Rx-OTC switch trends as a result of OTC market growth

Around 90 switches were approved by the US Food and Drug Administration (FDA) between 1976 and 2009. This translates into 700 products. Since 2001, changes in the legal and administrative status have been carried out for 24 pharmaceutical products. In the years 2005, 2008, and between 1 January and 31 March 2010 no Rx-to-OTC switches were registered.

 

 

The US, a market experienced in the Rx-to-OTC switch process, saved 7% of the cost of prescription medicines in 2007-2009 as a consequence of the development of switches. According to the US Centers for Medicare & Medicaid Services (CMS), the forecasts for the year 2014 assume the US market will save close to $13bn (over €10bn) thanks to the switches.

The Association of the European Self-Medication Industry (AESGP) and the World Self-Medication Industry (WSMI) have recorded the following switches in Poland: Naproksen (1998), Etofenamat (1999), Butylobromek hioscyny (2000), Bifonazol (2002), Orlistat (2009), Pantoprazol (2009).

Painkillers (e.g. Pyralginum, No-Spa) are a popular category of drugs undergoing switches in Poland, as are anti-flu and anti-cold products, immunity boosters (Biostymina, Nasorin), or medicines used in cardiovascular diseases (Otrex 600, Pelethrocin, Phlebodia) and diseases of the digestive system (Polprazol, Tabulettae laxantes).

Data released by PharmaExpert[1] shows that in 2009 the number of Rx-to-OTC switched products increased by a half on the year before. Fourteen such changes were introduced in Poland last year. The activity in the first five months of 2010 indicates the results for this year will be similar.

Reclassifying a pharmaceutical product from Rx to OTC is not always a smooth process. In some instances, the over-the-counter status can be withdrawn, as was the case with Tussipect tablets (produced by Herbapol), whose Rx-to-OTC status was withdrawn on 28 December 2007. According to PharmaExpert[2], in 2008 one product has changed its status from OTC to Rx, and in the following year there were eight such products.

Due to the financial benefits of self-medication, it is highly probable that the number of changes in the criteria of administrative and legal availability of Rx-to-OTC switches will gradually increase. The direction of changes dictated by market mechanisms may lead to a dynamic growth of the switch trend and to the extension of mechanisms supporting OTC sales.

The OTC turnover has been growing systematically from year to year. In 2009, the share of OTC sales in total pharmacy sales in Poland (by value) rose to 36%, compared with 29% in 2004.

 

 

Since 2005, the number of pharmaceutical products cleared for sale in Poland has grown every year, and in the first quarter of 2010 the value of all the products matched the figures from the entire period of 2005. This upward trend resulted in increased numbers of drugs on the Polish market – in 2009, the quantity of all products released for sale was more than double the results from 2004, and the number of OTC medicines was nearly four times higher.

 

 

The average price of medicines purchased in Polish pharmacies in 2009 was higher than the year before by 7.1%. In May 2010, the growth on May last year amounted to 8.8%. The rise in medicine prices has most likely been triggered by the consolidation of the market of drug distributors, who have consequently grown in strength, and are able to impose prices. The weakening of the zloty has also influenced the market, resulting in the increased production cost expressed in euro.

 

 

The average price of OTC medication purchased in pharmacies is approximately three times lower than the price of a refunded product. Such disparities, as well as the wish to save time, encourage patients to try self-medication. More and more drugs receive a double Rx/OTC status, depending on form, dosage and strength. Pharmaceutical products that have not undergone switches and are widely approved for self-medication on a global scale are those used in the treatment of vaginal candidiasis (imidazoles), and of chronic rhinitis (antihistamines). However, switches are also expected in the area of cholesterol-lowering products (HMG-CoA reductase inhibitors), and drugs mitigating asthma symptoms (bronchodilators).

 

 

In the US, pharmaceutical companies increasingly often cooperate to retain a double Rx/OTC status of products, which requires experience and significant investments. The tendency is equally popular in Europe – Procter&Gamble has begun working with Astra Merck to maintain the double status of Omeprazol, achieving highly successful sales as a result. Obtaining the double Rx/OTC status is likely to become the top priority for producers in the future. The trend stresses the independent choice of buyers, giving them a sense of control over the condition of their own health.

 

According to the Pharmaceutical Law, the basic requirements for receiving an OTC status are a documented safety profile of the drug and clear instructions of use intelligible for patients. A Ministry of Health regulation on leaflet clarity testing, introduced on 2 June 2010 (Journal of Laws No. 84, item 551), outlines a method of testing leaflet clarity and criteria for a subsequent report. It is the first legal act in Poland controlling the issue. The purpose of the regulation is to ascertain that a user will understand the essential information included in the leaflet, and that they will be able to properly use the product. A negative result in a leaflet clarity test keeps the product from entering the market as OTC medication, until the leaflet has been amended and tested again on a new group of users.

It is worth noting that the Pharmaceutical Law is currently being amended. On 18 June 2010, a bill has been sent to the Chancellery of Prime Minister of Poland, to be looked into by the Council of Ministers. One of the proposed changes regulates mail order sales of pharmaceutical products. The document is to eliminate online sales of prescription drugs altogether, which may result in increased sales of over-the-counter medicines.

As the range of pharmaceutical products cleared for sale in herbal and medicine shops is broadening, a new, detailed list of criteria of releasing the products onto the market has been included in the annex no.3 to the Ministry of Health regulation from 2 February 2009, passed for external arrangements on 15 June 2010. The deadline for submitting comments to the regulation expired on 22 June 2010. The changes in the list relate mainly to the dosage and form of pharmaceutical products. Another significant change proposed is listing products by the name of the active ingredient. It is likely to allow pharmacies to expand their assortment, and to help qualify some prescription drugs as OTC available.

In order to amend the Ministry of Health regulation from 6 October 2009 (Journal of Laws No.171, item 1335), a proposal for detailed listing of pharmaceutical products that can be sold in pharmacies and non-pharmacy outlets was released on 30 November 2009. Comments could be submitted until 13 December that year. On 29 April 2010, the legislative process was still not complete, the delay probably resulting from numerous mistakes and oversights, i.e. spelling errors in product names or wrong dosage information. A number of medicines that fulfil the classification criteria have been submitted for adding to the lists of products cleared for sale in either pharmacy or non-pharmacy outlets.

 

 

Agnieszka Paszczela