(After a terrific buffet lunch under a tent outside the USC School of Pharmacy I said to the assembled:) Great lunch! Do you guys eat like this every day? It almost makes me wish I were back in school, the operant word being almost. I see that there is no teleprompter, therefore I will be speaking from my prepared notes. FULL DISCLOSURE: I want to preface my remarks today by saying that this isn’t my usual Friday afternoon activity. Because on Fridays around this time I’m usually driving home after finishing lunch with the guys that I play softball with in the morning in the Sepulveda Basin in the San Fernando Valley. Instead, today I am speaking to you about the opioid crisis.
I will begin by sharing my thoughts with you where I think some of Washington’s proposals to solve the opioid crisis went off the rails. The next segment, I’ll relate to you my personal story regarding today’s subject. Finally, I’ll finish off with some possible solutions to the opioid epidemic.(PAUSE)
Because of the change in political climate two years ago, I have felt compelled to write about topical issues. Since then, I have written about a variety of subjects, but one in particular delineates my personal experience with opioids. That one piece is central to my presentation today. It is my story. I believe that it speaks to the power of these drugs, specifically I’m referring to a class of agents referred to as opioids, but also as narcotics. I call my story: “I Am a Drug Addict.” TO START, I wish to rebut two key aspects of the president’s proposal to solve the opioid epidemic. BUT FIRST, I have to say: (PAUSE)
Thank God I retired nearly twelve years ago. One of the legs
of President Trump's announced plan to solve the opioid
crisis is to impose the death penalty on all drug dealers.
Pharmacists deal with and dispense narcotic prescriptions to
alleviate pain on a daily basis, therefore, in a sense, they
could be considered drug dealers. Stories abound of patients
becoming addicted from RX drug use. The president's edict
would have caused me to worry that I might become a target
of the death penalty if one of my patients had died from an
overdose. Does this represent the president's thinking as well?
The president's proposal presents another challenge to the neighborhood pharmacist's practice. Pharmacies are often targets for desperate individuals and criminals in pursuit of drugs. During one particularly difficult time in my practice, I found myself confronted with two armed robberies and two burglaries within a six-month period. Two days after one such burglary, I was held-up at gun-point. I had had no time to restock my loss of stolen narcotics. My first thought was that I was a dead man. I told the gunman that I would gladly give him whatever he wanted (he had come with a shopping list), but that I had just been cleaned out two nights earlier, although luckily a few items on the robber’s list had been overlooked by the burglar. It was a scary moment. I feared for my life then, and over the subsequent six months I felt paranoid because of those events. At one point, I called the police because a customer had walked into my pharmacy after dark with a misshapen shopping bag. I did so because I feared it contained a concealed weapon, but fortunately it did not. Do pharmacists now have to fear for their lives because of a presidential edict?
President Trump appears to have derived his inspiration for implementing the death penalty to deal with drug dealers from his admiration of President Rodrigo Duterte of the Philippines. Mr. Duterte is in his early 70’s, was a democratically elected president who is a populist with authoritarian tendencies. Sound familiar? Duterte's war on drugs against drug dealers and drug users has resulted in extrajudicial killings of more than 12,000 citizens, more than 4,000 by police and the remainder by "unidentified gunmen." Most victims were urban and came from poor families. Critics of Mr. Duterte's anti-drug crusade are routinely impugned, criticized, harassed and threatened, tactics that President Trump understands, many of which he has used numerous times. Is this what the president has in mind?
