HDA UK Media And Political Bulletin – 19 December 2016

UK pharmacies selling benzodiazepines to ‘criminal market’

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.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

UK pharmacies selling benzodiazepines to ‘criminal market’

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”.

New reforms for Scottish medicines approval process

Pharma Times, Selina McKee, 15 December 2016

 

The Scottish government has announced plans for new reforms to the way treatments are approved in the country, to help boost access for patients. Previous reforms to the Scottish Medicines Consortium’s medicines appraisal process in 2014 have helped to “markedly increase” the acceptance of new medicines for NHS use. To further improve access, the Scottish government said it will follow new recommendations made by his review.

 

Parliamentary Coverage

Advisory Council on the Misuse of Drugs, Report on diversion and illicit supply of medicines, 15 December 2016

 

The ACMD’s report on diversion and illicit supply of medicines (DISM) is in response to the Home Office’s commissioning letter of September 2013, in which the then Home Secretary requested the ACMD to explore the potential for medical and social harms arising from the illicit supply of medicines – predominantly controlled medicines.

 

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
  • assess whether DISM displaces or replaces the use of known recreational drugs of abuse, such as heroin

 

In recent years, DISM has become of increasing public concern across the globe, although the hard evidence for this constituting a major problem other than in the United States is hard to find.

 

###

 

House of Commons Questions, 15 December 2016, NHS: Drugs

 

Jim Shannon: What recent discussions he has had with pharmaceutical companies on the price structuring of medicines they supply to the NHS.

 

Department of Health

Nicola Blackwood: Ministers regularly meet with stakeholders from the National Health Service and the Pharmaceutical industry where a range of issues are discussed. Details of external Ministerial meetings are published regularly:

https://www.gov.uk/government/publications/ministerial-gifts-hospitality…

 

Full Coverage

New reforms for Scottish medicines approval process

Pharma Times, Selina McKee, 15 December 2016

 

The Scottish government has announced plans for new reforms to the way treatments are approved in the country, to help boost access for patients.

 

According to a review of access to medicines in Scotland by former NHS Fife Medical Director Dr Brian Montgomery, previous reforms to the Scottish Medicines Consortium’s medicines appraisal process in 2014 have helped to “markedly increase” the acceptance of new medicines for NHS use, rising from 48 percent between November 2011 and October 2013 to 75 percent between May 2014 and March 2016 for orphan, ultra-orphan and end-of-life medicines.

 

Now, to further improve access, the Scottish government said it will follow new recommendations made by his review, devising over the coming months a revised approval process for true ultra-orphan medicines which will see final decisions on low volume high cost medicines being made without the SMC.

 

The SMC will also be given new powers to consider accepting a medicine on an interim basis so its clinical effectiveness can be further assessed with on-going data collection before a final assessment is made, in a similar process to that of the Cancer Drugs Fund in England.

 

Health Minister Shona Robison also announced improvements to the processes for non-routine access to medicines on an individual case-by-case basis, including a new national appeals process that will consider equity of access with other parts of the UK as a material part of its decision-making.

 

“The reforms I am announcing today will help more patients to get better access to treatments that can give them longer, better quality lives,” said Ms Robison.

 

“The Scottish Government, the SMC and the NHS have worked hard to reform access to new medicines. However, we now need pharmaceutical companies to do their bit by bringing forward much fairer prices for new medicines so that access is as wide as possible for the people of Scotland.”

 

The report also recommends that NHS National Services Scotland should play a stronger role in negotiating the cost of medicines in Scotland.

 

​Sandra Auld, director of ABPI – Scotland, said Dr Montgomery’s comments on “earlier collaboration between NHS Scotland and the pharmaceutical industry in bringing new medicines to market are very welcome and will be important in reducing delays for patients gaining access to new medicines”.

 

“Similarly, the recommendation that we need an alternative assessment pathway for ultra-orphan medicines is one that we feel could make a real difference to patients accessing these medicines,” she added.

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