LEGAL AND PRACTICAL ASPECTS OF PRESCRIBING OPIATE NARCOTICS FOR TREATMENT OF CHRONIC PAIN (with Frequently Asked Questions) IPS MLWhitworth, MD July 2008 FUNDAMENTAL PRINCIPLES OF OPIATE PRESCRIBING FOR CHRONIC PAIN: 1. Patients must be sufficiently responsible to use opiate narcotics as prescribed 2. Physicians must monitor patients appropriately that are receiving prescription opiates and be willing to take action to eliminate substance abuse and diversion 3. Physicians must be willing to work with the patient in achieving pain control by using a variety of methods outside of opiate prescribing and simultaneously adjusting the opiate narcotic dosing to achieve significant (but not complete) pain relief if side effects are minimal 4. Physicians cannot violate state or federal laws in their quest to provide sufficient pain relief 5. Opiates should only be prescribed for a legitimate medical purpose and in the usual course of business of a medical practice Chronic pain affects 70 million Americans and some will require long term treatment with opiate narcotic analgesics. In the context of a comprehensive pain treatment continuum, opiates may be a viable option for pain control in many patients. Opiates have the potential to reduce pain, improve function, and decrease psychological sequelae of focusing continually on pain. However, there are many pitfalls in prescribing these drugs, not in the least due to overlapping populations: A. Legitimate pain patients that utilize the medications appropriately B. Legitimate pain patients that engage in substance abuse C. Legitimate pain patients that divert part of the medications for sale to help pay expenses D. Legitimate pain patients with family members that steal or divert the elderly or handicapped patient medications E. Legitimate pain patients that lack the capability of protecting their medications from theft or diversion by others F. Chronic substance abusers that pose as pain patients in order to obtain opiate narcotics, benzodiazepines, and stimulants to misuse or abuse G. Drug diverters that pose as pain patients in order to obtain prescription medications to sell or trade, often for illicit drugs H. Agents of law enforcement or state medical boards that pose as pain patients in order to entrap physicians by using hidden cameras and wireless microphones I. Opiate induced hyperalgesia effects that actually spread and worsen the pain It is often very difficult initially to determine the group that best fits a patient or person posing as a patient. The motif is not static, and some may gravitate between groups in a short period of time. Prevention of substance abuse and diversion are of paramount importance for the physician due to the complex problems of drug addiction, drug overdose, and illicit use of drugs. The illegal street drug culture and the patient receiving opiate narcotics from physicians are not incisively separate groups, and the failure of physicians to recognize this fact leads to the physician becoming part of the drug trade pipeline since opiate medications are frequently used to trade or sell for illicit narcotics. The laws in Indiana and in the US regarding opiate prescribing are designed to prevent drug diversion, but not substance abuse. Physicians prescribing drugs to substance abusers may not run afoul of federal or state law, but may be culpable for substandard medical care and action taken by state boards of medicine for failure to recognize and act to eliminate substance abuse, especially if it results in injury or death of patients. The guidelines below will address federal and state laws in addition to good prescribing practices for the chronic pain population. Acute pain is a separate issue and is not addressed here. DEA REGISTRATION TO PRESCRIBE OR DISPENSING/ADMINISTERING CONTROLLED SUBSTANCES The granting of the DEA registration to prescribe controlled substances comes with legal and ethical attachments. The practitioner must attempt to assure drug diversion is not taking place and that the patient is using the medication in a manner consistent with that prescribed and good medical practice. FAQ: A. Are separate DEA licenses required for each location of practice? It depends on whether the drugs are being prescribed or dispensed/administered. If one is prescribing drugs only, then one DEA registration per state is used. However if there are multiple locations of administration/dispensing within the state, multiple DEA registrations are required. For multiple states, separate DEA numbers are required. B. Does the state of Indiana have a separate controlled substance registration? Yes. This is required in addition to the DEA. It may only be obtained after the DEA registration is granted. CONTROLLED SUBSTANCE SCHEDULES: The schedules of controlled substances by the federal government under USC 21-13-1- 814 categorizes the abuse potential/addiction potential of drugs based on expert opinion, not on evidence based medicine. Some classifications are anachronistic while others are inconsistent. For instance, the most abused prescription drug in the US during the recent past was hydrocodone, a Schedule III drug. Prescription drug abuse is more directly related to availability of the drug rather than the abuse potential as defined by the DEA Controlled Substance Schedules. Easy access to hydrocodone due to it being one of the most prescribed prescription drugs in the US along with its refillable status, creates part of the abuse issue with this drug. Hydrocodone, in a single tablet containing 15 mg is classified as Schedule II while 2 tablets of 10mg hydrocodone are classified as Schedule III. The most abused illicit drug in the US is the Schedule I marijuana, while THC, the active ingredient, is a Schedule III drug. Cocaine, methamphetamine, and PCP (angel dust) all have a very high potential for abuse (arguably much more than marijuana) yet are all Schedule II drugs. Hydrocodone 10mg tablets are Schedule III yet are approximately twice as potent as oxycodone 5mg, a Schedule II drug. Both Oxycontin 80mg and oxycodone 5mg are Schedule II even though the former contains 1600% the quantity of active ingredient as the latter. Notwithstanding the glaring inconsistencies in this system, it forms the basis for specific legal requirements for writing prescriptions. Schedule I: Marijuana, LSD, Ecstacy, GHB, many precursors and derivatives of other legal and illegal drugs. Schedule I drugs may be prescribed only with permission from the DEA for research purposes only. Schedule I drugs have no useful medical purpose. Schedule II: Cocaine, methamphetamine, PCP, poppy straw, opium, morphine, oxymorphone, oxycodone, hydromorphone, meperidine, methadone, fentanyl, sufentanil, alfentanil, remifentanyl, levodromoran Schedule III : buprenorphine, butalbital, codeine (up to 90mg/dose unit combination product), hydrocodone (less than 15mg/dose unit), morphine combinations up to 50mg/ml, ketamine, androgenic steroids, marinol Schedule IV:Darvocet, talwin, ambien, lunesta Schedule V: Lyrica, dilute dihydrocodeine, dilute opium The State of Indiana includes Soma (carisoprodol) in the Schedule IV classification under IC 35-48-2-10(c). WRITING PRESCRIPTIONS A. Legal Requirements for the prescription documents are?: A prescription for a controlled substance must include the following information: Date of issue (must be the date signed…cannot be post dated) Patient’s name and address, Practitioner’s name, address and DEA registration number, Drug name, Drug strength, Dosage form, Quantity prescribed, Directions for use, Number of refills (if any) authorized, and Manual signature of prescriber. The provider does not have to personally write out the information on the schedule III-V script: this may be done by one or more individuals. Prescriptions for Schedule II controlled substances must be written and be signed by the practitioner. (Note: It is permissible for an electronic medical record to print out the Schedule II-V script at the time of the patient visit, then be signed by the physician). In emergency situations, a prescription for a 48 hour supply (IC 35-48-3-9) of a Schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up with a written prescription being sent to the pharmacy within seven days. Prescriptions for Schedule III through V controlled substances may by written, oral or transmitted by fax. When written prescriptions are given to patients, often the pharmacist will verify address information and will usually input this data onto the script. FAQ: B. How many refills on scheduled drugs are permissible? 1. Schedule III/IV may be refilled up to 5 times and the scripts are valid up to 6 months, however good medical practice would dictate follow-up monitoring visits more frequently than 6 months. This is especially true if the most frequently diverted drug hydrocodone is prescribed. 2. Schedule II medications may not be refilled. However the DEA rules as of this writing do permit multiple (2 or 3) scripts for one month supplies each, with all scripts dated the same. Written on the script should be “To be filled on or after…<insert date>. 3. Schedule II drugs may be written as 3 month supply scripts for insurance plans that permit such, however it is suggested follow-up visits occur every 4-6 weeks for monitoring. It is also suggested these scripts not be mailed to patients by the physician’s office and that the patient mail the script to the pharmacy certified for tracking purposes. 3 month scripts should never be written on the first patient visit since the patient needs to establish a record of being able to take the drugs as prescribed and be on a stable dose for several months prior to instituting 3 month mail-in scripts. 4. It IS legal to write instructions to the pharmacist “To be filled on or after…..” on a script. It IS legal to write “no-partial refills” on a script although the pharmacist is not bound to follow this directive. It IS legal to write a refill interval (eg. May be filled no sooner than every 28 days). It IS legal to write a maximum number of tablets per day, week, or month. C. Are duplicate scripts or copies of the controlled substance prescription required? In Indiana, duplicate scripts are not required, however the use of such greatly enhances the ability to determine whether patients have altered scripts at the time they present them for refill. Also, duplicates or copies assist the provider’s office in determining exactly what was prescribed in the case of pharmacies or patients questioning the amounts or dosages. Electronic medical records with the ability to print narcotic scripts may serve as an alternative to paper duplicate copies or scanned copies of narcotic scripts. D. Is a special prescription form required for controlled substance scripts? Special non-alterable prescription paper must be used for prescriptions for controlled substances in some states including Indiana. Regular computer paper may not be used for controlled substance scripts. The DEA is strongly opposed to the use of scheduled drug prescription pads being used for non-scheduled drugs, although at this time, the practice is not illegal. E. Are there any special precautions needed when writing prn scheduled drugs? It is important to be crystal clear with patients on how frequent narcotics may be taken with imposed limits on the numbers of tablets per day. A script written 1-2 tablets PO Q4-6H prn would permit up to 12 tablets per day, therefore also write “Maximum __ tablets per day” with any prn narcotic script. F. Are there any special licenses required to write prescriptions for methadone, suboxone, or subutex? When used solely for the treatment of pain, there are no special licenses required outside of the DEA Controlled Substance License. However, when treating addiction or addiction in combination with pain when dispensing these medications, special registration is required for methadone treatment of addiction. Methadone addiction treatment requires the special DEA registration under 21 U.S.C. Section 823(g)(1). Subutex or Suboxone addiction treatment requires a DATA2000 waiver from the DEA. DATA2000 waivers permit the prescription or dispensing of suboxone and subutex in any setting, including hospitals, to treat addiction. . As the DEA notes the only drugs approved for narcotic addiction are the above three plus LAAM, the use of any other narcotic to treat addiction requires a new drug use application. Other forms of buprenorphine such as Buprenex are not approved by the US government for treatment of addiction and may not be used under the DATA2000 waiver program. Suboxone, subutex, and methadone may all be used to treat chronic pain without any special licensure. The treatment of a chronic pain patient with methadone followed by designation of the patient as an “addict” then continued treatment with methadone by physicians without the special DEA