Displaying publications 1 - 20 of 158 in total

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  1. Modi S, Kasmiran KA, Mohd Sharef N, Sharum MY
    J Biomed Inform, 2024 Mar;151:104603.
    PMID: 38331081 DOI: 10.1016/j.jbi.2024.104603
    BACKGROUND: An adverse drug event (ADE) is any unfavorable effect that occurs due to the use of a drug. Extracting ADEs from unstructured clinical notes is essential to biomedical text extraction research because it helps with pharmacovigilance and patient medication studies.

    OBJECTIVE: From the considerable amount of clinical narrative text, natural language processing (NLP) researchers have developed methods for extracting ADEs and their related attributes. This work presents a systematic review of current methods.

    METHODOLOGY: Two biomedical databases have been searched from June 2022 until December 2023 for relevant publications regarding this review, namely the databases PubMed and Medline. Similarly, we searched the multi-disciplinary databases IEEE Xplore, Scopus, ScienceDirect, and the ACL Anthology. We adopted the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement guidelines and recommendations for reporting systematic reviews in conducting this review. Initially, we obtained 5,537 articles from the search results from the various databases between 2015 and 2023. Based on predefined inclusion and exclusion criteria for article selection, 100 publications have undergone full-text review, of which we consider 82 for our analysis.

    RESULTS: We determined the general pattern for extracting ADEs from clinical notes, with named entity recognition (NER) and relation extraction (RE) being the dual tasks considered. Researchers that tackled both NER and RE simultaneously have approached ADE extraction as a "pipeline extraction" problem (n = 22), as a "joint task extraction" problem (n = 7), and as a "multi-task learning" problem (n = 6), while others have tackled only NER (n = 27) or RE (n = 20). We further grouped the reviews based on the approaches for data extraction, namely rule-based (n = 8), machine learning (n = 11), deep learning (n = 32), comparison of two or more approaches (n = 11), hybrid (n = 12) and large language models (n = 8). The most used datasets are MADE 1.0, TAC 2017 and n2c2 2018.

    CONCLUSION: Extracting ADEs is crucial, especially for pharmacovigilance studies and patient medications. This survey showcases advances in ADE extraction research, approaches, datasets, and state-of-the-art performance in them. Challenges and future research directions are highlighted. We hope this review will guide researchers in gaining background knowledge and developing more innovative ways to address the challenges.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  2. Lim JA, Jamil A, Ramli NA, Johar FM, Nor M
    Am J Health Syst Pharm, 2024 Jan 24;81(3):e69-e72.
    PMID: 37864830 DOI: 10.1093/ajhp/zxad264
    PURPOSE: Levetiracetam is an antiepileptic drug known for its high tolerability, and severe adverse drug reactions are rare. We report the case of a severe cutaneous adverse drug reaction in a patient who was switched from brand-name to generic levetiracetam.

    SUMMARY: A 29-year-old woman undergoing contrast-enhanced computed tomography developed lesions over her trunk starting 6 hours after imaging. Although initially diagnosed as an allergy to the radiocontrast agent, the condition progressively worsened into toxic epidermal necrolysis-drug reaction with eosinophilia and systemic symptoms overlap syndrome, despite adequate hydration and treatment. Investigation of the patient's medications revealed that she had been switched from brand-name to generic levetiracetam a week before the onset of symptoms. Levetiracetam was immediately discontinued, with the patient recovering after 2 weeks of intensive care. Adverse drug reaction analysis identified excipients in generic levetiracetam as the likely cause of the severe reaction.

