Displaying publications 61 - 80 of 155 in total

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  1. Hussain R, Hassali MA, Ur Rehman A, Muneswarao J, Hashmi F
    PMID: 32218355 DOI: 10.3390/ijerph17072209
    Developed countries have established pharmacovigilance systems to monitor the safety of medicines. However, in the developing world, drug monitoring and reporting are facing enormous challenges. The current study was designed to explore the challenges related to the understanding and practices of physicians in reporting adverse drug reactions in Lahore, Pakistan. Through the purposive sampling technique, 13 physicians were interviewed. All interviews were audio-recorded, transcribed verbatim, and analyzed for a thematic content analysis. The thematic content analysis yielded six major themes: (1) Familiarity with medication safety and adverse drug reaction (ADR) concept, (2) Knowledge about pharmacovigilance activities, (3) Practices related to ADR reporting, (4) Barriers impeding ADR reporting, (5) Acknowledgement of the pharmacist's role, and (6) System change needs. The majority of the physicians were unaware of the ADR reporting system; however, they were ready to accept practice changes if provided with the required skills and training. A lack of knowledge, time, and interest, a fear of legal liability, poor training, inadequate physicians' and other healthcare professionals' communication, and most importantly lack of a proper reporting system were reported as barriers. The findings based on emerging themes can be used to establish an effective pharmacovigilance system in Pakistan. Overall, physicians reported a positive attitude towards practice changes, provided the concerned authorities support and take interest in this poorly acknowledged but most needed component of the healthcare system.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions
  2. Hussain R, Hassali MA, Ur Rehman A, Muneswarao J, Atif M, Babar ZU
    PMID: 32349339 DOI: 10.3390/ijerph17093039
    The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient's response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  3. 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*
  4. Jabir RS, Ho GF, Annuar MABA, Stanslas J
    Biomarkers, 2018 Mar;23(2):142-146.
    PMID: 28554261 DOI: 10.1080/1354750X.2017.1334152
    CONTEXT: Rash and oral mucositis are major non-haematological adverse events (AEs) of docetaxel, in addition to fatigue, nausea, vomiting and diarrhoea, which restrict the use of the drug in cancer therapy. Alpha-1-acid glycoprotein (AAG) is an acute phase reactant glycoprotein and is a primary carrier of docetaxel in the blood. Docetaxel has extensive binding (>98%) to plasma proteins such as AAG, lipoproteins and albumin.

    OBJECTIVE: To study the association between plasma AAG level and non-haematological AEs of docetaxel in Malaysian breast cancer patients of three major ethnic groups (Malays, Chinese and Indians).

    MATERIALS AND METHODS: One hundred and twenty Malaysian breast cancer patients receiving docetaxel as single agent chemotherapy were investigated for AAG plasma level using enzyme-linked immunosorbent assay technique. Toxicity assessment was determined using Common Terminology Criteria of Adverse Events v4.0. The association between AAG and toxicity were then established.

    RESULTS: There was interethnic variation of plasma AAG level; it was 182 ± 85 mg/dl in Chinese, 237 ± 94 mg/dl in Malays and 240 ± 83 mg/dl in Indians. It was found that low plasma levels of AAG were significantly associated with oral mucositis and rash.

    CONCLUSIONS: This study proposes plasma AAG as a potential predictive biomarker of docetaxel non-haematological AEs namely oral mucositis and rash.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions/blood; Drug-Related Side Effects and Adverse Reactions/diagnosis
  5. Jabir RS, Ho GF, Annuar MABA, Stanslas J
    Clin Breast Cancer, 2018 10;18(5):e1173-e1179.
    PMID: 29885788 DOI: 10.1016/j.clbc.2018.04.018
    PURPOSE: Nonhematologic adverse events (AEs) of docetaxel constitute an extra burden in the treatment of cancer patients and necessitate either a dose reduction or an outright switch of docetaxel for other regimens. These AEs are frequently associated with genetic polymorphisms of genes encoding for proteins involved docetaxel disposition. Therefore, we investigated that association in Malaysian breast cancer patients.

    MATERIALS AND METHODS: A total of 110 Malaysian breast cancer patients were enrolled in the present study, and their blood samples were investigated for different single nucleotide polymorphisms using polymerase chain reaction restriction fragment length polymorphism. AEs were evaluated using the Common Terminology Criteria for Adverse Events, version 4.0.