methadone treatment registration is illegal. Non-physicians may not treat patients with methadone, suboxone, or subutex for addiction. G. Are there any accepted maximum limits on the daily or monthly amount of narcotics that can be written for a patient? There are no legal limits on the amounts of narcotics that may be written in mg or number of tablets, however prudent prescribing would dictate reasonable limits be employed. When prescribing significant amounts of schedule II narcotics (>60mg a day oxycodone equivalent), referral to pain medicine for evaluation of the appropriateness of dose prescribed is useful. Significant hydrocodone amounts have the same effect clinically as the schedule II drugs, therefore the amounts of hydrocodone prescribed should be limited. There is a recent movement by health insurers to limit the amount or type of medication that is covered due to solely financial considerations of the insurers expenditures. The most extreme case is a group of Washington State medical directors (of insurers) that have artificially contrived 120mg a day morphine or its equivalent as being the maximum dose needed for chronic pain. There is no scientific evidence to support this position. H. Is it legal to mail the prescriptions to the patient instead of having them come in to pick them up? Whereas this may be done in emergency situations such as when a patient becomes temporarily homebound to due severe weather or illness, routine mailing of opiate narcotic prescriptions is a very bad idea. There is no way for you to verify the intended person only would receive the prescriptions thereby creating a situation enabling drug diversion. Also, mailing of prescriptions fails to provide for routine and timely face to face patient assessment to insure lack of significant side effects and to explore substance abuse issues. INSPECT PROGRAM FAQ A. What is the INSPECT program? An Indiana program of the board of pharmacy that permits nearly instantaneous access on-line for all controlled substance prescriptions filled in the state for a given patient over the past 1-2 years. The data is returned includes the date the prescription was filled, the quantity and dose, pharmacy name and telephone number, physician/practitioner name and telephone number, and the number of days the script was estimated to last. ALL PHYSICIANS PRESCRIBING OPIATE NARCOTICS SHOULD UTILIZE THE INSPECT QUERY FOR ALL NEW PATIENTS AND RANDOMLY FOR CURRENT PATIENTS. B. How do I register for the INSPECT program? www.in.gov/pla then click on “Inspect” on the left hand side of the screen. Under FAQ is information on how to sign up. C. May my staff run INSPECT reports? Yes. The clinic staff may be designated as an agent of the practitioner and run the reports for the practitioner. There are penalties for misuse of this information. The information obtained from INSPECT is to be used only by the practitioner, however it may be shared with other physicians treating the patient. D. What patient information is required to run an INSPECT report? First name, last name, date of birth, street address, zip code. The INSPECT program has software to search for other addresses for the patient. RESPONSIBILITY OF THE PHARMACIST FAQ A. Is the pharmacist obligated to fill a presented script? No. Pharmacists have an obligation to assure controlled substance prescriptions are legally valid and whether they are therapeutically appropriate. This means the pharmacist is the last check on the patient’s prescription before the patient receives the controlled substance. If the pharmacist suspects diversion, overdose, or other irregularities (such as multiple prescriptions for narcotics being presented by several practitioners in a short period of time) , he has an obligation to with-hold the prescription and seek clarification. If there is obvious alteration of the script, the pharmacist will usually call the prescribing physician and in some cases may contact the police since script alteration is a felony offense. B. May a pharmacist legally change the script? The pharmacist may add the patient’s address or change the patient’s address upon verification. The pharmacist may change or add the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted on the prescription as well as the patient’s medical record. The pharmacist is permitted to make information additions that are provided by the patient or bearer, such as the patient’s address, and such additions should be verified. The pharmacist is never permitted to make changes to the patient’s name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber’s signature. C. May a pharmacist partially fill a narcotic script? Yes, but with restrictions. A schedule III script may be split into smaller fills as long as the total amount given to the patient does not exceed the amount prescribed. Schedule II scripts may be filled for less than the amount written with the option for the balance to be filled by the pharmacist within 72 hours. Partial refills of Schedule II scripts by law must be reported to the practitioner by the pharmacist. In order to avoid multiple patient visits to the practitioner in a given month, the physician may write or have typed on the script “NO PARTIAL FILLS” and instruct the patient to not accept partial fills of scripts. D. What is the responsibility of a mail in pharmacy to assure the patient receives their scripts in a timely manner? None. Mail in pharmacies may hold scripts for days or weeks before the patient receives their medication. Frequently mail in pharmacies tout to patients a 5-10 day turnaround time. However when the initial scripts are mailed, the timeframes are often much longer, therefore it is prudent to prescribe medications for one month, then have the patient come back the next week to pick up a 3-month mail in script to be mailed immediately. E. My patient tells me they have been receiving their medications through an off-shore internet pharmacy without a prescription. Is this legal? No, it is illegal because it involves unauthorized importation of narcotics into the US, and is a felony. If the patient seems not to understand the gravity of this situation or appears to be equivocal about cessation of this practice, it would be prudent for the physician to not prescribe any narcotics to such patients. F. A company has approached me about dispensing narcotics from my office in order to save the patient money and for their convenience. Is this a good idea? Although the practice is legal if record-keeping and storage requirements are met, there are several reasons not to do this. The practitioner’s office may become a target for break-in and theft of drugs along with destruction of property. The patient will receive less scrutiny from the practitioner that may have no idea the patient is receiving medications from multiple prescribers (pharmacists may have alternative avenues in determining subterfuge and diversion). The increased documentation requirements of having to input the patient’s entire list of drugs into a separate computer may not be efficient use of practitioner’s or staff time. Having a pharmacist serve as a final check on the patients in this population that necessarily includes drug abusers and diverters is an excellent idea to protect the patients and potentially protect the practitioner’s license to prescribe these potent substances. FEDERAL AND STATE BOARD ACTIONS AGAINST PHYSICIANS WRITING SCRIPTS FOR OPIATES IN CHRONIC PAIN TREATMENT Am I incurring risk to my medical or DEA license when prescribing opiates for chronic pain? In spite of all the press received by physicians having their medical license revoked or their DEA license surrendered as a consequence of prescribing opiates in their practice, the actual numbers are quite small, and most instances were due to physicians engaging self prescribing, prescribing for non-patients, inadequate documentation, etc. There are 120 physicians a year disciplined in the US for opiate related causes. There have also been several high profile cases in which physicians were involved in kickback schemes for money or drugs, or were averting their eyes from obvious drug diversion. Some physicians have warranted jail time, but for most of those disciplined, temporary or permanent licensure revocation was the order. The DEA primarily comes into contact with physicians when there is evidence of drug diversion by the physician, kickback schemes, etc whereas competency issues, self prescribing, and other issues are referred to state medical licensure boards. When the rare action is taken by medical licensing boards against physicians, most of the time the actions are justified. However, given the dichotomy in opinion within the medical community regarding the suitability of opiate prescribing for chronic pain, occasionally actions are taken by state medical licensure boards that are excessively harsh, frequently due to testimony by contrarian physicians opposing the use of opiates for the treatment of chronic pain. However, adhering to the Federation of State Medical Board Model Policy for the Use of Controlled Substances for the Treatment of Pain published 2004 will usually avert the physician from being directly targeted by state medical licensing boards and the DEA. The abridged version of these guidelines is listed in the section below “MINIMUM PROVIDER REQUIREMENTS…” Does Indiana have any regulatory protection for physicians prescribing opiates for chronic pain? No. As of May 2008, neither the legislature nor the state board of medical licensure has adopted any document that protects physicians as is specified by the Model Guidelines of the Federation of State Medical Boards (FSMB) 1999, revised 2004: “physicians will not be sanctioned solely for prescribing opioid analgesics for legitimate medical purposes”. Indiana is a member of the FSMB but remains one of the few jurisdictions in the US that has not adopted at the legislative or medical board level any policy on opiate prescribing. However, it appears through the very cryptic medical licensure board meeting minutes throughout the years that there has been a balanced and non-extremist view on opiate prescribing. APPROPRIATE CANDIDATES FOR PRESCRIPTION NARCOTICS Patients complaining of moderate to severe daily pain with legitimate appropriate medical diagnoses, lack of recent alcohol/substance abuse/illicit drug use, that have failed other more conservative therapies may be a candidate for opiate therapy. It is quite difficult to decide what constitutes a legitimate medical condition since in some diseases and syndromes commonly associated with the use of opiate analgesics, there are no objective findings to substantiate an anatomical/pathological reason for pain. The use of narcotics must be for a legitimate medical reason, therefore a correlative appropriate diagnosis is needed prior to institute chronic opiate prescribing. This may entail an appropriate medical workup including laboratory studies, neurological physical examination, thorough history, and radiological tests as indicated. Prescription opiates, as a means of pain control on a long term basis, should not be used in a vacuum without continuing evaluation and treatment of the psychological and functional deficits, and socioeconomic effects of chronic pain. Other means of pain control in addition to opiates should be simultaneously employed. In Indiana, an INSPECT report should be created prior to acceptance of any patient for narcotic therapy. The INSPECT report may be obtained far in advance of the initial patient visit, and if it is obvious the patient will not be a candidate for opiate narcotic therapy, the physician should give the patient this information in advance so as to avoid unrealized expectations of the patient. The appropriate candidate for short acting narcotics (excludes continuous release products, levorphanol, and methadone) include pain that has not responded to more conservative treatments or reasons more conservative treatments cannot be implemented. Acute pain, chronic pain, cancer pain may all respond to opiate prescribing and short acting opiates may be appropriate. Patients with substance abuse histories (other than recent prescription drug abuse) are ideally referred to comprehensive pain centers with psychological assessment capabilities for evaluation and dose stabilization. If opiates are to be prescribed in the community for those with a past substance abuse history (any illicit drug, alcohol, or prescription drugs), then extraordinary monitoring should be employed including a prescription history from all pharmacies the patient has visited in the past 6 months, short follow up intervals with limited narcotics being prescribed, use of maximum number of tablets per day being written on each script, compliance testing with urine drug screens (random), random pill counts, etc. Patients with