Center for Drug Evaluation and Research; Use of Innovative Packaging, Storage, and/or Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics; Request for Comments
cder cder2013144
2014-06-16 2014-05-02 2014-06-16 2014-06-16 2014-06-16 2014-05-28 2014-06-16 2014-06-16 2014-06-16
FDA-2014-N-0233-0012 FDA-2014-N-0233-0005 FDA-2014-N-0233-0013 FDA-2014-N-0233-0022 FDA-2014-N-0233-0019 FDA-2014-N-0233-0008 FDA-2014-N-0233-0024 FDA-2014-N-0233-0021 FDA-2014-N-0233-0023
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0012 https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0005 https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0013 https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0022 https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0019 https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0008 https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0024 https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0021 https://api.regulations.gov/v4/comments/FDA-2014-N-0233-0023
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The Notice seeks commentary on PREVENTING ACCIDENTAL USE by someone for whom the medication was not prescribed. This is a critically-important objective because opioids are currently the number one cause of child poisonings in the US, even with the implementation of universal child safe dispensing.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles the prescription drug abuse crisis directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.Divert-X packaging is assembled in pharmacies in order to have a broad impact. A dispensing system must be agnostic to dose, dosage form, and manufacturer to cater for all the forms of Controlled Substances that are diverted and misused. The broad applicability of Divert-X will greatly assist its adoption if shown to be effective. Unit dose packaging that meets F1 level requirements will be suitable for packaging any medication regardless of toxicity. Based on current Poison Prevention Packaging Act (PPPA) criteria (1-2), a blister system certified to an F1 level is far safer than a certified pharmacy dispensing bottle (assuming both fail). Specifically, if F1-certified packaging fails, then a single dose is available to a child; conversely, if a pharmacy dispensing bottle fails, then the entire contents are available to the child. Hence, blister systems have a role in opioid safety because opioids are currently the number one cause of child poisonings in the US, even with the implementation of universal child safe dispensing mandates (3). While factory-assembled blister packs have been certified to an F1 level, no child-safe features have been added to any blister system assembled in a pharmacy because no market need has existed to date. The main existing market for pharmacy-assembled blisters is long-term care facilities, and these facilities are exempt from PPPA requirements because their medication management practices are similar to hospitals. All Vatex products will achieve F1 certification prior to commercialization.The Notice also seeks commentary on packaging approaches to minimize in-home theft of medication by teens, visitors, caregivers, etc. Because blister packaging allows inventory assessment via a quick visual inspection and because blister packaging averts substitution schemes that use lookalike pills, this will have a preventive impact.  Additionally, patients using Divert-X can obtain recent dose-removal times via telephone, text message, etc. in order to conduct their own diligence. Most importantly, Divert-X provides strong incentives for returning unused medications soon after they are dispensed. These incentives are the subject of a separate submission to this docket (search for Safe Disposal). Because Divert-X will be challenged by users who are looking to subvert it, the packaging must possess many features to dissuade tampering but highlight it when it occurs. A tamper assessment by the pharmacist is the final step in the Divert-X cycle prior to obtaining a final score. Vatex is advantaged by the fact that the adhesives already in use for in-pharmacy assembly are far stronger than the materials used to make the packaging. Vatex has assessed products from all North American manufacturers of pharmacy-fill cards; in all cases, the cardstock and foils fail when attempts are made to disassemble or subvert a blister card. The strength of the seal itself serves as a child-safety feature. The strength of the seal relative to the materials of construction is a key in making tampering evident. Tamper-resistance features and child-proof features augment each other, and they are tested together under PPPA certification.The PPPA provides and mandates all details needed for child-resistant package testing, but the packaging must also be useable by senior adults in order to obtain any certification. Hence, the PPPA also provides mandated protocols for determination of the Senior Adult Use Effectiveness  score (1-2). The design of PPPA trials, for children and senior adults, are mandated to a very high level of detail, to include items such as the text of all allowable verbal interactions between testers and participants, the text of consent forms to be used, and scoring requirements. All Vatex products will achieve F1 certification prior to commercialization.