    CONCLUSION: This is the first reported case of severe cutaneous drug allergy after a brand-to-generic switch for levetiracetam. Brand-to-generic switches of medications can potentially cause severe allergic reactions due to differences in excipients.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  3. Parvizpour S, Elengoe A, Alizadeh E, Razmara J, Shamsir MS
    J Biomol Struct Dyn, 2023 Nov;41(19):10037-10050.
    PMID: 36451602 DOI: 10.1080/07391102.2022.2152868
    Worldwide, breast cancer is the leading type of cancer among women. Overexpression of various prognostic indicators, including nuclear receptors, is linked to breast cancer features. To date, no effective drug has been discovered to block the proliferation of breast cancer cells. This study has been designed to discover target-based small molecular-like natural drug candidates that have anti-cancer potential without causing any serious side effects. A comprehensive substrate-based drug design was carried out to discover the potential plant compounds against the target breast cancer biomarkers including phytochemicals screening, active site identification, molecular docking, pharmacokinetic (PK) properties prediction, toxicity prediction, and molecular dynamics (MD) simulation approaches. Twenty plant compounds extracted from the rambutan (Nephelium lappaceum) were obtained from PubChem Database; and screened against the breast cancer biomarkers including estrogen receptor (ER), progesterone receptor (PR), and androgen receptor (AR). The best docking interaction was chosen based on the higher binding affinity. Analyzing the pharmacokinetic properties and toxicity prediction results indicated that the fifteen selected plant compounds have good potency without toxicity and are safe for humans. Four phytochemicals with a higher binding affinity were chosen for each breast cancer biomarker to study their stability in interaction with the target proteins using MD simulation. Among the above compounds, Ellagic acid showed the high binding affinity against all three breast cancer biomarkers.Communicated by Ramaswamy H. Sarma.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  4. Manoharan A, Siti Nur Farhana H, Manimaran K, Khoo EM, Koh WM
    BMC Infect Dis, 2023 Sep 22;23(1):624.
    PMID: 37740196 DOI: 10.1186/s12879-023-08612-2
    BACKGROUND: Various factors influence tuberculosis preventive treatment (TPT) decisions thus it is important to understand the health beliefs and concerns of patients before starting TPT to ensure treatment compliance. This study aims to explore facilitators and barriers for TPT among patients diagnosed with Latent Tuberculosis infection (LTBI) attending six primary healthcare clinics in Selangor, Malaysia.

    METHOD: In-depth interviews were conducted face-to-face or via telephone among patients with a clinical diagnosis of LTBI using a semi-structured topic guide developed based on the common-sense model of self-regulation and literature review. Audio recordings of interviews were transcribed verbatim and analysed thematically.

    RESULTS: We conducted 26 In-depth interviews; Good knowledge of active tuberculosis (TB) and its associated complications, including the perceived seriousness and transmissibility of active TB, facilitates treatment. LTBI is viewed as a concern when immune status is compromised, thus fostering TPT. However, optimal health is a barrier for TPT. Owing to the lack of knowledge, patients rely on healthcare practitioners (HCPs) to determine their treatment paths. HCPs possessing comprehensive knowledge play a role in facilitating TPT whereas barriers to TPT encompass misinterpretation of tuberculin skin test (TST), inadequate explanation of TST, and apprehensions about potential medication side effects.

    CONCLUSIONS: Knowledge of LTBI can influence TPT uptake and patients often entrust their HCPs for treatment decisions. Improving knowledge of LTBI both among patients and HCPs can lead to more effective doctor-patient consultation and consequently boost the acceptance of TPT. Quality assurance should be enhanced to ensure the effective usage of TST as a screening tool.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  5. Reginald K, Chew FT
    Mol Immunol, 2023 Sep;161:11-24.
    PMID: 37480600 DOI: 10.1016/j.molimm.2023.07.004
    PURPOSE OF REVIEW: This review evaluates the current modes of allergen-specific immunotherapy for cockroach allergens, in terms of clinical outcomes and explores future trends in the research and development needed for a more targeted cockroach immunotherapy approach with the best efficacy and minimum adverse effects.

    SUMMARY: Cockroach allergy is an important risk factor for allergic rhinitis in the tropics, that disproportionately affects children and young adults and those living in poor socio-economic environments. Immunotherapy would provide long-lasting improvement in quality of life, with reduced medication intake. However, the present treatment regime is long and has a risk of adverse effects. In addition, cockroach does not seem to have an immuno-dominant allergen, that has been traditionally used to treat allergies from other sources. Future trends of cockroach immunotherapy involve precision diagnosis, to correctly identify the offending allergen. Next, precision immunotherapy with standardized allergens, which have been processed in a way that maintains an immunological response without allergic reactions. This approach can be coupled with modern adjuvants and delivery systems that promote a Th1/Treg environment, thereby modulating the immune response away from the allergenic response.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  6. Ng CG, Abousheishaa AA, Low SY, Zainal NZ, Thong KS, Awaluddin AB, et al.
    Asian Pac J Cancer Prev, 2023 Aug 01;24(8):2583-2591.
    PMID: 37642043 DOI: 10.31557/APJCP.2023.24.8.2583
    OBJECTIVE: Vortioxetine is a monoaminergic drug with a novel multimodal mechanism of action. We investigated its efficacy on depressive symptoms, cognitive function, and quality of life among cancer patients.

    METHODS: In this multicenter, open-label, single-arm, observational study, patients received flexible doses of Vortioxetine for a period of six months. All participants were assessed at baseline and scheduled for monitoring at weeks 2, 4, 8, 12, 16, 20, and 24. Depression severity was assessed using Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression (CGI) scale. The Perceived Deficiency Questionnaire (PDQ-5) assessed the perceived cognitive difficulties in concentration, executive functioning, and memory. The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) was used to assess the patients' quality of life. Side effects of vortioxetine were monitored using the Antidepressant Side-Effect Checklist (ASEC).

