Efforts to control prescription drug abuse: Why clinicians should be concerned and take action as essential advocates for rational policy

Faced with mounting evidence of a public health crisis so serious that the US Centers for Disease Control and Prevention (CDC) has termed it an “epidemic” of prescription painkiller abuse,1 resulting in an epidemic of prescription drug overdoses,2 federal and state government agencies have taken up the mantle in full force to implement a variety of far-reaching policy initiatives intended to address these related public health crises. Characteristic of most governmental efforts to rein in drug abuse over the past century or longer,3 many of these policy changes have focused almost exclusively on reducing the supply of medications available for abuse. Over the past decade, this has involved a particular emphasis on prescription opioid analgesics. From a policy standpoint, efforts to address the “supply side” of the drug abuse supply-and-demand equation are much easier to conceive and carry out than those focusing on primary prevention and access to appropriate substance abuse treatment on the “demand side.” Some have questioned the effectiveness of this heavy supply-side focus,4 but it nonetheless remains the staple of policy makers, regardless of whether the drugs in question are licit or illicit. For health care professionals and the patients with pain for whom they care, supply-side solutions pose a major concern. The CDC suggests that increased pain treatment involving more frequent prescribing of opioid analgesics is responsible for the abuse and overdose epidemics.1, 2 Clinicians certainly need to be cognizant of the potential for their opioid prescriptions to be misused, abused, and diverted, and they support taking reasonable steps to prevent such outcomes, not to mention the overdoses that can result. Concerned clinicians want to participate in a system that takes appropriate steps to prevent drug abuse and diversion, but they also need a system that allows them to provide optimal pain care for individuals with pain. Implementing a system that achieves both aims is challenging, especially in the current environment that focuses heavily on misuse, abuse, addiction, and overdose rather than on pain and suffering. Thus, the flip side of the connection between prescribing and misuse/abuse/diversion, as noted by the CDC, also should concern clinicians and their patients: the possibility that a restricted supply (in an effort to control prescription drug abuse) may reduce the availability of medications needed by patients who use them therapeutically to control their pain and maintain their quality of life. If supply limitations are severe enough, it is possible that many of the gains in controlling pain and relieving suffering over the past 2 decades could be reversed, which is a devastating consequence by any measure. Management of cancer-related pain has, for many years, understandably been a driving force behind policies focused on improving clinical access to prescription opioid analgesics, spurred largely by studies documenting a high prevalence of untreated pain, particularly among patients with metastatic disease. Over time, the resulting prescribing practices for these medications were extended to treat other types of chronic and disabling noncancer pain, causing opioid analgesic prescribing to increase dramatically overall. Now, however, the quality care gains made in pain treatment that have helped preserve the functional status and quality of life for many individuals with pain, whether or not the pain is related to cancer, may be in jeopardy. That is a steep and unacceptable price to pay in the name of taking a strong national stand against prescription drug abuse. Noteworthy among federal efforts to address prescription drug abuse are 3 recent policy initiatives that may significantly impair legitimate access to prescription opioid analgesics for individuals with pain. Each of these policies will be outlined briefly, with particular attention to their implications for access to care, followed by a discussion of alternative policy solutions that offer a more balanced approach to current challenges. An important role for health care professionals in advocating for policies that do not unduly restrict access to prescription opioid analgesics will be proposed, and available resources for assisting clinicians as advocates will be presented. In July 2012, a group calling itself Physicians for Responsible Opioid Prescribing (PROP) submitted a citizen petition to the US Food and Drug Administration (FDA), asking for changes to the label indication for long-acting or extended-release opioid analgesics (LA/ER OAs).5 At the time of PROP's petition, labels for prescription opioid analgesics stated that they were indicated for the treatment of “moderate to severe pain,” with additional language adding “…when a continuous, around-the-clock analgesic is needed for an extended period of time” in reference to LA/ER OAs. PROP requested 3 changes to this label indication: 1) strike the term “moderate” from the indication for noncancer pain; 2) add a maximum daily dose, equivalent to 100 mg of morphine for noncancer pain; and 3) add a maximum duration of 90 days for continuous (daily) use for noncancer pain.5 Notably, all 3 requests are specifically oriented toward “noncancer pain.” This petition generated 1927 written submissions to the FDA docket and resulted in a February 2013 public hearing. In written comments and testimony at the public hearing, several organizations, including the American Cancer Society and the American Academy of Pain Management (the Academy), argued that having different label indications for “cancer pain” and “noncancer pain” would be inappropriate.6, 7 These organizations also cautioned that the requested changes would significantly impair the ability of health care professionals to relieve pain effectively among many of their patients. The FDA responded to the PROP petition by denying the requests related to the dose and duration of therapy, as well as the limitation to noncancer pain, but approved the request to strike the term “moderate” from the label.8 The FDA ruled that the label for LA/ER OAs now must read “[Tradename] is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”8 The FDA expanded the label by adding a “Limitations of Use” section that reiterates the risks of addiction, abuse, and misuse of prescription opioid analgesics, and urges the prescriber to use LA/ER OAs only “in patients for whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”8 The language decided upon by the FDA seems to have left considerable room for the clinician's judgment when it comes to prescribing opioid analgesics. In its response letter, the FDA carefully elucidated the intention to not unduly tie the hands of prescribers by requiring them to progress through a “step therapy” protocol before being able to prescribe LA/ER OAs. However, by adding the phrase “…for which alternative treatment options are inadequate,” the FDA may have opened the door to the institution of step therapy protocols by third-party payers. Such a development would be unfortunate, and could result in individuals with pain suffering needlessly until they have worked through the payer's protocol. Health care professionals need to be vigilant for such an occurrence and stand ready to take action through advocacy if it does happen. Rescheduling of hydrocodone-containing combination products (HCCPs), which is an issue the FDA has been considering since receiving a citizen petition in 1999, has been a much-discussed policy decision that appears to be nearing its conclusion. In addition to the 1999 citizen petition, the US Drug Enforcement Administration (DEA) formally petitioned the FDA to move HCCPs from Schedule III to Schedule II in 2004. Four years later, the FDA recommended that HCCPs should remain in Schedule III.9 The DEA responded to this decision by requesting that the FDA reconsider, culminating in a 19-to-10 vote by an FDA advisory committee on January 25, 2013, recommending that HCCPs be moved to Schedule II.10 The FDA has followed the advisory committee's advice and recommended rescheduling to the DEA, which is now completing the rulemaking process for this change.11 Rescheduling of HCCPs, the most commonly prescribed medication in the United States,9 has the potential to create a fair amount of chaos and substantially limit its availability for a number of reasons. To begin with, storage and recordkeeping changes will be significant. As a Schedule II medication, wholesale distributors and retail pharmacies will need to store HCCPs more securely. For wholesalers, this likely means an expansion of secure holding areas in their warehouses, while retail pharmacies may be forced to expand the size of their vaults. Given the extraordinarily high volume of HCCPs prescribed, the increased storage area required may be substantial, costing millions of dollars and threatening supplies if that expansion does not occur in a timely manner and to a sufficient extent. Furthermore, retail pharmacies will be forced to check their inventories of HCCPs more regularly and, given the volume of medication affected, will require hours of additional time from pharmacy employees each week. The impact on wholesale distributors and retail pharmacies is potentially costly and very inconvenient, and may impose access limitations by virtue of insufficient capacity. However, the 2 greater challenges are related to the ability of health care professionals and the health care system to accommodate what is a potentially massive increase in the number of written prescriptions required by patients with pain. First, there are a number of states in which nonphysician prescribers (eg, nurse practitioners, physician assistants, optometrists, etc) have prescription privileges for Schedule III controlled substances, but not for Schedule II controlled substances. These health care professionals are responsible for a large number of prescriptions, but unless statutes and/or regulations in their states are changed, they would no longer be permitted to prescribe HCCPs after rescheduling. During 2014 state legislative sessions, optometrists in particular have sought to prepare themselves for this eventuality. They have advocated for bills that would permit them to continue prescribing HCCPs after they are shifted to Schedule II, but without expanding privileges to other Schedule II medications. This strategy, or else expanding the scope of practice to include full Schedule II prescribing privileges for nonphysicians, undoubtedly will be featured in a number of state legislatures over the next few sessions, assuming rescheduling proceeds as expected. By far the biggest threat to access posed by HCCP rescheduling involves the fact that, when classified in Schedule II, HCCP prescriptions no longer will be eligible for automatic refills at the pharmacy. Each time a Schedule II medication is dispensed, federal law requires a new written prescription. Furthermore, after rescheduling, HCCP prescriptions cannot be phoned in by the prescriber, except for an emergency supply that must be followed by a written prescription. Given that there were approximately 26 million automatic refills of HCCP prescriptions in 2011,9 rescheduling will translate to as many as 26 million additional written prescriptions needing to be generated