News

Media And Political Bulletin – 01 April 2020

Media and Political Bulletin

01 April 2020

Media Summary

Guidance: Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak

MHRA, 01 April 2020

Understanding that disruption to the supply chain has given rise to difficulties for wholesalers in applying the safeguards in GDP to meet supply needs, the MHRA has published guidance for industry on flexible approaches they are taking on good distribution practices.

The list of temporary regulatory flexibilities that will be allowed address the current exceptional circumstances. The challenges arising from to COVID-19 are likely to change. As more information becomes available the MHRA may periodically review previous decisions to ensure they are still valid. They are being regularly reviewed and may be updated at any time.

Wholesalers using these flexibilities should record the decision using existing local procedures for recording unexpected events, with a brief explanation of why this was necessary. It must also be reported to MHRA at Covid19.GMDP@mhra.gov.uk.

UK medicines watchdog warns over unsafe coronavirus tests

Financial Times, Camilla Hodgson, 01 April 2020

This article is subject to copyright terms and conditions. Please access full article here.

India likely to soon ease some drug export curbs after U.S. pressure – sources

Reuters, Neha Dasgupta, 01 April 2020

Two Indian government officials have told Reuters India will likely relax some export restrictions on pharmaceutical products soon due to intense pressure from the United States which is worried about drug shortages as the number of coronavirus cases surge.

An easing of the restrictions will probably come within two days and will likely include Paracetamol, a common pain reliever also known as acetaminophen, the government officials in New Delhi said.

The restrictions will be lifted for all countries, the officials said, but it was not immediately clear exactly how many drugs formulations would be exempted.

March/April supply issues update published

Dispensing Doctors’ Association, Ailsa Colquhoun, 01 April 2020

Dispensing Doctors’ Association reports that the Department of Health and Social Care (DHSC) Medicine Supply Team has published its March/April supply issues update. DDA members can view the full details of the notifications of new and ongoing issues by visiting the supply shortages library.

A summary of the new issues are included in the full transcript of the article further down.

COVID-19: English pharmacies to receive £300m in “advance funding”

C+D, Eliza Slawther, 31 March 2020

C+D reports that the PSNC has announced that community pharmacies in England will receive £300 million in “advance funding” over the next two months to alleviate cashflow issues caused by COVID-19. The total sum will be “paid as uplifts to contractors’ January and February payments” – payable in April and May.

The £300m is not new money for the sector and will have to be “reconciled at a later date”, the PSNC announced yesterday. The advance funding is “recognition of the significant cashflow pressures facing the sector at this point in the COVID-19 pandemic”, it said. There will be two cash injections, with the first payment of £200m made on or around April 1. The second payment, of £100m, will be made at the end of April or early May, the PSNC added.

Although the organisation “welcomes” the intention of the forward payment, the “funding gesture alone is not enough”, PSNC chief executive Simon Dukes commented.

This was also reported in The Pharmaceutical JournalP3 Pharmacy, and Pharmacy Business.

EMA warns consumers about falsified COVID-19 drugs from online pharmacies

European Pharmaceutical Review, Hannah Balfour, 31 March 2020

European Pharmaceutical Review reports that the EMA has advised consumers on how to recognise registered online pharmacies so they can avoid falsified medications, urging the public not to buy medicines from unauthorised online pharmacy websites and vendors. They state that any claim a product can treat or prevent COVID-19 is unfounded, as there are no approved therapeutics or vaccines as of yet.

They also stated that if a legitimate medicine that is otherwise in short supply is listed on an online pharmacy it is likely to be falsified, ie, a fake being passed off as the authorised product.

The EMA is advising consumers to buy products from local pharmacies or retailers and if using online pharmacies, ensure that it they are registered with the national competent authorities.

BMA speaks out as healthcare workers still waiting for protective gear

Metro, Harriet Line, 31 March 2020

Metro reports that the British Medical Association has said healthcare workers treating coronavirus patients should not have to risk their lives because they do not have adequate personal protection equipment. The BMA called on ministers to ‘clarify’ what medics should be expected to do after concerns about PPE shortages, with nurses on some Covid-19 wards without vital masks and gowns.

Communities secretary Robert Jenrick has said the government ‘cannot and should not ask people to be on the front line without the right protective equipment’.

Deputy chief medical officer Dr Jenny Harries has apologised, admitting distribution had been ‘tricky at times’.

This was also reported in the Financial Times.

GIRP Secretary-General discusses the challenges of medical supplies distribution

New Europe, 31 March 2020

As part of New Europe’s COVID-19 Livestream series, Monika Derecque-Pois, Secretary-General of GIRP, discussed the current challenges of distributing medical supplies across Europe.

