Embodiments of the present invention relate generally to methods and systems for management of medications and more particularly to method and systems to provide safe, secure and accurate point-to-point delivery of prescription and non-prescription drugs.
Multiple, potential risks or complications that exist in the administration of medicines are derived from patient, provider, pharmacy, and/or system level failures. These risks are significantly mitigated in the acute care setting through the use of automated pharmacy technologies that include unit dose packaging systems that match bar coded medication packets to patient's bar coded wrist bands, thereby establishing positive patient identification and electronically verifying the medication at the bedside. The same risks of medication errors found in the acute care setting are substantially magnified in the home or ambulatory care setting due to the lack of similar point-to-point medication delivery technology, as well as the absence of direct medical supervision. These risks have been shown to lead to increases in hospital readmission rates, long-term care admissions, morbidity and mortality events. According to the National Institute on Drug Abuse (NIDA), currently available technologies and methods to address these problems are inadequate.
One quarter of the prescription drugs sold in the United States are used by the elderly, often for problems such as chronic pain, insomnia, and anxiety. Multiple potential risks or complications that ordinarily exist in the administration of medicines in an institutionalized care setting are significantly magnified in the home care environment. If not adequately addressed and managed these risks have been shown to lead to increases in morbidity and mortality. Home-based elderly are perhaps among the most vulnerable population in this regard. For example, Medication Adherence (MA) by the elderly is often as low as 26% and contributes to limiting the achievement of therapeutic goals. The odds of good health outcomes are nearly three times lower for patients who do not adhere to recommended therapies than for patients who follow provider recommendations. Low MA increases patient and provider frustration and can increase health care costs, including avoidable hospitalizations. For older adults, MA difficulties may account for 10 to 25% of hospital and nursing home admissions, or re-admissions, and not only exacerbates disease severity but can cause fatalities. Approximately 125,000 Americans die annually due to poor MA. The estimated annual cost of patients not taking their medications as prescribed is approaching $290 billion.
Another overlapping issue is Adverse Drug Reactions (ADR), which some researchers believe increases exponentially with the number of medications taken. ADR among the general population is estimated to be between the fourth and sixth leading cause of death in the U.S. Many studies from around the world show a correlation between increasing age and the ADR rate with the most recent studies indicating that the ADR rate for the elderly in the U.S. and Europe was 20% greater than in studies carried out in general medical settings.
Prescription Drug Diversion and Abuse (PDDA), are large and rapidly growing problems in the U.S. health care delivery system. Abuse of several categories of prescription drugs has increased markedly in the United States in the past decade and has now reached alarming levels for certain agents, especially opioid analgesics and stimulants. This category overlaps with the preceding two in that abuse of prescription drugs, and their non-prescription counterparts, is associated with a range of factors, including dose and co-administration with other drugs. The prevalence of prescription drug abuse among the elderly may be as high as 11 percent with an increased risk among women, those who are socially isolated, subject to depression, and/or have a prior history of substance abuse. Beyond the direct risk to the elderly from PDDA, collateral risk to family members, especially teens and young adults, is growing alarmingly. According to the Drug Enforcement Agency, sixty-three percent of teens believe that prescription drugs are easy to get from friends' and family's medicine cabinets, including those of their grandparents. As of 2009 there were 7 million Americans aged 12 years and older who abused prescription drugs for non-medical purposes each month, up from 6.2 million in 2008. This represents a 13 percent increase in a single year. One in seven teens admit to abusing prescription drugs to get high and sixty percent of teens who abused prescription pain relievers did so before the age of fifteen. The number of emergency room visits attributable to pharmaceuticals alone is up 97% between 2004 and 2008. According to the Center for Disease Control, prescription drugs, including opioids and antidepressants, are responsible for more overdose deaths than “street drugs” such as cocaine, heroin, and amphetamines.
Proper disposal of unused prescription drugs has become another important public health issue as rates of PDDA, accidental poisoning, and the incidence of drugs found in the drinking water have gained more attention. As a result of the growing public awareness of this problem, and it's potentially deadly effects, local, state and federal entities are struggling with efforts to insure the safe distribution and handling of prescription medications. This includes the disposal of the unused quantities that typically accumulate in medicine cabinets. Among these efforts are proposed regulations requiring drug suppliers to collect and dispose of unused drugs, an effort being strongly resisted by the drug industry due to the complexity and high cost of implementation.
Current solutions have generally failed to address any one of these problems adequately, and certainly there are none that address all of them. Most focus on the economics of dispensing drugs at the point of care in order to facilitate convenience and/or to lower overhead costs for the distributor. Others, attempt to make drug dispensing more organized and manageable, but often result in products that are nightmarish in their complexity to setup, maintain and use. Both of these types of solutions also fail to provide the proper point-to-point security required to avoid drug diversion. Hence, there is a need for improved methods and systems for efficiently and effectively securing, controlling, and enhancing medication adherence.
USPTO Backgrounds
USPTO Backgrounds