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HDA UK Media And Political Bulletin – 5 October 2017

Media and Political Bulletin

5 October 2017

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Media Summary

My pharmacy could lose £2,500 a month if generics shortages continue

Chemist and Druggist, Jennifer Offord and Grace Lewis, 4th October 2017

Chemist and Druggist reports on the potential effect to pharmacists if generics shortages continue. A pharmacy owner has told the publication that not only are the shortages having an impact on the smooth operating of his business but also that he could stand to lose thousands of pounds a month if the issues continue.

Last month, the Pharmaceutical Services Negotiating Committee (PSNC) announced it is in “urgent discussions” with the Department of Health (DH) about the “catastrophic” effect of generics shortages on contractors’ cash flow.

Ensuring successful serialisation data management ahead of the EU FMD

European Pharmaceutical Review, Jean-Marie Aulnette, 4th October 2017

In this European Pharmaceutical Review article, Jean-Marie Aulnette, vice president of EMEA at TraceLink addresses the complexities of developing a comprehensive compliance solution, the importance of working collaboratively with trade partners and how the task of storing and exchanging huge amounts of serialisation data securely should not be underestimated.

Mr Aulnette argues that the task of introducing track & trace solutions has largely been underestimated by the supply chain. He also suggests that many manufacturers and packaging organisations have been slow to adopt new processes that will ensure compliance ahead of the deadlines for implementation, despite the benefits surrounding consumer protection and industry sustainability.

ABPI update on application for judicial review

ABPI, 4th October 2017

The Association of the British Pharmaceutical Industry (ABPI) have issued a statement regarding its application for judicial review versus The National Institute for Health and Care Excellence (NICE).

​​​​​​​Following confirmation from the Administrative Court that The ABPI’s application for judicial review has been turned down, the following statement has been issued:

“The ABPI is disappointed that the judicial review application has been turned down. It’s now appropriate for us to take time to reflect on the judgement with our members and decide next steps”.

This was also reported in The Telegraph.

Parliamentary Coverage

There is no Parliamentary coverage today.

Full Coverage

My pharmacy could lose £2,500 a month if generics shortages continue

Chemist and Druggist, Jennifer Offord and Grace Lewis, 4th October 2017

A pharmacy owner has told C+D he expects to lose up to £2,500 a month if generics shortages continue.

Last month, the Pharmaceutical Services Negotiating Committee (PSNC) announced it is in “urgent discussions” with the Department of Health (DH) about the “catastrophic” effect of generics shortages on contractors’ cash flow.

Speaking to C+D following PSNC’s announcement, Dipak Pau, owner and superintendent pharmacist of The Pill Box pharmacy in Chelmsford, said not only are the shortages having an “impact on the smooth running of my business”, but he could stand to lose thousands of pounds a month if the issues continue.

“Items I was buying for 15p are now in excess of £4,” Mr Pau told C+D last month (September 22).

“If I’m selling 1,000 packs a month in one single line in my pharmacy, I will lose £1,500 to £2,500.”

However, the real cost to the business will be higher, as “it’s not just one product” that is affected, Mr Pau explained.

“It’s 80 to 90 products, in different strengths and formulations,” he added.

Mr Pau claimed the cost of buying antipsychotic medication olanzapine from wholesalers increased “170 times” in just three weeks, following a shortage in the market.

The price of antipsychotic quetiapine is also increasing an “extraordinary amount”, he added.

Independents most impacted

Mr Pau warned that if the DH fails to act on the current supply issues, independent pharmacies could “slowly go bust”.

“[Independents] struggling to buy stock in, and buying stock at multiple times the value of what they are getting back from the DH, are losing money hand-over-fist,” he stressed.

“You can only sustain losses for so long.”

C+D has asked PSNC for an update on its “urgent talks” with the DH.

Ensuring successful serialisation data management ahead of the EU FMD

European Pharmaceutical Review, Jean-Marie Aulnette, 4th October 2017

Ensuring successful serialisation data management ahead of the EU FMD

Traceability and serialisation have been the talk of the industry for many years, with regulatory bodies worldwide starting to introduce legislation that will help to eradicate counterfeit medicines from the supply chain.

Despite this, it has not been top of the agenda for many pharmaceutical supply chain partners given the complexities that serialisation introduces, meaning that many marketing authorisation holders (MAHs) and contract manufacturers (CMOs) are now facing an uphill battle towards compliance.

Following the announcement that the active enforcement of the US Drug Supply Chain Security Act (DSCSA) for pharmaceutical manufacturers has been delayed due to a lack of readiness, it is vital the industry prepares for serialisation compliance not only in the US, but also in Europe. But what are the biggest challenges that companies face? And, what can contract partners learn from the DSCSA enforcement delay ahead of the EU Falsified Medicines Directive (FMD) deadline in February 2019?

In this article, Jean-Marie Aulnette, vice president of EMEA at TraceLink addresses the complexities of developing a comprehensive compliance solution, the importance of working collaboratively with trade partners and how the task of storing and exchanging huge amounts of serialisation data securely should not be underestimated.

The reality of serialisation

Counterfeit drugs cost the pharmaceutical market billions each year and the impact these medicines can have on patient safety is huge. As a result, over 55 countries are introducing legislation which will allow products to be tracked or traced throughout the supply chain, until they land in the hands of the patient.

However, the task of introducing track & trace solutions has largely been underestimated by the supply chain. Many manufacturers and packaging organisations have been slow to adopt new processes that will ensure compliance ahead of the deadlines, despite the benefits surrounding consumer protection and industry sustainability. In the US, the task of not only ensuring product transaction information, history and statements (T3 records) are available electronically but also that product identifiers are added at an item and case level has proved too great for many. As such, the DSCSA enforcement date has been delayed by one year to allow companies extra time to implement solutions.