each year. Although it is likely that prescribers will opt not to write new prescriptions in some unknown percentage of these cases, the increased volume of paperwork that will be needed is staggering, as will be the increased traffic through medical clinics' front offices. Furthermore, some prescribers may believe that, if they are going to write a prescription for a Schedule II prescription opioid analgesic, they should schedule an office visit to properly assess the patient and bill for that visit. The potential financial of up to 26 million additional office a dollars year. this that up to 26 million can be in a health care system that is to its some will not be involved they cannot prescribe Schedule II as Although HCCPs are most commonly prescribed for those pain to who are being for by a primary care individuals with cancer-related pain may be by rescheduling. with use HCCPs when they are pain to a cancer-related medical or such as a for pain in with an LA/ER or for around-the-clock treatment of chronic pain related to and its not to mention those who use HCCPs to treat pain that is to their options for health care professionals are at this of the from the Academy and several have a to the DEA in which HCCPs would remain in Schedule III but the amount that could be in would be and the amount with an prescription refills is to a Although this would a toward the it is unknown the DEA will may be that advocates will need to a impact on individuals with pain resulting from rescheduling, and or legislative changes that will these that will be a to In the past few years, the DEA has up its efforts to as well as other of opioid analgesics. These efforts have focused on wholesale distributors who have massive of controlled to retail pharmacies that such were retail pharmacies that these and medications to patients the of that the prescriptions were and prescribers who prescriptions that may not have been for a legitimate medical In 2012, the DEA the of controlled from for 2 and the controlled of 2 in the In 2013, the pharmacy million by the In as of this the DEA the controlled for until and of its retail until The DEA has that both wholesale distributors and retail pharmacies have a to their and to care to that all controlled to retail pharmacies and from them are going to be to and legitimate Faced with the need to more to the of each controlled substance responded by its requiring to take a of steps when with a controlled substance steps that include calling the prescriber to the patient and the and treatment and the prescriber as Physicians responded to what they to be by the by a at the American that or legislative and/or In the of these individuals with pain have pain medications patients with and a of by the that most were or other in receiving their controlled substance on patients pharmacy. have the efforts to control the supplies of controlled for these access Health care professionals the efforts to control medication and the those efforts have on their ability to care for patients with pain, have few options to the options with strong between prescribers and as a means of that will when with a prescription written by those the that to be resulting from the is much more the most federal both the DEA and at the and of the for individuals with pain. discussion has the of and supply-side policy to prescription drug abuse that may any of the more may in misuse and abuse and to those with pain. of opioid analgesics that individuals from their extended-release to high have considerable attention in the past few The FDA has to the steps to its as an but the have not been opioid analgesic on the has been an and suggests a resulting from that as a drug of abuse, it is also that there has been a toward other prescription and Although this will require its policy the of as a more and prevention to abuse by those who would otherwise their in that permit the of the for or are a major for opioid analgesic medications that are or abused, abuse prevention through and medication storage and from the 2013 on Drug and Health that of those who opioid analgesics the medications from a with greater than the medication given to them by a or at no An additional they or taken it from a or These the of in that and the of medication storage and including at the time opioid analgesics are prescribed and dispensed, to specifically of opioid analgesic misuse without the supply available for individuals with pain. the DEA has the in with law At these individuals can any ineffective, or medication opioid for and with no to expand and more frequent and to include pharmacies in addition to law would to to opioid analgesics they may otherwise in their which in would prevent those medications from for the by those to misuse or abuse The DEA is its for and these more available important for clinicians prescribing practices supply-side clinicians to prescribe only the number of they patients to need in pain and the of prescribing is of these Although clinicians are to provide for their pain particularly as a result of or a number of can and create of medication that could be for misuse and abuse. Prescribing more some for clinicians and patients in in which the amount prescribed be but an important clinical practice to prevent the possibility of prescription drug abuse. drug are on controlled substance They are by agencies state most of of or law Although they have since health care were intended to for and individuals who controlled substance prescriptions from of prescription that only of all individuals for this but that those individuals of all opioid prescriptions and of the of medication which is an of the medication for such a group of clinicians a before an opioid prescription