    RESULTS: Patients experienced a reduction in MADRS scores from 29.89 ± 5.997 at baseline to 11.59 ± 4.629 by Week 24. The PDQ-5 scores showed significant change from Week-4, whereas the EORTC role, emotional, and cognitive functioning scores showed a significant change from Week 2 onwards. CGI-Severity scores decreased from a baseline of 4.39 ± 0.746 to 2.41 ± 1.085 by Week 24. During the 24-Weeks of therapy, around three-quarters of the patients (73.3%) had one or more adverse events reported on the ASEC. The most frequently reported TEAEs were dry mouth, insomnia, somnolence, and headache, with more than a 30% incidence rate.

    CONCLUSION: Vortioxetine seems promising in the management of depression and enhancement of cognitive function and quality of life of cancer patients with Major Depressive Disorder.
    .

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  7. Ho JJ, Zakarija-Grkovic I, Lok JW, Lim E, Subramaniam P, Leong JJ
    Cochrane Database Syst Rev, 2023 Jul 18;7(7):CD013660.
    PMID: 37481707 DOI: 10.1002/14651858.CD013660.pub2
    BACKGROUND: Apnoea of prematurity (AoP) is defined as a pause in breathing for 20 seconds or longer, or for less than 20 seconds when accompanied by bradycardia and hypoxaemia, in a preterm infant. An association between the severity of apnoea and neurodevelopmental delay has been reported. Continuous positive airway pressure (CPAP) is a form of non-invasive ventilatory assistance that has been shown to be relatively safe and effective in preventing and treating respiratory distress among preterm infants. It is less clear whether CPAP treatment is safe and effective in the prevention and treatment of AoP.

    OBJECTIVES: 1. To assess the effects of CPAP on AoP in preterm infants (this may be compared to supportive care or mechanical ventilation). 2. To assess the effects of different CPAP delivery systems on AoP in preterm infants.

    SEARCH METHODS: Searches were conducted in September 2022 in the following databases: Cochrane Library, MEDLINE, Embase, and CINAHL. We also searched clinical trial registries and the reference lists of studies selected for inclusion.

    SELECTION CRITERIA: We included all randomised and quasi-randomised controlled trials (RCTs) in which researchers determined that CPAP was necessary for AoP in preterm infants (born before 37 weeks). Cross-over studies were also included, provided sufficient data were available for analysis.

    DATA COLLECTION AND ANALYSIS: We used the standard methods of Cochrane and Cochrane Neonatal, including independent assessment of risk of bias and extraction of data by at least two review authors. Discrepancies were resolved by involvement of a third author. We used the GRADE approach to assess the certainty of evidence for the following outcomes: 1) failed CPAP; 2) apnoea; 3) adverse effects of CPAP.

    MAIN RESULTS: We included four single-centre trials conducted in Malaysia, Spain, Germany, and North America, involving 138 infants with a mean/median gestation of 26 to 28 weeks. Two studies were parallel-group RCTs and two were cross-over trials. None of the studies compared CPAP with supportive care. All trials compared one form of CPAP with another. Two compared a variable flow device with ventilator CPAP, one compared two different variable flow devices, and one compared a variable flow device with bubble CPAP. Interventions were administered for periods ranging between six and 48 hours, with pressures between 4 and 6 cm H2O. We assessed all trials as having a high risk of bias for blinding of participants and personnel, and two studies for blinding of outcome assessors. We found a high risk of a carry-over effect in two studies where the washout period was not adequately described, and a high risk of bias in a study that appeared to use an analysis method not generally accepted for cross-over studies. Comparison 1. CPAP and supportive care compared to supportive care alone We did not identify any study for inclusion in this comparison. Comparison 2. CPAP delivered by different types of devices 2a. Variable flow compared to ventilator CPAP Two studies were included in this comparison. We are very uncertain whether there is any difference in the incidence of failed CPAP, defined as the need for mechanical ventilation (risk ratio (RR) 0.16, 95% confidence interval (CI) 0.01 to 2.90; 1 study, 26 participants; very low-certainty). We are very uncertain whether there is any difference in the frequency of apnoea events (mean difference (MD) per four-hour interval -0.10, 95% CI -1.30 to 1.10; 1 study, 26 participants; very low-certainty). We are uncertain whether there is any difference in adverse events. Neurodevelopmental outcomes were not reported. 2b. Variable flow compared to bubble CPAP We included one study in this comparison, but it did not report our pre-specified outcomes. 2c. Infant Flow variable flow CPAP compared to Medijet variable flow CPAP We are very uncertain whether there is any difference in the incidence of failed CPAP (RR 2.62, 95% CI 0.91 to 7.53; 1 study, 80 participants; very low-certainty). The frequency of apnoea was not reported, and we do not know whether there is any difference in adverse events. Neurodevelopmental outcomes were not reported. Comparison 3. CPAP compared to mechanical ventilation We did not identify any studies for inclusion in this comparison.