One of the most common barriers to adopting a suitable solution is the cost. Manufacturers report that on average, implementing a line management system (LMS) costs an average of €255K ($300K) per line. Added to that, the average timeframe is around 18 months, often lengthened by delays due to last minute equipment orders, which increases the cost further.

According to recent polls held at NEXUS 17 in June 2017, 60% of respondents are still in the early stages of implementation, with a further 10% having not started their serialisation journey yet. In addition, 68% of companies feel that CMOs are not well prepared for the regulations. Generally speaking, most CMOs have discovered too late that they have not allocated adequate time and resources to develop a solution and integrate it with customer requirements. With this in mind, it is imperative that pharmaceutical companies and CMOs alike learn from the mistakes that lead to the DSCSA delay.

Learning from the DSCSA enforcement delay

The lack of readiness across the external supply ecosystem can be partly attributed to a lack of understanding. No two markets have introduced the same serialisation governance and failure to understand the differences in market requirements can cause significant problems. So, what can companies learn from the industry’s mistakes thus far?

Serialisation is not a simple task. It goes far beyond simply printing a barcode. A scalable IT infrastructure that is able to adapt to different market requirements and customer demands is vital to ensure compliance and avoid supply shortages. In many cases, current infrastructures simply may not be suitable. Transaction volumes for serialisation can be in the region of tens of thousands of files, which are hundreds of megabytes in size and the capacity of each member of the supply chain will vary. For example, where one company might send and receive a single, large file, another may need to transfer and receive the data in smaller batches.

The complexity of the supply chain further complicates the task of serialisation. The pharmaceutical supply chain is not a linear one; it involves multiple partners in multiple locations from development to distribution. In addition, contract partners such as CMOs and contract packaging organisations (CPOs) are often supplying to more than one market, meaning a plethora of differing regulations to comply with.

Dealing with your data requirements

The polls held at NEXUS 17 indicated that the biggest concern for companies is data exchange. To give an idea of how much data serialisation generates, over 650 companies across the supply chain use the TraceLink Life Sciences Cloud for serialisation, which allows them to exchange data and connect to an ecosystem of 255,000 trading partners on its network.

The largest user on the TraceLink Life Sciences Cloud commissions around 18 billion serial numbers a year, and each of those will be used for an average of five transactions before the manufacturer even ships the product. This equates to at least 90 billion pieces of data that need to be validated and managed. Additional data is then generated as each serialised product passes through the supply chain after shipping.

Other stakeholders throughout the supply chain then need to be able to access this data, meaning in addition to storing their own data, supply chain partners need to be able to transfer it securely. For example, in the EU, this will be done via a central EU hub, which will share information with individual national systems that can be accessed by relevant dispensers to verify products. Given the sheer volume of medicines manufactured on a daily basis and the requirement of applying a serial number to each saleable drug unit, the data scalability and connectivity challenges for companies are massive and it is imperative that they find a way to store, manage and verify data in a way that doesn’t impact operational efficiency.

End-to-end testing is vital to ensure the successful transmission of data and to minimise disruptions to supply. The industry uses multiple formats to track serialisation information and while the GS1 global standard Electronic Product Code Information Services (EPCIS) is favoured by most, this is not a hard and fast rule. These challenges will define a company’s IT infrastructure and pharmaceutical companies may find the systems they currently have in place are simply not suitable. As the complexity of implementation is more widely recognised, many drug developers are now turning to well-prepared CMOs that they can outsource their serialisation requirements too.

Sizing up your service provider

CMOs are fast becoming an essential part of industry compliance and those who are well prepared are now in an ideal place to offer outsourced serialisation solutions. However, selecting the right partners is crucial. So, what should you be looking for in your service provider?

Taking a three-fold approach to vendor selection will help to ensure you make the right decision. Firstly, your service provider should have a reasonable implementation timeline. Even if a CMO is ready for deadlines, it will take time to integrate their solution with your requirements and considering time is tight it’s important they have a good idea of how long the process will take.

What is the capacity of your CMO? And, does this meet your future requirements as well as your current ones? Are its line systems ready for serialisation or is it still waiting on line equipment? Visit its facility, assess the scale of its operations and use the opportunity to get a feel for where it is in its implementation programme. Finally, given the complexities of handling serialisation data, how does your CMO plan to address your data management and connectivity requirements?

Going forward it is likely that regulations will change so your CMO also needs to be ready to make any necessary modifications. Failure to adapt will lead to future non-compliance so make sure your provider has a flexible solution that has been designed with the continued evolution of regulations in mind. It is the sole responsibility of the market authorisation holder (MAH) to ensure compliance, which makes vendor selection vital.

Summary

The delay to the DSCSA deadline offers the pharmaceutical industry an important insight into how best to tackle serialisation requirements in the run up to the EU FMD. Serialisation solutions stretch across the whole organisation and can present a number of resource conflicts and dependencies.

The task of developing an effective system to manage and transfer the vast amounts of data generated through serialisation is huge and as such many companies are looking to outsource their requirements to well-prepared third parties with a comprehensive solution already in place. Patient safety should be the core concern when it comes to traceability and serialisation so companies should act now to ensure full compliance ahead of the deadlines.

ABPI update on application for judicial review

ABPI, 4th October 2017

The Association of the British Pharmaceutical Industry (ABPI) have issued a statement regarding its application for judicial review versus The National Institute for Health and Care Excellence (NICE).

​​​​​​​Following confirmation from the Administrative Court that The ABPI’s application for judicial review has been turned down, the following statement has been issued:

“The ABPI is disappointed that the judicial review application has been turned down. It’s now appropriate for us to take time to reflect on the judgement with our members and decide next steps”.

HDA UK Media And Political Bulletin – 5 October 2017

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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