HDA Media And Political Bulletin – 05 May 2016

Revealed: Funding plans could increase multiples’ dominance

28 April 2016, Chemist & Druggist, Beth Kennedy

 

The Pharmaceutical Services Negotiating Committee (PSNC) has published The Department of Health’s (DH) source papers that informed initial discussions about cuts. The papers show the DH recognises that large chains may dominate the sector after the cuts, but thinks that the current model of pharmacy funding encourages clustering and does not offer incentives to provide a quality service.

 

The documents were also analysed by the Good Health Suite.

 

Chemist and Druggist also reports that London pharmacies may be hit by the funding cuts the hardest, according to Pharmacy London.

 

2016-04 Item-Level Only? A Closer Look at the Real EU-FMD Requirements

5 May 2016, Packaging Europe, Christoph Krähenbühl

 

Packaging Europe challenges the assumption that the European Falsified Medicines Directive (FMD) will be felt primarily by the pharmaceutical manufacturers and pharmacists, suggesting that it will also have a major impact on wholesalers and distributors. The article bases this claim off Chapter V of the DR which states that wholesalers must verify authenticity of products in their ‘physical possession’.

 

HDA welcomes PSNC proposals for enhanced role for pharmacy.

5 May 2016, HDA

 

The HDA welcomes the recent PSNC publication of plans for community pharmacy in 2016/17 and beyond as a credible and thoughtful set of proposals that as an Association we would urge the Government to consider.

 

Parliamentary Coverage

House of Commons, Written Answers, Drugs, 4 May 2016

 

Asked by Frank Field (MP): If his Department will reconsider the Medicines and Healthcare Products Regulatory Authority exemption which prior to 2013 enabled organisations to send surplus medicines to (a) developing countries and (b) other countries outside of the EEA.

 

Department of Health

 

Answered by George Freeman (MP): The Medicines and Healthcare products Regulatory Agency is the government body responsible for the safety and licensing of human medicines in the United Kingdom. The supply of a medicine for human use by way of wholesale requires the holding of a wholesale dealer’s licence. Following the transposition of the European Falsified Medicines Directive, the provisions of which are intended to prevent counterfeit medicines from entering the regulated supply chain, this requirement was extended to the export of medicines outside of Europe by way of wholesale from October 2013. The Directive does not allow any exception or exemption from this requirement.

 

House of Commons, Written Answers, Pharmacy; Finance, 4 May 2016

 

Asked by Michael Dugher (MP): If he will make an assessment of the effect of the budget reduction for community pharmacy in 2016-17 on high street vacancy rates.

 

Department of Health

 

Answered by Alistair Burt (MP): Community pharmacy is a vital part of the National Health Service and can play an even greater role. In the Spending Review, the Government re-affirmed the need for the NHS to deliver £22 billion in efficiency savings by 2020/21 as set out in the NHS’s own plan, the Five Year Forward View. Community pharmacy is a core part of NHS primary care and has an important contribution to make as the NHS rises to these challenges. The Government believes efficiencies can be made without compromising the quality of services or public access to them. Our aim is to ensure that those community pharmacies upon which people depend continue to thrive and so we are consulting on the introduction of a Pharmacy Access Scheme, which will provide more NHS funds to certain pharmacies compared to others, considering factors such as location and the health needs of the local population.

 

Full Coverage

Further details of pharmacy contract change proposals published

4 May 2016, Good Health Suite

 

Pharmacy organisations have learnt more about the proposals to change the community pharmacy contract at a Department of Health briefing.

 

A meeting on April 28 took place for pharmacy stakeholders at which the Department of Health addressed proposals in its Community Pharmacy Review. Discussions centred around the themes of the proposed Pharmacy Integration Fund, the Pharmacy Access Scheme, and issues around quality and services.

 

A background pack prepared for pharmacy stakeholders by the Department and the Department’s presentation slides have been made public. The background pack includes an interim summary of consultation responses (submitted to NHS England and the DoH up until February 12) as well as ‘source papers’ that were produced to inform initial discussions with the PSNC. “These ‘source papers’ were shared on a confidential basis with PSNC in February, and are now historic, but they will provide useful context for pharmacy contractors and other stakeholders,” said PSNC.

