Opioids for Managing Patients with Chronic Pain:

Article Outline

• Abstract
• Introduction
• Methods
• Results
  • Pain and Its Management
  • Addiction, Abuse, and Diversion
  • Perceived Legality of Prescribing Opioids for Chronic Pain
• Discussion
  • Pharmacists’ Concerns
• Conclusion
• Acknowledgements
• References
• Copyright

Abstract 

Previous studies of pharmacists have suggested poor availability of opioids and apprehension about dispensing these drugs. This pilot study surveyed 52 randomly selected New Jersey community pharmacists (response rate = 69%). Reluctance to stock opioids was attributed to concerns about robbery by 14% and to concerns about federal or state investigation by 17%. No correlation was found between respondents who had a high degree of concern about robbery and those who had incurred previous robbery. Of the 20% of respondents who had incurred a prior federal or state investigation, none expressed more than minimal concern about opioid regulatory issues. Pharmacist confidence in the acceptability of opioids for chronic pain was 75% for malignant pain in patients with no history of opioid abuse and declined to 3% for nonmalignant pain in patients with a history of opioid abuse.

Keywords:  Pain, pharmacist, opioids

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Introduction 

The impact of pain on a person’s well-being can be profound. Bonica extrapolated from the prevalence of chronic painful conditions (e.g., chronic back pain, painful arthritis, recurrent headaches, cancer) that one in three Americans have a chronically painful condition.¹ The American Cancer Society estimates that in the year 1998 1,228,600 new cases will be diagnosed and 564,800 people will die of cancer.² Sixty to 90% of patients with advanced cancer will experience significant pain.³, ⁴ Despite the fact that with proper management up to 90% of pain caused by cancer could be controlled with the use of oral analgesics,⁵ survey data show that 42% of these patients are undermedicated, while 36% had pain severe enough to impair their ability to function.⁶

Opioid analgesics are the mainstay of the treatment for chronic pain due to cancer.⁷ Inadequate knowledge and assessment as well as inappropriate prescribing practices of these drugs, compounded by the lack of availability for ambulatory patients have been cited as barriers to adequate cancer pain management.⁶, ⁷, ⁸, ⁹, ¹⁰, ¹¹, ¹², ¹³, ¹⁴ Because pharmacists often assume the role of advisor to patients regarding both over-the-counter and prescription medications, they can play an important role in a patient’s pharmacotherapy. Inadequate or incomplete knowledge regarding issues pertinent to pain pharmacotherapy may lead to adverse consequences for the patient.

Previous studies of pharmacists have revealed concern about stocking as well as dispensing opioids. Apprehension to stock opioids have been attributed to fear of robbery, lack of prescription demand, and concerns about federal or state investigation.⁷, ⁸ A survey of pharmacists by Holdsworth and Raisch⁸ found that >40% listed robbery and >18% listed federal or state investigation as the reason for being apprehensive about filling an opioid prescription for a cancer patient. In a study by Doucette et al,¹³ >50% of pharmacists surveyed believed that cancer patients who were prescribed opioids had a high risk of addiction.

The objectives of this survey were to: (1) assess pharmacist’s knowledge and attitudes regarding the use of opioids in chronic cancer and noncancer pain patients; (2) quantify the resistance to stocking and dispensing opioids attributed to concerns about robbery and federal investigation as well as the related incidence of robbery and federal investigation; and (3) determine the availability of opioid analgesics for patients with chronic pain.

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Methods 

The Kessler Pain Management Group developed a 19-question survey. Several questions were based on or developed from previous surveys.¹⁴ The survey contained questions about demographics, opioids that are regularly stocked, level of concern about robbery, level of concern about regulatory investigation, history of robbery and federal or state regulatory investigation, issues regarding morphine dosing, definition of addiction as well as perceived prevalence of addiction, perceived prevalence of diversion of prescribed opioids in New Jersey, and perceived legality of certain prescribing scenarios.

Participants were chosen from a list of 2304 New Jersey retail community pharmacies. Pharmacies were listed by county and zip code. A random number table was employed to randomly choose pharmacies from this list. Fifty-two randomly selected New Jersey retail pharmacies were called. The pharmacist who answered was told he/she would be sent a survey and his/her name was requested. Anonymity of the participants was assured. At the pharmacist’s request, surveys were either faxed or mailed, with attention to that specific pharmacist, along with a self-addressed stamped envelope. A cover letter was sent with the survey which explained who was doing the survey and the procedure to return the survey. Two weeks after the mailing one additional call was made to all nonresponders.

