rising amount of counterfeit drugs, inadequate regulatory oversight, along with poor monitoring of ADRs are among the challenges in drug safety. Electronic health records and social media data analysis demonstrated potential for detecting drug related adverse events which were not previously detected. Additionally, new drug development trends including personalized medicine and artificial intelligence create new drug safety concerns. Healthcare providers, regulators and policymakers have to work hard to overcome these difficulties through enhanced transparency, increased regulatory oversight, and also better reporting and monitoring of ADRs (Dabrowski, 2021).
The literature review implies that a few methods for drug safety enhancement have been recommended ranging from pharmacovigilance and HRM to data mining of overall health information.
Adverse drug reaction (ADR) detection and analysis are essential features of pharmaceutical systems, like the FDA's adverse Event Reporting System (FAERS) (Nwosu, 2020). Analyzing adverse event reports from these systems offers insight into drug safety profile for early detection and better patient outcome. Nevertheless, despite the crucial value of reporting adverse events, underreporting remains a significant danger in pharmacovigilance.
The research findings indicate that for a range of reasons, providers might delay reporting adverse events. Fear of adverse events and liability reporting outcomes might prevent providers from taking part in adverse event reporting methods. Further, healthcare providers may underreport because they are unsure of the cause of the adverse event that has been reported.
Enhancing healthcare provider training in the benefits of adverse event reporting is necessary to fight underreporting. Informing providers about the benefits of reporting ADRs might motivate them to get involved in pharmacovigilance. Furthermore, reorganization of reporting can simplify the
workflow for providers to report adverse events. Clear guidelines and user-friendly reporting systems can eliminate barriers and facilitate the reporting process.
Collaboration among regulators, healthcare companies and healthcare providers are essential to deal with underreporting. A supportive culture of open communication about ADRs and a culture of reporting can increase reporting rates. Moreover, feedback mechanisms and timely reporting of results of reported adverse events can improve the importance and impact of providers' involvement in pharmacovigilance.
Electronic medical record monitoring and healthcare information mining identified previously unreported adverse events (Harpaz, 2012; Harpaz et al. Laverty, 2014). The study concluded that electronic health records can include significant data about patients 'medical histories, medications, and side effects. Because of this data, possible adverse drug reactions might be detected, and severity evaluated. Another successful technique of pharmacovigilance was data mining of healthcare information including claims information and electronic medical records. Data mining proved that possible adverse drug reactions can be detected in real time to allow for early warning of damage.
Drugs developed in counterfeit present a threat to public health due to potentially poisonous contents or incorrect dosages which could result in therapy failures, allergic reactions and death. The research suggested blockchain technology as a response (Kshetri, 2018). Blockchain is a public, unmutable electronic ledger which is utilized to transparently and securely capture transactions.
Blockchain may make pharmaceutical supply chains safer and more transparent. While the supply chain remains out of producing to distribution, each phase can be rebuilt on the blockchain and, therefore, be tamper-proof of medicine authenticity and traceability. This enables stakeholders including regulators, health insurers and patients to independently evaluate the origin and quality of medicines. Blockchain will flag counterfeit medications at several supply points, decreasing counterfeit medication exposure to clients.
Besides blockchain technology, regulatory bodies are also crucial for medication safety (Bate, 2018). They determine and apply safety criteria for pharmaceuticals. Transparency and accountability might produce a regulatory framework whereby manufacturers, distributors and healthcare providers pertain severe quality control processes. More severe security rules, including inspections and restrictions will prevent the sale of counterfeit medicines.
In addition, authorities can collaborate with global agencies such as the World Health Organization to establish global standards and recommendations for the fight against counterfeit medications. By integrating legislation and employing information exchange, nations may cooperate to improve medication safety globally. By allowing the use of blockchain technology and track-and-
trace devices for medication monitoring and verification, regulatory agencies may also promote industry collaboration.
A multifaceted strategy is necessary to tackle counterfeit drugs. It entails collaborating and coordinating efforts by stakeholders including regulators, police officers, pharmaceutical companies, and healthcare providers. Blockchain technology along with higher security standards can help decrease the danger of counterfeit medications while providing patients with safe and effective medications.