    RESULTS: Fatigue, nausea, oral mucositis, and vomiting were the most common nonhematologic AEs. Rash was associated with heterozygous and mutant genotypes of ABCB1 3435C>T (P < .05). Moreover, patients carrying the GG genotype of ABCB1 2677G>A/T reported more fatigue than those carrying the heterozygous genotype GA (P < .05). The presence of ABCB1 3435-T, ABCC2 3972-C, ABCC2 1249-G, and ABCB1 2677-G alleles was significantly associated with nausea and oral mucositis. The coexistence of ABCB1 3435-C, ABCC2 3972-C, ABCC2 1249-G, and ABCB1 2677-A was significantly associated with vomiting (P < .05).

    CONCLUSION: The prevalence of nonhematologic AEs in breast cancer patients treated with docetaxel has been relatively high. The variant allele of ABCB1 3435C>T polymorphism could be a potential predictive biomarker of docetaxel-induced rash, and homozygous wild-type ABCB1 2677G>A/T might predict for a greater risk of fatigue. In addition, the concurrent presence of specific alleles could be predictive of vomiting, nausea, and oral mucositis.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions/genetics
  6. 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*
  7. Jatau AI, Shitu Z, Khalid GM, Yunusa I, Awaisu A
    Ther Adv Drug Saf, 2019;10:2042098619852552.
    PMID: 31258886 DOI: 10.1177/2042098619852552
    Background: The burden of adverse drug event (ADE)-related emergency department (ED) visits is increasing despite several preventive measures. The objective of this paper was to develop and validate a conceptual model for a better understanding of ADE-related ED visits and to guide the design and implementation of effective interventions.

    Methods: The development of the model involved a systematic review of the literature using PubMed and Embase databases. Studies reporting the risk factors associated with ADE-related ED visits were included. The methodological qualities of the included studies were assessed using the Mixed Methods Appraisal Tool (MMAT). The model was mapped and validated using face and content validity by an expert panel. Deficiencies and targeted interventions were identified, and steps for the design and implementation were recommended.

    Results: The literature search generated 1361 articles, of which 38 were included in the review; 41 risk factors associated with ADE-related ED visits were identified. All factors were mapped, and the model was validated through face and content validity. The model consisted of six concepts related to sociodemographic factors, clinical factors, ADE-related to ED visits, ADE while in the ED, outcomes, and consequences. Interventions could be targeted at the factors identified in each concept to prevent ADE-related ED burden.

    Conclusion: A conceptual model to guide the successful design and implementation of strategies to prevent ADE-related ED visits and the occurrence of ADE at ED was developed. Clinicians should take these factors into consideration to prevent untoward events, especially when treating high-risk patients.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions
  8. Jatau AI, Aung MM, Kamauzaman TH, Rahman AF
    Drugs Real World Outcomes, 2015 10 23;2(4):387-395.
    PMID: 26689834 DOI: 10.1007/s40801-015-0045-2
    BACKGROUND: Data on the prevalence of adverse drug event (ADE)-related emergency department (ED) visits in developing countries are limited. Malaysia is located in South-East Asia, and, to our knowledge, no information exists on ADE-related ED visits.

    OBJECTIVE: The objective of this study was to determine the prevalence, preventability, severity, and outcome of drug-related ED visits.

    METHODOLOGY: A cross-sectional study was conducted in consenting patients who visited the ED of Hospital Universiti Sains Malaysia over a 6-week period. The ED physician on duty determined whether or not the visit was drug related according to set criteria. Other relevant information was extracted from the patient's medical folder by a clinical pharmacist.

    RESULTS: Of the 434 consenting patients, 133 (30.6 %; 95 % confidence interval [CI] 26-35 %) visits were determined to be ADE related; 55.5 % were considered preventable, 11.3 % possibly preventable, and 33.1 % not preventable. Severity was classed as mild in 1.5 %, moderate in 67.7 %, and severe in 30.8 %. The most common ADEs reported were drug therapeutic failure (55.6 %) and adverse drug reactions (32.3 %). The most frequently implicated drugs were antidiabetics (n = 31; 23.3 %), antihypertensives (n = 28; 21.1 %), antibiotics (n = 13; 9.8 %), and anti-asthmatics (n = 11; 8.3 %). A total of 93 patients (69.9 %) were admitted to the ED for observation, 25 (18.8 %) were discharged immediately after consultation, and 15 (11.3 %) were admitted to the ward through the ED.

