Britain may make OTC codeine available by prescription only in order to reduce likelihood of misuse.
The Medicines and Healthcare products Regulatory Agency (MHRA) in Britain has confirmed it is considering reclassifying codeine, a painkiller commonly known as co-codamol, co-codaprin or Nurofen Plus, to make it available only by prescription. The potential decision would be made as part of the agency’s efforts to reduce inappropriate use of potentially addictive painkillers.
High dose codeine is already prescription-only. However, when combined with other drugs, such as paracetamol or ibuprofen, or in liquid form, it is still available over the counter (OTC). Although not intended for chronic pain and only to be used for a maximum of three days, there is growing concern as millions have become addicted to opioids that codeine may make users hooked.
In 2019, Public Health England (PHE) revealed “one in four adults in the UK is being prescribed potentially addictive drugs, with half of them still hooked a year later.” The first official mapping of drug dependence found “5.6 million people were on opioid pain medications.”
An MHRA spokesperson said, “The MHRA is keeping the safety of OTC products containing codeine under review and will consider other interventions, including the possibility of reclassifying all opioid-based painkillers as prescription only as necessary.”
The National Institute of Health and Care Excellence (NICE) issued new guidance two days earlier warning physicians not to prescribe paracetamol, ibuprofen and opioid drugs for chronic pain. The agency said there was “little or no evidence that the medicines improved quality of life.”
“The guideline doesn’t specifically address OTC medications, but the draft recommendation is not to offer opioids, by any route, to people aged 16 years and over to manage chronic primary pain,” a NICE spokesperson reported.
Although the most recent Global Non-Opioid Pain Relief Device Research Report indicated the alternative pain treatments market should “grow from $13.8 billion in 2019 to $31.8 billion by 2024 at a compound annual growth rate (CAGR) of 18.3% for the period of 2019-2024,” there is concern that pain alternatives, such as acupuncture, are not readily available in the market yet.
“There is no question that people misuse substances that make them feel good, but there is also a crisis of chronic pain, of which there is no cure,” said Dr. Jeffrey Gudin, a senior medical advisor for Quest and a pain management specialist at Englewood Hospital and Medical Center. The intense discomfort these patients experience won’t just go away, and they don’t want to live in agony waiting for alternatives to become available.
The 2019 PHE report found, “In England, almost 12 million adults a year are being prescribed drugs on which they may become dependent.” At the same time, “Greater than 20 million people in the UK are thought to be suffering from chronic pain. Up to a third of patients had been on them for at least three years, including 930,000 people on antidepressants, 540,000 on opioids, and 160,000 on gabapentinoids.”
Health Secretary, Matt Hancock, said, “I refuse to let this escalate to the level seen in the United States. This review is a wake-up call.”
While an official decision regarding the transition of codeine to prescription only has yet to be finalized, in the interim, the MHRA said over-the-counter medications containing the drug should be purchased “under the supervision of a pharmacist.”