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What is the public health white paper?

Last week, the coalition government published its promised public health white paper, Healthy Lives, Healthy People. It is a policy document outlining what it calls “radical” changes to the way public health is managed in England.

It builds on the NHS white paper published in July and fulfils several policy pledges Andrew Lansley made in opposition, including ring-fenced funding and a dedicated government department for public health.

Why is it needed?

Healthy Lives, Healthy People is the coalition government’s response to Sir Michael Marmot’s 2009 review of health inequalities, Fair Society, Healthy Lives.

The government says its “bold” approach to managing public health is necessary because of the “alarming levels” of lifestyle-driven health problems in England. Alongside the public health white paper, it has published a review of evidence on health and wellbeing in the country, Our Health and Wellbeing Today.

Its findings include:

• Maternal depression and anxiety affects between 10 and 15 per cent of pregnant women; rates are nearly twice as high among mothers living in poverty and three times as high for teenage mothers.
• There is a 70 per cent gap in infant mortality between the richest and poorest groups and rates for some ethnic groups are almost twice the national average.
• One in five mothers is obese, one in six smokes during pregnancy and breastfeeding prevalence at six to eight weeks is just 46 per cent.
• One in five three-year-olds and two-thirds of adults are overweight or obese.
• Obesity-related conditions cost the NHS an estimated £4.2 billion a year.
• One in five adults smoke – the single biggest preventable cause of early death and illness.
• The NHS spends more than £2.7 billion a year treating smoking-related illness, but less than £150 million on smoking cessation.
• Circulatory diseases, cancers and respiratory diseases together account for three-quarters of deaths across all ages.
• Over 30 per cent of deaths from circulatory disease could be avoided mainly through lifestyle changes.
• By 2024, half of the population will be more than 50 years old.
• Dementia costs the UK £17bn a year, with 750,000 people in the UK affected and numbers set to rise; half of dementias have a vascular component.
• 15.4m people in England have a longstanding illness; musculoskeletal conditions, circulatory diseases and mental health diseases account for over 70 per cent of the burden of longstanding ill health.
• The UK could save up to £100bn a year by reducing working-age ill health.
• One in 10 people who get an STI will become reinfected within a year.
• People living in the poorest areas will, on average, die seven years earlier than those living in richer areas, and will spend up to 17 more years living with ill health.

The government says England’s current approach to public health is “not up to the task of seizing these huge opportunities for better health and reduced inequalities in health”.

How will it work?

The coalition says “localism” will be at the heart of its proposed public health system. The core proposals of the public health white paper are:

• The transfer of the role of directors of public health (see White paper lingo decoded, left), currently within PCTs to local authorities, where they will be “strategic leaders” for public health in local communities.
• Ring-fenced public health funding, allocated to local authorities.
• A dedicated public health service, Public Health England, within the Department of Health.
• An evidence-based approach to public health initiatives, with the set up of a National Institute for Health Research (NIHR), School for Public Health Research and a Policy Research Unit on Behaviour and Health, and the regular publication of health outcomes.
• A central role for the chief medical officer and the planned NHS Commissioning Board (NHSCB) in public health.
• “Stronger” incentives for GPs to play a role in public health.

How will it be funded?

The public health budget, ring-fenced within the overall NHS budget, will be allocated to local authorities, weighted for inequalities. To encourage health inequalities reduction, authorities will receive “health premium” incentive payments for progress based on a public health outcomes framework.

The government’s “early” estimates suggest that the current spend on areas that will become Public Health England’s responsibility could be over £4bn. (The actual value will be influenced
by the government’s overall plans for cost reductions and efficiency gains.)

The government has promised to publish a consultation on the proposed funding and commissioning of public health “shortly”.

How will commissioning work?

The public health budget will fund services primarily aimed at prevention rather than treatment, including smoking cessation, screening and sexual health services.

Public Health England will have three main routes for funding such services:

1. Local authority allocations
2. NHSCB commissioning of services
3. Direct commissioning, such as national communications campaigns.

However, the government says there may be other options, such as GP consortia commissioning on behalf of Public Health England, if appropriate.

Where does pharmacy fit in?

While it is not yet clear exactly how the commissioning of local enhanced pharmacy services will be affected by the public health white paper proposals, other than the above, community pharmacy does get some significant mentions in the document. These suggest that
the coalition government does see a crucial role for the sector in tackling the public health challenges outlined.

The public health white paper says: “Community pharmacies are a valuable and trusted public health resource. There is a real potential to use community pharmacy teams more effectively to improve health and wellbeing and reduce health inequalities.”

The sector also gets the following specific pledges and mentions in the white paper:

• Community pharmacies are potential locations for NHS Health Checks.
• The DH will strengthen its working relationship with community pharmacies, as well as the pharmaceutical industry, on smoking cessation.
• GP consortia will be encouraged to work with “a diverse range of clinicians”, including pharmacists.
• Public Health England will influence the development of the community pharmacy contract alongside the NHSCB.
• Local authorities will produce pharmaceutical needs assessments (PNAs) that will inform the commissioning of pharmacy services by the NHSCB and local public health commissioning decisions.
• The chief pharmaceutical officer will work closely with public health leaders, including on the role of community pharmacies as businesses and employers.
• The Health Living Pharmacy initiative in Portsmouth is making “a real difference” (see What about Healthy Living Pharmacies?, below).

When will this happen?

The core elements of the proposed system will be set out in the upcoming Health and Social Care Bill, which will have to go through parliamentary approval. Subject to this, the government has pledged to have the proposed system in place by April 2013 (see Timetable for change, below).

The details of the arrangements needed to make this happen will be set out in “a series of planning letters throughout 2011”, according to the government.

In the immediate term, there is a public consultation on some of the white paper proposals, which is open until March 2011.

White paper lingo decoded

Public health: Defined by the Faculty of Public Health as “the science and art of promoting and protecting health and wellbeing, preventing ill health and prolonging life through the organised efforts of society”.

Directors of public health (DsPH): Currently a role within PCTs, moving to local authorities under the public health white paper proposals; defined by the government as “the lead public health professionals who focus on protecting and improving the health of the local population”.

Public Health England: The dedicated public health service to be established within the Department of Health during 2011 and take on full responsibilities – including functions of the Health Protection Authority and National Treatment Agency for Substance Misuse – for the national approach to public health by April 2012.

Health premium: Part of the coalition government’s proposed new funding mechanism for public health, which it says “will reflect deprivation and reward progress against health improvement outcomes in local areas”.

The 4 Rs

The government says its “radical” approach to public health will be:

• Responsive – owned by communities and shaped by their needs
• Resourced – with ring-fenced funding and incentives to improve
• Rigorous – professionally-led, focused on evidence, efficient and effective
• Resilient – strengthening protection against current and future threats to health

The 5 domains of public health

The public health outcomes framework will cover the following:

1. Health protection and resilience – Protecting people from major health emergencies and serious harm to health.
2. Tackling the wider determinants of ill health – Addressing factors that affect health and wellbeing.
3. Health improvement – Positively promoting the adoption of healthy lifestyles.
4. Prevention of ill health – Reducing the number of people living with ill health.
5. Healthy life expectancy and preventable mortality – Preventing people from dying prematurely.

What about Healthy Living Pharmacies?

“Healthy Living Pharmacies (HLPs) are making a real difference to the health of people in Portsmouth, with 10 pharmacies awarded HLP status by NHS Portsmouth. HLPs have to demonstrate consistent, high-quality delivery of a range of services such as stopping smoking, weight management, emergency hormonal contraception, chlamydia screening, advice on alcohol and reviews of the use of medicines. They proactively promote a healthy living ethos and work closely with local GPs and other health and social care professionals.

“Early indications show that HLPs have greater productivity and offer higher-quality services. Early evaluation results include a 140 per cent increase in smoking quits from pharmacies compared with the previous year; and 75 per cent of the 200 smokers with asthma or chronic obstructive pulmonary disease who had a medicines use review accepted help to stop smoking.” Source: Healthy Lives, Healthy People

Timetable for public health change

December 2010 – March 2011

• Consultation on the public health white paper, public health outcomes framework and funding and commissioning of public health.

2011

• Shadow Public Health England set up in DH.
• Working arrangements with local authorities begin to be set up, including matching PCT directors of public health to them.

Autumn 2011

• Public health professional workforce strategy developed.

April 2012

• Public Health England takes on full responsibilities, including functions of Health Protection Authority and National Treatment Agency for Substance Misuse.
• Shadow ring-fenced public health allocations to local authorities published.

April 2013

• Ring-fenced funding for local authorities.

The dilemma

A man comes in to the pharmacy and asks to speak to you. Once in the consultation room, he hands over a box of an emergency hormonal contraceptive, which was dispensed at a nearby pharmacy under a PGD.

The man states he found the box in his 14-year-old daughter’s room and she refused to tell him why she had taken it. He asks you what the drug is for, as he is concerned for her wellbeing.

The fundamental ethical principle at issue here is confidentiality and disclosure of what might be sensitive information.

Disclosure is always heavily dependent on context. Suppose a pre-registration pharmacy student had asked you “what is this drug and what is it for?” – you would have no problem responding to this query. Such information is anyway easily available to a reasonably competent user of the internet, so you may
feel you have no business to be circumspect about disclosure in this case either.

However, you now have context – and once you have it, you cannot disregard it.

The surrounding information suggests that you now have a professional duty of care to several parties.

Because the actual supply of emergency hormonal contraception was made from another pharmacy, you may argue that the daughter is not ‘your patient’ and you have no clear duty of care towards her.

However, she is a client receiving pharmacy services and you carry
the reputation of the pharmacy profession.

Moreover, you have invited the father into your consulting room and he is asking for your advice; you now have a professional duty of care towards him. You also have a duty to the fellow pharmacist who made the supply. Would your action in this case compromise his or her position?

Having identified these ethical issues, whose interests would you consider most important?

Under the Fraser guidelines, a girl may be considered “Gillick competent” at 14 years of age. The daughter also clearly has an expectation of privacy, having already refused to tell her father why she has taken the drug. You might consider that by now the father probably has a good idea of what the drug is for – so your job is to assist him in deciding what to do with this information.

Conversely, you might judge it better to direct the father to the supplying pharmacy and indeed to his daughter for a proper exploration of the situation. Could you be liable for the consequences that arise from your decision?

Joy Wingfield is special professor of pharmacy law and ethics at the University of Nottingham

Where does the law stand?

Principally, the pharmacist’s duty of confidentiality here arises out of the common law duty of confidentiality, human rights legislation and out of the professional ethic codes of the General Pharmaceutical Council and the NHS Code. A patient has a right to respect for private and family life: this right is universal and exists despite a patient’s age, but may be overridden where it is in a patient’s best interests to do so.

The right to family life also provides for a parent’s right to information about their child enabling them to carry out their parental responsibility. As the law stands, however, failing to inform a parent may be justified where another’s rights are jeopardised.

Under the law, the best interests of the child should be the pharmacist’s primary consideration. In the case of Gillick, it was held that a doctor (or other professional) may prescribe contraceptive treatment to a child without informing the parents where they are satisfied that the child understands the advice; they could not persuade the child to tell their parents; the child is likely to have sexual intercourse with or without contraceptive treatment; the child’s physical or mental health may suffer without such treatment; and their best interests require such treatment be offered without the knowledge of their parents. These are known as the Fraser Guidelines. A 14-year-old child may fit this criteria.

The pharmacist should explain the Fraser Guidelines arising from the Gillick case (without reference to the contraceptive element) and suggest the father tries to understand the legal and professional duties owed by pharmacists to certain minor patients. Failure to respect the duty of confidentiality could lead to professional sanction, breach of the NHS contract and, in extreme cases, potential action under human rights legislation.

Hilary D’Cruz is a partner at Ansons LLP, specialists in pharmacy

What would YOU do?

• Do you have another solution to this dilemma?
• What would you do if confronted with this situation in your pharmacy?
• Or do you have an ethical dilemma you would like to share with other pharmacists?