We all know that Mr. Trump has a brilliant mind. He's also very smart. Actually, a self-described “stable genius,” as he likes to point out. And with the best brain on the planet, or so he says. But certainly execution can't possibly be a part of smart solution for solving the problem of the opioid epidemic, can it? PAUSE: In the 80's and 90's we filled our prisons with persons who were selling and/or using drugs. At least one in five people among the 2.3 million imprisoned in various U.S. federal, state and local detention facilities in 2017 was incarcerated for a drug offense, according to the Prison Policy Initiative. This includes nearly half of all those inprisoned at the federal level. As of year end 2015, approximately 197,000 prisoners (15%) in state confinement were convicted of a drug-related offense as their most serious crime. In the most recent report, as of September 30, 2016, 56% of all females (7,600) in federal prisons were serving sentences for drug offenses, compared to 47% of males (75,600). Does anyone seriously believe that selling drugs should be a capital offense? Would the punishment fit the crime? Yet, on the other hand, it is one way to limit the prison population. According to the California Pharmacist Winter 2016 edition vol.63, no.1, a publication of the state pharmacists’ association, the article on Opioid Drug Abuse states that hydrocodone-containing products were the most frequently prescribed RX in the U.S. for 2011, with 136 million prescriptions dispensed. With just 4.6% of the world’s population, the U.S. consumes 80% of the world’s opioids and 99% of the world’s hydrocodone supply. THINK VICODIN. Symptoms of physical dependence or tolerance to opioids are frequently mistaken for signs of opioid addiction. Physical dependence, such as withdrawal symptoms upon discontinuing an opioid, as I experienced, and tolerance, such as requiring a higher dose to achieve the same effect, of themselves are not considered evidence of opioid addiction. A definition of opioid addiction was agreed upon by the American Pain Society, American Academy of Pain Medicine and the American Society of Addiction Medicine. Those additional criteria for addiction are: impaired control over drug use, compulsive use and continued use despite harm, or craving. Another leg of the Trump three-legged stool opioid crisis solution is a provision for E.R. overdosed addicts to be provided with naloxone (Narcan) upon being released from the E.R. I agree with this idea wholeheartedly and I believe it should be expanded. Naloxone will save lives because when an addict overdoses, this drug will nullify the effects that otherwise might result in death. According to The Consultant Pharmacist, the journal of the American Society of Consultant Pharmacists issue of February 2018, volume 33, No.2 (and I quote): “Many states have expanded accessibility to naloxone, an opiod reversal agent. Naloxone is safe, cost effective and non-addictive. In addition, simple administration allows patients, family members, caregivers and bystanders to use use naloxone in the event of an opioid overdose.” One hour training courses required for pharmacists to sell naloxone over-the-counter are readily available.
The third leg of Trump's proposal is to reduce by 33% within three years the available supply of prescription opioid drugs to wholesalers from manufacturers to be distributed to pharmacies. Such a "solution" is hugely problematic and misguided. Patients who use community pharmacies already are having difficulties obtaining their prescriptions due to supply limitations of narcotic drugs imposed by the government and in turn by distributors to those pharmacies. I know of one recent case where the patient was in severe pain from having broken his leg in four places and had to go to five different pharmacies before finding one that could fill his opioid prescription, because pharmacies were all out of the product. It was near the end of the month and they had already used up their monthly allotment. I know of a medical building pharmacy which has a pain management clinic in that building that no longer accepts new patients because the pharmacist barely can supply his current patients with their pain medication needs.
The situation is no better in hospitals. There is a shortage of numerous injectable narcotic medications, including but not necessarily limited to morphine, fentanyl and Dilaudid at many hospitals and surgical centers around the country. The cause is linked both to problems in the manufacturing process as well as the government's effort to restrict drug production. The situation is more severe in some areas than others. At some centers, elective surgeries such as gall bladder removal and hernia repair have had to be postponed. Pharmacists, doctors and nurses in consultation have had to change their drug formularies and protocols regarding drug use for certain patient conditions because of the shortage. Often this has resulted in patients being given less effective medications to control their pain levels. The situation has increased the likelihood of errors in calculating workarounds in dosing patients and in some cases it has been life threatening.
In summary, restrictions imposed on manufacturers and distributers of opioid drugs by the government have already put a strain on the system. To further reduce the availability of these important chemotherapeutic agents not only would further exacerbate the situation, but also would be totally unwise, causing harm to the patient. Making naloxone available to addicts makes sense, just as clean needle programs do. And the former proposal should be expanded beyond the E.R. Implementing the death penalty for drug dealers is inhumane, unwise and may be illegal. Additional policy components may be added, but as always, will there be sufficient funding for those programs? I am sure that knowledgeable professionals could come up with additional, and perhaps even better choices. Hopefully Congress will listen and act.
