Understanding the Experience of Hospital Pharmacists with the Effectiveness, Safety, Adverse Drug Reaction Reporting and Interchangeability of Biopharmaceutical Medicines

Al‐Jumaili, Ali Azeez; Fahmi, Hiba Leith

doi:10.31351/vol31iss1pp72-86

Cited by 5 publications

(3 citation statements)

References 16 publications

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“…Infliximab seems to have the highest proportion of adverse drug reactions (23%) reported to the Iraqi pharmacovigilance center (IqPhvC) compared to other biological therapy. (33) .…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness Analysis of Reference Infliximab (Remicade) Compared to its Biosimilar (Remsima) in Iraqi Patients with Rheumatoid Arthritis (Conference Paper )#

Fadhil

Al‐Jumaili

Al-Ani

2023

IJPS

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The study objective was to conduct Pharmacoeconomics study (cost-effective analysis) between infliximab reference (Remicade) and its biosimilar (Remsima) in patients with rheumatoid arthritis (RA) in Iraqi hospitals. This is a retrospective multicenter pharmacoeconomic analysis conducted at two large teaching governmental hospitals in Baghdad, Iraq which provided infliximab to patients with RA. Data were collected from patient’s medical records and face-to-face interviews with the patients from December 2021 to April 2022. The study included 57 patients with rheumatoid arthritis (RA). The patients were categorized into two groups according to the type of infliximab they received over 30 weeks: 27 patients received reference infliximab (Remicade) and 30 patients received biosimilar infliximab (Remsima). The two groups had comparable demographic and baseline disease parameters, with a mean age of 49.6 years and a BMI of 30.0. The vast majority of participants were women (82.5%) with low level of formal education (65%). Overall, both infliximab biopharmaceuticals had good effectiveness to reduce the RA disease activity (CDAI) and improve patient quality of life. They both had comparable adverse reactions including UTI, fatigue, and headache. There was no significant difference (P-value >0.05) in disease activity between the two groups according to RA clinical disease activity index (CDAI) score across all three-time measures: before biological therapy, 14 weeks post-therapy and 30 weeks post-therapy. In 2019, Remicade was slightly more effective and provide better quality of life, but costlier ($41,896 per QALY) compared to Remsima. It was not clear whether the reference biologic (Remicade) or its biosimilar (Remsima) was more cost effective. In 2021, Remicade was more cost effective compared to Remsima because Remicade was less expensive and relatively more effective according to CDAI and EQ-5D-5L scores. Registering and purchasing both reference infliximab and its biosimilar was good idea to keep the competition in the price and maintain infliximab for RA patients.

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“…Infliximab seems to have the highest proportion of adverse drug reactions (23%) reported to the Iraqi pharmacovigilance center (IqPhvC) compared to other biological therapy. (33) .…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness Analysis of Reference Infliximab (Remicade) Compared to its Biosimilar (Remsima) in Iraqi Patients with Rheumatoid Arthritis (Conference Paper )#

Fadhil

Al‐Jumaili

Al-Ani

2023

IJPS

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“…However, not all patients respond equally well to ARBs, and some may experience side effects such as dizziness, fatigue, or gastrointestinal upset. [ 2 , 3 ]…”

