Vicodin to Heroin
A well worn path
By Joan Trossman Bien 07/10/2014
Ventura County is facing a big problem, one that is plaguing medical communities around the country. The tragedy of overdosing on prescription painkillers has snaked into the public awareness along with the accompanying rise in heroin addiction. Now there is a new big boy on the block, Zohydro ER, a hydrocodone medication, which became available in June. Massachusetts has banned the sale of the drug. Zohydro already has a lot of powerful enemies, especially in Congress and the statehouses.
States are rallying to find ways to ban Zohydro ER, fearful that it will greatly add to the problem of prescription overdoses. This new pain medication, which can only be legally obtained from a physician, is delivered through an extended-release system. The big flaw according to critics? Zohydro ER was formulated without including any of the tamper-resistant features seen in similar drugs.
Tamper resistant refers to the ability of an abuser to transform the medication into a form that can be more easily abused through eating, snorting or injecting intravenously. Zohydro was formulated with a time-release mechanism that is not indestructible and, therefore, is more easily adapted for abuse. Other tamper resistant features used in opioids are the inclusion of antagonists or aversive agents, ingredients that do not affect the medication but that get the abuser sick if they tamper with the drug.
That is why politicians have rallied to pull Zohydro ER off the market. In addition to the potential for abuse, they fear this painkiller, which can be up to five times as potent as Vocodin and is formulated without acetaminophen making the entire capsule subject to abuse, will be responsible for many more overdoses. Drug experts have been saying that once the drug has been established in the medical community, making it more difficult to obtain that same drug it may cause some of those who are addicted to turn to heroin. Ventura County also has a rising number of heroin users.
Larry Snyder, M.D., is the medical director of the rehabilitation outfit Sovereign Health Group in Los Angeles. He explained the close link between prescription pain medications and heroin use.
Larry Snyder, M.D.
“Prescription medications are the most abused drugs and are far above all of the abused drugs put together,” Snyder said. “Because of the expense of prescription drugs, a lot of young people and others who develop a dependency on opiates will transfer to heroin.”
Patrick Zarate, director of the Ventura County Behavioral Health Department Alcohol and Drug Programs (ACP), said, “Our mission is to address the negative impact of alcohol and other drug problems in the community as we find them. We try to ‘go where the numbers lead,’ so a few years ago I formed an interagency group and my office convened the county’s Prescription Drug Abuse Work Group.”
That group created a program that encourages the proper and safe disposal of unused prescription drugs floating around the community and Zarate said it has been very successful.
“In the first year (2009) there were 343 pounds disposed of; as of September 2013, over seven tons of unwanted drugs have been disposed of here in Ventura County.”
Although Zarate won’t make a direct comment on the new drug Zohydro ER, he did say he believes that, where appropriate, drugs should be designed for abuse deterrence. He said that, according to California Healthy Kids, almost one-third of prescribed medications go unused. It also said that 20 percent of 11th grade students reported misusing prescription painkillers.
Prescription painkillers by the numbers
“There is a difference between dependency and addiction,” Snyder said. “Dependency is the physical manifestation of the effect of the drugs. If you stop it and your body withdraws, that is an addiction. Addiction is more an emotional and psychic condition associated with the use of a drug that creates an altered mood state and the euphoria.”
Snyder wanted to set the record straight about the dangers of drug withdrawal. “Alcohol withdrawal can kill you. Very, very serious withdrawal symptoms, seizures, etc. With opiates it is just like you have the bad flu where your muscles are aching, nausea, irritability, diarrhea, and you feel very sick.”
The Centers for Disease Control and Prevention (CDC) publishes data about the prescription drug problem, including the statement, “Deaths from drug overdose have been rising steadily over the past two decades and have become the leading cause of injury death in the United States. Nearly nine out of ten poisoning deaths are caused by drugs.”
Here is a surprising 2010 statistic: According to the CDC, out of more than 38,000 drug overdose deaths in the U.S., 60 percent were related to pharmaceuticals. More than three-fourths of those deaths were unintentional.
Stepping back to view the problem more broadly, drug overdose deaths have been rising steadily since 1990 and are now three times as likely to happen. Drug overdoses cause more deaths than motor vehicle crashes.
The Centers for Disease Control recently released a study about the differences in the number of opiate prescriptions state by state. California is in the bottom tier of states that write the fewest prescriptions. Alabama had the highest number of prescriptions per 100 people, almost three times that of Hawaii, the state with the lowest rate.
Geographically, there is a swath of high prescribing states covering what used to be called the Rust Belt, states that had thrived on major manufacturing. But those states have suffered economically since those industries closed American factories in favor of sending the work abroad. It runs from Oklahoma east to the East Coast, Louisiana north to Michigan. California, New York, and Illinois, the states where you might expect the highest numbers, actually had the lowest number of opiate prescriptions written.
