THE PRESCRIPTION DRUG CRISIS IN NEW YORK STATE:

A COMPREHENSIVE Approach

SENATE STANDING COMMITTEE ON HEALTH

Senator Kemp Hannon

EXECUTIVE SUMMARY

Like the rest of the nation, New York State is in the midst of a public health crisis: prescription drug abuse. There are more prescription drugs on our streets and in our homes than ever before. The Federal Centers for Disease Control and Prevention (CDC) recently released data showing only marijuana is abused with more frequency than prescription narcotics and more Americans die of prescription drug overdoses than heroin and cocaine combined.

New York is experiencing the sudden and unprecedented fallout from prescription drug abuse, including a record number of overdoses, suicides, new addictions, and armed pharmacy robberies resulting in casualties. Understanding all aspects of the problem is the only path to the solutions. For this reason, the New York State Senate adopted a resolution declaring April 28, 2012 “Prescription Drug Take-Back Day,” the Senate Health Committee held two roundtables, and the Committee issued this white paper.

The flaws in the current system help this crisis continue and grow. While there is a need for measures to remedy these flaws, we must also remain cognizant of the fact these medications relieve suffering, especially those treated by oncologists, orthopedists, and neurologists. Prescription pain medication is a hallmark of modern medical science. For the first time inhuman history, we can truly ease the  patients’ suffering. We can prolong the lives of people with non-paralytic spinal injuries, nervous system disorders, cancer, and many other maladies. Doctors can perform miraculous procedures, and thanks to advances in medication science, they can prescribe painkillers to treat subsequent and often intense pain. At the same time, modern painkillers have the potential to swiftly addict users -- in a fashion hardly seen before – and worse, oftentimes under the umbrella of legitimate prescriptions from licensed medical professionals. Accordingly, policy changes must strike a balance between our desire to minimize abuse and the need to ensure access to those legitimately needing these treatments. Meaning, first, we must recognize the system is broken, not useless. Second, we need to evaluate all potential solutions, selecting the ones effecting real change. In short, we must examine all tools at our disposal to create a system meeting the legitimate needs of all New Yorkers. The Health Committee submits this paper, which takes into account all information presented to the committee through its two roundtables on the subject, independent research, and information from stakeholders throughout the state. We have tried to be all encompassing, but are under no illusions that this represents the final word in fighting this crisis. Therefore, we welcome comments and suggestions. Considerable credit should be given to staff members of the Health Committee for their work on this effort, including Roslyn Martorano, Alison Kane, and Kristin Sinclair.

PRIME AREAS FOR ACTION

Insufficient safeguards for accessing painkillers (e.g. patients effectively receive 6-month supplyof drugs from one office visit).

Solution

· Eliminate the automatic 5-refills by elevating Hydrocodone to Schedule II, and add Tramadol to Schedule III, marking it a controlled substance. Medicine cabinets are flooded with leftover medication, and New Yorkers do not understand how to dispose of the excess pills.

Solution

· New Yorkers must recognize the importance of shedding excess medication and have frequent, convenient opportunities to surrender it to law enforcement .Some pharmacies refuse to stock painkillers because armed violence against pharmacists is at an all time high.

Solution

· Institute incentives for pharmacies to install protective measures like DNA tracking, bank-like glass counters, and time-release safes for painkillers. No one told the pharmacies when 1.4 million painkiller prescription pads were stolen.

Solution

· Implement a secure e-prescribing program for all controlled substances. NY has an ineffective prescription monitoring program (PMP), and it has yet to join the 21-state coalition who share data to eliminate doctor shopping.

Solution

· Strengthen NY’s PMP using smart software, data-mining, and provider education, then share this model and its data with other states. Patient gets a tooth removed and leaves with 30 days of highly addictive pain medication.

Solution

· Determine protocols to effectively treat acute pain, including limiting painkillers to 3-day supply for certain conditions. Extreme advances in medication science, but little-to-no education for practitioners about treating pain management, addiction, or palliative and end-of-life care.