 

The Pharmacy Integration Fund has been proposed to support work across primary care and to involve pharmacy services in primary care settings such as GP surgeries and care homes. The funding would target aspects such as medicines optimisation, while developing infrastructure support with aspects including workforce development, digital integration and referral pathways.

 

Among concerns acknowledged by the Department were questions over the sustainability of funding, whether pharmacists employed by general practice is going to be the only form of integration, and whether there could be conflicts of interests in supplying care homes. The Department has indicated that it will now establish governance arrangements for allocation of the Pharmacy Integration Fund and confirm the legal framework.

 

In terms of funding and the Pharmacy Access Scheme, the Department said it proposed to phase out the establishment payment over a number of years, removing around £25,000 per year for all pharmacies dispensing 2,500 or more prescriptions a month. In addition, the proposed Pharmacy Access Scheme “will provide more NHS funds to certain pharmacies compared with others, considering factors such as location and the health needs of the local population.” In addition, there will be a simplified NHS pharmacy remuneration payment system based on a single activity fee.

 

“We propose that a pharmacy access scheme would be a centrally-determined national scheme with two key elements,” said the Department. “These two elements combined would determine which pharmacies should be protected, which would be published in a list:

 

a formula based on population and pharmacy location data as well as population size and needs, which would be used to generate an index of pharmacies, giving a ‘score’ of importance for patient access for each pharmacy in England;

qualification criteria based on the index of importance for patient access, and used to set a fixed criteria for entry to the scheme, such as “a score of higher than ‘x’ on the index, or the top 1,000 pharmacies etc”.

Among those invited to the meeting were Pharmacy Voice, representing pharmacy owner organisations, the Royal Pharmaceutical Society, the Local Government Association, the General Pharmaceutical Council, the Association of Pharmacy Technicians (APTUK), and National Voices, the coalition of healthcare charities in England.

 

PSNC had published a set of counter proposals ahead of the meeting, and has since said it will publish further information shortly on the counter proposals it submitted to the Department and “proposals for a quality payment to be included within the Community Pharmacy Contractual Framework.”

 

The National Pharmacy Association will host a webinar, ‘Cuts and Efficiencies: The Facts’, on the evening of May 12. Among the questions to be addressed in the free online webinar will be:

 

  • what does a 6% cut in remuneration actually mean?
  • could pharmacies be forced to close, and what has the Government actually said about closures?
  • is hub and spoke actually safer, as the Government claims?
  • is being in a cluster of pharmacies a bad thing?
  • are the Government’s proposals driven by patient demand?
  • is the Support Your Local Pharmacy campaign having an effect?

 

 

2016-04 Item-Level Only? A Closer Look at the Real EU-FMD Requirements

5 May 2016, Packaging Europe, Christoph Krähenbühl

 

It is almost five years to the day – 8th June 2011 – since the EU-FMD (Directive 2011/62/EU) was adopted by the European Parliament and the European Council. As we know, this ‘Falsified Medicines Directive’ set out in broad strokes the legal requirements on the stakeholders in the European Healthcare Supply Chain.

 

The Directive was followed on 19th February 2016 by the ‘Safety Features’ Delegated Regulation (DR 2016/161) alongside a Q&A document issued by the European Commission; both documents have given us much more details of what compliance with the EU-FMD means.

 

The publication has also set the end date of the three-year implementation deadline across Europe as the 19th February 2019 for at least 25 of the 28 European Member States, plus the 3 EEA countries of Iceland, Liechtenstein and Norway, in addition to Switzerland, Belgium, Greece and Italy, who have been granted a longer implementation timeline which they may, however, not wish to use.

 

Now is the time to examine the requirements more closely and understand the full impact of this important legislation. A closer look, in fact, reveals some interesting areas aside from the well-established basic requirements. One area, in particular, has so far not received much attention. This is the question of what the impact will be on the various stakeholders, other than pharmaceutical manufacturers and pharmacists.

