The Royal Pharmaceutical Society (RPS) has published a guide to medicines optimisation for primary care professionals.

Medicines Optimisation: helping patients make the most of medicines places emphasis on safe and evidence-based medicine use to reduce wastage and improve patient outcomes.

The guide, endorsed by the ABPI and the Royal College of General Practitioners, reflects the growing role of community pharmacists in medicines management and the care of people with long-term conditions.

Sir Bruce Keogh, Medical Director of NHS England, said the guide “could revolutionise medicines use and outcomes”. It outlines four basic principles:

• Aim to understand the patient’s experience.

• Make sure the choice of medicine is made on the best available evidence.

• Ensure that medicines use is as safe as possible.

• Make medicines optimisation part of routine practice.

“I would encourage everyone to adopt these principles whether prescribing, dispensing, administering or taking medicines,” Keogh concluded.

The RPS guide is partly a response to evidence that 30–50% of patients are not compliant with prescribed medication, and £300m worth of NHS medicines are wasted each year.

Shilpa Gohil, Chair of RPS England, commented: “As care shifts towards primary care prevention, unprecedented economic challenges combined with problems around medicines waste, adherence and safety mean that medicines optimisation is now essential to good patient care and the effective use of NHS resources.

“Medicines optimisation will require health professionals to work across boundaries to individualise care and work in partnership with each other and patients to secure better outcomes and drive improved adherence.”

With the Government aiming to increase innovation within the NHS, pharma has been tasked with helping to meet the challenge. Omar Ali, in his Matrix Revolutions series, focuses on the means to help the industry find the next big thing.  

With so many documents to read – white papers, NHS initiatives and DH directives – keeping tabs on the direction of travel of the NHS, as well as the pace of change, makes life difficult; and that’s not including the latest clinical trials, review publications and NICE guidance. In this issue of the Matrix Revolutions, I want to review one of the most important and potentially game changing documents to have
crossed my desk: Innovation, Health and Wealth.

The document comes under ‘improvement and efficiency’ from the DH and has an impressive circulation list. However, if the cascade didn’t get past those at directorship level, the average GP and healthcare professional may not have received what is a very important document. It also goes hand-in-hand with a story from NICE in February – Improving access to NICE-approved drugs – which provided the NHS with a best-practice guide on the implementation of local formularies in accordance with national guidance.

Innovation, Health and Wealth calls for all NHS organisations to come to ‘action’ by starting planning processes for the implementation of innovative new treatments approved by NICE.

“…while the NHS is recognised as a world leader in invention, the spread of those inventions within the NHS has often been too slow, and sometimes even the best of them fail to achieve widespread use”

I think we would all recognise this symptom of the NHS and list numerous examples. The UK is well known in being conservative with its adoption and prescribing of new drugs. But when NICE makes deep probing evaluations of new treatments it may be disturbing to find such variation in the implementation of best practice and subsequent availability of new medicines for patients.

It’s well known that when HTA agencies reject drugs the NHS is very good at implementing rapid ‘decommissioned’ formularies, which make general prescribing and availability very limited. However, when NICE does approve a new treatment, the variable uptake observed within the NHS as a whole has resulted in this new initiative.

“The challenge both for the NHS and for its industry partners is to pursue innovations that genuinely add value but not cost”

This is interesting how it adds up… I’m supposed to work with you to find innovations that don’t add cost… The problem with documents is rhetoric and direction. In reality, implementation will come down to precise and specific details. There are not many new drugs that ‘don’t add cost’ – they all add cost! The modelling comes in finding those that may offset some of the costs (QIPP).

“This report has been developed as part of the Prime Minister’s UK Strategy for Health Innovation and Life Sciences. The aim of this strategy is to ensure that the UK maintains and builds on its world leading position for life sciences, that the potential of life sciences to contribute to UK growth is realised, and that the UK remains and grows as an attractive location for investment now and in the future”

The flavour of the document paints a clear picture of investment from pharma which will potentially deteriorate within the UK due to poor uptake/diffusion by the NHS. The difficulty lays in that ‘uptake’ criteria for the NHS doesn’t have ‘investment’ as part of the decision process. For example, if a company invests millions into UK R&D and produces a poor, non-innovative and non-cost effective drug, should we put it on formulary due to the fact they have invested in the UK economy? If the answer is ‘yes’, we all need to change the paradigm and throw QIPP out of the window. I guess the alternative is how long can pharma keep resourcing UK investment and see no return? Not long in this climate. Surely then the answer is as seen above: the challenge of making new, innovative drugs cost effective.

