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With a significant number of H M Revenue & Customs enquiries focusing on business expenses, this is an important area and one where it is easy to make mistakes. We look below at the most common types of business expenses and at what is, and is not, allowable for tax purposes.

The general rules

There are two basic rules. Firstly, in computing trading profits, no deduction is allowed for items of a capital nature and similarly capital receipts are not taxable.

So when buying items for on-going use in a business – a computer, say, or a car – the full cost is not automatically deducted from profits; instead, capital allowances are claimed, although the effect of the 100% Annual Investment Allowance (AIA) – of which more below – is that for many businesses the full cost of capital expenditure is deducted in the year it is incurred.

 

Secondly, in order for an expense to be deductible, it must have been incurred “wholly and exclusively for the purposes of the trade”. Expenses which have a dual purpose – trade and non-trade – are not deductible, although HMRC will allow the business proportion of an expense, where such a proportion can be defined.

Specific expenses

Travel and subsistence: The cost of travelling in the course of the business is allowable but not that of travelling between home and the place of business. The “dual purpose” rule means that where there is a material private element, the whole expense of a trip will be disallowed, even the part attributable to business purposes. Thus, no part of expenses incurred in travelling abroad partly for a holiday and partly on business is allowable.

The above rule also requires the disallowance of costs of food, drink and accommodation.  However, a deduction is allowed for any reasonable expenses incurred on food or drink by a individual either at, or travelling to, a place in the course of carrying on the trade, but only if two conditions are met:

• that a deduction is available for the associated travelling costs; and
• that either:

o   at the time the expenses on food and drink are incurred, the trade is itinerant; or

o   the trader does not visit the place more than occasionally in the course of the trade and the travel is not part of a normal pattern

Hotel accommodation is deductible where a business trip necessitates one or more nights away from home (and away from the business base).

Motor expenses: individuals can claim their actual business motoring costs in their accounts and in practice HMRC will generally agree a business-use proportion of total motor costs, based on mileage records; alternatively, taxpayers with a turnover not exceeding the VAT registration threshold (currently £70,000) at the time they first use the vehicle, may instead use the statutory tax-free mileage rates applicable to employees to arrive at an allowable amount. In that case, no other motoring expenses or related capital allowances may be claimed (other than interest on a loan to purchase the vehicle).

Entertaining: entertaining expenses are not allowable, except where provided for the trader’s employees.

Legal and professional costs: legal and professional costs associated with the taxpayer’s trade are broadly allowable, but following the general rule above, any such costs associated with capital items are not allowable against trading profits; where the item is a chargeable asset, e.g. property, related legal/professional costs may be claimed against the gain arising on its eventual disposal.

Use of home as office: if an individual uses part of his home for business purposes a proportion of the household expenses may be deducted in computing taxable profits, based on the usage of the property. In practice, where there is only small use of the home, HMRC will often agree a small flat-rate allowance for this purpose.

A point to note is that the exemption from capital gains tax for a gain arising on the sale of an individual’s home me be affected if a claim is made that a part of the property is used exclusively for business purposes.

Repairs & renewals: following the rule on capital expenditure, the cost of repairs and renewals are broadly allowable but the cost of enhancements or improvements are considered to be capital in nature.

Depreciation: although a business can chose the rate at which to depreciate its assets, any depreciation charged in the accounts will be excluded for tax purposes and replaced by capital allowances calculated at statutory rates.

For the current tax year, the AIA is £100,000, so 100% of capital expenditure of up to that amount can be deducted against profits. Where capital expenditure exceeds £100,000, the balance attracts capital allowances of either 20% or 10% on a reducing balance, depending on the type of asset.

Cars (purchased after April 2009), where expenditure is not covered by the AIA, attract capital allowances at 100% (where emissions do not exceed 110g/km) or 20% (where emissions are 110 – 160g/km) or 10% (where emissions exceed 160g/km).

Krystyna Knight, of Silver Levene provided research for this article.

Disclaimer

Umesh Modi BA ACA, is a Chartered Accountant and Tax Advisor, and a partner at Silver Levene (Incorporating Modiplus+). He can be contacted on 020 7383 3200 or umesh.modi@silverlevene.co.uk

What is non-alcoholic fatty liver disease?
Non-alcoholic fatty liver disease is defined as liver fat >5 per cent in the absence of other identifiable causes. It is the most common cause of chronic liver damage in western countries and around 70 per cent of patients with type 2 diabetes have fatty livers.

Why is it a problem?
It increases the risk of non-alcoholic steatohepatitis and hepatocellular carcinoma (HCC). It can cause cirrhosis, and doubles the risk of both chronic kidney disease and cardiovascular disease.

What should pharmacists do to help?
Reducing visceral fat seems to be a particularly important intervention, as it is a strong risk factor for hepatic steatosis, inflammation and fibrosis. In patients with diabetes, statins may reduce HCC risk by 25-40 per cent.

Case Study
The effects of a fatty liver Patricia is a 46-year-old call-centre worker with a BMI of 30.7kg/m2, dyslipidaemia and a three-year history of type 2 diabetes. She’s receiving vildagliptin and simvastatin. Before starting vildagliptin, her liver enzyme levels were within the normal reference range.

Patricia tells you that she feels fatigued and weak, and reports that she’s beginning to lose weight. She wants to buy a tonic to give her a boost, and an OTC sleeping aid. Patricia thinks that her fatigue and weakness result from tiredness brought on by sleepless nights spent worrying about her financial problems and working overtime. After noting that her HbA1c control has declined in recent months, you refer her to her GP, who asks the diabetic clinic for a review.

