scholarly journals A Retrospective Study of Injection Site Pain from Azithromycin Injection in Japanese Patient

2020 ◽  
Vol 32 (3) ◽  
pp. 207-213
Author(s):  
Hironori TANAKA ◽  
Makoto HAYASHI ◽  
Mariko AWAYA ◽  
Yumiko KUSUNOKI ◽  
Nao TANAKA ◽  
...  
2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1959.1-1960
Author(s):  
S. Gohil

Background:The advent of biosimilars has heralded a new era for cost effective biologic prescribing in the NHS. As patents expire for originator biologics, less expensive versions are now widely available as biosimilars. Non-medical switches (for reasons unrelated to a patient’s health) ensure prescribing of best value medicines, and cost savings can be redirected to patient care.1This practice resonates with recommendations from Lord Carter’s 2016 report regarding reducing unwarranted variation in the NHS and adopting cost saving opportunities.2In 2018/19, following loss of patent exclusivity for the expensive adalimumab originator biologic, UHCW worked in accordance with national directives to drive forward one of the largest non-medical biosimilar switches.Objectives:This qualitative review aims to explore the success of the adalimumab biosimilar switch and key themes associated with switch backs/refusals across the Rheumatology (R), Gastroenterology (G) and Dermatology (D) specialities at UHCW.Methods:The switch plan occurred between April-December 2019. 403 patients (R;189, G;176, D; 38) were eligible for switch. Patients were informed of the plan in advance via a patient information leaflet/hospital clinic visits. Switch refusals, withheld treatments and cancellations were documented and patients were advised to contact the hospital pharmacy/clinical teams if they encountered any concerns, adverse effects or lack of efficacy post switch. The clinician would then advise on subsequent management.Results:During April-December 2019, 264/403 patients had been successfully switched (R;122, G;109, D;33). 33/403 patients switched back to the originator biologic (R;22, G;10; D;1). Of the 22 rheumatology switch back patients; 6 patients reported injection site pain and variably headache, fatigue, disease relapse, gastrointestinal (GI) upset, erythema; 10=reported lack of efficacy and variably influenza-type symptoms, relapse in associated psoriasis, difficulty in walking/sleeping, hair loss, excessive perspiration, facial cellulitis, foot drop and GI upset; 1=blepharitis;1=latex allergy before injection; 3=later declined switch; 1=damaged two devices and did not wish to continue biosimilar. Of the 10 gastroenterology switch back patients; 1=injection site pain; 2=lack of efficacy; 1=developed needle phobia; 1=latex allergy before injection; 1=switch detrimental to health; 2=unstable disease; 1=insomnia; 1=pregnancy. The 1 dermatology switch back patient reported injection site pain and bleeding.38/403 patients refused the switch and remained on the originator biologic (R;11, G;27, D;0). 29/403 patients had treatment cancellations and were switched to an alternative biologic (R;17, G;9, D;3). 32/403 patients stopped treatment (R;13, G;19, D;0). Treatment was withheld for 7/403 patients (R;4, G;2, D;1).Conclusion:The UHCW adalimumab biosimilar switch plan succeeded in switching a total of 66% of patients; thus an annual cost saving of £73,020. Injection site pain, most likely due to the biosimilar citrate content, and lack of efficacy according to patient perception and subsequent clinical review, were the most predominant causative themes for switch backs. Gastroenterology patients accounted for 71% (27/38) of the total switch refusals. Additional data regarding patient refusals, identifies future opportunities to improve patient counselling and drive further cost savings.References:[1]Azevedo V, et al. Biosimilars: considerations for clinical practice. Considerations in Medicine. 2017;1(1):13–8[2]Lord Carter of Coles. (2016) Operational productivity and performance in English NHS Acute Hospitals: Unwarranted variations [Online]Acknowledgments:Mark Easter, Chief Pharmacist, Hardeep Bagga, Deputy Chief Pharmacist, UHCW Pharmacy Homecare Team, UHCW Specialist Clinical Teams.Disclosure of Interests:None declared


2020 ◽  
pp. 106002802096633
Author(s):  
Jacob Dresser ◽  
Kyle John Wilby

Objective: To compare the incidence and types of adverse effects between 3 recommended treatment options for gonorrhea and to compare the incidence of injection site pain between single-dose intramuscular ceftriaxone and gentamicin. Data Sources: A keyword search of MEDLINE (1966 to September 2020), EMBASE (1947 to September 2020), and International Pharmaceutical Abstracts (1970 to September 2020) was conducted. The electronic search was supplemented with manual screening of references. Study Selection and Data Extraction: Comparator studies reporting adverse effect outcomes of treatment with cefixime, ceftriaxone, or gentamicin for gonorrhea in humans were included. Data extracted included study year, authors, aim, setting, population, dosing protocols, and outcome results. Data Synthesis: A total of 298 articles were identified, of which 6 met inclusion criteria. Two randomized controlled trials compared ceftriaxone and gentamicin. Four randomized controlled trials compared cefixime and ceftriaxone. No differences were noted for the occurrence of at least 1 adverse effect between gentamicin and ceftriaxone (odds ratio [OR] = 0.81; 95% CI = 0.56-1.18) or between cefixime and ceftriaxone (OR = 1.11; 95% CI = 0.21-5.93). Injection site pain (ceftriaxone and gentamicin) and other adverse effects (all drugs) were common but occurred at similar rates between groups. Relevance to Patient Care and Clinical Practice: Results of this review show a lack of signal for safety concerns with gentamicin-based regimens for the treatment of gonorrhea. Future research should investigate patient acceptability, especially for intramuscular injections. Conclusions: The use of single-dose cefixime, ceftriaxone, and gentamicin-based regimens for treatment of gonorrhea appears to be safe and acceptable for use in practice.


Toxicon ◽  
2015 ◽  
Vol 93 ◽  
pp. S20-S21
Author(s):  
Dirk Dressler ◽  
Fereshte Adib Saberi ◽  
Hans Bigalke

2010 ◽  
Vol 38 (6) ◽  
pp. 428-434
Author(s):  
Pelin Kirpit ◽  
Zeynep Nur Akcaboy ◽  
Erkan Yavuz Akcaboy ◽  
Nermin Gogus

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