A best practice guide for sourcing and dispensing unlicensed medicines

Following a change in the law this summer allowing price lists for unlicensed medicines to be published and shared, a shakeup in the procurement of specials has been triggered.

A BBC investigation, which has since revealed that the cost of specials to the
NHS has risen from £57 million to £160.5m in England in four years, has made the case for reform urgent and the need for transparency essential.

PSNC is in discussion with the Department of Health about introducing a tariff for some standardised specials. But that will take months – at the earliest.

Alan Krol, chairman of the Association of Commercial Specials Manufacturers (ACSM), says they are also working with the DH “about systems for controlling the cost of specials which don’t compromise the supply to vulnerable patients”.

He says the change in regulation to allow publication of price lists has been “significant” and has been welcomed by the association.

He says: “Publication of price lists will promote a wider understanding of the costs of unlicensed medicines and lead to greater transparency and confidence within the specials sector.”

And, he adds, they are committed to “working with health professionals to ensure that patient need continues to be met, for example, the recently published RPS guidance on sourcing specials”.

Q: What should I do when I receive a prescription for a special?

Follow the RPS decision guideline for supplying a special (see further advice on page 30). The ACSM advises choosing the preferred option that carries the lowest risk.

The preferred choice would be to use an already existing UK licensed medicine ‘off label’. If this is not appropriate, consider whether the special might be available in a licensed formulation in another country –  then it could be imported.

Otherwise, turn to a UK specials manufacturer with a licence to formulate specials.

This is a preferred option over extemporaneous preparations as it carries a lower net risk.

For specials that have been produced in a batch, ensure the manufacturer has provided a certificate of analysis. However, a different type of certificate (Certificate of Conformity) should be provided for specials that are individually made-to-order.

Q: Should I get in touch with the prescriber?

Definitely contact the prescriber if any questions arise regarding filling in the prescription. Legally it is the prescriber who takes responsibility for any unwanted effects caused by any special, but the pharmacist can take some responsibility alongside the prescriber. The pharmacist should ensure therefore that all reasonable steps are taken to ensure certain criteria are met. This is laid out in the MHRA’s Guidance note 14 of The supply of unlicensed relevant medicinal products for individual patients.

Q: Who can/should I contact to source the special?

It may be advisable for the pharmacist to contact the specials manufacturer directly rather than go through a wholesaler, but it is accepted that this isn’t always possible, says the ACSM. Some pharmacists prefer to order from their wholesaler, but there are benefits to ordering direct from the manufacturer, for example, they will be able to answer any questions about formulation etc. And some specialists, such as Moorfields, which offers more than 120 different ophthalmic specials, should be able to answer any complex questions.

Asa Baudin, Moorfields marketing manager, says: “We now have a dedicated team who visit clinicians, theatre nurses and pharmacists up and down the country. We talk to them about their patient needs and also educate them about specials manufacture, such as the quality process involved.

“At the same time we can get feedback and identify areas of real clinical need where we can extend our specials’ portfolio. Equally, we can avoid requests for unnecessary specials where a suitable alternative might already be available. It means we can focus on innovating where there is genuine need.”

Q: How do I choose who to order from?

Again, follow the RPS decision guideline for supplying a special. But the ACSM adds: “For consistency, it’s good to use the same manufacturer or supplier for repeat prescriptions.”

Q: What details should be discussed when ordering?

Most manufacturers have qualified support desks and can give advice if required.

Q: How much do specials cost?

As many specials are bespoke, it is difficult to standardise costs (something the BBC investigation failed to explain). This is why it could be difficult to put a cap on the cost of specials, says Victoria Buyer, commercial director at Quantum Pharmaceutical. But she also agrees a transparent and fair costing system is needed.

Q: How will I be reimbursed?

As explained earlier, the PSNC is currently in discussion with the Department of Health on the reimbursement arrangements for specials and changes are expected “in the coming months”.

A PSNC spokesman adds: “The principal aim of this work is to reduce the overall amount specials cost the NHS, while ensuring that pharmacists can continue to obtain specialist medicines patients need in a timely and efficient way.”

Q: What risks are associated with sourcing, ordering and dispensing specials, and am I responsible?

For unlicensed medicine, any unwanted effects caused by the medicine are mostly the responsibility of the prescriber and, in small part, the pharmacist. This is the case unless the unlicensed medicine can be proven to be defective, and then the manufacturer would be responsible.

Quantum’s Victoria Buyer, says: “We do our utmost to make specials as safe as possible and have a dozen separate quality checks to verify the quality and accuracy of formulations. We’ve just formed a quality-control department to make sure quality and safety aren’t compromised in the need of speed.

“The responsibility for the safety of specials is a joint one. It is up to the prescriber to check the ratio of the actives is safe and effective for their patient, and for the manufacturer to police that as far as possible by asking the right questions at the order stage.”

Q: What record-keeping requirements are associated with specials?

As part of the MHRA’s Guidance note 14, reasonable steps should be taken by pharmacists in record-keeping, records of purchase, supply, product specification, batch number, expiry dates, quantity supplied and the details of the patient should be kept for a period of at least five years. Many manufacturers give a certificate of analysis for batch-produced specials or a certificate of conformity for one-off specials.

Q: What are the trends in the specials market?

Specials account for approximately 1 per cent of the total amount of prescriptions in the UK and are made up of over 75,000 different formulations.

In recent years, there has been a decline in extemporaneous preparation by pharmacists and an increase in ordering from specials’ manufacturers or suppliers – this is largely for reasons of quality, as pharmacy guidance is to use a source representing the lowest risk possible.

There has also been some increase in specials prescribing as a result of the ageing population – who represent the majority of demand for unlicensed medicines. According to the ACSM, this is a trend which will continue in line with the changing UK demographic.

In addition, there is a growth in niche areas where patient needs are being met through new unit dosage formats, preservative-free formulations and special treatment areas.

Asa Baudin at Moorfields points out that eye conditions are increasingly prevalent in old age, and they have seen some increase in specials prescribing around these conditions.

He says continuing focus on the patient will lead to a more specialist portfolio of options to meet clinical need.

“We want to build our business on trust and confidence. By supplying a consistently high-quality product, we will grow our business through recommendation and repeat orders.”

In summary

Neal Patel, head of corporate communications at the RPS, says: “Pharmacists always make the care of patients their first concern and have to be satisfied that the products they supply to patients are of the highest quality.

“Meeting the patient’s clinical need means that sometimes it is necessary to supply specials when there are not available ‘off the shelf’ medicines.  The Society has taken action on this topic already by issuing professional guidance to pharmacists and sharing this throughout pharmacy.

“We believe strong co-operation between GPs, pharmacists and PCTs is needed to ensure that patients get the medicines they need at the best possible value to the NHS. We understand that negotiation is taking place nationally between the DH and pharmacy to improve the situation.”

Tips for your CPD entry on specials

Reflect: What is my process for specials?

Plan: Read this article and the RPSGB’s practice guidance (see link below).

Act: Implement/update my process.

Evaluate: Can I justify using specials and am I delivering patient benefit?

What the BBC investigation said

According to the BBC’s figures, a saving of nearly £72 million a year
could be made if all specials were limited to £75 an item. In one city in the West Midlands, they found that costs varied from £50 to £1,556 for the same item.

The mark-ups occurred when pharmacists bought through wholesalers, not direct from the manufacturer, the BBC reported. Some wholesalers offered large discounts to pharmacists, the BBC added.

Specials Watch

Email: sales@pennpharm.com

• BCM Specials has recently relaunched its website: www.bcm-specials.co.uk
• Moorfields has a dedicated specialist helpline particularly for ophthalmic queries and has an online resource for ophthalmic professionals, including pharmacists at: www.dryeyesmedical.com
• PSNC: www.psnc.org.uk
• RPSGB good practice guidance: www.rpharms.com/support-pdfs/ppjune2010-specials.pdf

With organisations across Europe backing today’s European Antibiotic Awareness Day (November 18, 2010), Chris Chapman reveals the key facts all pharmacists should know about the resistance threat to some of the most useful drugs in our arsenal.

1. Antibiotics resistance has always existed. Previously medicine was able to stay ahead of the curve because of the discovery of new classes of antimicrobials. However, this has now stopped. In addition, the World Health Organization (WHO) recognise several other factors – such as urbanisation, pollution, the aging population, AIDS and increased travel – as increasing the number of infections. This, in turn, results in increased antibiotics use – and misuse.

2. Resistance varies wildly between geographical location. For example, in 2007 the Health Protection Agency (HPA) reported an overall rate of non-susceptibility of streptococcus pneumoniae to penicillin of 3.8 per cent. However, this ranged from 1.1 per cent in Wales to 8.0 per cent in London. Some drugs have become almost ineffective: in 2007 the rate of resistance of group B streptococci to tetracycline was 82.7 per cent.

3. Serious conditions have also seen an increase in resistance. The incidence of drug-resistant tuberculosis  has doubled since 2000, from 206 cases to 389 cases. In treating gonorrhoea, resistance to cefixime, the unlicensed first-line treatment, has increased from one in 1,000 cases to more than one in 10 since 2006.

4. The main driver of antibiotic resistance in the UK is inappropriate prescribing. According to Department of Health (DH) inspector of microbiology and infection control Brian Duerden: “Imprudent and misuse of antibiotics is one of the main factors driving both the increase in antibiotic resistance and the continued incidence of C. difficile infection in hospitals.” Key issues include not reviewing the use of broad spectrum antibiotics when microbiology results are available, and not including a stop date on antibiotic prescriptions, Professor Duerden adds.

5. Primary care accounts for 80-90 per cent of antibiotic prescribing, the majority for respiratory tract infections, and prescribing has increased 30 per cent since 2000. However, resistance is also a problem in hospitals: up to 50 per cent of all antibiotic use in hospitals in the UK is inappropriate.

6. In May, a meta-analysis on the effect of antibiotic prescribing was published by the BMJ. It looked at 24 studies and a variety of infection types, including urinary tract and respiratory infections. It found patients prescribed an antibiotic in primary care develop bacterial resistance to that antibiotic; the effect is greatest in the month following treatment, but may last for a year. A longer duration of course, or multiple courses, was found to be associated with higher rates of antibiotic resistance.

7. Antibiotic prescribing is complex, but one factor is patient expectations. However, patient satisfaction has been shown to be more reliant on effective communication than on receiving a prescription. In particular, patients should be advised on what to expect in the course of their illness, including the realistic recovery time.

8. Once an antibiotic has been prescribed, compliance is a major problem. Patients may stop taking a course of antibiotics once symptoms improve, which may not eliminate the pathogen, allowing resistance to develop. Therefore patients should always be advised to complete their course.

9. The WHO lists self-medication as another major concern. It warns self-medicated antimicrobials are often unnecessary and often dosed inadequately. In addition, counterfeit drugs may not contain adequate amounts of the active drug. Patients should be advised not to use antibiotics unless instructed to by a healthcare professional.

10. Last, there is one issue governing resistance pharmacists cannot impact. In Europe, the WHO estimates 50 per cent of all antimicrobials are used in food-producing animals and poultry as regular supplements – thus exposing large numbers of animals, regardless of health, to the drugs. This use has seen increased resistance to bacteria, such as Salmonella and Campylobacter, that can be spread through food and infect humans.

With minor ailments taking up nearly a fifth of GP workload, Chris Chapman looks at why patients are still turning up at surgeries and not community pharmacies

Getting patients to treat self-limiting conditions themselves is vital for the future of the NHS. Minor ailments take up a fifth of GP workload, responsible for 57 million consultations. Developing a culture of self-treatment is the only way the NHS will be able to curtail its spending and ease the demands of a system already creaking under the strain.

Last Wednesday, experts from across the NHS gathered at a self-care symposium organised by the PAGB and Royal College of General Practitioners to flesh out a game plan on how this could be delivered. The consensus was that community pharmacy had a central role – but there were barriers that need to be overcome.

The first is getting patients to recognise pharmacy’s skill set. “It’s important to big up the role of pharmacy, to give patients the confidence to treat their conditions,” says Jeremy Taylor, chief executive of patient charity National Voices.