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Results 

Of the 52 surveys faxed or mailed, 36 (69%) were returned and analyzed. Respondents represented 16 of 21 counties in New Jersey. The geographic distribution of respondents is presented in Table 1. The mean age of the respondents was 38.8 years (SD = 11.1 years) and 27.7% (10/36) were working at a chain pharmacy. Respondents received their pharmacy degrees between 1960 and 1995; the median year was 1983. The pharmacy settings are listed in Table 2. Pharmacists were asked to estimate their level of involvement in hospice care, including home-based and facility-based patients (Table 3).

Table 1. Geographic Distribution of Respondents by New Jersey County

Table 2. Pharmacy Settings

Table 3. Frequency of Involvement with Hospice Care

Three respondents (8.3%) had experienced an armed robbery or night break-in. Moderate to complete reluctance to stock opioids was reported by 14% (5/36) of respondents. No correlation was found between those respondents who had had a moderate to high degree of concern about robbery and those who had a previous robbery (Table 4). No correlation was found between those respondents who had a moderate to high degree of concern about robbery and those located in city or inner city settings (Table 5).

Table 4. History of Previous Robbery and Resistance to Stocking Opioids Due to Concern About Opioids

Table 5. Location of Pharmacy and Resistance to Stocking Opioids due to Concern About Opioids

Moderate to complete reluctance to stock opioids was attributed to concerns about federal or state investigation by 17% (6/35) of respondents. Interestingly, of the 20% (7/35) of respondents who had incurred a prior federal or state investigation, none expressed more than minimal concern about opioid regulatory issues (Table 6).

Table 6. History of Federal or State Investigation and Resistance to Stocking Opioids Due to Concern Over Federal or State Investigation

Pain and Its Management 

Pharmacists were given a list of opioids and asked to respond if they stocked the drug (Table 7). Respondents were asked the highest daily dose of morphine they had dispensed, had heard of, and are comfortable dispensing. The highest daily dose of oral morphine that respondents had dispensed ranged from 60 mg/day to 2000 mg/day with an average of 254.5 mg/day (SD = 344.1). The highest daily dose of oral morphine that respondents had heard of ranged from 60 mg/day to 5000 mg/day with an average of 737.4 mg/day (SD = 1042.0). The highest daily dose of morphine that respondents were comfortable dispensing ranged from 60 mg/day to 2000 mg/day with an average of 411.2 mg/day (SD = 522.6).

Table 7. Availability of Opioid Medications

The survey included a series of true and false questions. Thirty-three percent (12/36) of respondents believed that a patient, regardless of diagnosis, will become addicted if an opioid is taken on a daily basis for 1 month. Thirty-six percent (13/36) of respondents believed that it is illegal for a physician to prescribe methadone for pain unless he/she is certified in addiction medicine. Thirty-six percent (13/36) answered that they would be resistant to fill prescriptions from a single doctor for more than one opioid at a time.

Addiction, Abuse, and Diversion 

Respondents were asked the meaning of “addiction.” They were given three common definitions from which to select including: (1) physical dependence; (2) tolerance; and (3) psychological dependence. Respondents had the option to choose more than one of these definitions or “don’t know”. Forty-two percent (15/36) of respondents answered that the meaning of “addiction” was physical dependence, tolerance, and psychological dependence; 3% (1/36) answered tolerance and physical dependence; 3% (1/36) answered tolerance and psychological dependence; 17% (6/36) answered physical and psychological dependence; 25% (9/36) answered physical dependence; and 11% (4/36) answered psychological dependence.

Respondents were asked to judge how serious of a problem addiction and diversion are in their state. Thirty-six percent (13/36) believed addiction and diversion are serious problems; 36% (13/36) percent believed that it is a moderate problem; 6% (2/36) believed that it is a minor problem; and 22% (8/36) chose “don’t know” as their answer.