current co-morbidities of substance abuse and chronic pain require intensive monitoring and scrutiny in addition to psychological and addiction counseling that is usually far beyond the typical family physician office capabilities and often exceeds the capabilities of most pain clinics. If such intensive treatments for these co-morbidities are not available in the community, then referral to a university based program (regardless of how far the patient must travel for this treatment) may be appropriate. It is inappropriate and foolish to prescribe opiates to patients with these co-morbidities in the absence of addiction treatment and psychological support. It is inappropriate for community primary care, specialists, or pain specialists to prescribe chronic opiates to patients receiving methadone in a methadone addiction program. Primary care referral of a patient with current substance abuse issues to one pain clinic after another when the patient is discharged from each for substance abuse (or the pain clinic stops prescribing opiates to the patient due to substance abuse) is not only inappropriate and substandard medicine but is also perpetuating the patient’s addictive behaviors, sometimes for many years. Long acting narcotics (all continuous or sustained release drugs, methadone, levorphanol) should not be prescribed for acute post operative in patients that are not already taking significant amounts of narcotics. Long acting narcotics are inappropriate for those that have recently engaged in substance abuse with short acting narcotics. Other preclusions regarding co-morbidities of addiction/substance abuse and chronic pain as delineated above also apply to long acting opiate prescribing in the presence of chronic pain. Opiate narcotics should not be prescribed for those with a history of drug diversion at any time in the past (selling or trading narcotics, use of oral narcotics ground up and injected or snorted, alteration of prescription, prescription theft). These people, despite their claims of pain, are committing felony acts, and the continued prescribing of opiates given the knowledge about their behavior, is not only perpetuating a crime, but also makes the physician culpable as an accessory to a felony. A 2007 poll of Indiana county prosecutors found that nearly all prosecutors believe the physician may be charged with a felony if they know drug diversion is or has occurred and do not take immediate steps to stop this from occurring. You may not write narcotic prescriptions for yourself, your family members, or friends. The prescriptions must be written for selected patients during the usual course of business and only for legitimate medical purposes (see below). You cannot write prescription narcotics for patients you have not seen for recent evaluation or consultation, and must have performed a history and physical exam prior to writing prescription narcotics. FAQ: Are there any methods to predetermine who is an appropriate candidate for prescription narcotics on initial evaluation? RED FLAGS: DO NOT PRESCRIBE NARCOTICS 1. No available prior medical records even though patient is receiving narcotics 2. Will not divulge name or sign information release for prior physician’s records 3. Refuses all psychological, physical therapy evaluations, home exercise, and interventional techniques…wants drugs only 4. Needle track marks, skin pop marks 5. History of selling narcotics, forging prescriptions, manufacture of methamphetamine or other illegal drugs, or stolen prescriptions 6. Patient travels hundreds of miles to see you when there are many other pain physicians closer to the patient's home 7. Previously discharged from your practice for substance abuse or diversion 8. Refuses urine drug screen testing 9. Medical records have been altered to remove incriminating evidence YELLOW FLAGS: TREAT BUT WITH CAUTION Patients with substance abuse history (alcohol or any drug, legal or illegal) need continuous multidisciplinary care including psychology or addictionology in addition to frequent visits early on and random drug screens. Do NOT prescribe narcotics to these patients without first obtaining psychological consultation regarding the appropriateness of narcotic therapy and unless the patient is willing to continuously be engaged in a formal addiction counseling program while controlled substances are being used for chronic pain. Consider urine drug screen on first visit prior to prescribing any narcotics in patients who are self-referred or in those without a primary care physician. Patients who are "allergic" to nearly every narcotic you name except the one they want should be treated with great suspicion, especially if you mention new narcotics they could not have possibly tried yet. Patients who request name brand should be told that is contrary to your medical practice. (Name brands have a much greater street recognition and therefore increased street value). There are exceptions to this however in that not all sustained release drugs have the same absorption profile. Young patients ages 20-30. (Have a statistically significant increase in illicit drug use, binge drinking both of which may result in overdose when combined with narcotics.) This age group has 300% the substance abuse of the 40-50 age group. The illicit substance abuse rate is as high as 25% of the 19-26 age group. The prescription narcotic substance abuse rate in this population is 5% within the past month and is 4 times higher than older populations. Smokers have 500% the overall non-nicotine substance abuse rate of non-smokers. The unemployed have 300% the substance abuse vs. full time employed. Those with serious mental illness have 300% the substance abuse rate vs. those without serious mental illness. American Indians and Alaska Natives have the highest race linked substance abuse rate of 13%, Afro-Americans have a 10% rate, while Caucasians have an 8% rate. Asians have a 3% substance abuse rate. (2005 NHDUS data) Personal or social maladjustment, depression, personality disorder, or a family history of addictive problems may predispose to prescription medication abuse. The Medicaid population is much more at risk for substance abuse or diversion (Pain Med. 2007 Mar;8(2):171-83) with 60% of this population exhibiting prescription narcotic misuse or illicit drug use (J Ky Med Assoc. 2005 Feb;103(2):55-62). There are also several patient questionnaires that correlate to risk of substance abuse (eg. Pain Pract. 2006 Jun;6(2):74-88, J Pain Symptom Manage. 2006 Oct;32(4):342- 51), but these all depend on the veracity of the patient. Astute drug abusers or professional drug diverters will know not to give truthful answers and will therefore erroneously be gauged to be of less risk. PRESCRIPTION DRUG DIVERSION The license to prescribe narcotics comes with the responsibility to assure the drugs are not being diverted for sale or trade (federal and state obligation), the patient is not engaging in substance abuse (state obligation), and that the drugs are being used for the intended purpose. Providers writing prescriptions for narcotics are not policemen, but have an ethical and medical duty to insure both the safety of the patient and of the community. Drug diversion is the sale or trade of controlled substance prescription drugs (USC 21-1-841-D) for other legal or illicit drugs, possessing controlled substances without a valid prescription (USC 21-1-844), the use of controlled substance prescription drugs for recreational purposes, or illegally obtaining controlled substance prescription drugs through illegal manufacture or importation of the drugs (IC 35-48-4, USC 21-1-941-D) or via prescription forgery, obtaining controlled substances by subterfuge or false identity (IC 35-48-4-14c), or prescription theft. In 2007, the Drug Enforcement Agency reported hydrocodone continued its long history as being the top prescription drug diverted in the state of Indiana, primarily via illegal sale and distribution by health care professionals and workers, “doctor shopping” (going to a number of doctors to obtain prescriptions for a controlled pharmaceutical), and forged prescriptions. Xanax®, Valium®, and methadone were also identified as being among the most commonly abused and diverted pharmaceuticals in Indiana. Drug diversion is not limited to the patients receiving prescription drugs but may extend to family members using a patient to obtain opiate narcotics. The elderly are particularly at risk for this type of diversion as the family members may not have the elderly patient’s best interest in mind (Clin Geriatr Med. 2008 May;24(2):263-74). Prescription drug diversion is not at all uncommon and is facilitated primarily by physician controllable activities as below: As can be appreciated above, a significant amount of prescription drug diversion could be eliminated in Indiana if appropriate physician actions were employed. Doctor shopping is easily detected by an INSPECT report, requiring about 20 seconds of the physician’s time. Script theft is curtailed by never leaving scripts unattended, controlling access to prescription pads by keeping them in a safe, and using numbered prescriptions. Instituting clinic policies of no call-in scripts for controlled substances and making regional pharmacists aware of your policy serves to thwart patients from calling in their own scripts or your staff from profiting through the illegal sale of called in Schedule III scripts. Forgery and script alteration is detected by either employing duplicate scripts or by using an electronic medical record to print out all controlled scripts and electronically store the information. Physician pill mills, responsible for 5% of all drug diversion, may be eliminated by incorporating good medical practice in prescribing opiates as defined by the Federation of State Medical Board Guidelines on prescribing prescription opiates for chronic pain, incorporation of urine drug testing, pill counts, and employing inflexible clinic policies regarding prescribing. Virtually 80% of prescription drug diversion as defined by the study above, is due to inadequate physician monitoring of patients and physician prescribing practices (lack of control over prescription pads and duplication/electronic storage of prescriptions) as is indicated by the starred columns above. Requiring patients (as a condition of treatment of pain with prescription narcotics) to take simple precautions to avoid residential theft such as use of a safe to store prescription narcotics will eliminate an additional 5% of drug diversion. Because the tools to eliminate a significant amount of prescription drug diversion are readily available to physicians in Indiana, it would be difficult to justify not utilizing these tools if a medical practice comes under regulatory scrutiny for serving as a conduit for drug diversion. Physicians are legally culpable and may be charged as felons under relevant state (IC 35-48-4-13,14) and federal laws as a DEA registrant if they have knowledge of drug diversion and do not take action to stop this from occurring. A poll of Indiana county prosecutors conducted in 2007 by the Indiana Pain Society found a vast majority concur with this viewpoint. If drug diversion is known by the physician to have occurred or been attempted (identical under federal law), the first steps should be immediate cessation of prescribing of all prescription narcotics, entering the information into the medical record as a warning to future physicians regarding the patient’s behavior, notifying the dispensing pharmacy, and notification of all other physicians the patient lists as current physicians. It may also be appropriate to notify law enforcement (local police in the patient’s place of residence, police drug investigation units, and in some cases the DEA) since a felony has occurred. A poll of county prosecutors in Indiana in 2007 concurs with this position. Withdrawal medications such as tizanidine may be appropriate if the patient was ostensibly on high doses of opiates, but it is inappropriate to prescribe any more narcotics to a person that has committed a felony act based on obtaining, diverting, selling, or trading prescription narcotics. If drug diversion is suspected, investigative efforts should be employed by the physician to assure appropriate patient compliance with clinic policies and relevant laws. In cases where there are anonymous reports of diversion, the physician should require a mandatory pill count at their office or at the prescribing pharmacy within 24 hours of the call to the patient. Urine drug screens may also be useful, however those using a physician to obtain prescription narcotics for purposes of diversion may take the appropriate steps to assure an appropriate drug screen. Failure to comply is taken as prima fascia evidence of drug diversion and this pill count policy should be