Defense Law Articles
Written By:Stuart Colburn, Esq.
I. THE PROBLEM
We are killing our children. And we are killing their parents. When we are not successful killing our citizens, we destroy their lives and the lives of their families. The weapon is legal: prescription drugs.
Hyperbole aside, no one intends such damage on our citizens. America’s prescription drug abuse (PDA) problem is not nearly as well known as our War on Drugs. No war has been declared and yet American lives are being lost.
American citizens make up 4% of the world’s population. Yet, we consume 66% of the world’s legal drugs. Americans consume:
- 99% of hydrocodone
- 80% of opiates
- 71% of oxycodone
An estimated seven million Americans abuse prescription drugs: more than the number of Americans abusing cocaine, heroin, hallucinogens, ecstasy, and inhalants combined.
The Center for Disease Control estimated 11,500 people die a year from opiates, twice as many as cocaine and five times as many as heroin. Deaths have quadrupled over the last decade. We are fighting the wrong war.
In 1991, doctors wrote 40 million prescriptions for opioids. In 2007, the number of prescriptions rose to 180 million. Hospital admissions increased a staggering 400% from 1998 to 2008 with a 200% increase in the number of deaths. Two Americans die every hour from PDA.
PDA is also regional. The federal government identified three primary hubs: southern California, southern Florida, and Harris County (Houston area), Texas. In fact, one out of six Houston-area deaths is attributed to prescription drugs. In 2010, 734 million hydrocodone pills were prescribed in Houston: enough for every man, woman, and child to consume 30 doses.
Nationally, the number of deaths from PDA surpassed the number of deaths caused by alcohol and firearms. Recently, PDA deaths exceeded the number of deaths caused by motor vehicle accidents in such states as Ohio.
In Michigan, prescription drug overdose is the second leading cause of unintentional deaths. Perhaps more troubling is that 25% of those seeking medical care were younger than age 25.
PDA strikes our military forces. In 2009, our fighting forces were prescribed four times the number of pain medications they were prescribed 2001. In fact, 25% of soldiers admitted abusing prescription drugs in the last twelve months.
Although the federal government has not declared war on prescription drugs, the White House did announce a policy on April 21, 2011, calling the prescription drug epidemic “our Nation’s fastest drug problem.” The White House plan includes expanding prescription drug monitoring programs, educating doctors and patients, and expanding prosecution of pill mills.
II. Why the Prescription Drug Abuse Problem is Different than Illicit Drugs
Prescription drugs are qualitatively and quantitatively different than illegal drugs. First, abusers of prescription drugs have more access to scheduled narcotics than illegal drugs. Prescription drugs are more plentiful than their illegal counterparts. Prescription drugs are not prohibited, although they are controlled and regulated by the federal government. Manufacturers can legally make - and citizens can legally take - drugs prescribed by a doctor. There is less social stigma attached to the abuse of prescription drugs. In comparison, illegal drugs are in limited supply.
Second, abusers have greater access to not only drugs but also higher quality drugs. Large companies manufacture prescription drugs in a clean and safe facility with consistent dose and strength monitored by governmental agencies. Prescription drugs are taken orally with no risk of HIV and hepatitis B or C. The quality of illegal drugs such as cocaine or heroin is circumspect with no enforcement or regulatory safeguards. Illegal drug makers can dilute their product to expand profits without threat of regulatory sanctions or lawsuits. Deaths occur due to impurities.
Many drugs can be abused. The current favorites are as follows:
The public’s appetite for prescription drugs leads to a lucrative secondary market. The typical prescription drug abuser personally uses the drugs for nonmedical purposes. Drug diversion occurs when the prescription holder gives or sells drugs to others. For example, oxycontin has been known to sell for $40 a pill. MScontin fetched as much as $70 per pill. A Fentanyl patch was good for $50. Even Vicodin was worth $1-$4 per pill. One study revealed 85% of respondents received drugs from someone who had a prescription.
Young adults are generally the buyers and sellers in the secondary market. Kids steal from their parents’ medicine cabinets to feed their own habit or sell to others. The easy access to prescription drugs provides an adequate supply chain keeping the purchase price relatively low for other kids to enter the market. Peer pressure and addiction creates the demand. PDA moves outcasts to the “in” kids. Soon, it is accepted and “cool” to get high with prescription drugs. Kids throw “pharm parties”, where partygoers swallow handfuls of pills often not knowing what they are taking and ignorant of drug interactions. Alcohol is often the chaser. These actions can result in dangerous self-destructive behavior, injury, and death.
III. The Stakeholders
Unlike illegal drug manufacturers, the pharmaceutical industry includes Fortune 500 companies who are well-respected in their communities. Drug makers spend billions in research, development and testing. They truly make miracle drugs that save lives. Numerous pain management medications have also improved the quality of life for millions of Americans. Pharmaceutical companies must make a profit and create value for their shareholders. Like any good capitalist, they must create products people want. To reach their target audience and “hit their number,” they market drugs to their potential customers first using attractive drug reps visiting doctor’s offices and later directly to consumers. Profit motive leads to better drugs but can also lead to some perversions.