“Before and shortly after the lockdown, we have seen a surge in demand with [some] having tripled the normal volume [of orders],” Derecque-Pois said. “We have worked around the clock doing night shifts and weekend shifts to bring the medicines due to the surge of demands in pharmacies. Everybody tried to fill their prescriptions or to stock up on self-medication to not go out as often and there was a real peak [as a result].”

Some of the distribution challenges faced by GIRP have involved the harder access of drivers to countries going through a lockdown and increase border control security. GIRP is in constant talks with government officials to expedite the delivery to countries in need.

 

 

Parliamentary Coverage

 

There was no parliamentary coverage today.

 

Full Coverage

Guidance: Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak

MHRA, 01 April 2020

We understand that disruption to the supply chain has given rise to difficulties for wholesalers in applying the safeguards in GDP to meet supply needs.

The following list of temporary regulatory flexibilities that will be allowed address the current exceptional circumstances. The challenges arising from to COVID-19 are likely to change. As more information becomes available we may periodically review previous decisions to ensure they are still valid.

They are being regularly reviewed and may be updated at any time.

Supply chain

  • Periodic supplier and customer requalification may be deferred. Interim reliance may be placed upon regular review of our notifications of suspended wholesale dealer authorisations (WDA(H)) and any General Pharmaceutical Council registration updates
  • Medicines may be returned to saleable stock if returned from the wholesale distribution chain within 10 days

Transportation

  • Non-temperature-controlled transport may be used when the ambient temperature is less than 20°C
  • ‘Do not refrigerate’ products should be identified and shipped appropriately when the ambient temperature is less than 8°C. A risk assessment should be in place for products transported under these conditions, with mitigating measures implemented where necessary
  • Products may be held for up to 96 hours at a transit hub without a WDA(H) to assist in transportation. A risk assessment in respect of storage conditions and security should be in place, with mitigating measures implemented where necessary
  • Alternative arrangements to show proof of delivery will be permitted

Responsible Persons (RP)

Responsible Persons may act as RP for another company within the same group of companies without variation, provided they have an RP registration number issued by MHRA

Facilities and equipment

Storage and distribution equipment may be used with limited qualification and validation to allow equipment to be used as soon as possible. This should be supported by a risk assessment and additional mitigating measures where necessary. Remaining qualification and validation work should be completed retrospectively, with delay minimised as much as possible

Small changes in various elements of the quality system will be permitted to provide more RP resource and enable focus on supply

  • Management of deviations – following assessment by the RP to determine the impact of a deviation or non-conformance, investigation of ‘minor’ events may be put on hold. These should be tracked, with investigations initiated in response to an identified trend
  • Post inspection regulatory commitments relating to deficiencies classified as ‘Other’ may be put on hold. These should be recorded in the quality system and corrected after pandemic restrictions are lifted
  • Routine Standard Operating Procedure reviews may be extended
  • Electronic alternatives to wet signatures will be permitted. Distributors should ensure that interim ways of working are designed to accommodate data integrity principles
  • Internal audit (self-inspection) and GDP refresher training may be put on hold. Training new personnel in GDP principles, and training of procedural updates should continue

Flexibilities relating to verification of unique identifier codes required by the Falsified Medicines Directive remain under consideration and will be communicated later.

We recognise that the care of patients is your first priority. We will do everything we can to support you in the decisions you need to make. To do so we need you to ensure that when you make relevant decisions, you have carefully evaluated the risks and you are fully transparent.

Reporting your use of this guidance

Wholesalers using these flexibilities should record the decision using existing local procedures for recording unexpected events, with a brief explanation of why this was necessary.

It must also be reported to MHRA at Covid19.GMDP@mhra.gov.uk.

These reports do not require prior approval to implement. Reporting decisions will assist regulators in monitoring the national situation in real time and take further actions to address common difficulties as situations change.

If these flexibilities do not provide enough scope to enable quick actions to the current logistical challenges, please report this to us as soon as it becomes apparent. Reporting any difficulties will assist us to monitor the national situation in real time and take actions to support critical supply chains while continuing to protect public health.

UK medicines watchdog warns over unsafe coronavirus tests

Financial Times, Camilla Hodgson, 01 April 2020

This article is subject to copyright terms and conditions. Please access full article here.

India likely to soon ease some drug export curbs after U.S. pressure – sources

Reuters, Neha Dasgupta, 01 April 2020

India will likely relax some export restrictions on pharmaceutical products soon due to intense pressure from the United States which is worried about drug shortages as the number of coronavirus cases surge, two Indian government officials told Reuters.

India, which supplies more than a quarter of the world’s generic drugs, last month restricted exports of 26 pharmaceutical ingredients and the medicines made from them. The move was seen as an attempt to secure supplies for its domestic population after the outbreak played havoc with the industry’s supply chain globally.

