Guidelines from national pain management organizations remain available to Pa. physicians, while also forming the basis of state regulatory oversight and enforcement.

Clinical obstacles to effective pain management remain, as the health care system’s traditional focus on acute care treatment has historically not focused on pain management and many physicians have not received sufficient training to diagnose pain and prescribe appropriate treatments with confidence.

Remedies to this clinical knowledge gap are becoming increasingly available – including better training in pain management for all physicians, the emergence of pain specialists, and the development of multidisciplinary pain management centers – each of which promises to facilitate appropriate care for particular patients in particular circumstances.

Federal and state laws govern the availability and prescribing requirements of opioid analgesics, which are classified as controlled substances because they have an "abuse liability," i.e., they are targets for diversions, and some patients can become addicted. The federal Controlled Substances Act (CSA) is intended to accomplish both control and availability. Under this act, licensed professionals can prescribe, dispense and administer controlled drugs for legitimate medical purposes in the course of professional practice. The "control" portion of this act, which attempts to prevent diversion, establishes a system of security and requires record-keeping procedures that carry penalties, including criminal prosecution, if not followed by clinicians. Researchers say the federal laws governing controlled substances are fair and balanced, but for physicians, the mystique surrounding these laws appears to chill the prescribing of these medications, even when deemed medically necessary.

Health groups and law enforcement have been collaborating in an effort to quell practitioner fear in regard to prescribing pain medicine. Last August, the U.S. Drug Enforcement Agency (DEA), along with the University of Wisconsin Pain & Policy Studies Group (PPSG) and the Last Acts Partnership, issued a 48-page informational document entitled "Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel" (FAQ). This document was intended to provide a point of reference for clinicians and regulators on pain management best practices, laws and regulations. The FAQ, which was published on the DEA Office of Diversion Control Web site, was thought by some to encourage effective, lawful pain management. This "unprecedented" collaboration began in 2001, when DEA and 21 health groups – including the American Medical Association (AMA), the American Academy of Pain Medicine, and the PPSG – issued a consensus statement saying that effective pain management is an integral aspect of quality medical care, and calling for policy that works to prevent the abuse and diversion of prescription pain medicine, while not hindering patients’ ability to receive the care they need. The plan hit a snag when the DEA withdrew its support of the FAQ just two months after its publication saying that the document contained "misstatements." The principal members of the group that worked on the FAQ reacted with surprise, and responded promptly: David E. Joranson, Director of the PPSG, said in a letter to the agency that it’s sudden withdrawal threatened to undermine years of progress to further educate clinicians about pain management. The agency responded the following month.

DEA explained its position in the form of an Interim Policy Statement (IPS) published in the November edition of the Federal Register, which is the official daily publication for rules, proposed rules and notices of federal agencies and organizations. The IPS outlines three specific "misstatements" in the FAQ, including:

· Commencement of investigations. According to the IPS, "The FAQ erroneously stated that, ‘The number of patients in a practice who receive opioids, the number of tablets prescribed for each patient in a practice, and the duration of therapy with these drugs do not, by themselves, indicate a problem, and they should not be a used as a sole basis for an investigation by regulators or law enforcement.’" DEA asserts that indeed each of the forgoing factors may be an indicator of diversion and reason enough for investigation.

· Refills of Schedule II prescriptions. The IPS says that the FAQ states that, "Schedule II prescriptions may not be refilled; however, a physician may prepare multiple prescriptions on the same day with instructions to fill on different dates." DEA asserts that while the first part of the statement is correct, the Controlled Substance Act expressly states that, "No prescription for a controlled substance in Schedule II may be refilled," and that preparing multiple prescriptions on the same day, with instructions to fill on different dates, is tantamount to authorizing refills.

