Coroner’s report recommends tightening regulation around forms of codeine and morphine

A report calls for opioids that are prescription-only medicines to be regulated as schedule 3 drugs, to make them harder to access inappropriately.
Codeine phosphate opioids

Regulations should be tightened around prescription-only opioids, such as codeine tablets and morphine oral solution, to make them schedule 3 drugs, a coroner’s report has recommended.

The recommendation came in a ‘report to prevent future deaths’, following the death of Katie Emma Corrigan from “excess consumption of codeine” that had been obtained from online pharmacies.

The report, which was sent to health minister Nadine Dorries and the Care Quality Commission (CQC), also recommended the CQC take on the regulation of “all online prescribing services accessible by patients in England” regardless of the professional group undertaking the prescribing.

According to the report, Corrigan had been prescribed Zapain by her GP for chronic pain, but was later denied further prescriptions unless she agreed to attend an appointment to discuss the prescription.

However, Corrigan “continued to source codeine and (it is believed) amitriptyline (as well as other prescriptions, eg, propanolol and modafinil) … from a number of online pharmacies”.

“The identity of the doctor(s) who gave Mrs Corrigan a script for the medication (notably codeine or other opiates) has not been established, but it was heard in evidence that her registered GP had not been contacted by any other doctors who are likely to have been approached privately by Mrs Corrigan,” the coroner’s report said.

As a result, Andrew Cox, the acting senior coroner for Cornwall and the Isles of Scilly, said he had consulted with the lead controlled drugs accountable officer at NHS England and NHS Improvement South West, who recommended that “some less regulated controlled drugs (‘schedules 4 and 5’), should be regulated to a greater extent”.

“Specifically, opioids that are prescription-only medicines, such as codeine tablets and morphine oral solution, should be regulated as schedule 3 drugs, as has already happened with tramadol and pregabalin,” the report said.

“This would introduce new controls that would make them much harder to access inappropriately,” the report continued, adding that, “ideally the same would be done with benzodiazepines and steroid hormones”.

He added that a change in the status of “codeine linctus from a pharmacy medicine to a prescription-only medicine” should also be considered.

Codeine and morphine are currently listed as schedule 5 drugs, under which the only requirement is to retain invoices for two years.

As schedule 3 drugs, they would need to be stored in a controlled drugs cupboard and prescriptions would be limited to up to 30 days’ treatment.

The recommendations also advise that “all online prescribing services accessible by patients in England should be regulated by the CQC, regardless of which professional groups are doing the prescribing, regardless of where in the world those prescribers are registered, and regardless of where in the world the provider’s head office is”.

Currently, online prescribing services have only to register with the CQC — whose regulatory responsibilities include online primary care services — if they employ a listed healthcare professional, which does not include pharmacists or pharmacist prescribers.

Attempts to close loopholes in regulating online healthcare providers

In 2019, the General Pharmaceutical Council said it had written to the chief executive of the Care Quality Commission (CQC), supporting a switch for the CQC to take on the regulation of pharmacist-run online services outside of a registered pharmacy.

The CQC would not confirm at the time whether it had asked for a change to its regulatory jurisdiction, but said it was “in active discussions” with the government over closing loopholes in the regulation of online healthcare providers.

“We are fully supportive of the CQC asking for an amendment to its jurisdiction to enable them to regulate clinics and services operated solely with pharmacy professionals (including pharmacist independent prescribers) from somewhere other than a registered pharmacy,” the GPhC said in a statement.

Last updated
The Pharmaceutical Journal, PJ, April 2021, Vol 306, No 7948;306(7948)::DOI:10.1211/PJ.2021.1.76000

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