noted in the opiate agreement with the patient. The presence of hard drugs in a urine drug screen such as cocaine, methamphetamine, ecstacy, or heroin may indicate the patients are selling or trading their prescription drugs for these illicit drugs. Several law enforcement agencies have confirmed this assertion, especially with respect to methamphetamine. Therefore, the presence of the above illicit drugs in urine drug screens in patients receiving prescription opiates should be considered to be putative evidence of prescription drug diversion and action must be taken to stop prescription opiate prescribing. SUBSTANCE ABUSE OF PRESCRIPTION CONTROLLED DRUGS Substance abuse is defined as aberrant behavior in which the patient has lost control of their use of prescription opiates. Strongly suggestive behaviors include: negative drug screens for prescription opiates being prescribed, lost or stolen scripts or medications, positive drug screens for drugs not being prescribed by physicians, aberrant behaviors such as calls after-hours about opiate medications (not related to side effects of the medication), doctor shopping (on multiple occasions obtaining prescription opiates from multiple providers without a medical reason to do so), prevarication about opiate issues, inconsistent pill counts, and illicit drug use (see below). Other indicators include overdosing on drugs (taking more than prescribed or mixing with non-prescribed drugs/illicit drugs/alcohol) with resulting hospitalization. Unlike drug diversion, substance abuse of prescription drugs is not illegal in Indiana but a physician with knowledge of substance abuse is obligated to take action to curtail or eliminate it as consistent with the medical practice act. Failure to intervene in situations where there is substance abuse may lead to serious patient injury or death. It may be difficult at times to discriminate between substance abuse and drug diversion since both have may of the same common patient behaviors. For instance, regarding prescription drugs used for non-medical purposes according to the 2006 National Survey on Drug Use and Health (NSDUH), 55.7 percent reported that the source of the drug the most recent time they used was from a friend or relative for free. Another 19.1 percent reported they got the drug from just one doctor. Only 3.9 percent got the pain relievers from a drug dealer or other stranger, and only 0.1 percent reported buying the drug on the Internet. Technically, receiving a controlled prescription opiate from a friend is drug diversion although most patients are unaware of this. One study of substance abuse found the following indicators: In the US population over age 12, the number of prescription drug abusers now tops 11 million with a lifetime prevalence rate of 20% of the US population. Most of these prescription drug abuses are opiates. The number of new abusers of prescription opiates began to climb precipitously in the late 1990s when several potent drugs were introduced (eg. Oxycontin) and after some pain societies began to extol the virtues and benefits of opiates through policy statements. Several states began adopting intractable pain laws, then the Federation of State Medical Boards promulgated their guidelines for the prescription of opiates for chronic pain treatment, further legitimizing the wholesale prescribing of opiates. Manufacturers of narcotics in the 1990s began promulgating the idea that the “addiction rate” to prescription opiates was so insignificant that there should be virtually no concerns about this issue. While this assertion defied logic based on the available statistics of the time, the source was largely traced not to a study, but to a single 10one letter to the editor (not even a formal study) in a journal stated the addiction rate was less than 0.05% based on follow-up of acute surgical and medical pain treatment in a hospital setting. Even though this information was not relevant to the chronic pain population, the connection was nonetheless made by drug manufacturers. This type of nonsensical study was widely touted by the drug manufacturers in their advertising to physicians and in “seminars” at posh resorts designed to convince doctors to prescribe more narcotics and to prescribe liberally. The 0.05% statistic became the mantra of aggressive narcotic company manufacturers and also that of chronic pain patients attempting to justify to their physicians why virtually unlimited opiate prescribing should be acceptable. Other studies demonstrating very low addiction rates were in tightly controlled populations or with exclusion criteria of prior alcohol or substance abuse. The following graph indicates the degree to which some of the opiates have increased in sales in the US, with the highest increases predictably seen in the more potent drugs with active marketing campaigns. Not only is the total mass in grams of the prescribed drugs rising, but the overall potency of the prescribed drugs is increasing to an even greater degree. The amount of opiates sold retail in 2006 in the US increased to 250% of the 1997 levels, while the overall potency of the drugs sold increased by 425% over the same time period (IPS analysis and calculations). This permissive attitude of prescribing predictably resulted in a vast increase in opiate prescriptions and a 380% increase in substance abuse of prescription opiates by new users compared to the stable period 1970-1989. The number of prescription narcotic deaths soared across America and the pervasive degree of substance abuse of prescription opiates continues to be a major societal problem. Doctors have unwittingly created significant increases in a societal problem in their effort to provide better pain control. The increased availability of opiates has predictably resulted in an increase in the death rate from prescription opiates as shown above. Note the numbers listed are per 10 million population. The death rate associated with methadone per year is now nearly equal to that of all other prescription opiates drugs as seen in the chart below. For methadone related deaths, the majority, approximately 80% , are associated with polypharmacy and only 20% of the time is methadone the sole cause of death. Therefore, UDS screening for polypharmacy opiates or benzodiazepines or illicit drugs may help reduce the rate of death due to methadone. Similarly, polypharmacy is the rule, not the exception for deaths associated with other opiate drugs. For chronic pain patients legally receiving prescription opiates, the incidence of substance abuse varies by how the study is conducted (data acquisition from patient, pharmacies, computerized central prescription databank, etc), the selection criteria employed, exclusionary criteria (some studies exclude those from participating if they have prior history of substance abuse), the definitions used for substance abuse, and whether the study is a research study conducted or sponsored by drug manufacturers. Poorly conducted studies that exclude prior history of substance abuse, are tightly controlled drug trials, or have inadequate data acquisition (rely solely on patient self- reporting instead of community pharmacy and physician data) demonstrate absurdly low rates of substance abuse that are only a small fraction of the general population. Well conducted relevant studies have shown the range of substance abuse to be 24-50% in the chronic pain population (Ann. Intern. Med. 2007 Jan 16;146(2):116-27, BMC Health Serv Res 2006:46, Clin J Pain 1997 Jun;13(2):150-5, J Gen Intern Med 2002 Mar;17(3):173-9, Int J Addict 1992 Mar;27(3):301-16, Neurology. 2004;62:1687-1694). These relatively high percentages are many fold higher than the opiate prescription abuse rate for the general US population (2.1% NSDUH 2006 statistics). College aged individuals have a much higher substance abuse rate of around 10% for non-prescribed opiate pain relievers and frequently mix these opiates with other drugs or alcohol. Of college students that have taken prescription pain medications in the last year, 29.3% of the uses were at least partially for non-medical use of the drugs (Arch Pediatr Adolesc Med. 2008;162(3):225-231) Substance abuse is frequently equated to the disease of addiction, but this designation fails to recognize substance abuse, whether alcohol, illicit drug, or prescription drug abuse is frequently a lifestyle choice. Those that have made this choice do not want to modify their behavior and are perfectly satisfied in their mode of existence. Those that have chosen substance abuse as a recreational use of narcotics may be sophisticated enough to know the proper diagnoses (usually vague and unverifiable such as chronic abdominal pain, chronic pancreatitis in the absence of enzyme changes, chronic low back pain in the absence of any radiological or diagnostic findings, etc. There are websites in which substance abusers go to learn about these diagnoses for the purpose of fleecing the medical profession in order to obtain narcotics. These people will say anything to obtain narcotics including overt lying to their physicians. Studies have shown 21% patients will lie to their physicians regarding use of other prescription drugs than are being prescribed by the physician (Berndt S, Maier C, Schutz HW. Polymedication and medication compliance in patients with chronic non-malignant pain. Pain 1993;52:331-9). Lying about prescription narcotics being taken that are not disclosed by patients is not reserved to the young adult population. One study demonstrated the sensitivity for self reporting is only 66% in the general medical population with an average age of 72 (Clin Toxicol (Phila). 2008 Mar;46(3):239-42). Another study demonstrated 50.5% of chronic pain patients had other non-prescribed narcotics, illicit drugs, or alcohol in their random urine drug screens and 25% were negative for the drugs prescribed. (J Pain Symptom Manage 2000 Jan;19(1):40-4). Other studies demonstrate patients will lie about illicit drug use with 8.4% of the pain patient population engaging in this form of prevarication (Clinical Journal of Pain Volume 15(3), September 1999, pp 184-191). The same study found characteristics of those that lie about illicit or non-prescribed narcotics include a higher rate in those that are younger, are a workers' compensation CPP, and have been assigned a DSM-III-R diagnosis of polysubstance abuse in remission. Physician’s prescribing practices, referral practices, and lack of defined or absolute clinic policies are the main perpetuating factors in prescription narcotic substance abuse. Hydrocodone is the most commonly diverted and abused prescription narcotic and frequently physicians will call in prescriptions for this drug repeatedly for patients without appropriate patient monitoring. Patients rarely seek treatment for hydrocodone abuse (Pharmacoepidemiology and Drug Safety, 2007 (16): 827-840) therefore it may not be perceived by prescribing physicians to be a drug of significant abuse, therefore promoting lax prescribing and monitoring behavior by physicians. PATIENTS WITH KNOWN SUBSTANCE ABUSE ISSUES THAT HAVE BEEN DISCHARGED FROM A PAIN CLINIC FOR SUBSTANCE ABUSE SHOULD NOT BE REFERRED TO YET ANOTHER PAIN CLINIC FOR FURTHER SUBSTANCE ABUSE. Patients with a DSM-III-R diagnosis of polysubstance abuse in remission are at extremely high risk of abusing prescribed prescription opiates. There are some patients that cannot handle the responsible use of prescription opiate narcotics and the failure to recognize such by physicians may lead to years or decades of continued substance abuse. Physicians have a responsibility to not enable their patients to continue with substance abuse. That being said, not all infractions for substance abuse carry equal weight and physicians may have differing thresholds of tolerance of aberrant patient behavior. Each situation should be examined within the context of the clinic policies towards narcotic prescribing, patient explanation of what transpired causing their designation as a substance abuser, INSPECT reports, other physician records, patterns of lost/stolen drugs, etc. Prescription drugs being abused have traditionally thought to be those most prescribed, ie. hydrocodone. Those seeking treatment for substance abuse in treatment centers paint a different picture. Oxycodone ER appears to be one of the most abused drug per 1000 prescriptions and per 100,000 population in the US (Pharmacoepidemiology and Drug Safety, 2007 (16): 827-840 ). Buprenorphine also appears to be a highly abused drug, although since its purpose is to treat substance abuse in most cases, it is not surprising that it is strongly associated with continuing substance abuse, and makes the point that opiate narcotic treatment for chronic pain patients that are current substance abusers is extremely risky. The relative risk of substance abuse per 1000 prescriptions written are seen in the chart below: The evidence presented above in the 2006 NSDUH survey showed that for every person receiving treatment for prescription pain reliever abuse (547,000) there were 9 people that were not in 2006 (4.5million in US). When recreational use of alcohol/illicit drugs are evaluated in the same study, only 1 patient received treatment out of 65 that needed treatment. Given the rate in which patients are abusing oxycodone ER that are in treatment programs and noting the above ratios of untreatment/treatment, one may calculate the overall substance abuse rate for oxycodone ER is 5.4-39% of the prescriptions written. These numbers should give the physician pause when considering every third to eighteenth prescription written for Oxycontin will result in substance abuse. Another conclusion of the Pharmacoepidemiology and Drug Safety, 2007 (16): 827-840 study demonstrated the degree of substance abuse is directly correlated to the number of prescriptions written. In areas where many opiate prescriptions are written, the degree of prescription substance abuse is much higher. In fact, it has been suggested that prescription opiate narcotics now are a “major societal problem with an incidence that appears to exceed the use of street narcotics such as heroin in the US. “ (Curr Opin Investig Drugs. 