News

Chemist and Druggist, Jamie Waldron, 16 December 2016

Chemist and Druggist reports on the MHRA’s investigation into the “significant diversion of benzodiazepines and other hypnotics/anxiolytics” onto the black market in the UK. This investigation was launched on the back of referrals from enforcement authorities in Scotland and the Republic of Ireland, and led to the UK watchdog identifying the scale and extent of the diversion. The MHRA explained however that it did not believe these practices had resulted in medicine shortages or other issues with the legal supply chain.

This news was also covered by Pharmacy Business, more information on the full report below.

Diversion and Illicit Supply of Medicines (DISM), Advisory Council on the Misuse of Drugs (ACMD), December 2016

This report sets out to:

• explore the extent of DISM in the UK, to find out which drugs are being diverted;
• evaluate the extent of the medical and social harms of such diversion; and
• assess whether DISM displaces or replaces the use of known recreational drugs of abuse, such as heroin.

Opioids and benzodiazepines were found to be the most prevalent diverted drugs whereas increasing amounts of gabapentin and pregabalin are also being diverted. The ACMD also required further attention to be given to the misuse of codeine in over–the-counter (OTC) preparations as a precursor to the misuse of prescription opioids.

Regarding the source of diversion, the three areas below in order of priority were identified:

• By prescription prior to diversion
• Internet with many unregistered pharmacies online supplying prescriptions and medicines unethically
• Diversion of wholesale supplies, specifically as an important source of illicit benzodiazepines.

The report further discusses the diversion of wholesale supplies: “In June 2016, the MHRA informed the ACMD of the illegal diversion of POMs from the regulated supply chain into the criminal market. The issue of diversion of POMs, further controlled under the Misuse of Drugs Act 1971, into illegal markets was first brought to the attention of the MHRA by the Irish medicines regulator, Health Products Regulatory Authority (HPRA). Investigations into the prolific drug trafficking and misuse of benzodiazepines and Z-drugs in Ireland resulted in the seizure of products that appeared to originate from the legitimate supply chain in the UK. Intelligence work was carried out and the products were identified as originating from a UK wholesaler. As a result, an inspection of this wholesaler took place and the top ten sales of benzodiazepines and Z-drugs were examined. This examination then started to unearth significant levels of diversion of these products out of the regulated supply chain. The first significant step in this enquiry identified the diversion of multi-million doses to one source. The medicines were apparently sold to another business which had had their wholesale dealer’s authority suspended. The location of this huge amount of medicines has never been identified but it is the investigative hypothesis that they had been sold into the illegal market.”

The ACMD concludes with several recommendations to tackle this issue in the UK including:

• Maintaining a watch list of emerging prescribed substances with the potential for diversion from the legal supply chain
• Monitor the implementation of the NICE guidelines to ensure that prescribers follow best practice in reviewing repeat prescribing to identify dependent behavior
• Support the efforts of NHS England in developing standard specifications for prison healthcare systems.

No specific recommendation for tackling the diversion of wholesale supplies is included.

The full report is available here.

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Full Coverage

Chemist and Druggist, Jamie Waldron, 16 December 2016

Wholesalers and a “small number of pharmacies” are involved in a network selling benzodiazepines to the “criminal market”, the UK’s drugs watchdog has revealed.

As part of its investigation into the “significant diversion of benzodiazepines and other hypnotics/anxiolytics” onto the black market, the Medicines and Healthcare products Regulatory Agency (MHRA) uncovered an “extensive network of criminality”, it announced this afternoon (December 16).

This network included “wholesale dealers and a small number of registered pharmacies in the UK”, it added.

Two pharmacists arrested

Two pharmacists in Yorkshire have already been arrested in relation to the purchase of more than 200,000 packs of benzodiazepines “and other powerful drugs”, the MHRA said.

“The proportion of these medicines dispensed by the pharmacists is very small,” the MHRA stressed. “They have been arrested in relation to a number of offences, including possession with intent to supply a controlled drug.”

The watchdog launched its investigation on the back of referrals from enforcement authorities in Scotland and the Republic of Ireland, it said.

“Uncommonly, the medicines were legitimate UK products which had been diverted from the regulated supply chain. Following the referrals, investigations led by the MHRA identified the scale and extent of the diversion,” it added.

However, there is “no indication” that these practices have led to “medicines shortages or issues with the legitimate supply of medicines to the public”.

“Consequently, medicines supplied through registered pharmacies are unaffected,” it said.

MHRA head of enforcement Alastair Jeffrey said: “As a matter of priority, we are working with our regulatory and law enforcement colleagues to identify and prosecute those involved in this activity, and to implement preventative measures to make sure this illegal industry is shut down.”

The MHRA told C+D that as the case is ongoing, it is “not able to comment on the specifics”.