[please see the accompanying PDF attachment to view the references] The problem with opioids is not, generally speaking, a problem to be solved with technology. The problem is that there are too many legal opioids, and that physicians are too quick to prescribe them:- One in seven pregnant women has been prescribed an opioid at some point during her pregnancy (http://www.medpagetoday.com/PainManagement/BackPain/44603)- Nearly 50 percent of adolescents who visit a doctor complaining of a headache receive a prescription for one or more narcotics (http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/44647)- More than 25 percent of Americans who use opioids for non-medical indications 200 or more days per year have been prescribed these drugs by a doctor (http://www.upi.com/Health_News/2014/03/03/Prescription-painkiller-abusers-often-get-them-from-a-doctor/UPI-70241393880460/)With the average doctor visit lasting less than 20 minutes (http://www.asrn.org/journal-world-news-nursing-report/7-average-doctor-visit-grows-by-32-seconds-over-10-years.html), many physicians dont feel they can take the time to discuss pain management strategies -- or lifestyle changes -- with patients who visit them complaining of chronic pain. The situation is even worse in emergency rooms, where doctors may prescribe painkillers to addicts just to clear the decks for true emergency patients. Approving more painkillers -- opioid analgesics and others -- is only going to make it easier for doctors to take the easy way out and prescribe them for people who could solve their pain problems another way. Creating a new surveillance state, in which people prescribed pain medication are tracked, is not the solution. There is little enough medical privacy in this country. The FDA seems to think that it can make everyone happy by making dangerous drugs plentiful (nice payout to pharmaceutical firms) and then handing out naloxone auto-injectors for when things go wrong. Sometimes, the right answer is to do less: approve fewer pain drugs, prescribe pain drugs less often, track fewer patients. Ask people to manage their pain in other ways -- lose the weight that is causing the back pain, take the physical therapy that will make movement less painful, go through a pregnancy without the lifestyle drugs that will harm your baby.  The Notice seeks information on the EFFECTIVENESS and ACCEPTABILITY of interventions that can be applied to reducing the prescription drug crisis.  Vatex leverages established behavioral science to reduce diversion and misuse of Controlled Substances.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles this problem directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.The theory of action for our efforts is straightforward and evidence-based: checks  balances for oversight of psychoactive, addictive drugs promote thoughtful use, safer behaviors, and accountability. The Vatex hardware advancements are described in a separate submission to this Docket (search for Hardware Design) and are used to gather objective data on actual medication-use behaviors. These objective data are currently unavailable for individual patients. The application of proprietary analytics for assessing behavioral markers collected by the packaging is used in a management system designed to reduce diversion and misuse. The management system is termed Active MTM and is described in a separate submission to this Docket (search for Management Systems).Several behavioral big data analogies to the Vatex approach exist. For example, insurers use real-time analytics to remotely uncover dishonest doctors and prevent pay and chase schemes (1). Brick-and-mortar and online casinos use real-time analytics to intervene in gambling addiction (2). Efforts of online gambling companies to identify problem gamblers are directly analogous to Divert-X because all data are collected remotely, in real-time, in fine detail, and are related to addiction (2-6).  Another analogy is the proprietary credit scoring systems used by the consumer finance industry known as debt-repayment risk algorithms (7-9). The study of hidden human behavior has become central to several subfields of economics and finance (10). Because of this longstanding research focus, the behavioral and economics literature has firmly established that people are more accountable for their actions when they are being scored or merely aware that they might be scored (10-30), but the scoring system must remain somewhat opaque so that it is not subverted. For example, details of banking algorithms (used to score customers and employees) are tightly-held secrets (10). Similarly, the detailed methodology behind medication-use scoring will not be shared with the public generally in order to leverage behavioral science and to protect from subversion.Vatex sees strong parallels between the human desire to be seen as a good credit risk (rewards include improved loan pricing, employability in high-value positions, lower insurance rates (31-32)) and the desire to be seen as a credible patient (rewards include enhanced trust between provider and patient, straightforward access to needed medications, improved care quality). Bringing trust back to Controlled Substance prescribing and reducing