2004 Jan;5(1):61-6) Other authors concur with this conclusion (Drug Alcohol Depend. 2003 Apr 1;69(3):215-32.). A patient has been discharged from 3 pain clinics for prescription narcotic substance abuse issues and comes to me for opiate narcotics. Should I refer them to another pain clinic or prescribe the narcotics for him? Neither. The sad fact is that some patients will never be able to control their use of opiate narcotics and therefore are simply not candidates for narcotic therapy. Referring the patient to yet another pain clinic or you as a practitioner prescribing narcotics is exacerbating the problem. This patient is not a candidate for further narcotic therapy period, and alternatives should be explored. There is an extremely high rate of recurring substance abuse in patients with substance abuse histories, especially if recent. Even those being actively treated in methadone treatment centers continue to abuse oxycodone and other drugs (J Subst Abuse Treat. 2008 Feb 21). PSEUDOADDICTION Pseudoaddiction is a concept first published in 1989 that has no scientific merit. It was based on observation of the behavior of a single leukemia patient. The term was coined by a person that became the vice president of one of the largest narcotic manufacturers in the US. The premise is that people without enough opiate narcotics can justifiably lose control of their behavior regarding opiate narcotics and will subsequently engage in behavior that appears to be substance abuse. The author’s contention was that those that may engage in aberrant use of opiate narcotics are merely under-medicated. The solution proposed by the author is to give more opiate narcotics to those exhibiting substance abuse behaviors. Patients all over America have become familiar with this pseudoscientific term and use it to try to convince their physician prescribing pain medication that they need more and more narcotics. The embracement of the concept of pseudoaddiction may lead to a chronic pain population that is out of control with their use of opiate narcotics since the concept encourages excess permissiveness in the absence of any definable or objective endpoint, and transfers legal and ethical responsibility for misuse of opiates from the patient to the physician. Physicians may not ethically use the erroneous concept of pseudoaddiction to absolve themselves of the responsibility of adequate patient monitoring and taking action to prevent substance abuse. ILLICIT DRUG USE There is a definite association between prescription drug abuse and the use of illicit drugs. The use of urine drug screens (UDS) is therefore not merely an academic exercise. Positive urine drug screens (UDS) for cocaine or marijuana were found in 38% of chronic pain patients and was the most common reason for discontinuation of opiate prescribing in patients suffering from chronic pain (J Gen Intern Med. 2007 April; 22(4): 485–490) . There is a direct link between prescription substance abuse and lifetime use of illicit drugs. Statistics show those that have used marijuana in their lifetime has a 7 fold risk of prescription substance abuse, those that have used cocaine have a 5 fold risk of prescription substance abuse and those having used heroin have a 4 fold risk of prescription substance abuse (Clin J Pain. 2006 Nov-Dec;22(9):776-83). One logical regression analysis found the odds ratio for prescription drug abuse was 3.5 for positive marijuana UDS and nearly 6 for those with a positive cocaine UDS. (J Pain. 2007 Jul;8(7):573-82). Still another study demonstrated a 40% positive UDS rate for cocaine or methamphetamines (BMC Health Serv Res. 2006 Apr 4;6:46) in patients receiving prescription opiates for chonic pain. Illicit substance abuse not only serves as a marker for prescription opiate abuse but also may predispose the patient to overdose, respiratory depression, and death. For instance, there is a 20x greater death rate when cocaine is mixed with fentanyl than by fentanyl use alone (J Forensic Sci. 2007 Nov;52(6):1383-8. Epub 2007 Oct 17) As seen in the graph below there is a direct correlation between illicit drug use and abuse of prescription opiates. When it becomes apparent that either the patient has lost control over their use of the drugs, the patient is selling or diverting the drugs, or that the drugs are no longer providing any relief when given in escalating doses, then the narcotics must be withdrawn with alternative non-narcotic therapies being instituted, changing to another narcotic, re-evaluated for other medical reasons for increased pain, or tight controls imposed to assure compliance. Providers do not have a duty to provide complete pain relief, and the use and availability of narcotics are not absolute rights of the patient: prescription narcotics are a privilege afforded to those that can maintain control over their use of the drugs, have legitimate medical needs for the drugs, and are not diverting the drugs. Monitoring of patient use of the drugs (through patient history and pharmacy query) and the effect the drugs are having on the patient by self assessment and family reports are the minimum requirement for continuing to prescribe narcotics. When higher potency/dose narcotics are used, urine drug screening and random pill counts are of benefit and may ultimately save the patient from overdose or death. If there exists a acute pain problem, small doses of opiate narcotics with frequent follow-up visits may be implemented but patients with recent illicit drug use should not receive opiate narcotics for non-acute chronic pain (>2 months) without being referred to a comprehensive pain clinic with addictionology available. The referral should be made regardless of the distance the patient would have to travel or the inconvenience to the patient. If the patient refuses, then the narcotics should be withdrawn and no further narcotic prescribing rendered. FAQ: A new patient admits to recently taking cocaine and methamphetamine. Is it legal to prescribe narcotics for pain therapy? It is legal, but very unwise. A person that so flagrantly disregards US drug laws will have no respect for clinic rules regarding self control of narcotic use. The risk of untoward drug interactions between uncontrolled use of illicit drugs and prescription narcotics cannot be predicted, and may result in death or overdose. Also, a person taking illicit drugs has connections to divert the use of the prescribed narcotic for purposes of sale or trade for other drugs and is therefore at very high risk of drug diversion. OPIATE INDUCED HYPERALGESIA A seriously downplayed or unrecognized effect of opiates is opiate induced hyperalgesia (OIH) that may result in long term global body pain, reduced time effectiveness of the narcotic, and potentially permanent changes in the neurological system. Animal models in all tested species demonstrate this effect that is mediated by opiate activation of the NMDA receptor (pain producing) along with activation of the mu receptors. It is not necessary to take opiates for long periods of time for this effect to occur. There is a dose dependent activation of OIH in animal models. NMDA blockers that are non-competitive such as MK801 can eliminate OIH, however clinically available blockers are competitive at the receptor site, and therefore cannot block OIH from occurring. Methadone is a partial NMDA antagonist but OIH occurs with the use of that drug, albeit slightly slower in onset than with other opiates. OIH does not occur in all patients taking opiates, even those using high doses, although those taking high dosages tend to develop the syndrome more frequently. All route of administration of opiates produce OIH including intrathecal. There is some evidence in animal models that the neural changes are mediated by the NMDA receptor but the ultimate pathology results from new and permanent neural connections being made in the central nervous system. We have no clinical method to prevent OIH nor do we have an effective treatment. Additional opiate loads only amplify the problem and do not result in reduced pain. Drug seeking behavior of patients may be an attempt to counteract the iatrogenic opiate induced hyperalgesia in some cases. URINE DRUG SCREEN MONITORING BY PHYSICIANS Physicians who do not look for substance abuse or diversion in medical practices prescribing potent opiates will not find substance abuse or diversion, and are lulled into a false sense of security. Improper results on urine drug screens may be a red flag that the patient is diverting drugs but also may indicate the patient is in trouble with substance abuse issues. Polysubstance abuse is the rule rather than the exception in cases of drug overdose or death and the physician performing the drug screen may be the last hope in preventing such tragedies. In cases of oxycodone overdose leading to death, there are only 3% of patients that do not have drugs with sedative or respiratory depressant properties as a co-drug. In fact as can be seen in the following chart, there were 600 mentions of benzodiazepines as co-drugs in 1014 deaths, more than 450 mentions of prescription opiate narcotics, at least 300 mentions of illicit drugs, 170 mentions of carisoprodol or its metabolite, and 232 mentions of ethanol. Therefore, UDS should include benzodiazepines, carisoprodol, illicit substance, in addition to opiates. In the methadone death statistics shown previously in this paper, only about 1 in 5 have methadone listed as the sole cause of death since there are frequently other drugs present. Physicians are obligated to assure patients are not taking illicit drugs with their prescription opiate narcotics, are not taking undocumented or undisclosed controlled substances, and are taking potent prescription opiate medications as prescribed. The accuracy of UDS depends on the absence of interfering substances, the technology employed in the measurement, submission of an unaltered true urine specimen, and whether secondary confirmation tests such as GC/MS or HPLC/MS is used. GC/MS confirmation testing is always recommended before any action is to be taken against the patient since this test is virtually 100% accurate. The physician needs to assure the non-prn medications show up in the UDS, that no illicit substances are found, and that no unprescribed drugs of concern show up. One study demonstrated only 31% of patients with positive oxycodone on a specific oxycodone test strip showed up positive on the opioid strip of a multidrug test strip, therefore confirmation of positive or negative UDS for opiates via GC/MS or other sensitive method is imperative (J Subst Abuse Treat. 