Dr Chris Ford finds that in the US, new restrictions have had negative consequences for patients in pain
I was recently discussing the increase in use of prescription opioids in the UK and the US with Alex, an American doctor, who specialises in pain treatment, and I asked whether their new restrictions were helping the situation and was shocked to learn of the negative consequences of these Drug Enforcement Administration (DEA) actions.
He began by telling me about his patient John. ‘John had returned from Iraq in 2013 in a very bad way. He had lost both his legs and part of his left hand, as well as having internal injuries and severe depression. John was very determined and progressed well in rehab, soon became mobile and his mood began to lift. But the thing that didn’t really improve was his pain. He tried everything but nothing helped until we hit on hydrocodone. With his pain under control, John was able to continue his rehabilitation, start a part-time job and even began to play football.’
Then Alex told me the regulations around hydrocodone had changed and so did John’s life. He had always regulated his own intake and sometimes took more and sometimes less, but always within the parameters of the prescription. His pharmacist was ever helpful but was now nervous of the new regulations and wanted John to go to another pharmacy. This unsettled John and he had again become suicidal.
Alex explained further that it is now much harder for him to prescribe opioids, leading to a dramatic reduction in his ability to provide appropriate care for his patients in pain.
In 2014 hydrocodone combination products were ‘rescheduled’ to be like codeine and oxycodone, which were already Schedule II under the US Controlled Substances Act. In the US, there are over 60,000 kg of hydrocodone prescribed a year, a medication that is essentially only available in North America. Primarily available as a combination product, the maximum dose per day has been limited by the amount of paracetamol in the combination. Rescheduling now means that the medicine cannot be called into pharmacies and refills are no longer allowed on a prescription. Additionally, in some states prescribing authority will be limited to physicians, not nurses or physician assistants.
Add to this the increasing restrictions on pharmacies in some states. Many can’t serve their customers who need opioid analgesia because the wholesalers who supply the pharmacy will no longer distribute the amount of medications that is needed. In some areas DEA agents have visited pharmacies to review the quantity of opioids being dispensed. Some pharmacies have reported being warned of increasing DEA review, if the quantity of dispensed medication was greater than the state average. So pharmacies make adjustments to stay in line and that is why John was sent away from his pharmacy. None of this is based on patient need, demographics or doctors but is quite simply a policy developed by bureaucrats, who have no understanding of the problem. Alex has also heard of pharmacists asking patients if they could reduce their dose or change to a non-scheduled alternative. In some cases, patients with advanced cancer have had difficulty filling their opioid prescriptions.
Yet the DEA say they are ‘simply enforcing the law, taking bad people off the street and essentially, trying to interrupt the supply of illegal prescriptions.’ But the agency takes no responsibility about the effect on people who need these medications.
Neither Alex nor I are saying that there isn’t a problem with prescription opioids. But it is complex, and punishing patients who need pain relief is not the solution. There has been an increase in the USA in opioid associated deaths (causality is not often established). However 60 per cent of the deaths are associated with poly-pharmacy (opioids, benzodiazepines and alcohol) and 30 per cent are associated with methadone, although it only represents 3 per cent of pain prescriptions. These deaths are almost all from using methadone as pain relief, not from OST. Some states mandate the use of methadone as a second line opioid after morphine in order to save money, although most physicians have little education in its prescribing.
Concurrently some people who have become dependent on prescription opioids are turning to heroin, which is becoming increasingly available in US. There has been much in the press about this but the increase in deaths is only partially related to this change and more to do with increasing purity of heroin. People then using this heroin-prescription drug combination are not the traditional population of people who use drugs. This problem is increased dramatically among white people and especially among young white men. Eliminating or restricting opioid analgesics doesn’t make the problem of dependency go away.
Khary K. Rigg, Assistant Professor of Mental Health Law and Policy, University of Southern Florida; and Shannon Monnat, Assistant Professor of Rural Sociology, Demography, and Sociology, have recently published on the complexity of this problem and identify three groups of opiate users, who are distinct demographically, socioeconomically and psychologically. While heroin use is typically characterised as being a problem in black, poor and urban areas, an increasing number of people who use heroin and prescription opioids are white, employed and live in rural and small urban areas. The third group they identified are people who are addicted to prescription opioids alone and tend to be the most socially connected of the three groups. This group is the least socioeconomically disadvantaged and have better physical and mental health.
Professionals who treat people with drug problems should recognise the unique needs of each group of addicts, according to the researchers.
So what is happening in the UK? Prescription opioid dependence is a growing problem here and best-practice management is as yet not well defined. In 2013, 757 people died with a prescription opioid in their blood stream, almost the same number as for heroin and illicit morphine (765) and more than for methadone (429). It is critical that we understand this problem and respond appropriately, and avoid falling into the trap that the US has set for the people caught up in this situation.
 DEA Schedule II rules. http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section5.htm
 Bernadette Hard. BMJ, 2014
 Office of National Statistics, 2014