Sunday, 22 March 2015

What Price Switching To Generic Medicines? The Case of The Contraceptive Pill

Amidst the budgetary pressures on the NHS these days, a tremendous amount of managerial effort goes into getting doctors to prescribe generic medicines - and plenty of press tries to get patients to take them. Four pills of the generic version of Viagra (erectile dysfunction drug sildenafil) cost just £3.40, compared with Pfizer's £26 treasure-trove. Yet patients bring generic sildenafil back to The Times' Dr Mark Porter, complaining that it doesn't work as well. 'Do yourself, and the NHS, a favour,' he says, 'and keep an open mind about generics.' Analysts estimated that if two thirds of the branded prescriptions for statins had been changed to generic forms, the NHS would have saved £200 million in 2011-12. Just statins! £200 million! No wonder doctors are pleading with their patients to keep an open mind.

In that plea, however, lies the problem, and the problem is not necessarily what you think. In response to Mark Porter's article, commenter Iolar Mara summed it up nicely:

'I take care of dispensing the myriad of medication that my mother takes on a daily basis...Frequently one or other medication is changed to a different "generic". All well and good, except it may not only be in entirely different packaging, may be a capsule rather than the tablet previously prescribed, may also be confusingly similar in colour to another medication. Instead of arriving in a blister pack, they may be loose in a tub, which requires Herculean efforts to push down and turn the lid to gain access. A task I confess that has defeated me more than once. Imagine therefore the confusion and frustration that an elderly patient may experience when faced with a small yellow capsule and a small white one with a large yellow band, or suddenly a tiny white tablet when previously it was a tiny blue one.'

Generic medicines might cost much less upfront. The problem is that for patients on recurrent medication who are being switched to generic medicines, there is a hidden cost. The cost is how much disruption and error occurs in the duration of the time it takes for the patient to adjust to the different medicine - because 'taking medicine' is, in fact, quite a complex process. 'Patient adherence' is frequently cited by health professionals as a major problem in the efficacy of treatment. Patients simply don't take their medicine as prescribed - the right dosage, the right frequency, the right duration. Yet people who take repeat medication on a frequent basis know that what helps their own adherence is simple: familiarity. 

Familiarity is multi-faceted. It's the knowledge of what your medicine looks like (big pill, little pill, blue pill, white pill), feels like (in a bottle, in a packet), how it's taken (with water, with food, not with other pills), and how often it's taken (once a day, twice a day, within a four-hour window). It's also about what taking your medicine is tied in with: turning off the alarm and rolling over; your first forkful of breakfast; last thing at night before you switch the light off. Familiarity means there is less to remember. The moment there starts to be more to remember, more to think about, more to decide, that helpful complex of familiarity that means that you take your medicine in the same way without fail time and time again starts to dissipate. Perhaps your routine is broken by going on holiday, or a family emergency - or switching to a new pill that looks and feels different. A small change throws out the whole delicate and rather skilful system. Suddenly, for the first time in years, you forget your medicine. This has consequences: some are small, some are big, and some are costly. 

A good example of this is the contraceptive pill. The New York Times reported in late 2014 on research from Princeton University, showing the failure rates for different contraceptives after years of typical use. For every 100 women who have taken the pill for 3 years, 25 will have an unplanned pregnancy. After 7 years, that rises to 48 in every 100. Those are big numbers. The pill is far from fail-proof under ordinary circumstances, by which I mean women doing their best to take it correctly because they do not want to get pregnant. That rising number reflects the aggregate of all the tiny things that could go wrong in the complex system of Taking Medicine, over many years. 

These statistics interested (and scared the hell out of) me because I had happily and with no ill-effects taken the pill for 7 years. It had been the same pill, and it and I had become familiar friends. Taking my pill was the first thing I did every morning, so I always had a glass of water by my bed. I knew the instruction booklet backwards. I had a spare pack stashed in my purse in case of emergency ill-health or luggage disruption. The shape and size of the pack and the patterning of the pills within it - a neat loop around the outside - meant it was easy to take, especially after 7 years. It was familiar to me, and it had always done what it was meant to do. 

Then, six weeks ago, I picked up my repeat prescription and the pharmacist had dispensed me a different pill. It had a different name and came in a different packet. It looked different and it was distributed within the packet in a snake pattern, from left to right, to left to right. It had a different instruction booklet, which told me that ideally I should have started it five days before I picked it up from the pharmacy, as this is what you do when you switch to a different pill. Except I hadn't known to pick up the prescription in time, because I had not switched: someone had switched me and not told me about it. 

I had questions. If it was exactly the same drug, why should I have started it several days earlier than I would have done otherwise? Did I need to replace my emergency stash with a new, generic emergency stash? Why had I suddenly been switched after 7 years? 

The whole business bothered me, because I could feel that for all my familiarity with taking this type of medicine for a number of years, and my firm intention to continue to do so, the switch had slightly thrown my finely-honed Pill Taking system. I remembered it the first two days and then I had a bad night's sleep and forgot it for a few hours, which had never happened before. Somewhere between the novelty of holding, examining, and extracting a pill from this new packet in a slightly different way, and the bad night's sleep, my patient adherence had temporarily failed.

The problem in the case of the contraceptive pill is three-fold: the cost of 'non-adherence' is high - an unplanned pregnancy; adherence is a complex process; 'non-adherence' happens surprisingly often. This means that it's not enough, when doctors switch a woman's contraceptive pill, to ask her to have an open mind, because it is not just about having an open mind. The best defence against an unplanned pregnancy for a woman on the pill is the familiarity, reliability, and predictability of her pill-taking. The potential cost of that process's upheaval is huge - that's why women take it in the first place.

After thinking about it for a couple of days, I called the pharmacist to ask her my questions. She didn't know why the pill I had been dispensed had suddenly changed, because they have been dispensing 'generic' prescriptions for years. So it had just happened; it was random and banal, in the way that the start of something big and costly often is. Although it was not the start of such a thing for me, it was enough to make me sit and think about it for a while. 

When doctors consider switching a patient to a generic medicine, it seems to me that they must make a particular calculation: they need to weigh up the savings to the NHS versus the costs likely to be incurred for the patient in that critical period between novelty and familiarity. Does the patient struggle with their memory? Do they have difficulty with fine motor skills - will they struggle with the new bottle or the size of the pill? Do they travel a lot? Are they sleep-deprived women with small children? How can these costs be managed? To what extent might the costs of switching come back to bite the NHS? 

If the potential costs are relatively high, as I believe they are in the case of the ever-political contraceptive pillthe switch should be controlled. Women should be informed, their questions answered, their preferences explored. It needn't be much - but it could make all the difference. 

So, statin-users, contraceptive-takers, Viagra-poppers, let's do our best to take our medicine 'properly' and to keep our minds open: we are grateful for the wonders and privileges of national healthcare, we want the best for our health, and we don't want to see the NHS crippled by cash shortages. But the gap between 'our best' and perfect 'adherence' needs filling with medical sympathy and systemic skill. Patient adherence is a jigsaw, not a tick-box, and several parties can play. 

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