دورية أكاديمية
Importance of right communication with healthcare providers and patients about the new levothyroxine formulation: an expert opinion from Asia Pacific Thyroid Advisory Board.
| العنوان: | Importance of right communication with healthcare providers and patients about the new levothyroxine formulation: an expert opinion from Asia Pacific Thyroid Advisory Board. |
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| المؤلفون: | Razvi S; Clinical Research Institute, Newcastle University, Central Parkway, Newcastle upon Tyne, UK., Nicodemus N; Department of Medicine, University of the Philippines Manila-College of Medicine, Manila, Philippines., Ratnasingam J; Endocrine Unit, Department of Medicine, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia., Arundhati D; Department of Endocrinology, Rudraksh Superspeciality Care Hospital, Siliguri, West Bengal, India., Soh WEA; Abel Soh Diabetes, Thyroid and Endocrine Clinic, Singapore., Kunavisarut T; Division of Endocrinology & Metabolism, Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand., Zufry H; Department of Internal Medicine, Universitas Syiah Kuala/Dr Zainoel Abidin Hospital, Banda Aceh, Indonesia., Chaudhari H; Merck Specialities Pvt. Ltd. Vikroli (E), Mumbai, India., Markova A; Merck Healthcare KGaA, Darmstadt, Germany. |
| المصدر: | Current medical research and opinion [Curr Med Res Opin] 2024 Sep; Vol. 40 (9), pp. 1533-1536. Date of Electronic Publication: 2024 Aug 07. |
| نوع المنشور: | Journal Article; Review |
| اللغة: | English |
| بيانات الدورية: | Publisher: Informa Healthcare Country of Publication: England NLM ID: 0351014 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1473-4877 (Electronic) Linking ISSN: 03007995 NLM ISO Abbreviation: Curr Med Res Opin Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 1995- : Newbury, Berkshire, U.K. : Informa Healthcare Original Publication: London, M. D. Promotions, ltd. |
| مواضيع طبية MeSH: | Thyroxine*/administration & dosage , Thyroxine*/pharmacokinetics , Health Personnel*, Humans ; Therapeutic Equivalency ; Advisory Committees ; Expert Testimony ; Communication ; Drug Compounding/methods ; Drug Compounding/standards ; Hypothyroidism/drug therapy |
| مستخلص: | Levothyroxine (LT4), being "narrow therapeutic index" drug, may lead to significant fluctuations in thyroid stimulating hormone (TSH) levels. Such fluctuations can result in clinically noteworthy disruptions in thyroid function and give rise to adverse clinical consequences. Consequently, regulatory standards for LT4 potency have been tightened, with the most stringent specifications requiring maintenance of potency within the range of 95-105% of the labeled dose throughout the entire shelf-life of the product. The LT4 new formulation with tightened specification adheres to these rigorous standards, demonstrating established bioequivalence to its older formulation while upholding an equivalent standard of safety and efficacy. Furthermore, the novel formulation exhibits enhanced stability and an extended shelf-life. Of paramount significance is its capacity to provide patients with accurate and consistent dosing, thereby effectively catering to their medical requirements. The primary objective of the Asia-Pacific advisory board meeting (held in June 2022 with endocrinologists, experts from India, Indonesia, Philippines, Thailand, Malaysia and Singapore) was to establish the importance of appropriate communication to HCPs, patients and other stakeholders regarding the LT4 new formulation. The aim of this brief review is to highlight the importance of communication with healthcare professionals that should focus on providing accurate information on the LT4 new formulation, emphasizing efficacy, safety, and bioequivalence with clear guidance and ensure that patients and clinicians are fully informed about any changes to medications such as LT4 to reduce the risk of unrelated adverse events being incorrectly attributed to the newer formulation. |
| فهرسة مساهمة: | Keywords: TSH; Thyroid; hypothyroidism; levothyroxine; thyroxine |
| المشرفين على المادة: | Q51BO43MG4 (Thyroxine) |
| تواريخ الأحداث: | Date Created: 20240806 Date Completed: 20240830 Latest Revision: 20240904 |
| رمز التحديث: | 20240904 |
| DOI: | 10.1080/03007995.2024.2378984 |
| PMID: | 39104288 |
| قاعدة البيانات: | MEDLINE |
PDF full text from Publisher | تدمد: | 1473-4877 |
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| DOI: | 10.1080/03007995.2024.2378984 |