· Reselling of controlled substances. The IPS says that while the FAQ did indeed list (correctly) a number of behaviors, or red flags that are "probable indicators of abuse, addiction, or diversion," including "selling medications," the document "understated the degree of caution that a physician must exercise to minimize the likelihood of diversion." For example, rather than it being "recommended," as in the FAQ, that a physician engage in additional monitoring of the patient’s use of narcotics when such red flags exist, DEA asserts that it is a physician’s responsibility, as a DEA registrant, to exercise a much greater degree of oversight. DEA also contends that the FAQ, "incorrectly minimized" the significance of a family member expressing concern that the patient may be abusing pain medication.

"What bothers me is the tone of the statement," says June L. Dahl, Ph.D., Professor of Pharmacology at the University of Wisconsin Medical School and a member of the review committee for the FAQ. DEA emphasizes in the IPS that the FAQ was not published in the Federal Register indicating that it was not approved as an official statement, and "did not and does not have the force and effect of law." According to Dahl, the FAQ was a document two years in the making, with 20 drafts considered and reviewed by DEA prior to its release. "The withdrawal was a surprise," she says. "We are very much wanting to know what happened." For the purposes of this article, the DEA declined comment saying that the agency stands behind that which is communicated in its IPS.

The IPS’s assertion of "misstatements" in the FAQ has caused concern among researchers and drug-control policy experts alike. DEA’s withdrawal from the FAQ, and its subsequent IPS, "shows an agency that doesn’t understand what is happening," says David B. Brushwood, RPH, J.D. Professor, Health Care Administration, University of Florida and Mayday Scholar, American Society of Law, Medicine and Ethics. He says the withdrawal flies in the face of two years of discussion, and is contrary to past instruction in regard to the dispensing of controlled substances. Specifically, according to Brushwood, the DEA has stated in the past, as reflected in the FAQ that, "85a physician may prepare multiple prescriptions on the same day with instruction to fill on different dates." Posted on the PPSG Web site is letter from the DEA to a Virginia physician that confirms Brushwood’s assertion of contradiction. The letter reads that, "Although Title 21 of the Code of Federal Regulations, Section 1306.1285prohibits the refilling of prescriptions for a Schedule II controlled substance, the DEA does not consider multiple prescriptions as refills, and has authorized this practice, provided it does not violate the laws of the state in which the practitioner is licensed." Additionally, Brushwood says, it is burdensome and economically prohibitive to require a patient to visit his or her physician every month in order to receive a prescription. He further takes issue with the IPS-identified red flags for the commencement of an investigation, such as a large numbers of prescriptions issued. He says these red flags could also be considered quality indicators for effective pain management, "[The IPS] leaves uncertainty as to what is appropriate in the minds of doctors."

The FAQ has since been pulled from pain-policy Web sites, and the local health care community is responding with concern. "There are two contradictory things brewing in pain medicine," says Michael B. Furmin, M.D., Director of the Pain Management Program at the Center for Pain Management and Rehabilitation in York, "Physicians are being told to handle pain properly, including using opioids, but now with this DEA stuff, physicians, especially those in primary care, may be afraid to prescribe."

That said, statistics show such fear may be unfounded. According to government figures the likelihood of criminal prosecution is rare for physicians prescribing controlled substances. DEA statistics reveal that in 2003, only approximately less than one-tenth of one percent of all physicians registered with the DEA were investigated, and that nationally a total of just 50 physicians were arrested. According to the FAQ, in order for a physician to be convicted of illegal sale, the authorities must show that the physician knowingly and intentionally prescribed or dispensed controlled substances outside the scope of legitimate practice.

States also regulate the prescription and dispensing of controlled substances as part of their responsibility for regulating medical, pharmacy and nursing practice. Nationally, there is a push for all medical boards, including the Pennsylvania State Board of Medicine, to adopt policy that encourages adequate pain management, including prescribing opioids when appropriate. As far as state pain policy goes in Pennsylvania, researchers say the state scores well.