2008 Feb 21). An accurate questionnaire regarding when last doses of drugs were taken is imperative. The percentage of compliance of patients receiving chronic opiates is quite poor on a national level. Ameritox has as of mid 2008 590,518 specimens tested and queries patients prior to the drug screen about what drugs they are taking and when the last dose taken. The following shows significant non-compliance with physician prescribing: FAQ: A patient positive for opiates not prescribed, illicit substances, and is negative for the prescribed medication absolutely insists the test was wrong and demands to be retested. What should my response be? Retesting when the patient is expecting it when they are receiving prescription opiates is futile since substance abusing patients will have taken corrective action to ensure the retest would be negative. Discuss the specificity and sensitivity of the test with the lab for each class of drugs in question. Ask the lab about interferences in the specimen that may explain the positive values and non- positive values expected to be positive. Usually the list is small. If there are any potential interfering agents that the patient discloses that are not illicit substances and there is no other good reason the patient has for UDS to positive, then you may consider tagging the patient with presumptive substance abuse, then take the appropriate action in accord with clinic policies. If the patient is to continue receiving opiates, was a few months to recheck the UDS. MINIMUM PROVIDER REQUIREMENTS FOR PRESCRIBING CONTROLLED SUBSTANCES FOR PAIN Most state medical licensing boards incorporate the the Federation of State Medical Boards Guidelines for Prescribing Narcotics. Below is an abridged version of these guidelines. Following these guidelines will eliminate most problems regarding scrutiny of the state medical boards with respect to prescribing opiate narcotics. 1. Evaluation of the Patient: A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance. 2. Treatment Plan: The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of eachpatient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. 3. Informed Consent and Agreement for Treatment The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient or with the patient’s surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician may employ the use of a written agreement between physician and patient outlining patient responsibilities, including urine/serum medication levels screening when requested; number and frequency of all prescription refills; and reasons for which drug therapy may be discontinued (i.e., violation of agreement). 4. Periodic Review: At reasonable intervals based on the individual circumstances of the patient, the physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the physician’s evaluation of progress toward stated treatment objectives, such as improvement in patient’s pain intensity and improved physical and/or psychosocial function, i.e., ability to work, need of health care resources, activities of daily living and quality of social life. If treatment goals are not being achieved, despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance in medication usage and related treatment plans. 5. Consultation: The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangement pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation and consultation with or referral to an expert in the management of such patients. 6. Medical Records: The physician should keep accurate and complete records to include the medical history and physical examination; diagnostic, therapeutic and laboratory results; evaluations and consultations; treatment objectives; discussion of risks and benefits; treatments; medications (including date, type, dosage and quantity prescribed); instructions and agreements; and periodic reviews. Records should remain current and be maintained in an accessible manner and readily available for review. 7. Compliance With Controlled Substances Laws and Regulations: To prescribe, dispense or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations. Physicians are referred to the Physicians Manual of the U.S. Drug Enforcement Administration and (any relevant documents issued by the state medical board) for specific rules governing controlled substances as well as applicable state regulations A. How frequently should I have follow-up visits with patients receiving chronic opiate narcotic therapy? There are no legal requirements to see patients at specific follow-up intervals or frequencies, however in general for a compliant patient with no substance abuse history and a stable dose of medications, every 4-6 weeks for schedule II drugs and every 2-3 months for schedule III drugs. It is inappropriate and poor medical practice to have patients show up at the office reception area to be routinely given scripts by a nurse or receptionist without a practitioner follow-up visit. Acute pain issues or non- stable dosing require more frequent follow-up visits. B. What documentation is needed for follow-up patients receiving chronic opiate narcotics? The following elements should be documented on each patient receiving narcotic opiate prescriptions: 1. measure of the severity of the pain (eg. VAS scale or pain % reduction with medications) 2. some measure of the functionality of the patient (Activities of daily living, ability to work, etc) 3. any side effects that may be related to opiates 4. physical status including assessment of the patient’s level of consciousness, slurred speech, conversant level, any potentially opiate related physical exam effects 5. the reason for continuing opiate prescribing 6. plan including any changes in amounts of opiates with the reason for such 7. any substance abuse or diversion evidence including urine drug screening if performed C. A new patient is seen at 5 PM and presents an apparently legitimate prescription bottle of MS Contin 100mg TID, telling me he ran out of medications today, and will go into withdrawal without the medication. He has no medical records from the prescribing physician and their office is now closed. What should I do? If there are no other red flag signs (admits to recently taking illicit drugs, no self reported prescription substance abuse history, no other inconsistencies in the history and physical exam), it would be reasonable to provide the patient with a prescription for a one day supply only, to return the following day when medical records are available. Caution should be used in treating late Friday afternoon new patients, especially when they were told they must have medical records, since this may be a ploy by a diverter or substance abuser to obtain drugs surreptitiously in larger quantities for the entire weekend. The other option is to give the patient tizanidine for a day until the full medical record can be faxed from the former provider. D. A new patient arrives with their own medical records but it appears a page is missing. Should I prescribe narcotics if everything else is reasonably consistent? Substance abusers frequently will edit out parts of their medical record they do not wish to be seen by a physician. For that reason, it is a much more prudent policy to obtain the medical records directly from the prior physician’s office via fax. In this case it would be wise to avoid narcotics until the full and complete records are faxed. SETTING UP A NARCOTIC PRESCRIBING PROGRAM FOR CHRONIC PAIN TREATMENT. If the provider does not have formal training in pain medicine, then sending a patient for consultation with a pain physician may be judicious and is consistent with FSMB guidelines. The pain physician may recommend a treatment therapy, may stabilize the patient on a specific regimen then return the patient to the provider for chronic maintenance, or may assume the care of chronic narcotic prescribing. Chronic pain is a neurological disease, not a solely a nociceptive symptom such as acute pain. Accordingly, the philosophies and goals of treating chronic pain with opiate narcotics are quite different than in acute pain. There are no long term studies demonstrating positive outcomes from long acting opiate narcotic use for controlling chronic pain. The longest prospective study is 16 weeks and demonstrated only marginal improvement. In fact there are a few studies demonstrating patient’s pain actually improved once they stopped taking narcotic pain medications (Am J Ther. 2006 Sep-Oct;13(5):436-44)- ostensibly due to the NMDA receptor effects. There are very high degrees of comorbidity with psychiatric disorders and prescription drug abuse (J Clin Psychiatry. 2006 Jul;67(7):1062-73). Patients with pre-existing psychiatric diseases are three times as likely to have opiate management initiated and over twice as likely to opioid pain management continued long term (J Clin Psychiatry. 2006 Jul;67(7):1062-73). Therefore the psychiatric assessment, when available prior to initiation of opiate narcotics, may help to prevent substance abuse. Unlike other types of medical therapy, the informed consent aspect must be very specific and dictate that a patient may be withdrawn from narcotics or have the narcotics discontinued abruptly if certain conditions exist. The patients should be given a written copy of the policy in advance and you should keep a copy signed by the patient that they understand the rules, obligations, and the actions that will be taken against them if they abuse or divert drugs, engage in subterfuge to acquire drugs, or become hostile to the staff in order to obtain drugs. It should be stated there are limits on what the clinic will prescribe regardless of how bad the pain is perceived to be, and those limits are solely the determination of the practitioner. Before any self-escalations of dosing of drugs, the patient must contact the physician first and discuss the situation. Consistent with drug monitoring precepts, it is necessary the patient disclose all other controlled substances being prescribed each month and whether the patient received any opiate narcotics from another physician or from anyone else in the past month. PRECEPTS OF AN OUTPATIENT OPIATE TREATMENT PROGRAM FOR CHRONIC PAIN -Communication to the patient of the rules of the clinic on the patient’s initial visit with the patient signing an opiate agreement that they understand and agree to abide by the clinic rules -Uniform enforcement of rules of the clinic over time and between different staff -Responsibility of patient for maintaining physical control over their scripts and narcotics (lock box, don’t leave them in a car, use of a small bottle for daily use and larger bottle to keep at home), no refills on lost scripts or medications -Responsibility of patient for taking the meds as directed -Monitoring (observation, calls from family or the police, urine drug screens and GC/MS or HPLC confirmation, pill counts, pharmacy printouts, etc) INSPECT program (see below) -Consequences of drug diversion are known to the patient and staff, and are enforced with cooperation with law enforcement -The patient understands up front that opiates have addictive potential and that they will be monitored for substance abuse using a variety of methods. They also must understand addiction to opiates may require outpatient or inpatient treatment The INSPECT program in Indiana is a 20 second on-line query of patient controlled substance prescriptions for the past year or more. All physicians prescribing controlled substances should be employing this program as it is a major advancement in the tools available to prevent substance abuse and diversion. All new patients coming into a pain practice should have the INSPECT program queried and also at random and targeted intervals when substance abuse is suspected. Tactics to Bring Borderline Substance Abuse Patients Into Compliance a. Switch to fentanyl patches without breakthrough medications or with limited breakthrough medications b. Use more frequent follow-up visits of weekly intervals c. Do not write for refills on any narcotic script d. Reduction in the number of tablets prescribed e. Use of a pill box with daily sections Signs your patient may be in trouble: 1. Usage Increase- Previously, the erroneous 6. Change in Daily Habits and Appearance - concept of pseudoaddiction was used to justify ever Personal hygiene may diminish as a result of a drug increasing doses of opiates. Increased pain may addiction. Sleeping and eating habits change, and a indeed justify the need for increasing opiates, but person may have a constant cough, runny nose and patients absolutely must be held accountable to red, glazed eyes. their controlling their use of the drugs. Increases in opiates must be met with either a reduction in pain 7. Neglects Responsibilities - A dependent person or improvement in function. may call in sick to work more often, although in the case of chronic pain this may be common also. 2. Change in Personality –this can sometimes be quite dramatic with patients lashing out at their 8. Increased Sensitivity - Normal sights, sounds physician, alienating their home support system and emotions might become overly stimulating to members, or becoming excessively passive the person. Hallucinations, although perhaps difficult to monitor, may occur as well. 3. Social Withdrawal – ask patients about their activities, children, grandchildren and record these 9. Blackouts and Forgetfulness - Another clear on the chart. If there is withdrawal from these later, indication of dependence is when the person substance abuse may be in play. regularly forgets events that have taken place and appears to be suffering blackouts. This may also 4. Ongoing Use - Continued usage after a medical indicate polypharmacy