A non-profit group has threatened the government with legal action unless it revokes new powers designed to allow pharmacists to switch patients’ medicines if there is a shortage.
The Good Law Project has said it will start judicial review proceedings over newly implemented “serious shortage protocol” powers if the Department of Health and Social Care (DHSC) fails to remove the amendments in legislation by 25 February 2019.
Amendments to the Human Medicines Regulation 2012, which came into force on 9 February 2019, mean the government can now issue protocols asking pharmacists to respond to a medicines shortage in one of four ways: to dispense a reduced quantity, a therapeutic equivalent, a generic equivalent or an alternative dosage form of the drug.
Under the protocol, the pharmacist would not have to consult the patient’s GP before making the switch.
The Good Law Project is now seeking to launch a judicial review of the amendments, partially on the grounds that the government’s initial consultation – which lasted one week on 5–12 December 2018 – was “insufficient and unlawful”.
In a legal document sent on 19 February 2019 from the group’s lawyers to the DHSC to inform them of their intent to start the review proceedings, the Good Law Project said it was “unclear exactly who the Secretary of State consulted with and how/on what basis”.
It added: “The failure to consult properly with organisations representing specific patient interests was unlawful.”
“The importance of consulting specific patient-interest groups is demonstrated by the Secretary of State’s subsequent undertaking that an exception for epilepsy sufferers will be granted,” the document said, adding that the lack of consultation with other patient groups “is notable and disturbing”.
The DHSC had clarified in its consultation response that therapeutic or generic switching will not be suggested for treatments for epilepsy or those “requiring biosimilar products where the medicines that are prescribed need to be prescribed by brand for clinical reasons”.
Jolyon Maugham QC, director of the Good Law Project, said: “Both doctors and patients have proper concerns about their safety in the event of medicine shortages.
“We want the government to withdraw the prospect of [serious shortage protocols] until it has complied with its legal duties and consulted properly on their use.
“If the government does not take this step, the Good Law Project will launch judicial review proceedings in the High Court.”
Jane Hanna, chief executive of Sudden Unexpected Death in Epilepsy Action, who is supporting the judicial review, added: “For people with long-term conditions, like epilepsy, what is on the prescription may represent months and years of trying out the best medication schedule.”
She added: “If under this law the clinical prescriber who knows the patient is to be bypassed by a group of centralised clinicians and individual pharmacists, we need the government to take the time to make sure this is safe. Lives cannot be risked because of short deadlines.”
Other representative groups have raised concerns regarding the length of the government’s consultation on the protocols, with the Pharmacists’ Defence Association (PDA) describing it as a “rushed job”, while the Academy of Medical Royal Colleges said it was “inexplicable and unacceptable that an issue of this importance is not the subject of wide consultation”.
Commenting on the potential judicial review, Alima Batchelor, head of policy at the PDA, told The Pharmaceutical Journal: “The PDA recognises that medicines shortages could have a profound effect on patient care and we support increasing the role of pharmacists in the right way to use their expertise in medicines, however we do agree that a decision of this gravity should not have been rushed through.
“There are still no details about which clinicians will be involved in drawing up these protocols and what relevant expertise they will have. A fuller consultation would have allowed closer examination of the law to check whether the legal changes would achieve their intended effect, and what the implications could be.”
However, most pharmacy organisations were broadly supportive of the move.
The Good Law Project has requested that the DHSC “confirm, by 4pm on Monday 25 February 2019, that the regulation will be withdrawn”, otherwise judicial review proceedings will go ahead.
The DHSC confirmed to The Pharmaceutical Journal that it has received the document from the Good Law Project and is considering it.