Last year, the PPSG published a "Progress Report Card" on state pain policy in which each state was graded on "balance" in regulatory policy, e.g., policy "that is aimed at preventing drug abuse while also recognizing that pain medications are necessary for medical purposes, and efforts to prevent abuse should not interfere with legitimate prescribing and patient care." In the report, no state scored an A or an F, 41 percent of states scored above a C, and thirty-five percent earned a grade of C. Pennsylvania was one of only eight states to receive a B, with only five states scoring higher. Those states that scored well generally recognized that opioid pain medications are necessary for public health, explicitly encouraged better pain management, recognized pain management and prescription medications are part of "good medical practice," and provided guidelines to address physicians’ fear about being investigated.

In regard to Pennsylvania regulation, Brian McDonald, deputy press secretary for the Department of State, says physicians need not fear regulatory scrutiny. He says the state regulation asks for three things when prescribing a controlled substance: "Make a decision about the pain, follow up with the patient and keep accurate records." The state relies on physicians to make an educated diagnosis, says McDonald, "We know they’re the experts."

Some states have gone one step further to calm clinician fear and to shield physicians from regulatory scrutiny when treating pain. Recently, both Texas and California have adopted "intractable pain acts" to protect physicians from state medical board disciplinary action if they prescribe controlled substances for intractable pain. But most states and medical professionals agree that adopting treatment guidelines is the key to successful pain policy. In fact, just this past December, the AMA released a statement requesting state medical societies and boards of medicine to develop or adopt mutually acceptable guidelines protecting physicians who appropriately prescribe and/or administer controlled substances to relieve intractable pain before seeking the implementation of legislation to provide protection. Guidelines are not legally binding, but serve as officially adopted policy that expresses a governmental agency’s attitude about a particular matter, such as the medical use of opioids. Such guidelines are meant to clarify standards of practice for regulated clinicians, and to define conduct the board considers to be within professional practice. Guidelines already exist in Pa. and across the nation, and have so for some time.

Pa. physicians have another authoritative source of pain management guidance, in the form of guidelines established by the Federation of State Medical Boards in 1988. The Federation’s Model Guidelines for the Use of Controlled Substances for the Treatment of Pain advises physicians and regulators on appropriate patient evaluations, treatment plans and medical records, and the document has been adopted in whole or in part by 24 states, including Pennsylvania. "The goal is to protect the public and to empower physicians to adequately treat pain," says James M. Compton, M.D., President and CEO of the Federation. According to the guidelines, criteria considered by a state medical board when evaluating a physician’s treatment of pain, including the use of controlled substances, include, but are not limited to:

· An evaluation of the patient, including documentation in the medical record of things such as, but not exclusively, a medical history, a physical examination, the nature and intensity of the pain and the presence of one or more recognized medical indications for the use of a controlled substance.

· A treatment plan. The written treatment plan should state, among other things, objectives that will be used to determine treatment success, such as pain relief and improved function.

· Informed consent and an agreement for treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient, and among other things, consider the use of a written agreement between physician and patient outlining patient responsibilities.

· A periodic review. The physician should periodically review the course of pain treatment and any new information about the etiology of the pain or the patient’s state of health.

· Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives.

· Medical records. The physician should keep accurate and complete records to include, among other things, medications including date, type, dosage and quantity prescribed.

· Compliance with controlled substance law 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, such as Pa. Code A716.92. for the prescribing, administering and dispensing controlled substances.

The Federation has recently updated the guidelines, renaming it a "Model Policy," and has included language that says, in effect, "when a physician inappropriately treats pain, he or she is providing substandard care."

It is inappropriate care that can result in disciplinary action by state medical boards, including Pa.’s. In order for a physician to be considered for disciplinary action in regard to improper prescribing, a complaint must be filed first, which can come in various forms. "We can open cases based upon complaints from other states, law enforcement agencies, other licensed professionals, even media reports," while most complaints come from patients, says McDonald. Once a complaint is filed, a prosecuting attorney reviews the facts and decides whether to investigate further for evidence to push for disciplinary action.