or relative overdoses of condition has improved will result in the person combinations of sedating drugs including opiates, needing extensions on his/her prescription. The but does require investigation. person might talk of how they are "still feeling pain" and need just a little longer on the medication in 10. Defensiveness - When attempting to hide a order to get well. He or she might also complain drug dependency, abusers can become very frequently about the doctors who refused to write defensive if they feel their secret is being the prescription for one reason or another. discovered. They might even react to simple requests or questions by lashing out. Alarms 5. Time Spent in Obtaining Prescriptions- the should go off if family members are insisting on patient may drive great distances or out of state to increasing the opiates prescribed when the patient obtain prescriptions for opiates. is passive or when there are untoward side effects being demonstrated with the use of the medications. HOW TO HANDLE DRUG DIVERSION Drug diversion includes alteration of the quantity, dosing frequency, or milligram amounts on the script. It also includes theft of a drug, attempting to obtain drugs by subterfuge. Drug diversion should be immediately reported to the police where the patient resides. Documented drug diversion requires immediate cessation of narcotic prescribing. To continue prescribing in this situation is to risk the license to prescribe these potent opiate narcotics in addition to risking the provider going to jail. Both drug diversion and substance abuse should be reported to the referring physician, primary care physician, any other specialists the patient told you they have been seeing. When patients engage in substance abuse and are receiving no more narcotics from a clinic, their first response is to call one of the other physicians with which they have a relationship, and ask them to prescribe the narcotics. Communication by the provider discovering substance abuse to other providers may save the patient from overdose or death. In reporting to the local police that you received telephone calls from more than one person that a patient is selling prescription opiates, you are notified the patient has 3 arrest warrants outstanding for cocaine sale. The police wants to be notified when the patient arrives at your office so they can arrest her. Should I comply? No. Our role as physicians is not to actively invite law enforcement into our clinic to arrest patients for felonies that have nothing to do with our practice of medicine, unless the felony is committed on clinic grounds. For instance, if a patient is seen by clinic staff selling prescription drugs in the parking lot, then having the police arrest them is indicated. However, reporting a felony as a dutifully law abiding citizen and actively participating in the arrest are different issues, with the latter being beyond the scope of our profession. DISCHARGE VS CHANGE IN THERAPY The requirements for discharging a patient from the practice are much higher than that of simply changing therapies to non-narcotic therapy. If a patient violates opiate agreements or clinic policies, consider not discharging the patient (usually requires yet another 30 day supply of drugs the patient can abuse, formal written notice of the discharge that you have to prove the patient received, and in some states requires you to find another physician for the patient), but simply tell them they are no longer a candidate for narcotic therapy, and offer them non-narcotic therapy. Weaning or use of non-narcotic withdrawal medications may be appropriate. In such cases, if the patient on their own volition elects to seek care elsewhere, you are not responsible for providing any other narcotic treatment nor are you responsible for finding another physician for the patient. It should be noted in your chart that the patient stated they plan on finding another physician. When a change of therapy approach is used, the provider is required to provide continuing treatment of the patient in order to avoid patient abandonment claims, but do not have to provide the patient with narcotics if they are not a candidate for that therapy due to their abuse or diversion. Injections, physical therapy, psychological therapy, referral for acupuncture, non-narcotic medications are all other avenues to explore in the case when patients are no longer candidates for narcotic therapy. GOOD PRESCRIBING PRACTICES If all the criteria are met for opiate prescribing and opiates are to be prescribed on the first visit, then appropriate dosage, drug, and followup interval with a plan for monitoring must be employed. For patients already receiving opiate narcotics from another physician that is transferring pain care to your practice, assessment of the effectiveness of the opiate is necessary. The Oswestry, Beck Depression tests, and Zung anxiety tests are easy to administer functional and psych screening tests in the office setting. These tests also serve as a baseline assessment to gauge the effect of further therapies. A VAS scale range of pain experienced on a daily basis is far more useful than having the patient trying to pick an average VAS for an entire month. Use of the Hochman pain scale may be useful to identify what each of the VAS numbers mean. The initial prescription should not consist of more than a 100% increase in current medication load regardless of how severe the pain may be. Methadone should not be increased any more rapidly than 25% every week while other medications may be safer for more rapid increases as necessary. The goal of pain therapy is to reduce the pain by 50-70%. Further reduction in pain through the use of opiate narcotics may lead to rapid development of tolerance. Strict controls must be implemented on the initial patient visit. For patients that are found not to be able to control their narcotic use in the first month will prove to be very poor candidates for future opiate therapy. Excessive permissiveness with patient’s use of opiate narcotics in an early phase of treatment may send the message that substance abuse is acceptable, and may result in overdose or death during higher dose narcotic use. Followup visits initially should not further apart than monthly intervals for at least 3 months. During escalations of dosage by the physician, more frequent visits may be necessary. For borderline substance abusers intervals as little as one week or every 2 days may be appropriate. Side effects should be addressed in advance of their occurrence including constipation, nausea, sedation, lowered testosterone levels. I have a patient that is to undergo some major abdominal surgery and will need pain medications post operatively. He takes 80mg Oxycontin TID for low back pain from another provider, but I am afraid prescribing that amount after surgery may cause respiratory distress. Should I wean the patient off oxycontin prior to the surgery coming up in a week? In this case, there are several options, but weaning the patient off this high dose of medication is impractical one week prior to surgery. There is little evidence mu receptors will reset to a lower level after one week of reduced opiate dosing. First, ask the anesthesiologist to place and manage an epidural infusion for several days after surgery. Secondly, patients on chronic stable high dose opiates typically will go through a very unpleasant and painful withdrawal when the dosage is adjusted downwards. Due to activation of the NMDA system, the pain during withdrawal is much worse than the original pain, and other pain sources are amplified in their intensity. Therefore it would be prudent to continue the same dose of oxycontin or equivalent dose during the post operative period unless post surgical GI hypomotility or respiratory issues arise. Additional pain medications may be needed on top of the usual daily dose of oral narcotics. Thirdly, it would be wise to consult the opiate prescribing physician and ask them to help manage the patient post operatively if they have hospital privileges at that location. PROBLEM SITUATIONS Most problems can be averted in advance by having a clinic policy that gives direction to the patients regarding clinic requirements for narcotic use responsibility. Since the substance abuse rate is present in approximately 25% of those receiving opiate narcotic medications from physicians, compliance and monitoring must be imposed to protect the integrity of the clinic and the continued prescribing ability of the practitioner. Strict clinic policies are easier to enforce than those that are nebulous, and also are easier to defend legally when necessary. THEFT: The entire month’s supply of Oxycontin was stolen from home-patient calls in to obtain a refill Patients must be required to assume personal responsibility for the safekeeping of these medications. The clinic rules should specify there will be no replacement of lost or stolen drugs. The clinic rules should specify the patient must have a lock box well hidden or a safe at home. Theft of the lockbox or safe with a police report may be grounds for refilling a medication once. Single incident theft in the absence of a lock box or safe are usually not refilled. Repeated theft in light of patient refusing to buy a lock box should cause the patients therapy to be changed to non-narcotic therapies from that point on. High dose medications stolen may require withdrawal medicines for several days, or in the case of methadone, for several weeks. My patient is a 38 year old female with a 16 year old son that she says is a drug addict. The patient reports for the third time in a year, he has stolen her Oxycontin, that was not locked up. She refuses to report him to the police and will not engage him in mandatory drug rehabilitation stating “he is just confused right now”. How should this be handled? The patient should be withdrawn from all narcotics and given non-narcotic therapy. She is effectively enabling a drug addict and is aware that felony diversion is occurring with her prescribed narcotics, but is unwilling to take any action nor hold her son responsible for his actions. She has lost control over the prescription opiates and is no longer a candidate for opiate therapy. The entire month’s supply was stolen from their vehicle-patient wants a refill Clinic policy: no refills for lost or stolen drugs. The patient should be informed the pharmacist will create a smaller travel bottle for daily use and larger bottle to be kept at home. The entire quantity of medications for a month should never be left unattended in a car. Solution: withdrawal medications for high dose narcotic prescriptions and have the patient follow-up for the regularly scheduled appointment. LOST MEDICATIONS: Patient lost their medication script for MS Contin 60mg TID at home prior to filling it, calls you on the weekend for a refill. Solution: clinic policy that does not replace lost or stolen scripts or medications. Anyone can fill a prescription under the guise they are filling it for the patient that cannot get out of the house. Prescriptions are like money: if you walk out of the bank with a hundred dollar bill then lose it, the bank will not replace it. Neither should we as physicians replace lost scripts since the drugs may end up on the street. Also, the lost script excuse is commonly seen in substance abuse and in drug diversion. It would be acceptable to call in a script (such as tizanidine) to mollify the extent of the withdrawal response. DESTROYED MEDICATIONS: Patient spilled all the tablets into the commode when trying to take the medications- young healthy 23 year old new patient Answer: withdrawal medicines until the next scheduled script. Cancel all remaining refills on scripts and have the patient follow- up one month from the original prescription date. Spilled the tablets into the commode when trying to open the bottle-arthritic 75 year old Answer: If there are no other violations of clinic policy, then refill the script and have them ask the pharmacy for an easy open (non-child proof) lid. UNAVAILABLE FOR INSPECTION: Patient cannot tolerate the drug and threw it all away (nearly a full prescription), wants another drug Solution: Clinic policy that requires non-tolerated drugs to be brought to the clinic for disposal. The practitioner then witnesses the patient pouring the drug into the commode. This prevents multiple drugs being available in a household (available for theft, sharing, sale). If a clinic policy is in force, then withdrawal medications (non-narcotic) until the next scheduled visit. Clinic receives an anonymous call that the patient is selling the prescribed opiate narcotic and is told to go to the pharmacy within 24 hours for a pill count. The patient does not do so but shows up for a refill at the next visit Solution: change to a non-narcotic