Having helped bring NHS payers, CCG commissioners and pharma together, it brings some common ground on market access. I have found that with all of the details, some dedicated quality time with stakeholders and some flexibility from pharma, we can always find some manner of value-added to the product and/or a financial/value proposition that changes the paradigm. The truth is we don’t spend enough quality time talking together about the real issues. We tend to spend poorly co-ordinated NHS/pharma interactions looking at insane cost-models and budget impacts that are largely irrelevant. Add to that ABPI/compliance and internal concordance issues, and the NHS and pharma are often dancing around the tables instead of having decent commercial business discussions that pave the way to a healthier, wealthier future for both.

Potential barriers
“Poor access to evidence, data and metrics”

I have been impressed with some of the data informatics I have seen that actually represent data handling with a view to Secondary Uses Service (SUS) information, hospital episodes and prescribing by the CCG sector or a PCT. Here, pharma is beginning to excel themselves and it does have an influence on working together. This approach is far better than those companies who have a black-box approach to health economics.

“Insufficient recognition and celebration of innovation and innovators”

It’s hard for NHS innovators to ‘step out’ and stick their heads above the parapets when those around them are stuck in the same old ways. Far from recognition or reward, one can expect pushing uphill and against the grain. The only way to succeed here is to believe in the cause of innovation and true improvement. My feeling is those ‘beacons of light’ are beginning to shine in healthcare – and love it or hate it – one of the strengths of the Health Bill is bringing those leaders to the forefront through sheer necessity. My observation is that the pharma culture celebrates innovation from the core – it’s what you do and what you believe in. Being an optimist, I believe pharma has a role on the ground in bringing some of that innovation to ‘rub-off’ on your NHS customers.

“Financial levers do not reward innovators and can act as a disincentive to adoption and diffusion”

You may have read my previous Matrix Revolutions ‘case’ on Prolia (denosumab) – it had a NICE TAG but saw variable uptake, even a year after its recommendation. This case clearly outlined how micro-economics and financial levers can stall the introduction of new innovative therapies. But getting the tariffs to match, commissioning to fund and finding the code to unlock prescribing took a long time… why? Partly because our own informatics is poor – an example of the NHS barrier – and partly because dealing with payer issues doesn’t come first-hand to most brand teams.
Other financial levers that will inhibit uptake include:

• Enhanced LES & DES warfarin payments to GPs which will be a threatened source of income with new oral anticoagulants.
• QoF cholesterol targets of 5mmol/l in the face of innovative agents which may achieve lower cholesterol targets and reduced outcomes.
• QIPP Indicators aiming for a percentage of metformin and sulphonylurea when newer agents for type 2 diabetes reduce incidence of hypoglycaemic episodes and save money on blood glucose testing strips.

In the next issue of Matrix Revolutions, Omar Ali continues to review the DH’s modernisation plans and also focuses on what makes the diffusion of innovation happen. 

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He can be reached at omar.ali@sash.nhs.uk.

The new Bribery Act makes UK pharma companies legally responsible for any kickbacks their reps or distributors may offer to health officials anywhere in the world. Maxine Vaccine asks whether UK politicians who point the finger at traders can really be serious.

Compliance is the new CRM. In an era of globalised pharmaceutical trading, the UK Bribery Act and the US Foreign Corrupt Practices Act have sent a shock wave of pure terror through the industry. Basically, what the new legislation means is that a company is responsible what anyone acting on its behalf, even under contract, may do to advance its business. A local sales team or freelance distributor on the other side of the world might treat a village doctor to a bottle of whisky in return for a commission – and a biotech company in Cradley Heath might find itself fined out of existence. It’s scary.

According to a new Cegedim report 94% of life science companies now enforce corporate standards for spending on HCPs, while over half have a project team to address compliance issues. However, Cegedim warns that good intentions are not enough: without robust surveillance and reporting systems, those unmarked envelopes may slip through the cracks.

Closer to home, the ABPI Code of Conduct imposes very strict limits on the industry’s freebies and favours to its customers. Marcus Brigstocke raised some nervous laughter at last week’s Pf Awards by suggesting that pharma reps might moonlight as biro salesmen. The rules on hospitality threaten drug reps with wholesale loss of mates. Bourbons are completely banned. Only digestives are permitted, and they must be from Costcutters. In fact, you can offer branded biscuits only when selling generic drugs.