Factors that influence whether disciplinary actions are taken may include attorney caseload and how quickly a given investigation may take, says McDonald. Nonetheless, "If there is not sufficient evidence, then the file can be closed." And while the varied origin of complaints and the process for investigation sounds fearsome, government statistics show the occurrence of disciplinary action in Pa. over pain management is minimal. According to 2003 data provided by the state, a total of 89 complaints of improper dispensing were filed, with just 20 complaints resulting in some form of disciplinary action such as suspension, revocation or fine. Understanding proper clinical pathways in regard to the treatment of pain may be the best protection from regulatory scrutiny.

While fear of regulatory sanction has inhibited effective pain management, clinical factors also impede treatment. Education about pain management, especially management of chronic pain, has historically been of low priority leaving many clinicians ill prepared to treat with confidence. AMA research shows that health care professionals may have inadequate knowledge of analgesic pharmacology and pain therapy and poor pain assessment skills. The answer, they say, is more education about pain. A 2000/2001 survey of 125 medical schools conducted by the Association of American Medical Colleges (AAMC) found that only three percent of medical schools have a separate required course on pain management, and just four percent require a course in end-of-life care. In a statement about the study results, Jordan Cohen, M.D., President of AAMC, said, "If we are going to effectively treat a future generation of pain patients, we must first educate the next generation of doctors who will care for them."

Chronic pain management presents its own set of challenges. Unlike acute pain, which may result from injury, surgery or a medical illness, chronic pain may develop for no apparent reason, while acute pain that has resulted from injury may later present as chronic pain after the injury has healed. Moreover, pain is subjective and can be invisible to the diagnostic tests clinicians have come to rely upon. "There is no pain-o-meter," says Kathryn A. Padgett, Ph.D., executive director American Academy of Pain Management (AAPM). But that does not mean the pain does not exist. "Our research shows that nine out of 10 patients who say they are in pain – are in pain," says Padgett, who urges physicians to take patients’ pain seriously.

Local pain specialists agree. "Clinicians need to be more aggressive with pain – earlier," says Doris K. Cope, M.D., director of the Pain Medicine Program at the University of Pittsburgh Medical Center. The World Health Organization’s three-step pain ladder which basically says, "Start with Tylenol first" is out of date, she says, and for diseases such as complex regional pain syndrome and herpetic neuritis, primary care physicians should refer patients to a pain specialist early. These conditions can cause chronic pain if left untreated or undertreated, but when the pain is treated early, "you can turn it around," she adds.

Experts say confusion about addiction-related terms remains a significant impediment to pain relief. A study published in The Journal of Pain in 2001 warns that the misuse of terminology has the potential to mislabel a patient an "addict," and interfere with treatment. Researchers found that physicians, unclear about the definition of an addict and the regulations surrounding writing for pain medicine for an addict, may err on the side of caution when treating pain. And the American Pain Society (APS), the American Academy of Pain (AAP), and the American Society of Addiction Medicine (ASAM) have all come out to say that the inconsistent use of addiction-related terms creates a significant barrier to effective pain management for everyone. According to the Progress Report Card, 24 state regulatory board policies, including Pennsylvania, correctly define addiction-related terms, but 18 states still have inaccurate definitions on the books. The Federation provides physicians with definitions in its Model Policy. The need for clarity in terms does not end with clinicians. FDA Consumer magazine reports that patients, confused about the difference between addiction and physical dependence, stop taking their pain medication unnecessarily. "There is a terrible stigma about these drugs," says Dahl. She says clinicians must be clear in explaining to patients and their families that "physical dependence does not mean addiction."

Referring a patient early on in the pain cycle can also be a challenge for physicians because data shows patients delay seeking relief. A 1999 Gallup survey of 2,002 adults found that, while 42 percent of those surveyed experienced pain daily and 89 percent experienced pain each month, 64 percent said that they visit their doctor only when they can’t stand the pain any longer. That said, primary care physicians have a variety of referral options available when a patient finally does seek relief for pain that is unresponsive to traditional care.

