American Journal of Therapeutics 22, 80–84 (2015)
So Patients Suffer—It’s for Their Own Good!!! Gary W. Jay, MD, FAAPM* The Food and Drug Administration (FDA) is the agency responsible for the approval of medications— for infections, cancer, hepatic problems, and pain, to name a few. It was not too long ago that there was an Advisory Committee that met to evaluate hydrocodone extended release (ER). What surprised me was that the committee did not focus on the drug—good, bad, or indifferent, but essentially they spent their time focusing on opioid abuse, an important and appropriate topic, but not for this time and place. It was reported that the Advisory Committee denied approval of this drug but the FDA, which has the ability to override such committee recommendations, exercised the override process and approved the medication. So, the Advisory Committee that was to negotiate the issues of this drug, dealt instead on the issue of substance abuse and expressed attitudes about the use of opioids, not factual information on the topic (medication) at hand. There is a lot of that going around. In my career, in my first 25 years of practice (I ran a tertiary care interdisciplinary pain and neurorehabilitation center) I saw more than 35,000 patients. No one, not one, overdosed or died. And I felt professional satisfaction doing what I could to help these patients decrease their pain and maintain or improve function. I was not fearful to use medications that would be useful and appropriate. But that was then and this is now: It is the attitude of those who have chosen sides—what is good for patients—irrespective or irresponsive to their needs. I would not go into the PROP versus PROMPT rivalry/contrary views on how to treat patients— how to help patients—or not. One group had its axe to grind and I was impressed and gratified by how the FDA handled this issue—it kept the ability of patients to obtain opioids alive. But, as can be seen by the FDA Advisory Committee, even when one question is asked, with an answer
AdviseClinical, Raleigh, NC. The author reports no conflicts of interest. *Address for correspondence: Chief Medical Officer, AdviseClinical, 1114 Rosepine Dr., Cary, NC 27519. E-mail: [email protected]
needed to be based on facts, the question was obviated by emotion/nonfact. Do not misunderstand. Does addiction occur—absolutely! Is it a bad thing? Of course. Do accidental overdoses occur—unfortunately. But that says nothing about the reason for the ad board. I have been in the interesting position of having a well-known politician who made a name by condemning the use of opioids because of “the horrors of addiction” come to see me for a clinical problem. He came to see me because he was IN PAIN! So, I asked him how he would like me to treat him—as I figured he did not want opioids. Well, I was wrong, he wanted opioids, and STRONG opiates. He was a politician; so essentially, he felt that he deserved it, as he would not be someone who was “emotionally weak enough to develop an addiction.” By the by, he had a 45 pack per year smoking habit. The level of hypocrisy is incredible. After 25 years, I spent some time just doing consults, and then returned to full time practice in Florida. In 2002–2003, I had been the President of the Florida Academy of Pain Medicine. Were there problems then in the state with pill mills? Absolutely. But the state, in its questionable wisdom driven by politics, fixed that problem in a most draconian manner. It hit that fly with a sledgehammer. It changed the way pain centers were to be developed (this was after 2011) and it changed the way patients would be/could be treated—an unfortunate secondary problem that consisted of significant “unintended consequences.” The entire way the pharmacies took care of business changed. There are, according to several pharmacists and drug representatives I spoke to, supposedly unwritten rules about how the Drug Enforcement Agency (DEA) and pharmacies interact and work together. Several problems occurred in Florida—and national groups of pharmacies decided to make changes that would have significant negative effects on real chronic pain patients. This was documented by a News channel (13WTHR—in Indianapolis), in an article published in March 2014.1 A former pharmacy technician who had worked at Walgreens spilled the beans re: the companies “Good Faith Dispensing Policy Checklist,”
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Copyright ª 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Patients Suffer
which had been mentioned before but never saw the light of day OUTSIDE of Walgreens. According to this story (and the copy of the checklist I found on line), this checklist includes 4 mandatory steps before filling a prescription for one of the Good Faith Drug Policy target drugs, that is, opioids. These include:
Check Walgreens’ national Itercom Plus computer system to confirm that the prescription has not been previously denied by another Walgreens pharmacy. Review a customer’s personal prescription drug history maintained by a State Prescription Drug Monitoring Program. Photocopy a valid government photo ID for the individual(s) dropping off and picking up each prescription. Answer 7 more questions about the prescription, patient and prescribing doctor to look for “red flags” of possible prescription drug abuse. Things were looking pretty reasonable until number 4 above and the 7 below:
Whether the patient has previously received the same medications from Walgreens (NEW Prescriptions or NEW Patients are red flags). Whether the prescription is written for the same medication and from the same doctor as the previous fill (NEW DOCTOR is a possible red flag). Whether the patients and the doctor listed on the prescription are within close geographical proximity to the drug store (far distances that cannot be explained are a red flag). Whether the prescription is being filled on time (attempting to fill early is a red flag). Whether the patient is paying for the prescription using insurance (cash is a red flag). Whether the quantity of pills prescribed is considered excessive (more than 120 pills is a red flag if paying by insurance; more than 60 pills is a red flag if paying cash). Whether the patient has been taking the same medication and dosage for a long time (more than 6 months is a red flag). Therefore, if a patient is in a new accident, develops pain and receives a prescription for pain medications, and he or she was injured in a motor vehicle accident in another state, and does not have insurance so would need to pay cash for the prescription—3 red flags, the patient may not get a needed prescription. If the patient is a large person with a history of chronic low back pain, for example, who is in the accident and is given stronger pills, and, because of tolerance, is given 150 pills—the odds of a filled prescription www.americantherapeutics.com