Compliance means more than just obeying those rules you know about in those transactions you personally carry out. You have to find out what all the relevant rules are and then apply them to every commercial interaction that touches your company. Being compliant takes proactive commitment, intelligence and good teamwork. Though when I put ‘Totally compliant’ on my Facebook profile I got some interesting messages.

So it was with some amusement that I read a recent newspaper story: the Conservative Party’s co-treasurer Peter Cruddas told undercover journalists posing as financiers that a minimum donation of £250,000 to Party coffers would gain them direct access to the PM’s policy unit. Make with the cash, he told them, and “things will open up for you”. In case they were unsure what that might be worth, he clarified the point: “It will be awesome for your business.”

Pardon my naive attitude, but WTF? The only part of ‘Foreign Corrupt Practices’ not implied by such promises is the word ‘Foreign’. Perhaps, before they legislate to rein in pharma industry reps, some of these politicians should look in the mirror.

It’s worth noting here that the private healthcare corporations currently in line for a share of the NHS franchise now the new Health Bill has become law are major donors to the Conservative Party, just as they were to Andrew Lansley’s campaign fund when he was Shadow Health Secretary. In addition, the BMJ reports that half of the doctors on the new CCG boards have financial interests in private healthcare companies that will be bidding to provide NHS services.

And meanwhile, we get stamped on for giving away a few biros. Are they having a laugh?

Maxine’s views are not necessarily those of Pharmaceutical Field.

Merck & Co has appointed Michael J. Holston as its Chief Ethics and Compliance Officer as of June 25, 2012.

Holsten, an experienced business lawyer, will serve on Merck’s Executive Committee and be responsible for driving ethical standards and compliance for the company on a global basis.

He succeeds Richard S. Bowles, who is retiring after more than 35 years with Merck and the former Schering-Plough (which merged with Merck in 2009).

Holston joins from Hewlett-Packard, where as Executive VP and General Counsel he was responsible for overseeing compliance, government affairs, privacy, ethics operations and legal affairs.

Previously, he was a partner at law firm Morgan, Lewis & Bockius LLP, where he served as external counsel to Merck on product litigation and regulatory compliance.

Merck CEO Kenneth C. Frazier said: “We are delighted to welcome Mike as our new chief ethics and compliance officer. His extensive experience managing compliance with healthcare laws across international businesses and his background with Merck and our industry make Mike a terrific leader for our ethics and compliance organisation and a member of our Executive Committee.”

Frazier also praised Richard S. Bowles: “His strong leadership established the global compliance organisation for the combined new company following the merger with Schering-Plough.”

Hosten said he was “excited to be joining Merck at this important period of change for the company and the pharmaceutical industry” and looks forward to “helping to champion Merck’s high ethical and compliance standards so the company can focus on what it does best – discovering and developing innovative new medicines and vaccines.”

Merck is known as MSD outside the US and Canada.

This month’s Pharmaceutical Field looks at some of the major issues affecting UK pharma at present; the evolution of its customer-base, an increased focus on compliance, the developing training needs of medical sales professionals and pharma companies’ ongoing challenge to attract and, crucially, retain talent.

The DH’s Innovation Health and Wealth document, published at the tail end of 2011, seeks to address the most significant challenge for UK healthcare – accelerating the adoption of innovation within the NHS. There is much that pharma can do to help enable innovative medicines reach patients more quickly.

Regulatory compliance remains a key priority for pharma as recent and impending global legislation puts pharma’s engagement with customers under increased scrutiny. In the process, the changing legislative landscape is having a significant impact on the training needs of medical sales professionals in the UK. This, in turn, is having a domino-effect on the pharmaceutical employment market, where a notable ‘skills gap’ is having a huge impact on recruitment and the quality of applicants for commercial roles.

Faced with an apparent dearth of quality candidates for sales positions, companies are needing to work hard to create the best working environment to retain their most talented employees. Pf’s annual attitudinal survey of the UK sales force reveals that, in some parts of the industry, there remains much to be done to ensure that the company culture advertised in the corporate brochure matches that experienced by employees in the workplace.

Pharma industry veteran Nigel Brooksby has been appointed Deputy Chair at Health Information – a UK company that provides and distributes patient information on medications.

Health Information, which recently secured funding from MVM Life Science Partners, works with the NHS to improve patient medication compliance.

Brooksby has almost 40 years’ experience in the pharmaceutical industry. His past roles include chair and MD of Sanofi UK and president of the ABPI.

His current roles include chair of the UK Life Sciences Council, board advisor at Doctors.net.uk, board strategic advisor at Healthcare at Home and director at Novocta Biosystems.