    CONCLUSION: The prevalence of ADE-related ED visits was high; more than one-half of the events were considered preventable and one-third was classed as severe. As such, preventive measures will minimize future occurrences and increase patient safety.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  9. Jose J, Chong D, Lynn TS, Jye GE, Jimmy B
    Int J Pharm Pract, 2011 Aug;19(4):246-52.
    PMID: 21733012 DOI: 10.1111/j.2042-7174.2011.00113.x
    The aim of the study was to explore, in the Malaysian general population: knowledge and beliefs of the characteristics in general of medication-related side effects and side effects associated with different types of medicines; behaviour related to the safe use of drugs before and after taking a medication; and behaviour in the event of a medication-related side effect.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  10. Jose J, Rao PG, Kamath MS, Jimmy B
    J Altern Complement Med, 2009 Jul;15(7):793-7.
    PMID: 19534607 DOI: 10.1089/acm.2008.0128
    The objectives of this study were to initiate a pharmacist-coordinated program to improve the adverse drug reaction (ADR) reporting on complementary and alternative medicines (CAM) in a tertiary care hospital and to evaluate the pattern of the reported ADRs.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions
  11. Kaur RJ, Charan J, Dutta S, Sharma P, Bhardwaj P, Sharma P, et al.
    Infect Drug Resist, 2020;13:4427-4438.
    PMID: 33364790 DOI: 10.2147/IDR.S287934
    Background: COVID-19 caused by SARS-CoV-2 virus emerged as an unprecedented challenge to discover effective drugs for its prevention and cure. Hyperinflammation-induced lung damage is one of the poor prognostic indicators causing a higher rate of morbidity and mortality of COVID-19 patients. Favipiravir, an antiviral drug, is being used for COVID-19 treatment, and we currently have limited information regarding its efficacy and safety. Thus, the present study was undertaken to evaluate the adverse drug events (ADEs) reported in the WHO pharmacovigilance database.

    Methods: This study analyzed all suspected ADEs related to favipiravir reported from 2015. The reports were analyzed based on age, gender, and seriousness of ADEs at the System Organ Classification (SOC) level and the individual Preferred Term (PT) level.

    Results: This study is based on 194 ADEs reported from 93 patients. Most frequent ADEs suspected to be caused by the favipiravir included increased hepatic enzymes, nausea and vomiting, tachycardia, and diarrhea. Severe and fatal ADEs occurred more frequently in men and those over the age of 64 years. Blood and lymphatic disorders, cardiac disorders, hepatobiliary disorders, injury poisoning, and procedural complications were more common manifestations of severe ADEs.

    Conclusion: This study revealed that favipiravir appears to be a relatively safe drug. An undiscovered anti-inflammatory activity of favipiravir may explain the improvement in critically ill patients and reduce inflammatory markers. Currently, the data is based on very few patients. A more detailed assessment of the uncommon ADEs needs to be analyzed when more information will be available.

    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. Khan K, Khan AH, Sulaiman SA, Soo CT, Akhtar A
    Jpn J Infect Dis, 2016;69(1):56-9.
    PMID: 26073728 DOI: 10.7883/yoken.JJID.2014.246
    In the current study we explored the occurrence of adverse drug reactions (ADRs) to antiretroviral therapy among human immune-deficiency virus (HIV)/AIDS patients. We concluded an observational retrospective study in all patients who were diagnosed with HIV infection and were receiving highly active antiviral therapy from Jan. 2007 to Dec. 2012 at Hospital Pulau Pinang, Malaysia. Patient socio-demographic details along with clinical features and susceptible ADRs were observed during the study period. Out of 743 patients, 571 (76.9%) were men, and 172 (23.1%) were women. Overall 314 (42.2%) patients experienced ADRs. A total of 425 ADRs were reported, with 311 (73.1%) occurring in men and 114 (26.8%) in women, with a significant statistical relationship (P value (P) = 0.02, OR = 1.21). Overall 239 (56.2%) ADRs were recorded among Chinese, 94 (22.1%) in Malay, and 71 (16.7%) in Indian patients, which had a statistically significant association with ADRs (P = 0.05, OR = 1.50). Out of a total 425 among ADRs, lipodystrophy was recorded in 151 (35.5%) followed by skin rashes in 80 (18.8%), anemia in 74 (17.4%), and peripheral neuropathy in 27 (6.3%) patients. These findings suggest a need of intensive monitoring of ADRs in HIV treatment centres across Malaysia.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions
  14. Khan Q, Akmeliawati R, Bhatti AI, Khan MA
    ISA Trans, 2017 Jan;66:241-248.
    PMID: 27884392 DOI: 10.1016/j.isatra.2016.10.017
    This paper presents a fast terminal sliding mode based control design strategy for a class of uncertain underactuated nonlinear systems. Strategically, this development encompasses those electro-mechanical underactuated systems which can be transformed into the so-called regular form. The novelty of the proposed technique lies in the hierarchical development of a fast terminal sliding attractor design for the considered class. Having established sliding mode along the designed manifold, the close loop dynamics become finite time stable which, consequently, result in high precision. In addition, the adverse effects of the chattering phenomenon are reduced via strong reachability condition and the robustness of the system against uncertainties is confirmed theoretically. A simulation as well as experimental study of an inverted pendulum is presented to demonstrate the applicability of the proposed technique.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions
  15. Khanuja HK, Awasthi R, Mehta M, Satija S, Aljabali AAA, Tambuwala MM, et al.
    Recent Pat Nanotechnol, 2021;15(4):351-366.
    PMID: 33357187 DOI: 10.2174/1872210514666201224103010
    BACKGROUND: Nanosuspensions are colloidal systems consisting of pure drug and stabilizers, without matrix or lyophilized into a solid matrix. Nanosuspensions improve the solubility of the drug both in the aqueous and organic phases. Nanosuspensions are also known as brick dust molecules, as they increase the dissolution of a system and improve absorption.

