Expert Opinions

Wendy Klein-Schwartz, Pharm.D., MPH

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June 15, 2010

 

TO WHOM IT MAY CONCERN:

l am writing this letter of support for the activated charcoal cookie developed by De Novo Inc.  The charcoal cookie is unique and could have a significant impact on home and possibly health care facility gastrointestinal decontamination for poisoning, especially in children.

Pediatric poisoning is usually unintentional and, therefore, the quantities ingested are often substantially less than in intentional overdoses in adults. As such, many pediatric poisonings can be managed at home. Until recently, the mainstay of gastrointestinal decontamination in the home was syrup of ipecac but ipecac is no longer used.

Activated charcoal is considered the primary method of gastrointestinal decontamination and has a potential role in home management of childhood poisonings. Since it is most beneficial if administered within one hour of overdose, activated charcoal may also have a role in the pre-hospital setting for patients requiring transport, in order to reduce time to charcoal administration compared to when it is administered in the emergency department. Many poison centers have been reticent to adopt the routine use of activated charcoal in the home, in part because of its poor palatability and concem that parents will be unable to convince children to drink a therapeutic dose. The activated charcoal slurry is unappealing in appearance (black suspended particles) and bland tasting with a gritty texture. Adding substances to the activated charcoal slurry, such as tlavoring agents, to improve palatability is discouraged since these substances may decrease the adsorptive capacity of the charcoal.

There is a need for a pleasant tasting appealing activated charcoal product which would increase compliance with home administration. The activated charcoal cookie developed by De Novo Inc. is an innovative method for delivery of activated charcoal that could improve the ease of charcoal administration, especially in children. The adverse effect protile is anticipated to be low, like similar food products.

In the emergency department, the same advantages hold, especially for children. Time is often lost trying to cajole the patient to drink the activated charcoal and if refused often necessitates physical restraints and an orogastric or nasogastric tube. This not only takes a great deal of staff time but may emotionally traumatize the child and sometimes produces injury. Although use of the charcoal cookie in adults may be less compelling, many adults cannot tolerate the slurry; therefore, the cookies may offer a practical alternative.

In in-vitro studies the cookie has compared favorably with an aqueous charcoal product.  I conducted a human volunteer study in which not only did the charcoal cookie compared favorably to an aqueous product at decreasing absorption of the marker drug (cimetidine), but the charcoal cookie was also uniformly deemed more palatable than the aqueous charcoal product.  Having long been supportive of the concept of charcoal product with improved palatability, after observing these results I am enthusiastic about the cookie's prospects.

Sincerely,

Wendy Klein-Schwartz, Pharm.D., MPH

Coordinator of Research and Education, Maryland Poison Center 
Associate Professor, Department of Pharmacy Practice and Science 
University of Maryland School of Pharmacy


Bio

Wendy Klein-Schwartz, Pharm.D., M.P.H. is Coordinator of Research and Education at the Maryland Poison Center and Associate Professor in the Department of Pharmacy Practice and Science in the School of Pharmacy at the University of Maryland Baltimore.  Dr. Klein-Schwartz received the Doctor of Pharmacy at the University of Maryland School of Pharmacy in 1977 and the Master of Public Health at the Johns Hopkins University School of Hygiene and Public Health in 1996.  Dr. Klein-Schwartz has been on the faculty of the pharmacy school for 33 years during which time she has served as Assistant Director and Director of the Maryland Poison Center.  She is Director of the Clinical Toxicology Fellowship at the Maryland Poison Center.  She is coursemaster of didactic courses and experiential rotations in clinical toxicology and poison information.  During her tenure at the School of Pharmacy she has served on numerous committees and chaired several standing committees.

Dr. Klein-Schwartz is active in the American Association of Poison Control Centers (AAPCC). She is on the editorial board of Annals of Pharmacotherapy and serves as referee for toxicology, emergency medicine and pharmacy journals. Dr. Klein-Schwartz conducts research in the areas of poison information and clinical toxicology with emphasis on epidemiology of poisoning as well as optimal management of poisonings. She has lectured locally and nationally and has presented platform and poster presentations at national and international meetings.  She has authored over 50 research publications as well as chapters in clinical toxicology and pharmacy texts. In 2008 she was received the Maryland Society of Health System Pharmacists’ W. Arthur Purdum Award for sustained and significant contributions to the profession.