Communication is the best medicine when it comes to generics

It’s probably fair to say no other issue in Irish healthcare has caused as much confusion in recent years as generic medicines. With their abundance of weird and wonderful names, such as Eklira Genuair, and occasional mix-up with DNA – genetic medicines? – it shouldn’t be surprising, really.

Our generics usage has increased from historically low levels since legal and regulatory changes were introduced in 2013 to facilitate increased use of generics, accompanied by various information campaigns. So why are so many people still reluctant to change to a generic brand?

The first question someone will often ask when given the option of a generic is “Is it the same thing?” A generic contains the same quantity of the same drug as an original brand medicine. Not only that, the manufacturer must carry out research – a bioequivalence study – to show that the drug levels in the blood are comparable whether people are taking the generic or the original brand.

For a small number of treatments, such as warfarin and epilepsy drugs, slight variation in blood levels of a drug can make a difference clinically. For these, it is not advisable to switch and patients should stick with the same brand, be it a generic or the original. Barring these exceptions, changing brands of a medicine should have no clinical impact.

The Health Product Regulatory Authority (formerly the Irish Medicines Board) is compiling lists of brands of common drugs that are interchangeable and can be switched without medical supervision.

Better value

One of the prime advantages of generic medicines is that they are generally better value than the original brand. This lower price tag can be a cause for concern if someone assumes this is due to lower quality. However, generics must meet the same quality requirements as original brand medicines.

Most of the price difference between generics and original brands is nothing to do with the manufacturing process. Pharmaceutical companies carry out research and development in order to produce new drugs. Drug discovery, running clinical trials and marketing a new medicine for the first time is a costly business, so manufacturers are granted a patent for up to two decades. With exclusive rights to market their original brand, a company will try to recoup the costs of drug development during this time.

However, once the patent expires, other manufacturers can launch a generic version without the same R&D costs and, therefore, can afford to sell it at a lower price. In fact, in some cases, the manufacturer of an original brand may even produce a generic version themselves to maintain some market share as patients switch to generics.

A difference between brands is that the excipients, or non-active ingredients, for example any coatings, colourings or flavourings, can vary. It is possible to have an intolerance to these components that could lead to unpleasant side effects. However, these inert ingredients are not pharmacologically active and so are less likely to cause adverse effects than the actual drug in the medicines. Also, these excipients are not exclusive to generics and are used in a variety of medicine brands. So a reaction due to these is as likely between two completely different medicines as two brands of the same medicine.

The placebo effect

Enough about what medicines contain, how about what’s not in them? Part of the effect of all treatments is nothing to do with what’s in the tablet but is down to the placebo effect; the physiological response to taking part in the therapeutic process. This can be a powerful effect and subject to variation depending on many factors, for example the number or even colour of tablets. So could some people’s bad reaction to generics be related to this?

A study investigated this by giving a dummy tablet to people, telling them it was an original brand to treat anxiety by lowering blood pressure (iti.ms/1Me3IQZ).

When measured, both their blood pressure and anxiety had decreased. They then changed some people to a generic brand, while continuing to give them inactive pills. When their measurements were taken again, those who had switched had higher blood pressure and anxiety levels and reported more side effects relative to the group still taking the “original brand”.

This goes to show how the attitudes to medicine can have a big impact not only on subjective but on objectively measured symptoms. Perhaps in some cases it’s not the switching itself, but how a brand is switched, that contributes to ill effects. If people’s concerns are not allayed, it’s not surprising they may be primed to have a bad experience with a new brand.

How can this be addressed? Recent research at the University of Limerick found that patients’ trust in their doctor often overrules personal mistrust of generic medicines (iti.ms/1Me5MrX). So perhaps more open and frank conversations would help patients worried about generics to make an informed decision, and could even lead to a better therapeutic response if they do decide to switch. The best medicine for our generics problem may be good old-fashioned communication.

Frank Moriarty is a pharmacist undertaking a PhD through the SPHeRE programme at the HRB Centre for Primary Care Research in the Royal College of Surgeons in Ireland.