    AUTHORS' CONCLUSIONS: Due to the limited available evidence, we are very uncertain whether any CPAP device is more effective than other forms of supportive care, other CPAP devices, or mechanical ventilation for the prevention and treatment of AoP. The devices used in these studies included two types of variable flow CPAP device: bubble CPAP and ventilator CPAP. For each comparison, data were only available from a single study. There are theoretical reasons why these devices might have different effects on AoP, therefore further trials are indicated.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  8. Zulkeflee RH, Hassan MN, Hassan R, Saidin NIS, Zulkafli Z, Ramli M, et al.
    Transfus Apher Sci, 2023 Jun;62(3):103658.
    PMID: 36805153 DOI: 10.1016/j.transci.2023.103658
    Acute hemolytic transfusion reaction following ABO-incompatible platelet transfusion: two case reports An ideal platelet transfusion should provide ABO identical platelet concentrate, and cross match compatibility is not routinely performed in the standard practices. However, ABO non identical platelet transfusions are not uncommon with the limited resources and short shelf life of platelet concentrate. Though rare, acute hemolytic transfusion reaction (AHTR) may occur following minor ABO-incompatible platelet transfusion. Here, we report two cases of thrombocytopenic patients (one child and one adult) type as Group B RhD positive and received Group O RhD positive platelet transfusions. Both patients experienced an AHTR evidenced by a drop in hemoglobin level, spherocytosis and small agglutinations on the blood film, and positive direct Coombs test. They were treated symptomatically, recovered and discharged well post-event without any morbidity. No anti-B isohemagglutinins titer were done to confirm the high titer of the antibody in the platelet donors. Our cases highlighted the importance of ABO-compatible platelet transfusion, especially to children and those vigilant groups of patients.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  9. Ibrahim N, Foo LK, Chua SL
    PMID: 36833984 DOI: 10.3390/ijerph20043289
    Osteoporosis is a serious bone disease that affects many people worldwide. Various drugs have been used to treat osteoporosis. However, these drugs may cause severe adverse events in patients. Adverse drug events are harmful reactions caused by drug usage and remain one of the leading causes of death in many countries. Predicting serious adverse drug reactions in the early stages can help save patients' lives and reduce healthcare costs. Classification methods are commonly used to predict the severity of adverse events. These methods usually assume independence among attributes, which may not be practical in real-world applications. In this paper, a new attribute weighted logistic regression is proposed to predict the severity of adverse drug events. Our method relaxes the assumption of independence among the attributes. An evaluation was performed on osteoporosis data obtained from the United States Food and Drug Administration databases. The results showed that our method achieved a higher recognition performance and outperformed baseline methods in predicting the severity of adverse drug events.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  10. Rahman MA, Ahmad R, Ismail I
    Environ Sci Pollut Res Int, 2023 Feb;30(6):15689-15707.
    PMID: 36173521 DOI: 10.1007/s11356-022-23189-0
    This study measures the impact of the implementation of the Regional Greenhouse Gas Initiative (RGGI) on firms' green innovation initiatives. We used 20 years of panel data from the Fortune 500 list of the US largest companies. Based on DID, a benchmark regression, the RGGI has a significant adverse effect on the green innovation of Fortune 500 companies, and we verified these findings with multiple robustness tests. As we investigate how energy-intensive industries were affected by RGGI, we found that it slowed down green innovation, but it was not statistically significant. This study provides a novel perspective on how the RGGI influences green innovation in firms and how different types of sectors respond to the policy. The findings indicate that the "weak" Porter Hypothesis has not been confirmed in the present carbon trading market (particularly the RGGI) for Fortune 500 firms in the USA. In terms of policy, we believe that a well-covered and differentiated legislation that fosters green innovation while being realistic about the policy's goal and the firm's environmental attitude, like emissions reduction through green innovation, is essential.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  11. Fahrni ML, Misran NFL, Abidin ZZ, Chidambaram SK, Lazzarino AI
    J Infect Public Health, 2023 Jan;16(1):96-103.
    PMID: 36508946 DOI: 10.1016/j.jiph.2022.12.001
    BACKGROUND: While efavirenz-associated adverse drug events (ADEs) were widely established, the clinical relevance is uncertain.