Drugs all sound the same
The names of the pain medications are confusing with monikers like hydrocodone, oxycontin, morphine, heroin and acetaminophen (Tylenol). You may be surprised to read that Tylenol is the most dangerous overdose drug despite not being a recreational drug. That may be because acetaminophen is included in many other concoctions and patients don’t keep track of exactly how much they have taken. Or perhaps someone had a couple of drinks at lunch and then took the over-the-counter drug for a post-dinner headache. Enough acetaminophen can lead to sudden liver failure. The only way to save the patient is with a liver transplant.
Vicodin is Enemy No. 1 at the Drug Enforcement Agency (DEA). The agency’s fact sheet about hydrocodone (Vicodin) states: “Hydrocodone is the most frequently prescribed opioid in the United States and is associated with more drug abuse and diversion than any other licit or illicit opioid.”
It is common sense that the most prescribed drug, which is a narcotic, is also the most abused drug. Aside from Vicodin, other brands of opioids include Lortab and Lorcet. The DEA listed the drugs that have that all have a similar effect: hydrocodone, morphine, heroin, oxycodone, codeine, proproxyphene (Darvon, which has been pulled off the market), fentanyl (usually in a patch called Duragesic) and hydromorphone.
These narcotic drugs are not the only ones that are popular with abusers. Opioids are but one category. Also a target for abuse is tranquilizers, such as pentobarbital sodium (Nembutal), diazepam (Valium), and alprazolam (Xanax). Another class of drugs being sought by abusers is stimulants, which are dextroamphetamine (Dexedrine), methylphenidate (Ritalin, Concerta) and amphetamines (Adderall).
These drugs may be confusing because of frustratingly similar names, but physicians and drug abusers are quite clear about them. There was a lot of criticism a few years ago over the ease of abusing oxycodone (OxyContin). The manufacturer reformulated the drug to be tamper-resistant. No drug can be completely tamper-proof. It is not clear why Zogenix or the government agencies did not require some tamper-resistant measures for Zohydro ER.
Making a case for Zohydro ER
The most passionate defender of Zohydro ER may be its manufacturer, Zogenix of San Diego. In a press release, the company addressed some of the concerns.
According to a press release from Zogenix, “Zohydro ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”
In the same release dated April 4, 2014, Zogenix addressed politicians who seek to ban or restrict access to the drug.
“It is vitally important for the health and safety of all Americans that our expert professional regulators and health care officials in federal and state agencies are allowed to do their jobs without political interference from politicians who have neither medical or scientific training. … Because there are risks of misuse and abuse to all opioid medications, we believe that any restrictions should be applied to all Schedule II opioids.”
The release also said, “Zogenix is the first and only opioid pharmaceutical which has implemented a number of voluntary and novel safeguards from the first day of availability of their product to minimize the potential diversion, overdose and misuse of Zohydro ER.”
These safeguards include the establishment of a board of experts to monitor and review prescriptions and report patterns of abuse to the FDA: compensating the product representatives in their efforts to ensure the education of physicians, pharmacists and patients about the risks and benefits of the product, and providing free locking pill-bottle caps and discounted safe-storage units to protect the drugs at home.
These steps are not the measures that critics have been demanding. They want the drug pulled from the shelves until it is reformulated as tamper-resistant, while acknowledging that a determined drug abuser can get around all forms of drug-abuse prevention.
There is now a bill floating around the U.S. Senate, introduced by Sen. Joe Manchin, D-West Virginia, that would order the FDA to rescind its approval of Zohydro ER.
Zogenix claims to be aware of and is proactive on prevention of abuse. But it concludes that the drug restrictions would “outweigh its therapeutic potential.” Critics say there are already enough hydrocodone drugs to treat patients in pain and that the patients do not need another drug.
When you are in serious pain
Some pain doctors see the value in Zohydro ER where it fills a need, a pain medication that is not as strong as morphine but lasts longer than Vicodin, which lasts between three and six hours. Zohydro ER is an extended-release drug and lasts 12 hours.
On his blog, James Patrick Murphy, M.D., of the Murphy Pain Center in Kentucky, wondered what the fuss was all about with Zohydro. First, he said, some advantages of the drug are how long it lasts and that it is easy on the liver. He also mentions that the non-tamper-resistant system is also still used with other extended-release drugs such as Ritalin LA, Luvox CR and Avinza. Yet Zohydro has been singled out by a bill in the Senate. The blog said the only real difference between Zohydro and the other extended-release opioids is not the level of danger but the perception of the drug by non-medical politicians as being another way to get high.
Pain specialist Robert Frey, M.D., does not use primarily pain medications for his patients because, he says, he has so many other methods of treating pain.
“Tightening patient access to opioids may mitigate the complication of excessive use,” Frey said. “If the opiate class is restricted then treatment plans may be modified to employ other alternatives by board-certified pain specialists willing to educate and formulate a plan superior to medication alone. Many ‘pain management’ providers dispense medication but have no board certification in the specialty. These self-proclaimed pain treaters rely on opiates. I employ a multidisciplinary approach: diet, exercise, prayer, coping skills, self-directed fitness, postural evaluation, water therapy, physical therapy, socialization and more. A proper pain management clinic complements government controls with clinic tools which allow oversight of patient activity.”
