HDA Media And Political Bulletin – 24 March 2016
|China vaccine scandal stokes anger as regulators come under fire
23 March 2016, Reuters, Adam Jourdan and Brenda Goh
Last week a nearly $90 million black market vaccine ring was exposed in China. The vaccines have been sold in dozens of provinces around China since 2011. The scandal has shown that large loopholes exist in the regulation of the world’s second-largest medicine market, with regulators such as the Food and Drug Administration blaming a lack of resources and personnel for their failure to adequately regulate the sector.
23 March 2016, Pharmaceutical Processing, Andrew Moore
With the expansion and growth of the pharmaceutical market, there are increasing opportunities for counterfeiters to take advantage of vulnerabilities in the supply chain. Notably the globalisation of the supply chain has resulted in potential gaps in the supply chain, from manufacturers to wholesalers to dispensing units. Regulatory initiatives such as the EU Falsified Medicines Directive aim to tackle these challenges.
23 March 2016, C&D, Samuel Horti
Mr. Markey, NHS England’s head of pharmacy in London, has suggested there will be another national pharmacy flu service this year in addition to a specific London flu service that will target additional patients.
Further coverage on the community pharmacy funding cuts can be found on Pharmacy Biz.
|HM Government, Consultations, Department of Health, 23 March 2016
DH: Pharmacy dispending models and displaying prices on medicines
Seeks views on proposed changes to the Human Medicines Regulations and the Medicines Act.
This consultation seeks views on proposed changes to medicines legislation. These changes are to:
• allow independent pharmacists to make use of ‘hub and spoke’ dispensing models – a ‘hub’ pharmacy dispenses medicines on a large scale, often by making use of automation, preparing and assembling the medicines for regular ‘spoke’ pharmacies that supply the medicines to the patient
• allow the price of medicines and a statement on how the costs of medicines are met to be published on dispensing labels should this be required for NHS medicines dispensed as part of the NHS pharmaceutical services
• clarify the current dispensing label requirements for monitored dosage systems and medicines supplied under patient group directions
• amend the pharmacists’ exemption in section 10 of the Medicines Act, regarding the preparation and assembly of medicines, following a judgment of the Court of Justice of the European Union.
|China vaccine scandal stokes anger as regulators come under fire
23 March 2016, Reuters, Adam Jourdan and Brenda Goh
A widening scandal over illegal vaccine sales in China has sparked anger and drawn criticism from the government over glaring loopholes in the regulation of the world’s second-largest medicine market.
Police detained 37 people in Shandong province, official news agency Xinhua said on Wednesday, after a nearly $90 million black market vaccine ring was exposed over the last week.
The vaccines, including ones against meningitis, rabies and other illnesses, are suspected of being sold in dozens of provinces around China since 2011.
The scandal has stirred angry debate, casting a shadow over government ambitions to bolster the domestic drug industry and underlining the challenge it faces to regulate a widespread and fragmented medicine supply chain.
“We don’t know if our children have properly had the vaccine or whether it is ineffective or even if they are at risk,” said Zhang Jieqi, 32, who works at a tourism company in the city of Chengdu and has a child under two years -old.
She said she was angry that the case, which started early last year, had not been made public widely until now.
The government has said the vaccines themselves were real, although traded illegally.
The issue of regulation, from food and drugs to online sales, has become increasingly contentious in China as it looks to cast off a reputation for poor quality and safety.
However, regulators such as a Food and Drug Administration (CFDA) have pointed to a lack of resources and personnel to adequately regulate their sectors.
The vaccine case drew ire from Premier Li Keqiang, who said regulatory bodies – including the CFDA, health ministry and police – needed to work more in tandem, and that “dereliction of duty” would not be tolerated.
“This vaccine safety case has drawn close attention, and shows there are many gaps in terms of regulation,” Li said in a statement posted on the central government’s website late on Tuesday.
‘SWINDLED EVERY DAY’
Some people said the case echoed a scandal in 2008 when milk tainted with the industrial chemical melamine led to the deaths of six infants and made thousands sick.
Xinhua cited the health ministry as saying it had not found any spike in abnormal reactions to inoculations.
The World Health Organisation (WHO) said in a statement that improperly stored or expired vaccines rarely cause a toxic reaction and the most common risk is that they are ineffective.
Nonetheless, the case – centred on a mother and daughter illegally selling vaccines to re-sellers around the country – raises questions about regulators, even as China vows to boost its domestic market and raise exports.
