Terry Maguire examines the issues of counterfeit medicine and dispensing errors in the pharmacy, and though the law regarding the regulation of medicines has been updated, in the UK a dispensing error remains a criminal offence
In October, the BBC reported that £800,000 worth of illegal prescription tablets had been seized during a week-long operation by police in Northern Ireland. Twelve people were arrested after 23 properties had been searched. The Police Service of Northern Ireland (PSNI) said the operation was designed “to disrupt the online sale of counterfeit and unlawful prescription drugs”. The drugs were intercepted as part of an international police action, Operation Pangea. Locally, the prescription drugs seized included Zopiclone, Pregabalin, and Xanax but also diazepam, Botox and weight-loss products.
This was not a local operation. Interpol, which runs Operation Pangea, gave the scale of the operation on its website as a significant crackdown on illicit medicines across 89 countries. It is described as an annual campaign targeting illicit medicines that pose a serious threat to consumer safety. The main targets in Operation Pangea are counterfeit medicines and medicines diverted from legal and regulated supply chains. Erectile dysfunction medications continue to be the most seized pills.
In the early 2000s I was, for two years, working as a Principle Pharmaceutical Officer at the Department of Health. I accompanied colleagues on a raid of a sex shop in a seedy part of the city where, I must confess, I was nervous I might be observed entering the premises early on a Monday morning by somebody who would spring to a wrong conclusion. We confiscated 3,000 Kemviagra 100mg tablets without much resistance. The bulk of the tablets remained in my filing cabinet for the duration of my employment at the department (and might still be there) with a small sample sent to the UK medicines regulator for analysis. The report came back stating the tables contained 100mg of Sildenafil with bioavailability of greater than 85% compared to the licensed market drug Viagra. In other words, these tablets were the real thing but as unlicensed medicines they were classified as counterfeit.
Because of the legal structure, there remains a direct link to a counterfeit medicine and dispensing errors in the pharmacy. Dispensing errors are much more than a simple mistake. When a pharmacist makes a dispensing error, he or she is supplying an incorrect medicine with potentially serious consequences to the patient. This is why a dispensing error in the UK remains a criminal offence and a main issue of contention for the pharmacy profession. Some high-profile cases in recent times, such as the peppermint oil case where the incorrect dose of the oil was used in an extemporaneously prepared medicine that caused the death of an infant, secured a criminal conviction of the pharmacist and ruined her life as she was forced to leave the profession and bear much unjustified shame.
Why should pharmacists have this sanction when it does not apply to mistakes made by other healthcare professionals? The issue is inherent in the Medicines Act 1968, which retains this criminal sanction for dispensing errors from previous acts it replaced. Even the amendments to the Act such as the 2012 Amendments failed to remove the criminal sanction. The Rebalancing Medicines Legislation and Pharmacy Regulation Programme was set up about 10 years ago to address this issue but has not yet come up with ways of fully removing the sanction. There is, it seems, great nervousness towards removal because counterfeit medicines are now a greater problem in our globalised market place and government is seeking to retain as much regulatory control as it can even if this means that now and then a genuine pharmacist making an honest mistake gets caught up in the regulatory machinery.
The first law properly controlling supply of medicines was the Pharmacy Act 1868, which recognised the chemist and druggist as the custodian and seller of named poisons (as medicine was then formally known). Indeed, the requirement for record keeping and the requirement to obtain the signature of the purchaser is currently upheld in the UK under the Poisons Act 1972 for ‘non-medicinal’ poisons and in the Misuse of Drugs Act 1972. The government of the 1860s also brought in more legislation, the Sale of Food and Drugs Act 1875, regulating the adulteration of foodstuffs which directly impacted quality of medicines.
The origins of both 19th century laws are in an incident that shocked the nation and forced the government of the day to legislate. The 1858 Bradford humbug poisoning involved the accidental arsenic poisoning of more than 200 people of which 21 died when sweets accidentally made with arsenics salts were sold from a market stall in Bradford.
Sugar, a big component of the humbug, was imported from the West Indies and in the 1850s cost two shillings a pound (£50 today). On 30 October 1858, James Archer was sent to collect ‘daff’, a cheap innocuous substitute for sugar, from a druggist Charles Hodgson who owned a pharmacy in Shipley. Hodgson was present in his pharmacy but did not serve Archer owing to ill health. He instructed his assistant, William Goddard, to make the sale and when Goddard asked Hodgson where the daff was kept, he was directed to a cask in a corner of the attic store. Goddard chose the wrong cask and rather than daff, sold Archer 12 pounds (5.4kg) of arsenic trioxide.
The humbugs were manufactured without the mistake being detected but it was noted that the finished product looked different from the usual humbugs. The sweet maker was suffering symptoms of illness during the sweet-making process and was ill for several days afterwards with vomiting and pain in his hands and arms.
Forty pounds (18kg) of lozenges were sold to a sweet seller who also noticed the sweets looked unusual and used this to obtain a discount. The sweet seller, one of the first to taste the sweets, immediately became ill. Arsenic trioxide is a white, crystalline powder that closely resembles sugar in appearance but it has no odour or taste.
Five pounds (2.3kg) of the sweets were sold from his market stall that night and within a day 21 people were dead with more than 200 severely ill. Unsurprisingly, the first deaths – those of two children – were thought to be cholera related but growing casualties soon identified the humbugs. Goddard was arrested and stood trial in Bradford on 1 November, with druggist Hodgson later tried on charges of manslaughter.
Analysis at the time estimated that each humbug contained between 14 and 15 grains (910 and 970 milligrams) of arsenic, though a contemporary account suggests nine grains (580 milligrams), twice the lethal dose. The case against Goddard was later withdrawn and Hodgson was also acquitted. The public sentiment was that the law needed changing, which led to the Pharmacy Act 1858.
The case had a profound impact on the regulation of medicines that resonates today. The Pharmaceutical Society of Great Britian founded in the Pharmacy Bill of 1851 benefited greatly from the Pharmacy Act 1968, which strengthened the need to be a registered practitioner, operating in registered premises with competence defined through an educational curriculum. It also provided the basis on which, within the UK, Operation Pangea prosecutes those in the illicit drug business. Sadly, it also means those of us making an honest mistake in the dispensary are still likely to be dealt with as criminals by the judiciary.