Biopsy reveals that Patricia’s liver contains fat deposits and fibrosis. The hepatologist diagnoses non-alcoholic steatohepatitis.

A year later, Patricia presents to her GP with fluid retention and gastrointestinal bleeding, leading to the diagnosis of cirrhosis. She dies six years later from hepatocellular carcinoma.

Diabetes causes numerous well-known complications, including chronic kidney disease (CKD), heart disease and retinopathy. However, the increased risk of liver diseases such as non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC) with diabetes is less well known.¹

Nevertheless, diabetes-related liver disease can prove fatal (NASH can cause a 10-fold rise in the risk of liver cancer),² increase the risk of developing ‘classic’ complications including retinopathy, and influence treatment choice.

Diabetes-related liver disease
Non-alcoholic fatty liver disease (NAFLD) is defined as liver fat >5 per cent in the absence of other identifiable causes such as alcohol abuse, viral hepatitis or certain medications including corticosteroids and oestrogen.¹ It is the most common cause of chronic liver damage in western countries.

Obese people and those with insulin resistance or diabetes are especially vulnerable to NAFLD.³ Indeed, around 70 per cent of patients with type 2 diabetes have fatty livers and NAFLD tends to be particularly aggressive in people with diabetes. Nevertheless, most diabetic NAFLD patients have normal liver transaminase levels.¹

Although fatty liver has traditionally been considered relatively benign,⁴ 20-30 per cent of people with NAFLD develop NASH.³ This is characterised by chronic necrosis, inflammation and, in many patients, fibrosis.¹

NASH can progress to cirrhosis, fatal liver failure and HCC.³ Around one in 200 NASH patients develop HCC within seven years.⁴

Despite these risks, healthcare professionals often overlook people with significant NASH due to the condition’s long, indolent clinical course.⁵ NASH causes few symptoms, there are few sensitive, non-invasive diagnostic tests, and liver function tests are often normal.¹

Fatty livers are both a cause and consequence of diabetes. Cirrhosis, for example, can cause diabetes,⁶ while diabetes increases mortality among patients with cirrhosis.⁷

Around 30 per cent of cirrhosis patients have concurrent diabetes.
Furthermore, more than 40 per cent and 17 per cent of patients with chronic hepatitis C infections show glucose intolerance and diabetes respectively, while 30-70 per cent have fatty livers.

Indeed, hepatitis C’s core protein can induce insulin resistance, steatosis (fatty liver) and diabetes.⁷

On the other hand, steatosis predisposes to diabetes. Scores on the Fatty Liver Index (FLI) range from 0 to 100 and are equivalent to the percentage chance of having a fatty liver.

Among people who do not drink excessive amounts of alcohol, after adjusting for potential confounding factors, a FLI >70 increases the risk of developing diabetes over the next nine years five-fold in men and more than 20-fold in women compared with those with a FLI <20.³

 

Consequences
Despite a relatively benign reputation,⁴ NAFLD is associated with considerable morbidity and mortality. For example, after adjusting for age and sex, patients with type 2 diabetes and NAFLD are more likely to develop non-proliferative or proliferative retinopathy and CKD than those without NAFLD. Indeed, NAFLD doubles the risk of developing CKD and proliferative retinopathy independently of other factors such as BMI, waist circumference, hypertension, diabetes duration, HbA1c and medication.⁸

After adjusting for confounders, NAFLD also roughly doubles cardiovascular disease (CVD) risk in patients with type 2 diabetes.⁹ Adjusting for
the metabolic syndrome (which also increases NAFLD risk5) reduces the strength of the association, but the risk arising from NAFLD is 50 per cent higher than among patients with type 2 diabetes alone.⁹

As mentioned above, NASH can progress to cirrhosis and cancer. Fibrosis progresses in 26-37 per cent of NASH patients, while up to 9 per cent develop cirrhosis within around five years. Another 18-29 per cent of NASH patients show improved histology, with the disease remained stable in the remainder.

BMI and diabetes increase the risk that fibrosis will progress and 4-27 per cent of cases of NASH eventually transform into HCC. Diabetes increases HCC risk between 1.86-fold and four-fold.⁵

Implications for pharmacists
Detecting and treating NAFLD presents problems. For example, NASH often produces few or no symptoms, especially during the early stages. Patients with advanced NASH or cirrhosis may report fatigue, weight loss and weakness.

Cirrhosis can also cause fluid retention, muscle wasting, gastrointestinal bleeding and liver failure.10 Elevations in liver tests, such as alanine aminotransferase (ALT) or aspartate aminotransferase (AST), may raise a suspicion of NASH.¹⁰ However, NASH may also develop without altering liver transaminases.

Currently, a liver biopsy is necessary for a definitive diagnosis, although new imaging methods and biomarkers may reduce the need for invasive procedures in the future.¹

As around 70 per cent of type 2 diabetes patients show fatty livers,¹ it may be reasonable to assume that a patient has NAFLD until proven otherwise. Pharmacists could suggest that patients raise the issue with their diabetologist or GP.

Currently, there are no proven treatments for NASH and lifestyle modification remains the gold-standard approach to management.¹ However, some interventions already used to treat obesity and type 2 diabetes may help.

For example, in people with NAFLD or NASH, weight-loss decreases hepatic steatosis and liver transaminases, as well as modestly improving necrosis, inflammation and fibrosis.