Some parents also went online to vent their anger. One mother said she wanted to take her child out of China to escape “poisoned milk, gutter oil and ineffective vaccines”. Gutter oil refers to sub-standard, recycled cooking oil.
“It seems every day we are being swindled with something,” she wrote on China’s the Sina Weibo site, using the handle “Sunziyue”.
“No one is coming to sort it out.”
23 March 2016, Pharmaceutical Processing, Andrew Moore
The global pharmaceutical market has witnessed major regulatory shifts in recent years to secure the drug development supply chain. Countries across the globe are adopting uniform regulations that bolster enhanced visibility, track and trace, and safe manufacturing practice. These initiatives should come as no surprise: industry expansion and growth— both in the US and in global “pharmerging” markets—is beneficial but can also prompt counterfeiters to take advantage of vulnerabilities in the supply chain system. In other words, heavy growth in pharma across the globe also means more instances and/or attempts of drug counterfeiting.
Accurate, efficient, and high-quality labels play a crucial role in streamlining the supply chain and discouraging drug counterfeiting. Manufacturers must be prepared to tackle the increasingly complex supply chain, by using reliable technologies that enable a safe and high-quality labeling process without compromising production timelines, cost, or company credibility.
Rise in Pharma, Rise in Counterfeiting
The pharmaceutical market is projected to grow by 5.1 percent annually over the course of the next five years, with total global spending set to reach $1.2 trillion in 2017.1,2 To remain active in an increasingly competitive industry, companies are investing heavily in growing, global markets. But as the market for life-saving medicines and pharmaceuticals expands, rising incidences of drug counterfeiting increase the potential risk of harm to patients. At least 10 percent of all pharmaceuticals across the globe are recorded as counterfeit, with select developing countries experiencing jumps as high as 30 percent.3 Manufacturers looking to turn global promise into profit, while also protecting patients, are tightening up anti-counterfeiting regulations and serialization practices.
In the U.S., the rise of drug importing and exporting led the charge for harmonized serialization mandates, which took shape through the FDA’s Drug Quality and Security Act (DQSA). Meanwhile across the globe, the push for a more secure drug supply chain has resulted in regulations such as the EU Directive on Falsified Medicines + Delegated Act—intended to preempt instances such as in 2011 when EU authorities apprehended more 30 million counterfeit drugs at borders.4 In light of these policies, manufacturers and distributors must adopt new standards—and technologies—within relatively short timelines.
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Closing the Gaps
The rapid growth and globalization of the pharmaceutical industry gives way for even more holes in the supply chain. Gaps in drug movement can occur from pharmaceutical manufacturers to distributors to point-of-purchase distributors, such as hospitals or pharmacies. However, drugs may also move laterally from authorized distributors to trade brokers or secondary wholesalers—further adding to the risks.
Counterfeit drugs often result in product recalls and liability issues that can significantly impact revenue and brand credibility.5,6 As a result, companies are investing in better business practices and improved anti-counterfeiting technologies that help secure parts of the process at the system level, facility level, and individualized product level.7 Manufacturers and distributors however, require technologies that easily integrate into preexisting workflow and can streamline in-house production—providing a quicker, convenient means of producing better quality labels that can help prevent counterfeiting.
Simplify Inventory Management
Counterfeiters—who already benefit from fragmented global regulations—are also enabled by facility-level mismanagement. Non-compliance with Good Manufacturing Practices (GMP) can lead to overstock—ultimately resulting in product expiry and added waste. Maintaining large inventories is cost ineffective for a number of reasons, including risk of increased product excess due to expiry dates. This level of management adds complexity that when compounded by human error, opens the door to further delays or production inaccuracies. On-demand color printing produces labels as needed, minimizes excess label inventory, and reduces labeling costs by approximately 50 percent. By reducing the amount of in-house overstock, there is less room for confusion along the production line.
Improve Production Flow, Reduce Waste
Real-time label production eliminates the need for pre-print labels—making management more feasible through less buildup of overstock or label waste, and significantly reducing lead time. Shorter lead times can minimize the frequency of product or shipment error as well as overall delays in supply chain production. Manufacturers and distributors can also adhere to the principles of First-Expired-First-Out (FEFO) with a smoother production flow, less build up on the shelves, and less waste produced.8,9 Technologies that enable manufacturers to efficiently carry out the FEFO method of inventory management ensure safer drug production, deployment, and end-use, while also reducing the possibility of counterfeiting. Ultimately, products that are more readily available help reduce in-house complications, closing up potential (and often overlooked) gaps for drug counterfeiters to take advantage.
