Generic medicine: What’s in a name?

Atorvastatin, Lansoprazole, Olanzapine. Do you know what these names mean? If you do, it’s likely that your medicine, which you once called by its brand name, has been changed to a generic version that goes by the active ingredient name.

Atorvastatin is a drug used for the treatment of high cholesterol, and prevention of heart attack and strokes, while Lansoprazole belongs to a group of drugs called proton pump inhibitors that decrease the amount of acid produced in the stomach, and help treat reflux. Olanzapine is used in the treatment of schizophrenia and bipolar disorder.

Generic medicines are essentially copies of branded medicines and contain the same active ingredient as the product they’re based on. They are just as effective and just as safe. The only difference, apart from the name, packaging and sometimes the appearance, is that the generic version is usually available at a lower cost.

Generic medicine usage in Ireland has traditionally been very low; in 2007 just over 19 per cent of prescription items were dispensed generically, and generic prescribing accounted for just 8.2 per cent of total expenditure under the HSE’s medical card scheme.

Ireland is well known for its love of brands and willingness to pay higher prices for high-end products, from teabags to clothes to medicines, though the recession has helped encourage a more critical approach to affordability, by both State and patients.

Last June, the long-awaited Health (Pricing and Supply of Medical Goods) Act 2013, which provides for the introduction of a system of generic substitution and reference pricing for authorised medicines, was commenced in Ireland.

Previously, if a specific brand name medicine was prescribed, the pharmacist had to dispense this brand, even when less expensive versions of the same medicine were available.

Under the new law, the pharmacist may substitute the prescribed branded medicine for a safe and less-expensive generic version that has been deemed interchangeable by the Irish Medicines Board (IMB).

The first medicine to be deemed interchangeable was atorvastatin, with 96 atorvastatin products included on the list published last August in four separate groups.

Reference pricing means the HSE sets one price that it will pay for groups of medicines on the IMB’s interchangeable list. If you want your more expensive branded medicine, you have to pay for it.

Reference pricing, like generic interchangeability, is being introduced one medicine at a time, to ensure adequate supplies can be provided. The first reference price, for atorvastatin medicines, was published on November 1st, 2013.

The IMB is still working through the 40 active medicine substances prioritised for substitution by the Department of Health, due to their cost and volume of use.

To date, the board has published interchangeable groups for 23 active substances (including amoxicillin/clavulanic acid-containing products that were not on the original priority list), has initiated consultation on a further 12 active substances, and anticipates that consultation on the six remaining priority active substances will have begun by August.

Acceptance

So, one year on, how have the changes been accepted by the medical community and patients?

The HSE, Department of Health and IMB created a health-education campaign in 2013 to support the new legislation and to help ensure a smooth introduction.

“We had to explain a complex new pricing system, which could potentially involve switching from a branded medication to a generic version, in a simple and clear manner.

"The campaign was also designed to assist GPs, pharmacists and other healthcare staff to fulfil their central role in supporting patients through these changes," the HSE told The Irish Times.

The campaign includes a website, hse.ie/generics, and posters and leaflets were distributed to 1,750 pharmacies and more than 1,600 GP surgeries nationwide.

The pharmaceutical company Pfizer conducted consumer research to evaluate its reference pricing adverts to see how people’s knowledge, awareness and understanding had changed.

Before the campaign, 41 per cent of people said they had no awareness that they may be offered an equivalent medicine by the pharmacist; this reduced to 26 per cent afterwards. Before, 70 per cent of people said they had not heard the term reference price: this reduced to 50 per cent afterwards.

Separate research undertaken by the IMB showed a high level of awareness of generic medicines among the public. The research, published last year, found that 92 per cent of people who had personally used a generic medicine said they had a positive experience.

Familiarity with the term “generic medicine” was high, at 72 per cent, with willingness to accept and use a generic medicine if recommended by their healthcare professional also high, at 80 per cent.

Since November 2013, more than 500,000 patients have been brought into the reference pricing system, and the HSE says it has received no negative feedback.

Kathy Maher, the president of the Irish Pharmacy Union, is a pharmacist in Co Meath and says pharmacists have worked very hard to implement the legislation and explain the changes to patients. This has changed their role and workload considerably.

While there was some resistance to the changes from patients and some doctors, Maher says patient trust in pharmacists is very high, though she said more information from the HSE for doctors and patients would be helpful.

Darach Ó Ciardha, a GP and chairman of communications at the Irish College of General Practitioners, says GPs see the generic substitution and reference pricing changes as a positive development. They retain the power under the legislation to decide whether a particular medicine should be substituted for patients.

He adds that it is a good thing for patients to get to know their medications by the active ingredient name, especially if they are abroad, as brand names and availability can vary internationally.

Savings

A key aim of the legislation has been to save money for both the HSE and patients. It has been widely publicised that the State and the public have long being paying much higher prices for many common prescription and over-the-counter medicines, both branded and generic, than people in the UK and in Europe.

