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HDA Media And Political Bulletin – 14 January 2016

Choosing an authentication service supplier is just the start

Securing Industry, Graham Smith, 13 January 2016

Ahead of the publication of the Falsified Medicines Directive, relevant bodies in each country will be gathering to form the national medicines verification organisation (NMVO) with the responsibility of running the medicine verification system (NMVS). An important decision this committee will have to make first is to choose an authentication partner for the next 5 to 7 years.

 

Half of readers will reduce staff to counter funding cuts

C&D, Samuel Horti, 13 January 2016

A Chemist and Druggist poll reveals that a fifth of respondents are concerned that a funding cut of 6% will result in the closure of their pharmacy while nearly half expect to reduce their staff. A quarter of the votes further stated that the forecasted biggest impact of the cut will be a reduction in services offered to patients.

 

NPA Chairman renews attack on government cuts at House of Commons

Pharmacy Biz, Neil Trainis, 13 January 2016

At an event at the House of Commons, Ian Strachan renewed his attack against the UK Government regarding its announcement of funding cuts for community pharmacy and efforts towards more efficiencies. This proposal is subject to a consultation, ending on March 24, while the hub and spoke model will be the focus of another consultation this year.

 

Write to your local MP, says NPA

P3 Pharmacy, 13 January 2016

The NPA has called on independent pharmacists to mobilise the general public’s support, in particular by personally writing to their local MP. This letter should aim to explain the value of local pharmacies in order to gain political support.

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Choosing an authentication service supplier is just the start

Securing Industry, Graham Smith, 13 January 2016

Across Europe in the coming months many representatives from the pharmaceutical industry will be sitting down with people who they may know as colleagues or as competitors; those who they are in-step with and those who have a different point of view. These unlikely groupings will be forming the national medicines verification organisation (NMVO) in their respective countries whose responsibility will be to run the medicine verification system (NMVS) for that jurisdiction.

One of the first things that this important collective will have to do is make a choice. Not the one about who will be the chairman and other committee posts, although these will be essential, no they will need to choose a company who will be their authentication partner for the next 5-7 years. This company will not only be a key supplier, they will be the cornerstone of the NMVO’s ability to deliver on its responsibilities in regard to the Delegated Act and the Falsified Medicines Directive.

So maybe not a choice as profound as the one described by Yeats above but a pretty important one nevertheless.

To make that decision a number of criteria will be used – broadly covering areas such as:

Service Choice. Does the service meet all the requirements detailed in the Delegated Act?

Systems and Architecture. Where questions around the flexibility and scale of systems need to be answered. The Delegated Act calls for medicines to be guaranteed by an end-to-end verification system.

Security. This is very important in an authentication service. Essential questions will need to be considered – How will users be checked to ensure they are authorised to use the system? How secure is the database? What happens if security is breached? How will medicines be dispensed safely?

Design and Implementation. A complex area with a wide range of considerations, from commitments to service delivery and not just software. Plus how will incumbent authorisation and authentication procedures be supported?

Regional Requirements. Ultimately, who in the NMVO is accountable for the decision?

Support and Issue Resolution. Here one of the key questions relates to disaster recovery, is there a credible plan in place from the provider? How will the NMVO react if a suspicious pack is identified?

Regulation. In order for a service to achieve and maintain GxP compliance, all software needs to be validated that supports the service, this includes pharmacy and wholesaler software if this has been changed to interface with the repository. Additionally, all parties and systems that interact with the system – particularly those engaged in the exchange of data – may be subject to secondary audits to ensure system integrity.

Privacy and Compliance. An important topic where assurances around compliance with local privacy regulations and confidentiality of all information are required.

(These topics have been seen regularly in our meetings with prospective NMVO representatives and groups. Specific questions have been grouped together into broad themes for the purpose of this article.)

To paraphrase another well-known saying, as the manufacturers’ representatives, ‘You are paying the money so you get to make the choice’. There might be a temptation for that to be that for the NMVO. Job done, decision made, sit back and relax. That would be a mistake.

The responsibilities of the NMVO will be deeper and wider than simply choosing a supplier and passing all of the responsibility for delivery on to them. The NMVO will need to have a clear understanding of where its own liabilities begin and end. Without this knowledge it cannot start its recruitment of executive officers or to put in place the checks and balances required to ensure full compliance with not just the Delegated Act but also the expectations and demands of the ultimate customer, the patients in their country.

Which leads to the question, what happens if these standards are not met? Is there a process in place should a supplier, or the NMVO itself, fail to meet all that is expected of it?

Does the country’s national regulator step in if the system fails in its governance, cost control or actual ability to deliver the required levels of patient safety? What are the likely outcomes of such a decision?