patient-access disparities are key long-term Vatex goals. Employing a sophisticated device as an integral part of dispensing will emphasize to the patient, the family, and caregivers the serious safety risks associated with Controlled Substances. Because many people do not understand the risks of their medications, the packaging itself serves to warn (a behavioral nudge (33)) and should result in greater caution being taken to comply with prescribed regimens. Hence, the Divert-X packaging emphasizes safe-use and educational principles.Precedent from the medical, behavioral, and economics literature show that Divert-X is likely to be a high-impact system. Vatex is combining key refinements of historical systems with its own innovation to address a pressing problem. The medical literature is replete with studies (34-37) showing that compliance to medications not regulated by DEA can be increased through a variety of actions with corresponding improvements in health and cost. Improving compliance to Controlled Substance regimens is much more challenging, however, because overconsumption is spurred by experimentation and addiction, because of the financial windfall for those patients who divert their ongoing prescriptions (38-43), and because current clinical tools cannot separate authentic patients from those exaggerating the intensity and duration of disease (44-49). Hence, the literature describing methods that improve Controlled Substance adherence is sparse. A single Europ [please see the PDF provided for the full version with references] The Notice seeks information on PAYER INCENTIVES and the feasibility of implementation of interventions that can be applied to reducing the prescription drug crisis.  Innovative packaging that reduces opioid misuse can generate significant economic benefit by reducing the excess medical costs consequential to abuse and fraud. Outcomes improving financial returns for private and public healthcare payers will drive implementation of an evidence-based drug safety system.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles prescription medication abuse by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.The insurance community - private, Medicare, Medicaid, workers compensation, self-insured employers, and VA - will be the customer base for Divert-X. The market for an IT service to infer patient behavior towards opiates and other Controlled Substances and to provide actionable information must be developed. Vatex expects that data from Divert-X pilots will successfully demonstrate the identification of anomalous patient behaviors and reduction in the misuse and diversion of medications. This will allow an estimate to be made quantifying the economic benefit from the introduction of Divert-X. The economic outcome will be used to petition medical insurance companies and government payers that the use of the system will generate significant healthcare savings for their organizations. Currently there are no technology-driven methods to differentiate between legitimate opiate patients and those abusing and diverting. Without effective tools, medical practice involving Controlled Substances has devolved to speculative, ineffective patient profiling (1-5), spawning numerous lawsuits and administrative actions (6-9), documented discussion of how to lie to patients (10-12), public battles between pharmacy and physician groups (13-15), and uncertainty expressed by DEA in court regarding how to establish the legitimacy of prescriptions (16). In the 2011 Government Accounting Office publication Prescription Pain Reliever Abuse (17), DEA officials report that based on the available prescription and sales data, there is no method to calculate which prescriptions are issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice and which are not. As a result of the inability to identify and take broad action against diverters, the DEA increase their quota for opiate and Controlled Substance production based on demand- which naturally includes diverted medications. The recent Compounded Annual Growth Rates for opiate and stimulant DEA quotas are a staggering 27.0% and 33.4% respectively (18-19). Because Divert-X establishes dose-level accountability, it will reduce fraud, street medication supply, and diversion. It will provide an objective means to identify patients who are misusing opiates and other Controlled Substances and provide a novel method to combat the epidemic.The Vatex sales channel will be direct to insurers. We expect that insurers will mandate the use of Divert-X for opiates and other Controlled Substances for their patient populations once they are convinced of the magnitude of savings that it will generate. The high volume of Controlled Substance prescribing will ensure that pharmacies are responsive to the dictates of health insurance payers to dispense using Divert-X. In order to facilitate the cooperation of pharmacies, the Divert-X device is designed so that it can be filled in a very efficient manner with only a moderately longer pharmacy process. A dispensing fee for Divert-X will be paid to the pharmacy that is in excess of and in addition to standard medication dispensing fees. Divert-X adoption will therefore create a new source of revenue for the pharmacy, which will facilitate