Brooksby commented: “There is a real need for patients to understand their conditions and medicines better, and Health Information has helped millions of patients to do this. I am looking forward to the opportunity to help develop this success further.”

Dr Grace Lomax, co-founder of Health Information, said Brooksby’s industry experience “will enable us to support more patients, and to fortify our leading position in the UK market”.

Hospira has appointed several new leaders to strengthen its quality and compliance capabilities.

Zena G. Kaufman joins on February 27^th, 2012 as Senior Vice President, Quality, and takes on responsibility for global quality systems. She will also serve as a member of the company’s senior leadership team.

Michael Ball, CEO, says he is now confident the company has a team in place to provide the “highest-quality products and best possible service for our customers”.

Ms. Kaufman, who most recently served Divisional Vice President, Global Quality Systems, Global Pharmaceutical Operations at Abbott Laboratories, is joined by a number of appointments in similar roles.

Matt Stober, who joined from Johnson & Johnson last year, has been promoted to Corporate Vice President, US Pharma Operations, and has primary responsibility for Hospira’s Rocky Mount facility in North Carolina, as well as plants in McPherson, Kansa, Austin, Texas, and Clayton, North Carolina.

He is joined at the Rocky Mount plant by Shane Ernst who will take on the role of Vice President, Quality, and by Marty Nealey, Vice President, Operations and Plant Manager.

Andrew Knudten will take on the role of Vice President, Operations and Plant Manager at the McPherson site, where he will be responsible for operations from March 5^th.

Dr Thomas Templeman completes the appointments in the newly created position of Vice President, Pharma Operations Excellence.

“In their previous roles, our new team members have successfully delivered the highest standards of quality and regulatory compliance,” said Mr. Ball. “These seasoned industry veterans will work with Hospira’s current leadership to remediate the Rocky Mount facility and extend improvements there across all Hospira sites. I’m confident that their extensive backgrounds in operations and quality, expert knowledge of FDA regulations and strong leadership abilities will help take Hospira to the next level of operational excellence.”

Fearless pharma blogger Maxine Vaccine considers the significance of a report highlighting the ‘information gap’ between patients and their doctors regarding side-effects.

Last month I wrote a blog about the ‘cascade’ syndrome of patients taking medication to deal with the side-effects of other medication. It was based on a handful of individual cases within my select circle of friends. Now a major study, focusing on treatment for a life-threatening illness, has highlighted the issue of unreported side-effects in a way the industry cannot afford to miss.

A team from Northwestern University in the USA questioned 686 women who had been prescribed aromatase inhibitors (AIs) for a five-year period as treatment for breast cancer. AIs inhibit the production or action of oestrogen, a hormone that promotes the growth of about two-thirds of breast cancers. Following successful treatment by surgery, chemo and/or radiotherapy, the use of AIs has been shown to help prevent recurrence of the cancer.

The study found that 36% stopped their medication because of side-effects such as joint pain, hot flushes and nausea. However, previous studies had shown that only 5% of women given AIs reported moderate to severe side-effects.

Dr Lynne Wagner, who led the study, commented: “There’s a significant gap between patient-reported symptoms and provider-reported symptoms. That gap widens when we’re talking about more subjective symptoms, things like pain or fatigue that only a patient can report.”

She also noted that “clinicians consistently underestimate the side-effects associated with treatment,” while “patients don't want to be complainers and don't want their doctor to discontinue treatment”. So there is a conspiracy of silence that results in poor compliance, with a negative effect on clinical outcomes. And AIs are unlikely to be an isolated case.

Two further points are worth noting. Those women still suffering side-effects from their earlier, more radical treatment were more likely to give up taking AIs, because their endurance threshold was lower. And the likelihood of stopping the medication increased steadily with time – because over a period of years, the patient’s endurance runs out and their subjective sense of the risk-benefit equation changes.

You may be wondering: this is my fault how? If a drug is effective, surely making good decisions about its use is down to the doctor and the patient, not the supplier? But if we can step back from the (rarely helpful) question of blame, there are important lessons for pharma in this study.

For a start, every patient who stops taking a drug without notifying their doctor is negatively affecting the clinical outcomes data. If they’re lucky and their clinical outcome is not affected, clinicians and suppliers are still left with an incomplete picture of the drug’s risk-benefit profile, which helps nobody and is a step back from patient-centred care.

As more and more patients take powerful medications on a long-term basis, reliable data on side-effects – enabling them to be treated through dose adjustment and other strategies – is the only way to get the optimum patient benefit out of the drugs that exist. We need to know much more about how side-effects accumulate with time, how multiple medications affect the patient in combination, and what the best compromise dosage level is for each medication and each patient.