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keep going down. If the patient has cancer pain or Complex Regional Pain Syndrome and has it for more than 6 months, and is comfortable on their medication dosages, that is a red flag? To add icing to the cake, the pharmacist can “further verify the prescription” using their “professional judgment” to determine whether they need to call the physician to verify the description and should ask:
If the prescription is written within the prescribers’ scope of practice. Diagnosis. Therapeutic regimen is within standard of care. Expected length of treatment. Date of last physical and pain assessment. Use of alternative/lesser prescription medications for pain control. Coordination with other clinicians involved in patient care. I was not aware that it was OK to break the Health Insurance Portability and Accountability Act (HIPPA) laws by giving diagnoses to pharmacists, although I may be wrong. In reality, it is legal to do so, but not mandatory, and the patients have in the past asked me not to talk about their diagnoses except with their insurance companies: i.e. patients with HIV/AIDS neuropathy get their antiretrovirals from one place and don’t want the “HIV” part of the diagnosis of neuropathy broadcast. I, for one, flunked my courses on prognostication, and cannot tell the patient, never mind the pharmacist how long the patient may be in treatment. I was not aware that I, as a Pain Medicine Practitioner for more than 3 decades, could be asked by a community pharmacist about the use of other prescriptions for pain control, as they are not provided the clinical training for making a diagnosis or treating a true acute or chronic pain patient. This information deals with a national program at Walgreens, not a Florida program. The American Medical Association, the American Academy of Pain Management, and even the Florida Medical Association have been sent concerns from patients who cannot get a legitimate prescription filled. The DEA itself denies being a part of this problem, stating that it is the pharmacists and doctors who create the atmosphere for pain-med denials.2 They note that they are “not doctors. We’re regulators and enforcers of the law. If something is prescribed for a legitimate medical purpose, we’re certainly not going to get in the way,” noted DEA spokesman Rusty Payne.2 He further notes in that article that, “There have been no new regulations. There have been no rule changes. There have been no changes in the Controlled Substances Act.”2 American Journal of Therapeutics (2015) 22(1)
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The DEA Chronicles3 from 2013 notes the DEA’s regulations regarding corresponding responsibility. It is the responsibility “for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescriptions.” The DEA has apparently created the notion that pharmacists must identify and resolve certain red flags before a prescription for controlled substances is dispensed. These red flags may include:
Pattern prescribing—prescriptions for the same drugs and the same quantities coming from the same doctor. Prescribing combinations or “cocktails” of frequently abused controlled substances. Geographic anomalies. Shared addresses by customers presenting on the same day. The prescribing of controlled substances in general. Quantity and strength. Paying cash. Customers with the same diagnosis code from the same doctor. Prescriptions written by doctors for infirmaries not consistent with their area of specialty. Fraudulent prescriptions. Really? I can see and understand some of these, but all being red flags? If a patient sees a specialist at one of the big University Medical Centers in another state and wants to fill a prescription; if a doctor prescribes controlled substances in general (who else can do it?); if a patient cannot afford medical insurance so needs to pay in cash? These are reasons for not filling a prescription? In an article from October 20134 from WTLV in Florida, they quote (and show in a video feature—but not so he can be identified) a pharmacist who states that, “It appears that there are limits imposed by the Drug Enforcement Administration that they imposed limits at the wholesale level and forced wholesalers to impose limits on pharmacies.” Furthermore, the pharmacist states, “They view pharmacists as criminals— they use intimidation. We’re told we had to be at the state average or else. So you get to the state average,” he said, referring to the number of pain pills he can dispense each month. He adds, “Now we turn down a lot of patients who are cancer patients, sickle cell anemia patients, that the untrained person can look at and see that they have a serious medical condition. and those are the people we can’t fill prescriptions for.. because we don’t have the supply. We can’t get the medication.” He continues, “Some of the things American Journal of Therapeutics (2015) 22(1)