Several remedies for these challenges are now becoming available, including the emergence of pain specialists, multidisciplinary pain management centers and better training for primary care physicians.

There is an assortment of disciplines involved in pain medicine, including anesthesiology, orthopedic surgery, physiatry and psychiatry, while the specialty is growing. In Pa. there are multiple pain management centers located throughout the state, some independent, some hospital or hospice based, and some that provide pain medicine training programs as well. The Orthopeadic and Spine Specialists in York offer two ACGME accredited pain medicine (PM&R) fellowships a year. The PENN Pain Medicine Center at the Presbyterian Medical Center provides a fellowship in pain medicine (anesthesiology). "We train three pain medicine board-eligible fellows a year," says Kevin Dolan, M.D., director of the PENN Pain Management Center. "The specialty is definitely growing." As for pain-medicine education for all physicians, Dolan says physicians are much more knowledgeable about pain management than they were five or six years ago, but more needs to be done. Everyone leaves medical school with some understanding of pain, he says, but there is still a need for a better understanding of the physiology and pharmacology of the different subsets of pain.

Accreditation agencies are now recognizing the importance of pain management. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has declared pain "the fifth vital sign," thus requiring accredited institutions to recognize, measure and monitor pain as a part of standard care. JCAHO contends that the measurement of pain, as well as the measurement of organizational performance, is a key strategy to improving pain management. The Lancaster Long Term Care Task Force has taken this directive as a call to action. The Task Force promotes community-wide standards for pain management, and has worked to define measurable outcomes that are meaningful, not only to long-term care facilities, but their residents as well. "Standards enhance consistency," says Joan Harrold, M.D., Medical Director of the Hospice of Lancaster County and a member of the task force. She says with standards, there’s no confusion about what to do clinically. "Clinicians feel comfortable treating all pain patients – even the outliers."

Optimal pain management includes not only pharmacological therapy, but psychological, physical rehabilitation, and in some cases surgical treatment strategies. Multidisciplinary pain management centers such as The Pain Management Center in Bala Cynwyd, which is staffed by an array of clinicians providing surgery, diagnostic imaging, physical therapy, and even counseling for patients in pain. Anthony Palmaccio, M.D., an orthopedic surgeon at the center, says the center’s goal is to restore function and a quality of life to its patients. The AAPM agrees with the multimodality approach to pain management and advocates it in its literature and medical educational forums. "Pain medicine has been a fragmented specialty," says Palmaccio. "We take a comprehensive approach to pain management."

Randall N. Smith, M.D., a Certified Pain Specialist at the center, says that, "There is a group in pain management that believes narcotics is all you do - that’s not what we believe." Smith says his group works closely with patients and their primary care physician to integrate previous medical information and treatment in an effort to provide the most minimal treatment that produces the most effective pain relief. "We offer minimally invasive techniques to reduce pain, such as radio frequency lesioning (RFL) for lower back pain and nerve blocks for back and /or neck pain," says Smith, "But we are also prepared and equipped to provide advanced procedures such as posterior spinal stimulation and/or a surgical solution when necessary." The Center also offers some forms of complimentary and alternative medicine (CAM), such as acupuncture - a growing pain treatment alternative.

Care that includes CAM has become increasingly popular in pain medicine, and has resulted in the growth of new specialties such as palliative medicine. Neil Michael Ellison, M.D., who practices palliative medicine at the Geisinger Health System, says this type of interdisciplinary approach to pain integrates symptom control, along with consultative services, including utilizing social workers and clergy as well.

As the population ages, pain management is set to become an increasingly important part of everyday medicine. A knowledge gap exists between what is known about the medical management of pain and the actual practices of clinicians treating pain, and inconsistencies still exist between knowledge and attitude about pain, particularly the use of opioid medications.