The restrictions are not complete bans but impede sales of drug and drug ingredients overseas by specifying circumstances for their export and requiring firms to procure a “no objection” certificate from the government.

An easing of those restrictions will probably come within two days and will likely include Paracetamol, a common pain reliever also known as acetaminophen, the government officials in New Delhi said.

“There is so much (U.S.) pressure on the government. For U.S. what matters is Paracetamol, it matters to them significantly,” said one official, adding that India had adequate stock of the drug for domestic use for at least four months.

The restrictions will be lifted for all countries, the officials said, but it was not immediately clear exactly how many drugs formulations would be exempted.

Both officials declined to be identified due to the sensitive nature of the discussions. India’s commerce ministry did not immediately respond to a request for comment.

The U.S. government said in a statement on Tuesday that Secretary of State Mike Pompeo had spoken with India’s foreign minister and sought cooperation in strengthening global pharma manufacturing and supply chains, but gave no further details.

President Donald Trump has warned Americans of a “painful” two weeks ahead in fighting the virus. Nearly 3,900 people have died in the United States, and the total confirmed U.S. cases has risen to 187,000.

Imports from India accounted for 24% of medicines and 31% of medicine ingredients to the United States in 2018, according to the U.S. Food and Drug Administration.

India was, however, unlikely to ease a ban on the export of malaria drug hydroxychloroquine, which came in addition to the restrictions on the 26 drugs and formulations. The drug is being tested to see if it is effective in treating patients with COVID-19.

The United States’ Health and Human Services has listed hydroxychloroquine as a medical resource that was subject to hoarding prevention measures.

March/April supply issues update published

Dispensing Doctors’ Association, Ailsa Colquhoun, 01 April 2020

The Department of Health and Social Care (DHSC) Medicine Supply Team has published its March/April supply issues update. DDA members can view the full details of the notifications of new and ongoing issues by visiting the supply shortages library.

A summary of the new issues are as follows:

Injectables

Diazepam (Diazemuls) 10mg/2ml emulsion for injection

Gadovist preparations

Orals

Calcium Folinate 15mg tablets

Clozapine (Zaponex) 25mg oro-dispersible tablets

Cycloserine 250mg capsules

Diclofenac/Misoprostol (Arthrotec 50) 50mg/200 microgram tablets

Fluoxetine 10mg tablets

Levodopa/carbidopa/entacapone (Stanek) tablets – various strengths

Medroxyprogesterone (Provera) 400mg tablets

Paracetamol tablets

Promazine 25mg/50mg tablets

Valproate semisodium (Depakote) 250mg/500mg tablets

Others

Proctosedyl (cinchocaine 0.5%/hydrocortisone 0.5%) Ointment

Clenil Inhaler Range

Eye drops/treatments

Betamethasone (Vistamethasone) 0.1% eye drops

Fluocinolone Acetonide (Iluvien) 190 mcg Intravitreal implant in applicator

COVID-19: English pharmacies to receive £300m in “advance funding”

C+D, Eliza Slawther, 31 March 2020

Community pharmacies in England will receive £300 million in “advance funding” over the next two months to alleviate cashflow issues caused by COVID-19, the PSNC has announced.

The total sum will be “paid as uplifts to contractors’ January and February payments” – payable in April and May.

The £300m is not new money for the sector and will have to be “reconciled at a later date”, the Pharmaceutical Services Negotiating Committee (PSNC) announced today (March 31).

The advance funding is “recognition of the significant cashflow pressures facing the sector at this point in the COVID-19 pandemic”, it said.

There will be two cash injections, with the first payment of £200m made on or around April 1. The second payment, of £100m, will be made at the end of April or early May, the PSNC added.

The NHS Business Services Authority (NHS BSA) is “working to recalculate payments”, with the intention that the initial £200m will be paid alongside the planned April 1 payment.

The PSNC said it is “in ongoing discussions about the need for more funding for the sector” to help contractors with costs arising from “increasing prescription numbers, staffing costs, one-off costs and rising drugs bills” as a result of the COVID-19 pandemic.

“While this funding injection is a step in the right direction, PSNC has told HM Government that it is not sufficient to cover contractors’ rising costs and to help them to manage the new pressures on their businesses,” the negotiator added.

“Funding gesture is not enough”

Although the organisation “welcomes” the intention of the forward payment, the “funding gesture alone is not enough”, PSNC chief executive Simon Dukes commented.

The negotiator has informed the government that “it simply will not be sufficient to help many contractors to meet the rapidly increasing costs that they are facing as a result of this pandemic”, he said.

“Community pharmacy is at a critical point, with pharmacy teams and businesses under extreme pressure and many pharmacies now not financially viable,” Mr Dukes added.