“Men hugely under-use pharmacy,” adds Peter Baker, chief executive of the Men’s Health Forum. “They are not aware pharmacies can dispense advice as well as tablets, are open long hours, and don’t require an appointment. Pharmacies are not marketing themselves enough to men.”

But this isn’t a new idea: despite pilots from the Department of Health aiming to boost patient awareness of what pharmacy can provide locally, warnings of the sector’s lack of publicity sound like a broken record. And the figures speak for themselves.

According to a PAGB survey of 3,052 minor ailments, only 12-15 per cent of patients, depending on social grade, asked a pharmacist for advice. Between 15 and 24 per cent consulted their GP or practice nurse.

However, BMA GP committee chair Dr Laurence Buckman says it’s not just patients who need to change their attitudes.

“We’ve got to get patients to see pharmacy as a source of information,” he says, “and that requires pharmacists to feel that way too. Most do, and are proud of their professional role… but pharmacists have to feel confident to say ‘if you’re no better, come back’. The person who deals with it first should be the first response.”

Perhaps some criticism is justified. Pharmacists, like all health professionals, have a little voice in the back of their mind during every consultation, asking ‘what if…?’.

A child’s rash is highly unlikely to be an indicator for meningitis, but many pharmacists would feel uncomfortable in ruling it out. Telling patients to go to see their GP if symptoms don’t improve is a safety net, if not sometimes the only sensible option available.

But this notion of pharmacy shows a lack of understanding from medical colleagues on what pharmacists provide. According to the PAGB survey, while 12-15 per cent of patients said they consulted a pharmacist, only around 2 per cent said they were referred on to a GP. Pharmacists are taking responsibility for treatment. And as PAGB director of health policy Gopa Mitra points out: “Pharmacists… are already [giving advice]. They’ve been doing this for decades… their normal role is advice.”

The problem, says Ms Mitra, is that while pharmacists are capable and confident of giving advice, they are not going far enough.

“Around £700 million OTC medicines are sold each year in the UK,” she says. “That’s 700 million opportunities to give advice. And that’s something we haven’t made enough of.”

And according to Ms Mitra, community pharmacists can’t wait for a publicity campaign to deliver results. “It needs to come from the profession itself,” she argues. “It’s suggesting a fundamental role change… we need to say that self-care is the norm.”

Ms Mitra has a point. Ultimately, pharmacists have it within their power to transform self-care into the status quo. When pharmacists are available to offer advice on how to self-medicate, word of mouth quickly takes hold, creating informed patients.

This in turn changes patient attitudes toward self-care, easing the burden on the NHS. And while GPs may lack understanding of what pharmacists do, the strongest change in viewpoint will only occur when surgery waiting rooms empty thanks to the care pharmacists deliver.

Self-care has to be a priority for change in the NHS, and it’s a new way of thinking that needs pharmacy at the vanguard.

It is an unfortunate hazard of a pharmacist’s job – as with any job in the service industry – that from time to time you may not see eye to eye with a customer.

Angry customers have become such a prevalent feature of public life that they have almost become a caricature of themselves. Yet it is important not to dismiss the distressed patient with a wave of the hand or, worse still, have a shouting match with them. Your ongoing relationship with a customer is crucial and it is imperative a pharmacist does nothing to adversely impact on that.

As Numark training manager Yvonne Tuckley explains: “Anyone working in a retail environment will experience angry customers at one time or another, but there is an added complexity in pharmacies because it could be directly related to their condition or medication.

“This is where your knowledge of your customers can be really important, perhaps knowing if they are being treated for something that can make them volatile or understanding that you need to be discreet when talking to them.”

The key to dealing with situations like this, according to one pharmacist, can be summed up in one word: empathy. “The great thing is to empathise with them – to understand what their point of view is and then you can try and take their side by saying, ‘Yes, I absolutely agree with you’,” suggests Alan Kurtz, owner of Fishers Chemist in the Croydon suburb of South Norwood. “I’ve had people come in here who are basically fuming and I’ve taken them into the consultation room – it’s about looking at things through their eyes.”

Experts in the anger management field agree that understanding the customer’s problem can help solve whatever issue they may have.

Mike Fisher, founder of the British Association of Anger Management, contends that coming to terms with the other person’s annoyance is vital to a successful resolution.

“It’s important to look at the bigger picture – this is a customer who is distressed. Realise the distress that the other person is in. Also, shut up and listen! When they’ve finished ranting and raving, you have the opportunity to say something.”

It is vital, too, not to be angry yourself when talking to customers, because that anger will show in your demeanour. As psychologist Abraham Maslow said: “When the only tool you have is a hammer, you tend to treat everything as if it were a nail.”

Be sensitive to your own feelings, suggests Mr Fisher: “The big thing is to monitor your own feelings and, if you’ve had a challenging week, be sensitised to them. Thinking about your own issues and using whatever resources you have in your support network can be key.”

If this means talking to colleagues, friends or family to resolve any personal issues you may have, then so be it, advises Mr Fisher.

Comprehension of a patient’s medicines or illness, and why they might bring about an onset of anger, can also be crucial. Ms Tuckley gives advice and an example: “You can take steps to avoid confrontational situations if you know what your customers expect. For instance, some patients who come in for methadone can get very anxious if there is a delay, so spotting them as they come in and trying to help them as soon as possible can alleviate a tense situation.”

Above all, advise those in the know and don’t take things personally. A distinction must be drawn, says Mr Fisher, between anger due to a personal problem with  somebody and anger that has its root in frustration because someone is not receiving a particular product or service.

“Remember: don’t take it personally. It’s a professional relationship and most people who work in these [customer service] fields don’t take it personally,” he says.

And remember: dealing successfully with the stressed-out and put-out can be imperative to a successful working relationship with customers. Any pharmacist should heed the maxim: ‘If we don’t take care of our customers, someone else will.’

Case study
Angela Chalmers, Boots, Goodge Street, London

“I had a guy spit at me once, all because we didn’t have one of the items on his prescription. He started calling me all sorts of names; then, as he turned to leave, he turned and spat at me from a distance of about 6ft.

“It is amazing how violated you feel when somebody spits at you. I was traumatised – I think I had a bit of post-traumatic stress – and I didn’t sleep properly for a couple of months.

“I do reflect and think ‘Is there anything I could have done differently?’. But, to be honest, there isn’t. We spoke to him in a very low tone, and it was only when he started abusing us that I said ‘I think it’s time for you to leave, sir’. It was then that he spat.

“I heard later that he’d gone into another local pharmacy and acted as if nothing had happened to get the items for his prescription. That was how the police were able to identify him.

“I didn’t press charges, because he wasn’t a well man, but the police did go to round to his home and explained to him why what he did was unacceptable. His wife was appalled.

“In any situation with an angry customer, you need to seek to understand before seeking to be understood. Let them get it out of their system and don’t block any exits because, if they want to leave the store, they are going to leave the store whether you are in front of them or not.”

How I handle Mr Angry
“You just have to be patient – be very polite and clear in what you are saying to them. More than 95 per cent of our customers are fine – it’s just the odd one or two.”

David Badham, Stewart Pharmacy, Evesham, Worcs
“It’s best to think that they are always right, even if you don’t think they are. You want to do everything within reason to keep them happy and maintain a good professional relationship.”

Gordon Couper, Handbridge Pharmacy, Chester
“Take them aside and ask them what the problem is. If you can’t solve it at that time, explain to them that you are busy, but that you’d be very happy to make an appointment with them to try and solve things later.”

Jignesh Patel, Rohpharm Pharmacy, Plaistow

Tips for your CPD entry on customer complaints

Reflect Are customer complaints handled effectively in my pharmacy?

Plan Review customer complaints procedures and observe actual incidents.

Act Update procedures and arrange training where necessary.

Evaluate Are customer complaints handled more effectively in my pharmacy?

The news that pharmacies on the Isle of Wight have launched a scheme that will allow pharmacists to dispense a month’s worth of the progesterone-only contraceptive pill without a prescription has caught the attention of the nation.

Much of the furore has focused on the fact that the scheme is open to women over the age of 13, meaning pharmacists could supply under-16s with the pill without their parents’ knowledge.

The scheme was criticised in the national press, and at the height of hysteria the island’s Conservative MP Andrew Turner submitted an oral question to health minister Andrew Lansley over the plans, claiming: “Many of my constituents are horrified.”

With so much public unease, it’s easy to wonder what such a scheme actually brings for the profession.

The scheme on the Isle of Wight will mean that if a patient under the age of 16 presents at a pharmacy for EHC then they will be given one month’s supply of the contraceptive pill if the pharmacist deems it appropriate. They will also be referred to an outreach nurse or to their GP. Patients over the age of 16 will be referred to the sexual health service. And all patients will also be offered chlamydia screening and a supply of condoms.

The decision to offer the pill to women over the age of 13 differs from a similar scheme in Southwark and Lambeth PCTs, which only offers the contraceptive pill to women presenting over the age of 16, but it is in line with case law. A decision by the House of Lords in a 1985 case ruled that women under the age of 16 do have the legal capacity to consent to medical treatment without parental consent. And health secretary Andrew Lansley alluded to this in the House of Commons when asked about the scheme, stressing that young persons are competent to make such decisions.

Chief officer of Hampshire & Isle of Wight LPC Mike Holden says the negative publicity has not been helpful, but he says much of the commentary has been from ill-informed people. He says: “Everyone needs to understand it is not [primarily] aimed at people who are under 16. It is for people who are using EHC, so these are people who have already decided to engage in underage sexual activity.”

Pharmacist Cuthbert Chirinda completed training at Kings College London before he began offering the pill at his pharmacy as part of the Lambeth and Southwark PCTs pilot. He says that patients have been impressed by the opportunity to obtain the contraceptive pill at his pharmacy and he completed nearly 400 consultations during the one-year pilot.

Mr Chirinda says: “I think we have had a lot of improvement and patients were excited about it. We have done 400 consultations and patients like the fact that they didn’t have to book.”

Patients also appear to be benefiting from the scheme, as Mr Chirinda has seen a drop in the number of women presenting for EHC since he started the pilot. And 40 per cent of the patients receiving the pill in the pilot were first-time pill users, suggesting they would not have accessed long-term contraception elsewhere.

The patient benefits seem to be clear, but it still remains to be seen how much of an impact the negative coverage of the scheme will have on community pharmacy.

Industry leaders are convinced that patient confidence will not be affected by this latest pharmacy story, though. Chair of the RPS English Pharmacy Board Lindsey Gilpin says that she feels the backlash has more to do with attitudes to sexual behaviour in young people than people’s attitude towards pharmacists, but that the profession could do more to target those in positions of authority.

As Ms Gilpin says: “People do still trust their pharmacists.”

And a spokesperson from the NPA says the matter has been dealt with well by the Isle of Wight, adding: “The local NHS and pharmacy representatives on the Isle of Wight handled the matter with the confidence you would expect from people with the facts behind them.”

Mr Holden points out that the criticism seen last week came from a few uninformed commentators and says: “You can’t be tasked with making sure that people are informed before opening their mouths – and you can’t be held accountable for that.”

So whatever the latest coverage may have been, it seems that the Isle of Wight scheme could well be good for the sector as a whole.

If the public are convinced by the scheme, as patients were by the London equivalent, it could enhance the sector’s profile in the clinical services arena.

Pill perspectives

“This service has been provided with consummate professionalism.”
Sue Sharpe, CEO, PSNC

“Nowhere else, I am told, shares that approach. Many of my constituents are horrified.” Andrew Turner, Conservative MP, Isle of Wight

“The coverage of the service illustrates the need for attitudes and public awareness to be brought up to speed with developments in community pharmacy.”
Stephen Fishwick, head of external relations, NPA

1 Ask early for landlord’s consent

Apply for your landlord’s consent at least six weeks before you want to start the works. You will have a timetable that you and your contractors need to stick to in order to avoid an adverse impact on your business plan. Your landlord does not have the same motivation so you need to allow a comfortable period of time to obtain consent.