Physicians are held in high regard and command significant salaries. Like others, doctors can often be influenced by relationships and business opportunities. For example, one study of physicians found the following:
- 94% had a relationship with pharmaceutical companies;
- 83% receive food or drinks in the workplace;
- 78% receive drug samples;
- 35% receive reimbursement to attend meetings including continuing medical education, usually at plush resorts.
- 28% receive payment for consulting, speaking or enrolling patients in clinical trials.
Physicians are both healers and entrepreneurs. Many in the profession view themselves as more than a provider of medical services to their patients but rather as business professionals. Prescription drugs are one profit center.
And like any good capitalists, many doctors continually look to expand their profit centers. One company marketed on LinkedIn how doctors’ offices could expand their profit margin by dispensing drugs. Physician dispensing is a hot topic across the nation. Studies show that physician dispensing increases the number of prescriptions and the cost of those prescriptions in the states that allow it. For example, payers reimburse doctors 148% more for ibuprofen in Florida and 464% more for Soma. Louisiana doctors were reimbursed 81% more than a retail pharmacy for ibuprofen and “only” 268% for Soma.
Closely associated with physician dispensing is repackaging. Repackagers deliver bulk medications to physician offices. The packages are then divided into smaller amounts for dispensing to patients. Drugs are reimbursed at higher amounts per pill. A California study noted 80% of the drugs and costs are prescribed by 20% of the doctors. A new study focused on a breakdown of the top 10%. For example, the top 10% of physicians prescribed 79% of all Schedule 2 opioid prescriptions and 87% of opioid morphine equivalents. Worse, the top 1% of California physicians are responsible for a whopping 33% of all Schedule 2 opioid prescriptions and 41% of all Schedule 2 opioid morphine equivalents.
The business of some medical providers is supplying pain medications. Some of these providers and businesses have come to be known as “pill mills.” States are choosing to regulate the business of prescribing drugs. For example, Texas recently began regulating pain management facilities. The Texas legislature heard horror stories of pill mills popping up in strip centers around town with long lines and accepting little or no insurance. The “Houston Cocktail” was a prescription for three drugs that should never be prescribed together: hydrocodone, valium, and Xanax. From January 2009 to March 2010, one Houston doctor wrote more than 43,000 prescriptions for the Houston Cocktail. In 2009, 70% of the 144,000 prescriptions of the Houston Cocktail were in fact from Houston. After Esther Scarborough’s son died of an overdose after his first visit to a Houston-area pain clinic, she said, “These doctors are using our loved ones as cash cows or ATM machines. They make a lot of money off these drugs.” The pill mill bill requires facilities and their owners to register if they derive 50% or more of its business from writing pain prescriptions. All facilities must be owned by a doctor who spends at least 33% of his time treating patients at the facility. After the pill mill bill became law, there was a 45% drop in scheduled narcotics prescribed in Houston compared with the same time the year before.
Dr. Gerald Ratinov was the largest prescriber of hydrocodone in the State of Texas. Prosecutors and law enforcement successfully used the pill mill bill to crack down against doctors improperly prescribing or diverting scheduled narcotics. Dr. Ratinov is now in jail.
The pill mill bill author, Senator Williams (R-The Woodlands), successfully passed a new law (SB 158) in 2011 that makes it a crime for individuals, including patients and people in the industry, to divert drugs. A patient may no longer conceal a material fact when seeking or filling a prescription. Concealment of a material fact is defined as follows: “For purposes of this subsection, a material fact includes whether the person has an existing prescription for a controlled substance issued for the same period of time by another practitioner.” The addict or diverter who attempts to fill a prescription for a drug, while already receiving that drug for the same period from a different source, commits a crime.
Few doctors receive education and training about drug addiction and drug diversion. This is especially true for more mature doctors.
Pharmacies make money dispensing pharmaceuticals. But pharmacies have also become victims. More pharmacies report robberies. In fact, there has been an 81% increase in robberies since 2006 resulting in 1.3 million pills stolen. Some robberies have turned lethal. In Long Island, NY, a robber shot the pharmacist, teenage store clerk, and two customers in her pursuit of hydrocodone. An Idaho man dressed in a suit and tie threatened “to light this place up” if not provided oxycontin. Robbers are taking some extreme measures including squeezing into air-conditioning shafts, using an electric saw to cut off a door knob, and in one instance, a woman attempted to break in a Walgreens drive-through window with a crowbar. Some pharmacies are posting signs saying the do not carry oxycontin or oxycodone.