The PSNC and other pharmacy bodies are trying to “persuade” the government of the “very urgent need for further emergency funding support”, he said.

This was also reported in The Pharmaceutical JournalP3 Pharmacy, and Pharmacy Business.

EMA warns consumers about falsified COVID-19 drugs from online pharmacies

European Pharmaceutical Review, Hannah Balfour, 31 March 2020

The European Medicines Agency (EMA) has advised consumers on how to recognise registered online pharmacies so they can avoid falsified medications.

The European Medicines Agency (EMA) is urging the public not to buy medicines from unauthorised online pharmacy websites and vendors. They state that any claim a product can treat or prevent COVID-19 is unfounded, as there are no approved therapeutics or vaccines as of yet.

They also stated that if a legitimate medicine that is otherwise in short supply is listed on an online pharmacy it is likely to be falsified, ie, a fake being passed off as the authorised product. Falsified medicines may contain the wrong or no active pharmaceutical ingredient (API) or the correct API in the wrong dosage. They are often found to also contain harmful substances, unsafe for human consumption.

The EMA is advising consumers to buy products from local pharmacies or retailers and if using online pharmacies, ensure that it they are registered with the national competent authorities.

Online pharmacies registered in Europe carry a common logo with the flag of the European Union country where the pharmacy is registered below it. Clicking on the logo should redirect customers to the website of their national authority and show a list of all legally operating online pharmacies, allowing them to check if the pharmacy they are using is registered before purchase.

Click here for the lists of registered online pharmacies in EU countries.

BMA speaks out as healthcare workers still waiting for protective gear

Metro, Harriet Line, 31 March 2020

Healthcare workers treating coronavirus patients should not have to risk their lives because they do not have adequate personal protection equipment, the British Medical Association has said.

The BMA called on ministers to ‘clarify’ what medics should be expected to do after concerns about PPE shortages, with nurses on some Covid-19 wards without vital masks and gowns.

Communities secretary Robert Jenrick has said the government ‘cannot and should not ask people to be on the front line without the right protective equipment’. And on Monday, 2.5million aprons, 870,000 eye protectors, 218,000 respiratory masks, 1million surgical masks and 11million pairs of gloves were delivered to NHS trusts. But they have yet to reach many hospitals and GP practices.

Deputy chief medical officer Dr Jenny Harries has apologised, admitting distribution had been ‘tricky at times’.

She said the Army had been called in to help. The BMA’s Dr Rob Harwood said: ‘We need clarity from the government on what it is that healthcare staff should do and, particularly, what risks they should not have to take if they do not have adequate PPE.

‘Doctors are placing themselves at significant risk by treating patients on the front line and there are concerns that sometimes this is without adequate PPE.

‘While the government has been letting us know that protection is on the way, there are still doctors and other NHS staff who today, tomorrow and in the coming week, may face the daunting prospect of having to consider treating patients without adequate protection.

‘A lack of adequate protection is not only dangerous, it may be fatal.’

Meanwhile, many care workers are still without masks or hand sanitiser, with just plastic aprons and gloves for protection. Unison’s Christina McAnea said: ‘Care workers are being treated as though their safety doesn’t matter. They feel forgotten about — at the bottom of the pile.’

This was also reported in the Financial Times.

GIRP Secretary-General discusses the challenges of medical supplies distribution

New Europe, 31 March 2020

As part of New Europe’s COVID-19 Livestream series, Monika Derecque-Pois, Secretary-General of the European Health Care Distribution Association (GIRP), discussed the current challenges of distributing medical supplies across Europe.

GIRP is responsible for the yearly wholesale distribution of around 15 billion packs of medicines as well as a wide range of healthcare products to pharmacists in 34 European countries. With the COVID-19 pandemic, GIRP’s works have been more vital than ever in making sure the access to medicine and healthcare products continues amid lockdown measures.

“Before and shortly after the lockdown, we have seen a surge in demand with [some] having tripled the normal volume [of orders],” Derecque-Pois said. “We have worked around the clock doing night shifts and weekend shifts to bring the medicines due to the surge of demands in pharmacies. Everybody tried to fill their prescriptions or to stock up on self-medication to not go out as often and there was a real peak [as a result].”

Some of the distribution challenges faced by GIRP have involved the harder access of drivers to countries going through a lockdown and increase border control security. GIRP is in constant talks with government officials to expedite the delivery to countries in need like Italy. The best advice right now is to be mindful of others and purchase only what you need.

“We should plead for solidarity. People should only purchase or ask for the medicines they really need because other patients need those medicines. So, no hoarding, be reasonable and just take what is actually needed,” Derecque-Pois said.

Media And Political Bulletin – 01 April 2020

From Factory to Pharmacy

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