co-operation.Extrapolation from a 2007 insurance industry estimate (20) suggest that opiate misuse results in at least $100 billion in excess annual medical costs for insurers driven by the costs of emergency room visits, increased physician visits, diagnostic and drug-test spending, falls and other accidents, and abuse treatment programs. When this economic burden is considered against the annual volume of 200 million opiate prescriptions, abuse and fraud can be estimated to cause an average hidden cost burden of $500 in excess medical spending added to every prescription. Vatex corporate goal is to reduce Controlled Substance misuse and   [please see the PDF provided for the full version with references] Friday, June 6, 2014Colleen Brennan, Center for Drug Evaluation and ResearchOffice of Surveillance and EpidemiologyFood and Drug Administration 10903 New Hampshire Ave., Bldg. 22, Rm. 4410 Silver Spring, MD 20993-0002Re: Docket No. FDA2014N0233; Use of Innovative Packaging, Storage, and/or Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics Ms. Brennan,PillGuard Medication Delivery Systems appreciates the opportunity to comment on innovative packaging, storage, and disposal systems, technologies or designs (designs) that could be used to prevent or deter misuse and abuse of opioid analgesics by patients and others. In 2003, Dr. Robert Muncy and I were discussing the widespread abuse of controlled prescription medications in areas of Kentucky. As doctors, we were concerned that legitimately prescribed medications were being diverted and abused in many ways. Hoping to help alleviate the complex problems and the human tragedy associated with the widespread and growing abuse of dangerous prescription drugs, we wanted to create a device that would both reduce current levels of prescription drug abuse, and help prevent future abuse of prescription medications. Moreover, we wanted to increase public health and safety in our communities. We further realized that both our state and federal governments could benefit from a reduction in the skyrocketing costs for law enforcement, criminal justice, health care, and social services associated with prescription drug abuse. We saw a need for a better-protected pill bottle designed to prevent diversion of dangerous medications and took the idea to the University of Kentucky Center for Manufacturing.Powerful prescription medications can be life saving when taken under the supervision of a physician, but when abused, they can be just as life threatening as illicit drugs. The team concluded that the new kind of pill dispenser envisioned by the doctors should be one that: (a) would allow dispensing of a prescribed medication only in the prescribed amount no faster than the prescribed rate; (b) would detect tampering if someone were to try to break open the container or to otherwise forcibly remove the medication early; and (c) upon detection of tampering, pharmacists could be alerted.The PillGuard medicine dispenser will address the prescription drug abuse problem by allowing doses of dangerous drugs only at carefully regulated times. Controlling the time of delivery for addictive medication will deter over dosage and criminal action. Misrepresenting the facts and current state of our company, commenter Divert-X (ID: FDA-2014-N-0233-0010) indicated that our company closed in early 2014 due to reimbursement factors. On the contrary, this past week we launched a pilot program at the James A. Haley Tampa VA Medical Center to demonstrate the effectiveness of the device on our nations veterans. The Department of Veterans Affairs likely recognizes the immense danger to the take as needed approach and attributes that approach to the growing issue of abuse of controlled substances. While PillGuard, other limited access devices, tamper-resistant formulations, smart blister packaging, dispensing and behavioral monitoring systems, and other abuse deterrent technologies will not likely eliminate our nations prescription drug abuse problem, they can deter a large percentage of illegal abusers. With more assurance that the patient will not take their pills more frequently than prescribed or sell them all on the street, physicians can be more willing to prescribe these highly addictive medications when they will improve the patients health. The attachment recommends specific device characteristics and addresses several of the topics of interest.We thank the FDA for allowing us to comment on this important matter and pledge our support to the FDA in fighting this national epidemic.Sincerely,Dr. Anthony McEldowneyCEO, PillGuard Medication Delivery Systems(304) 514-9426anthony.mceldowney@rammllc.com The Notice seeks commentary on the subject of systems that could prevent or deter misuse and abuse without diminishing access for patients with legitimate prescriptions.  This is indeed a critically-important issue because provider-patient trust has been lost.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles this problem directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.Regarding patient access issues, our hypothesis is that providers, if given an objective, evidence-based method to judge the behaviors of their patients, will treat their patients with trust rather than trepidation.  