The study described the emerging role of social media data analysis in pharmacovigilance, stating that "social media websites like Twitter and Facebook supply important patient generated information about medication experience including negative events (Dabrowski, 2021). Individuals frequently post their views, questions or experience regarding drugs on social networks, and, therefore, present an aggregate and existing database which might predict damaging drug reactions.
Mining social media data might help scientists and healthcare providers determine patient-reported adverse events and inform early detection and preventive harm minimization. Social media offer an invaluable chance to record real life happenings and drug related experience to find out negative drug reactions not reflected by typical pharmacovigilance mechanisms.
Social media data analysis may offer numerous advantages in pharmacovigilance. To begin with, it offers a huge amount of data created by a heterogenous sample to represent a wider variety of patients and experience. This might help identify unusual or underreported adverse events that are not apparent in smaller studies. Secondly, real-time information from social media platforms might allow for quicker action and early warning of adverse events. Thirdly, social media information may capture consumer point of view to comprehend their questions and context for greater understanding and patient protection.
But social media information analysis does have its limits in pharmacovigilance. Information noise (misinformation, partial information, and lack of context) which may impede the precision and dependability of results were identified. Protection of privacy and ethics also comes up with publicly accessible, yet confidential data shared on social networking sites. Data privacy and ethical concerns while mining social networking information for pharmacovigilance are crucial.
Scientists and clinicians require sophisticated data collection, processing, and analysis methods to tap the potential of social media information for pharmacovigilance. Natural language processing and machine learning techniques may be utilized to mine pertinent data from millions of unstructured social networking information for quick detection and classification of adverse events. Such methods need collaboration among scientists, hospitals, and technology specialists.
In conclusion, social media data analysis belongs to a brand-new tool for pharmacovigilance in terms of real time patient experience and potential negative drug reactions. Although social media information is not without its drawbacks (information interference and privacy concerns), changes in data mining and cooperation amongst stakeholders are able to help boost utilization of this useful information for predictive drug safety monitoring and magnified patient care.
Along with ADR reporting and monitoring, advancements by healthcare providers could enhance drug safety. This is achievable with electronic medical records and various other electronic solutions which help support the collection along with analysis of data regarding ADRs (Lammers et al., 2017). Enhancing ADR reporting and monitoring may help providers in determining safety concerns earlier and more appropriately.
Despite the different strategies recommended to enhance drug safety, the study indicated considerable challenges persist. A significant pharmacovigilance challenge is the underreporting of adverse reactions, particularly in low and middle income nations. Adverse event reporting and data collection among places and health systems aren't standardized, making adverse event comparisons and evaluations difficult. Technical procedures and improvement changes represent continuing risks to drug safety licensing and drug development.
CONCLUSIONS. Drug safety management is a multifaceted process including numerous strategies, and stakeholders should take a holistic approach. By systematic evaluation of the literature, this article analyzed the present drug safety situation and determined methods and approaches to its improvement.
Literature review results show that pharmacovigilance tools including FDA's Adverse Event Reporting System are crucial to detecting and analyzing adverse drug reactions. Nevertheless, underreporting of adverse events continues to be a significant challenge. Priority must be given to training of medical providers and simplified reporting.
Electronic health record monitoring and data mining of healthcare data demonstrated the ways of detecting drug-related adverse events. Such methods can provide real time information on possible adverse drug reactions for early warning of damage. The comparison and evaluation of adverse events call for uniformity of adverse event reporting and data collection amongst nations and medical systems.
The study also highlighted the need to address the risk-posed medications issue for public health. Technology helps in a clear supply chain for drug authenticity and integrity checking. Drug safety is ensured by regulators by transparency, accountability and safety standards.
In addition, media information analysis has become a pharmacovigilance strategy. Social media websites offer real time information regarding drug
adverse reactions from users. Yet, challenges like information noise and privacy concerns must be dealt with to uncover total value from social media information for drug safety monitoring.
Guidelines for better drug safety practices from regulatory bodies, healthcare providers, pharmaceutical companies and patient advocacy organizations are crucial to keeping supervision and improvement. Technology trends including personalized medicine and artificial intelligence bring both challenges and opportunities to drug safety that expect innovation and adaptation.