    OBJECTIVES: We aimed to assess the extent of treatment interruption caused by efavirenz-associated ADEs.

    METHODS: A case-control study of efavirenz recipients who did, versus did not (control) develop adverse drug events (ADE), and who were matched for baseline CD4 + at a ratio of 1:1.3 was conducted. Antiretroviral -naïve patients who were started on efavirenz were followed up retrospectively, and their records scrutinized every month for 2 years. Demographic and clinical predictors of treatment interruption were computed using Cox proportional hazard models. Kaplan- Meier curves were plotted to assess time to treatment interruption for the two groups. Clinical endpoints were: i) efficacy -improved CD4 + counts and/or viral load (VL) suppression, ii) safety -absence of treatment-limiting toxicities, and iii) durability - no interruption until follow-up ended.

    RESULTS: Both groups had comparable CD4 + counts at baseline (p = 0.15). At t = 24-months, VL in both groups were suppressed to undetectable levels (<20 copies/mL) while median CD4 + was 353 cells/µL (IQR: 249-460). The mean time on treatment was 23 months (95% CI, 22.3 -23.4) in the control group without ADE and 20 months (95% CI, 18.9 - 21.6) in the ADE group (p = 0.001). Kaplan-Meier plots demonstrated that 59.5% of patients who experienced ≥ 1 ADE versus 81% of those who did not experience any ADE were estimated to continue treatment for up to 24 months with no interruption (p = 0.001). Most interruptions to EFV treatment occurred in the presence of opportunistic infections and these were detected within the first 5 months of treatment initiation. Independent predictors which negatively impacted the dependent variable i.e., treatment durability, were intravenous drug use (adjusted hazard ratio, aHR 2.17, 95% CI, 1.03-4.61, p = 0.043), presence of ≥ 1 opportunistic infection(s) (aHR 2.2, 95% CI, 1.13-4.21, p = 0.021), and presence of ≥ 1 serious ADE(s) (aHR 4.18, 95% CI, 1.98-8.85, p = 0.00).

    CONCLUSION: Efavirenz' role as the preferred first-line regimen for South-East Asia's resource-limited regions will need to be carefully tailored to suit the regional population. Findings have implications to policy-makers and clinicians, particularly for the treatment of patients who develop ADEs and opportunistic infections, and for intravenous drug user subgroups.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  12. Khalid K, Anuar A, Ang WC, Jamaluddin R
    Curr Drug Saf, 2023;18(2):167-174.
    PMID: 35570535 DOI: 10.2174/1574886317666220514154931
    BACKGROUND: Per oral methadone maintenance therapy [MMT] was introduced as part of harm reduction strategy to manage rising numbers of HIV infections caused by intravenous use of illicit drugs.

    METHOD: We aim to review published articles related to the side effects of long-term methadone therapy, focusing on hematological derangements in human studies published between 1 January 2000 till 31 January 2021.

    RESULTS: Our search databases include Web of Science, Scopus, and Medline. Our search yielded 971 articles, of which 55 articles were related to the effects of MMT on various organ systems: cardiovascular [n=12], respiratory [n=1], endocrine [n=10], central nervous system [n=12], neurobehavioral [n=10], gastrointestinal [n=1], and bone [n=1]. There were eight articles specifically related to the hematological side effects of chronic methadone therapy that include [i] immune system hyperactivation, [ii] reduced circulating lymphocytes, and [iii] increased blood viscosity.

