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HDA Media And Political Bulletin – 16 May 2016

Globalisation of drugs manufacturing raises concerns over quality

16 May 2016, Financial Times, Andrew Jack

 

The Financial Times discusses the risks involved in the globalisation of drug manufacturing. With Asia producing a growing share of both completed drugs and raw materials that go in to them, regulators in the EU and US are under more pressure to ensure high standards are maintained, reports the Financial Times. This is further complicated by differing standards between the EMA and FDA. Many companies importing drugs from foreign countries must then spend significant amounts of money on retesting, which the European federation of pharmaceutical industries and associations states has ‘no added value to patient safety’.

 

Record amount of fake Viagra seized

12 May 2016, BBC News, Jean Mackenzie

 

More than £11m worth of counterfeit erectile dysfunction drugs were seized in the UK last year. Danny Lee-frost from the MHRSA explains that while websites look legitimate, the drugs do not come from a pharmacy but from unhygienic locations. At a counterfeit testing lab run by Pfizer, counterfeits are identified by looking at the colour of the label and tablets or by testing the chemical footprint. BBC news concludes by suggesting that the only way to prevent counterfeit medicine trade is to stop people buying it.

 

Footage of the programme is available on the MHRA website.

 

Contractor notice: Category M price reduction

13 May 2016, PSNC

 

The Department of Health (DH)_H has announced reductions worth £48m to Category M (generic medicine reimbursement) prices which will apply to prescriptions between June and September 2016. This is in response to the preliminary findings of the 2015/16 medicines margin survey. The DH intends to reclaim excess margin that they believe was delivered to contractors in 2015/16.

 

The price reductions are also reported in P3 Pharmacy and Dispensing Doctors’ Association.

 

Contractor update: community pharmacy funding and negotiations

13 May 2016, PSNC

 

The PSNC Committee met last week to review the outcome of discussions with the Government concerning community pharmacy funding. Peter Cattee, Chair of PSNC Funding, stated the Government remain determined to implement the funding cuts.

 

Chief pharmaceutical officer admits he misled MPs over hub and spoke dispensing

13 May 2016, The Pharmaceutical Journal

 

Last March at an APPG event England’s chief pharmaceutical officer, Keith Ridge compared the 3% dispensing error rate in England with a ‘0.00001% error rate in “large scale automated dispensing facilities” in Sweden. Dr Ridge has now admitted that the comparison between the two countries was not appropriate. He has further admitted that the UK community pharmacy data error of ‘around 3%’ that he quoted was based on observational data.

 

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Contractor notice: Category M price reduction

13 May 2016, PSNC

 

The Department of Health (DH) has announced reductions to Category M prices which will apply to prescriptions between June and September 2016, after which they will be reviewed.

 

The changes represent a reduction to generic medicine reimbursement prices (Category M) for June to September 2016 worth £12m per month, equivalent to £48m for the four-month period.

 

The reductions are being made by DH in response to the preliminary findings of the 2015/16 medicines margin survey. Their intention is to reclaim excess margin that they believe was delivered to contractors in 2015/16 above the agreed allowed £800m. PSNC accepts that margin levels were high during the period, but has not agreed to the reduction.

 

DH stated in a letter to PSNC that they felt the data was robust enough to support at least a £12m per month reduction. DH said they would reconsider the position for October onwards in consultation with PSNC, once finalised 2015/16 medicine margin survey results are available. DH projections suggest that the October Drug Tariff is unlikely to see a significant recovery.

 

The Drug Tariff will be amended to reflect the new prices and the June 2016 prices will be available shortly on the NHS Prescription Services website.

 

 

Record amount of fake Viagra seized

12 May 2016, BBC News, Jean Mackenzie

 

More unlicensed erectile dysfunction drugs were seized in the UK by the authorities last year than ever before – worth more than £11m. The Victoria Derbyshire programme joined a raid to find out why they are a problem.

 

The market for unlicensed Viagra is huge and most of it heads for the internet, where pills are sold for £2 to £3 each. These tend to be imitations or a generic Indian version of the drug – Kamagra – which are shipped to the UK in bulk, packaged up and posted on.

 

But what the computer-based consumers may not realise is the pills are made in unhygienic, unregulated locations and could contain toxic chemicals like lead and arsenic, the agency which regulates medicines says.

 

The Medicines and Healthcare products Regulatory Agency (MHRA) conducted its biggest-ever operation last week in an attempt to find the fakes, with search warrants at 24 properties conducted by 50 officers across London.