Secondarily, those patients showing aberrancy will receive guidance and assistance that should greatly improve patient care quality.The inability to judge motive and intent is fundamental to all Controlled Substances that are addictive or coveted by diverters.  Differentiation of patient motive is the most important problem to be solved because it affects all Controlled Substances, all authentic patients, and all formulations.  The truth of this statement is demonstrated by our realization that criminals (diverters) and addicts crowd out the authentic patients, driving the production and sales of Controlled Substances ever higher.  According to the GAO, DEA officials said that, based on the available prescription and sales data, there is no method to calculate which prescriptions are issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice and which are not. [U.S. Government Accountability Office Report Number GAO-12-115, Dec 22, 2011.]  We expect that the growth trend shown below will continue until a behavioral differentiation system such as Divert-X is established as a new standard of care.[please see the accompanying PDF attachment to view the chart]If there were any doubt that patients sell their pills, then a study conducted in Florida is instructive.  A university-based survey team that had engendered trust with regional criminals conducted a scientific study during 2008-10.  They found that 44% of pill dealers specialized in accessing their supplies from local, insured patients who feigned intensity and duration of illness for financial gain; given that this study was conducted during a time when open-air prescription markets (pill mills) were tolerated in Florida, insured patients are surely a more important contributor to the supply chain in 2014. [Rigg KK, Kurtz SP, Surratt HL. Patterns of prescription medication diversion among drug dealers. Drugs (Abingdon Engl). 2012;19(2):144-155. PMCID: 3365597.]Because of the high profitability of the black market, honest and authentic patients are effectively pushed to the back of the line.  Rather than diminishing access, Divert-X is intended to improve access for those patients who are authentic and who demonstrate safe use. The Notice seeks commentary on SYSTEM INCENTIVES AND WORKFLOW ISSUES associated with adoption of new medication management systems. It is important that pharmacy workflow disruptions are minor and thus not an impediment to adoption relative to financial and other benefits afforded to stakeholders. It is critical that packaging and medication management systems (a) are agnostic to dose, dosage form, and manufacturer; (b) do not force pharmacies to alter their supply chains and preferred vendor networks; and (c) need not be adopted by pharmaceutical manufacturers.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles the prescription drug abuse crisis directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.Payers will capture the bulk of financial returns from the implementation of Divert-X and its management system, Active MTM. Active MTM is the subject of a detailed submission to this docket (search for Management Systems). Adoption will reduce spending by abating fraud and by reducing medical spending (clinic visits, falls and other accidents, addiction, etc.) caused by patient misuse of Controlled Substances. Payer incentives have been addressed in a separate response submitted to this docket (search for Payer Incentives). The reputation of the medical industry generally  of its prescribers, pharmacists, and corporations  will increase by adopting proven abatement systems. The prescription drug abuse epidemic has exposed the public to the rudimentary state of current Controlled Substance management systems and controls and has become an egg-on-face event for the industry. Adoption will also lower the enforcement burden on conscientious medical providers, because they can demonstrate a track record of diligence, enhancing community trust.  Although financial incentives are not shared equally, the various types of incentives outlined below are of high value and are aligned among the participants. Active MTM incents pharmacies and other providers to take more responsibility for Controlled Substance disposition and medication-use behaviors. In order to facilitate the cooperation of pharmacies, the Divert-X device is designed so that it can be filled in a very efficient manner with only a moderately longer pharmacy process. Filling Divert-X in the pharmacy is critical to success because it does not change pharmacy purchasing preferences and makes the intervention broadly and immediately applicable to most dosage forms, doses, and manufacturers. History shows that product-specific interventions are expensive, slow, and have failed to change the magnitude of the national crisis. Divert-X utilizes cold-seal assembly of the single-use smart blister packaging  a process already used by pharmacies nationally. Cold-seal assembly requires no capital equipment or dedicated bench space in the pharmacy, yet it provides a seal that is stronger than the paperboard used to house the individual doses.Pharmacies charge payers a fee for the act of dispensing and a separate fee for the medication itself. A dispensing fee for Divert-X will be paid to the pharmacy that is in excess of and