    CONCLUSION: In view of all foreseeable health risks seen with prolonged methadone therapy, pharmacological modulation is warranted to find a better substitute for managing patients with opioid dependence.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  13. Jairoun AA, Saleh Al-Hemyari S, Shahwan M, Saeed BQ, Godman B, Kurdi A, et al.
    Am J Mens Health, 2023;17(2):15579883231158531.
    PMID: 36987378 DOI: 10.1177/15579883231158531
    Sexual enhancement supplements (SESs) that have illegal additions of pharmaceuticals or analogues pose a significant health risk, particularly with long-term usage. When supplements are adulterated with phosphodiesterase type 5 (PDE-5) inhibitors, dosages can vary widely and there may be an increase in adverse effects and drug-drug interactions which cannot be avoided. Consequently, there is a need to evaluate the public risk awareness toward SES and the associated adverse events as well as explore significant factors associated with knowledge and risk awareness. A cross-sectional community-based study was conducted among University male students and staff at Ajman University, United Arab Emirates (UAE), using a self-administered survey via a web-based electronic link to explore key issues. A total of 1,101 male subjects participated in the study and completed the questionnaire. Four hundred and thirty-three(39.3%) (95% confidence interval [CI]: 33.2-44.5) participants reported using SES products. Of these, 137 (31.6%) [95% CI: 28.6-37.2] experienced adverse effects from SES product use. SES use was more prevalent among participants aged 60 to 69 years (odds ratio [OR]: 2.94; 95% CI: 1.63-5.28), diabetic patients (OR: 2.61; 95% CI: 1.75-3.90), hypertension patients (OR: 2.12; 95% CI: 1.45-3.1), and those overweight or obese (OR: 1.84; 95% CI: 1.44-2.35). This study indicates that SES is a popular practice among the UAE university staff and students. However, there is a need to implement risk awareness programs to raise public awareness regarding SES use and safety. Regulatory bodies are encouraged to provide additional advice on the proper use and possible risks of consuming SES.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  14. Qureshi A, Syed Sulaiman SA, Rehman W, Mehmood A, Idrees S, Kumar N
    PLoS One, 2023;18(5):e0285736.
    PMID: 37220099 DOI: 10.1371/journal.pone.0285736
    BACKGROUND: The response to the vaccine may vary among individuals. Hence, it is important to know how often individuals experience side effects after immunization against COVID-19.

    OBJECTIVE: This study aimed to assess the incidence of side effects following COVID-19 vaccination across different vaccine recipients in Southern Pakistan and identify the potential factors associated with these side effects in the population.

    METHODS: The survey was conducted across Pakistan through Google-forms Links from August to October 2021. The questionnaire included demographic information and COVID-19 vaccine information. Chi-square (x2) was performed for comparative analysis to check the significance level with P <0.05. The final analysis included 507 participants who had received COVID-19 vaccines.

    RESULTS: Of the total 507 COVID-19 vaccines recipients, 24.9% received CoronaVac, 36.5% received BBIBP-CorV, 14.2% received BNT162b2, 13.8% received AZD1222, and 10.7% received mRNA-1273. The most prominent side effects after the first dose were fever, weakness, lethargy, and pain at the site of injection. Moreover, the most commonly reported side effects after the second dose were pain at the injection site, headache, body ache, lethargy, fever, chills, flu-like symptoms, and diarrhea.

    CONCLUSION: Our results suggested that the side effects due to COVID-19 vaccination can vary between the first and second doses and type of COVID-19 vaccine. Our findings suggest continuing monitoring of vaccine safety and the importance of individualized risk-benefit assessment for COVID-19 immunization.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  15. Mustafa ZU, Maqbool F, Wahid M, Salman M, Haroon S, Khan YH, et al.
    Rev Soc Bras Med Trop, 2023;56:e0044.
    PMID: 37283345 DOI: 10.1590/0037-8682-0044-2023
    BACKGROUND: Safety and efficacy concerns regarding coronavirus disease 2019 (COVID-19) vaccines are common among the public and have a negative impact on their uptake. We aimed to report the adverse effects currently associated with the vaccine in Pakistan to build confidence among the population for its adoption.

    METHODS: A cross-sectional study was conducted in five districts of the Punjab province of Pakistan between January and March 2022. The participants were recruited using convenience sampling. All data were analyzed using SPSS 22.

    RESULTS: We recruited 1622 people with the majority aged between 25-45 years. Of these, 51% were female, including 27 pregnant women and 42 lactating mothers. Most participants had received the Sinopharm (62.6%) or Sinovac (17.8%) vaccines. The incidences of at least one side effect after the first (N = 1622), second (N = 1484), and booster doses (N = 219) of the COVID-19 vaccine were 16.5%, 20.1%, and 32%, respectively. Inflammation/erythema at the injection site, pain at the injection site, fever, and bone/muscle pain were common side effects of vaccination. No significant differences were observed in the adverse effect scores between all demographic variables except for pregnancy (P = 0.012) after the initial dose. No significant association was observed between any variable and the side effect scores of the second and booster doses of the vaccine.

    CONCLUSIONS: Our study showed a 16-32% prevalence of self-reported side effects after the first, second, and booster COVID-19 vaccinations. Most adverse effects were mild and transient, indicating the safety of different COVID-19 vaccines.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  16. Hayat M, Ahmad N, Mohkumuddin S, Ali Khan SL, Khan AH, Haq NU, et al.
    PLoS One, 2023;18(4):e0284439.
    PMID: 37058504 DOI: 10.1371/journal.pone.0284439
    BACKGROUND: Drug therapy problems (DTPs) are common among patients suffering from chronic kidney disease (CKD). However, there is a lack of information about DTPs and its predictors among CKD patients from Pakistan.

