Priadel (lithium carbonate) 200mg and 400mg tablets, which are used in the treatment of bipolar disorder, will be discontinued from April 2021, its manufacturer Essential Pharma announced last month (August 19).
The manufacturer made the “difficult decision…due to restrictions on permitted pricing” that mean the manufacture and supply of the tablets is “no longer viable”, Essential Pharma told C+D at the time.
“We have sought to minimise disruption to patients and to allow time for the transfer to suitable alternative lithium products by providing the Department of Health [and Social Care] with an extended notice period of such discontinuance,” it added.
In a letter sent to Matt Hancock last week (September 15), senior figures at 12 healthcare bodies, including the Royal Pharmaceutical Society (RPS), expressed concerns over the discontinuation of Priadel and Essential Pharma having, the letter said, “significantly increased” the cost of one of its other lithium carbonate brands Camcolit.
The letter claimed that the withdrawal of Priadel from the market will “increase cost to the NHS, add pressure on already over-stretched primary and secondary care services, and most importantly potentially compromise patient safety”.
The organisations asked Mr Hancock to “personally intervene” so that the drug remains available in the UK with an “appropriate pricing structure”. It also requested that the “urgent” issue be referred to the Office of Fair Trading.
“Finally, if both these approaches prove unsuccessful, we are seeking special dispensation to import Priadel from overseas for use as an unlicensed product,” the letter said.
Essential Pharma declined to comment on the letter when approached by C+D.
Lithium carbonate an “essential medicine”
Priadel, and other brands of lithium carbonate, are used to treat patients with bipolar disorder and to prevent suicide. However, lithium has a “narrow therapeutic index”, which means that for safe and effective treatment, the blood levels need to remain “within a tight range”, the letter said.
“The various brands [of lithium] are not necessarily comparable and, in switching, we risk either losing the effectiveness of the medicine or the development of serious toxicity,” it explained.
Increased cost to NHS
The letter also claimed that the discontinuation of Priadel could cost the NHS “approximately £15 million annually” in direct drug costs alone due to Essential Pharma raising the price of its lithium carbonate brand Camcolit.
The British National Formulary lists the price of a pack of 100 400mg modified-release lithium carbonate tablets at £4.02, based on Priadel. Meanwhile, it lists the Camcolit brand price at £48.18 for a pack of 100 – a difference of £44.16.
The letter accused Essential Pharma of “exposing some of the most vulnerable members of our society to unnecessary and unacceptable risk of harm when there is already an unprecedented health emergency” and called on Mr Hancock to “stop this happening”.
Although Priadel is not being discontinued until April 2021, the letter said that pharmacists are “already reporting stock shortages”, while patients, doctors and pharmacists are “increasingly concerned about potential hazards”.
Blood tests during COVID-19
According to the letter, changing a patient who is taking Priadel over to another brand “requires patient review, a plan to swap, changing the prescription, and follow-up monitoring”. This will increase pressure on healthcare professionals at a “very challenging time”, the letter said.
“A significant part of the workload will fall onto primary care because long-term lithium treatment is often prescribed and monitored within primary care,” the letter continued.
“Services will need to carry out extra blood tests when switching brands, therefore exposing patients to hazards associated with attending for blood tests during the [COVID-19] pandemic, as well as causing anxiety about potential loss of effectiveness and risks of side effects,” it added.
The letter, which is publicly available to be read in full, is jointly signed by RPS president Sandra Gidley and 11 other individuals and representative bodies – including the Royal College of General Practitioners, the College of Mental Health Pharmacy and mental health charity Mind.