Maybe Tom Lehrer, the former Harvard math professor, lyricist and performer, should start shaking in his boots because of a song he wrote entitled 'The Old Dope Peddler.' Trump may be out to get him next because of the lyrics: HERE GOES: "When the shades of night are falling, comes a fellow ev’ryone knows, it's the old dope peddler spreading joy wherever he goes. Ev’ry evening you will find him around our neighborhood. It’s the old dope peddler, doing well by doing good. He gives the kids free samples, because he knows full well, that today's young innocent faces will be tomorrow's clientele. Here’s a cure for all your troubles. Here’s an end to all distress. It’s the old dope peddler with his powdered ha-happiness. " Better beware, Tom Lehrer.
(PAUSE)
The purpose for using myself as an example, as if I were an addict, is to spread awareness about the opioid crisis through a first person experience. We all know for a fact that the personal story has far more impact than mere statistics. Here is my story. For maximum impact I have titled it:
I Am a Drug Addict. You most likely did not know that about me. I do not fit the profile. No, I haven't been trying to hide it from you. No, I don't have tattoos to cover up needle marks on my arms. No, I didn't shoot-up drugs in dens or alleyways. No, I have never been homeless or arrested. No, I never even experienced the highs of drug use. I am a therapeutic addict. I exhibited symptoms of addiction and withdrawal from a prescription that my surgeon prescribed for me after my hip replacement surgery in December 2017. For ten days prior to my surgery, I was in excruciating pain, yet took only one or two Vicodin during that period. Immediately after my surgery all signs of my pain had ceased. Yet, my doctor prescribed Percocet, a brand of oxycodone 5mg. and acetaminophen 325mg. This drug is a Class II drug, so classified because of its abuse potential. My physician told me to take one every six hours, around the clock, to stay ahead of the pain and to do so for ten days. I had read in the literature that addiction can occur within fourteen days, while Marji, my wife, pointed to her research discovery saying that it can occur within one week. Just last month I saw a spot on TV where a young mom crashed her car into a dumpster in order to have an excuse to obtain more Vicodin. The ad stated that you can become addicted after just five days. However, post-op, I had no pain what-so-ever, not even break-through pain, which is pain that occurs when the effects of a dose of a drug wears off. But I was a compliant patient, until I decided not to be. After seven or eight days, I decided to wean myself off my meds. It was then that I began experiencing narcotic withdrawal, a symptom of dependency. I had body sweats. I became depressed. My temperature vacillated in both directions and I experienced nausea, the latter effect lasting two weeks. In my studies leading up to becoming a pharmacist I learned a great deal about the body and about these chemotherapeutic agents. Over a forty-one year professional career I witnessed first hand the risks and rewards of patients using these drugs. Yes, patient comfort is a priority, but prescriber and patient beware. Also, let us remember the physician’s oath: First do no harm. I have always had a strong respect for my body and for these potent drugs. When I was practicing, I always counseled my patients to listen to their bodies, they will give messages regarding what is going on. I avoided taking drugs whenever possible. Yet, with aging and the development of certain conditions, I understood the value of taking specific agents for specific conditions. It never occurred to me that I could or would ever become dependent or addicted. It wasn't in my personality. It wasn't in my mindset or vocabulary. But think again. It happened to me and it could happen to you or someone you love. When these agents grab hold of you, most often they won't let go and, in too many cases, it is deadly. Preliminary figures in 2017 from the National Center for Health Statistics suggest that more than 64,000 people died from drug overdoses in 2016, more than the total number of U.S. soldier deaths in the entire Vietnam War. Nearly 45,000 of that total were from opioids, including heroin and other contraband narcotics. The front page of the July 3rd 2018 edition of USA Today stated that the Center for Disease Control has downgraded its estimate of the number of prescription only opioid deaths in 2016 from roughly 32,000 to 17,087. Thus illicitly used opioids like carfentanil, which is possibly 10,000 times the potency of morphine and is used to lace heroin, are strong contributors to these statistics. Most heroin addicts, the numbers estimated as high as four out of five, started out as I did, taking prescription opioids. Luckily, my dependency symptoms were mild and ephemeral; and my story is short and has a happy ending. Recognition of addiction can be difficult, even if, or maybe especially if the addict is