Thousands of drugs at risk if no Brexit deal, European pharmaceutical companies warn

Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

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Supplies of thousands of medicines are at risk of disruption if Britain leaves the European Union without a trade deal, European pharmaceutical companies warned on Thursday. More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction. Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

The European Federation of Pharmaceutical Industries and Associations (Efpia) said a survey of its members showed 45 percent of companies expected trade delays if Britain and Europe fell back onto World Trade Organization rules after Brexit. Drugmakers also face an additional hurdle when it comes to licensing their products, since more than 12,000 medicines will require a separate UK licence in order for them to be prescribed. “For life-saving and life-improving medicines, the EU and UK cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the UK leaves the EU,” said Efpia Director General Nathalie Moll.

Pharmaceutical companies have insisted since last year’s Brexit referendum that a comprehensive agreement is needed to ensure maximum alignment between EU and British pharmaceutical regulations. But with the clock ticking down to Brexit in March 2019 with no sign yet that a trade deal will be concluded, many companies are now starting to draw up plans to protect drug supply chains, including building extra testing centres in Europe.

 

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RPS says pharmacists must always be present in pharmacies

The three RPS national boards have jointly called for legal guarantees that a pharmacist will always undertake a clinical assessment or check, and that there must be no legal loopholes that can bypass this requirement.

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Source: Alamy.com

The leaked document, prepared by a working group of the Department of Health’s Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, suggested that current legislation could be changed to allow a registered pharmacy professional, which could include a technician, to take responsibility for the sale and supply of pharmacy and prescription-only medicines.

The Royal Pharmaceutical Society (RPS) has said it believes a pharmacist should always be present in a pharmacy, apart from occasional short periods of time.

Responding to a leaked document produced for the Department of Health (DH) on the issue of whether pharmacy technicians should be allowed to supervise pharmacies, the RPS has issued an eight-point position statement on the role of registered technicians supervising the sale and supply of medicines.

Read More: http://snip.ly/3pujp#http://www.pharmaceutical-journal.com/news-and-analysis/news/rps-says-pharmacists-must-always-be-present-in-pharmacies/20203609.article

Pharmacist in deadly meningitis outbreak heading to trial

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After watching his mother die from meningitis in a nationwide outbreak caused by contaminated steroids, Scott Shaw is determined to make sure something like that never happens again.

A stiff punishment for the Massachusetts pharmacist Shaw believes is partially responsible may help, he says.

“I believe as surely as I’m talking to you right now that if something isn’t done, we will repeat this again,” the North Carolina man said.

Glenn Chin, the supervisory pharmacist at the now-closed New England Compounding Center in Framingham, about 22 miles (35 kilometers) west of Boston, is to go on trial Tuesday for his role in the 2012 fungal meningitis outbreak that killed 76 people and sickened hundreds of others.

Chin faces up to life in prison if convicted of all counts of second-degree murder under federal racketeering law.

Experts, and Chin’s defense attorney, believe prosecutors have a stronger case against Chin than they did against the co-founder of the compounding pharmacy, Barry Cadden. Cadden was sentenced in June to nine years in prison after being acquitted of second-degree murder charges but convicted on conspiracy and fraud charges.

Chin ran the so-called clean rooms where steroid injections were made. He is accused of failing to properly sterilize the drugs, among other things. Chin also faces conspiracy, mail fraud and other charges.

“I’m just a little concerned that the judge and the jury might be a little more harsh on Glenn Chin because he was doing the work in the clean room,” Chin’s attorney, Stephen Weymouth, said.

Throughout Cadden’s trial, the co-founder’s lawyers tried to push the blame onto Chin. Chin intends to point the finger back at Cadden.

Weymouth said he will argue that Chin was essentially a “puppet” for Cadden, who made working in the clean rooms so difficult that “mistakes might have been made.” Cadden was the one calling the shots and pushing the orders to line his own pockets, Weymouth said.

 

Read More: http://snip.ly/kx5et#http://abcnews.go.com/US/wireStory/pharmacist-deadly-meningitis-outbreak-heading-trial-49907214

Pharmaceutical companies gave $12m to doctors, nurses and pharmacists

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Pharmaceutical companies gave Australian doctors, nurses and pharmacists almost $12m in fees and expenses to attend conferences and give talks between November 2016 and April 2017.