Perceived Legality of Prescribing Opioids for Chronic Pain 

Pharmacists were asked their opinion regarding the acceptability of prescribing opioids for more than several months in four patient scenarios involving cancer and noncancer pain, with and without a history of drug abuse of the opioid type. There were four levels of perceived legality for each scenario: (1) lawful and is generally acceptable medical practice; (2) lawful in my state but is generally not acceptable medical practice and should be discouraged; (3) probably a violation of my state’s standard medical practice and should be investigated; and (4) probably a violation of federal or state controlled substances laws and should be investigated. Respondents were allowed to give more than one response or answer “don’t know.” Results are shown in Table 8.

Table 8. Perceived Legality of Prescribing Opioids for More Than Several Months^a

Scenario A: Cancer pain only. Seventy-five percent of respondents thought prescribing opioids for more than several months was both lawful and generally acceptable medical practice. Only 2.8% thought this practice was legal but not generally acceptable and should be discouraged. None of the respondents thought this was a violation of standard medical practice or a violation of federal or state substance laws warranting investigation. More than one-fifth (22.2%) chose “don’t know.”

Scenario B: Cancer pain with a history of substance abuse. In the scenario of a patient with chronic pain of cancer origin with a history of drug abuse of the opioid type, only 36.1% of respondents thought prescribing opioids for more than several months was both lawful and a medically acceptable practice; 19.4% thought this practice should be discouraged; 13.8% thought this was a violation of standard medical practice and therefore should be investigated; and 8.3% thought it was a violation of federal or state substance laws warranting investigation. “Don’t know” was chosen by 38.9% of respondents.

Scenario C: Chronic nonmalignant pain only. Only 16.6% of respondents believed that if pain was of nonmalignant origin then prescribing opioids for more than several months was both lawful and a generally acceptable medical practice. Nearly half (47.2%) thought this practice should be discouraged; 5.5% thought this was a violation of standard medical practice and therefore should be investigated; and 2.8% thought it was a violation of federal or state substance laws warranting investigation. Don’t know was chosen by 38.9% of respondents.

Scenario D: Chronic nonmalignant pain with a history of opioid abuse. Confidence in the acceptability of a physician prescribing opioids for several months to a patient with nonmalignant pain and a history of opioid abuse fell to 2.8%; 44.4% thought this practice should be discouraged; 36.1% of respondents thought this scenario was probably a violation of standard medical practice; and 22.2% thought this is a violation of federal/state controlled substance laws and therefore should be investigated. “Don’t know” was chosen by 22.2% of respondents.

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Discussion 

Pharmacists’ Concerns 

Previous studies of pharmacists have found concerns about robbery and regulatory investigation to be leading reasons for apprehension about stocking and dispensing opioids.⁷, ⁸ Few respondents in this study, even those with a history of robbery, answered that they were moderately or completely resistant to stock opioids due to concerns about robbery. No significantly higher level of concern about robbery was found in pharmacists located in city or inner city settings.

Moderate to complete reluctance to stock opioids was attributed to concerns about federal or state investigation by 17% of respondents. Interestingly, of the 20% (7/35) of respondents who had incurred a prior federal or state investigation, none expressed more than minimal concern about opioid regulatory issues. This may indicate that these investigations have been of a benign nature and/or that these pharmacists believe that investigations are part of the risk of dispensing opioids.

In this study, most of the common opioids used for pain management, including short-acting drugs and long-acting preparations, were stocked by 80% or greater of respondents. The American College of Physicians¹⁵ has cited methadone as extremely useful in the treatment of cancer pain, but methadone was stocked by only 16.6% of respondents. The stigma that methadone can only be used in the treatment of addiction is likely the reason that more than one-third of respondents thought it was illegal for a physician who is not registered in addiction medicine to prescribe methadone for pain unless he/she is certified in addiction medicine. It is illegal for a physician to prescribe methadone for an addict to treat their addiction but not for a physician to prescribe methadone for an addict or nonaddict to treat their pain.