Frey summed up his professional opinion. “(Government restriction of opioids) should not affect anyone’s access to medication provided there are medical diagnoses meriting use of an opiate [opioid] in a patient’s plan. Access to opiates is not a right, it is a privilege. As a specialist, my patient’s safety is priority No. 1, their pain control is No. 2.”
Frey is referring to legitimate pain patients who have been on narcotics without strict medical monitoring and found themselves unable to stop taking the drugs. They then also become patients with addictions.
Sources of prescription drugs
Where do drug abusers get their drugs? That depends on how much medication is being used and for how long it has been abused. It also depends on the perception of the prescriber.
The knee-jerk response to the question of who is the source of opioids, is doctors.
“The main source for these drugs are doctors’ offices primarily,” Snyder said. “The use of prescription drugs has increased primarily because the pendulum has swung toward the liberalization of use of opiates to treat pain syndrome. The emergency room also dispenses a huge amount of drugs.”
As a front line participant in the struggle to help addicts break away from drugs, Snyder said the other drug that stands ready to replace prescription painkillers is heroin.
“The use of heroin has just skyrocketed,” said Snyder. “It is really peaking right now because the cost of heroin is cheaper than the cost of prescription drugs. People can’t get OxyVontin, they can’t get Percocet or Dilaudid so easily but heroin is pretty available. The age for heroin has gone down. I’ve seen many patients that I would describe as the girl next door, the classic Leave it to Beaver-type of kid, and they are an addict. These are high school kids.”
Snyder added, “Almost a third of prescribed meds go unused and, according to California Health Kids survey data, 20 percent of 11th graders here in Ventura County reported misusing prescription painkillers. While prescription drug-related deaths have increased moderately (2008-2012), heroin-related deaths have greatly increased since 2009.”
This trend disturbs the experts. Different treatments are sometimes drastically different in their approach. Pain specialist Frey has strict rules for detox.
“There are some that would suggest that addicts should be allowed to receive prescription opiates so that they will not turn to heroin use,” Frey said. “This logic is deeply flawed. No addict should be given access to any opiate. The best way society can help a heroin addict is to impart education and limit exposure to opiate use.”
There are several sources for acquiring painkillers aside from the doctor’s office. A recent study is the Journal of Addiction Medicine presents the most likely sources of prescription drugs. Aside from obtaining the drugs from a doctor, drugs are given to the addict by friends and family, followed less often by having the drugs bought by friends or family, and much less often, the drugs are bought on the street from a dealer or even just a stranger.
That same study, however, identifies the highest-use, highest-risk group as most likely to obtain opioids from a doctor.
Treatment and Prevention
Frey said there is a way out for the addict. “Fortunately there are ways to get off of medication that were not present a decade ago. Suboxone is a fantastic medication to convert someone off of heroin, or even someone who has become addicted to prescription opiates after being prescribed the medication after a medical illness.”
Rehab specialist Snyder joined in the praise of Narcan (naloxone) and similar drugs. They are special narcotics that reverse the effects of other narcotics. “Outpatient treatment for people with opiate dependency is becoming more common. Methadone is a dirty drug. It is very long acting. People get very dependent on this and it takes forever to wean them off the drug. Suboxone lets you take someone off very quickly if the strategy is to get them drug free.”
Frey has several ways to help an addict return to sobriety. “Most of my patients need an expert to employ a very controlled titration of their medications, even as slow as one tablet less per day for an entire month.”
Still, doctors are the gatekeepers for prescription opioids. Frey said there are some techniques for doctors to get a better understanding of how each patient handles these medications.
“Proper medication writing is also a significant way to keep patients controlled,” Frey said. “I try to write an amount maximum on the prescription itself so patients know there is an amount that they are not allowed to exceed. Secondly, there are no early refills. Patients are not allowed to take as much as they want. Thirdly, clinicians need to know from their patients if the medication is causing increased risk, side-effects and any problems. This involves open dialogue, and firm speech as to the opiate dosing guidelines.”
Finally, county panel administrator Zarate wants parents to participate in preventing anyone who has not been prescribed painkillers from getting their hands on unused but powerful drugs.
“Message for parents: Lock them up or throw them out!” Zarate said. “It is important to begin monitoring your medications. Know where they are, inventory them, secure what you need and dispose of what you don’t. For drugs you keep on hand, be sure to count them and track their quantities.”
Editor’s note: An opiate is a narcotic analgesic that directly depresses the central nervous system. Natural opiates are derived from the dried “milk” of the opium poppy, while synthetic opiates are manufactured in chemical laboratories with a similar chemical structure. Natural and synthetic opiates are collectively known as opioids. The most commonly abused opioid is heroin. Source: www.isate.memphis.edu/opiate.html.