A lesson from history
By Rob Darracott
I first met Roger Scarlett-Smith in 2007. He was president of PAGB at the time, and running the consumer healthcare side of GSK. I’d been at the Company Chemists’ Association for two months. We had a mutual interest: pseudoephedrine.
Seeing Roger again recently reminded me how important building a coalition can be in gaining credibility and achieving influence. It worked in 2007 when the Medicines and Healthcare products Regulatory Agency (MHRA), spurred on by the Serious Organised Crime Agency, proposed reclassifying pseudoephedrine to prescription only.
Only a handful of discoveries of UK meth labs, at least one of which had exploded, law enforcement were keen to shut off the opportunity before things got out of hand. Their approach to the medicines regulator was to urge a clampdown on the availability of the methamphetamine precursor pseudoephedrine, with tales of pharmacy shelves in the US being stripped of packs in organised raids by holdall-wielding criminals used as evidence of the potential threat.
Given the widespread use of pseudoephedrine, under pharmacy control, for many years, the pharmacy bodies and the PAGB and its members with interests in the molecule, led by Roger and Carlton Lawson from J&J, decided a reverse switch was a draconian response. As Walter White and Jesse Pinkman demonstrated in Breaking Bad, large scale meth production requires bulk raw materials rather than hundreds of packs of decongestant.
We needed an alternative that recognised the legitimate concerns about diversion, but would convince the authorities that pharmacy would take the issue seriously and manage it effectively. Both parties had a commercial interest, but we were also motivated to preserve as an OTC an ingredient that benefitted millions, including user groups like airline pilots, for whom it represented the only symptomatic treatment they could trust.
Our proposal involved restrictions on pack sizes and single sale quantities, enforced by pharmacists, with till bars where necessary, and a mass awareness campaign across pharmacy, using a bespoke UK version of a US online programme. It was accepted by the Commission on Human Medicines after a joint presentation by the pharmacy organisations and the industry. Compliance, including numbers of people completing the awareness training, was checked annually by the MHRA for years afterwards.
Issue, options, policy, presentation, agreement, implementation plan, delivery, audit. Job done. But the catalyst for the solution which was agreed as a better alternative was the coalition of the willing. We wanted the same outcome, and we were prepared to work on an answer which would convince the other side we could do it.
This module highlights a new opportunity to treat heartburn and reflux in the pharmacy with Omeprazole 20mg, which is newly available for customers to purchase OTC.