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that they’ve tried to get us to institute are criminal background checks on patients. They told me that if they’ve been arrested, not necessarily convicted, in their lifetime of a drug or alcohol event that would deny them medications for the rest of their life.” He adds, “One of the unwritten rules is no one below the age of 35. I can tell you we’ve turned down several wounded warriors who can’t get their medicine. We’ve been encouraged to discriminate based on age,” he stated.4 I would hate to think that this is true, but I have no way to validate these statements. In Florida, there is a state wide drug query site, as in most states, that is, fairly useful, if you do not mind the fact that it is typically a few weeks to a month behind (so you do not know what the patient did—what medications they received in the preceding month) and you cannot find out what medications a patient, who just moved to Florida from New Jersey, for example, was taking. Another example is the Illinois prescription monitoring program, which has only a 7- to 14day posting of scheduled substances and goes back 2 years. I can only get what I can get in terms of records, and then I have to accept the word of the patient (just like we used to before pain physicians were made into “policemen”). Just like I teach other physicians, in my practice, patients fill out an Opioid Management/controlled substance Agreement, they get the information regarding the known side effects of opioid use; they fill out an Opioid Risk Tool and the Screener and Opioid Assessment for Patients with Pain-Revised, before I see them; I expect (but find it very hard to get) past medical records to review before my seeing the patient; and they get Urine Drug Screens on a random basis, and are “discharged from the clinic” if an illegal substance is found in their urine (cocaine, etc). And all that is, before I even see the patient. Then, after seeing them, finding out that they have been on opioids for 8–10 years, finding out that no one has ever explained the relationship of receiving opioids and physical functioning to them (so they expect they can “coast” and why can’t they— especially if they are disabled for orthopedic, neurological or other reasons that are associated with pain). Yes, a patient with Complex Regional Pain Syndrome, who is disabled secondary to that diagnosis, deserves pain medications. There are hundreds of thousands of patients who have survived cancer but have developed a severe neuropathic pain syndrome secondary to the chemotherapy and/or radiation therapy that helped save their lives. But the oncologists may www.americantherapeutics.com
Copyright ª 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
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deny them pain medications after they are officially in remission. Their Primary Care Physicians will not give them opioids. Many PCPs relate to me that this is because they are scared of the wonderful new treatment environment. And while that goes on, as the “Affordable Care Act—ACA” gets ready to drop more problems on the masses, including making the primary care physicians responsible for taking care of most things, and therefore will most probably be expected to give their patients opioid medications and know how to do it correctly. But still, up to this date, in Florida, patients do not receive prescriptions for opioids from their primary care physicians. They do not want to expose themselves to risk of DEA observation. But they may have to soon. Excellent groups/meetings such as Pain Week, which is pretty much the largest yearly pain meeting, does its best to teach the primary care physicians what to do and how to do it, providing care of the pain patients in their practice. Interventional Pain Medicine procedures may, according to interventionists I have spoken to, diminish as the ACA may not want to reimburse “adequately” for these procedures. The Interventionalists comprise more than 89%–90% of the existing pain physicians. Politicians and physicians on advisory boards and in groups of “like minded physicians” like PROP do what they can to again, use the proverbial sledgehammer to kill a fly, and ignore the unanticipated damage that would occur to anyone with more than a few functioning neurons. If you are so afraid of the relatively small percentage of pain patients who may become “addicted” that you want to stop all pain patients who do not have cancer from receiving appropriate pain medications, then in this author’s opinion, you are small minded and cannot understand or see the big picture—statistics state that about a third of the people who live in the United States have chronic pain. And to prevent addiction in a small percent of them you want to stop opiates to the majority of them? Absurd. This specious argument, the “let’s stop giving patients pain medications so we can prevent drug addiction” and prevent millions of appropriate patients from receiving needed pain medications has been and is being seriously debated. And, so the reader makes no mistake, I do not practice by using opioids as a rule. Opioids, depending on the type of pain, may be secondary or tertiary medications. I treat neuropathic pain, for instance, with www.americantherapeutics.com
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anticonvulsants first—then, when they are optimized, I consider the use of antidepressants (specifically norepinephrine/serotonin reuptake inhibitors, antiarrhythmics, and even anesthetics). Then, if necessary, opioids could/would be titrated up to enable decreased levels of pain in patients who need it, and increased function in the patients whose pain levels on a numerical rating scale may still be a 5/10 after they are on appropriate levels of anticonvulsant medications and/or antidepressants. The level of unintended consequences is enormous. What I have seen in Florida over the past 5 months in my patients is, to me, incredible; and demeaning to the patients as well as the physicians like myself. Patients who tell me that they are treated like addicts in some pharmacies when they go in to fill a legal prescription of hydrocodone or oxycodone and acetaminophen. Patients who tell me that, when I prescribe something more appropriate for a patient than sustained release morphine, they cannot find the medication in any pharmacy. Pharmacists who tell patients that they do not think that they (the patient) needs “that much” medication! A patient of mine being treated for chronic pain, a wounded warrior, was in a car accident. He went to the hospital ED, where they refused to see him, as he told them he was being seen in a chronic pain clinic. Therefore, they did not look for or