The HSE estimates it spent just over €2 billion on medicines in 2013, compared with €1.95 billion in 2012. In the context of a fivefold increase in the HSE’s bill for medicines between 1999 and 2009, and €4 billion being cut from the health budget in the past six years, these costs are simply unsustainable, Prof Michael Barry, HSE national lead of medicines management and head of the National Centre for Pharmacoeconomics, told the Hospital Pharmacists Association of Ireland annual educational conference in April.

Interchangeable

Barry said Irish doctors were very fond of branded medicines and were more likely to prescribe the most expensive medicine in its class, but he said the legislation was improving generic prescription rates, at least in the medicines deemed interchangeable to date.

The new legislation is expected to save the taxpayer €50 million in 2014 alone. Out of the HSE’s total drugs bill, up to €1.6 billion is made up of the actual medicine costs, of which €400 million is off-patent, which means it can be substituted under the new legislation.

A HSE spokesperson has told The Irish Times that of the first three medicines deemed interchangeable, the generic penetration rate has risen to 90 per cent, with the earmarked savings well on track for this year.

The HSE is still paying more than the NHS, for example, for many branded and generic medicines, but this is partly due to the smaller market and the need to ensure Ireland is not seen as too unprofitable for some pharmaceutical companies, the spokesperson says, although the HSE will continue to push down drug prices as much as it can.

Substitute

Colin Galligan, managing director of the Medipharm pharmacy group, runs two pharmacies in Dublin and says the majority of his customers are happy to accept a generic substitute.

He says many people, particularly private patients, seek out the generic version of their medicine before the pharmacist suggests it.

So the consensus is that the legislation has been very successful to date though many drugs still need to be deemed interchangeable, with patients keen to be able to choose the generic version of all their medications that are off patent.

Competition: How the figures add up

The are 1,826 pharmacies and 5,219 pharmacists registered in Ireland, according to new statistics this month from the Pharmaceutical Society of Ireland (PSI), the regulator of the profession.

This is a rise of 8.7 per cent and 17.4 per cent respectively on the numbers in 2007 alone, despite the recession, a succession of cuts to pharmacists' professional fees from the State, and a loss of retail business in cosmetic and toiletries sales to the supermarket sector.

Dublin alone has 485 pharmacies and it is common to see more than one pharmacy even in small villages. In addition, Ireland's independent pharmacies are increasingly feeling the competition and buying power of the large commercial pharmacy chains.

New chains This pressure has seen the emergence of a number of new chains of independent pharmacies. Last October saw the launch of Totalhealth Pharmacy, a network of 40 existing independently owned chemists undergoing a €4 million rebrand and overhaul. The group plans to increase its store numbers to more than 160 by 2018, mainly through signing up more existing independent pharmacies to its network.

A separate group, Haven Pharmacy, launched earlier this month. Haven Pharmacy is a new brand created by the Indepharm co-operative group for its 46 local, independent community pharmacies based in urban and rural parts of the country.

All over Ireland, €2 million has been invested in the rebranding of 40 pharmacies, and another six pharmacies are due to be rebranded by the end of 2014. The group says it is the fastest-growing independent co-operative pharmacy group in Ireland with more than 100 pharmacists and more than 300 staff, practising in urban and rural areas.

Daragh Connolly, chairman of Haven Pharmacy, is calling on the HSE to recognise and support the increasing role the pharmacist plays in managing the health of local communities.

"We already know the success that flu vaccinations can have in pharmacies. We need to learn from this and recognise that the pharmacist plays an important role in community health; as we all work as one team to build a healthier Ireland," says Connolly.

Helix Health, which sponsors the annual Pharmacist Awards, recently surveyed more than 100 pharmacists, of whom 86 per cent said they believe Government cutbacks had a direct impact on their ability to look after patients.

Three-quarters (74 per cent) of pharmacists in the survey said they had patients who had lost their medical cards recently, despite poor circumstances or severe illness; while almost two-thirds (64 per cent) said the biggest challenge facing pharmacists today was Government cutbacks; 28 per cent believe the biggest challenge will be the increase in the number of customers in financial difficulty.

Job creation In relation to job creation, survey respondents indicated that the numbers employed in their organisations had either dropped slightly or remained largely the same over the past five years: 52 per cent said their place of work had retained the same number of staff over the past five years; 31 per cent said staff had been let go; while 17 per cent said their place of work had recruited additional pharmacy staff.

When questioned on what enhanced roles they would like to see for pharmacists, 46 per cent of survey respondents said they would like to see pharmacists empowered to undertake medication usage reviews.

Almost half (45 per cent) of respondents want an enhanced role for pharmacists in the management of chronic illness such as diabetes, while a small number of survey respondents thought pharmacists should play a greater role in administering childhood vaccines and needle-exchange programmes.