Splitting Of Erectile Dysfunction Pills

by Simon Delicata

Pill splitting is the practice of splitting a pill in half, thus creating two pills, each aimed at being half the dose of the entire pill. This is typically done with a knife, using a pair of scissors, by hand or with a designated pill splitter. The main reason for pill splitting is a financial one. Pharmaco-economically speaking, a drug which is twice as strong as another may not be twice the price, in fact it may indeed be the same price. In order to make costs savings, patients choose to split a high-dose tablet to create two lower dose tablets.

What’s the latest data on pill splitting?

In May 2009, Bayer surveyed 500 erectile dysfunction (ED) patients in five European countries (France, UK, Italy, Germany and Spain). The findings shed new light on the prevalence of and reasons for pill splitting¹:

• 50% of those ED patients surveyed admitted to splitting their medication. This rose to 59% amongst high dosage users, which is more than every second patient;
  • Of the total number who split their pills, 36% always split them and 40% split them every second time;
• Other reasons cited for pill splitting, over and above cost savings, were the belief that half the dosage is sufficient and that side-effects will be reduced, as well as concerns about too strong / lasting effects;
• Cutting with a knife was identified as the most popular way to split pills.

The implications of pill splitting

There is much debate amongst healthcare professionals and authorities regarding the implications, both positive and negative, of pill splitting. Although the cost-saving benefits are widely accepted, there are concerns about the impact on both patients and healthcare professionals. The US Food and Drug Administration (FDA) and the

American Medical Association  for example, advise against pill splitting unless it’s specified in the drug’s labelling². There are a number of reasons for this:

• Confusion over the correct dose. There have been cases when people have purchased higher strength tablets intending to split them, but then haven’t, leading to patients accidently taking the wrong dose.

Equal distribution of medicine. FDA studies² have shown that the actual dose in each half of a split tablet often is different. So while the two halves may look the same, they don’t necessarily contain equal amounts of medicine. For the uniformity of mass of subdivided tablets a requirement has recently been set by the European Pharmacopoeia. Loss of mass upon breaking can be limited to not more than 1%.

• Difficulty splitting. Some tablets are too small to split, may have an unusual shape that makes them hard to split, or may crumble more easily when split.[i]

From a healthcare professional’s point of view, pill splitting means that they have limited control over the exact dose their patients take.

Bayer Cuts Price of its Erectile Dysfunction Drug Levitra^®

Levitra^® (vardenafil) is available in three different dosages – high (20mg), medium (10mg) and low (5mg) dose

Based on Individual Member State data, the most frequently prescribed dosage is the high one, but the most frequently taken is the medium dosage. This is because of pill splitting. ED treatment is different from many other therapy areas. It is a common, life-changing condition, yet there is no government reimbursement for treatment in most countries.

Because patients have to pay for ED treatment themselves, more than 50% of men with ED have been saving money by buying the high dose tablet and splitting it in half.

Bayer has therefore taken the decision to lower the price of Levitra^® dramatically as a responsible course of action to meet men’s needs – both therapeutic and economic – to help tackle this important ED treatment issue. Bayer has proactively reduced the price of its medium (10mg) and low (5mg) dose Levitra^® (vardenafil HCL) in Malta so each dose is now approximately half the price of the next higher dose.

Now, patients who are currently splitting ED tablets such as Levitra^® will have an option that specifically meets their dose requirements at significant savings, and doctors will have better control over the dose they prescribe.

In Malta, Levitra^® is being sold at the revised prices with effect from 1^st October 2010.  The quality and efficacy of Levitra^® will not be compromised as a result of this price revision. Bayer Schering Pharma has consistent quality standards, which are checked periodically by local and regional health authorities. On the contrary, the reduced price of Levitra^® removes economic hurdles for all ED patients who split pills and offers them greater convenience by removing the hassle to split pills, eliminating the possibility for wastage during splitting and lowering the financial outlay compared with competitor brands.

Levitra^® is a proven ED medication which is well tolerated, and with a good safety profile in patients of all ages, with or without underlying medical conditions. It is the only PDE-5 inhibitor that extends duration of erection, as measured by a stopwatch method, up to 3 times over placebo.³ It is now available in pharmacies in Malta and Gozo at a new and more competitive price.

References

1. Market research: ‘Pill Splitting Behaviour Among PDE V users’ Conducted by PSYMA in May 2009

2. US Food and Drug Administration : Consumer Updates. July 2009 http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm171492.htm

3. Rosenberg MT et al. Improvement in duration of erection following phosphodiesterase type 5 inhibitor therapy with vardenafil in men with erectile dysfunction: the ENDURANCE study. Int J Clin Pract 2009; 63:1