 

The assumption so far has been that the impact would be felt particularly by the pharmaceutical manufacturers and the pharmacists, but that other stakeholders are getting off lightly by comparison – for example, in the US – where the Drug Supply Chain Security Act (DSCSA) legislation sets out a full end-to-end drugs traceability process involving all trading partners by 2023 – placing a significant obligation on all trading partners in the pharma supply chain, especially wholesalers and distributors.

 

But a closer examination of the EU-FMD requirements – especially those set out in Chapter V of the DR  – shows that the differences between the US traceability approach and the European point-of-dispense approach may be much smaller, and that there may, in fact, be a lot more to the EU-FMD requirements for wholesalers and distributors than a first glance reveals. Potentially, this will have a major impact on wholesalers, distributors and, by implication, their main trading partners – the pharmaceutical manufacturers.

 

The first concerns ‘risk-based’ verification. It is true that the EU-FMD does not require full end-to-end tracking of the medicines as they make their way through the distribution chain, i.e. it does not oblige wholesalers to systematically scan all shipments as they pass through their hands. But Article 20 of the DR clearly sets out scenarios where wholesalers will be obliged to verify the authenticity of the UI of the products in their ‘physical possession’ to ensure that the pack in question is not marked as blocked, dispensed, exported etc.

 

This applies to all returns and for all products not received directly from the manufacturer or the manufacturer’s official distributor. While this will only cover a limited share of the medicinal products flowing through the European supply chain, a quick calculation shows that the number of checks that must be carried out will not be insignificant.

 

It is also worth taking a peek across the pond to compare notes with the situation in the United States; in particular, the letters that were sent in January 2016 by McKesson and more recently by CardinalHealth – two of the three major distributors in the US supply chain – to all their pharma manufacturer trading partners. These letters deal with the obligation that will arise in November 2019, on distributors such as McKesson and CardinalHealth under the terms of the DSCSA, to verify all the saleable returns they handle. McKesson calculate that even a small percentage of returned goods mean they will need to carry out 18 million verifications every year.

 

The conclusion is that this can, realistically and cost-effectively, only be achieved if their pharma manufacturer partners do their bit; they would need to provide McKesson with the electronic data, including not only the item serial numbers, but also aggregated data up to shipment. This would allow the scan to be carried out at an aggregated level – shipper case, pallet, even shipment – to check the Unique Identifiers of all contained individual pharmaceutical item sales packs.

 

The message McKesson gives to their pharma manufacturing partners is very clear: “As your company prepares to implement your serialization solution, please be sure to consider the need for aggregation.” The Cardinal letter is even more direct: “Aggregation is necessary to efficiently provide serial numbers as part of Transaction Information and to easily move product through the supply chain. Cardinal Health expects that manufacturers will aggregate individual units up to the case level.”

 

So even though aggregation is an explicit US requirement only in the 2023 time-frame, major trading partners are issuing implicit requirements to establish aggregation and aggregated data exchange capability far earlier than the explicit legal requirement.

 

Given the comparable numbers of sales packs flowing through the European healthcare supply chain that fall under this risk-based verification requirement, it would be a fair assumption that manufacturers will start receiving ‘McKesson letters’ in the not too distant future that will ask them to seriously consider establishing the technical and process capabilities to supply their goods as well as the corresponding data in aggregated form.

 

In fact, the issue may become more urgent in Europe because of further requirements listed in Chapter V of the DR, where wholesalers would be required to scan the packs they manage systematically that extend beyond the returns use case. Article 22 – Decommissioning of Unique Identifiers by Wholesalers –deals with UIs of packs exported from Europe, whilst Article 23 recognises the need to accommodate the rich variety of processes across Europe by allowing Member States to define additional points in their national supply chains when the verification of the safety features and the decommissioning can be delegated to wholesalers.

 

How the Member States will interpret this provision is not yet clear, but given the primary aim of the EU-FMD legislation – to protect patients by closing all loopholes through which counterfeit medicines might infiltrate the legal medicines supply chain – it would be a safe assumption that national authorities will want to maximise the powers granted to them by the European legislation.

 

Likewise, whilst we don’t yet know what the details of these interactions are, it is likely that this obligation on wholesalers will, in turn, extend to pharmaceutical manufacturers. It is therefore likely that we will see bilateral agreement being sought by wholesalers with their pharmaceutical manufacturer trading partners that will demand not only the aggregation of physical products but also the provision of the corresponding data asset, including item, case, pallet and possibly shipment aggregation.

