Last week, the documentary “Freedom from Pain” was released on Al Jazeera. I personally have received considerable feedback including from my adult children who have watched the documentary, made by students of their own age, with their friends and workmates. In view of these comments and others, I undertook to address the issue of “balance.” Let me share two comments that were posted on this site that sparked the “balance” discussion.
“It is very difficult to watch people suffer needlessly because of overly restrictive opioid regulations.”
Noelle LoConte M.D., UW Medical Oncologist.
It is very difficult to watch people suffer needlessly because of overly restrictive opioid regulations. But if you consider the immense pain and suffering caused by the epidemic of opioid analgesic addiction and overdose deaths hitting the U.S., Canada and Australia (where lax opioid regulations and aggressive marketing for chronic non-cancer pain have led to overconsumption of opioids) it’s hard to say that we’re better off. Of course… it’s impossible to compare the pain felt by a parent, when their child dies of a drug overdose, with the pain felt by a woman with metastatic breast ca who’s denied access to morphine. The answer here is to find the right balance.
Andrew Kolodny M.D., Psychiatrist
It would seem that there is agreement on the need for “balance.” The issue is to establish that balance, to decide where we draw the line in the sand. This concept of balance (as it relates to opioids) has been accepted by the WHO, the International Narcotic Control Board and the United Nations Commission on Narcotic Drugs (CND). In fact in 2010 from the CND meeting in Vienna:
“The central principle of “balance” represents a dual obligation of governments to establish a system of control that ensures the adequate availability of controlled substances for medical and scientific purposes, while simultaneously preventing abuse, diversion and trafficking. Many controlled medicines are essential medicines and are absolutely necessary for the relief of pain, treatment of illness and the prevention of premature death. To ensure the rational use of these medicines, governments should both enable and empower healthcare professionals to prescribe, dispense and administer them according to the individual medical needs of patients, ensuring that a sufficient supply is available to meet those needs. While misuse of controlled substances poses a risk to society, the system of control is not intended to be a barrier to their availability for medical and scientific purposes, nor interfere in their legitimate medical use for patient care (1).
This CND resolution, that was supported by many countries including the USA and Russia, contains the language of “adequate availability of controlled substances for medical and scientific purposes.” This is not defined in the resolution. In fact the resolution uses further language that is not specific: “the individual medical needs of patients” and “their legitimate medical use for patient care.”
The UN Office on Drugs and Crime (UNODC) would very much say that defining “legitimate medical use for patient care” is not their role. On a global platform it is in fact the role of the World Health Organization. And this is very much the case with PPSG (from About PPSG):
PPSG participates in international and national meetings for health professionals and government officials, provides technical assistance to government and non-government organizations, and promotes better understanding of the principle of balance that should guide national narcotics control policy to ensure availability of opioid pain medications and adequate control to prevent abuse and diversion.
Defining legitimate medical use of opioids for patient care remains a significant challenge, given the paucity of high level evidence. As with many clinical guidelines, the “medical profession” has had to rely on expert consensus, drawing from other clinical experiences, e.g. the treatment of chronic cancer pain (where most would agree it is safe and effective when used appropriately) to draw conclusions about such practices as the use of opioids for chronic non-cancer pain . It has not been PPSG’s role to define that legitimate medical practice.
So, drawing on the literature and and my practice as a physician, where can I agree (with myself) that opioids have an established role in legitimate medical practice?
- Post operative pain
- Procedural pain
- Cancer Pain
- Obstetric pain
- Traumatic pain (including war).
The list may be longer but I don’t want to enter into a debate over this. The point I am making is that we need, according to the Commission of Narcotic Drugs (Resolution 53/4, 2010) and the UN Single Convention for Narcotic Drugs (1961), to ensure that opioids are available for what we consider legitimate medical practice. This then raises a number of questions.
- Should opioids be an “option of last resort” for post operative pain? Not at my next knee surgery thank you!
- Should there be a daily dose limit for cancer pain? Not for my patients or according to Dr LoConte for the patients shown in “Freedom From Pain.”
- Should regulations prevent women from having adequate pain control during childbirth?
Our legislators are not in the business of writing laws that include details of medical practice. That is really for Professional Societies, Licensing boards and drug approval bodies to determine. In fact US State Licensing Boards and State Attorneys Generals have adopted many of the legislative changes required to ensure control measures do not interfere with legitimate medical practice. But do we have an effective system for doing this? What happens when we want to use a new controlled substance for the relief of pain.
Oral transmucosal fentanyl citrate is one example of this (Potential COI: I was involved in the original breakthrough pain studies with this in the late 1990 with a company called Anesta). Safety was a considerable issue when discussed at the FDA hearing and the labeling was to include use only in opioid tolerant patients (>Morphine 60 mg/day) and the FDA said it should be only used for cancer patients. Anesta agreed to this and to having a “SWAT” team that would monitor prescribing and quickly educate clinicians who were not using it appropriately. However, after another company bought Anesta, 90% of the OTFC that was prescribed was for patients who did not have cancer! I don’t have data on the impact of this, but it took some years for the regulators to catch up, and attempt to limit the companies influence on prescribers.
This was an unbalanced situation. It is not likely that this was the result of laws that allowed “legitimate medical practice.” It is possible that it was the result of drug availability in a situation where physicians may not have been appropriately educated. It is possibly about pharmacists who were filling these prescriptions without addressing these issue of appropriateness. It is possibly about insurance companies that paid for it, despite it being outside of the recommendations of the FDA. Other that the original study patients who remained on the medication, I prescribed very little because of the financial impact of such an expensive product on hospices.
Education of clinicians for this and other new opioids was largely done by “pharma.” But a number of companies have been brought to task because of problems with this education process. But many clinicians did not have appropriate “pain management” training in medical school or residency. If all clinicians were educated appropriately on the use of opioids, no clinician should have an irrational fear of opioids. We would know how to use them and, with appropriate use in the right populations, as outlined by clinical guidelines such as those by Chou et al (2), how to make their use safer while also reducing the risk of abuse and diversion.
Another interesting situation at the FDA hearing on OTFC, related to calls by advocates for non-cancer pain groups. They were asking that OFTC be available to them, and not just the cancer population. This call had resulted in changes in labeling in some longer acting opioids in the mid 90s, but did not result in a change for OTFC. This pressure for “equality in pain management” has not been a goal of PPSG, but is evident in the change of the Wisconsin Cancer Pain Initiative to the Wisconsin Pain Initiative, and with it the Alliance of State Pain Initiatives (ASPI). To give approriate dues, ASPI activities were not restricted to the use of opioids for pain relief.
So I can only agree to the statement from the Ensuring Balance Guideline, released by the WHO and now available on line in 14 languages.
The availability, accessibility and affordability of controlled medicines are important issues for all countries, but problematic for most of them. The World Health Organization (WHO) encourages governments, civil society and other interested individuals to strive for the maximum public health outcome of policies related to these medicines. WHO considers the public health outcome to be at its maximum (or “balanced”) when the optimum is reached between maximizing access for rational medical use and minimizing hazardous or harmful use.
PPSG will continue its work, with the full approval of the World Health Organization as the Collaborating Center for Pain Policy and Palliative Care to:
“Improve global pain relief by achieving balanced access to opioids worldwide”
(1) Commission on Narcotic Drugs. Resolution 53/4: Promoting adequate availability of internationally controlled licit drugs for medical and scientific purposes while preventing their diversion and abuse. 10th Plenary Meeting. 2010. (http://www.unodc.org/documents/commissions/CND‐Res‐2000‐until‐present/CND53_4e.pdf, accessed 4 January 2011).