Don’t be tempted not to ask your landlord for consent to carry out the works. If you fail to obtain consent, you will find yourself paying for the works all over again at your next rent review, when your landlord will be entitled to value the rent for your pharmacy as if your landlord had paid for the works rather than you.

2 Talk to your local planning authority

Check whether or not you need planning consent and building regulations consent for your works. Speak to your local planning officer and building regulations officer and check how long your local authority will take to provide the relevant consents.

Make sure you stay in touch with your building regulations officer while you carry out the works so that any ongoing inspections take place when they should. When the works have been completed, the building officer will need to make a final inspection and issue a completion certificate. You will also be required to produce these consents to your landlord for approval.

3 Sign a contract

Make sure you have a written contract with your shopfitter. You should have a clear written record of exactly what your contractor will be responsible for and exactly what you will be responsible for, together with clear details of how the costs will be calculated and when payments will be due. Do not rely on a verbal agreement, which will be difficult to enforce if there should be a dispute.

4  Check out your contractors

Make sure your contractors are solvent and insured. Make sure you can terminate your contract if the contractor becomes insolvent. Your contractor should have an insurance policy that covers negligence, public liability and damage. Make sure you talk to your contractor about who will be responsible.

5 Ensure accessibility

Make sure that your access and layout complies with the Disability Discrimination Act 1995. As a “service provider” under the Act, you must make reasonable adjustments in relation to the physical features of your pharmacy in order to overcome any physical barriers to access. If your premises did not comply before your shop fit, view this as an opportunity to rectify the situation. There are special rules under the 1995 Act that relax certain requirements in your lease to obtain landlord’s consent. Think laterally and embrace the legislation; compliance will produce a more accessible pharmacy and happier customers and staff.

6 Beware of asbestos

The group of people most at risk from asbestos in the UK today are tradesmen carrying out works to premises. The Control of Asbestos at Work Regulations 2006 place on the person whose responsibility it is to maintain and repair your pharmacy a duty to assess the premises, to establish whether or not asbestos is present. Once the risk has been assessed, you are obliged to prepare a written plan identifying the measures to be taken and either steps must be taken to maintain the current condition of any asbestos found or the asbestos must be safely removed. If there is asbestos at your pharmacy and it does not need to be removed, you must clearly identify where it is so that your contractors do not disturb it. Failure to comply with the regulations is a criminal offence.

7 Consider fire safety

Since October 2006, fire certificates issued by the local fire officer have not had a legal status. Instead, duties are imposed on “the responsible person” to carry out a fire risk assessment, implement its recommendations and keep the assessment under review, ensuring the safety of employees and visitors. As the person in control of the premises, you are the “responsible person”. Make sure that you assess the shopfitting works that you intend to carry out to ensure that proper fire safety measures are incorporated.

8 Keep a record

Keep a record of the layout and condition of your premises before the works are carried out. Your lease will oblige you to remove your alterations when your lease ends and reinstate the premises to their former condition. By the time this is due to happen, your recollection of how the pharmacy originally looked will be hazy. Keep a copy of the original layout drawings and photographs of the premises with your lease and keep them in a safe place. If you are able to, attach a copy to the licence from your landlord consenting to the carrying out of the works.

9 Keep your landlord in the loop

Keep your landlord informed as you carry out the works so that your landlord has the opportunity to inspect when it needs to. Notify your landlord when the works have been completed. Your landlord should then insure under its buildings insurance policy any parts of the works that have become the fabric of the building. Any items that do not become part of the building should be added to your contents insurance policy.

10 Reap the benefits

Stand back, be proud of the fruits of your labour and go forward with renewed vigour knowing that your pharmacy is now fit to take your business to new heights. 

Ingrid Saffin is a commercial property partner and head of healthcare at law firm Mundays

Tips for your CPD entry on pharmacy design

Reflect Does my pharmacy present a professional image and support work processes?
Plan Consider how a refit or smaller     layout changes could improve image and work processes
Act Implement refit or layout changes
Evaluate Have public image and workflow improved?

SOURCE

If a pharmacist claimed too much money from the NHS, they would be “shown no mercy”, according to David Reissner, head of healthcare at Charles Russell solicitors. Even if the claim was a genuine mistake, he says, the NHS Counter Fraud and Security Management Service would step in and the pharmacist could find themselves at a police station or even struck off the register.

Yet when the boot is on the other foot, and NHS Prescription Services (part of the NHS Business Services Authority, NHS BSA) is underpaying contractors on a seemingly regular basis, no such action is taken. Just a few phone calls to contractors this week uncovered a raft of unsettling stories: NHS BSA is seemingly trying to put contractors off requesting pricing checks; the authority has lost submitted prescriptions; and the underpayments continue.

In her latest batch of recounts, Lila Thakerar, of Shaftesbury Pharmacy in Harrow, was underpaid by almost £4,000. And Umesh Modi, specialist pharmacy financial advisor at Silver Levene accountants, says he too is still seeing errors being made, often to his clients’ detriment.

Speaking at the C+D Conference last month, Sue Sharpe, PSNC chief executive, also admitted pricing errors were still a “massive problem”. She says the NHS BSA automated CIP payment system wasn’t introduced or tested properly and has not been fit for purpose.

The good news is that NHS Prescription Services head of client and customer services Michael Wood says he recognises the importance of accurately paying contractors and that they have a continuous programme of accuracy improvement. He also says staff are committed to pricing accurately.

But sometimes it just doesn’t feel like it. The standard apology note Ms Thakerar says she receives each time she is informed of an underpayment from the NHS Prescription Services does little to reassure her.

And the authority seems to make life difficult for contractors requesting payment checks. Mr Reissner said one client, who had been underpaid by NHS BSA by £180,000, asked for additional payments to be checked.

The NHS BSA refused to do this, despite the previous underpayment, saying it needed evidence for each month to be rechecked. The contractor concludes: “I believe they are trying to reduce their workload by insisting on evidence before rechecking scripts.”

Clearly engaging more proactively with contractors would be a very welcome start.

Ms Thakerar is particularly alarmed that she is never told how the money she is owed has been calculated, nor what the errors have been. Ms Thakerar would like to know this as it might help her see where errors are being made so she could improve her submissions to the NHS BSA and stop future errors. This dialogue, she feels, could help “avoid miscalculations so I’m not having to do this for the next 10 years”.

Mr Modi agrees transparency should be top of the agenda for NHS Prescription Services and Uma Patel, of Dunns Chemist, Cranford, says PSNC could also help with this. He would like to see the auditing data they do on payments. “I would like to see the results of their statistical analyses… that would make us comfortable [about pricing].” Or perhaps more uncomfortable, as the case may well be.

Alongside this apparent reluctance to work with contractors, the fact remains that pharmacists are still having to foot the administrative bill of the failed system. New sorting arrangements introduced in April take more work and, Mr Modi adds: “The administrative costs of checking the statements must run into hundreds of pounds over the year because clients do not have any confidence in the payments they receive.” None of which helps to boost NHS BSA’s reputation among contractors.

While there are little things that could make a difference now – such as a willingness to engage – many believe broader change is needed, and have called for the introduction of a new, transparent payment mechanism for pharmacy. The topic is set to be debated at PSNC’s upcoming LPC conference, where Hampshire & Isle of Wight LPC has submitted the motion that it has “no confidence in the ability of the Prescription Services to deliver their core function”.

Chief officer Mike Holden explains that he hopes this will push PSNC to pursue the matter actively and work to regain trust in the system. Mr Holden believes a new system in which pharmacists can accurately work out what they should be paid, and then invoice the NHS, is needed.

Transparency of payments was an NHS white paper commitment, so Mr Holden says he hopes it will happen, but it may take some work.

PSNC head of pharmacy audit Janet Edginton says PSNC is continuing to have discussions with the DH and NHS BSA to establish ways to improve transparency of payments and Mrs Sharpe told the C+D Conference the NHS BSA needed to be kept under some pressure, so perhaps now is the time to really start stepping that up.

As Mimi Lau, director of professional and training services at Numark, concludes: “It’s high time that we demand a new system which is transparent, robust and has high pharmacist confidence.”#

SOURCE

With spam from rogue pharmacies hitting our inboxes every day, Chris Chapman asks how the sector can protect patients while harnessing the potential for legitimate online growth

The one certainty about owning an email account is that, at some point, you’ll be sent an email promising drugs to enlarge your penis – whether or not you have one.

Last month internet giant Google launched charges against online rogue pharmacies, probably sending emails like these, slamming them as bad for “our users, for legitimate online pharmacies and for the entire e-commerce industry”.

And earlier this month the MHRA and UK Border Agency seized £570,000 worth of illicit medicines as part of a global crackdown, raiding premises linked to 12 websites.

The problem isn’t going away, with police currently trying to close down a further 183 websites in the UK. But what does this thriving cyber trade in knock-off medicines mean for community pharmacy, and how can patients know who to trust on the internet?

Online pharmacy is a popular area of expansion for pharmacy retailers, with multiples such as Boots, Lloyds, Rowlands and Asda offering medicines safely and legally. The internet is an area with big potential, and it could provide patients with a convenient new way to access their medicines and deliver care to patients who are housebound or unable to access a pharmacy.

But where there is potential for legal profit, there is also potential for illegal profit and for crime. And Pfizer estimates the value of the European illicit drugs market is around £9 billion.

The problem seems to be a lack of knowledge, says Pfizer medical director David Gillen. Around a quarter of patients in a survey the company conducted in 2009 didn’t consider taking medicines without a prescription to be risky. Dr Gillen says there is a “clear need” for greater public awareness and education. “People are not only unaware of the very real dangers of counterfeit medicines, but also that they’re fuelling an illegal and harmful drug market,” he said.

This lack of education puts patients at risk, exposing them to medicines with no quality control. And it’s bad for the sector, as the counterfeiters are also undermining public trust in pharmacy, creating a bad name for sites that provide appropriate, quality-assured healthcare.

“It’s bad, because this tarnishes all online pharmacy,” says Mitesh Soma, founder of online pharmacy Chemist Direct. “We do show we’re reputable with the green cross [linked to the regulator’s register], our telephone number, and a whole section to show we’re a real business. All of these things help to reinforce [the fact that] there are legitimate businesses out there.”

The General Pharmaceutical Council (GPhC) acknowledges there is “a great deal of confusion” about the regulation of internet pharmacies among the general public. In 2008, the RPSGB took steps to rectify the situation, introducing a non-mandatory logo for sites. However, a recent report by the Nuffield Council on Bioethics said patients were not sufficiently aware of this.

And the GPhC recommends patients should take additional steps to confirm the source of their medicines (see panel above).

But even where patients can distinguish between real and bogus sites, human factors come into play, too. According to the MHRA, the types of drugs counterfeiters thrive on are predominantly lifestyle drugs, such as those for erectile dysfunction and weight loss, or drugs open to abuse, such as pain relief and antidepressants.

“With prescription-only medicines, there are a lot of people who don’t want to get a prescription, because they are embarrassed,” says Kimberley Estenson, of online pharmacy Express Chemist. While this embarrassment exists, it’s going to create a hurdle to purchases and keep people going online. And it also creates a tightrope that pharmacists supplying online must walk.

For example, in May, Boots and Lloydspharmacy faced criticism from the BBC’s Watchdog, which showed an underage customer purchasing Alli at Boots’ online store, and an anorexic customer buying the drug online at Boots and Lloydspharmacy after lying about her BMI. But as Boots points out: “We cannot let the actions of a few individuals prevent the vast majority of customers who need and are entitled to purchase these products from accessing them.”

Pharmacists have a responsibility to put restrictions on purchases, and ask questions to ensure medicines are appropriate. However, the key advantage of online pharmacy is that it is accessible, so making access too difficult can drive consumers to unregulated sites, with no guarantees of the quality, safety or appropriateness of medicines. Checks must be carried out where needed, but not at the expense of making online purchases too restrictive.

The threat of counterfeit medicines and bogus pharmacies isn’t going anywhere – the trade is too lucrative – so trying to end counterfeit medicines online is a tough ask. Instead, perhaps pharmacy needs to use the hard-won relationships it has formed with patients to make sure they understand which sites are safe to use.

