HEALTH-SYSTEM RX
F I NAL GU I DANCE FOR COMPOUNDERS ’ FAC I L I T I ES
I BUPROFEN SHOWS BETTER THAN ACETAMI NOPHEN I N NEW STUDY
Custom designed mounts were installed on Spot robots, essentially creating a mobile telemedicine platform. An iPad mount, with a two-way radio, allowed doctors to remotely triage patients as they approached the hospital. Dr Spot now carries a number of cameras designed to remotely mea- sure a patient’s vital signs. Since April, the team has rapidly expanded Spot’s abilities, ultimately developing what is being called VitalCam, “a robot- ic-assisted vital sign acquisition platform to facilitate contactless vital signs in hospital settings”. Some patient vital signs are easier than others to measure remotely. Body temperature, for example, can be gathered relatively simply using an infrared camera. To accommodate these variances, in this instance, the research team developed algorithms to more accurately use infrared camera data to measure body and skin temperature by incorporating factors such as ambient temperature and distance from the patient. The infrared camera can also measure a patient’s breathing rate by calculating temperature changes in their face mask. As they breathe in and out the small fluctuations in the temperature of the mask allow for breathing rate measurements to be collected. Three other monochrome cameras are incorporated into the VitalCam system. Each camera is set to filter a highly specific spectrum of light (670, 810, and 880 nanometers, respectively). Tracking these particular wavelengths allows the system to detect tiny color changes in skin blood vessels. These changes can be used to calculate a patient’s pulse and their blood oxygen saturation. The entire system is designed to be remotely oper- ated using a handheld controller. So hypothetically, patients could be triaged and monitored by Dr Spot without ever needing to come into contact with a human health care worker. The results of the latest VitalCam tests are yet to be published in a peer-re- viewed journal, however, they have been posted to a preprint journal. The system so far has only been tested in a small cohort of healthy subjects and not in hospital conditions with sick patients yet. But its measurements have been accurately confirmed on healthy subjects. The next step will be a prelimi- nary test in a hospital emergency environment with COVID-19 patients. Amongst the huge benefit uti - lizing DR. Spot with COVID patients, researchers wrote that Dr. Spot can not only help to conserve PPE but can also help curb transmission of corona- virus by keeping hospital staff and patients separate. Source: https://newatlas.com/robotics/ boston-dynamics-spot-coronavirus-patients-remote-medicine/ https://www.engadget.com/boston-dynamics-dr-spot-203745150.html
A fundamental part of the U.S. Food and Drug Administration’s (FDA) drug compounding pro- gram is to protect patients from exposure to poor quality compounded drugs. Compounded drugs are often made due to the lack of medical needs that can be met by a FDA-approved drug product. Unfortunately, compounded drugs typically have not been reviewed by the FDA for safety, effective - ness or quality. Only the individual ingredients. The FDA is constantly trying to help improve the quality of compounded drugs and reduce risk to patients. Under federal law, a drug is considered adulterated if it is prepared, packed or held under unsanitary conditions that could cause the drug to become contaminated with filth or rendered injurious to health. While some compounders work hard to meet quality standards, too often, FDA inves- tigators continue to observe poor conditions at compounding facilities such as dirt, mold, insects, unclean exhaust vents and dirty high-efficiency par - ticulateair (HEPA) filters that impact drugqualityand have the potential toharmpatients who use the drugs.
According to a new study published in JAMA Network Open, ibuprofen was associated with better fever reduction and less pain than acetamin- ophen when used to lower fever and associated pain in infants and toddlers. Nearly every parent at one time or another has sought advice for their young children who have headaches or pain. Often the advice leads to dosing of acetaminophen or ibuprofen or the alternating dosages of both. Parents often wonder which one really works best. Recently, researchers conducted a meta-analysis in which they compared acetaminophen and ibupro- fen treatment in 240,000 children younger than 2 years old. Patients included in the research came from various health care settings in seven different countries. Compared with acetaminophen, ibupro- fen resulted in reduced temperature and less pain within the first 24 hours of treatment more often. The superiority of ibuprofen as an antipyretic did not continue beyond 24 hours after treatment onset, however, and no data were available on analgesic outcomes at less than 4 hours. Equivalent safety was found for these two widely prescribed and available over the counter (OTC) medications for fever and pain in children. Acetaminophen and ibuprofen appeared to have similar serious adverse event pro- files and adverse events were uncommon. The study authors added that the evidence regarding the risk of serious bacterial infection remains inconclusive. Of note: ibuprofen is said to pose a higher risk of kidney toxic effects in younger children, which is why it is commonly avoided. But these researchers said they did not find any evidence to support this view.
Numerous compounders have voluntarily recalled drug products intended to be sterile, and also tem- porarily or permanently stopped sterile operations because of these inspectional observations. The FDA has also taken regulatory and enforcement actions when we observe these insanitary conditions. Because of concerns like these, the FDA has released a final guidance to help compound - ers identify and prevent unsanitary conditions at their facilities. This final guidance provides recent examples of unsanitary conditions at com- pounding facilities and details corrective actions that facilities should take when they identify these conditions. The guidance applies to both tradi- tional compounders and outsourcing facilities. They have also added recommendations for com- pounders to use risk management tools to develop appropriate controls toprevent unsanitary conditions at their facilities. The guidance also addresses the regulatory actions that the FDAmay take in response to insanitary conditions sometimes involv- ing their collaborative work with states and the Department of Justice remains ongoing. To download the final guidance document or for further information go to https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ insanitary-conditions-compounding-facilities-guidance-industry Source: https://www.news-medical.net/news/20201106/ FDA-releases-final-guidance-to-help-identify-and-prevent-insanitary-conditions- at-compounderse28099-facilities.aspx https://www.fda.gov/news-events/press-announcements/fda-takes-efforts-pro - tect-patients-potentially-harmful-compounded-drugs-through-finalizing
Source:https://www.pharmacist.com/article/ could-ibuprofen-fare-better-acetaminophen-kids-reducing-fever
WHO I S DR SPOT?
After more than a decade of development, a col- laborative team of researchers has turned a Boston Dynamics’ dog-like robot into a tiny mobile doctor, now able to remotely measure patients’ vital signs from a distance of over six feet making it beneficial for use with hospitalized COVID patients. Dubbed Dr Spot, the robot is currently being tested as a way to safely triage potentially contagious COVID- 19 patients. Spot robots are four legged and able to nimbly navigate areas such as hospitals where needed. They are designed to self-navigate or be remote controlled to maneuver areas that wheel robots cannot. This technology has been used to inspect building sites and work on oil rigs. But now it looks like Mr. Spot could be used during COVID to minimize exposure of healthcare workers to contagious patients. Back in April 2020 Boston Dynamics began working with staff at Brigham and Women’s Hospital in Massachusetts. Where healthcare workers had suffered a significant raft of infections. Dr. Spot was looked at as a way to help.
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