ES: There were double digit switches of prescription-only medicines to pharmacy medicines in the late 1990s and early 2000s, but there were only two switches made in 2012 and one in 2013. Why have there been so few switches in recent years?
GM: There are a number of factors that have slowed it all down. A lot of that is to do with the regulatory burden placed on companies, which has been very difficult. If they go down the switch route, it is unclear whether they are going to come out with an application that is going to be granted in the right circumstances. For example, Flomax (tamsulosin), which was switched in 2009 for treating the urinary symptoms of benign prostatic hyperplasia, has an over-the-counter (OTC) sale protocol that is lengthy and convoluted, and by the time you get to the end of it, the feeling of the pharmacist and the patient is perhaps he should just go to the doctor. There are a lot of questions that the pharmacists have to go through in the protocol.
The regulatory burdens have definitely slowed down the number of applications because it costs an awful lot to make a POM-to-P [prescription-only medicine to pharmacy medicine] switch, costing a company about £1.3m over three years. There is a Medicines and Healthcare products Regulatory Agency (MHRA) switch guideline, published in 2012, which should make the process less burdensome, but we haven’t seen the impact of this as yet.
The future trend should be — and it is slowly getting there — more switches of lifestyle products for weight loss or smoking cessation, for instance, as people understand which lifestyle changes they can make for their health. And that is why I see the role of the pharmacist in public health as being such an important one. People are going to have to take greater responsibility for their health and the pharmacist can help them with this.
Were there other reasons for Flomax’s lack of success?
Men don’t, in fact, go anywhere near their doctors as much as they should do. But the problem is men don’t like going to the pharmacy either because they don’t see the pharmacy as an environment that is particularly open to them. They think it is about nappies and perfumes.
What was the best POM-to-P switch in your opinion?
The most exciting were the POM-to-P switches that occurred in 1983 because they were the first. We had the switch of the anti-inflammatory medicine Nurofen (ibuprofen), and the antidiarrhoeal Imodium (loperamide). Another switch that still strikes me as one of the best was Zovirax (aciclovir), the cold sore cream, in 1993. Patients knew exactly what they have because they will have had that diagnosis from their GP the first time they had a cold sore. From then on, they knew exactly what they have to do and knew they have to act quickly. When Zovirax was switched, it was very well accepted by GPs and the public.
A good switch is where you find a consumer need healthcare professionals’ support for that need, and you’re able to communicate the product’s benefit
What makes a good candidate for a POM-to-P switch?
A good switch is where you find a consumer need (for example, discomfort or being embarrassed by a condition), healthcare professionals’ support for that need, and you’re able to communicate the product’s benefits and how it can be used easily through advertising and the information in the pack.
Could self-selection of pharmacy medicines have an impact on patient safety?
No, I don’t think so, because the pharmacist is always there. There is always the opportunity for the pharmacist to intervene at the time of the purchase. At the moment, every pharmacy medicine sale should be under the supervision of the pharmacist. That wouldn’t change.
The British pharmacist professional body, the Royal Pharmaceutical Society (RPS), is against self-selection of P medicines. What is your position on this?
Whether pharmacies put something on self-selection or not is up to the profession to decide. The PAGB has done projects on this and found that when you put general sale list products (GSL) on self-selection, the consumer thinks that the pharmacy has more medicines than the supermarkets. We studied the impact of putting GSL products specifically on self-selection in 1993–1994 because during that time the profession’s Code of Ethics, administered by the RPS, did not allow self-selection of any OTC medicines in pharmacies. I expect that with P medicines on self-selection the consumer is likely to think that the pharmacist has even more medicines available. I can only think that is good news for pharmacy.
From our research, the perception in the consumer’s mind is that the supermarkets have more medicines than the pharmacy because they don’t see the full range of medicines on display. They see shelf upon shelf of medicines in the supermarket.
For those who are not sure about what they need to get, they will not just pick a medicine off the shelf. They will want to speak to somebody.
In the supermarket, the purchasing behaviour of consumers is that they know what they want because they have already bought it before, so they are stocking their medicine cabinet. That is not usually what they are doing in a pharmacy, so I think they will actually ask questions if they need to before making a purchase.
What do you think of the criticisms surrounding lack of evidence of efficacy for some OTC products, such as cough medicines?
Cough medicines are the main category of products that always comes up for this type of criticism because of the nature of what they are treating. Doctors will always want to know what’s causing the cough before they think about what they might do to treat it. Everyone forgets that a cough medicine is meant to relieve symptoms only. Let’s say you have a cough and you have a meeting you need to attend or need a good night’s sleep; you take it for that purpose. You know it will wear off in a couple of hours because you know you haven’t cured it. The consumer knows that. Doctors describe that as not being effective, but actually it is from the consumer’s point of view.
What about the inappropriate use or abuse of certain OTC products, such as laxatives by those seeking weight loss? How can this be better managed in pharmacies?
The reason that we pay so much attention to the labelling of products is because we stress over and over to take the medicine according to the packet and the leaflet instructions. You can’t go wrong if you do that. It tells you how much to use, what to use it for, when not to use it, and what happens if you overuse it.
Most people use laxatives according to the instructions. A minority may be misusing laxatives. We have to rely on the instructions being good enough for them to understand. It’s important to treat the eating disorder first and not focus on the laxative.
Sildenafil is available OTC in New Zealand, Spain and Greece. In the summer of 2014, Sanofi said it wants to make another erectile dysfunction drug Cialis (tadalafil) available as a P medicine. What is the impact to men’s health if this were to happen?
From the Men’s Health Forum perspective (of which I am vice-chairman), the distress that erectile dysfunction causes and the additional distress when it is linked with a long-term condition like diabetes should be helped. So this can only be good news for men. It is even better news for pharmacy because this is one area where pharmacists can use their clinical judgement to help men who don’t always see a healthcare professional.
How does the UK compare to other large OTC markets such as the United States and Germany?
The UK is the leader in switches, after New Zealand, and the leader in Europe. In terms of self-care policies, we probably have more than even the United States. Since 2000, there have been more than 20 policy documents about either self care of minor ailments or self management of long-term conditions.
Is the UK the most innovative in terms of POM-to-P switches?
We don’t always lead with the ingredients, but we have done more than others in terms of the numbers of switches. The first topical hydrocortisone switch was in 1983 in Sweden and it took us until 1987 to switch it in the UK. But then we had the first statin in the world and the first emergency hormonal contraceptive, Levonelle, available over the counter.
Self Care Week is an annual national awareness week that focuses on embedding support for self care across communities, families and generations. For information and ideas on how you can support customers with self care, visit http://www.selfcareforum.org/events/self-care-week-resources/
Interview by Elizabeth Sukkar