My opinion
 

By Dr. Deepak Gupta
Corresponding Author Dr. Deepak Gupta
Wayne State University, - United States of America 48201
Submitting Author Dr. Deepak Gupta
ANAESTHESIA

Scopolamine, Sugammadex, Litigation, Patient Education

Gupta D. Scopolamine and Sugammadex: Gateway To Litigation In Absence of Patient Education. WebmedCentral ANAESTHESIA 2018;9(3):WMC005442

This is an open-access article distributed under the terms of the Creative Commons Attribution License(CC-BY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
No
Submitted on: 15 Mar 2018 03:40:53 PM GMT
Published on: 19 Mar 2018 05:27:24 AM GMT

My opinion


As an anesthesiologist, my personal experience with scopolamine transdermal therapeutic system (TTS) patch as a counter-measure against postoperative nausea and vomiting (PONV) and sugammadex as a rapid reversal agent against neuromuscular blockade is limited. Still, I wonder if these medications can be gateway to litigation when patient education about them may NOT have been ensured.

Scopolamine is often portrayed in mass media as "zombie" drug inducing hyper-suggestibility among its users. Even the United States (U.S.) Department of State (Bureau of Diplomatic Security) has warned in its travel advisory for citizens visiting Colombia about the crime threats secondary to scopolamine's effects lasting greater than 24 hours after its accidental ingestion or inhalation.[1] Although scopolamine as TTS patch is safer with insignificant incidence of confusion probably due to onset of action being 4 hours and peak plasma levels reaching in 24 hours to deliver total dose of 1mg scopolamine over 72 hours, the half life of 9.5 hours may point towards its lasting effects as scopolamine's withdrawal symptoms unravel only 24 hours after removal of the patch.[2] Essentially, the anesthesia provider teams must ensure thorough patient education regarding precautions to follow when choosing scopolamine TTS patch as a component of multimodal strategy to counter PONV.[3] The anesthesia provider teams and the patients can comprehensively discuss the possibility of the cognition impairment that may qualitatively (in unknown quantities) effect their abilities to consent for the surgical procedures if scopolamine TTS patch is preemptively applied more than 4 hours prior to consenting for the procedure. The discussions can also include the potential legal incompetence for yet-to-be-defined periods in case the patients were expected to be sworn in or to sign legal documents with scopolamine TTS patch in situ and for 24 hours thereafter removal of the patch.

Sugammadex is a good addition to anesthesia provider teams' armamentarium, especially when the return of normalcy in neuromuscular junction transmission is objectively targeted at train-of-four ratios >0.9 that has become a major component of continuing medical education (CME) programs to make anesthesia practice of neuromuscular blockade safer without being cost-prohibitive for the patients. Interestingly, these CME programs' abundance and popularity may have coincided with residual neuromuscular blockade concerns' solution (sugammadex) becoming readily available for peri-operative use after U.S. Food and Drug Administration (FDA) approval in December 2015.[4] However, during these CME programs, the documented interaction of sugammadex with hormonal contraceptives cannot be overlooked as a mere footnote information for the anesthesia care providers.[5] Irrespective of whether sugammadex administration becomes standard practice for all patients' reversals from rocuronium-vecuronium induced neuromuscular blockade or its administration is limited to the rescue reversals after unintentional prolonged-residual neuromuscular blockade, the anesthesia provider teams should always educate their female patients about the need for alternate contraceptive methods' use for seven days post-sugammadex administration so as to counter the decreased efficacy of hormonal contraceptive methods as caused by sugammadex.[6] This information can be shared with the female patients preoperatively if the anesthesia departments use sugammadex as default reversal agent among all patients, or postoperatively if the anesthesia departments use sugammadex only as a rescue reversal agent in rare clinical scenarios. Interestingly, it remains to be seen in the future whether peri-menopausal and post-menopausal patients on hormonal replacement therapy report sudden flaring up of menopausal symptoms postoperatively for seven days after sugammadex administration.        

Summarily, to ensure patient safety and to avoid potential litigation when the non-quantified duration of legal incompetence being possible around scopolamine TTS patch-in-situ and the unplanned pregnancies being possible after sugammadex catch patients unawares, educating patients about these medications and their effects is of utmost importance for anesthesia provider teams peri-operatively.

Reference(s)


  1. United States Department of State, Bureau of Diplomatic Security, Overseas Security Advisory Council [homepage on the Internet]. Washington: U.S. Government inter-agency website; [updated 2017 Apr 7; cited 2018 Jan 17]. Colombia 2017 Crime & Safety Report: Cartagena; [about 2 screens]. Available from: https://www.osac.gov/pages/Con tentReportDetails.aspx?cid=21611
  2. Transderm Scop® (Scopolamine) Transdermal System 1.5mg [homepage on the Internet]. Middlesex: GlaxoSmithKline plc.; c2017 [cited 2018 Jan 17]. Information for medical professionals. Prescribing information; [about 2 screens]. Available from: http://www.transdermscop.com/prescri bing-information.htm  
  3. Transderm Scop® (Scopolamine) Transdermal System 1.5mg [homepage on the Internet]. Middlesex: GlaxoSmithKline plc.; c2017 [cited 2018 Jan 17]. Information for patients; [about 2 screens]. Available from:  http://transdermscop.com/tran sderm-scop-patient-information.htm
  4. U.S. Food & Drug Administration [homepage on the Internet]. Silver Spring: Federal Agency of the U.S. Department of Health and Human Services; [updated 2015 Dec 16; cited 2018 Jan 17]. FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during surgery; [about 2 screens]. Available from:  https://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm477512.htm  
  5. Merck [homepage on the Internet]. Kenilworth: Merck & Co., Inc.; c2009-18 [updated 2017 Jun; cited 2018 Jan 17]. Bridion® (sugammadex) injection, for intravenous use. Full prescribing information; [about 20 screens]. Available from: https://www.merck.com /product/usa/pi_circulars/b/bridion/bridion_pi.pdf
  6. Michigan Health System: University of Michigan [homepage on the Internet]. Ann Arbor: Regents of the University of Michigan; c2018 [updated 2016 Dec; cited 2018 Jan 17]. Birth control drug interaction with sugammadex (Bridion®) and/or Aprepitant (Emend®): Information for female surgery patients; [about 2 screens]. Available from:  http ://www.med.umich.edu/1libr/Anesthesiology/BCPInteractionsSugammadexAndAprepitant.pdf

Source(s) of Funding


NOT APPLICABLE

Competing Interests


NOT APPLICABLE

Reviews
0 reviews posted so far

Comments
0 comments posted so far

Please use this functionality to flag objectionable, inappropriate, inaccurate, and offensive content to WebmedCentral Team and the authors.

 

 

What is article Popularity?

Article popularity is calculated by considering the scores: age of the article
Popularity = (P - 1) / (T + 2)^1.5
Where
P : points is the sum of individual scores, which includes article Views, Downloads, Reviews, Comments and their weightage

Scores   Weightage
Views Points X 1
Download Points X 2
Comment Points X 5
Review Points X 10
Points= sum(Views Points + Download Points + Comment Points + Review Points)
T : time since submission in hours.
P is subtracted by 1 to negate submitter's vote.
Age factor is (time since submission in hours plus two) to the power of 1.5.factor.

How Article Quality Works?

For each article Authors/Readers, Reviewers and WMC Editors can review/rate the articles. These ratings are used to determine Feedback Scores.

In most cases, article receive ratings in the range of 0 to 10. We calculate average of all the ratings and consider it as article quality.

Quality=Average(Authors/Readers Ratings + Reviewers Ratings + WMC Editor Ratings)