News

Media And Political Bulletin – 25 September 2018

Media and Political Bulletin

25 September 2018

Media Summary

Companies stepping up efforts to ensure medicine supply post Brexit

European Medicines Agency, Press Release, 24 September 2018

Concerns about disruption in the EU to supplies of more than 100 drugs made only in the UK after Brexit have eased, according to a press release issued by the European Medicines Agency, although it warned that almost 40 products could still be at risk.

On Monday, the EMA said the number of medicines for which there were “concerns of Brexit-related supply disruptions” had more than halved from the 108 identified in July to 39. The regulator said it was looking at alternative medicines to which patients could be switched in the event of shortages of those drugs it still considered vulnerable to supply disruption.

The EMA said the sharp drop was a result of pharmaceutical companies stepping up their planning to guard against shortages when the UK leaves the EU on March 29 next year. The original warning was issued because drugmakers had failed to take the necessary action to duplicate approvals and safety procedures carried out in Britain. Under EU rules such processes must be carried out in a member state in order for medicines to be sold throughout the bloc.

Purple Drank: Fears over lethal cough syrup drug that British kids are ‘getting hooked on’

The Mirror, Sophie Evans, 20 September 2018

The Mirror reports that there are growing fears that the recreational use of the concoction ‘Purple Drank’ by UK school children is on the increase. Purple Drank, also known as Sizzurp, Syrup and Purple Jelly, is a mixture of codeine-based over-the-counter medicines and fizzy pop.

The Mirror reports that earlier this year, a Devon school warned that pupils’ lives were at risk over the drink craze, telling parents that there was a danger of overdoses.

Because the products in the ‘cocktail’ are above-the-counter, it is technically legal – but it has been described as extremely dangerous.

The prescription ingredients can create a dazed effect, with a subsequent high.

St Peter’s Church of England Aided School in Exeter previously issued a warning on its website amid reports several pupils had been using it.

The school told parents that although the effects of Purple Drank vary, users have reported euphoric and dissociative effects.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Companies stepping up efforts to ensure medicine supply post Brexit

European Medicines Agency, Press Release, 24 September 2018

Focus is now on 39 centrally authorised medicines, down from 108

The European Medicines Agency (EMA) has revised the number of centrally authorised medicines (CAPs) for which, based on current knowledge, there are concerns of Brexit-related supply disruptions from 108 to 39*. This revision results from EMA’s follow-up activities with the marketing authorisation holders of the 108 medicines that were identified as deemed to be at risk of supply shortages once the United Kingdom (UK) leaves the European Union (EU) on 29 March 2019 in EMA’s survey on industry preparedness earlier this year.

Results of the survey showed that marketing authorisation holders for 58% of the 694 CAPs with an important step in their regulatory processes in the UK were on track with their regulatory planning to ensure that their marketing authorisations would remain valid once the UK leaves the EU. However, for 108 medicines (88 human and 20 veterinary) EMA had serious concerns that there might be potential supply shortages.

After EMA contacted the marketing authorisation holders of these 108 medicines between July and September, reassurance on the planning was received for a significant proportion of these medicines.

“Over the past few months, EMA has made a concerted effort to reach out to the marketing authorisation holders of these 108 centrally authorised medicines to minimise the risk of supply issues for patients,” said Noël Wathion, EMA’s Deputy Executive Director. “This is a positive development for human and animal health, and, as regards the remaining 39 medicines, we want to take this opportunity to remind the marketing authorisation holders of these medicines to step up their planning now to protect patients and animals from non-supply.”

Marketing authorisation holders for over half of the 108 medicines have either taken steps to transfer their marketing authorisation to an EU27 country, change their qualified person for pharmacovigilance (QPPV), relocate their pharmacovigilance system master file (PSMF), adapt their logistics, supply chains and contracts, or relocate some manufacturing sites. According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the European Economic Area (EEA) in order for a company to be able to market a medicine in the EU.

For each of the 39 remaining products (25 human medicines and 14 veterinary medicines), EMA is analysing how to minimise supply disruptions and any resulting impact on public and animal health.

The Agency will work directly with the marketing authorisation holders of these products to address the outstanding issues on an ongoing basis. It will also discuss with its scientific committees relevant mitigation measures, including recommendations on possible therapeutic alternatives to which patients could be switched if necessary.

This information is being shared with participants at an industry stakeholder meeting taking place at EMA today.