Making sure patients embrace the GPhC logo, in the same way that the Kitemark has become a recognised safety standard, could make a huge difference. Only then will pharmacy be able to capitalise on the potential of online pharmacy, and also safeguard patients against dangerous counterfeit medicines.

Drugs in this class are used for: Treatment and/or prophylaxis of infections
Metronidazole is an antiprotozoal and antibacterial medication used to treat anaerobic infections, protozoal infections, Helicobacter pylori eradication and susceptible skin infections. Metronidazole is bactericidal and its mechanism of action is more likely to be attributable to the disruption of existing bacterial DNA and inhibition of its synthesis in prone organisms. Metronidazole is selectively taken up by such organisms due to the ability of these organisms to reduce metronidazole to its active form intracellularly.

Dosage regimen

Please refer to SPC for children’s doses.

Patient knowledge

•   Medication should be taken with or after food to reduce chances of gastrointestinal disturbances.

•   Complete the course to optimise treatment success and to reduce chances of resistance.

•   Must avoid consumption of alcohol while taking metronidazole as it causes a disulfiram-like reaction (this can include; nausea, vomiting, flushing of the skin, tachycardia, shortness of breath). The half-life of Metronidazole is about 8 hours, so avoid consumption during the treatment and at least 1-2 days after the course has been completed.

•    Metronidazole may reduce contraceptive effect of hormonal contraceptives. Therefore patients need to be aware that additional contraception may need to be used (e.g. condoms) to prevent pregnancy.

•    In addition to those discussed above, a patients current medication will need to be checked as metronidazole can interact with drugs such as; anticoagulants, phenytoin, barbiturates, disulfiram, lithium and cimetidine.

Is the medicine working?

•    Most infections only need metronidazole between three and seven days but if infections are recurrent perhaps patient compliance to medicines needs to be analysed.

•    Assessment of possible swallowing difficulties should be analysed. Pharmacists can acquire syrup forms of the metronidazole.

Side effects
•    Gastro-intestinal disturbances (eg nausea, vomiting)
•    Taste disturbances
•    Furred tongue
•    Oral mucositis
•    Anorexia
•    Hypersensitivity reactions (eg rashes and anaphylaxis)

Monitoring

•    Those that are taking metronidazole for more than ten days are advised to undergo clinical and laboratory monitoring. Tests may include liver function tests, white blood cell counts or even check for side effects. It is important that patients keep all doctor and lab appointments for that their condition can be checked regularly.
•    Compliance assessment (eg conduct monthly tablet counts).

Lifestyle

•    Maintain a varied, healthy diet to build up the immune system. Ensure adequate hydration (especially in the elderly and children).
•    Encourage compliance to minimise risk of resistance.

What treatments are used?
Treatment can include chemotherapy and radiotherapy, as well as bone marrow and stem cell transplantation or monoclonal antibodies. The choice of treatment depends on the type of leukaemia and the progression of the disease.

How can I manage side effects?
Many side effects can be managed by drugs or simple interventions. An effective prophylaxis strategy to prevent nausea and vomiting is vital, as this can lead to non-compliance. Acute emesis can be managed by domperidone or metoclopramide, or a specific serotonin antagonist given with dexamethasone if high risk. Lorazepam is used in patients who have anticipatory emesis because of its amnesic, sedative and anxiolytic effects.

Treatments for leukaemia range from conventional anticancer chemotherapy and radiotherapy to advanced biological drugs that target the disease’s underlying molecular pathophysiology. Individual management decisions are complex and varied, guided principally by the type of leukaemia and key patient factors such as age and genetic profile.
Main types of treatment for leukaemia include:
– chemotherapy
– radiotherapy
– transplantation – bone marrow or stem cell
– tyrosine kinase inhibitors
– monoclonal antibodies.

Treatment

1. Acute myeloid leukaemia (AML).
Chemotherapy is the main treatment approach for AML, divided into two phases – induction and consolidation. The goal of induction therapy is to achieve “morphological complete remission” – this involves normalisation of neutrophil and platelet counts and reduction in leukaemic blasts to <5 per cent of total white cell count in the bone marrow.1 Patients with a favourable cytogenic profile generally receive two courses of induction, followed by one or two rounds of consolidation. AML sufferers designated ‘intermediate’ or ‘poor risk’ after profiling may be candidates for allogenic stem cell transplantation (SCT) if they respond to induction.¹ Consolidation is aimed at preventing the recurrence of leukaemia once remission has been achieved. It can consist of further chemotherapy, a donor transplant or – rarely in AML – an autologous stem cell transplant.²

Common cytotoxics used in AML chemotherapy include daunorubicin, cytarabine, etoposide, fludarabine, idarubicin, doxorubicin, thioguanine, amsacrine and mitoxantrone – at different doses and in various combinations. Most patients will have an induction regimen that starts with cytarabine and an anthracycline (any of the three rubicin drugs), with potentially a third agent added.²

First-line therapy of acute promyelocytic leukaemia (APML), an AML subtype with good prognosis, involves the retinoid all-transretinoic acid (ATRA; tretinoin). In combination with an anthracycline, this produces cure rates in excess of 80 per cent.¹ ATRA is not a cytotoxic but promotes maturation of malignant cells. Arsenic trioxide is the second-line treatment for APML and also gives high complete remission rates.

2. Chronic myeloid leukaemia (CML)
CML management has been revolutionised by the advent of the tyrosine kinase inhibitor (TKI) imatinib, which offers overall survival rate of  89 per cent after five years, and has now replaced the previous gold-standard therapy, cytarabine plus interferon alpha.1 Nice recommends imatinib as first choice treatment for Philadelphia (Ph) chromosome carriers in the chronic phase of CML and as an option for patients presenting in the accelerated phase or with blast crisis, the terminal phase of CML, provided imatinib has not been used previously.³

Imatinib is generally preferred over allogenic SCT for the first-line therapy of newly-diagnosed chronic phase CML patients; however, SCT offers the only confirmed potential for a complete cure.1 In patients eligible for SCT, rates of long-term remission or cure are approximately 60 per cent.¹

For imatininb-resistant patients, the newer TKIs – dasatinib and nilotinib – are alternatives with greater potency, although nilotinib is not licensed for blast crisis.

3.Chronic lymphocytic leukaemia (CLL)
Currently, CLL is not curable. However, most patients with early-stage disease do not require treatment until the cancer progresses or symptoms become troublesome. Studies have shown immediate treatment offers no significant survival advantages but poses potentially serious side effect problems.⁴ Instead, a policy of ‘watchful waiting’ is adopted, with regular blood tests and monitoring.
For patients in later disease stages of CLL (known as Binet stage two or three), treatment is recommended. Chemotherapy is the mainstay of CLL management and oral chlorambucil is the first-line agent of choice. Fludarabine, a purine analogue, is recommended by Nice as a second choice option for CLL patients who have failed or are intolerant of chlorambucil and would otherwise have received combination chemotherapy.⁵ Typical chemotherapy combinations used in CLL include:
¥ CHOP – cyclophosphamide, doxorubicin, vincristine and prednisolone
¥ CAP – cyclophosphamide, doxorubicin and prednisolone
¥ CVP – cyclophosphamide, vincristine and prednisolone.

Newer monoclonal antibody therapies for CLL include alemtuzumab and rituximab. Rituximab is a chimeric antibody that binds selectively to the CD20 antigen expressed on the surface of mature B-lymphocytes and tumour cells. It is recommended by Nice – in combination with fludarabine and cyclophosphamide – as a first-line option for CLL in patients suitable for fludarabine and cyclophosphamide combination therapy.⁶

Like rituximab, alemtuzumab also causes lysis of B lymphocytes and is licensed for CLL where fludarabine treatment is not appropriate.⁷ Nice has not yet reviewed alemtuzumab but the Scottish Medicines Consortium has accepted it for restricted use in previously untreated B-cell CLL patients with the cytogenetic abnormality 17p-deletion.⁷

4. Acute lymphoblastic leukaemia (ALL)
Chemotherapy is the main treatment for ALL and 80 per cent of patients will achieve remission. Treatment for ALL follows three phases:⁷
¥ Induction – an initial intensive phase of treatment to destroy leukaemic cells. Common chemotherapy drugs used are vincristine, daunorubicin or doxorubicin, methotrexate, crisantaspase (asparaginase), mercaptopurine and cyclophosphamide.
¥ Intensification (consolidation) – further chemotherapy to destroy residual leukemic cells
in the blood or bone marrow. Drugs include cytarabine, etoposide and tioguanine (thioguanine).
¥ Maintenance – to reduce the risk of recurrence. Usually oral mercaptopurine or methotrexate, or intravenous vincristine.
Some ALL patients will be suitable for high-dose treatment (including total body irradiation and high doses of etoposide or busulfan) followed by stem cell transplant. Carriers of the Ph chromosome may receive imatinib.

Cytotoxics
Side effects common to most cytotoxic drugs include: oral mucositis, tumour lysis syndrome (a particular risk in ALL and AML if white counts are high or there is bulky disease), hyperuricaemia, nausea and vomiting, bone marrow suppression, alopecia, reproductive toxicity and thromboembolism.⁷ All cytotoxics are contraindicated during pregnancy. Drug interactions are common and widespread – see BNF for details.

Anthracyclines
The anthracyclines doxorubicin, daunorubicin and idarubicin are cardiotoxic, with high cumulative doses potentially causing cardiomyopathy and heart failure. Doxorubicin and idarubicin are contraindicated in patients with severe myocardial insufficiency, recent myocardial infarction and severe arrhythmias. Side effects include cardiac disorders, extravasation, elevated bilirubin, diarrhoea and red coloration of the urine.

Alkylating agents
Key problems with the prolonged use of alkylating agents are impaired gametogenesis and increased risk of acute non-lymphocytic leukaemia (especially when combined with excessive irradiation).

Rarely, chlorambucil can cause widespread rashes that may progress to Stevens-Johnson syndrome or toxic epidermal necrolysis. If a rash occurs, it should be substituted for cyclophosphamide. Chlorambucil should be used cautiously in patients with a history of epilepsy and children with nephrotic syndrome, and avoided in acute porphyria.

Side effects of cyclophosphamide include anorexia, cardiotoxicity at high doses, interstitial pulmonary fibrosis, inappropriate secretion of diuretic hormone, disturbances of carbohydrate metabolism, urothelial toxicity, and pigmentation of palms, nails and soles. A urinary metabolite of cyclophosphamide can cause haemorrhagic cystitis – increased fluid intake for 24-48 hours after intravenous injection is recommended.
Cyclophosphamide is contraindicated in haemorrhagic cystitis and caution is required in acute porphyria and renal or hepatic impairment.

Antimetabolites
Cytarabine is a potent myelosuppressive and requires haematological monitoring.
Fludarabine has a powerful and prolonged immunosuppressive effect. Co-trimoxazole is used to prevent pneumocystis infection and only irradiated blood products can be given (to avoid graft-versus-host reaction). Immune-mediated haemolytic anaemia, thrombocytopenia and neutropenia are less common side effects. Monitoring is required for signs of haemolysis, neurological toxicity and skin cancer. Fludarabine is contraindicated in haemolytic anaemia.

Methotrexate causes myelosuppression, mucositis and rarely pneumonitis. It is contraindicated in severe renal or hepatic impairment and pleural effusion or ascites. Concomitant folic acid can reduce side effects.

Vinca alkaloids
Neurotoxicity – typified by peripheral paresthesia, loss of deep tendon reflexes, abdominal pain, constipation or ototoxicity – is a limiting side effect of vincristine.

Vincristine can cause severe local irritation, extravasation and bronchospasm.

Tyrosine kinase inhibitors (TKIs)
Side effects of TKIs include diarrhoea, elevated transaminases, hypophosphataemia, muscle cramps, nausea and vomiting, periorbital or peripheral oedema, pleural effusion, QTc prolongation and skin rash. Imatinib should be used cautiously in cardiac disease, with monitoring of fluid retention and liver function.

