Viable alternatives to prescription pain medication:
Advent of Medical Foods
By Yusuf (JP) Saleeby, MD
With recent reports of increased visits to the emergency rooms across this nation for reasons pertaining to prescription drug abuse there is ever more reason to focus on alternatives. In a 2011 report from the Substance Abuse and Mental Health Services Administration statistics reveal that from 2004-2009 in America there was a rise in Emergency Department (ED) visits due to drug reactions. Prescription medications, OTC meds and even herbal remedies of all types saw a rise in misuse, abuse, suicide attempts, adverse reactions and accidental ingestions resulting in ED visits. Part of the rise is due to poly-pharmacy, as the population at large is being prescribed more than one medication by their physicians. Multiple medication use results in increase risk for untoward effects and complication. With our aging population this becomes even more an issue, as they tend to “collect’’ medications as they age.
In 2009 the report by SAMHSA goes on to state that over 120-million visits were made to nationwide EDs and of these at least 4.5-million were drug/medication related. Drug-related ED visits increased by over 80-percent since 2004. In 2009 estimates of about 2.1-million ED visits resulted from the misuse or abuse of medications. That is about 674 ED visits per 100,000 people per year. Those 20-years old and younger was at a rate of 473 visits and those 21-years and older was double that. Just over thirty-five percent involved pharmaceuticals alone and another 25-percent involved pharmaceuticals plus illicit drugs and/or alcohol. The visits to EDs with side-effects and medical emergencies related to prescription drugs in one fashion or another amounted to 60-percent for that group. While visits remained stable from 2004 to 2009 on medication alone, there was a 117% rise in the non-medical use of pharmaceuticals, and a 97% rise in pharmaceuticals used with illicit drugs.
No matter how you look at it, it is a big national problem. Some of it is avoidable; others pertain to social issues and the rise of illicit drug use in this country. From the perspective of a physician this trend can be reversed if doctors prescribe less medication, are judicious in their use of multiple medications, and use the lowest doses possible that results in goal of therapy. I see too many patients in their 5th decade of life or greater that are on more than one pharmaceutical (both in the Emergency Department and the wellness clinics I staff). The older they present, often the larger their purse of drugs and therapeutics.
Making changes to improve safety:
First step is counseling patients on pharmaceuticals. Even a single prescription medication is not without side effects; each and every patient should be made aware. Add a second or third drug and the risk for drug-drug interactions goes up precipitously. A published study in the December 2008 JAMA by the University of Chicago revealed that in some 3000 individuals surveyed aged 57 to 85 the use of prescription and OTC drugs resulted in a one in 25 risk of major drug-drug interactions. Halting the behavior of continually adding medication on top of medication is a paradigm that must be adopted by primary care physicians. After all they are the gatekeepers who monitor and when appropriate should selectively withdraw unnecessary medication.
Alternatives to powerful drugs with harmful side effects and strong drug-drug reactions are the more subtle and oftentimes safer herbals and dietary supplements. However, before we proceeded, many dietary supplements and herbals can themselves be linked to drug-herb interactions often as worrisome as we see with two pharmaceuticals interacting.
A more appropriate alternative is the judicious use of ‘’medical foods’’ as alternatives to pharmaceuticals. Medical foods are those that have a nod from the FDA as approved for medicinal use and prescribed by a physician. Medical foods are just that, food or compounds often times amino-acids and natural substances which have been studied to show benefits similar to their more powerful pharmaceutical brothers. The term medical food, is defined in section 5(b) of the Orphan Drug Act (1983) as "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
Medical foods are not limited by FDA required labeling often seen on supplements and herbals. An examples would be the combination of amino-acids, neurotransmitters and select substances in a patented medical food called Theramine® used to augment a lower dose of an NSAID (Naprosyn®) and eventually replacing it completely in some cases. This process can be undertaken to reduce and eliminate the use of scheduled and habit forming pain medication such as oxycodone, hydrocodone, morphine, and tramadol. Other medical foods can replace side effect wrought pharmaceuticals such as the SSRI class of anti-depressants (Prozac®, Celexa®) and the anti-anxiety benzodiazepines (Xanax®, Ativan®). Medical foods are extremely popular on the West Coast, but are gaining momentum in the East. Additional benefits of Medical Foods, besides their safety record, are that many health insurance policies will cover their use. So now we witness insurance coverage for not only pharmaceuticals (generally not covering supplements and herbals) but coverage for medical foods such as Theramine®. As more clinical data is collected there will be better acceptance for the use of medical foods by healthcare practitioners.
Making Medical Foods available:
Medical foods must be prescribed by a physician. While not a pharmaceutical in the strict sense, they are FDA approved and accepted for specific use in fighting disease and illness. Wellness One (First) is one of the first center in the region that offers these medical foods through prescription from their staff physicians. Let us not forget Hippocrates (460-377 BC), the father of Western medicine, is known for saying “Let food be thy medicine and medicine be thy food.”
Dr. Saleeby is medical director of Wellness One of Myrtle Beach and Wellness First of Charleston. Both centers are integrative wellness and health spas with a focus on integrative protocols for management of illness and disease prevention. Wellness One and Wellness First are the leaders in bringing the use of Medical Foods to the coastal Carolinas.
Substance Abuse and Mental Health Services Administration, Drug Abuse Warning Network, 2009: National Estimates of Drug-Related Emergency Department Visits. HHS Publication No. (SMA) 11-4659, DAWN Series D-35. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2011.
Qato, DM., et al, Use of Prescription and Over-the-counter Medications and Dietary Supplements Among Older Adults in the United States. 2008;300(24):2867-2878.
Medical Foods FDA website, Retrieved from http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/MedicalFoods/default.htm (accessed 11/10/2012)
Shell, W.E., et. al., A Double-Blind Controlled Trial of a Single Dose Naproxen and an Amino Acid Medical Food Theramine for the Treatment of Low Back Pain., Am. Journal of Therapeutics, 17(2):133-139, March/April 2010
Theramine from Physician Therapeutics, Retrieved from http://ptloffice.com/downloads/marketing/Theramine_latest.pdf (accessed 11/10/2012)
Orphan Drug Act FDA website, Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/OrphanDrugAct/default.htm (accessed 11/10/2012)