in addition to standard medication dispensing fees. Because the medication sourcing and the medication charge (to payers) will not change under Divert-X, pharmacies will have the same level of profitability from this sales category. The high volume of Controlled Substance prescribing will ensure that pharmacies are responsive to the dictates of health insurance payers to dispense using Divert-X. Divert-X adoption will therefore create a new source of revenue for the pharmacy, which will facilitate co-operation.Regarding pharmacy reimbursement and workflow, Vatex will establish a new HCPCS dispensing fee (a substitute for the bottle-fill fee) that we call a drug-safety system fee, or DSS fee. Here is an example of a pharmacy transaction: instead of the payer or payers designee replying to a benefits query with an electronic OK to fill message, the payer would instead reply with a fill using DSS message for any medication of concern.  These instructions can only be fulfilled by pharmacies that participate in the Divert-X System or a competing evidence-based system and, because Controlled Substances are among the most commonly prescribed medications in America, market forces would drive adoption by the pharmacy industry.  A part of the DSS fee will flow to the pharmacy and  [please see the PDF provided for the full version including a summary table] The Notice seeks information on MANAGEMENT SYSTEMS that could prevent patient harm by helping prescribers monitor for signs of abuse or diversion by facilitating effective patient management and follow-up.  This is the core function of the Divert-X System that provides actionable real-time information to cause discovery and integrate follow-up.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles the prescription drug abuse crisis directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.The pilot of Divert-X includes an additional layer of management tools for prescribers, pharmacists, and payers that is termed Active MTM.  Medication Therapy Management (MTM) is a well-regarded and proven drug safety approach that is used by all insurers that offer Medicare plans.  The goal of MTM is to identify and intervene in complex poly-pharmacy cases so that patient safety and care efficiency (e.g., spending) can be assured.  These interventions are typically made by physicians and pharmacists who have the specialized training and practice focused on clinical pharmacology issues.  The interventions are mandated, scheduled regularly, and comprised of written, patient-specific guidance and reporting.  Unfortunately, MTM is uncommon for Controlled Substance safety enhancement because 1) prescribing of Controlled Substances is voluminous and 2) addiction, misuse, and diversion are deeply hidden behaviors  hence, MTM resources cannot be targeted with any efficiency.Because MTM principles are not used to guide therapy with Controlled Substances, Vatex employs a healthcare analytics approach, Active MTM, to nominate patients who appear to need help.  The principles of Active MTM are depicted in Figure 1 below.  Under the current system, there is a paucity of information surrounding the intent, motive, and medication-use idiosyncrasies of each patient.  Pharmacies lack detailed clinical and diagnostic information and are essentially bystanders in the process.  Clouding the clinical picture further, nearly all Controlled Substances treat diseases that lack objective measures for diagnosis and follow-up such as pain, anxiety, and ADHD.  As a result, patient self-report  known to be unreliable when addiction or street sale is involved - drives spending for excessive clinical, diagnostic, and pharmacy services.[please see the accompanying PDF attachment to view Figure 1]Active MTM is the Vatex approach to uncovering hidden fraud and to indentifying and helping patients who are misusing their medications.  Active MTM uses real-time, objective data collected from Divert-X devices, combined with state PMP data and insurer records, to afford rapid nominations for MTM intervention.  As shown in Figure 1, all parties have access to patient-specific objective information and scoring and so, they are aware that significant checks  balances exist.  The current islands of autonomy (see Figure 2) that now exist will be disrupted, and this should cause each act of prescribing and dispensing to be more thoughtful.  For example, repetitive prescribing or dispensing in the face of external red flags will be more quickly noticed by other participants on the healthcare team because of broadly dispersed data. Prescribers take direct clinical responsibility for the care of patients but, unique to the Controlled Substance arena, they must also shoulder significant regulatory and law enforcement burdens.  Hence, patient care and access suffer because of overburdening, fear, and lack of training and interest in law enforcement techniques.  The addition of objective data beyond patient self-report allows for a broad shift of risk and responsibilities that can be easily adopted by any system and any payer.  Active MTM is scalable and transferrable among healthcare systems, all of which are afflicted by the prescription drug abuse crisis.  Comparison of Figure 1 (Active MTM) with Figure 2 (current system) shows the additional risk shifting and checks-and-balances that are afforded by Active MTM.  