Insurers pay 80% of the nation’s $230 billion drug bill and are therefore the main financiers and enablers of drug diversion. The Coalition Against Insurance Fraud indicates PDA costs $72.5 billion per year. In 2006, almost one half of Aetna’s member fraud investigation involved prescription drug benefits.
Prescription drug costs are rising faster than inflation and the medical CPI (medical inflation). Payers are implementing strategies to combat the high cost and higher utilization of scheduled narcotics. A cottage industry of prescription benefit managers (PBM) has developed to combat utilization and costs of prescription drugs. Each payer is developing internal procedures to identify potential drug abuse or diversion. But each state has different laws and attitudes towards PDA complicating their efforts.
Patients are being prescribed and are taking more pain medications. More frequent prescriptions and more pills inevitably lead to more addicts. Addicts rob, steal and lie. Their addiction affects those they love, destroying families. One judge recently explained the cycle: “The addict soon breaks the law and either steals or diverts the drugs to fund the drug habit. Eventually, the addict is arrested for violation of a state or federal law leaving his family to pick up the pieces. Patients do not choose the addiction but the statistics of the lives affected do not lie.” Some patients trust the physician. Others may have ulterior motives. Detoxication programs are not a failsafe cure and often administered after so many lives are destroyed. They are costly when compared to strategies to stop the addiction from ever taking hold of the patient.
Prescription drug abuse and diversion is a problem requiring close interaction between public and private sectors. Stakeholders must work together using tools at their disposal in a coordinated effort to fight supply and demand. The most successful action the government can take in partnership with other stakeholders is a prescription drug monitoring program (PDMP). Some states have created their own programs with varying degrees of success. A model program includes:
- Scheduled and other highly abusive substances
- Real time data transmission between stakeholders
- A requirement for doctors to check the PDMP database before writing a prescription
- A requirement for pharmacies to check the PDMP database before dispensing narcotics
- Integration with neighboring states
A PDMP must be mandatory for either doctors or pharmacies and must be in real time. No comprehensive strategy will be successful without it. The front line suppliers (doctors who prescribe and the pharmacies who fill) will instantly know if the patient is taking prescription drugs from another source reducing supply. The PDMP protects the front line suppliers from charges of creating an addict. Regulators can monitor the prescribing habits of outlier doctors for more education or oversight.
The public has an unreasonable view of the knowledge base of healthcare providers. Although every doctor graduated from medical school, knowledge itself comes from specialized training. Scheduled narcotics should only be prescribed by doctors with the requisite training and experience. Those doctors granted the additional license to prescribe scheduled narcotics would be subject to additional regulation.
Physicians should be required to check with the PDMP database before writing a prescription for dangerous drugs. A doctor who fails to comply risks prescription license forfeiture and possible lawsuits. A physician who does verify using the database should enjoy immunity from lawsuits.
Prescribers of narcotics should enter into drug contracts with their patients. Routine and random monitoring of the patient’s urine will confirm the drugs are being taken (to avoid drug diversion) and at the right levels (to avoid abuse). Violations of the drug contract should be reported to the PDMP database.
Drug dispensing by physicians does have some benefits. Critics argue physician dispensing can result in abuse by the inevitable bad actors statistically present in every large group. Indeed, the cost to human life and dollars are staggering even if only 1% of all providers were problem dispensers. If physician dispensing is allowed, the reimbursement rate should be no higher than the retail pharmacy removing the profit motive to dispense more drugs or stronger, more addicting (and expensive) drugs. The physician dispenser should be allowed to bill extra for drug contracts and urine testing.
Pharmacies should be required to participate in a prescription drug monitoring program for scheduled narcotics before dispensing scheduled narcotics.
Drug companies should design drugs to deter abuse. Drug companies employ manufacturing techniques making it more difficult or impossible for drugs to be ground up into a powder. Pharmaceutical companies should not be allowed to market scheduled narcotics for off-label use. (The most famous example is Fentanyl, an end-stage cancer pain drug, marketed for low back pain.)
Public education about prescription drug abuse should be paramount on billboards and in our school systems. Every day, 7,000 young people abuse prescription narcotics for the first time. Patients who receive a prescription or scheduled narcotics should also undergo approved education and information.
Payers should implement strategies designed to identify addicts, diverts and outliers. Payers should urge policy makers to adopt PDMP and common sense laws giving regulators the information and power necessary to fight PDA. Payers have ever more increasing sophisticated software able to perform advanced predictive modeling and performance analytics that can identify outlier doctors and possible addicts. Communication with other stakeholders early in the process works well both as preventive education and as proactive identification of early PDA. Use of PBM and drug formularies are currently available for implementation.
Many people believe America is losing (or lost) the war on drugs. That war is important. But PDA kills more people and causes more family destruction than all illegal drugs. All stakeholders should be collectively engaged in the search for solutions to PDA and when necessary demand action. Doing nothing creates addicts and destroys families.