find the broken scapula I diagnosed when I saw him 2 days later. Medicaid and Medicare will cover only 2 extended release drugs in Florida: morphine and methadone. The latter, of course, is associated with the highest percentage of overdoses typically secondary to physicians who really do not know how to use it correctly but are forced to use it. If a patient (or 2, or 3, or more) cannot metabolize morphine-3 glucuronide, a pronociceptive metabolite of morphine sulfate, they cannot take the drug. Oxymorphone ER? Hyromorphone ER? Oxycodone/APAP ER? Tapentadol ER? Cannot get them anywhere. Not in this city or close, surrounding cities. It is amazing! I saw a patient released from the hospital on Oxycontin 20 mg, 3 tablets 4 times a day—secondary to a severe motor vehicle accident. Even I would not order 12 tablets a day times 30 days—but I did change it to 60 mg 4 times a day. The patient could not get it here. Another group of unintended consequences stems from both the economy, in which people with vocational loss, and insurance through the ACA, in which people cannot afford coverage in the “affordable care act”. I have had 2 patients with specific ACA issues: one stated that she made too little money to get on Obamacare (I am just reporting here, not speaking American Journal of Therapeutics (2015) 22(1)
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negatively, politically, regarding the ACA) and another patient was given a prescription for hydrocodone/ acetaminophen 4 times a day, and came back to me the next day and reported that the pharmacy told him that Obamacare (which he had) would only allow him to receive 90 pills. Two patients reported these issues. Are they true? I am accurately reporting what was related to me, and the one patient with the pharmacy issue was only given, per his state pharmacy query, 90 tablets, and I have a copy of my prescription for 120 tablets. I could not give him another prescription for more medication until a month was gone, as a patient cannot fill 2 monthly prescriptions in the same month [I do not have a problem with that per se, but when a patients is not given what was legally ordered and has to wait a month on less medication than was prescribed (and needed), I have a problem with that]. In Florida and elsewhere, one of many “red flags” is cash pay patients. But, in the depressed economy, with people losing their job and then not being able to afford an insurance plan (even Obamacare with its 3–12 K deductibles) who have pain problems have no choice but to pay cash for a medical appointment or their medications (red flags!). If that is all that they can do, secondary to a series of unintended consequences that occurred because some politicians thought that they knew better for people than the people did for themselves, that is just wrong. Because “cash pay” is a red flag, we should not see these patients who have legitimate pain problems? I do not think so. After a comprehensive history and examination is performed, if there is no reason for a pain medication or other treatment, they should not receive any prescriptions for any medication or treatment. What happened to allowing physicians to do what is right after they do what they were trained to do? The bottom line—secondary to both intended and unintended consequences, patients with real pain problems who need appropriate treatment that may include opioids analgesics cannot get them for any number of reasons, even with a valid, legal prescription given for legitimate medical issues within the scope of practice of the prescriber. They just cannot get them! They cannot be as functional as they need to be. They may be forced to obtain opioids illegally as they cannot get them legally despite doing everything right. Another unintended consequence.
American Journal of Therapeutics (2015) 22(1)
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So is there a bad guy here that is, “making this happen?” I do not think there is a single bad guy. The DEA is doing its job, the pharmacists are doing their job, but everyone is so busy doing their job no one looks at what that means to real patients. Unintended consequences. The Federal Register,5 which is the Daily Journal of the United Government stated a final rule describing the schedules of controlled substances rescheduling (upscheduling) of all hydrocodone and all hydrocodone (dihydrocodeinone) combination products used for pain or cough in all dosage forms. This rule was dated 22 August 2014 and which became effective 45 days after this date, which was 6 October 2014. This may precipitate the prescribing of codeine combination products and tramadol with or without acetaminophen by many PCPs, dentists, podiatrists, and emergent care providers who resist the need to prescribe a Schedule II controlled substance for their patients who need to ameliorate their painful acute or chronic conditions. I can only verify the truth of what I have personally witnessed. But the politicians and attorneys who make such patient unfriendly laws under the guise of helping to prevent drug addiction and other medical calamities laugh. They do not care, until they themselves or members of their families need to be treated for pain. And then they want what they want, because after all, they deserve it. Even opioids. Strong opioids. The physicians are impotent to help. And the patients—yes, so they suffer.
REFERENCES 1. http://www.wthr.com/story/23469086/2013/09/18/ walgreens-secret-checklist-reveals-controversial-newpolicy-on-pain-pills. Accessed August 17, 2014. 2. http://drugtopics.modernmedicine.com/drug-topics/ news/dea-official-blames-pharmacists-doctors-pain-meddenials?page5full. Accessed August 17, 2014. 3. http://deachronicles.quarles.com/2013/08/a-pharmacistsobligation-corresponding-responsibility-and-red-flags-ofdiversion/. Accessed August 17, 2014. 4. Crawford, H. Florida’s pill mill crackdowns hurting those in real pain. First Coast News. October 31, 2013. http:// www.firstcoastnews.com/news/article/333761/10/Pillmill-crackdowns-hurting-those-in-real-pain. Accessed August 17, 2014. 5. https://www.federalregister.gov/articles/2014/08/22/ 2014-19922/schedules-of-controlled-substances.
