Raeford Eugene Brown

Introduction: A review of the medical device adverse events submitted to the United States Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was undertaken to determine the major sources of the information. Methods: The reporter’s occupation and source of the medical device report were determined for acquisition dates Jan 1, 1997 to Dec 31, 2018. A total of 7,766,737 adverse event records were analyzed. Results: 96.6% of reports originated with the manufacturer. Patients (patients/family/friend) were the most frequent submitter of reports directly to the FDA, almost five times as often as physicians. Nurses submitted reports directly to the FDA 2.77 times as often as physicians. Only 0.49% of physician reports were submitted directly to the FDA, representing 0.09% of total MAUDE reports. Conclusion: Increasing physician reporting directly to the FDA and MAUDE through the MedWatch reporting system is an imperative. Incorporating information from the perspective of the physician has the potential of increasing the quality of the data and improving the reliability of post-market surveillance.

This Clinical Report was reaffirmed November 2024.: This clinical report addresses the topic of pre-existing do not attempt resuscitation or limited resuscitation orders for children and adolescents undergoing anesthesia and surgery. Pertinent considerations for the clinician include the rights of children, decision-making by parents or legally approved representatives, the process of informed consent, and the roles of surgeon and anesthesiologist. A process of re-evaluation of the do not attempt resuscitation orders, called “required reconsideration,” should be incorporated into the process of informed consent for surgery and anesthesia, distinguishing between goal-directed and procedure-directed approaches. The child’s individual needs are best served by allowing the parent or legally approved representative and involved clinicians to consider whether full resuscitation, limitations based on procedures, or limitations based on goals is most appropriate.

* Abbreviations: AAP — : American Academy of Pediatrics AAPD — : American Academy of Pediatric Dentistry AAP-CA — : American Academy of Pediatrics, California ASA — : American Society of Anesthesiologists PALS — : pediatric advanced life support In July 2016, the American Academy of Pediatrics (AAP) and the American Academy of Pediatric Dentistry (AAPD) released their joint updated “Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures.”1 The purpose of this update, as stated by the authors and supported by the AAP and AAPD, was to “unify the guidelines for sedation used by medical and dental practitioners; to add clarifications regarding monitoring modalities…; to provide updated information from the medical and dental literature; and to suggest methods for further improvement in safety and outcomes.” They described the substantial differences between sedation for children and adults, and emphasized the subtlety and rapidity with which young children can pass from 1 level of sedation to another unintended level. The need to have practitioners that can quickly recognize the signs of deeper levels of sedation and have the skills, equipment, and support personnel to rescue the child from potential adverse responses to these unintended levels of sedation is critical. My nephew Caleb was a strong, healthy, 6-and-a-half year old when he died. Caleb was scheduled to have a mesiodens tooth extracted, a supernumerary tooth between the 2 central incisors. His oral surgeon had recommended general anesthesia. Caleb’s parents did not consent lightly to … Address correspondence to Rita Agarwal, MD, Department of Anesthesiology, Perioperative Medicine and Pain Management, Stanford University Hospital, 300 Pasteur Dr, Stanford, CA 94305. E-mail: agarwalr{at}stanford.edu

Abuse-deterrent formulations of opioids: Many questions still to answer

The United States is in the midst of a devastating opioid misuse epidemic leading to over 33,000 deaths per year from both prescription and illegal opioids. Roughly half of these deaths are attributable to prescription opioids. Federal and state governments have only recently begun to grasp the magnitude of this public health crisis. In 2016, the Centers for Disease Control and Prevention released their Guidelines for Prescribing Opioids for Chronic Pain. While not comprehensive in scope, these guidelines attempt to control and regulate opioid prescribing. Other federal agencies involved with the federal regulatory effort include the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA), and the Department of Justice. Each federal agency has a unique role in helping to stem the burgeoning opioid misuse epidemic. The DEA, working with the Department of Justice, has enforcement power to prosecute pill mills and physicians for illegal prescribing. The DEA could also implement use of prescription drug monitoring programs (PDMPs), currently administered at the state level, and use of electronic prescribing for schedule II and III medications. The FDA has authority to approve new and safer formulations of immediate- and long-acting opioid medications. More importantly, the FDA can also ask pharmaceutical companies to cease manufacturing a drug. Additionally, state agencies play a critical role in reducing overdose deaths, protecting the public safety, and promoting the medically appropriate treatment of pain. One of the states’ primary roles is the regulation of practice of medicine and the insurance industry within their borders. Utilizing this authority, states can both educate physicians about the dangers of opioids and make physician licensure dependent on registering and using PDMPs when prescribing controlled substances. Almost every state has implemented a PDMP to some degree; however, in addition to mandating their use, increased interstate sharing of prescription information would greatly improve PDMPs’ effectiveness. Further, states have the flexibility to promote innovative interventions to reduce harm such as legislation allowing naloxone access without a prescription. While relatively new, these types of laws have allowed first responders, patients, and families access to a lifesaving drug. Finally, states are at the forefront of litigation against pharmaceutical manufacturers. This approach is described as analogous to the initial steps in fighting tobacco companies. In addition to fighting for dollars to support drug treatment programs and education efforts, states are pursuing these lawsuits as a means of holding pharmaceutical companies accountable for misleading marketing of a dangerous product.

Introduction: Great strides have been made in the last twenty years in providing safe anesthesia care for infants and children. Despite a historical record of safety, recent findings have called to question the toxicities of many anesthetic agents. Observations concerning the inherent safety of these agents, their appropriate management in infants, and new findings which suggest overlooked toxicities will be discussed. Areas covered: A literature search using Pub Med identified journal articles relating to the safety of anesthetic agents in infants and children. From this group, representative classical articles, as well as more recent offerings, were chosen that were germane to the topic of anesthetic drug safety in children. Expert opinion: Anesthetic agents used in children in the US are generally safe in the short term and are administered to thousands of children daily without demonstrable harm. The question of a deleterious effect of anesthetics on the developing central nervous system when used for long periods and on multiple occasions continues to be open to debate. Conservative elective management of these agents in infants and young children is reasonable until such time as more is known about the toxicities on the central nervous system.