 

The conclusion is that the established view that European Requirements are item-level only is too narrow a view to take. True, the data reporting to the European Hub will be sales pack item UIs – as will the scan at the pharmacy – checking back against the connected National Systems.

 

But in order to support the physical and logical flow through the European Medicines supply chain in a cost-effective way for all stakeholders, 3C Excellis Europe are certainly advising all customers to aim their systems and processes to be aggregation-ready from the start.

 

For more information, visit www.3cintegrity.com

 

 

HDA welcomes PSNC proposals for enhanced role for pharmacy.

5 May 2016, HDA

 

The Healthcare Distribution Association (HDA UK) welcomes the recent PSNC publication of plans for community pharmacy in 2016/17 and beyond as a credible and thoughtful set of proposals that as an Association we would urge the Government to consider.

 

The HDA is particularly supportive of the suggestion for pharmacists to be responsible for emergency, out of hours, prescription provision, to eliminate the need for patients to go via a doctor for vital medicines. Our members provide emergency supplies of drugs to pharmacies across the four nations of the United Kingdom and would be well placed to support pharmacy in the delivery of such a service. It is clear that an important part of any reform of pharmacy must be enabling the sector help relieve pressures on GPs and A&E through taking an enhanced role within the NHS.

 

Another suggestion that the HDA agrees with the PSNC is the broadening of the pharmacy-led flu vaccination programme. Successful trials in areas such as London and Manchester have demonstrated that patients appreciate the flexibility and convenience of receiving their annual flu vaccination in pharmacy. HDA member wholesalers are crucial to such a scheme as they are able to deliver the vaccines to the pharmacy as and when they are required, through the twice daily deliveries offered by all our full members. This is a far more efficient model, as it avoids unnecessary storage and wastage of flu vaccines.

 

Finally, the HDA is in favour of the generic substitution service included in PSNC’s plan. The HDA’s predecessor the BAPW, supported the substitution of branded medicines for their generic equivalents during the last round of negotiations on the Pharmaceutical Price Regulation Scheme as it is a safe and efficient way for the NHS to save money on its medicines bill. As new innovations are introduced by pharmaceutical manufacturers it is increasingly important that the Government uses its scarce resources wisely, in order to deliver the best treatments for patients.

 

The HDA’s support for PSNC’s proposals is yet another example of the strength of the collaboration seen in the medicines supply chain, which sees the HDA working closely with partners at the regional, national and international level, across pharmacy, dispensing doctors and pharmaceutical manufacturers.

 

The PSNC’s counter proposal to the Government’s plans for community pharmacy in 2016/17 and beyond is available here.

EU’s Falsified Medicines Directive: Preparing for Compliance

30 March 2016, Pharmaceutical Processing, Brian Daleiden

 

Pharmaceutical processing reports on the publication of the EU Falsified Medicines Directive last February. FMD introduces new harmonised pan-European regulation with flexibility for each market to apply their own requirements. Pharmaceutical companies serving the EU market ought to understand the full scale of the changes that the new regulation will bring. The healthcare supply chain has until February 2019 to comply with these new requirements.

 

March NCSO/Price Concessions update

30 March 2016, PSNC

 

The Department of Health granted the following price concessions for March 2016:

 

The price concession only applies to the month that it is granted.

Drug Pack size Price concession
Bumetanide 1mg tablets 28 £2.50
Celiprolol 200mg tablets 28 £19.83
Celiprolol 400mg tablets 28 £39.65
Cimetidine 400mg tablets 60 £19.99
Clindamycin 150mg capsules 24 £12.49
Desmopressin 10micrograms/dose nasal spray 60 dose £25.02
Ferrous Sulfate 200mg tablets 28 £2.85
Flecainide 50mg tablets 60 £5.61
Flecainide 100mg tablets 60 £5.88
Fludrocortisone 100mcg tablets (new) 100 £87.00
Lamotrigine 5mg dispersible tablets sugar free 28 £7.99
Lercanidipine 10mg tablets 28 £5.99
Lercandipine 20mg tablets 28 £9.85
Mefenamic acid 500mg tablets 28 £10.25
Pioglitazone 15mg tablets 28 £24.00
Pioglitazone 30mg tablets 28 £34.99
Pioglitazone 45mg tablets 28 £39.55
Procyclidine 5mg tablets 28 £14.00
Trazodone 50mg/5ml oral solution sugar free 120ml £140.00
Trazodone 100mg capsules (new) 56 £28.14

 

No additional endorsements are required for price concessions.