Dasatinib may cause severe neutropenia and thrombocytopenia in up to 50 per cent of patients.¹ Nilotinib is less myelosuppressive but associated with biochemical abnormalities such as elevated bilirubin, transaminases and lipases. Caution should be exercised in patients susceptible to QT-interval prolongation.

Metabolism of TKIs is primarily via the cytochrome P450 CYP3A4 so enzyme inducers
(eg rifampicin and phenytoin) and inhibitors (eg itraconazole, clarithromycin, grapefruit juice) should not be given concurrently.¹

ATRA
ATRA is generally well tolerated but can cause retinoic acid syndrome – a serious adverse event characterised by fever, fluid retention, low blood pressure and dyspnoea.

Monoclonal antibodies
The main adverse effects with rituximab and alemtuzumab are infusion-related reactions, usually occurring during the first intravenous administration. Symptoms include fever and chills, nausea and vomiting, allergic reactions, flushing and tumour pain. Premedication with analgesic, antihistamine and corticosteroid is recommended.

Other rare but serious side effects of rituximab include neutropenia, leucopenia, infection and cardiovascular events.6 Progressive multifocal leucoencephalopathy (a rare and often fatal viral disease causing damage to the white matter of the brain) has also been reported and warrants close cognitive, neurological and psychiatric monitoring.

Rituximab should be used with caution in patients on cardiotoxic chemotherapy or with a history of cardiovascular disease due to the risk of exacerbating angina, arrhythmia or heart failure.

Compliance
Leukaemia treatment involves powerful drugs that bombard and batter the body, eliciting a whole host of unwanted effects. Maintaining compliance with the treatment plan can therefore prove extremely challenging. Pharmacists have an important role to play minimising and managing these medication side effects, offering lifestyle advice and self-help measures to help patients obtain maximum benefit from treatment. See table ¹.

Nausea and vomiting are among the most infamous of chemotherapy side effects and can cause considerable distress, sometimes leading to refusal of further treatment. Effective prophylaxis strategies are therefore vital. Certain patients will show increased susceptibility to emesis including women, patients under 50 years of age, anxious patients and sufferers of motion sickness. Pharmacotherapy choices will depend on whether the symptoms are acute (occurring within 24 hours of treatment), delayed (onsetting after 24 hours) or anticipatory (experienced prior to subsequent doses):⁷
¥ Acute: patients at low emesis risk – domperidone or metoclopramide, with dexamethasone or lorazepam as additional options; high-risk patients – a specific serotonin antagonist (given orally) in combination with dexamethasone.
¥ Delayed: oral dexamethasone, alone or in combination with metoclopramide or prochlorperazine.
¥ Anticipatory: lorazepam is good for its amnesic, sedative and anxiolytic effects.
Table 1, further information and references are available online in the full version of this article at www.chemistanddruggist.co.uk/update

Helen Boreham is a freelance medical writer with an MSci in medicinal chemistry.

Reflect
What does Nice recommend for the treatment of CML? What are the side effects of anthracyclines? How are the side effects of chemotherapy such as sickness and nausea managed?

Plan
This article describes the treatment of the different types of leukaemia and includes information about cautions, contraindications and side effects of the drugs that are used. The management of side effects such as nausea and vomiting and sore mouth are also discussed.

Act
¥ Find out more about the side effects and contraindications of cytotoxic drugs from section 8.1 in the BNF.
¥ Read more about stem cell transplant on the Patient UK website at http://tinyurl.com/leukaemia04.
¥ Read the information about sore mouth and taste changes on the Cancer Research website at http://tinyurl.com/leukaemia05.
¥ The Cancer Research website also has some useful advice for patients suffering from nausea and vomiting at http://tinyurl.com/leukaemia06.

Evaluate
Are you now confident in your knowledge of the drugs used to treat leukaemia? Could you advise patients about how to cope with sore mouth and nausea and vomiting due to chemotherapy?

Useful further information
¥ Cancer Research UK www.cancerresearchuk.org
¥ Leukaemia and Lymphoma Research www.beatbloodcancers.org
¥ Leukaemia Care www.leukaemiacare.org.uk
¥ Children with Leukaemia www.leukaemia.org
¥ Children’s Cancer and Leukaemia Group (CCLG) www.cclg.org.uk

References
1. Duncan N. Adult myeloid leukaemias: current and future treatments. Clinical Pharmacist 2010; 2: 122-127.
2. Cancer Research UK www.cancerresearchuk.org
3. Nice Technology Appraisal: TA70 Leukaemia (Chronic Myeloid) – Imatinib: Guidance. Guidance on the use of imatinib for chronic myeloid leukaemia. October 2003. http://www.nice.org.uk/nicemedia/live/11516/32754/32754.pdf
4. Smith V. Chronic leukaemia – characteristics and treatment. Hospital Pharmacist 2003; 10: 110-116
5. Nice Technology Appraisal: TA29 Leukaemia (Lymphocytic) – Fludarabine: Guidance. Guidance on the use of fludarabine for B-cell chronic lymphocytic leukaemia. September 2001. http://www.nice.org.uk/nicemedia/live/11437/32238/32238.pdf
6. Nice Technology Appraisal: TA174 Leukaemia (Chronic Lymphocytic, First Line) – Rituximab: Guidance. Rituximab for the first-line treatment of chronic lymphocytic leukaemia. July 2009. http://www.nice.org.uk/nicemedia/live/11907/44906/44906.pdf
7. British National Formulary (BNF) 57
8. Macmillian Cancer Support http://www.macmillan.org.uk/Home.aspx

Opioid replacement therapy (ORT), most commonly with methadone, is one pharmacy service that is constantly under threat. The reason is obvious: the patients are drug misusers, and so are often vilified as symptomatic of societal problems.

An example is Project Prevention, a US group arriving in the UK that offers drug misusers cash incentives to use birth control or to get sterilised. I’m not even going to give that idea publicity.

This week battle lines were drawn up yet again, with a paper in the BMJ possibly tangling up the government in conflicting policies.

The government view on methadone is not a positive one. In April, Prime Minister David Cameron said opioid substitution therapy “does not deal with the problem” of drug misuse, stating “we must be mad as a country not to get people into that residential rehab”.

During the election I spoke to now-health secretary Andrew Lansley, who echoed Mr Cameron’s words. But a paper this week has come out in favour of longer term ORT in a big way. Using the UK General Practice Research Database, the BMJ study looked at 5,577 patients with 267,003 prescriptions for ORT, following them until one year after the expiry of their last prescription – a total of 17,732 years.

The study found that mortality rates for patients on ORT were around half those for patients not on the therapy – the crude mortality rates were 0.7 per 100 person-years and 1.3 per 100 person-years. respectively. There were peaks in mortality in the first weeks starting treatment, and in the first weeks of withdrawing treatment.

Overall, ORT was found to have more than an 85 per cent chance of reducing mortality if patients remain on treatment for more than a year.

For pharmacists, there is an important message: extra vigilance is needed when treating patients who are starting, or finishing, ORT.

The paper creates a conundrum for a government that has previously set out its stall in favour of residential rehabilitation (despite the cost). In its white paper consultation on outcomes, the Department of Health states a core principle as: “People should not die early where medical intervention could make a difference.” Opioid replacement therapy has shown it fits the bill.

I have noticed an increase in PCTs using legal sticks with which to beat 100-hour pharmacies. I have to be neutral about 100-hour pharmacies, because I have some clients who own them and others who object to them. But if PCTs are going to use the law, they had better get it right.

A number of PCTs have been trying to use powers under LPS regulations to designate an area in which they say they are interested in awarding a contract for local pharmaceutical services, then announce they will not consider any applications for contracts.

I suspect the motive is to avoid having to grant applications for 100-hour contracts. However, some of these designations are of dubious legality and I have successfully challenged some of them.

Then there’s Christmas opening. The NHS terms of service say that for the purpose of counting core hours, pharmacies are deemed to have been open on Christmas Day and bank holidays if they would ordinarily have been open on that day of the week. Bank holidays are defined in the Banking and Financial Dealings Act 1971.

In England, the definition includes December 26 – or December 27 if, like this year, December 26 falls on a Sunday.

So Boxing Day will not be a bank holiday this year. This could be a problem for pharmacies that ordinarily open on Sundays, if pharmacists want December 26 with their families, or because they want to give their staff that day off.

This is an issue for supermarket pharmacies that are normally open for 100 hours a week. It is obviously impractical to open a pharmacy within a store that is closed. However, some PCTs have shown little tolerance, insisting that in-store pharmacies should open, often without taking into account other pharmacies that are open.

At about 6pm on Christmas Day last year, my daughter received her secret code number for Tamiflu. My wife and I set off for the nearest open pharmacy. We rang ahead and the pharmacist, who was due to close, agreed to stay open till we got there. This year, I hope that instead of fixating on pharmacies that close at Christmas, PCTs will join me in paying tribute to the ones that open.

David Reissner is a specialist in pharmacy law and head of healthcare at Charles Russell LLP (www.charlesrussell.co.uk). Contact him on 0207 203 5065 or email david.reissner@charlesrussell.co.uk

With newspapers highlighting them, patients groups responding to them and local pharmaceutical committees (LPCs) scrutinising their every word, pharmaceutical needs assessments (PNAs) – although they may not sound like the most exciting reads – are difficult to ignore at the moment.

PCTs are at last starting to get to grips with the assessments and most either have, or are about to have, a version out for consultation. And with the deadline for having sign-off approaching in February 2011, and at least a two-month consultation period required before then, it’s probably about time they did.

But with the trusts on their way out under radical NHS reforms, pharmacists are right to ask just how much PNAs are going to matter in the future. Experts are unanimous in their response to this, however: they do matter, and you do need to look at them.

Simply put, the documents are going to be used as commissioning tools, identifying health needs so services can be planned around them, and industry leaders think for this reason they will always be useful.

Jonathan Mason, the Department of Health’s community pharmacy tsar, points out that, whatever the NHS looks like in future, needs assessments are always going to be an important function. It’s difficult to tell exactly how the documents will be used, but it’s possible GP consortia will need to consider them, for example. And as the documents are supposed to link to joint strategic needs assessments (JSNAs) produced with local authorities, they’re unlikely to be completely forgotten.

Furthermore, even if considering them isn’t vital in future, pharmacy could use them as evidence for services it would like to offer. As one PCT employee told C+D, the assessments provide real evidence-based documents showing the need for services: “Pharmacy has got a very powerful weapon here if they are used correctly – they can present these documents to commissioners as evidence for the need for services.”

Where they work, this should all bode well for pharmacy. And the good news is that C+D has found, using the Freedom of Information Act, that in the last 18 months 96 per cent of trusts have met with their LPCs to discuss the PNA (see p6), which must be a start at least. But multiples have told C+D the PNAs they have seen are not consistent, with some good and others “a mish-mash mosaic”
of information.

It’s clear where they are not good pharmacy needs to have a say – but how can you tell good from bad and what exactly should you look for when your PCT puts its PNA out for consultation?

If you can’t face reading the whole thing, the most important points to check are the ones about your own pharmacy, looking at whether they are accurate. For example, John Evans, superintendent pharmacist at Asda, says one PNA had commented that the nearest parking to an Asda pharmacy was over half a mile away, when in fact there were nearly 1,000 spaces in the store car park.

Errors or omissions can be dangerous. As Steve Lutener, head of regulation at PSNC, says: “If the PNA map of current providers does not show all pharmacy premises, then that could mean that the PCT has not taken into account services being provided by the pharmacy. If the public look at the PNA when they are seeking out services, then the ‘missing’ pharmacies could lose out.”

Furthermore, as PNAs may be used as the basis for entry to the sector in future, if it appears on the PNA that existing pharmacies are not meeting a need even if, in reality, they are, the trust could be obliged to allow new applications to succeed regardless of the existing businesses.

Things are tricky here as there is a delicate balance to be struck. On the one hand it could be good for the PNAs to identify gaps in service provision, giving scope for new services and possibly pharmacies, but on the other, these gaps need to be genuine or competition may become unsustainable. PSNC is urging contractors to look at the documents and where necessary align their offering to the needs identified, and multiples have told C+D this is their strategy.