Solution

· Develop an education program for providers on pain management, addiction, and palliative and end-of-life care. Painkillers ease intense, chronic pain, but they are highly addictive and there are no standards for how doctors should manage chronic pain.

Solution

· Create standards for chronic pain management care, including pain management plans, patient agreements, and unannounced pill counts. People share medication and believe painkillers must be safe if they are FDA-approved and prescribed by a doctor.

Solution

· Teach people to respect painkillers and watch for signs of addiction. New York penal laws make it hard to prosecute pharmacists who act like drug dealers.

Solution

· Create a criminal penalty for pharmacists clearly operating pill mills. Highly addictive opioids are the second-most abused drug after marijuana, and addiction, overdose, and suicide rates are at an all-time high.

Solution

· Implement a culture of rehabilitation and access to care for addicts.

ACTION PLAN: A COMPREHENSIVE SOLUTION

Prescription medication can represent a marvel of modern medicine; it can also represent a slippery slope into addiction. Nearly one-third of Americans over the age of 12 reported their first experience with drug abuse involved the non-medical use of prescription drugs.

Traditional policies created to fight the nation’s War on Drugs (for such drugs as heroin, morphine, cocaine, and even marijuana) do not affect this current crisis because 70% of prescription painkiller abusers got their drugs from a family member or friend — only five percent from a drug dealer. This crisis touches all of us, and we cannot continue on the same course. New York State must take steps to stem the tide, and we must act quickly.

There are four global areas we can target to combat the crisis: getting drugs off the streets; monitoring prescriptions; educating providers and the public; and rehabilitating addiction, while prosecuting real offenders. Moreover, this problem requires more than a one-size-fits-all solution. Each global area requires multiple smaller alterations. Some are legislative or regulatory changes, and others require a sea change in professional practice or social attitudes. The most important aspect of combating this crisis is to act quickly, in ways creating actual, on-the-ground change for New York residents. The result will be a modern, comprehensive system providing New Yorkers with the best possible treatment and interaction with prescription pain medication, to usher in an era of effective and efficient treatment of chronic pain.

I. GETTING DRUGS OFF NEW YORK STREETS

Part of the growing public health crisis originates in the sheer volume of prescription pain medication consumed in the United States. In many cases, the United States accounts for more prescription painkiller consumption than any other Western nation. Specifically, the amount of prescription opioids — or controlled-substance pain medication — consumed in the United States continues to grow exponentially. According to a 2011 White House Report, the United States saw a 402% increase in the “milligram per person use of prescription opioids” between 1997 and 2007.

In 2009 alone, there were 257 million opioid prescriptions dispensed nationally. In 2010, New York practitioners issued 22 million painkiller prescriptions  — not including refills.

Not only does this demonstrate a 40% increase in prescriptions over five years, but it also reveals the New York health system issued roughly two million more prescriptions for pain medication than there are citizens in this state.

Access to these highly addictive painkillers is made even easier through multiple refills, leftover unused medication, and doctor shopping. The broad solution to this is simple: keep excess drugs off New York streets.

A. Strengthening Requirements for Certain Controlled Substances

Modern painkillers provide a lifeline for patients suffering chronic pain. The goal should not be to regulate them out of use, but instead, to safeguard and monitor that use through appropriate medical management plans (see page 10 for further elaboration). The initial steps toward this result requires altering the classifications for two common drugs: Tramadol and Hydrocodone. The federal Controlled Substances Act places various restrictions on drugs falling into certain schedules, which, generally, the NY schedules mirror. Tramadol is an opioid, which “works by changing the way the body senses pain,” and under current law, it is not a controlled substance. It is less addictive than Hydrocodone and Oxycodone, but prescriptions for it and patients seeking Tramadol-addiction treatment are on the rise. Hydrocodone is an opioid compound more commonly known as Lortab, Norco, or Vicodin. It is highly addictive and portions of the chemical compound can be found in 20 different pain medications. Due to its “compound” nature, the federal government left certain forms of the highly addictive medication in Schedule III.

This means a doctor may write one, 30-day prescription with five refills. Thus, the very first prescription yields six months of medication before a patient returns for a physical visit with the doctor. This can be useful and convenient for the appropriate patient, but all too often, it can domino into chemical dependency.