living with you. They are very good at either denying that they are addicted and/or lying and covering up the fact that they are. But after you discover the addiction, recognize the aberrant behaviors, the struggle actually begins, lasting usually for years, often decades. I have found Al-Anon to be a beneficial resource for those relatives or friends of alcoholics and/or opioid addicts. The program gives family members effective tools for dealing with the addict and with their own feelings about their addict’s addiction and behavior. The stories one hears are in themselves both harrowing and healing. But the support you feel makes you realize that you are not alone in this battle. Al-Anon provides tools to deal with the addict and to repair and regain broken relationships. Perhaps the most important benefit for family members is to gain a perspective on addiction, the addict, and how and where to set acceptable boundaries for yourself. (PAUSE) My first wife died from an opioid overdose. Yes, she was one such victim. Hers was not an accidental overdose of her own doing. Hers came about because of a miscalculation in dosage delivery and because of the prescriber's lack of consideration of other medications she was taking. Eileen was put on hospice care because of metastatic breast cancer. She was diagnosed as terminal and was given large amounts of morphine sublingually. The doctor told her attendant to give her a pill at the first sign of facial twitching. She had a lot of twitching. Also, she was administered a 25mcg. Duragesic patch, known generically as fentanyl. On a Saturday in December 2003, the visiting nurse, an RN, calculated that she required seven times (7x) the dose of the fentanyl patch that currently had been applied to her body. In eight hours Eileen was dead. There I was, a pharmacist, standing there. There was my brother, a physician, standing there. Neither one of us, despite our professional knowledge, could exercise that judgment because of our emotional involvement with the patient. We could not tell that nurse, no that's too much of a dose, please consider how much morphine the patient has already consumed.
In the following weeks and for two years thereafter, I played this scenario over and over in my mind. I knew the rule of thumb: Three times the therapeutic dose is toxic. Ten times the therapeutic dose is lethal. But being already emotionally bereaved, my mind was cloudy and I was incapable of thinking straight. I personally have felt the effects of opioid addiction and I also have witnessed the result of an opioid overdose resulting in the death of a loved one. Even, as in the case of my first wife, where her death was imminent, it was additional and unnecessary trauma heaped on top of my existing grief. Today there is a societal epidemic of addiction that all too often results in the premature loss of life. But there are steps that can be taken to sustain the lives of addicts and prevent many, if not most, of these untimely deaths. A multi-pronged approach always works best. Changes in physician opioid prescribing habits can lead to safer prescribing and is one small part of the solution. The lead article of the LosAngeles Times reported just one week ago today on a three month study conducted in 2017, published in the Journal of Science on August 9th, 2018 and formulated by researchers right here, at the USC Leonard D. Shaeffer Center for Health Policy and Economics. The study, the first of its kind, was conducted in SanDiego County. The chief medical examiner sent letters to physicians whose patient had died within one year from an overdose and who had prescribed at least one of several drugs with known risks. The letter was delineated as a courtesy. It stated the patient’s name, DOB and when the patient died along with five prescribing tips, or evidence based initiatives proven to lower overdose death rates. A control group of similar size, received no such letter. Those clinicians who got the letter reduced their prescribing of opioids by 10%. The study proved that physician awareness of their opioid prescribing habits can result in less opioid RX’s written, and also less powerful ones. In another vein, Congress needs to enact laws that provide more money for state programs, facilities, education and for therapeutic, life-sustaining drugs. But money is starting to flow that way. From the drug side, naltrexone(ReVia & Vivatrol), methadone (Dolophine) and buprenorphine (Subutex) are drugs proven to maintain addicts without euphoria if taken at therapeutic levels and can allow the addict to sustain a normal life. But according to the New York Times front page story of June 24, 2018 only 5% of the nation’s doctors are licensed to prescribe buprenorphine and only half the counties in the United States have a single buprenorphine prescriber. Clearly, something has to be done to license more clinicians. Scientific research has shown that people taking buprenorphine are less likely to die and more likely to stay in treatment than