The paper highlights the importance of taking an integrated, multifaceted approach to drug safety that encompasses pharmacovigilance systems, electronic health record monitoring, healthcare data mining via blockchain technology and social media data analysis as part of healthcare stakeholders' collaboration for improved drug safety, reduced risks and effective medication usage for patient welfare and public health purposes. By understanding their strengths, limitations, potential cooperation ways, healthcare stakeholders can work collaboratively towards increased drug safety and mitigate risks through safe medication usage for better patient well-being and public health benefits.
References
1. Abidi, H., Lakhani, P., & Shafi, M. (2021). Blockchain for drug supply chain management: A review. Journal of Medical Systems, 45(1), 1-18.
2. Abidi, S. H., Khalid, S., & Umar, A. (2021). Counterfeit drugs: A major threat to public health. Journal of Applied Pharmaceutical Science, 11(1), 154-160.
3. Aronson, J. K. (2012). Drug safety. British Journal of Clinical Pharmacology, 74(4), 581-592.
4. Bate, R., & Mathur, A. (2018). The role of regulatory agencies in pharmacovigilance. Journal of Medical Toxicology, 14(2), 151-156.
5. Dabrowski, M. J., Kostka, K., & Jarosz, M. J. (2021). Mining social media data for pharmacovigilance: A review. Drug Safety, 44(3), 273-291.
6. Food and Drug Administration. (2022). FDA Adverse Event Reporting System (FAERS).
https://www.fda.gov/drugs/surveillance/fda-adverse-event-reporting-system-faers
7. Harpaz, R., DuMouchel, W., Shah, N. H., Madigan, D., Ryan, P., Friedman, C., & Huang, S. (2012). Novel data-mining methodologies for adverse drug event discovery and analysis. Clinical Pharmacology and Therapeutics, 91(6), 1010-1021.
8. Institute of Medicine. (2006). The future of drug safety: Promoting and protecting the health of the public. National Academies Press.
9. Kshetri, N. (2018). Blockchain's roles in meeting key supply chain management objectives. International Journal of Information Management, 39, 80-89.
10. Lammers, E., Adler-Milstein, J., Kocher, K. E., & Shah, N. H. (2017). Accuracy and completeness of electronic patient care process documentation from providers' notes: A structured chart review. Journal of the American Medical Informatics Association, 24(2), 390-396.
11. Nwosu, C., Roter, D., Erby, L., Potor, K., & Wutoh, A. (2020). Adverse drug reaction reporting in the United States: An overview of the Food and Drug Administration's Adverse Event Reporting System (FAERS). Expert Opinion on Drug Safety, 19(6), 669-676.
12. Pal, S. N., Duncombe, C., Falzon, D., Olsson, S. (2013). WHO strategy for collecting safety data in public health programs: Complementing spontaneous reporting systems. Drug Safety, 36(2), 75-81.
13. Rahman, M. M., & Islam, M. R. (2020). Challenges and opportunities of pharmacovigilance in developing countries: A review. Journal of Pharmaceutical Policy and Practice, 13(1), 1-10.
14. Rahman, M. S., & Islam, R. (2020). Current perspectives on drug safety monitoring in developing countries. Journal of Drug Assessment, 9(1), 15-21.
15. Rawlins, M. D., & Davies, D. M. (2012). Pharmacovigilance: Fifty years of progress. British Journal of Clinical Pharmacology, 73(6), 875-886.
16. Ward, M. J., Rieder, M. J., & Matsui, D. M. (2019). Drug safety: Moving beyond the medical profession. Canadian Medical Association Journal, 191(26), E733-E734.
17. Ward, R. M., Bates, D. W., & Singh, H. (2019). Monitoring the safety of medications: Addressing the challenges of detecting and evaluating adverse drug events. Clinical Pharmacology and Therapeutics, 106(1), 74-77.
18. World Health Organization. (2017). Adverse drug reactions. https://www.who.int/medicines/areas/quality safety/safety efficacy /pharmvigi/en/
19. World Health Organization. (2017). The importance of pharmacovigilance: Safety monitoring of medicinal products. https://www.who.int/medicines/areas/quality safety/safety efficacy /pharmvigi/en/