Reducing visceral fat seems to be a particularly important intervention, as it is a strong risk factor for hepatic steatosis, inflammation and fibrosis.¹ While agents such as orlistat help reduce BMI, they seem to have no additional benefit in NAFLD or NASH compared to weight loss alone.¹ Many obese people and those with type 2 diabetes take statins as primary or secondary prevention. In patients with diabetes, statins may reduce HCC risk by 25-40 per cent. Future studies are needed to confirm these results.⁵

Some oral antihyperglycaemic drugs may improve NASH, including dipeptidyl peptidase-4 (DPP-4) inhibitors. DPP-4 inactivates glucagon-like peptide-1 (GLP-1), which stimulates insulin secretion and inhibits glucagon production.

So, blocking GLP-1 improves glycaemic control. However, DPP-4 metabolises several other substrates, including several chemokines implicated in NASH pathogenesis.

DPP-4 may also mediate fibrogenesis. Indeed, NASH patients show increased levels of serum DPP-4 compared to controls.

Furthermore, DPP-4 levels in the liver correlates positively with the severity of hepatic steatosis. Animal studies suggest that linagliptin, a DPP-4 inhibitor currently in phase III trials, reduces hepatic fat accumulation.⁴

Finally, hepatic disease can also influence the choice of antihyperglycaemic drug. For example, patients with hepatic impairment – including pre-treatment ALT or AST greater than three times the upper limit of normal (ULN) – should not receive vildagliptin¹¹ or Eucreas (vildagliptin and metformin). Pharmacists need to be familiar with hepatic restrictions on drugs taken by type 2 diabetes patients.

Liver disease is both a cause and consequence of diabetes. NASH, for example, markedly increases the risk of complications, including CKD, retinopathy and HCC. Early detection and treatment is important to try to interrupt progression,¹ although many patients are asymptomatic and liver enzymes may be normal.

Weight loss and several drugs used in type 2 diabetes management may attenuate the risk, although more research is needed. Pharmacists also need to remain cognisant of the impact of liver impairment on treatment choice.

Liver diseases are an under-appreciated complication of diabetes and obesity, but healthcare professionals should not underestimate their influence on morbidity and mortality.

Mark Greener, a former research pharmacologist, is a freelance writer on health-related issues.

Non-alcoholic fatty liver disease – what you need to do

 

Non-alcoholic fatty liver disease (NAFLD)
NAFLD is indicated by more than 5 per cent liver fat in the absence of other identifiable causes. Due to its high prevalence, NAFLD should always be suspected in patients with type 2 diabetes. Patients should be advised to discuss the condition with their GP or diabetes specialist, as it increases the risk of several complications.

 

Non-alcoholic steatohepatitis (NASH)
Characterised by fat in the liver along with inflammation and damage, NASH often has few symptoms. It may be indicated by elevated liver test readings, but this is not guaranteed. There are no confirmed treatments for NASH, and patients should be given lifestyle advice, focusing on reducing visceral fat. Drugs such as orlistat have shown no additional benefit in treating the condition compared with weight loss alone.

 

Hepatocellular carcinoma (HCC)
The majority of liver cancers are caused by HCC, which develops in about 0.5 per cent of patients with NASH in seven years. HCC has a poor prognosis as around 80-90 per cent of lesions cannot be removed completely by surgery, and HCC is usually fatal within six months. Prevention by changing lifestyle choices to reduce risk is the main focus of treatment, although statins may reduce the risk of developing HCC by 25-40 per cent.

 

Key facts about non-alcoholic fatty liver disease

• Around 70 per cent of patients with diabetes have NAFLD, while 30-70 per cent of patients with hepatitis C are affected.

• Between 20 and 30 per cent of patients with NAFLD will go on to develop NASH.

• About one in 200 patients with NASH will develop liver cancer in seven years.

• Patients with type 2 diabetes and NAFLD are at double the risk of a host of conditions, including CVD, CKD and proliferative retinopathy.

Reflect
What are the symptoms of NAFLD? What is the risk of hepatocellular carcinoma for patients with non-alcoholic steatohepatitis? Which antihyperglycaemic drugs have been shown to benefit NASH and reduce hepatic inflammation?

Plan
This article discusses non-alcoholic fatty liver disease and its link with type 2 diabetes. It details how fatty livers can be a cause and a consequence of diabetes, the progression to cirrhosis and hepatocellular cancer as well as implications for pharmacists.

Act

• Find out more about NAFLD including information that might help you explain the condition to patients from the Patient UK website at

• http://tinyurl.com/ NAFLD01 and http://tinyurl.com/NAFLD02.

• Read more about cirrhosis and its symptoms and diagnosis from the British Liver trust website at http://tinyurl.com/NAFLD03.

• Find out more about hepatocellular cancer from the Cancer Research UK website at http://tinyurl.com/NAFLD04.

• Revise your knowledge of retinopathy, of which the risk is increased with NAFLD, from the RNIB website at http://tinyurl.com/NAFLD05.

Evaluate

 Are you now confident in your knowledge of NAFLD and its link with diabetes? Are you familiar with the conditions that NAFLD can progress to such as cirrhosis and cancer?

