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A Legal Dilemma for the Healthcare Industry
Garfunkel Wild PC
Healthcare facilities, including Nursing Homes and Long Term Care Facilities (LTCFs) are currently facing confusion regarding the legal requirements for the disposal of pharmaceuticals, especially controlled substances, in light of recent related enforcement actions. The following ME-P alert is a synopsis of current Federal and New York State laws and regulations regarding this issue. It also incorporates the context of recent letters and discussions with representatives from the Federal Drug Enforcement Agency (DEA), the New York State (NYS) Office of the Attorney General (OAG), the NYS Department of Environmental Conservation (DEC) and NYS Department of Health (DOH) Bureau of Narcotics Enforcement (BNE).
OAG
Over the last year, the OAG ordered several hospitals and nursing homes in the NYS upstate watershed area to stop “flushing” pharmaceuticals, including controlled substances, down drains. The impetus for these actions was the discovery of new science indicating that pharmaceuticals may be getting into drinking water. However, such actions, in part, tried to effect policy change beyond current law. Further prosecution has since waned, while the OAG engages in dialogue with environmental and drug enforcement agencies to determine a policy consensus that both benefits the environment and avoids drug diversion within the constraints of current regulations.
DOH Estimates
DOH estimates that about 5% of pharmaceutical waste stream is regulated as a hazardous waste and about 5% may also be regulated as a controlled substance. However, the regulatory structures for managing these wastes may be different, as each waste category has specific regulations and procedures that apply to its management and disposal.
What is the Current Law Governing Disposal of Pharmaceuticals?
The current law is that, hazardous waste, including hazardous pharmaceuticals and controlled substances must be disposed of by licensed haulers under a hazardous waste manifest, as required under the Federal Resource Conservation and Recovery Act (RCRA) and NYS Environmental Conservation Law (ECL) analogs. However, flushing non-hazardous pharmaceuticals, including non-hazardous (most) prescription medications is and has been a legally acceptable practice for many years, in part from concern against drug diversion. Although the EPA recently proposed that facilities not dispose of pharmaceuticals down the drain as a best management practice, this procedure does still comport with Federal and State environmental laws as well as the Federal Controlled Substance Act (CSA) administered by the DEA and State drug management regulations administered by the BNE.
As long as there are no additional local sewer ordinances prohibiting discharges or specific legal Orders against the facility to the contrary, hospitals and nursing homes can dilute waste pharmaceutical and controlled substances and then flush them down the drain. Prior to disposal, for security, any controlled substance waste must be stored in double-locked narcotics cabinets affixed to the wall. The identity, quantity and means of disposal of each controlled substance to be disposed is submitted for approval to the DOH on Forms DOH-2340 (Request for Approval of On-Site Destruction for Controlled Substances) and DOH-166 (Controlled Substances Inventory Form). Upon receipt of approval by DOH of the requested method of disposal (i.e., flushing, incineration or other), the destruction of the drug must take place with appropriate supervision and witnessing, usually in the presence of two NYS licensed nurses.
Long Term Care Facilities Have Special Issues
Because of the “closed system” of distribution of controlled substances prescribed under the CSA to prevent diversion of narcotics, prescription drugs may be transferred only between persons or entities who are DEA Registrants or who are exempted from the requirement of registration. LTCFs across the State which do not have pharmacies on site are not “Federal DEA Registrant” facilities or “NYSDOH Class 3 Institutional Dispensers”. Because LTCFs merely take possession of narcotics to safeguard and administer to patients, they are holders of only a NYSDOH Class 3A license as an “Institutional Dispenser Limited” of controlled substances. Thus, LTCFs are more limited with regard to legally permitted disposal methods. For example, whereas fully-licensed Class 3 facilities can send unused pharmaceuticals, including unused controlled substances for credit to a DEA Registered reverse distributor or pharmaceutical manufacturer for credit, Class 3A facilities not licensed as pharmacies cannot. If the patient is transferred to another facility or otherwise leaves, the pharmaceuticals must go with them. If the patient dies, or the narcotics no longer work or expire, the LTCF may be left with excess controlled substances that must be disposed of to avoid diversion. That is why LTCF’s are especially concerned about the possibility of not being able to flush unused patient pharmaceuticals.
What Will be the New Paradigm for Disposal of Pharmaceuticals?
The good news is that the BNE — and now the OAG and DEC — recognize this as a priority issue and, as previously mentioned, have been working jointly to achieve policy consensus on the matter. In August 2010, the BNE released a controlled substance disposal/destruction guidance letter. It provides Class 3A facilities wider latitude regarding disposal methods for controlled substances, while minimizing drug diversion. Although the BNE guidance specifically includes flushing, other methods of disposal/destruction suggested by BNE include incineration at DEC-permitted solid waste incinerators (for non-hazardous controlled substances), surrender of controlled substances to local law enforcement, or collection at pharmaceutical take-back events sponsored by communities and/or the DEC. Again, all options for the disposal/destruction of controlled substances are subject to BNE approval and the other applicable requirements.