Section: Introductionmentioning

confidence: 99%

Clinical Pharmacogenetics of Angiotensin II Receptor Blockers in Iraq

Al-Hussaniy

Hassan

Oraibi³

et al. 2023

Journal of Pharmacy and Bioallied Sciences

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Background: Clinical pharmacogenetics is a rapidly growing field that focuses on the study of genetic variations and their impact on drug metabolism, efficacy, and safety. Angiotensin II receptor blockers (ARBs) are commonly used to treat hypertension in Iraq but not all patients respond equally to these drugs. Aim: This article aims to review the current evidence on the clinical pharmacogenetics of ARBs in Iraq and its implications for personalized medicine. Materials and Methods: We conducted a literature review of studies on the genetic variations that affect the response to ARBs in Iraq. We also reviewed the prevalence of these genetic variants in the Iraqi population and discussed the potential clinical implications for personalized medicine. Results: The most studied genetic variations associated with ARB response in Iraq are the angiotensin-converting enzyme gene insertion/deletion polymorphism and the angiotensin II type 1 receptor gene A1166C polymorphism. The angiotensin-converting enzyme gene insertion/deletion polymorphism is associated with variability in response to ARBs, while the angiotensin II type 1 receptor A1166C polymorphism is associated with an increased risk of cardiovascular events in patients treated with ARBs. The prevalence of these genetic variants in the Iraqi population varies widely depending on the region and ethnic group. Conclusion: The clinical pharmacogenetics of ARBs in Iraq suggests that pharmacogenetic testing could improve the selection and dosing of ARBs in Iraqi patients, leading to better patient outcomes and cost-effective healthcare.

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“…Healthcare providers and government decision-makers in Iraq should first get familiar with biosimilars before approving them in Iraqi treatment protocols (14). The majority of pharmacists in Iraqi hospitals had limited expertise with biosimilar pharmaceuticals and were uncertain about the efficiency and safety of these drugs due to this lack of knowledge (15).…”

Section: Introductionmentioning

confidence: 99%

Comparison between Reference Infliximab (Remicade) and its Biosimilar (Remsima) in Patients with Ankylosing Spondylitis: A Field-based Pharmacoeconomic Study

Fadhil

Al‐Jumaili

Ani

2023

Al-Kindy Col. Med. J

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Background: Ankylosing spondylitis is a chronic inflammatory disease that mostly involves the spine and sacroiliac joints. It is associated with a decreased quality of life. Biological medicines such as infliximab and its biosimilar are the mainstay treatments for active ankylosing spondylitis. Objective: The study objective was to conduct a pharmacoeconomic study comparing the cost-effectiveness of the reference infliximab with its biosimilar in ankylosing spondylitis patients visiting public hospitals. Subjects and Method: This is a two-center pharmacoeconomic study performed at two large teaching governmental hospitals in Baghdad, Iraq, which supplied infliximab to outpatients with ankylosing spondylitis. The outcome data were obtained from patient’s medical records and face-to-face interviews with the patients from December 2021 through April 2022. The Independent T-Test was used to measure the differences in areas of utility, and quality of life, between the two infliximab groups. Results: The study recruited 62 patients with ankylosing spondylitis who received infliximab (31 received Remicade, and 31 received Remsima) for at least 12 weeks at two public teaching hospitals. The mean age of the patients was 37.85 years and 83.9% were men. In general, both reference infliximab and its biosimilar were successful in increasing the quality of life. Their importation costs were different from 2019 to 2021. The incremental cost-effectiveness ratio of reference infliximab versus biosimilar was $ 40,909/quality-adjusted life year (QALY) according to 2019 pricing. In contrast, in 2021 reference infliximab (Remicade) was less expensive and yielded slightly better quality of life improvement than biosimilar (Remsima) making Remicade more cost-effective (dominant). Conclusion: Remicade was slightly superior to Remsima in quality of life improvement. However, it was difficult to determine whether the reference or its biosimilar was more cost-effective in 2019 because the health officials did not specify a willingness to pay per quality-adjusted life year. Compared to Remsima, Remicade was more cost-effective in 2021 because it was less expensive and more effective in terms of quality of life improvement.

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Understanding the Experience of Hospital Pharmacists with the Effectiveness, Safety, Adverse Drug Reaction Reporting and Interchangeability of Biopharmaceutical Medicines

Cited by 5 publications

References 16 publications

Cost-effectiveness Analysis of Reference Infliximab (Remicade) Compared to its Biosimilar (Remsima) in Iraqi Patients with Rheumatoid Arthritis (Conference Paper )#

Cost-effectiveness Analysis of Reference Infliximab (Remicade) Compared to its Biosimilar (Remsima) in Iraqi Patients with Rheumatoid Arthritis (Conference Paper )#

Clinical Pharmacogenetics of Angiotensin II Receptor Blockers in Iraq

Comparison between Reference Infliximab (Remicade) and its Biosimilar (Remsima) in Patients with Ankylosing Spondylitis: A Field-based Pharmacoeconomic Study

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