According to numbers from New York’s Bureau of Narcotics Enforcement (BNE), between 2008 and 2010, high-dosage prescribing of Hydrocodone increased dramatically. An average introductory dose of Hydrocodone is around 40 milligrams per day. In just two years, 236, 319 more New Yorkers received prescriptions for between 50 and 99 milligrams per day. The number of patients receiving over 100 milligrams per day rose by 29, 602. There are three major benefits to elevating the controlled substance schedule of certain forms of Hydrocodone and treating them the same as Oxycodone.

First, it limits patient access to only enough pills for 30 days (and we discuss the “30 Day Rule” in this whitepaper). This will decrease the practice of doctor shopping, wherein patients seek numerous doctors for the same prescription; thus enabling them to get numerous prescriptions for the same drugs. Rescheduling Hydrocodone drastically limits the number of pills a doctor-shopper can access. Instead of an automatic six-month supply of Hydrocodone from each of five doctors, the patient can only access less. This step is not enough to end doctor shopping, but as a first step, it will make a significant impact.

Second, the new 30-day supply limit also requires a physical visit between doctors and patients before dispensing additional medication. In cases of intermittent chronic pain, the patient will revisit the doctor much earlier in the medication cycle. This, combined with appropriate medical management standards, could wean people off addictive drugs sooner or avoid automatic re-prescriptions in uncalled for situations. For those who must continue on the medications for longer periods of time, it will enable doctors to see patients at more regular intervals. Hopefully, this will create an environment where drug-seeking behavior can be seen and caught much earlier.

Finally, changing the scheduling of these drugs enhances criminal penalties of possessing or selling large quantities of Hydrocodone; it closes a statutory loophole and enables the Special Prosecutor of New York City to prosecute drug offenses in boroughs other than Manhattan.

This change closes that loophole. Rescheduling these painkillers is not only necessary, but embraced by the medical community. In September 2011, the American Society of Addiction Medicine wrote the Commissioner of the FDA asking the administration to add Tramadol to Schedule III, and elevate Hydrocodone to Schedule II.

Within New York, pharmacists, pain management associations, and law enforcement agencies support all these changes.

B. Statewide Drug Take-Back Programs

Many New Yorkers have unused medication in their homes and do not know how to properly dispose of them. The New York State Department of Environmental Conservation urges citizens not to flush their medications because it can pollute drinking water.

The situation becomes even more confusing after a loved one passes away. Routinely, surviving family members are left with bags of medication — much of which are controlled substances — from the care of their deceased relatives. In an attempt to make sure controlled substances do not get into the wrong hands, federal DEA rules make it more difficult to return them. These drugs can only be surrendered to law enforcement agencies.

For this reason, and like many other groups and associations, I hold “Shed the Meds”  programs on Long Island, where we partner with law enforcement officials to provide a simple way for residents to dispose of old prescriptions. In Suffolk County, police agencies maintain round-the-clock “Shed the Meds” at police headquarters or precinct buildings. At each event, we collected more than 200 pounds of unused and unwanted medication. This amounts to thousands of pills which will not become part of an illegal drug trade nor sit idle and available for dangerous misuse. Changing the prevailing attitude about prescription drugs is an important goal. Drugs in a medicine cabinet are not benign; they cause pollution, raise resistance to the benevolent actions of antibiotics, and can be addictive. Currently, Long Island residents and other residents with robust take-back programs can participate in this solution, but it must be expanded to all areas of the state.

We must encourage law enforcement to provide many opportunities for the public to properly dispose of controlled substances. There should also be a special emphasis on making it easier for hospice careworkers, residential health care facilities, and surviving family members to return controlled substances in a safe and timely manner. Without expanding New York’s take-back program, we will have no way to cut back on the millions of pills sitting, unused, in medicine cabinets throughout the state. As an immediate step, the Senate adopted a resolution declaring April 28,2012 Prescription Drug Take-Back Day, in conjunction with National Prescription Drug Take-Back Day.