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Session 3: RX to OTC – Deregulation of Prescription-only Medicines
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Chair: Ingunn Björnsdóttir, EuroPharm Forum Executive Committee Member and Member of the EuroPharm Forum Professional Advisory Board |
 The Manufacturer’s View
(link to PowerPoint)
Hubertus Cranz, Director General, Association of the European Self-Medication Industry (AESGP), Belgium
Dr Cranz stated that there were interesting developments underway in deregulation of prescription-only medicines (DPM).
Dr Cranz particularly touched upon the areas of anti-allergy, acid-related disorders, analgesics, antiinflammatories and antirheumatics, which had all undergone a change in administration from prescription to DPM in the past. The first centralised switch to take place (in 27 EU countries and related countries concerned the H2 antagonist Pantoprazole. Lately, antimigraine medicines were being deregulated in some countries, just as cholesterol and obesity were coming into focus, the latter being of particular importance to pharmacists and their role. The deregulation of Simvastatin in the UK had represented a disappointment, as it had not received support from the pharmacists, and sales had declined to virtually non-existing. On the other hand, Orlistat had been successfully released, centrally and initially, as a non-prescription medicine. Moreover, the trends showed that more medicines for treatment of pain, colds/allergies, gastrointestinal and skin conditions and long-term conditions relating to the heart (smoking, obesity, cholesterol etc.) were being deregulated.
The deregulation of some medicines, Dr Cranz continued, depended on their use, for instance antifungals which had moved to non-prescription status for dermatological and gynaecological use. A more controversial case was in the area of STDs where, for instance, the UK had recently decided to move Azithromycin (for treatment of Chlamydia) to non-prescription status despite the risk of developing bacterial resistance. This was done as a service to the public to increase the health level based on the concept: less restriction and wider accessibility means better public health, as this medicine focuses mainly on young people who would tend not to consult a GP for treatment. This concern was also an issue for some gastrointestinal conditions.
In conclusion, Dr Cranz added that it was imperative for a successful switch to have the support of the pharmacist, as advertising alone could not do it. The industry, therefore, saw an important role for the pharmacist, and it was in the companies’ interest to provide pharmacists with sufficient support for their counselling services. He also believed that it was politically important for pharmacists to play an evident role in switches. Finally, Dr Cranz referred to the public “Switch Database” compiled by his organisation over a number of years.
National Example: Hungary
(link to PowerPoint)
Balázs Hankó, Secretary, National Committee of Pharmaceutical Care, Hungary
Dr Hankó referred to a patient survey carried out by the Hungarian Chamber of Pharmacists. In this survey, 70 % of the patients stated that they required professional information on RX drugs; only 51 % stated the same with respect to OTC drugs. 68 % of the respondents obtained their information on RX drugs from the GP, whereas 48 % of the patients were informed by pharmacists about OTC drugs. Looking at how people trust this information, 79 % trust the information from the GP, while 82 % trust the information from the pharmacists. Dr Hankó concluded that, to patients, pharmacists represent the most trusted source of information.
In order to match this trust, the Hungarian National Committee of Pharmaceutical Care has developed protocols for RX and OTC dispensing. These include algorithms on how to ask questions and provide information to patients.
National Example: The Netherlands
(link to PowerPoint)
Maayke Fluitman, Vice President, KNMP, The Netherlands
Ms Fluitman provided a brief introduction into the situation in The Netherlands where pharmacies and druggists exist in parallel. Druggists may sell medicines on the general sales list. In order for a drug to be on the general sales list, the following criteria must be met: minimum five years’ experience with the active substance in the EU or in the USA as a medicine available OTC; negligible risk of harm; no indications of abnormal use; number of units per package relatively low, and; package and package leaflet warn about possible risky situations. Pharmacy druggist medicines (PDM) can be sold through druggists and pharmacies and pharmacy-only medicines (POM) can only be sold through the pharmacy.
Concerning patient counselling, the pharmacists have a number of tools available from various sources: professional standards (with GP’s input), customer questionnaires (digital), training modules and fact sheets from the KNMP.
In The Netherlands, it is possible to obtain payment for professional advice/services, but not many pharmacists make use of this opportunity for income.
Ms Fluitman ended her presentation by stating that pharmacists should be professional and prove themselves as healthcare professionals and let the patient decide whether or not to buy a medicine in question. However, it is difficult to get all Dutch pharmacists to think this way and not focus entirely on sales.
Discussion
Following Dr Cranz' presentation and the two national examples, the audience raised a good discussion on the topic of switch medicines. Members clearly expressed that they welcomed the fact that the Forum had raised the question of the role of the pharmacist in dispensing switch medication, and they would like to see the field investigated further on another occasion.
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Welcome to the EuroPharm Forum!