Lukas Radbruch, Chair of Palliative Medicine, University of Bonn, Germany
Opioids are the mainstay of symptom control in palliative care. This is most evident for cancer pain management, as recently confirmed by the new EAPC guidelines, but also for management of pain in other palliative care patients such as HIV/AIDS or management of dyspnea in cancer patients, COPD (chronic obstructive pulmonary disease) or ALS (amyotrophic lateral sclerosis) patients.
Palliative care advocates fight an endless battle for using opioids early enough, with adequate dosages, and continuously in patients who need them. Inadequate accessibility or availability of opioid medications is one of the major barriers for the relief of suffering in severely ill and dying patients. However, this political quest for adequate access to opioids is always balanced with the concern that prescription of opioids may lead to misuse and abuse, if there are inappropriate prescriptions.
This discussion seems to have reached a crescendo in the US just now. Much concern has been raised by a report of the Centers for Disease Control and Prevention (CDC) ‘Vital signs: overdoses of prescription opioid pain relievers – United States, 1999-2008.’ This report describes a steep increase in the rate of prescription-drug overdose deaths in 2008 compared to 1999. Even though the report does not state this, there is a clear implication that increased prescriptions has led to increased sales and increased number of deaths. A critical review with more probable alternative explanations of the CDC report can be found in the Pain topics blog post of Bob Twillman.
The Federal Drug Administration (FDA) had recently been concerned with iatrogenic abuse of opioids and has initiated REMS (a Risk Evaluation and Mitigation Strategy), which is an education programme for prescribers. The FDA makes the pharmaceutical companies provide and pay for this programme. However, training is not mandatory for prescribers, and just now a panel of prominent physicians has submitted a petition to the FDA asking for much more severe restrictions in opioid prescriptions:
- Opioids should be indicated only for severe and not for moderate non-cancer pain.
- The maximum daily dose should be restricted to 100 mg of morphine for non-cancer pain.
- The maximum duration for continuous daily use should be 90 days for non-cancer pain.
These changes would apply for immediate-release opioids as well as for extended-release opioids. The panel argues that “overly broad indications” imply that long-term use of opioids is safe and effective, whereas an increasing body of literature suggests that for many patients it may be neither safe nor effective.
I have worked for more than ten years in a tertiary pain centre in Germany, and I have to say that the enthusiasm that we felt in pioneer days about opioid treatment for non-cancer patients has certainly waned with the years. I would be very reluctant to treat some chronic pain conditions with opioids nowadays, for example chronic low back pain or fibromyalgia, and recent evidence-based guidelines on long-term opioid treatment for non-cancer pain support this reluctance. Colleagues from Germany and Canada have told me that they spend an increasing amount of time telling other physicians to prescribe opioids only for the right indications, to patients who will benefit from them.
However, palliative care is not only for cancer patients, and the palliative care needs (including access to opioids) of many non-cancer patients with life-threatening disease are increasingly acknowledged. This not only concerns patients with HIV/AIDS, but also those with end-stage cardiac, pulmonary or renal diseases or a multitude of neurological diseases. All these patients would be cut off from relief of pain or dyspnea if the FDA were to change its regulations.
Fortunately, I do not live in the US, and in Germany the legislation on opioid prescription has been modified in recent years so that adequate palliative care has become easier and not more difficult. I hope that my colleagues in the US will have the same benefit and that the FDA does not change the regulations!