for a patient this by reducing supplies for abuse and/or than to prevent and drug also provide support for clinicians who need to prescribe opioid analgesics to treat their pain. In many cases, clinicians may be so they only the related to them by their as well as that is in their may be it may not include from other clinical and patients may not and for or clinicians and to the full controlled substance prescription by a will those and the to prescribe access for the appropriate clinical use of the of the most important challenges in to their full potential is the of use by in states in which use is from that, than of all prescribers and are to access the and to request on their patients a year. Given that no can be for any if it is not must be practices that support and other steps (eg, to access the to increase and use of the to create policies that require to access before prescribing have been in many given these evidence is needed to effectiveness at both reducing the of prescriptions and improving patient The policies that reduce supplies of for misuse and abuse are policies the for prescription drugs may be as to prevent individuals from the of of and have been in for many to primary drug abuse prevention more is and the of these prevention efforts as a national should be by including through their For individuals who have a substance use 2 of treatment also are that to prevent have for and continue to an important role in prescription drug abuse. The most recent for opioid involves products in treatment for substance use has but is by the of who are able to take on new patients. to the availability of are including the maximum number of patients for each and nonphysician such as nurse and physician assistants, to provide this is an important of and policy must take steps to availability of that as for changes in pain management policy can be and Clinicians are to time many when considering in policy the issue is high on the of organizations such as the American Cancer Society and its advocacy the American Cancer Society Cancer as well as the Academy through its Pain by the Academy in 2012, the of is to as a and for individuals and organizations advocating for balanced pain management As a focused on policy pain has the resources to provide the issue policy and required to to policy and both organizations and large national and have significantly in national advocacy including policy legislative and and organizations have patient access to appropriate pain medication as a high policy and legislative If pain management policy is to be to clinicians to provide optimal pain care, clinicians must more involved in the impact that government policies are having on their ability to provide what is for their patients. The of patients with pain who can the impact of supply-side to prescription drug abuse on their ability to access pain treatment are especially with clinicians and and the can provide the advocacy needed to policy to these advocacy the of Pain and has a of progress and that as that both and have to and implement advocacy action pain a policy on the of the Pain and state from a of all and policies medical and pharmacy practice related to the treatment of pain, with a particular on the with the legitimate use of opioid analgesics for pain a by the American Cancer and the the most recent policy were in July all and policies in by The most recent that, in the states or policies language or more in of those states the policy resulted in a states have an having the most balanced pain policies in the of states now have a the of with in no since or since resulted policies to appropriate pain care, or and 2) state legislatures or agencies or policy The policy over the seems to be with government and agencies that could with legitimate medical practice and patient However, in the a number of state legislatures bills that, when in could create to appropriate pain Although these bills were not in large to the advocacy of such organizations as and is required to policy and increase possible policy does not In the potential for policy to clinical practice on the to which it is and Clinicians should be and with the federal and state policies that their pain management including when the and of opioid analgesics. The public policy challenges of controlled substance abuse and chronic pain can be at for health care practitioners, and individuals pain and other medical Clinicians and their patients with the of optimal from these while at the time the of use and with and other policies that are enough to clinicians the required for enough to prevent the of the prescription drug abuse By focusing on supplies of the policy initiatives outlined are to these efforts to reduce prescription drug abuse. related to the in this that are on or are to by being to effectively address the on patient care or there is evidence available to in policies that have been to reduce prescription drug abuse without unduly access to the medications. As a all are involved in a with areas of is that any new policy to address these has a required and that the new with to its intended as well as the and of its this will of policies when to optimal for In addition to the federal policies in this state and regulations to access and must be also by advocacy Clinicians and patients with pain who themselves access limitations should to out to the and in this area of policy advocacy it is going to be the of and individuals that has the potential to to their when this is given the attention to prescription drug abuse will as a the and to of 2 public health that of prescription drug abuse and untreated or chronic pain. That is a but that can be if and with pain and their who are suffering