The payments comprised more than $6.5m for travel expenses and accommodation; more than $4.2m in speaking and consultancy fees; and more than $700,000 to cover registration at medical conferences and events.

The drug companies Bristol-Myers Squibb and Amgen both spent more than $1m over the six months and one doctor received more than $39,000.

Health economists Prof Philip Clarke from the University of Melbourne and Dr Barbara de Graaff from the Menzies Institute for Medical Research in Tasmania conducted an analysis for Guardian Australia on the $11,667,253 in pharmaceutical payments made to healthcare professionals.

Under the updated Medicines Australia code of conduct, pharmaceutical companies were required to disclose all payments made to healthcare professionals by 29 August. Previously, this disclosure required the consent of the health practitioners, which in many cases

 

Read More information: http://snip.ly/mulqf#https://www.theguardian.com/australia-news/2017/sep/12/pharmaceutical-companies-gave-12m-to-doctors-nurses-and-pharmacists

CURE Pharmaceutical Launches New Academic Partnership Program Providing the Company’s Proprietary CureFilm™ for More Humane and Effective Animal Research

OXNARD, Calif., Sept. 06, 2017 (GLOBE NEWSWIRE) — CURE Pharmaceutical (OTCQB:CURR), (“CURE”), a leading disruptive drug delivery technology company, today announced the launch of a new academic partnership program, CureDotsTM. Under the CureDotsTMprogram, academic institutions may access the Company’s patented, multilayer oral thin film (OTF), CureFilm Oral™, for more humane and effective animal research and testing. CureDotsTM are punch-hole dot size versions of CureFilm Oral™ appropriate for pre-clinical testing with smaller animals such as mice.

Translation of a drug to human clinical trials requires that safety and efficacy studies be performed in animal models using the intended clinical route of administration, which is the oral route for many drugs. Oral gavage is the standard method for consistent and precise delivery of an investigational agent to an animal. However, oral gavage is often not well tolerated by the animal causing stress, which can jeopardize the integrity of the experiment.

According to published research by the University of Southern California School of Pharmacy, “Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals,” preclinical, oral drug delivery using the CureDotsTM represents a safe, convenient, and humane alternative to oral gavage for repetitive pharmacological and toxicological testing performed on animals.

 

Read More: http://snip.ly/sp598#http://markets.businessinsider.com/news/stocks/CURE-Pharmaceutical-Launches-New-Academic-Partnership-Program-Providing-the-Company-s-Proprietary-CureFilm-for-More-Humane-and-Effective-Animal-Research-1002345676

Pharmaceutical production batch record review

We can understand pharmaceutical production batch record review as meaning the controls and processes that pharmaceutical organizations have to build into the batch records of pharmaceutical products they manufacture. This is a means to ensuring that products meet compliance standards and are easy to detect whenever a problem arises from a sample in the batch or in the entire batch.

What does the 21 CFR 211.100 (a) say?

21 CFR 211.100 (a) is clear in its expectations. This and related subsections lay out the process by which pharmaceutical production batch record review has to be done. It states that all requirements have to written down in a prescribed format. The aim is to ensure that the core qualities of the drug relating to its molecule, such as the strength, quality, purity and identity are adhered to in every batch.

WHO requirements

The World Health Organization (WHO) lists the requirements for pharmaceutical production batch record review. These are the main points that go into it:

Pharmaceutical production batch record review consists of reviewing production and quality control records being made part of the approval process of batch release. Whenever there is the slightest deviation or failure on the part of any batch to meet its specifications; this should be properly and completely investigated. To ensure the quality of pharmaceutical production batch record review; the WHO states that the investigation can extend to other batches of the same product if necessary. On any observation and action taken, there should be a written record created of the investigation. This record should include the conclusion and details of the follow-up action that was taken.

The WHO also states that retention samples from each batch of finished product should be kept for at least one year after the expiry date. These have to be kept in the prescribed methods and conditions. Pharmaceutical production batch record review requirements state that where starting materials are concerned, the retention period is two years from the date of expiry.

References:

http://apps.who.int/medicinedocs/en/d/Js5517e/20.4.17.3.html#Js5517e.20.4.17.3

http://pharmaceuticalvalidation.blogspot.com/2010/03/batch-manufacturing-record-review.html

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