www.americantherapeutics.com
Copyright ª 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
So Patients Suffer—It’s for Their Own Good!!! Gary W. Jay, MD, FAAPM* The Food and Drug Administration (FDA) is the agency responsible for the approval of medications— for infections, cancer, hepatic problems, and pain, to name a few. It was not too long ago that there was an Advisory Committee that met to evaluate hydrocodone extended release (ER). What surprised me was that the committee did not focus on the drug—good, bad, or indifferent, but essentially they spent their time focusing on opioid abuse, an important and appropriate topic, but not for this time and place. It was reported that the Advisory Committee denied approval of this drug but the FDA, which has the ability to override such committee recommendations, exercised the override process and approved the medication. So, the Advisory Committee that was to negotiate the issues of this drug, dealt instead on the issue of substance abuse and expressed attitudes about the use of opioids, not factual information on the topic (medication) at hand. There is a lot of that going around. In my career, in my first 25 years of practice (I ran a tertiary care interdisciplinary pain and neurorehabilitation center) I saw more than 35,000 patients. No one, not one, overdosed or died. And I felt professional satisfaction doing what I could to help these patients decrease their pain and maintain or improve function. I was not fearful to use medications that would be useful and appropriate. But that was then and this is now: It is the attitude of those who have chosen sides—what is good for patients—irrespective or irresponsive to their needs. I would not go into the PROP versus PROMPT rivalry/contrary views on how to treat patients— how to help patients—or not. One group had its axe to grind and I was impressed and gratified by how the FDA handled this issue—it kept the ability of patients to obtain opioids alive. But, as can be seen by the FDA Advisory Committee, even when one question is asked, with an answer
AdviseClinical, Raleigh, NC. The author reports no conflicts of interest. *Address for correspondence: Chief Medical Officer, AdviseClinical, 1114 Rosepine Dr., Cary, NC 27519. E-mail: [email protected]
needed to be based on facts, the question was obviated by emotion/nonfact. Do not misunderstand. Does addiction occur—absolutely! Is it a bad thing? Of course. Do accidental overdoses occur—unfortunately. But that says nothing about the reason for the ad board. I have been in the interesting position of having a well-known politician who made a name by condemning the use of opioids because of “the horrors of addiction” come to see me for a clinical problem. He came to see me because he was IN PAIN! So, I asked him how he would like me to treat him—as I figured he did not want opioids. Well, I was wrong, he wanted opioids, and STRONG opiates. He was a politician; so essentially, he felt that he deserved it, as he would not be someone who was “emotionally weak enough to develop an addiction.” By the by, he had a 45 pack per year smoking habit. The level of hypocrisy is incredible. After 25 years, I spent some time just doing consults, and then returned to full time practice in Florida. In 2002–2003, I had been the President of the Florida Academy of Pain Medicine. Were there problems then in the state with pill mills? Absolutely. But the state, in its questionable wisdom driven by politics, fixed that problem in a most draconian manner. It hit that fly with a sledgehammer. It changed the way pain centers were to be developed (this was after 2011) and it changed the way patients would be/could be treated—an unfortunate secondary problem that consisted of significant “unintended consequences.” The entire way the pharmacies took care of business changed. There are, according to several pharmacists and drug representatives I spoke to, supposedly unwritten rules about how the Drug Enforcement Agency (DEA) and pharmacies interact and work together. Several problems occurred in Florida—and national groups of pharmacies decided to make changes that would have significant negative effects on real chronic pain patients. This was documented by a News channel (13WTHR—in Indianapolis), in an article published in March 2014.1 A former pharmacy technician who had worked at Walgreens spilled the beans re: the companies “Good Faith Dispensing Policy Checklist,”
1075–2765 Copyright © 2014 Wolters Kluwer Health, Inc. All rights reserved.