In June 2010, DEC also issued a letter to affected facilities/programs to provide guidance on its regulations applicable to the management of pharmaceutical waste.
Take Back Programs
To address the current legal obstacles that prevent patients and LTCFs who are not DEA Registrants from utilizing reverse distributors and drug return policies, the President just signed on October 12, 2010 the Secure and Responsible Drug Disposal Act. This Act amends the CSA to allow individuals to dispose of unwanted controlled substances in their household to appropriate entities through community Take Back programs in accordance with parameters to be set by the US Attorney General. Also, under the new law, LTCFs may dispose of controlled substances on behalf of ultimate users who reside or resided at the LTCF in accordance with regulations to be promulgated by the U.S. Attorney General “that will provide effective controls against diversion and be consistent with public health and safety.”
Pharmaceutical Wastes as Universal Wastes
The EPA has proposed an amendment to the Universal Waste Rule which would add hazardous pharmaceutical wastes to the Federal Universal Waste program by April 2011. The Universal Waste program is essentially a streamlined management program for certain hazardous wastes designed in part to ease the burden of managing wastes and promote collection and recycling of commonly generated wastes. Adding pharmaceuticals to the Universal Waste category would result in definitive Federal regulations governing their disposal. However, states are permitted to enforce regulations that are more stringent than the Federal Universal Waste regulations, and there is no guarantee that New York would accept the more lenient practice of including waste pharmaceuticals as Universal Waste.
Class 3A Facilities Priority
As mentioned, disposal of controlled substances at the Class 3A facilities are receiving top priority right now by regulators. However, next on the horizon is for the agencies to establish consensus as to more environmentally-sustainable alternatives to flushing for Class 3 facilities. For example, BNE is considering allowing Class 3 facilities to mix waste controlled substances with chemical wastes or absorbents such as DAWG® or “kitty litter”, but only if the BNE deems that the alternative practice renders a controlled substance completely “unrecoverable” or “beyond reclamation.” This may still run a risk with the DEA, however, which does not recognize a definition of rendering a drug “non-recoverable” or “irretrievable.” DEA says that the CSA and its implementing regulations do not reference the general form, state of concentration (with specific exceptions) of any material, compound, mixture, or preparation that contains any quantity of a controlled substance.
Assessment
According to the DEA, mixing controlled substances with chemicals, absorbent materials, or other undesirable substances does not invalidate its status as a controlled substance, nor may the controlled substance be considered “destroyed” at that point. Lastly, disposal vendors may not thereafter pick up the mixed controlled substance waste, either because either they are not DEA-licensed to do so – or because of concern that the method used may not have rendered the substance totally “unrecoverable” and they will be liable.
Since this area of the law is developing rapidly. Healthcare colleagues are urged to consult with legal counsel to keep pace with changing future requirements.
Notes:
[i]There are mainly three hazardous controlled substances – chlorohydrate, paraldehyde and phenteramine, which are used in deodorants, to treat convulsive disorders and to suppress appetite, respectively.
[ii]42 U.S.C.A. §§6901 et seq.
[iii] New York State Environmental Conservation Law Article 27, Title 9; NYCRR Part 370.
[iv] Best Management Practices for Unused Pharmaceuticals at Health Care Facilities Fact Sheet, http://water.epa.gov/scitech/wastetech/guide/unusedpharms_factsheet.cfm
[v] NYCRR Part 80 (Rules and Regulations on Controlled Substances in New York State) sets forth requirements for the disposal/destruction of controlled substances by those entities registered by the federal Drug Enforcement Administration (DEA), as well as those licensed by DOH. 10 NYCRR Section 80.51 requires that DOH’s Bureau of Narcotic Enforcement (BNE) approve the manner and detail of all such disposal/destruction pursuant to a written requests. In destroying controlled substances they must be rendered totally unrecoverable and beyond reclamation.
[vi] Drain discharge of 15 kg (approximately 33 pounds) or greater of U-listed (chemotherapeutic) or characteristic hazardous waste in a calendar month, or any amount of P-listed (acutely hazardous) waste requires notification to the local publicly owned treatment works, the DEC Director of the Division of Solid and Hazardous Materials and USEPA’s Region 2 Director of the Division of Environmental Planning and Protection. In the case of P-listed waste, notification must include a certification that a program is in place to reduce the volume and toxicity of hazardous waste generated to a degree determined to be economically practicable.