    OBJECTIVES: To evaluate the frequency, type and predictors of various types of DTPs among CKD patients at a tertiary-care hospital in Pakistan.

    METHODOLOGY: This was a cross-sectional study carried out at Sandeman Provincial Hospital, Quetta between 1-11-2020 and 31-1-2021. It included 303 non-dialysis ambulatory patients of CKD-stage 3 and above. Cipolle et al., criterion was used for classifying the DTPs and a clinician at the study site checked the identified DTPs for accuracy. Data were analyzed by SPSS 23. Multivariate analysis was conducted to find the predictors of individual types of DTPs. A p-value <0.05 was considered statistically significant.

    RESULTS: The patients received a total of 2265 drugs with a median of eight drugs per patient (range: 3-15 drugs). A total of 576 DTPs were identified among 86.1% patients with a median of two DTPs (interquartile range 1-3) per patient. Dosage too high (53.5%) was the most common DTP followed by adverse drug reactions (ADRs) (50.5%) and need of additional drug therapy (37.6%). In multivariate analysis, patients' age of >40 years emerged as a predictor of unnecessary drug therapy and dosage too high. The odds of needing a different drug product was significantly high in patients with cardiovascular diseases (CVD) and diabetes mellitus (DM). The dosage too low had significant association with CVD. The risk of ADRs was significantly high in elderly patients (>60 years) and those with CVD. The presence of hypertension, DM and CKD stage-5 emerged as predictors of dosage too high.

    CONCLUSION: This study revealed a high prevalence of DTPs among CKD patients. Targeted interventions in high risk patients may reduce the frequency of DTPs at the study site.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  17. Tok PSK, Wong LP, Liew SM, Razali A, Mahmood MI, Chinnayah T, et al.
    PLoS One, 2023;18(9):e0289222.
    PMID: 37676902 DOI: 10.1371/journal.pone.0289222
    BACKGROUND: Loss to follow-up (LTFU) is an unsuccessful treatment outcome for tuberculosis (TB) patients. In Malaysia, LTFU affects around 1 in 20 TB patients. Integration of qualitative research methods and evidence will provide a better understanding of LTFU and its underlying issues. In this study, we qualitatively explored TB patients' experiences in receiving treatment and their reasons for leaving TB care.

    METHOD: In-depth interviews of 15 patients with a history of LTFU were conducted from January to September 2020. Interview guides were developed to explore TB patients' experiences while receiving treatment, including challenges faced and reasons for treatment interruption. Data were thematically analysed using the framework method.

    RESULTS: We identified 11 emerging themes that occurred at four levels of interaction with TB patients. First, at the patient personal level, TB beliefs referring to patients' perception of illness and wellness, patients' perceived role of traditional and complementary medicine, and substance abuse were important. Second, the healthcare system and treatment factors that were highlighted included the organisation of care and treatment, interaction with healthcare professionals, particularly in communication and counselling, and TB medications' side effects. Third, structural factors including financial burden, logistical and transportation issues and work-related factors were identified to be barriers to treatment continuation. Fourth, the interpersonal level interaction of patients should not be neglected; this includes family relationships and support as well as peer influence.

    CONCLUSION: Study findings put forth issues and challenges faced by TB patients while receiving treatment and underscore areas where actions can be taken. This will contribute to informing the development and implementation of future TB control strategies that are responsive to TB patients' needs and concerns, to effectively address LTFU and ensure better treatment completion rates among TB patients in Malaysia.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  18. Aggarwal D, Yang J, Salam MA, Sengupta S, Al-Amin MY, Mustafa S, et al.
    Front Immunol, 2023;14:1203073.
    PMID: 37671162 DOI: 10.3389/fimmu.2023.1203073
    Cancer is one of the deadliest diseases, causing million of deaths each year globally. Conventional anti-cancer therapies are non-targeted and have systemic toxicities limiting their versatile applications in many cancers. So, there is an unmet need for more specific therapeutic options that will be effective as well as free from toxicities. Antibody-drug conjugates (ADCs) are suitable alternatives with the right potential and improved therapeutic index for cancer therapy. The ADCs are highly precise new class of biopharmaceutical products that covalently linked a monoclonal antibody (mAb) (binds explicitly to a tumor-associated surface antigen) with a customized cytotoxic drug (kills cancer cells) and tied via a chemical linker (releases the drug). Due to its precise design, it brings about the target cell killing sparing the normal counterpart and free from the toxicities of conventional chemotherapy. It has never been so easy to develop potential ADCs for successful therapeutic usage. With relentless efforts, it took almost a century for scientists to advance the formula and design ADCs for its current clinical applications. Until now, several ADCs have passed successfully through preclinical and clinical trials and because of proven efficacy, a few are approved by the FDA to treat various cancer types. Even though ADCs posed some shortcomings like adverse effects and resistance at various stages of development, with continuous efforts most of these limitations are addressed and overcome to improve their efficacy. In this review, the basics of ADCs, physical and chemical properties, the evolution of design, limitations, and future potentials are discussed.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  19. Raghvan HPN, Fatokun O
    Int J Pharm Pract, 2021 Oct 18;29(5):435-442.
    PMID: 34244775 DOI: 10.1093/ijpp/riab036
    OBJECTIVES: It is known that community pharmacists in Malaysia underreport adverse drug reactions (ADRs). In order to improve ADR reporting, a theory-based understanding of the factors associated with the community pharmacists' reporting behaviour is important. This study used the theory of planned behaviour (TPB) to identify the predictors of behavioural intention to report ADRs to the regulatory authority among community pharmacists in Malaysia and to assess the relative importance of the predictors.