www.americantherapeutics.com
Copyright ª 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Patients Suffer
which had been mentioned before but never saw the light of day OUTSIDE of Walgreens. According to this story (and the copy of the checklist I found on line), this checklist includes 4 mandatory steps before filling a prescription for one of the Good Faith Drug Policy target drugs, that is, opioids. These include:
Check Walgreens’ national Itercom Plus computer system to confirm that the prescription has not been previously denied by another Walgreens pharmacy. Review a customer’s personal prescription drug history maintained by a State Prescription Drug Monitoring Program. Photocopy a valid government photo ID for the individual(s) dropping off and picking up each prescription. Answer 7 more questions about the prescription, patient and prescribing doctor to look for “red flags” of possible prescription drug abuse. Things were looking pretty reasonable until number 4 above and the 7 below:
Whether the patient has previously received the same medications from Walgreens (NEW Prescriptions or NEW Patients are red flags). Whether the prescription is written for the same medication and from the same doctor as the previous fill (NEW DOCTOR is a possible red flag). Whether the patients and the doctor listed on the prescription are within close geographical proximity to the drug store (far distances that cannot be explained are a red flag). Whether the prescription is being filled on time (attempting to fill early is a red flag). Whether the patient is paying for the prescription using insurance (cash is a red flag). Whether the quantity of pills prescribed is considered excessive (more than 120 pills is a red flag if paying by insurance; more than 60 pills is a red flag if paying cash). Whether the patient has been taking the same medication and dosage for a long time (more than 6 months is a red flag). Therefore, if a patient is in a new accident, develops pain and receives a prescription for pain medications, and he or she was injured in a motor vehicle accident in another state, and does not have insurance so would need to pay cash for the prescription—3 red flags, the patient may not get a needed prescription. If the patient is a large person with a history of chronic low back pain, for example, who is in the accident and is given stronger pills, and, because of tolerance, is given 150 pills—the odds of a filled prescription www.americantherapeutics.com
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keep going down. If the patient has cancer pain or Complex Regional Pain Syndrome and has it for more than 6 months, and is comfortable on their medication dosages, that is a red flag? To add icing to the cake, the pharmacist can “further verify the prescription” using their “professional judgment” to determine whether they need to call the physician to verify the description and should ask:
If the prescription is written within the prescribers’ scope of practice. Diagnosis. Therapeutic regimen is within standard of care. Expected length of treatment. Date of last physical and pain assessment. Use of alternative/lesser prescription medications for pain control. Coordination with other clinicians involved in patient care. I was not aware that it was OK to break the Health Insurance Portability and Accountability Act (HIPPA) laws by giving diagnoses to pharmacists, although I may be wrong. In reality, it is legal to do so, but not mandatory, and the patients have in the past asked me not to talk about their diagnoses except with their insurance companies: i.e. patients with HIV/AIDS neuropathy get their antiretrovirals from one place and don’t want the “HIV” part of the diagnosis of neuropathy broadcast. I, for one, flunked my courses on prognostication, and cannot tell the patient, never mind the pharmacist how long the patient may be in treatment. I was not aware that I, as a Pain Medicine Practitioner for more than 3 decades, could be asked by a community pharmacist about the use of other prescriptions for pain control, as they are not provided the clinical training for making a diagnosis or treating a true acute or chronic pain patient. This information deals with a national program at Walgreens, not a Florida program. The American Medical Association, the American Academy of Pain Management, and even the Florida Medical Association have been sent concerns from patients who cannot get a legitimate prescription filled. The DEA itself denies being a part of this problem, stating that it is the pharmacists and doctors who create the atmosphere for pain-med denials.2 They note that they are “not doctors. We’re regulators and enforcers of the law. If something is prescribed for a legitimate medical purpose, we’re certainly not going to get in the way,” noted DEA spokesman Rusty Payne.2 He further notes in that article that, “There have been no new regulations. There have been no rule changes. There have been no changes in the Controlled Substances Act.”2 American Journal of Therapeutics (2015) 22(1)
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The DEA Chronicles3 from 2013 notes the DEA’s regulations regarding corresponding responsibility. It is the responsibility “for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescriptions.” The DEA has apparently created the notion that pharmacists must identify and resolve certain red flags before a prescription for controlled substances is dispensed. These red flags may include:
Pattern prescribing—prescriptions for the same drugs and the same quantities coming from the same doctor. Prescribing combinations or “cocktails” of frequently abused controlled substances. Geographic anomalies. Shared addresses by customers presenting on the same day. The prescribing of controlled substances in general. Quantity and strength. Paying cash. Customers with the same diagnosis code from the same doctor. Prescriptions written by doctors for infirmaries not consistent with their area of specialty. Fraudulent prescriptions. Really? I can see and understand some of these, but all being red flags? If a patient sees a specialist at one of the big University Medical Centers in another state and wants to fill a prescription; if a doctor prescribes controlled substances in general (who else can do it?); if a patient cannot afford medical insurance so needs to pay in cash? These are reasons for not filling a prescription? In an article from October 20134 from WTLV in Florida, they quote (and show in a video feature—but not so he can be identified) a pharmacist who states that, “It appears that there are limits imposed by the Drug Enforcement Administration that they imposed limits at the wholesale level and forced wholesalers to impose limits on pharmacies.” Furthermore, the pharmacist states, “They view pharmacists as criminals— they use intimidation. We’re told we had to be at the state average or else. So you get to the state average,” he said, referring to the number of pain pills he can dispense each month. He adds, “Now we turn down a lot of patients who are cancer patients, sickle cell anemia patients, that the untrained person can look at and see that they have a serious medical condition. and those are the people we can’t fill prescriptions for.. because we don’t have the supply. We can’t get the medication.” He continues, “Some of the things American Journal of Therapeutics (2015) 22(1)