 

Speaking outside a suburban street where one of the raids was taking place, Danny Lee-Frost from the MHRSA says: “When you log on to a website and you see a picture of a scientist in a white coat and stethoscope, it all looks above board. But your medicines are not coming from a pharmacy, they are coming from a street like this.

 

“We’ve recovered medicines that are being sold from a shed in a back garden that was damp and rotten, there were rats and mice crawling all over the stuff.”

 

Viagra is a prescription drug, meaning it needs to come from a doctor or pharmacist. But doctors believe there are many more people buying it on the internet and using it in a completely unregulated way.

 

Dr Hamed Khan GP said: “I’ve had a number of people who’ve had very serious side affects like visual problems, people could potentially faint, you could have dangerous reductions in blood pressure or even potentially heart problems.”

 

So how do you spot a fake? At a counterfeit testing lab run by Pfizer – the drug company that makes Viagra – they examine products from around the world, and have found counterfeits in 111 countries.

 

They can tell by the colour of writing on the pack, while the actual tablets might be a different shade of blue. They then test them by taking a small amount and looking at its chemical footprint.

 

Pfizer vice-president Tommy Dolan says people may not know they are buying counterfeit products if they have nothing to compare them with.

 

“Sometimes the match can be close enough that the counterfeit is reasonably good, other times due to a lack of medication or too much medication in the product or agents that have been added that shouldn’t be in the product that are toxic, the patient could come to significant harm,” he says.

From 2014 to 2015 the MHRA seized fake Viagra valued at £3,890,516 from a yearly total of counterfeit drugs of £8,696,067. From 2015 to 2016 this had tripled to £11,205,342, making up 90% of counterfeit drugs seized that year.

 

While no pills were found at the property we saw being searched, the agency has £25m of fake medicine collected over the past few years in its lock-up.

 

Where is the demand coming from?

Mr Lee-Frost says there is a strong youth market for the drug. “It’s used by adult males who don’t actually have the medical condition which this could be prescribed for. They use it as a sexual enhancement for the weekend.”

 

Dr Hamed Khan adds: “Increasingly younger people have been trying to obtain Viagra as they see it as a sort of recreational drug almost and it boosts them psychologically, which it absolutely doesn’t, it’s a drug that only has physical effects and that misconception is leading to younger people trying it even if they don’t need it.”

 

After dozens of searches and three arrests, the agency finds some bags of pills, but it is not as much as they had hoped. They believe the only way to win is to stop people buying it.

 

 

BREAKING: Contractors get double dose of bad news

13 May 2016, P3 Pharmacy

 

Pharmacy contractors in England are to be hit by a double whammy of category M price reductions of £48m for the period June to September and a likely negative outcome to the consultation on the Government’s community pharmacy reforms.

 

In a statement to contractors, Peter Cattee, chair of PSNC’s funding and contract subcommittee, said the negotiating body was “very pessimistic” about the situation. Taken together with the prospect of the £170m funding cut, “this financial year will be very difficult for the sector,” he warned.

 

Click here for the full statement and press release from PSNC.

Click here for the details about the category M clawback.

 

 

£48m cut to Category M

16 May 2016, Dispensing Doctors’ Association, Alisa Colquhoun

 

The Department of Health (DH) has announced reductions to Category M prices which will apply to prescriptions between June and September 2016, after which they will be reviewed.

 

According to PSNC, the changes represent a reduction to generic medicine reimbursement prices (Category M) for June to September 2016 worth £12 mllion per month, equivalent to £48m for the four-month period. For dispensing practices, which account for around 7 per cent of dispensing volume, this will equate to a monthly cut of £840,000 for the period, or a total £3.36m drop in reimbursement.

 

The reductions are being made by DH in response to the preliminary findings of the 2015/16 medicines margin survey. The intention is to reclaim excess margin that it believes was delivered to contractors in 2015/16 above the agreed allowed £800m. PSNC accepts that margin levels were high during the period, but has not agreed to the reduction.

 

DH stated in a letter to PSNC that it felt the data was robust enough to support at least a £12m per month reduction. DH said it would reconsider the position for October onwards in consultation with PSNC, once finalised 2015/16 medicine margin survey results are available. DH projections suggest that the October Drug Tariff is unlikely to see a significant recovery.

 

The June Drug Tariff will be amended to reflect the new prices.

 

PSNC warns: “Earnings from the first half of this financial year will be adversely affected by the Category M price reductions,” and for pharmacy owners adds: “but [they] will still be significantly above those expected for the second half. Combined with the determination to remove £170m from community pharmacy in October, this financial year will be very difficult for the sector.”