By adding Divert-X monitoring, patients showing addictive or diversionary behaviors can be objectively nominated for intervention by an MTM Provider, specifically trained to address substance abuse issues, who can assist and share responsibilities. Active MTM should cause a major shift in risk and accountability and should improve care quality and access to care.  Figure 2 below shows the structure of the current  [please see the PDF provided for the full version with figures] The Notice seeks commentary on methods and systems to help ensure SAFE DISPOSAL. Because the Divert-X System is a drug-safety system that establishes a closed loop of distribution that begins and ends at the pharmacy, strong incentives can be employed to cause the return of unused medications for destruction.Divert-X  the dispensing and behavioral monitoring system under development by Vatex  tackles the prescription drug abuse crisis directly by seeking to separate authentic patients from those who are exaggerating the intensity and duration of symptoms.  Those who subvert the system to feed an addiction or sell their medications are far less likely to demonstrate the spectrum of dosing behaviors exhibited by compliant, authentic patients.  A healthcare insurer has permitted Vatex to pilot Divert-X in a region it serves so that Vatex can demonstrate the efficacy of the intervention via robust science.Figure 1 shows a DEA-generated summary of the closed loop of distribution that is federally mandated for Controlled Substances.  Unfortunately, as noted by the question mark, the loop is not truly closed because contemporary management systems have no disposition information for medications that have been transferred to patients. Stated differently, no one knows where the tablets, capsules, patches, etc. go after they leave the pharmacy. When prescribed quantities exceed the needs of the patient, the spare doses often remain in homes for long periods of time. Unused doses in homes are one source of supply for non-medical use, particularly for people who have not progressed beyond occasional experimentation. While prescription take-back programs organized by DEA have destroyed 4.1 million pounds of unused medications since 2010 (1), these programs are stopgap measures offered while long-term solutions proceed through the federal rule-making process. The Secure and Responsible Drug Disposal Act of 2010 (2) establishes in-pharmacy disposal boxes and mail-back procedures for patients to return unused Controlled Substances for destruction.  As of this writing (May 2014) DEA leadership claim that the rulemaking process will be completed quickly because all external-agency steps are complete (3). While Divert-X is compatible with all principals and rules associated with the Act, it goes one step further by adding incentive mechanisms to encourage return and safe disposal soon after dispensing.While details of the Divert-X System are provided in other submissions to this docket (search for Management Systems and Patient Confidentiality and Hardware Design among others), Figure 2 shows the general features of a prescription cycle. Return of the device is the most important part of the cycle that is related to drug disposal. Completing the closed cycle for a single prescription, the packaging and electronics are returned to the pharmacy for tamper assessment by the pharmacist, for recovery of the reusable electronics, and for disposal of unused medications. Return of the intact packaging and device are fundamental to maintaining a record of high behavioral scores that would result in the patient being viewed as and treated as compliant  all necessary for trust and a basis for continued prescribing. In the case of an ongoing prescription for a chronic condition, doses may go unused and prescriptions may change because of tolerability or any number of other clinical or practical reasons.In the case of short-term prescriptions in support of conditions that are expected to be self-limiting, we expect to see innovation from payers. For example, a number of incentive programs such as coupons or in-store rewards can be offered to prompt the return of unused doses (known to exist because of the Divert-X data) soon after dispensing.  These alerts may come from the payer (whose incentive is to reduce the clinical costs of prescription drug abuse) or from the dispensing pharmacy (whose incentive is to generate another in-store visit). In either case, the public will view these steps as professional stewardship of medications that have safety concerns.As discussed, authentic patients on chronic therapy have a natural incentive to obtain high scores. Additionally, payers are incented to help close the loop  and recover unused medications  in order to reduce their abuse-related costs. Because the insurer will be financially responsible for the economic value of lost devices, payers have a second reason to encourage, incent, and properly explain to patients the need to close the loop. Vatex believes that alignment of patient and payer self interests can be more effective in reducing the crisis than law enforcement, regulation, and education.[please see the PDF provided for the full version with figures and references]