those not doing so. It is a relatively weak opioid itself. It works by activating the brain’s opioid receptors enough to ease cravings, yet not enough to provide highs in people accustomed to stronger drugs. Health and Human Resources Secretary Alex Azar has said that trying to recover without one of these drugs is “like trying to treat an infection without antibiotics.” Yet, buprenorphine is not a total panacea. It does not have a 100% success rate. Some patients do relapse, or drop out of treatment, while others may have setbacks but remain. Programs often combine 12 step meetings like Alcoholics Anonymous or Narcotics Anonymous. Then there are group and/or individual therapies. The most successful patients have strong family support, a permanent place to live, and often a job. Patient motivation and dosing adjustments at the right time for the cravings are other factors in success. Personally, I know of three people who have been taking buprenorphine for a number of years and they are doing quite well. Insurance authorization is often a problem, requiring volumes of paperwork and proof in urine testing that patients are not being prescribed narcotics or anti-anxiety drugs. The irony is that a prescriber can write prescriptions for opioids without having to jump through hoops, even though these agents cause addiction. Yet, for a patient to get insurance to pay for buprenorphine, there is paperwork galore in order to obtain authorization for something that deals with that addiction. (WAIT) Last month I checked the website of the Substance Abuse Mental Health Services Administration or SAMHSA. They are the licensing body for allowing clinicians to prescribe buprenorphine.The website states that in order to qualify for a physician waiver, one must complete a minimum of eight hours of training for the treatment and management of patients with opioid use disorders. I verified by phone that Physician Assistants and Nurse Practitioners are included by calling the governmental agency at (240) 276-1660 and was told on July 20th that contrary to the website, PA’s and NP’s are included. They informed me that the site will be updated by year-end. After qualifying, the practitioner will receive a special DEA number, with an “X” before it. During the first year the clinician may treat only 30 patients and in the second year not more than 100. Yet the question remains, with such a low bar for training, why aren’t there more practitioners licensed to prescribe buprenorphine? The bigger question might be, why the need for a special license? (PAUSE) The short-acting narcotic antagonist naloxone (Narcan) is used to resuscitate narcotic abusers who have overdosed, and may be unconscious or are so. Many pharmacists (sale is available without prescription in some pharmacies), the police and first responders are trained in its administration. Besides drug therapy, psychotherapy, either individual and/or a support group are useful adjuncts. These are just two approaches for use in the toolbox for this epidemic. I recommend to all to become more aware of our national epidemic, which has no bias over age, race, gender, religion, sexual orientation or class. The March 5th, 2018 edition of Time Magazine is one resource that I would recommend for raising your knowledge and awareness about the crisis. The entire issue is devoted exclusively to the problem of opioid addiction. One can read and see the effects of addiction on the person, the family and society in this photo-journal publication. After all, one picture is worth a thousand words. A recently published book by Beth Macy, titled: “Dopesick” Dealers, Doctors and the Drug Company That Addicted America, according to a New York Times Book Review of August 5, 2018 QUOTE“is a masterwork of narrative journalism, interlacing stories of communities in crisis with dark histories of corporate greed and regulatory indifference.” New information is coming out almost daily about this crisis. A case in point is that just yesterday the CDC issued a preliminary estimate of drug overdose deaths for 2017 at 72,000. Also on August 10th the CDC reported in Morbidity and Mortality Weekly Reports which was disseminated on August 14th in APhA Focus, an online newsletter of the American Pharmacists Association. In it researchers state that the rate of opioid use disorder (OUD) among females giving birth in hospitals more than quadrupled between 1999 and 2014, from 1.5 cases per 1,000 deliveries to 6.5. These OUD births have far reaching consequences, especially for the newborn and its development as well as the costs to society. In closing, a multitude of resources are available for educating yourself and others. My parting message is SPREAD THE WORD. After all, the life you save might be a neighbor, a loved one or a friend’s.
THANK YOU.
I WILL ENTERTAIN ANY QUESTIONS OR COMMENTS
Dr. Fond gave this speech before a national conference of pharmaceutical scientists, other academics and students at the USC School of Pharmacy on Friday, August 17, 2018.