 

References

1. Cusi K Nonalcoholic fatty liver disease in type 2 diabetes mellitus Curr Opin Endocrinol Diabetes Obes 2009;16:141-9

2. Zhou XH, Qiao Q, Zethelius B et al. Diabetes, prediabetes and cancer mortality. Diabetologia 2010;53:1867-76

3. Balkau B, Lange C, Vol S et al. Nine-year incident diabetes is predicted by fatty liver indices: the French D.E.S.I.R. study. BMC Gastroenterol 2010;10:56

4. Schuppan D, Gorrell MD, Klein T et al. The challenge of developing novel pharmacological therapies for non-alcoholic steatohepatitis. Liver Int 2010;30:795-808

5. Starley BQ, Calcagno CJ, Harrison SA. Nonalcoholic fatty liver disease and hepatocellular carcinoma: a weighty connection. Hepatology 2010;51:1820-32

6. Nordenstedt H, White DL, El-Serag HB. The changing pattern of epidemiology in hepatocellular carcinoma. Dig Liver Dis 2010;42 Suppl 3:S206-14

7. Garcia-Compean D, Jaquez-Quintana JO, Gonzalez-Gonzalez JA et al. Liver cirrhosis and diabetes: risk factors, pathophysiology, clinical implications and management. World J Gastroenterol 2009;15:280-8

8. Targher G, Bertolini L, Rodella S et al. Non-alcoholic fatty liver disease is independently associated with an increased prevalence of chronic kidney disease and proliferative/laser-treated retinopathy in type 2 diabetic patients. Diabetologia 2008;51:444-50

9. Targher G, Bertolini L, Poli F et al. Nonalcoholic fatty liver disease and risk of future cardiovascular events among type 2 diabetic patients. Diabetes 2005;54:3541-6

10. de Marco R, Locatelli F, Zoppini G et al. Cause-specific mortality in type 2 diabetes. The Verona Diabetes Study. Diabetes Care 1999;22:756-61

11. Galvus Summary of Product Characteristics http://www.medicines.org.uk/emc/medicine/20734 accessed 25 September 2010

 

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Last month’s Health and Social Care Bill paved the way for the establishment of Monitor, an economic regulator with competition powers relating to health and adult social care services, including pharmacy. Lawyer Suzanne Rab (pictured, right) reveals what this means for your practice

 

1. Will pharmacies need to be licensed by Monitor?

Any provider of a health care service for the purposes of the NHS must hold a licence.  Monitor will award licences.  In the consultation on the initial proposals there was general support that the economic regulator’s licensing regime

should encompass all providers of NHS-funded services in England, whether foundation trusts or from the private or voluntary sector.  Details of an exemption regime will be set out in secondary legislation.  Pharmacies should generally assume that they will be subject to regulation by Monitor.

 

2. How will Monitor recover fees for licensing?

Monitor will have the power to levy fees on providers to meet licensing costs.  However, the licence fees must only be used to support licensing functions such as issuing licences, assessment of providers and any related enforcement action.  Monitor will fund other regulatory activities within its remit (including competition inquiries) through funding from an allocation agreed with HM Treasury.

3. How will Monitor and the Care Quality Commission co-operate in operating their different regimes?

Although Monitor will be the economic regulator, the role of the Care Quality Commission (CQC) will be strengthened as a quality inspectorate.  The health bill requires Monitor and the CQC to co-operate in the operation of their respective regimes.  In particular, they have a duty to work to create a single integrated process of licensing and registration.  The government has emphasised that safety must not be compromised in the interests of economic regulation.

4. What protections will be available if Monitor wants to modify licence conditions?

Monitor will have a duty to consult when developing the first set of licence conditions that will be applied to all licensed providers in a specific defined category.

If Monitor wants to amend licence conditions, it will have a duty to consult with providers who will be able to raise objections.  If the number of objections is above a certain threshold (which will be defined in regulations) Monitor will need to respond to the objections or make a reference to the Competition Commission.  The Competition Commission will then have a power to make a decision that is binding.

5. How will Monitor address anti-competitive behaviour by pharmacies and what are the risks of being involved in anti-competitive practices?

Monitor will have concurrent powers with the Office of Fair Trading (OFT) to apply competition legislation in health and adult social care services.  These powers will include a power to levy fines of up to 10 per cent of relevant turnover for breach of the competition law prohibitions on restrictive agreements and abuse of a dominant position.

The competition law powers will work in combination with the licensing regime.  For example, relevant licence conditions could include prohibitions on tying or bundling products or services.

6. How will Monitor address anti-competitive behaviour by commissioners?

The bill contains a power for regulations to be issued by the Secretary of State which will govern procurement by commissioners.  There will be a right for parties with a legitimate interest to complain to Monitor if they believe that commissioners have breached the rules.  The overall aim is to help to prevent commissioners from reaching agreement or taking action that restricts competition.  NHS commissioners will be subject to equivalent rules which prohibit anti-competitive activity as those applying to providers under competition law.

7. What will be the role of Monitor in relation to price setting?

Monitor must publish a national tariff that sets out certain health care services which are or may be provided for the NHS and the method used for determining prices for those services, specifies the maximum price and provides rules for determining the price for health care services which are not specified in the national tariff.  Where commissioning consortia object to Monitor’s proposals, Monitor may make a reference to the Competition Commission, who may veto the changes or put the matter back to Monitor.

8. Will the new regime help create a more level playing field for pharmacies?

The new regime could be expected to promote a level playing field for pharmacies.  For example, one concern highlighted in the consultation was that, under current arrangements, GPs and community pharmacies provide the same services so that when commissioning decisions are made by GP consortia there may be a risk that they will favour their GP practices.  A concern raised by community pharmacies is that discrimination may not necessarily be overt but could take the form of more subtle discrimination such as setting conditions which other providers cannot meet. The Bill provides a framework to seek to ensure that commissioning decisions are based on objective criteria and that the NHS Commissioning Board and GP consortia are subject to competition law requirements.

9. What will happen next and how soon can we expect changes in practice?

The bill will now have to go through a series of readings and amendments before it becomes legally-binding legislation.

The wider changes to the NHS will be completed over the next four years.  The next year will focus on designing and planning the framework.  According to the proposals, the NHS Commissioning Board and the new-look Monitor will come into effect from April 2012 and the first full year of the new system will be 2013/14.