Background on the survey

The aim of the EMA survey, which was launched in January 2018, was to obtain information on the timelines for submission of the necessary regulatory changes and to identify CAPs potentially at risk of supply shortages.

The survey was sent to marketing authorisation holders of the 694 CAPs (661 human and 33 veterinary products) who are located in the UK or who have quality control, batch release and/or import or manufacturing sites, or a QPPV or PSMF in the UK.

Reminder to industry on preparations for Brexit

Companies are reminded to plan for the UK’s withdrawal from the EU on 29 March 2019 and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. In particular, EMA encourages companies to refer to the updated questions and answers and practical guidance for industry published on 19 June 2018.

While the evaluation of the risk of supply and shortages of centrally authorised medicines is on-going, all marketing authorisation holders are reminded to inform the Agency of any change of plans which may affect medicine supply to patients in Europe.

In addition, applicants submitting new marketing authorisation applications to EMA are reminded to ensure that the arrangements they are proposing in their application remain valid after Brexit and likewise make the necessary changes by 29 March 2019.

Companies are also reminded that, if they foresee a product supply issue with a medicine, they have a legal obligation to inform EMA.

Purple Drank: Fears over lethal cough syrup drug that British kids are ‘getting hooked on’

The Mirror, Sophie Evans, 20 September 2018

It is the ‘cocktail’ that rapper Mac Miller was once addicted to.

And while there’s nothing to suggest Purple Drank caused Miller’s death, UK parents have been warned over the dangers of the potentially lethal drink.

The concoction, dubbed ‘liquid heroin’ by some, is a mixture of codeine-based over-the-counter medicines and fizzy pop like Sprite or Mountain Dew.

It is made using a prescription-strength cough syrup containing codeine and an antihistamine, typically in higher doses than is medically advised.

This is usually mixed with the soft drink and, optionally, a hard fruit candy.

Purple Drank, also known as Sizzurp, Lean, Syrup and Purple Jelly, hit the headlines this month following Ariana Grande’s ex-boyfriend’s death.

Miller, 26, whose real name was Malcolm McCormick, passed away after a suspected drug overdose at his home in Los Angeles, California, US.

Although there is no suggestion Purple Drank was behind his death, the rapper admitted in a previous interview that he had been addicted to it in 2012.

He said he was on the substance “very heavy” and was “so f***ed up all the time” and “lost” after his recreational use of it turned into an addiction.

Since Miller’s death, Internet search trends have shown a huge spike of interest in the concoction, which is regularly referenced in rap lyrics.

Usually deep purple in colour and drunk from a styrofoam cup, it originally became popular in the hip-hop community in southern US states in the 1990s.

However, there have been fears of British schoolchildren getting hooked on it.

Earlier this year, a Devon school warned that pupils’ lives were at risk over the drink craze, telling parents that there was a danger of overdoses.

Because the products in the ‘cocktail’ are above-the-counter, it is technically legal – but it has been described as extremely dangerous.

The prescription ingredients can create a dazed effect, with a subsequent high.

St Peter’s Church of England Aided School in Exeter previously issued a warning on its website amid reports several pupils had been using it.

The school told parents that although the effects of Purple Drank vary, users have reported euphoric and dissociative effects.

It said: “Other effects may include constricted pupils, slow/slurred speech, uncontrolled eye movement, droopy eyes, slowed heart rate, drowsiness, loss of balance, loss of co-ordination and paleness.

“There is a risk of overdose particularly because of the codeine, and this will be increased when taken in conjunction with alcohol.”

The colour of Purple Drank comes from the dyes in the cough syrup and the amount of syrup used can exceed up to 25 times the recommended dose.

The concoction is said to produce euphoric side effects, as well as a dissociative feeling from other parts of the body.

It can also cause blurred vision, shallow breathing, hallucinations and a slowed heartbeat – and can interfere with the digestive system.

The school’s warning to parents offered them advice about what to tell their children about the substance, and the risks of it.

It said: “Our best advice is, wherever possible, to avoid using Purple Drank completely. However, if someone says they will be using Purple Drank anyway, the following harm-reduction advice should be given.

“You should say that there is a risk of overdose attached to Purple Drank, especially when used with alcohol. You should never use Purple Drank – or other drugs – when you are on your own.

“If someone becomes ill or unconscious having used Purple Drank – or other drugs – you should ring 999 immediately and ask for an ambulance.

“Even though the ingredients can be legally bought without a prescription, they can be very damaging when used above the recommended levels.”

Media And Political Bulletin – 25 September 2018

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?