This can be a useful business planning exercise to ensure you are really meeting your patients’ needs, and means you can respond to the consultation explaining your willingness to provide services in the future.

If you’re struggling, try contacting your LPC for help with a PNA. Mr Mason says you could also compare the assessments with JSNAs to ensure no key health needs have been missed. Colleagues and other local contractors may also be willing to discuss the document with you.

But, however you do it, you should take the time to respond to the consultation. As Mr Mason says: “Pharmacists should be reading what is in there and if they’re happy with it they can just say so. If they feel there are statements relating to their pharmacy that are wrong or questionable, it’s very important that they do respond.”

And with the deadlines looming, it’s probably now or never for the documents that may very well shape the sector’s future.

As a former health secretary warns the NHS white paper is simply the outer edge of a jigsaw puzzle, Hannah Flynn hears how pharmacy could help fill the middle

Far from being a complete plan for the future NHS, Andrew Lansley’s health white paper simply provides the outer border of the jigsaw puzzle, according to former secretary of state Alan Milburn. Speaking at the C+D Conference at the Pharmacy Show in Birmingham on Monday, Mr Milburn called the paper a “sketch”, and he urged pharmacy to help complete the picture.

“Pharmacy is the most cost-effective provider of primary care services, and the government will ask,

‘How do we get more outcome for lower cost?’. That is what Andrew Lansley’s white paper is all about,” Mr Milburn said. But he warned pharmacy against waiting for the current health minister to hand the sector its future on a plate.

Other speakers at the C+D Conference agreed the white paper offered pharmacy many opportunities, but warned the sector needed to grasp these. Many called for a more united voice from leadership bodies to outline to politicians where pharmacy should fit into the NHS, for example.

Chief executive of the Royal Pharmaceutical Society (RPS) Helen Gordon agreed the NHS reforms could offer many prospects for pharmacy as a low-cost healthcare provider. However, she expressed concerns that an outcome-based framework as outlined in the paper might prove to be unworkable for the sector.

Ms Gordon said: “The new reward systems focus on outcomes for patients and quality, and it is a welcome change. But this is hard to measure in healthcare as all of us work in systems where many people can have an influence on outcomes. We don’t have the metrics to measure this.”

Ms Gordon said a meaningful outcomes base was needed, and her view was echoed by director of pharmacy at Lloydspharmacy Andy Murdock (pictured). Mr Murdock invited anyone to let him know about pharmacy interventions that had meaningful outcome measures, warning: “The outcome-based framework will be very hard to measure. We only have measurements for asthma and COPD.”

Mr Murdock also expressed concerns about pharmacy’s ability to influence crucial factors in the NHS framework, saying they had already been decided. “We are not in consultation, the train has already gone. The PCTs have been disbanded and we are unsure about what services they will still be offering by Christmas,” he said.

Clearly, pharmacy will need a strong lobby in order to have an influence in the coming times of severe financial restraint. But Mr Murdock said he felt the sector could survive the changes, although it would need to change significantly over the next couple of years.

Commissioning will be high on the agenda, as GP consortia gear up to take over the role from health trusts, and pharmacy will need to ensure it has some influence.

As a multiple, Lloydspharmacy had the wherewithal to approach commissioners directly, Mr Murdock said, but other groups, including wholesalers and LPCs, could also help.

Concerns regarding commissioning were raised repeatedly at the C+D Conference, and it is clear there is no guarantee that pharmacy will see any of the money given to GP consortia. Director for clinical commissioning at NHS Alliance Julie Wood said she was aware of the concerns pharmacists had over the future of NHS commissioning. And she agreed that currently the future of commissioning was a blank slate.

Some influence could come from the national NHS Commissioning Board, as Ms Wood pointed out: “If consortia have to do all commissioning they will be weighed down with a millstone.”

But there will still need to be local flexibility. For example, considering how a new pharmacy contract might work, Ms Wood said: “It will be a disaster if consortia up and down the country draw up their own contracts. But the new contract needs to be able to be tweaked. My concern would be that it won’t be able to be tweaked and will be centrally driven.”

One of the biggest uncertainties, she pointed out, is that the future structure of the NHS Commissioning Board is not yet decided. Whether this will exist purely on a national level or have local offices is not yet known. This will, of course, have a significant effect on how LPCs and pharmacists will operate going forward.

If local offices do exist, LPCs might be able to coalesce around them, for example.

As Mr Murdock told conference attendees: “LPCs could help, but not LPCs as we know them.”

And while the future for LPCs is unclear, the same is true for everyone in pharmacy – from the representative bodies, to individual pharmacists at the coal face. There may be many informed guesses, but exactly how all of these changes will develop is clearly still up for debate.

Why is lithium treatment difficult?
Lithium has a narrow therapeutic range. Its target levels are 0.4-1.0mmol/l, with the lower end required in older patients and for maintenance therapy. Toxicity is seen above 1.5mmol/l, and plasma levels over 2.0mmol/l can be fatal. Medicines adherence is low, and the drug can take a year to have a prophylactic effect.

What are the side effects?
Common effects experienced when the drug is used within its therapeutic range include thirst, increased urination and weight gain.

Less common side effects include: blurred vision, slight muscle weakness, occasional diarrhoea, fine hand tremor, feeling ‘a bit ill’. These side effects can indicate that the dose is too high.

Missed doses
If a dose is missed by less than three hours, it should be taken as normal. If missed by more than three hours, the dose should be omitted.

Lithium is most commonly used in bipolar disorder, but also in depression, premenstrual tension and unlicensed in cluster headache prophylaxis.1 It was the first effective mood stabiliser, with its antimanic properties first discovered in 1949.2 Despite over 50 years of use, the mechanism of action is still not fully understood.3

As lithium resembles sodium in excitable tissues, it penetrates them via fast voltage-sensitive channels responsible for action potential generation. It is not pumped out to the same degree as sodium and therefore accumulates inside these cells to a greater extent, resulting in partial intracellular potassium loss and partial cell depolarisation.4

Lithium acts selectively in the brain and kidney.4 Acutely, lithium appears to increase brain noradrenaline and serotonin turnover, but inhibit its release on cell depolarisation by noradrenaline-sensitive adenylyl cyclase inhibition, which may produce its antidepressant and antimanic effects.5 It also affects various second-messenger system enzymes, the most well-documented being inositol phosphates.

Its long-term mechanism of action may be due to its alteration of protein kinase C-mediated signalling, changing gene expression and protein production implicated in long-term neuroplastic events.5

Treatment
Lithium is used for the acute and prophylactic treatment of bipolar disorder. It is also used to augment unipolar depression treatment after failed antidepressant therapy, or for prophylaxis of unipolar depression. Lithium has slower onset of action than valproate or other antipsychotics7 and can take six to 12 months for a full prophylactic effect to occur. Acutely ill patients, however, usually respond within three to seven days.

Long-term pharmacological treatment usually lasts for at least two years after an episode of bipolar disorder, or up to five years if there are risk factors for relapse.10 There is a high rate of non-compliance (18-53 per cent) with reasons including side effects, dislike of taking mood-controlling medication and being identified as having a chronic illness.6 However, it has been shown that lithium therapy reduces overall relapse risk by 30-40 per cent,3 so it is important that patients continue treatment.

Lithium has a narrow therapeutic range. Its target levels are 0.4-1.0mmol/l, with the lower end required in older patients and for maintenance therapy. Toxicity is seen above 1.5mmol/l, and plasma levels over 2.0mmol/l can be fatal and require urgent treatment.

Nice states a target of 0.6-0.8mmol/l should be aimed for in long-term treatment, although a range of 0.8-1.0mmol/l may be of benefit in patients with predominiantly manic symptoms, and those who have previously relapsed while on lithium.10

Patients are usually started on a dose of 750-1,000mg daily in divided doses, which is then titrated to the appropriate concentration.6 The maintenance dose is usually 200-400mg (carbonate salt), which is taken at night.9 Brands are not bioequivalent (see table 2), so must be brand prescribed.

Lithium should usually be reduced over at least four weeks10 as studies have shown 50 per cent of patients relapse, mostly into mania rather than depression, within five months of rapid discontinuation.6 There does not appear to be evidence of rebound psychosis or withdrawal syndrome. If a dose is missed by less than three hours, it should be taken as normal. If missed by more than three hours, the dose should be omitted and the next taken as normal.11

Side effects
Side effects can start in the first few weeks of treatment, but often reduce with time. Common effects experienced when the drug is used within its therapeutic range include thirst, increased urination and weight gain.

Less common side effects include blurred vision, slight muscle weakness, occasional diarrhoea, fine hand tremor and feeling ‘a bit ill’.

These side effects can indicate that the dose is too high and should be reduced.
Patients should seek urgent medical attention if any side effect becomes more pronounced, or if the patient becomes muddled or confused, as this indicates plasma levels are too high.7

Lithium inhibits T3 and T4 secretion, and can result in hyper- and hypothyroidism. Other side effects include ECG changes; a diabetes insipidus-like syndrome; reduction in bone calcium;8 skin rashes; a metallic taste. Mild cognitive and memory impairment can also occur.

Lithium increases foetal malformation risk, with the risk greatest in the first trimester, but it has been deemed safe after 26 weeks and is safer than other mood stabilisers.3 It is contraindicated in breastfeeding. See table 1 for a list of possible drug interactions.

Pharmacokinetic profile

* Has a plasma halflife of eight to 55 hours6 (which is increased in older patients and patients with reduced renal function). The halflife is around 24 hours for most patients.
* Takes five to seven days to reach steady state.
* Is readily absorbed from the gastrointestinal tract and distributed through the body over several hours.
* Is almost exclusively excreted by the kidneys, but also in sweat and saliva.
¥ Is not plasma protein bound.
* Crosses the placenta.
* Is excreted in breast milk.

Monitoring
Plasma levels should be measured one week after initiation and one week after every dose change until levels are stable, then every three months,10 with blood taken 12 hours after the last dose.

Patients must also undergo general and specific monitoring to ensure safe treatment (see table 3) and because bipolar patients have a higher morbidity rate than the general population.

Early features of overdose are non-specific, such as apathy and restlessness, and can be confused with mental health changes due to depression. Tremor, twitching, vomiting, weakness and ataxia can follow. Severe poisoning is associated with electrolyte changes, dehydration, convulsions, coma and renal failure.

Concentrations over 2.0mmol/l are associated with serious toxicity, requiring haemodialysis if renal failure or neurological symptoms are present.

Overdose
Deliberate acute overdose may not manifest until more than 12 hours after the medicine has been taken due to slow entry of lithium into the tissues, or staggered absorption with modified release preparations.1 An overdose can result in higher concentrations without toxicity features. Increasing urine output by increasing fluid intake should resolve the overdose;1 diuretics should never be used. Gastric lavage can be considered if the patient presents within one hour of acute ingestion.

Supportive treatment, with special attention to electrolyte balance, renal function and controlling convulsions, is required in patients who have taken an overdose. Serum lithium should be monitored for at least seven days as a rebound rise is possible due to delayed tissue release.12

The National Patient Safety Agency released an alert ‘Safer lithium therapy’ in December 2009, detailing the steps required by all involved in lithium treatment to help ensure patient safety. The report’s recommendations must be implemented by December 2010.

The main points for action are:

* monitoring should be according to Nice Guidance 38
* systems must be in place to ensure blood test results are communicated between laboratories and prescribers
* patients must receive verbal and written information throughout treatment
* patients must receive a record book to record lithium levels and other clinical test results
* prescribers and pharmacists must check that bloods tests have been carried out and it is safe to issue/dispense medications
* systems must be in place to deal with medication interactions.