 

Parliamentary Coverage

 

There is no Parliamentary Coverage today.

 

Full Coverage

EU’s Falsified Medicines Directive: Preparing for Compliance

30 March 2016, Pharmaceutical Processing, Brian Daleiden

 

With the publication of the Delegated Act on safety features, those who manufacture, sell, or dispense medications in the European Union (EU) have until February 2019 to comply with complex new track-and-trace regulations outlined in the Falsified Medicines Directive (FMD).

 

Because the EU is one of the largest global markets, it is crucial for pharmaceutical companies, their CMO/CPO partners, and their 3PL partners to start now in understanding the extensive serialization, compliance reporting, verification, and other requirements to ensure full EU FMD compliance.

 

An Overview of the EU FMD and its Track-and-Trace Model

 

The Falsified Medicines Directive introduces tougher rules to improve the protection of public health with new harmonized, pan-European measures to ensure that medicines for human use are safe and that the trade in medicines is rigorously controlled. The FMD includes diverse rules for API producers, guidelines for GMP of active substances, logos for online pharmacies, and on-package authenticity features known as Safety Features.

 

The Safety Feature regulations of FMD impose the greatest data management and transaction processing challenges for all stakeholders in the supply chain, with on-package authenticity features coupled with new serialization, compliance reporting, and verification regulations. Some of these align with other global regulations and standards, and some of these are completely unique to the EU.

 

Medications in Europe are generally packaged and sold at the “unit of use” level, so the unit volume of product that needs to be serialized can range into the hundreds of millions of units per year for a given company. Serialized product will generate 1,000 times the data storage requirements and 10,000 times the transaction volumes of those seen today for lot-level product. Overall, the universe of data to be produced, managed, and reported on will be massive—and in Europe, there is the added complexity that each EU Member State is given flexibility to apply their own unique requirements.

 

Serialization

 

The FMD requires serialization at the saleable pack or secondary level. For each unit of drug product, a unique serial number, coupled with the manufacturer product code, batch number, and expiration date, are to be encoded in both a GS1 2D DataMatrix and in human readable form. A fifth data element, such as a national reimbursement number, may be required based on country requirements.

 

 

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Serialization at other packaging levels, such as at the transport case level, is not required nor is aggregation required under law. Regardless, considerable industry discussion has already started on the potential business or operational needs for multi-level serialization and related aggregation activities.

 

Compliance Reporting

 

The Marketing Authorization Holder has several reporting and notification requirements under the FMD. The two primary ones are for product master data and serialized product pack data. First, master data about the product including product codes, form, strength, doses per pack, pack type, and target market(s) for distribution must be reported to the European Hub for each unique product form produced. Subsequent updates to product master data must also be reported. Serialized product pack data must also be reported, including product codes, lot/batch number, expiry data, and serial numbers for each unit of drug product shipped into the supply chain. Drug product status must also be maintained and updates made to the EU Hub. These status updates may be required at a batch level if a recall is initiated, or at a saleable unit level in situations such as the decommissioning of serial numbers due to destruction of drug product.

 

Verification and Safety Features

 

EU FMD provides for verification of the safety features, including the serialized product identifier, at least once before the product leaves the supply chain and is dispensed to the patient. This may be a fairly simple process executed at point of dispense under simple distribution. Or, it may be a highly complicated one involving risk-based verification by wholesale distributors or parallel importers/repackagers depending on the supply path of the drug product and whether or not the drug product was repackaged.

 

A Compliance Data Exchange Example for Simple Distribution

 

In a simple distribution scenario, a pharmaceutical manufacturer sells a drug product to a wholesale distributor and that wholesale distributor sells the drug product directly to a pharmacy.