Jay
that they’ve tried to get us to institute are criminal background checks on patients. They told me that if they’ve been arrested, not necessarily convicted, in their lifetime of a drug or alcohol event that would deny them medications for the rest of their life.” He adds, “One of the unwritten rules is no one below the age of 35. I can tell you we’ve turned down several wounded warriors who can’t get their medicine. We’ve been encouraged to discriminate based on age,” he stated.4 I would hate to think that this is true, but I have no way to validate these statements. In Florida, there is a state wide drug query site, as in most states, that is, fairly useful, if you do not mind the fact that it is typically a few weeks to a month behind (so you do not know what the patient did—what medications they received in the preceding month) and you cannot find out what medications a patient, who just moved to Florida from New Jersey, for example, was taking. Another example is the Illinois prescription monitoring program, which has only a 7- to 14day posting of scheduled substances and goes back 2 years. I can only get what I can get in terms of records, and then I have to accept the word of the patient (just like we used to before pain physicians were made into “policemen”). Just like I teach other physicians, in my practice, patients fill out an Opioid Management/controlled substance Agreement, they get the information regarding the known side effects of opioid use; they fill out an Opioid Risk Tool and the Screener and Opioid Assessment for Patients with Pain-Revised, before I see them; I expect (but find it very hard to get) past medical records to review before my seeing the patient; and they get Urine Drug Screens on a random basis, and are “discharged from the clinic” if an illegal substance is found in their urine (cocaine, etc). And all that is, before I even see the patient. Then, after seeing them, finding out that they have been on opioids for 8–10 years, finding out that no one has ever explained the relationship of receiving opioids and physical functioning to them (so they expect they can “coast” and why can’t they— especially if they are disabled for orthopedic, neurological or other reasons that are associated with pain). Yes, a patient with Complex Regional Pain Syndrome, who is disabled secondary to that diagnosis, deserves pain medications. There are hundreds of thousands of patients who have survived cancer but have developed a severe neuropathic pain syndrome secondary to the chemotherapy and/or radiation therapy that helped save their lives. But the oncologists may www.americantherapeutics.com
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deny them pain medications after they are officially in remission. Their Primary Care Physicians will not give them opioids. Many PCPs relate to me that this is because they are scared of the wonderful new treatment environment. And while that goes on, as the “Affordable Care Act—ACA” gets ready to drop more problems on the masses, including making the primary care physicians responsible for taking care of most things, and therefore will most probably be expected to give their patients opioid medications and know how to do it correctly. But still, up to this date, in Florida, patients do not receive prescriptions for opioids from their primary care physicians. They do not want to expose themselves to risk of DEA observation. But they may have to soon. Excellent groups/meetings such as Pain Week, which is pretty much the largest yearly pain meeting, does its best to teach the primary care physicians what to do and how to do it, providing care of the pain patients in their practice. Interventional Pain Medicine procedures may, according to interventionists I have spoken to, diminish as the ACA may not want to reimburse “adequately” for these procedures. The Interventionalists comprise more than 89%–90% of the existing pain physicians. Politicians and physicians on advisory boards and in groups of “like minded physicians” like PROP do what they can to again, use the proverbial sledgehammer to kill a fly, and ignore the unanticipated damage that would occur to anyone with more than a few functioning neurons. If you are so afraid of the relatively small percentage of pain patients who may become “addicted” that you want to stop all pain patients who do not have cancer from receiving appropriate pain medications, then in this author’s opinion, you are small minded and cannot understand or see the big picture—statistics state that about a third of the people who live in the United States have chronic pain. And to prevent addiction in a small percent of them you want to stop opiates to the majority of them? Absurd. This specious argument, the “let’s stop giving patients pain medications so we can prevent drug addiction” and prevent millions of appropriate patients from receiving needed pain medications has been and is being seriously debated. And, so the reader makes no mistake, I do not practice by using opioids as a rule. Opioids, depending on the type of pain, may be secondary or tertiary medications. I treat neuropathic pain, for instance, with www.americantherapeutics.com