10. What other health care regulatory developments should pharmacists keep in mind?

The proposals must be seen against the background of government and regulatory policy to promote competition in the health care sector.

Competition law applies only to undertakings that are involved in economic activity.  There has been some uncertainty regarding the extent to which this applies to providers of health care that are funded by the state.  The previous government established the Cooperation and Competition Panel to review anti-competitive activity in the health service.  However, this introduced further complexity since it remained possible for both the OFT and the Cooperation and Competition Panel to have power to investigate.  The upcoming legislation giving Monitor concurrent power with the OFT to enforce competition law within the NHS should be seen in this context.

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You must raise your business game to survive in the new health service, says Protomed CEO Norman Niven (pictured, right)

There’s no turning back, folks. £40 million worth of cutbacks and the dissolution of PCTs are just some of the changes we have to contend with over the next few years. But behind all of this uncertainty is opportunity. This is the nudge pharmacists need to raise their game – a chance to revolutionise the pharmacy business model to make sure they don’t just survive the next three years, but grow. By shifting their income away from the NHS, pharmacists should aim to gain 50 per cent of their revenue from fee-for-service means by 2016.

With the role of GPs and primary carers morphing into that of a business manager, they will come to rely even more on pharmacists to advise patients on how to manage conditions and medication. But as the new system forces pharmacists to show a return on investment, it’s time to think beyond the community and re-consider the bottom line.

We’re all agreed, diversification is key, but pharmacists need to be careful about commercial avenues they venture into. As in any sector, uniqueness commands a premium. And that means offering what are truly pharmacy-only services and not getting dragged into schemes that any untrained wannabe can offer – screening comes readily to mind. Avoid putting all your eggs in one basket, yes, but be sure to put them in the right baskets.

“But how to reduce our reliance on the NHS,” I hear you cry? By thinking like an entrepreneur. Do what you do best. At school we had the three Rs, in pharmacy it’s the three Ms, managing dispensing, managing medication usage and monitoring patient compliance. These are truly pharmacy-only services that are marketable to the private sector. Collaborating with health insurance companies to monitor compliance and reduce claims, managing clinical trials for big pharma companies and running discharge programmes for hospitals – these all boost revenue alongside the business of dispensing medication. E-health is another as yet untapped service that pharmacy can and should take ownership of.

This is the biggest transformation in the NHS’s 63-year history. Pharmacy has shown time and time again it isn’t scared of change, and now’s the time to act so you come out of it with a clean bill of health.

Protomed designs and develops medication management solutions including flagship product Biodose, a monitored dosage system

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Cyklo-F is the latest POM to P transfer, which has been launched amid controversy after it was announced the product would be available exclusively through Boots. Here, Alan Nathan gives you the facts you need to know about the medicine.

What is Cyklo-F?
Tranexamic acid 500mg film-coated tablets. Each pack contains 18 tablets.

What is it licensed a P medicine for?

s
The reduction of heavy menstrual bleeding (menorrhagia) over several cycles in women with regular, 21-35 day cycles, with no more than three days of individual variability in cycle duration.

 

What is meant by “heavy menstrual bleeding”?
Menorrhagia has been defined as menstrual blood loss exceeding 80ml per cycle. Approximately 10 per cent of women of reproductive age have blood loss exceeding 80ml and 5-15 per cent of women are thought to be affected to such a degree that treatment should be considered. However, in practice menorrhagia is generally self diagnosed through a woman’s subjective assessment of blood loss.

How does it work?
The fibrinolytic system contributes to the prevention of blood clots through conversion of an inactive plasma enzyme, plasminogen, to plasmin, which has a fibrinolytic action. Women with menorrhagia have been found to have increased levels of plasminogen activators in the endometrium of the uterus compared with women with normal blood loss. Tranexamic acid is an antifibrinolytic agent that competitively inhibits the activation of plasminogen to plasmin. It therefore has an antifibrinolytic effect, but it is not thrombogenic. As a POM, it is also indicated for preventing blood loss during surgical procedures.

What is the dosage?
Two tablets three times daily for as long as is needed, for a maximum of four days. The dosage may be increased if there is very heavy menstrual bleeding, but a total dose of 4g daily should not be exceeded.  Treatment should not be initiated until menstrual bleeding has started. Patients should consult their doctor if menstrual bleeding is not reduced after three menstrual cycles.

 

How safe is it?
Tranexamic acid has been in use as a POM for over 40 years (in the UK since 1983) and has been available without prescription in Sweden since 1997; treatment for menorrhagia with the drug corresponds to 3.2 million patient-years, and a further 15 million patients have been treated for other indications. The risk of thromboembolic events in women taking the drug is considered to be no higher than that in fertile women generally. There is no evidence that tranexamic acid increases the risk of thrombosis in women taking hormonal contraceptives.

What are the side-effects?
Common side-effects (more than 1 in 100 patients, less than 1 in 10 patients):
•    Nausea
•    Diarrhoea
•    Vomiting
Uncommon side-effects (more than 1 in 1,000 patients, less than 1 in 100 patients)
•    Allergic skin reactions

 

Are there any interactions with other drugs?
Cyklo-F will counteract the thrombolytic effect of fibrinolytic preparations.

What are the contraindications?
•    Mild to moderate renal insufficiency
•    Hypersensitivity to tranexamic acid or any of the excipients
•    Active thromboembolic disease, a previous thromboembolic event or a family history of thrombophilia
•    Haematuria
•    Irregular menstrual bleeding, patients using warfarin or other anticoagulants
•    Women taking oral contraceptives.