Recognize the Role of Color
Labels produced in color (using pigmented ink) minimize errors in medical identification, improve the overall process of accuracy, and can make the process of counterfeiting more challenging. In one instance, the FDA found that counterfeit drugs en route to the U.S. had differences in patterns and shading, as well as misinformation in color boxes when compared to the original brand.10 By differentiating each label, brand, or marker with color labels, companies can take preemptive steps in protecting their products and credibility while also making it more difficult for counterfeiters to easily replicate drug labels. Increased use of color labels could also deter potential counterfeiters who would have to invest in costly technologies to even try and mimic a particular drug label with multiple markers. Color labels that draw attention to specific details make it easier to both read and identify any differences in graphics or information—improving the overall process of immediately recognizing an original drug and its counterfeit.
Work with Durable Technology from a Credited Supplier
Manufacturers should partner with label technology suppliers who incorporate pigment ink into their color on-demand label production. Pigment inks improve label durability and security by resisting fading and smudging due to water or chemicals—ensuring that barcodes and graphics remain intact. Inventory management and the process of recognizing counterfeits can be improved at the ground level with high-quality color labels and precise barcodes that won’t smudge or smear.
Suppliers who take it one step further with third party testing, such as ensuring BS-5609 certification for their product line, provide even higher quality labels capable of withstanding a three-month long exposure to salt water. Certified labels that are continuously tested enable suppliers to better recognize any possible label alterations, and provide manufacturers with precise labels that have ultra-sharp text and recognizable graphics. Manufacturers working to secure their facility, and companies working to secure their line, require durable, high-quality technologies that can also streamline in-house management and production.
The industry has recognized how fragmented regulations set up a landscape for counterfeiters to take advantage, and responded to this growing challenge by implementing harmonized regulations. However, manufacturers must now work toward implementing these mandates into their facilities and production lines. Color on-demand labeling technology can improve compliance and efficiency, while also minimizing the threat of counterfeiting due to facility-level mismanagement and unit-level errors. Label printers that provide enhanced text and image quality while streamlining the overall in-house production process, enable better unit, facility, and system-level security—benefiting companies, brands, manufacturers, and ultimately patients in the long run.
23 March 2016, Pharmacy Biz, Neil Trainis,
John D’Arcy, the managing director of Numark, has refused to rule his organisation out of future legal action against the government over the validity of its consultation on its controversial pharmacy efficiency plans.
In an exclusive interview with Pharmacy Business, D’Arcy (pictured) criticised the government over a lack of detail around its proposals to introduce a hub and spoke dispensing model and a lack of an explanation behind the social care minister Alistair Burt’s admission that as many as 3,000 pharmacies may need to close as ministers look to make efficiency savings.
Eight clients belonging to the law practice Charles Russell Speechlys were said to be considering legal action against the government over what they regard as an improper consultation which was recently extended to May 24.
That extension looks increasingly unlikely to help the government avoid a legal battle with the pharmacy profession. David Reissner, a partner at Charles Russell Speechlys, revealed at the weekend that government lawyers had sent his firm a letter expressing the government’s belief that its consultation was not flawed, making legal action a possibility.
Reissner has also said it is “too early to say what clients including pharmacy bodies might be asked to join in” with any future legal action.
When asked if Numark would join the eight clients of Charles Russell Speechlys and take the government to court, D’Arcy said: “You never say never. From our perspective we take the view that we are not a representative body for pharmacy in that sense. We’re not one of the associations that has full membership across the sector.
“That said, part of our role is to provide leadership, so we’ll be responding to the consultation in our own way. But what we’re doing first and foremost is supporting the national campaign. We’ll support the PSNC and their efforts.
“We are supporting the NPA campaign and we’re having discussions with them because to be honest, the last thing pharmacy needs is to be any more divided than it already is. So we are supporting that campaign. If there was ever a particular position where we felt our members are being wronged, we’d look at that.”
Describing the government’s infamous letter of December 17 outlining its cuts to pharmacy funding and efficiency drive as “warfare-ish in nature,” D’Arcy added: “Whatever Charles Russell do is what Charles Russell do. If the NPA, PSNC, the powers that be say there needs to be legal action, we’ll support that legal action.
“But we’re not going to do something precipitous. We want to work through the existing infrastructure because that makes sense for us.”
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
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