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anticonvulsants first—then, when they are optimized, I consider the use of antidepressants (specifically norepinephrine/serotonin reuptake inhibitors, antiarrhythmics, and even anesthetics). Then, if necessary, opioids could/would be titrated up to enable decreased levels of pain in patients who need it, and increased function in the patients whose pain levels on a numerical rating scale may still be a 5/10 after they are on appropriate levels of anticonvulsant medications and/or antidepressants. The level of unintended consequences is enormous. What I have seen in Florida over the past 5 months in my patients is, to me, incredible; and demeaning to the patients as well as the physicians like myself. Patients who tell me that they are treated like addicts in some pharmacies when they go in to fill a legal prescription of hydrocodone or oxycodone and acetaminophen. Patients who tell me that, when I prescribe something more appropriate for a patient than sustained release morphine, they cannot find the medication in any pharmacy. Pharmacists who tell patients that they do not think that they (the patient) needs “that much” medication! A patient of mine being treated for chronic pain, a wounded warrior, was in a car accident. He went to the hospital ED, where they refused to see him, as he told them he was being seen in a chronic pain clinic. Therefore, they did not look for or find the broken scapula I diagnosed when I saw him 2 days later. Medicaid and Medicare will cover only 2 extended release drugs in Florida: morphine and methadone. The latter, of course, is associated with the highest percentage of overdoses typically secondary to physicians who really do not know how to use it correctly but are forced to use it. If a patient (or 2, or 3, or more) cannot metabolize morphine-3 glucuronide, a pronociceptive metabolite of morphine sulfate, they cannot take the drug. Oxymorphone ER? Hyromorphone ER? Oxycodone/APAP ER? Tapentadol ER? Cannot get them anywhere. Not in this city or close, surrounding cities. It is amazing! I saw a patient released from the hospital on Oxycontin 20 mg, 3 tablets 4 times a day—secondary to a severe motor vehicle accident. Even I would not order 12 tablets a day times 30 days—but I did change it to 60 mg 4 times a day. The patient could not get it here. Another group of unintended consequences stems from both the economy, in which people with vocational loss, and insurance through the ACA, in which people cannot afford coverage in the “affordable care act”. I have had 2 patients with specific ACA issues: one stated that she made too little money to get on Obamacare (I am just reporting here, not speaking American Journal of Therapeutics (2015) 22(1)
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negatively, politically, regarding the ACA) and another patient was given a prescription for hydrocodone/ acetaminophen 4 times a day, and came back to me the next day and reported that the pharmacy told him that Obamacare (which he had) would only allow him to receive 90 pills. Two patients reported these issues. Are they true? I am accurately reporting what was related to me, and the one patient with the pharmacy issue was only given, per his state pharmacy query, 90 tablets, and I have a copy of my prescription for 120 tablets. I could not give him another prescription for more medication until a month was gone, as a patient cannot fill 2 monthly prescriptions in the same month [I do not have a problem with that per se, but when a patients is not given what was legally ordered and has to wait a month on less medication than was prescribed (and needed), I have a problem with that]. In Florida and elsewhere, one of many “red flags” is cash pay patients. But, in the depressed economy, with people losing their job and then not being able to afford an insurance plan (even Obamacare with its 3–12 K deductibles) who have pain problems have no choice but to pay cash for a medical appointment or their medications (red flags!). If that is all that they can do, secondary to a series of unintended consequences that occurred because some politicians thought that they knew better for people than the people did for themselves, that is just wrong. Because “cash pay” is a red flag, we should not see these patients who have legitimate pain problems? I do not think so. After a comprehensive history and examination is performed, if there is no reason for a pain medication or other treatment, they should not receive any prescriptions for any medication or treatment. What happened to allowing physicians to do what is right after they do what they were trained to do? The bottom line—secondary to both intended and unintended consequences, patients with real pain problems who need appropriate treatment that may include opioids analgesics cannot get them for any number of reasons, even with a valid, legal prescription given for legitimate medical issues within the scope of practice of the prescriber. They just cannot get them! They cannot be as functional as they need to be. They may be forced to obtain opioids illegally as they cannot get them legally despite doing everything right. Another unintended consequence.
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So is there a bad guy here that is, “making this happen?” I do not think there is a single bad guy. The DEA is doing its job, the pharmacists are doing their job, but everyone is so busy doing their job no one looks at what that means to real patients. Unintended consequences. The Federal Register,5 which is the Daily Journal of the United Government stated a final rule describing the schedules of controlled substances rescheduling (upscheduling) of all hydrocodone and all hydrocodone (dihydrocodeinone) combination products used for pain or cough in all dosage forms. This rule was dated 22 August 2014 and which became effective 45 days after this date, which was 6 October 2014. This may precipitate the prescribing of codeine combination products and tramadol with or without acetaminophen by many PCPs, dentists, podiatrists, and emergent care providers who resist the need to prescribe a Schedule II controlled substance for their patients who need to ameliorate their painful acute or chronic conditions. I can only verify the truth of what I have personally witnessed. But the politicians and attorneys who make such patient unfriendly laws under the guise of helping to prevent drug addiction and other medical calamities laugh. They do not care, until they themselves or members of their families need to be treated for pain. And then they want what they want, because after all, they deserve it. Even opioids. Strong opioids. The physicians are impotent to help. And the patients—yes, so they suffer.
REFERENCES 1. http://www.wthr.com/story/23469086/2013/09/18/ walgreens-secret-checklist-reveals-controversial-newpolicy-on-pain-pills. Accessed August 17, 2014. 2. http://drugtopics.modernmedicine.com/drug-topics/ news/dea-official-blames-pharmacists-doctors-pain-meddenials?page5full. Accessed August 17, 2014. 3. http://deachronicles.quarles.com/2013/08/a-pharmacistsobligation-corresponding-responsibility-and-red-flags-ofdiversion/. Accessed August 17, 2014. 4. Crawford, H. Florida’s pill mill crackdowns hurting those in real pain. First Coast News. October 31, 2013. http:// www.firstcoastnews.com/news/article/333761/10/Pillmill-crackdowns-hurting-those-in-real-pain. Accessed August 17, 2014. 5. https://www.federalregister.gov/articles/2014/08/22/ 2014-19922/schedules-of-controlled-substances.
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Copyright ª 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