That calls for better sharing of information between companies, healthcare providers and patients, rather than quasi-antagonistic relationships based on competition. The human body is not a marketplace.

Maxine Vaccine is keen to receive your feedback on these and other pharma industry issues. Be nice (but don’t be NICE)!

Over a third of women prescribed a long-term breast cancer therapy stop taking it because the side-effects are intolerable, US researchers have said.

Aromatase inhibitors (AIs), given to women following surgery, chemotherapy or radiotherapy treatment for oestrogen-sensitive breast cancers, has side-effects including joint pain, hot flushes and nausea.

The study has drawn attention to the gap between clinicians’ reporting of drug side-effects and the subjective experience of patients.

About two-thirds of breast cancers are oestrogen-sensitive. AIs, which either block the production of oestrogen or block its action on receptors, have been shown to reduce the risk of breast cancer recurring.

A team from Northwestern University questioned 686 women who had been prescribed aromatase inhibitors for up to five years. It found that 36% stopped their medication because of increasing side-effects. Those still experiencing side-effects from chemotherapy or radiotherapy were more likely to stop taking AIs.

In previous studies, doctors had reported that only about 5% of patients given AIs had moderate to severe side-effects.

Dr Lynne Wagner, who led the study, commented: “There’s a significant gap between patient-reported symptoms and provider-reported symptoms. That gap widens when we’re talking about more subjective symptoms, things like pain or fatigue that only a patient can report.

“Clinicians consistently underestimate the side-effects associated with treatment. Patients don't want to be complainers and don't want their doctor to discontinue treatment.”

“It is worrying if breast cancer patients are stopping life-saving treatment early without consulting their doctor,” said Dr Susie Jennings, Senior Policy Officer at UK charity Breakthrough Breast Cancer. “It is important there is a continued discussion throughout treatment.”

Maxine Vaccine, blogger with attitude, takes a look at some key issues affecting the pharma industry – this week, the potential impact of minor side-effects on a drug’s sales.

Let’s consider a hypothetical case. A male patient has chronic disease A, which requires careful monitoring and treatment with drug Z. Because of the risks of developing co-morbidities, he is also put on statin Y and anti-hypertensive X. So far so good.

But Z has digestive side-effect B, which is socially embarrassing, while Y causes dysfunction C, which affects his private life. His GP prescribes famous drug W (or rather, its generic equivalent) for the latter condition. The patient’s girlfriend notes the improvement, but W also causes the patient to suffer headaches, insomnia and loss of peripheral sensation, which detracts from the point of the drug (for him at least).

This conflict of interests, combined with the untreated side-effect B, results in the girlfriend packing her bags. As a result, the patient develops affective disorder D, for which he is prescribed famous drug V (or rather, its generic equivalent).

By now, the patient is beginning to feel his life is an exercise in product placement. And in generic equivalents – but let’s not dwell on that. Before he develops carpal tunnel syndrome and the two ends of the alphabet converge, let’s ask why this is happening.

Some of you may recall the classic Flanders and Swann song ‘The Gasman Cometh’, in which a gasman carrying out a domestic repair creates a new problem that requires a plumber, who in turn creates the need for an electrician, and so on. Do pharma reps invariably create business for other pharma reps, regardless of company?

Of course not, you’ll reply. All side-effects are duly listed in the product literature, and they only affect a minority of patients anyway. That’s true – but only major side-effects are reliably reported. Many persistent symptoms may not be reported due to denial or embarrassment – or, once reported, they may not be recognised as side-effects. After all, when you’ve got lots of things wrong with you, who knows the precise cause of a symptom? Does it even matter?

Yes, it does. We’re moving rapidly towards a model of community-based prevention and treatment of chronic diseases through long-term medication. Patients need to recognise, understand and deal with the side-effects of these drugs. The same patients are increasingly aware of, and able to choose from, the range of treatment options available. They are sharing their experiences via the Internet (as are GPs). And when they give a drug a bad name, you can bet that it always sticks.

Many patients and their GPs are surprised and confused by the side-effects of medication. By raising their awareness of these side-effects and the best ways of dealing with them, you’re providing a patient-focused solution rather than just a product. You’re also helping to improve patient compliance. In the era of personalised medicine, that’s the best route to customer loyalty.

If you ignore the yellow card, the red card may follow.

Maxine Vaccine is keen to receive your feedback on these and other pharma industry issues. Be nice (but don’t be NICE)!