therapy and consider relaying the report to the police. HOSTILE/THREATENING BEHAVIOR: Patient is hostile and threatening physical harm against the physician if medications are not given Have the staff call the police immediately. This constitutes the crime of terroristic threatening and/or attempted extortion. Discharge the patient from the practice immediately with no further therapy. The clinic rules should specifically state such discharge will occur under those conditions. Patient is hostile and threatens to sue the physician unless prescriptions for opiate narcotics or benzodiazepines are given Document this behavior in the medical record, and if there are no medical reasons or drug diversion reasons not to prescribe these medications, write the prescriptions for one month and discharge the patient from your practice. Remember to follow this with a letter to the patient stating you will be available for 30 days only for emergency medical treatment issues and no more controlled substances will be prescribed by your practice to the patient in the future. OVERUSE OF PRESCRIPTION NARCOTICS: Patient took the month’s supply of narcotics in 7 days because the patient claims he cannot read. Answer: Patient is not a candidate for narcotics. He poses a risk to himself and potentially to others through uncontrolled usage of narcotics. Change to a non-narcotic therapy. Patient took all the prn hydrocodone in 10 days rather than the 30 days due to his increased pain, but the prescribing practitioner was not notified, and now the patient wants more drugs. Answer: Patient has lost control over their use of the drug. If this is the first offense, then tell the patient to take Tylenol or advil per the recommendations on the bottle, then the drug will be available for refill one month after it was originally filled. If this constitutes more than one offense, then the patient should be changed to a non-narcotic therapy. Such escalations should also provoke the instigation of further testing and examination of the patient to assure there are no acute issues at play. The patient overdoses on the prescribed opiate plus cocaine and is in the ICU intubated for 2 days. You are not notified by the hospital at the time and are unaware of the overdose (non-disclosed by the patient) until after the patient’s next follow-up visit. Response: call the pharmacy and cancel all refills on remaining controlled substances and call and write the patient telling him you are converting the patient to a non- narcotic therapy. DRUG DIVERSION: The script for narcotics presented to the pharmacy has the amount of medication altered from #90 to #190 and the pharmacist notifies you by telephone. Answer: Ask the pharmacist to call the police and have the person arrested at the pharmacy. If the patient left the pharmacy and the pharmacist has the script, have the pharmacist fax back to you a copy of the altered script, then call the police where the patient lives and report a felony. A husband and wife are both patients in the clinic taking different narcotics. The UDS on each shows they are sharing drugs. Response: withdrawal from narcotic therapy. The patients do not respect the US laws regarding drug diversion and have little control over their use of the narcotics. If family members or two patients living together are being seen in your clinic as patients, make sure they are taking different opiate drug classes. A patient states Fedex delivered the 3 month mail-in script for opiates to her front door and they were stolen from the porch. What should my response be? Response: This assertion requires some investigation by the physician’s office as this allegation may be true. The mail in prescription pharmacies usually require Fedex or other delivery service obtain a signature from the patient. Usually this is done, however some delivery drivers will simply drop the package on the front porch without signature. The possible scenerios include: a. theft by the delivery driver 2. theft by a passerby or a person aware the patient is receiving opiates 3. The patient is lying and actually had signed for the medication. In the latter case, the delivery driver will have a signature on file. Compare this with the patient’s signature in your clinic charts. If there is a match, then action must be taken against the patient including confronting them directly about the matched signatures. If there was no signature obtained, then the delivery service should be reported to local law enforcement and the DEA for possible company diversion of the drug. In either case, if the patient is to be retained in the practice, switch to monthly opiate prescribing with monthly office visits regardless of the increase in cost to the patient compared with 3 month mail-in prescriptions. The patient states when they went to the pharmacy to pick up their hydrocodone script, someone else had already signed for it and picked it up. Response: Call the pharmacist that filled the prescription and ask if he recognized the person that picked up the prescription as the patient. If this is affirmative, then the patient is attempting to use subterfuge to obtain opiate narcotics which is drug diversion. Notify the local police. If the pharmacist doesn’t remember the person picking up the prescription, then fax over the patient’s photo from their driver’s license copy in your file or photo from your electronic medical record. Ask the pharmacist to fax you the signature in their logbook for the transaction. If the signature matches that which you have on file, then notify the police of the attempted prescription drug diversion, and cancel all remaining refills. ILLICIT DRUGS ON UDS A random UDS picks up methamphetamine in a patient that denies it is being used. What should the response be? Always offer GC/MS confirmation of the same sample to the patient at the patient’s expense (usually urine specimens are retained by the lab for up to 3 days). UDS have many interferences and should not be relied upon as an absolute test of patient veracity. If the GC/MS is positive for methamphetamine, then consider changing to a non-narcotic therapy. If it is negative for methamphetamine, continue therapy uninterrupted. A random UDS picks up marijuana. The patient claims they were with friends in a closed car that were smoking pot. Very low levels of marijuana can be absorbed in tight quarters but the levels should be below 50mcg/dl. If the levels are higher, consider the patient to be actively smoking marijuana as this is very common in our society. Some pain centers in the US do not permit marijuana to be used at all while a patient there while others in states with “medical marijuana” laws do permit its use. In Indiana, it is illegal to use marijuana for any purpose, therefore a more conservative approach is warranted. LACK OF PRESCRIBED DRUG IN UDS One of my long term patients had an in-office urine drug screen dipstick method today but none of the opiates being prescribed, oxycodone, showed up on the screen. The patient swears they are taking the medicine and took the last dose this morning 4 hours before the drug screen. What should be my response? There are several reasons why a prescribed drug may not show up on a urine drug screen. The sensitivity of the test may not be sufficiently high due to the test limits of detection (eg. In polyclonal antibody systems, it may take 100 times as much oxycodone as morphine to trigger the “Opiates” screening strip. The patient may have substituted urine of another person or powdered reconstitute for their own urine to avoid detection of illicit substances. The patient may have not taken any of the prn narcotics in several days. The patient may have sold their medication or abused it with escalation of dose resulting in none being available. There may be a lab error or break in the chain of custody of the sample. However, a negative drug screen does require some response, so it is prudent to offer GC/MS confirmatory testing at the patient’s request. There are some drug screens now available that have a much greater specificity for specific drugs (oxycodone, hydrocodone) but in any case where the UDS is negative, confirmatory screening should be offered prior to taking any specific action. In the case above, it may be appropriate to continue with the usual prescriptions while obtaining GC/MS confirmation. If the patient does not want to pay for this but insists on the medications, you may elect to go forward with your own GC/MS confirmation that typically costs about $20. NON PRESCRIBED CONTROLLED SUBSTANCES IN UDS Methadone showed up in a UDS in a patient in which we are not prescribing methadone. What are the implications? The patient may be simultaneously receiving treatment in a methadone treatment center surreptitiously. These centers do not have to report either prescribing or distribution of methadone to the INSPECT program and permit patients to continue abusing methadone and other drugs since they operate outside physician monitoring programs. They will not voluntarily call other physicians known to be treating the patient and the only way to obtain patient information from them is via a signed release of information by the patient. Therefore, if you are not prescribing methadone, immediate cessation of all narcotics is warranted since this potent drug is either being prescribed by methadone clinics or is being obtained via felony act. The husband of a husband-wife patient pair in our practice had a UDS positive for a drug being taken by the wife. What should my response be? The husband is either stealing the medicine from the wife or is being given the medicine by the wife. Immediately call both in for pill counts and drug test the wife simultaneously. If there are discrepancies, you must take action against the husband and possibly against the wife. FREQUENT ER VISITS A patient being treated for chronic low back pain and lumbar spondylosis with oxymorphone PO has been in the emergency departments of 3 hospitals on 3 consecutive nights for calf spasticity and severe cramping requiring IV valium. The last hospital refused the IV valium. The patient did not contact their pain physician about the increased pain. What should my response be? Have the patient come to your office with their medications for a pill count and simultaneously evaluate for new sources of pain. If there is a drastic change in pain pattern or character or intensity, emergency department or office practitioner evaluation is always indicated. Do not tell patients they should not visit the emergency department for pain, but it is acceptable to tell them they should not visit the emergency department for the same chronic pain pattern and intensity that is common for them on a daily basis. MULTIPLE PRESCRIBERS The potential patient demographic data was entered into the INSPECT program and demonstrated frequent large prescriptions for opiate narcotics at 2 week intervals. The amounts were unreasonable by any stretch of the imagination. Should I accept this patient into my practice if I mandate a narcotic contract/agreement? This person has a serious substance abuse issue or is selling the drugs. It would be prudent to both contact the police in the city where the patient lives reporting a potential felony diversion and to contact each prescribing physician to make them aware of the patient’s substance abuse. Under no circumstances should this patient be accepted into the medical practice for narcotic prescribing, but may be accepted for interventional invasive therapy or PT. If the patient is uninterested in pursuing pain management sans opiates, then notify the referring physicians of this posturing. A longstanding chronic pain patient is found through random INSPECT query to have been receiving monthly opiate narcotics simultaneously for year from my practice and that of the family physician. What should my response be? Give the patient withdrawal medications and institute a no-more-narcotics treatment regimen for this patient. Notify the family physician. (Note: withdrawal of narcotics is only warranted if the patient has either falsified information about their narcotic use or violated a written signed narcotic agreement…if you do not ask the patient about receiving narcotics from other physicians, they may not tell you and if the narcotic agreement does not spell out one doc for prescription narcotics, the culpability becomes that of the physician) A patient that has been legitimately receiving opiate narcotics from my practice was discovered on INSPECT to have received narcotics from several dentists and surgeons after surgical procedures. What should my response be? If the surgical situations are bona fide, then additional opiate narcotic medications in small limited time and numerical quantities are warranted and acceptable. This should be reflected in your narcotic agreement with the patient.