 

We will follow the information flow in this scenario:

 

The pharmaceutical manufacturer generates and reports product master data to the EU Hub. Then, as products are packed, serialized, and shipped, product pack and serialization compliance data is also reported to EU Hub for each unit of drug product. The European Hub pushes some of the information down to the National System repositories of the target markets for the products.

 

In the simple distribution scenario, a verification of safety features is then performed at point of dispense: the pharmacy. The pharmacy scans the drug product, and a verification inquiry for the product identifier is sent to the National System supporting the member state where the pharmacy is located. The National System checks to verify that the product code and serial number of the product scanned matches an active unique identifier in the system.

 

The regulations provide for a myriad of additional verification checks, reports, and notifications depending on product path and changes in packaging. Should one wholesaler purchase product from another wholesaler, they must verify the safety features of the purchased product prior to resale. Saleable product returns also trigger verification inquiries prior to resale. In addition, if parallel importation and repackaging occurs of an original manufactured product, a cascade of verification inquiries, decommissioning status updates, product master data reports, and product pack/serialization data reports are required against the original product and the repackaged product.

 

The Falsified Medicines Directive Creates Diverse Serialization Challenges

 

The EU FMD creates an umbrella regulation covering the member states of the European Union, plus several other countries aligning to FMD requirements. The EU FMD also acknowledges the uniqueness of each member by providing flexibility in how the regulations apply for drug products targeted for dispensation within a given country. So, a pharmaceutical company preparing for EU FMD regulations needs to design their serialization and compliance infrastructure both for the extreme scalability challenges presented by the FMD and the flexibility required to serve the member states.

 

For example, a drug product may be regulated as a prescription medicine in one member state but not another, thereby creating serialization requirements for some drug packages and not others. Certain prescription drug products may be white-listed, or exempted, from the safety feature requirements. A member state may choose to allow a standard GS1 GTIN to identify the drug product, or they may require a unique national product code. Member states may also require additional data to be captured, stored, and reported with each drug product, such as a national reimbursement number. These are some of the complexities facing a pharmaceutical company preparing their internal packaging sites and external CMO network, and the CMO looking to serve a diverse pharma client base.

 

How to Prepare Now for the 2019 Deadline?

 

With the publication of the final Delegated Acts and a closer look at the many nuanced operational and data management requirements they create, the industry is now realizing the highly complex set of product information, serialization data, and serialized product events which need to be planned for and exchanged with network partners to enable a secure, scalable, and cost-effective EU compliance infrastructure. In order to meet the EU Falsified Medicines Directive requirements by the February 2019 deadline, the thousands of pharmaceutical companies, CMOs, and 3PLs serving the EU market have a lot of work ahead of them to ensure serialization readiness at a massive scale and full compliance readiness for a complex set of reporting requirements.

 

Therefore, it is crucial to take a network-centric view of your supply ecosystem to fully understand the compliance requirements imposed by your product portfolio and their target markets, the network of supply partners you work with, the product master data and serialized product data exchange issues you will need to master across internal systems and external partners, and the operational process changes required in your finished goods distribution network. This is particularly important if your company or partners also serve markets outside of the EU.

 

For any individual company, this is a considerable effort that will involve the coordination of dozens to hundreds of supply/distribution partners and integrated connections to an equal amount of enterprise, packaging, and distribution systems. By starting now, you can develop a clear strategy for understanding the data you need to collect and manage, the network you need to exchange information with, and the serialization management and compliance reporting tools that will ensure you reduce time, cost, and risk in meeting FMD requirements.

 

February 2019 may seem far away, but as experience across the United States, India, South Korea, China, and Brazil has shown, serialization and compliance readiness always takes much longer and is much more complicated than expected. The time to prepare for EU compliance is now.

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.

 

Countering Drug Counterfeiting

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.

 

Senior NHS England pharmacist hopeful of national flu scheme

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.

 

Parliamentary Coverage

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.

 

Full Coverage

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.”

 

Countering Drug Counterfeiting

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.

 

 

Numark legal actions against the government? Never say never

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.

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