 

Who should consult their doctor before taking Cyklo-F?
Women who meet any of the following criteria should consult a doctor before taking Cyklo-F:

•    Older than 45 years
•    Obese
•    Diabetic
•    Has polycystic ovary syndrome
•    Has a history of endometrial cancer in a first-degree relative
•    Is receiving unopposed oestrogen or tamoxifen.

 

Which symptoms prompt a pharmacist to refer a patient requesting Cyklo-F to her GP?
•    Irregular periods
•    Bleeding between periods
•    Bleeding after the menopause
•    Pain during intercourse
•    Bleeding after intercourse
•    Premenstrual pain
•    Pelvic pain
•    Symptoms of thrombosis – pains or feelings of heaviness in the chest, unusual pains or swellings in the arms or legs; sudden shortness of breath; fainting; haemoptysis.

 

What serious conditions can be associated with menorrhagia? 
•    Endometrial cancer
•    Ovarian cancer
•    Endometriosis
•    Fibroids
•    Chronic pelvic inflammatory disease
•    Thyroid disorders
•    Blood clotting abnormalities.

Can Cyklo-F be taken while breastfeeding?
The concentration of tranexamic that passes into breast milk is around 1 per cent the concentration in the mother’s blood. An antifibrinolytic effect in the infant is unlikely, but nevertheless breastfeeding women should consult their GP before taking the drug.

 

How much does Cyklo-F cost?
The recommended retail price is £8.99 for a pack of 18 tablets.

When is Cyklo-F available?
It will be launched on January 31 2011.

 

When will pharmacies get supplies?
Cyklo-F will be available initially only from Boots stores as the company has an exclusivity arrangement with the product’s manufacturer, Meda Pharmaceuticals. Concerns have been expressed by some pharmacy organisations over the deal.

At the Update Pharmacy pre-reg trainee Jan is on prescription reception. A woman approaches her holding a consultant physician’s private prescription form.

“Can you do this prescription for my husband?” she asks. “I’ve been to two other chemists already. They both seemed puzzled by it and then just said that they didn’t have it.”

“Well,” Jan replies, “even if we don’t have it in stock I’m sure we could get it for you very quickly. Can I have a look at the prescription?”

The woman hands it over and Jan looks at it. It reads:

‘Sativex spray 1x3x10ml

Start with one spray daily, increasing gradually if necessary by one spray per day until optimum relief is obtained. Maximum dose: 12 sprays daily.’

“I’m afraid that I’m not familiar with this medicine,” Jan says, “but give me a minute.”

She then takes it to pharmacist David Spencer, who looks at it and says: “Yes, I know what it is. But if she wants it, she’ll have to go back to the prescriber. And, in any case, I think she’ll be wanting to get this on the NHS.”

QUESTIONS

1. What is Sativex and what is it used for?
2. What is its legal classification?
3. Why will the patient or his representative need to go back to the prescriber?
4. Why will the patient be wanting to get the drug on the NHS?

ANSWERS

1. Sativex is an oromucosal spray containing the cannabinoids cannabidiol and delta-9-tetrahydrocannabinol in a 1:1 ratio.

It is derived from whole plant extracts of the plant Cannabis sativa. In the UK it is indicated as an add-on treatment for patients with moderate to severe spasticity as a result of multiple sclerosis who have experienced an inadequate response to other anti-spastic medicines.

2. Sativex is a Schedule 1 controlled drug, but the Home Office has issued an open general licence for the product; this removes the legal requirement for doctors, pharmacists and patients to apply for individual licences with the Home Office in order for it to be prescribed, dispensed and possessed respectively. To be legally valid prescriptions must comply with the prescription-writing requirements for CD Schedule 2 drugs, but Sativex is exempt from CD record-keeping requirements.

3. In line with Schedule 2 prescription requirements, for private prescriptions Sativex must be prescribed on standardised private prescription forms issued by PCTs. Also, the total quantity of the medicine must be stated in words and figures.

4. The cost. The basic price of a 3x10ml pack is £375.

REFERENCES

1. Royal Pharmaceutical Society, Sativex factsheet (www.rpharms. com/support-tools/sativex.asp)

2. SPC for Sativex Oro-mucosal Spray (www.medicines.org.uk/EMC/ medicine/23262/SPC/Sativex+Oromucosal+Spray/#COMPOSITION)

Mobility aids are a huge, largely untapped market and pharmacists could become the first port of call for their provision in England if a fledgling scheme takes off, finds Francesca Robinson
A government scheme to make mobility and daily living aids available through pharmacies is set to open up an interesting and profitable new market.
The government is looking to pharmacies in England to provide these products because there have been growing problems with the way the service has traditionally been provided.
The equipment – ranging from simple aids for daily living such as eating and drinking utensils, grab rails and raised toilet seats to more complex equipment such as pressure care mattresses, hoists and lifts – helps millions of people to live independently in their own homes.

But currently only 40 per cent of people who are entitled to have the equipment provided by the state are receiving it.

There are long waits for assessment by occupational therapists and for subsequent delivery of the equipment from a loan store. The process is expensive for local authorities, which provide the products in most areas and have to pay for delivery and recycling of the equipment.

So the Department of Health (DH) has launched the Transforming Community Equipment Services (TCES) programme, which will see people entitled to state-funded mobility aids issued with prescriptions by occupational therapists. The prescriptions can be exchanged for products stocked by any accredited retailer – and the DH is targeting pharmacies to become such providers.

If they wish, users can top-up the prescription by paying extra for a more advanced or luxurious piece of equipment. Pharmacists will be reimbursed for TCES products at a price fixed by a national tariff.

Phil Stephens, the then DH TCES project lead who launched the scheme, says: “We wanted to create an open marketplace, not only for the people who receive prescriptions but also for those who want to buy the equipment themselves.