The average daily dose of oral morphine that pharmacists were comfortable prescribing was 411mg/day. This corresponds well with previous studies of pharmacists, which found a significant increase in apprehension when pharmacists were asked about dispensing greater than 500 mg/day of oral morphine to a cancer patient.⁸ There is no ceiling for pure agonist opioids, and in fact, very large doses of morphine, e.g., several hundred milligrams every 4 hours, may be needed for severe pain.⁵

The respondents’ answers to questions regarding the definition and risk of addiction reflect common myths and misperceptions among health care professionals. Several studies of physicians and pharmacists have revealed misconceptions by health care professionals about tolerance, physical dependence, and addiction.¹⁰, ¹¹, ¹², ¹⁴

Tolerance is a pharmacologic property of opioid drugs defined by the need for increasing doses to maintain effects.¹⁶ It is a common misconception that this property limits the long-term use of opioids for pain management. Clinically relevant tolerance to the analgesic effects of opioids seldom develops after the initial days or weeks of therapy. In contrast, tolerance does develop to some of the side effects of opioids such as sedation, respiratory depression, nausea and vomiting, but not to constipation.¹² Research from the cancer population indicates that the need for increased dosing in patients previously on stable doses of opioids tends to accompany progressive disease.¹⁷, ¹⁸

Physical dependence is also a pharmacologic property of opioid drugs defined solely by the occurrence of an abstinence syndrome (withdrawal) following abrupt dose reduction or administration of an antagonist.¹⁶ This property of opioids does not offer a rational premise to not prescribe them. In the event that the need for an opioid no longer exists, tapering the drug will avoid intolerable withdrawal symptoms.

Addiction is a psychological and behavioral syndrome in which there is drug craving, compulsive use and other aberrant drug-related behaviors, and relapse after withdrawal.¹⁶ Fears about addiction are repeatedly cited in the literature as contributing to the less than optimal level of pain management in patients with pain. Unlike physical dependence or tolerance that are attributes of the drug, addiction is the product of medical, social, and economic factors surrounding the patient, and not the result of opioid use for pain control.¹⁹ Studies indicate that medical patients who receive opioids for pain and have no history of drug abuse have less than a 1% risk of iatrogenic addiction.²⁰, ²¹, ²²

Confusion between the legitimate and illegitimate use of opioids clearly limits their prescribing for pain management. Physicians may limit their prescribing of opioids due to fear about risking investigation. Pharmacists may fear stocking or dispensing opioids due to similar concerns. The Federal Controlled Substance Act states that the use of opioid analgesics to treat intractable pain is considered a legitimate medical purpose. The Drug Enforcement Agency has emphasized that physicians should not hesitate to prescribe controlled substances when they are indicated for pain in patients with terminal illness or chronic disorders.¹⁴ It is likewise interpreted that pharmacists should not fear dispensing for a legitimate medical purpose. Appropriate communication between the prescriber and the dispenser may be necessary to enhance legitimate medical practice.

State laws tend to be more restrictive than federal law regarding the use of opioids and may substantially contribute to fears of prescribing or dispensing. Some state restrictions include government-issued prescription forms, reporting of patients using certain controlled substances for more than a few months, and limiting amounts that can be prescribed at one time. Berina et al. found that multiple copy prescription programs have hampered the prescribing of Schedule II opioids for terminally ill patients with chronic pain.²³

Confidence by respondents in the acceptability of a physician prescribing opioids for chronic pain was 75% for malignant pain in patients with no history of opioid abuse. Confidence declined to 3% for nonmalignant pain in patients with a history of opioid abuse, despite the fact that it is not illegal to prescribe or dispense opioids for the management of chronic malignant or nonmalignant pain at either the federal or state level. Furthermore, it is not illegal to treat a patient with a history of substance abuse with opioids for pain, despite the fact that it is illegal to treat an addict with opioids (methadone) for addiction unless the physician is registered in addiction medicine.¹⁴

There are two limitations to this study. The first is its small size, which may limit its generalizability. The second is that it only included retail community pharmacies. These community pharmacists may not be serving the population requiring the highest doses of opioids. This may be reflected by the low rate of involvement of the respondents with hospice care (Table 3).

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Conclusion 

The prevalence of chronic pain and its attendant suffering has reached epidemic proportions. While the physician has the responsibility of providing appropriate treatment and treatment structure, reinterpretation of intended treatment, either overtly or covertly, by the pharmacist may impact on patient outcome. Pharmacists, like many people in the health care profession, could benefit from education regarding issues related to the use of opioids for chronic pain. This may be literally vital so that pharmacists can continue to make a positive impact and play an important role in the multidisciplinary care of patients with chronic pain.

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Acknowledgements 

We would like to thank David Joranson, MSSW and Aaron Gilson, Ph.D. of the University of Wisconsin Pain and Policies Studies Group for their help and advice on this study.

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