    METHODS: Extensive information related to nanosuspensions and its associated patents were collected using Pub Med and Google Scholar.

    RESULTS: Over the last decade nanosuspensions have attracted tremendous interest in pharmaceutical research. It provides unique features including, improved solubility, high drug loading capacity, and passive targeting. These particles are cost-effective, simple, and have lesser side effects with minimal dose requirements. However, the stability of nanosuspensions still warrants attention.

    CONCLUSION: Nanosuspensions play a vital role in handling the numerous drug entities with difficult physico-chemical characteristics such as solubility and can further aid with a range of routes that include nasal, transdermal, ocular, parenteral, pulmonary etc. This review highlights the relevance of nanosuspensions in achieving safe, effective and targeted drug delivery.

    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  16. Khor AH, Lim KS, Tan CT, Kwan Z, Ng CC
    PMID: 27763865 DOI: 10.18176/jiaci.0085
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions/drug therapy; Drug-Related Side Effects and Adverse Reactions/etiology*; Drug-Related Side Effects and Adverse Reactions/immunology
  17. Koh KH, Tan HH
    Med J Malaysia, 2006 Mar;61(1):109-11.
    PMID: 16708747 MyJurnal
    Acute severe intoxication with carbamazepine is associated with seizures, coma and respiratory depression. Traditionally, charcoal haemoperfusion is used to remove the drug. We present a case of carbamazepine intoxication, successfully treated with three hours of high-flux haemodialysis. Thus, haemodialysis using high-flux membranes is a feasible and effective therapeutic option for carbamazepine intoxication.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions/therapy
  18. Kotyla PJ, Engelmann M, Giemza-Stokłosa J, Wnuk B, Islam MA
    Int J Mol Sci, 2021 Feb 28;22(5).
    PMID: 33671049 DOI: 10.3390/ijms22052449
    Recent advances in immunology enabled the characterization of several signal transmitting pathways responsible for proper cytokine and chemokine signaling. Among them, Janus kinases (JAKs) are essential components of receptor activation systems. The discovery of JAK kinases enabled the synthesis of JAK kinase inhibitors (JAKi or Jakinibs), which have proven to be efficacious in the treatment of hematologic malignancies and several rheumatological disorders and continue to be investigated in many clinical indications. Blocking multiple cytokines belonging to several cytokine families with a single small molecule may, however, create a potential risk for the patients. Recently, a higher risk of thromboembolic complications, namely, deep vein thrombosis and pulmonary embolism, has been recognized as the main concern during treatment with Jakinibs. At present, it is not entirely clear whether this increased risk is related to direct cytokine blockade, the presence of concomitant diseases in treated patients or other unknown circumstances that work together to increase the risk of this side effect. In this review, we discuss data on the risk of thromboembolic side effects, with special emphasis on the mechanism that may be responsible for this increased risk. Many indirect data indicate that higher thromboembolic risk may be related to the specificity of JAK inhibitor action, such that preferentially blocking one signaling pathway upsets the balance between pro and anti-thrombotic activities.
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions/etiology; Drug-Related Side Effects and Adverse Reactions/pathology*
  19. Kua KP, Jamil MFB, Liew MH, Si JY, Lee SWH
    Pharmacoepidemiol Drug Saf, 2019 12;28(12):1560-1561.
    PMID: 31736190 DOI: 10.1002/pds.4913
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
  20. LIM G
    Med J Malaya, 1961 Mar;15:157-9.
    PMID: 14465286
    Matched MeSH terms: Drug-Related Side Effects and Adverse Reactions*
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