 

All contractors are advised to make whatever provisions they can for the funding reductions.

 

 

Contractor update: community pharmacy funding and negotiations

13 May 2016, PSNC

 

The Department of Health (DH) and NHS England published a letter on 17th December 2015, Community pharmacy in 2016/17 and beyond.

 

The letter states that funding for the community pharmacy service in 2016/17 will be reduced by £170m from the agreed sum in 2015/16, to £2.63bn, and it sets out a number of other wide-ranging policy ideas.

 

PSNC has been working, both with the other national pharmacy organisations and in discussions with DH and NHS England, to convince policy makers of the need to make better use of community pharmacy. This work included putting a counter proposal to the NHS, setting out how community pharmacy could be used to make the £170m savings while also improving care for patients.

 

The full PSNC Committee met in Durham this week to review the outcome of our discussions and agree next steps. Peter Cattee, Chair of PSNC’s Funding and Contract Subcommittee and CEO of PCT Healthcare, has made the following statement to contractors:

 

“In our meetings with the Department of Health and NHS England it has become clear that they have little interest in commissioning additional national community pharmacy services or in our constructive proposals to make better use of community pharmacy to help the NHS to make savings. The Government appear unshaken in their determination to remove a sum of £170m from community pharmacy funding this year, and to do so via reductions in fees and allowances. As a committee of contractors PSNC is extremely concerned about this and we continue to work with the other pharmacy organisations seeking to persuade policy makers of the value of community pharmacy and the dangers in implementing a funding reduction of this nature.

 

In addition to this we realise there was a major over delivery of margin in 2015/16, and the Drug Tariff changes also announced this week begin a programme by the Department of Health to recover that margin from community pharmacy. Combined with the determination to remove £170m from community pharmacy in October, this financial year will be very difficult for the sector. We strongly advise all contractors to make whatever provisions they can for the funding reductions. Earnings from the first half of this financial year will be adversely affected by the Category M price reductions, but will still be significantly above those expected for the second half.

 

PSNC met this week and we are very pessimistic about the outcome of the consultation on community pharmacy’s future. We are also very concerned that the NHS and Government have not been clear about their aims, for example on hub and spoke dispensing and the community pharmacy access scheme. We will continue our work seeking the best possible outcome for contractors and will continue working with our colleague organisations to try to find new ways to convince policy makers at both a national and local level of the value of our current services, and the opportunities for the NHS to make better use of community pharmacy.”

 

 

Chief pharmaceutical officer admits he misled MPs over hub and spoke dispensing

13 May 2016, The Pharmaceutical Journal

 

England’s chief pharmaceutical officer Keith Ridge has admitted that data he gave to an All-Party Pharmacy Group (APPG) inquiry suggesting that hub and spoke dispensing is ‘much safer’ than traditional dispensing was inaccurate.

 

Giving evidence to the APPG’s inquiry into primary and community care on 16 March 2016, Ridge said that community pharmacists have a ‘professional obligation’ to adopt automated dispensing because the error rate is much lower. Ridge cited evidence from literature that the error rate in community pharmacy in the UK “is around 3%” compared to large-scale automated dispensing facilities in Sweden, which he said had an error rate of 0.00001%.

 

However, the error rate for Sweden turned out to be almost double the rate Ridge quoted. In a statement published on 11 May 2016, Ridge said: “I was referring to the error rate published by Apotekstjanst AB in Sweden – in fact the published rate is 0.0000185%.” Additionally, this Swedish error rate is for dispensing “pouches” of medication, something which is not routine practice in the UK.

 

Ridge also admitted that the UK community pharmacy data error rate of “around 3%” that he quoted was based on observational data. “Now that I know the error rate from Sweden is determined by reporting, it is not appropriate [to] draw a direct comparison. I apologise for inadvertently misleading the committee and for any subsequent confusion,” he added.

 

That community pharmacy figure comes from a 2009 review which quotes a UK observational study showing dispensing error rates of 3.32%.

 

A spokesperson for the National Pharmacy Association (NPA), the trade association for independent community pharmacy professionals in the UK, says: “The Department of Health’s hub and spoke proposal is flawed – and this is just one of many claims that are unravelling.”

 

The NPA also criticised the references that Ridge had relied on. “Those significant criticisms of the research should, we believe, have been declared to the APPG,” the spokesperson added.

HDA Media And Political Bulletin – 16 May 2016

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