On the positive side of this argument there maybe additional areas of influence and performance management where the NMVO could become involved. It surely does not have to stop with just delivering the minimum requirement? What about faster responses? Or more secure processes? What about an ongoing dialogue with stakeholders that drives continuous innovation and improvement? If I was not only paying for a service but also had the responsibility for shaping it and ensuring that it delivered to a European standard then I would want to ensure that I knew exactly what I could and could not do.

It would seem to make sense for the boundaries of influence on the one hand, and the consequences of poor performance on the other, to be fully understood by all concerned. This is a discussion that members of NMVO’s, confirmed or otherwise, should be having with each other and the Commission if necessary. Now is the time to do this and not when things start to go wrong.

 

NPA Chairman renews attack on government cuts at House of Commons

Pharmacy Biz, Neil Trainis, 13 January 2016

Ian Strachan, chairman of the National Pharmacy Association, renewed his attack on the government’s cuts to community pharmacy funding during a debate at the House of Commons, warning starkly that the plans will “disable” pharmacy and endanger patients’ safety.

In a committee room in the heart of the House of Commons, Strachan (pictured) used an event organised by Lambeth, Southwark and Lewisham LPC to reiterate his staunch criticism of the government’s attempt to achieve efficiency savings through swingeing cuts as well as its desire to get people using online services to access medicines and introduce a hub and spoke dispensing model across community pharmacy.

The Department of Health’s proposals are the subject of a consultation which ends on March 24. Plans to introduce a hub and spoke model will be consulted on separately this year.

Strachan has been one of the more vigorous protesters to the 6% cut to community pharmacy funding, accusing the Department of Health and NHS England of “an assault” on pharmacy following the announcement of the reduction in revenue.

Addressing an audience of healthcare luminaries such as Ash Soni, president of the Royal Pharmaceutical Society, and Gul Root, principal pharmaceutical officer at the Department of Health, as well as the Labour MP Kate Hoey, Strachan again pullled no punches.

“It’s difficult to be strategic when government want to pursue an October implementation of a series of proposals which will, if anything, disable community pharmacy and marginalise it,” he said.

“It’s a consultation, from my perspective, (which) is short on detail. We have got a threat right now to try and make people understand the value of this network and the pharmacists who work in it.

“The proposals to commoditise supply, to alternate supply, all of those have adverse implications to cost and safety. There’s proposals in there to make greater access to medicines through IT solutions, the internet, home delivery. If you think that’s going to reduce volume and demand, it won’t. It will increase volume and demand.

“The only way we will reduce volume and demand is by getting pharmacists close to patients because we are the experts at dealing with patients.

“It’s a series of unevidenced assertions which are extremely worrying for patients and for communities. And we’ll do every we can to try and redress that.”

Strachan’s remarks appeared to draw a response from Hoey, who called on the community pharmacy profession to not merely decry funding cuts but react more proactively.

“When there are cuts that are happening, we have to find ways of not just saying ‘these are dreadful, we must fight them,’ which obviously people will do in their own individual ways and whatever their party politics are,” she said.

“Surely also, sometimes (funding cuts) can be the instigator of actually making people work differently. There are a number of things that are happening that are actually, if not wasteful, certainly spending money that could be spent differently.”

She added: “Pharmacies are doing a huge amount of good work which sometimes the public take for granted. Maybe more has to be done to make sure they realise the effects, reductions in money.”

Dilip Joshi, chair of Lambeth, Southwark and Lewisham LPC, said: “We do need to work together (but) working together is not just about health professionals. We need our politicians to facilitate this working together, create the right environment. We can’t be having top-down cuts and get ongoing efficient savings forever.”

 

Write to your local MP, says NPA

P3 Pharmacy, 13 January 2016

The National Pharmacy Association had called on independent pharmacies to begin “mobilising local political opinion”, in readiness for a “concerted campaign” against Department of Health proposals to cut pharmacy funding and introduce efficiencies. Independent pharmacies should write to their local MP about the value of local pharmacies, said an NPA statement.

“Today I have written to my own MP about the value of local pharmacies and I urge all NPA members to do the same. This is about beginning to mobilise political support across the country for what could be a long and difficult struggle ahead,” said NPA chairman Ian Strachan.

An NPA webinar on ‘Cuts and efficiencies’ will take place on the evening of 25 January. Mr Strachan will outline the NPA’s plans and the resources the association is making available to support campaigning activity. Registration is open to all at www.npa.co.uk/events.

“What we have seen so far is a jumble of half-explained ideas coming out of government, and a justifiably worried and angry response from the profession.

“The Government proposals are light on detail, but the direction of policy is already clear, and independents must mobilise to oppose it. It is a drift away from valuing local pharmacies and a retreat from any serious effort to maximise the benefits of the bricks and mortar pharmacy network,” added Mr Strachan.

HDA Media And Political Bulletin – 14 January 2016

From Factory to Pharmacy

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