[vii] http://www.health.state.ny.us/forms/doh-2340.pdf; http://www.health.state.ny.us/forms/doh-166.pdf; http://www.health.state.ny.us/forms/instructions/doh-2340_instructions.pdf
[viii] August 2010 NYSDOH Guidance Letter from Commissioner Richard F. Daines, M.D. to Class 3A Institutional Dispenser Limited Administrators.
[ix] 10 NYCRR Part 80.
[x] Public Law 111-273 – Secure and Responsible Drug Disposal Act of 2010 – Signed October 12, 2010.
[xi] See, Federal Register, Dec. 2, 2008, Volume 73, Number 232.
Conclusion
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Filed under: Alerts Sign-Up, Drugs and Pharma, Health Law & Policy | Tagged: DEA, Disposal of Controlled Substances, Disposal of Pharmaceuticals, EPA, Garfunkel Wild PC, Suzanne M. Avena |
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Marketing Use of Prescriber Data OK’d
Good post on drug disposal, but how about RX data use?
For example, did you know that a Vermont law that prevents pharmaceutical companies and their sales forces from obtaining data on a physician’s prescribing behavior without his or her approval is “an impermissible restriction on commercial speech” and therefore just ruled as unconstitutional?
http://www.medscape.com/viewarticle/733247
Shawn
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Are Medicaid patients’ prescription drugs going to dealers?
http://www.msnbc.msn.com/id/40521295/ns/us_news-crime_and_courts
Officials have charged 33 people so far in a large-scale investigation.
Sam
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Press Release:
OBAMA ADMINISTRATION RELEASES ACTION PLAN TO ADDRESS NATIONAL PRESCRIPTION DRUG ABUSE EPIDEMIC;
Click to access rx_abuse_plan.pdf
ANNOUNCES FDA ACTION REQUIRING DRUG MAKERS TO DEVELOP EDUCATION PROGRAM FOR PRESCRIBERS ABOUT SAFE USE OF OPIOIDS
http://www.whitehousedrugpolicy.gov/news/press11/041911.html
Conrad
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Pharmaceutical spending
Pharmaceutical spending increased 11% in 2014, most of it due to the spiral in specialty drugs. Ever the data explorer, I’d ask the question on the cost trend a bit differently: is the upward spiral in specialty drug costs a good thing? Did patients get better, did they return to work and family?
I ask this because of the enormous pushback I’ve gotten when I tell plan sponsors that increasing adherence to medications for diabetes, hypertension, and other conditions will definitely increase the cost trends for those drugs, so we must continue to look at the total costs of the patients that are prescribed these drugs. Did their total costs come down? Did they have fewer ED visits or inpatient days, even if the total cost of the patient did not come down (which would show a trend towards stabilization of the costs per patient)? Were there fewer images/tests/outpatient visits in these patients, all of which, again, show a potential opportunity for better management and stabilization? Looking at costs in silos-in this case the costs of drugs alone-does not give a rich enough picture of the total cost trend.
This is how we should be valuing the total costs of specialty drugs as well. In the case of Sovaldi, for which I researched the economic crises of highly compromised individuals with Hepatitis C, we saw the enormous wave of liver cancers that will develop in a small percentage of the population with HepC. Sovaldi promises to resolve the HepC and avoid the liver cancer (estimated costs for surgery and treatment can be $250,000 to $500,000 per year). People who go on to have a liver transplant can expect those costs to continue for the remainder of their lives. So the question of the high cost of Sovaldi or other new drugs that promise to cure HepC in the completion of one full round of treatment should be calculated on the savings over the lifetime of the patient. As always, I do not want anyone to walk away from this use case saying that I promoted the $84,000 price tag. My goal is to shift the conversation to what is the value of the drug, and if it can prevent high cost conditions from becoming higher costs, then a higher priced drug may well be worth the negotiated spend. (you can read more on the business case and contract here)
On the other hand, some of the drugs in the specialty arena are going thru yearly increases of thousands of dollars without new technology or formulations. In this case, the price escalation without better outcomes must be considered when negotiating the price of the drugs. We are even seeing many-hundred-percent increases in some common drugs, not specialty, for common chronic illnesses, again with little or no attribution to new technology in the drugs.
In each case, I’d like to think that we will not simply deny a drug to a patient because of the cost, and that we would not waste valuable time demanding that folks fail on the drugs we know will not suit them because they are cheaper.
This is the moment for open data of pre-competitive successes of both specialty drugs and combination therapies, seeking the best in personalized application (or personalized medicine) based upon a suite of conditions or attributes in successful population. We have to break down the silos of prescribed medications and patient outcomes in order to see the patterns of success. When we have better information on what therapies work on constellations of people, beyond just the disease definition, then we will be better able to manage cost trend escalation and total costs of populations.
Cyndy Nayer
President – CyndyNayer.com
[Founder/CEO of Center of Health Engagement]
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