Pharmacists should ask patients about their last lithium blood test and results. If unavailable, medication should not be withheld (unless clinically necessary), but the prescriber should be informed the medication was supplied without blood test data being available.9

Lifestyle advice
* Drink plenty of water or other unsweetened drinks, increasing in hot weather or when active.
* Maintain a stable intake of caffeinated drinks (increasing such drinks results in increased urination and reduced lithium blood levels).3
* Eat a balanced diet.
* Do not abruptly change the amount of salt in the diet – a low salt diet will increase lithium levels.
* Eat regularly.
* Drink alcohol as per national guidelines.
* Exercise as per current guidelines.
* Learn to recognise signs of mood changes and have plans in place to avoid full-scale change.
* Avoid stressful situations that can trigger manic or depressive episodes, or at least learn how to deal with them to help prevent this occurring.
* Try to have someone to confide in and maybe give a list of signs/symptoms to alert others to impending mood changes.
* Make time to relax.
* Keep occupied – activity planning can help.

Rosemary Blackie MRPharmS is a community pharmacist in Sheffield.

Reflect
What are the most common side effects of lithium? Which drugs can increase lithium levels? Why is it important for those taking lithium to maintain a stable intake of caffeinated drinks?

Plan
This article discusses the drug lithium and includes information about its action, side effects and the monitoring of patients who are taking it. It also describes interactions with other drugs, overdose, the NPSA safer lithium therapy alert and lifestyle advice for patients.

Act

• Find out more about lithium from the Clinical Knowledge Summaries website at http://tinyurl.com/lithium01.
• Update your knowledge of bipolar disorder from the Royal College of Psychiatrists website at http://tinyurl.com/lithium02.
• Read more about lithium overdose on the MHRA website at http://tinyurl.com/lithium03.
• Revise your knowledge of the NPSA safer lithium therapy alert by reading the information on the NPSA website and the standard operating procedure for supplying lithium at http://tinyurl.com/lithium04.

Evaluate
Are you now confident in you knowledge of lithium and its side effects and interactions? Are you familiar with the safer lithium therapy guide? Could you advise patients about lithium therapy?

References

1. British National Formulary Number 58 September 2009
2. Lithium Patient UK www.tinyurls.co.uk/W7778
3. Bipolar Disorder (manic depression) The Royal College of Psychiatrists  www.tinyurls.co.uk/P7779 accessed July 2010
4. Pharmacology Chapter 29 Dugs used in affective disorders Rang, Dale and Ritter Third Edition
5. Basic and Clinical Pharmacology 11th Edition (2009) Chapter 29 Antipsychotic Agents and Lithium Herbert Meltzer www.tinyurls.co.uk/L7780 accessed via the RPSGB online full text books
6. Therapeutic drug monitoring of psychotropic medications British Journal of Clinical Pharmacology,49, 303-312
7. Understanding Bipolar Disorder Pharmaceutical Journal April 2010 www.tinyurls.co.uk/H7781
8. Lithium GP Notebook www.tinyurls.co.uk/U7782
9. Patient Safety Alert NPSA 2009/PSA005 Safer Lithium Therapy Supporting Information NPSA December 2009
10. Bipolar Disorder Nice Guideline 38 Quick reference guide July 2006
11. Making Sense of Lithium and Other Mood Stabilisers MIND www.tinyurls.co.uk/V7783 12. Camcolit SPC
13. Priadel SPC
14. Li-Liquid SPC
15. Liskonium SPC

Patient support

There are many sources of information and support, including:

• The Royal College of Psychiatry www.rcpsych.ac.uk
• MIND www.mind.org.uk
• MDF-Thewww.mdf.org.uk Bipolar Organisation

Further resources

1. The Royal College of Psychiatry www.rcpsych.ac.uk
2. Clinical Knowledge Summaries www.cks.nhs.uk/bipolar_disorder#
3. NPSA Safer Lithium www.nrls.npsa.nhs.uk/resources/?entryid45=65426
4. Nice Guideline 38 http://guidance.nice.org.uk/CG38
5. Patient UK www.patient.co.uk/doctor/Bipolar-and-Manic-Depression.htm

Codeine supplied OTC is a continuing issue for pharmacists. This year new rules were introduced to reduce the risk of addiction in pain relief, and in 2007 the MHRA issued a warning about the use of codeine-containing medicines in breastfeeding.

Now the MHRA has continued the codeine crackdown, advising linctus that contains codeine is not suitable for dry cough in those under 18 years.

The reasons for the decision seem to be legion, but high up on the list is the big question mark over whether the products work for this indication.

Recent evidence looking at codeine, pholcodine and dextromethorphan has been conflicting, with most trials rating the antitussives as little or no better than placebo. The MHRA puts the lack of efficacy at the top of its list of reasons for the advice, pointing out that dry coughs are generally self-limiting and rarely harmful.

Another key factor in the decision are safety concerns due to its central mode of action. Codeine is converted into morphine by the cytochrome P450 CYP2D6, but this has substantial variation of expression in individuals, which means different patients can get substantially different levels of morphine.

Finally, the MHRA expresses concern about accidental ingestion of OTC liquid codeine, and has advised all liquid codeine medicines should be packaged in child-resistant containers by June 2012.

Fortunately, the new recommendations should have little impact in immediate practice. Products containing dextromethorphan, the most widely used opioid in OTC cough remedies, are not affected by the advice – probably because of its lack of side effects compared with codeine (which can cause sedation, constipation and addiction).

The MHRA advises the affected products, such as Codeine Linctus BP, do not need to be removed from shelves. Instead, pharmacists are urged to consider the new advice when advising on cough medicines, and consider alternative treatments in households with children present.

While not enshrined in regulation, the advice seems to herald the end for codeine products in anything other than short-term pain relief.

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The fact that pharmacy enhanced services are offered to contractors on a postcode lottery basis comes as no real surprise. But while we would expect appalling figures from the underperforming trusts, whittle things down to the average PCT and the figures are still upsetting – they are spending just under £5,000 per year annually on enhanced services at each pharmacy.

Pharmacy financial experts agree this is simply not good enough given the investment required to offer services, often in terms of both training and equipment.

Umesh Modi, partner at accountancy firm Silver Levene, says many pharmacies will be losing money and businesses that have taken on extra pharmacists to provide services will be hit especially hard.

“A day per week of a second pharmacist costs around £10,000 [annually], not to mention the cost of management time and extra floor space allocated to provide such services. I would estimate that the total additional cost per annum is £20,000, so the pharmacist would need around £30,000 of services income to make it worthwhile,” Mr Modi adds.

Andy Harwood, director of business development at pharmacy finance company Pharmacy Partners, agrees: “Pharmacists have spent money on consultation rooms and how many of those are being used all the time for services?”

He says consultation rooms could cost between £6,000 and £8,000 to install, so for some the investment just will not have been worth it.

Further pressures are coming from recently announced category M hits, and Mr Harwood says as money is being taken out of drug reimbursement it is disappointing not to see trusts putting that back into community pharmacy. He asks: “Where are pharmacists supposed to make up the difference?”

Mimi Lau, Numark’s director of professional services, agrees: “What we signed up to in the contract was that a category M mechanism would put money back into services, but looking at these figures some contractors are benefiting from this and some aren’t. This is unfair.”

Even where services are being offered, there is concern about ongoing funding. Mandeep Mudhar, head of NHS development at the Co-operative Pharmacy, says where services do exist the challenge is always “securing the continuing provision and funding”.

“We could put a lot of time and investment into the service in terms of pharmacist training and development, but we need to ensure there is longevity in those services,” he warns.

Pilots can be a particular frustration. As Salim Jetha, CEO at buying group Avicenna, says: “We seem to spend a hell of a lot of money doing trials – if other PCTs have done similar work, use their data and come to a speedy conclusion.”

But aside from sharing data, where do we go from here?

The answer must come from nationally agreed enhanced services, experts and pharmacy bodies agree. National services would mean fairer pay and could mean that all pharmacies can deliver the services, eliminating another spending problem.

As Mr Jetha points out: “Within each PCT, services are only offered to a handful of contractors and not to all willing providers. In some cases it’s the same few, merely because they open longer hours. I believe all patients have rights to services and that they should be available to all contractors.”

To get this resolution, all eyes have turned to PSNC. Ms Lau says the committee and the Department of Health must make it a priority to address this, and Mr Harwood says that, while clinical services were presented some time ago as “PSNC’s big idea”, things have not developed adequately in the real world.

“Ultimately PSNC needs to push for this – they pushed for this contract and we’re not getting anywhere near what we should be from it,” he says.

PSNC’s head of NHS services Alastair Buxton says such national funding is very much on the committee’s agenda. And indeed negotiations on some, such as a first prescription service for patients with long-term conditions, are ongoing. But Mr Buxton warns the challenge is great, especially given how small enhanced service income is relative to overall turnover at the moment.

“There’s got to be a huge change to move to a position where enhanced services form a substantial amount of funding and give significant financial incentives,” he says.

It seems things are moving in the right direction, at least, but timeliness could also be vital, as NHS changes to commissioning could cause further problems. As James Lindsay, head of corporate relations at AAH, says: “There is also the risk that [some] schemes could fall victim to budget cuts or inaction as PCTs transition their responsibilities to GP-led consortia.”

So contractors and the rest of the sector will have to hope some agreements on national services are reached sooner rather than later.

The dilemma
You are a pharmacist prescriber who runs a clinic for a local surgery, specialising in respiratory medicine. You carry out an annual review of a patient’s condition, and you have access to their medical notes so are aware of their co-morbidities and regular repeat medication. At the end of a consultation, as you are busy writing out the relevant prescription, the patient asks: “While I’m here, could you just prescribe me some of my water tablets?” The patient has been on furosemide 40mg OD for several months. What do you do?

The RPSGB advises that all pharmacist prescribers, whether supplementary or independent, must prescribe within their competencies and only medication appropriate for the patient.

You know the patient is already being prescribed the requested item by a GP, but it is for a condition you do not normally deal with.

Patients can put pressure on pharmacists and it would be easy to cave in. However, it is your signature on the prescription and you would be held to be legally responsible if anything were to go wrong – even if the item is normally prescribed by a GP. It would be difficult to defend your actions in a court of law if you could not demonstrate your expertise in a particular area.

In Scotland, pharmacists are able to prescribe on a community pharmacy urgent supply (CPUS) prescription any repeat medication that a patient gets for their usual quantity (generally up to two to three months), as long as the patient is registered with a Scottish GP. If the patient is from elsewhere in the UK, pharmacists have to make an emergency supply, as in England and Wales, and can only give up to 30 days plus levy a charge for the medication.

If the patient asks for something that I would normally be comfortable selling to them over the counter, such as emollients, antihistamines, or laxatives, I would not have a problem issuing them with their normal prescription. However, if they were asking for their usual medication for a more serious condition, such as heart failure or epilepsy, I would have to refuse as I do not have expertise in those areas.

Valerie Sillito is an independent prescriber working in the community for Alliance Boots in Aberdeen

What the law says
The July 2010 edition of the Society’s Medicines, Ethics and Practice (which will be replaced by a new code on September 27 when the General Pharmaceutical Council [GPhC] takes over pharmacist regulation) provides that “Pharmacist independent prescribers can prescribe any medicine (licensed or unlicensed) with the exception of controlled drugs for any clinical condition, but they must only prescribe within their professional and clinical competence”, and it is difficult to imagine that the GPhC will adopt a different approach.

Since a breach of the code of ethics may be evidence of misconduct, any pharmacist prescribing that falls outside of the pharmacist’s “professional and clinical competence” could lead to an investigation by the GPhC.

There could be other consequences of prescribing errors. For example, if a patient falls ill as a result of a prescription written by a pharmacist then, like a doctor, that pharmacist could be the subject of a claim for damages. If a patient were to die as a result of a prescription written by a pharmacist, that pharmacist could be investigated by the police for manslaughter.

In conclusion, given the consequences of an error, care should always be taken when prescribing. The pharmacist in this scenario (who refused to prescribe the item despite pressure from the patient) is adopting the wisest course of action.

Noel Wardle is a solicitor at Charles Russell LLP, specialists in pharmacy law

Tips for your CPD entry on prescribing ethics
Reflect What are your areas of clinical competence when prescribing?

Plan Consider what you would do if a patient asks you to prescribe.

Act Roleplay the consultation with a colleague to practise your skills.

Evaluate Are you confident in refusing a request to prescribe?