    METHODS: A questionnaire-based study was conducted among 188 randomly selected community pharmacists in the state of Johor, Malaysia. The questionnaire included four main TPB constructs (intention, attitude, subjective norms and perceived behavioural control) and related measures, including perceived moral obligation, past reporting behaviour and sociodemographic variables. Descriptive and hierarchical regression analyses were conducted.

    KEY FINDINGS: A total of 164 questionnaires were collected. The mean score of intention to report ADRs was 15.43 (SD = 2.99). The final model of the hierarchical regression analysis showed that attitude towards ADR reporting (P = 0.004), subjective norm (P = 0.010) and perceived moral obligation (P = 0.014) were significant predictors of intention to report ADRs. Attitude was the most significant predictor, followed by subjective norm and perceived moral obligation.

    CONCLUSIONS: Interventions targeting community pharmacists' attitude, subjective norms and perceived moral obligations towards ADR reporting, with a specific focus on attitude would likely have a positive impact on improving ADR reporting in Malaysia.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  20. Tan BK, Chua SS, Chen LC, Chang KM, Balashanker S, Bee PC
    J Oncol Pharm Pract, 2021 Oct;27(7):1644-1656.
    PMID: 33040675 DOI: 10.1177/1078155220964539
    PURPOSE: Chronic myeloid leukaemia (CML) patients on long-term tyrosine kinase inhibitor (TKI) therapy are susceptible to drug-related problems (DRPs). This study aimed to evaluate the acceptability and outcomes of pharmacist-led interventions on DRPs encountered by CML patients.

    METHODS: This study included participants from the intervention arm of a randomised controlled trial which was conducted to evaluate the effects of pharmacist-led interventions on CML patients treated with TKIs. Participants were recruited and followed up in the haematology clinics of two hospitals in Malaysia from March 2017 to January 2019. A pharmacist identified DRPs and helped to resolve them. Patients were followed-up for six months, and their DRPs were assessed based on the Pharmaceutical Care Network Europe Classification for DRP v7.0. The identified DRPs, the pharmacist's interventions, and the acceptance and outcomes of the interventions were recorded. A Poisson multivariable regression model was used to analyse factors associated with the number of identified DRPs per participant.

    RESULTS: A total of 198 DRPs were identified from 65 CML patients. The median number of DRPs per participants was 3 (interquartile range: 2, 4). Most participants (97%) had at least one DRP, which included adverse drug events (45.5%), treatment ineffectiveness (31.5%) and patients' treatment concerns or dissatisfaction (23%). The 228 causes of DRPs identified comprised the following: lack of disease or treatment information, or outcome monitoring (47.8%), inappropriate drug use processes (23.2%), inappropriate patient behaviour (19.9%), suboptimal drug selection (6.1%), suboptimal dose selection (2.6%) and logistic issues in dispensing (0.4%). The number of concomitant medications was significantly associated with the number of DRPs (adjusted Odds Ratio: 1.100; 95% CI: 1.005, 1.205; p = 0.040). Overall, 233 interventions were made. These included providing patient education on disease states or TKI-related side effects (75.1%) and recommending appropriate instructions for taking medications (7.7%). Of the 233 interventions, 94.4% were accepted and 83.7% were implemented by the prescriber or patient. A total of 154 DRPs (77.3%) were resolved.

    CONCLUSIONS: The pharmacist-led interventions among CML patients managed to identify various DRPs, were well accepted by both TKI prescribers and patients, and had a high success rate of resolving the DRPs.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
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