“Pharmacies are well trusted by their customers and are located in the communities where people live, so they tend to know the people who will be receiving the prescription and any other health needs they might have. It is an ideal fit.”

The scheme has already been piloted by councils in the north west and in the last year has gone live in several London boroughs. The DH hopes to have two-thirds of local authorities on board within three to five years.

How to get involved
The first thing a pharmacy will hear about the scheme is when a letter drops through their door from their local authority inviting them to a briefing event. This is the point at which they can register an interest.

Pharmacists who want to take part must be accredited by their local council. This involves going on a short training programme to ensure they and their staff are competent to advise on the suitability of products and demonstrate the safe and correct use of equipment. Some authorities are providing free training, while others are charging pharmacists cost price – anything up to £130.

Pharmacies will be expected to stock smaller items so that customers can pick them up in-store. Bulkier items will be sold from catalogues and pharmacies will negotiate with wholesalers to deliver the products on a daily basis. They will then have to either deliver and install the products themselves or pay a company to fulfil that part of the transaction.

The benefits for pharmacies
Around 60 per cent of people who need mobility aids are not getting them and Mr Stephens estimates the retail value of the market is potentially worth more than £1 billion.

“Pharmacists will make more profit from selling daily living aids than from selling shampoos and trying to compete on price with Asda. If people go to the pharmacy to buy a daily living aid, they will tend to buy more than one. There are good margins to be made on them,” he says.

“What we are trying to do is create an accessible marketplace for these products. At the moment, consumers don’t know there is a market out there.”

Hatul Shah – an independent contractor who is part of the pharmacy supplier Sigma, which has a mobility aid arm, Sigmobility – has been working with the DH to develop the programme and believes the scheme represents a significant business opportunity for pharmacists.

“Mobility products will give an instant profit margin and is a niche market, which will bring new customers into the shop. Also, it fits well with what we do in the pharmacy; it is all about providing care,” he comments.

Mr Shah says pharmacists can expect to make a profit of around 20 per cent on a TCES line and around 45 per cent on a product sold privately. This compares with around 5 per cent profit on selling disposable nappies.

He observes: “Pharmacists have been hesitant about this new area – they are reluctant to change. But slowly they are realising there is a market here and with the ageing population there is an increasing requirement for these products.

“There is potential for massive growth in this market which could generate a lot of revenue for pharmacists. When you have got the government pushing a scheme like this, you can’t ask for anything more.”

Case study 1: Boots

Earlier this year, Boots trialled the TCES scheme in “a number” of its stores across the UK.

The multiple is interested in supplying independent living aids because it fits with its ethos of offering a wide choice of products and services to meet the requirements of its customers, a spokesperson says.

Boots is no longer dispensing the equipment in-store, because the trial found local variations in requirements, expectations and market conditions made it difficult for the multiple to operate the service consistently across its national chain. “For a national retailer, meeting the different requirements that each local authority naturally has brings operational complexity,” a spokesperson says.

The company also found some logistical challenges in delivering the in-store service. A spokesperson explains: “Unlike independent mobility retailers, pharmacies do not normally have space to store or display the tariff products, so order them when a prescription is received. The customer then comes to the store to collect the product once it has been delivered.

“This can be a disadvantage, particularly when the customer wants a product urgently.”

But Boots is still providing the independent living aids online. Over 600 daily living and mobility aids are stocked at www.boots.com – customers can order online or in any store, and orders are delivered direct to their home addresses.

Case study 2: Holborn Pharmacy, Camden, London

Pradip Patel became involved in the scheme, partly because he viewed supplying mobility aids as part of his caring role – and also because he felt his business could make money on the products.

“We are currently dispensing about two or three items a week,” Mr Patel says. “The most popular items have been bath boards, perching stools and bath stools and raised toilet seats. So far only a few people have topped up their prescriptions.

“We are now stocking around 30 of the lines we know will sell. We always keep a selection of walking sticks and crutches and we will start displaying these items as well, so people might see them and buy more.

“Delivering mobility aids can be difficult as we are in central London and a lot of people live in flats. It can also be time consuming – for example, it can take 10 to 15 minutes to put up a perching chair.”

Mr Patel has two members of staff accredited to dispense mobility aids and says the two-hour training provided free by Camden Council was good.

“I see the scheme as an add-on to what we are doing at present, but it is still early days. When there are bigger volumes, it will be worth keeping more items in stock,” he says.

Case study 3: Southwark Council

The scheme went live in Southwark in February with 14 accredited retailers, 10 of which are pharmacies, and the council’s TCES project manager Taylor Jakks says it is now “mainstreamed – part of our day-to-day business”.
The number of monthly prescriptions is increasing and the council has now redeemed almost 400. Retailers have also reported that customers have been topping up their products and self-funding additional items, Mr Jakks says.

The most frequently prescribed items are: plastic grab rails, pick-up and reaching aids, perching stools, bath steps, commodes, general furniture raisers, raised toilet seats, bed lever and trolleys.

To join the scheme, pharmacies paid £130 per person for accreditation training, which involves a four-hour e-learning course, plus a further three hours face to face, familiarising retailers with the equipment and related issues, so that they become experts and can give good information and advice. “We expect the price of the training will fall as the market for assessor training grows,” Mr Jakks says.

Pharmacists redeem the prescriptions through the council’s online ordering portal and are on immediate payment terms to receive reimbursement within a week.

One issue has been the size of pharmacists’ shops and their ability to keep large amounts of stock. “We have three pharmacies that are a good size and can keep stock and exchange products immediately for prescriptions. We encourage the smaller shops to keep four or five different catalogues so they can offer people a choice of products so that they don’t have to hold vast amounts of stock,” says Mr Jakks.

Pharmacists make a profit of around 22 per cent on TCES items. “But what my retailers have realised is that it’s the top-up and additional sales on which they can make higher margins,” says Mr Jakks. “Getting a retailer to hold stock and become a source of information and advice encourages people to buy more items earlier privately for themselves. This might prevent accidents, while encouraging people to become more independent and less reliant on the state.”

Tips for your CPD entry on mobility aids

Reflect: Would my patients benefit from an independent living aids service?

Plan: Consider whether my pharmacy could get involved in the TCES scheme or  otherwise provide mobility equipment.

Act: Join the TCES scheme where possible, or introduce independent living aids to pharmacy if appropriate.

Evaluate: Do my patients benefit from my independent living aids service?

The public health white paper recognises the value of community pharmacy, but what slice of the cake will the sector get? Zoe Smeaton looks at the best and worst case scenarios

As a “valuable and trusted public health resource” with a key role to play in smoking cessation campaigns and a chief pharmaceutical officer working closely with the public health community, pharmacy seems to have done pretty well out of the government’s public health white paper. Healthy Lives, Healthy People highlights pharmacy as a valuable profession, with the potential to do much more. And as Alastair Buxton, head of NHS services at PSNC, says: “Securing such a positive endorsement is a huge win and a testament to what’s been happening in pharmacy.”

Best case scenario
Experts agree that in a best case scenario, pharmacy could stand to gain considerably from this white paper. The ability of Public Health England to direct the NHS Commissioning Board could open the door for nationally agreed pharmacy services, Mr Buxton says.

Alternatively the reforms could lead to service templates, Boots UK says, which could enable more consistent commissioning at a local level. Or local commissioners could even be told they have to consider pharmacy as a provider, in DH community pharmacy tsar Jonathan Mason’s best case world.

The services in question could include smoking cessation, weight management and sexual health services, and as Georgina Craig, commissioning community pharmacy network lead at NHS Alliance, says, even some services currently in the GP contract could be up for grabs.

However, rosy as this all sounds, pharmacists would be right to have reservations. “I am concerned that the Department of Health has a track record of praise and promises for community pharmacy, but nothing actually changes. Will it be different this time?” asks James Lindsay, head of corporate relations at AAH.

Worst case scenario
If it isn’t, experts agree the worst case scenario would not make a happy ending for community pharmacy. They warn if pharmacy doesn’t make its case to commissioners, other providers could step in and secure all the public health funding for their own services. As Ms Craig puts it: “GPs [could] make a more compelling case than pharmacy and corner the market in public health services through their inclusion in GMS in areas where pharmacy is starting to grow its evidence base.” There could be no new services for pharmacy, alongside decommissioning of existing services, Mr Mason fears.

John Nuttall, managing director of the Co-operative Pharmacy, says: “A worst case scenario would see nothing concrete happening and huge local variability in terms of accessibility to services and health outcomes.”

Hemant Patel, secretary at North East London LPC, goes a step further, suggesting: “The worst case is that pharmacy is left with very little other than dispensing, then [we see] a reduced number of pharmacies because it will be more efficient to have 20 pharmacies doing 15,000 items a month than 40 doing 5,000.”

Pharmacy can avoid this fate, experts agree, but not without some effort. Andy Murdock, pharmacy director at Lloydspharmacy, says to achieve a best outcome, “pharmacy must step up to the plate and not expect it to be delivered as a matter of right”.

And whether the white paper is a threat or an opportunity “depends on how active pharmacists are in promoting the case for community pharmacy”, Mr Lindsay agrees.

Making the case
Making that case and ensuring commissioners understand the benefits pharmacy services can bring are the keys to success. As Ms Craig says: “How big a slice of the cake pharmacy gets will depend on the quality of its sales pitch to commissioners and the general public.”

But the work must be done at all levels, right down to individual pharmacists promoting their services to GPs and local directors of public health. Boots UK says it will be “essential” for contractors to engage with GP consortia and directors of public health in the future, for example. And pharmacists need to be collecting data on their services and interventions, Mr Mason advises. As Mr Murdock warns: “Pharmacy will need to record data far more rigorously than ever before in order to demonstrate our value.”

Quite whether pharmacy is up to this challenge remains to be seen: a C+D poll last week showed 88 per cent of readers were not talking to GP consortia yet and had no plans to do so. But experts have been quick to condemn those not making the effort and are clear that pharmacy has no choice but to start doing so quickly. Education and guidance from the national bodies and employers may well be needed, but as Mimi Lau, Numark’s director of professional services, concludes: “Pharmacy needs to wake up and act now.”

Five ways to help get the best from the white paper

1. “Get to know who’s who in your area – who are the directors of public health? – and put yourself in front of them.”
   Jeremy Main, managing director, Alliance Healthcare
2. “Take small steps: find out what is going on locally, talk to your practices, do some research, talk to others that can help and then develop an action plan.”
   Mimi Lau, director of professional services, Numark
3. “Consider creating pharmacy-led consortia which could engage GP-led consortia. Pharmacies will need to think about collaborating.”
   James Lindsay, head of corporate relations, AAH
4. “Individual pharmacists need to share their success stories with local commissioners.”
   Liz Stafford, clinical commissioning lead, Rowlands Pharmacy
5. “Contractors should develop a clinical business development plan (if they have none) and decide what role they plan to have in delivery of public health services. “
   Georgina Craig, commissioning community pharmacy network lead, NHS Alliance

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?

[SOURCE]

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

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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.

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