There is excitement in the OTC, and it's not just the Italian one and not even the dispensing through supermarkets. Or rather, not only.
There are in fact some more general trends, on both sides of the Atlantic, which are moving the scenario. He revealed them in a long article by Pharma Voice, a specialized US periodical. In the first place, there is a strong observation: 700 products that are on free sale today were still subject to prescription 25 years ago. This has at least two consequences. The first is that we are witnessing, today and in the future, a slowdown of the switch, simply because the cases in which this can be done easily are less and less. Furthermore, if you want to consider the transition to free sale as a standard element of a product's life cycle, it is good for the company to think about it in time.
There are in fact some more general trends, on both sides of the Atlantic, which are moving the scenario. He revealed them in a long article by Pharma Voice, a specialized US periodical. In the first place, there is a strong observation: 700 products that are on free sale today were still subject to prescription 25 years ago. This has at least two consequences. The first is that we are witnessing, today and in the future, a slowdown of the switch, simply because the cases in which this can be done easily are less and less. Furthermore, if you want to consider the transition to free sale as a standard element of a product's life cycle, it is good for the company to think about it in time.
For Andy Tisman, head of the consumer sector of IMS, if the transition to OTC status is envisaged, ad hoc research must already begin in phase III of the clinical trial, so as to evaluate the efficacy and safety of different dosages. Certainly not everyone is inclined to an investment that could give a return only after about fifteen years. As for the areas that remain more attractive and practicable, there is the gastroenterological one, where AstraZeneca's Prilosek has paved the way, and that of upper respiratory tract disorders, with the possible arrival of Pfizer's cetirizine, again on the basis of Schering's loratadine Plough. Then there is the classic sector of painkillers, but we are talking about a crowded segment, given that ibuprofen, naproxen and the other more or less tested NSAIDs have been depopulating for some time. Also according to Tisman, the novelties could come in the treatment of asthma and with regard to lifestyle products, ie treatments for obesity, erectile dysfunction and hormonal contraception. For these last two points it is easy to guess a very American vision of the question, i.e. distant from religious conditioning, as far as the pill is concerned, and from a slightly more cautious gaze of the Regulatory Authorities on drugs for erection (and never mind if they are also sold through porn-shops). Moreover, also in the United States the arrival of levonorgestrel for emergency contraception (Plan B by Bar Pharmaceuticals) has given rise to a double mode of dispensing: by prescription for under-18 women and as OTC for eighteen-year-olds and beyond.
There are also those who foreshadow developments in the sector of medicines dedicated to risk factors, such as statins in primary prevention. Here too there is a precedent: simvastatin, introduced as OTC in the British market. The idea has not been successful in terms of sales and, according to Tisman, this is due to targeting. The statin was in fact aimed at young people with mild-to-moderate hypercholesterolemia, people who were not inclined to consider themselves ill and, therefore, to undertake chronic therapy, even if a recent comment, signed by Cesare Sirtori in the Lancet, believed that there were sufficient elements, from public health point of view, to recommend such a strategy. The point, however, remains that OTC is still considered the go-to resource for acute and ultimately self-limiting conditions. In practice, without the discomfort of the symptom, it is difficult for the patient, in the absence of the doctor, to develop adequate compliance and adherence. Unless, and perhaps in Italy this would be the right moment, we rely on pharmaceutical care.
Paradoxically, the arrival of molecules with more problematic management would encounter fewer difficulties in a situation such as the European one where even the f
There are also those who foreshadow developments in the sector of medicines dedicated to risk factors, such as statins in primary prevention. Here too there is a precedent: simvastatin, introduced as OTC in the British market. The idea has not been successful in terms of sales and, according to Tisman, this is due to targeting. The statin was in fact aimed at young people with mild-to-moderate hypercholesterolemia, people who were not inclined to consider themselves ill and, therefore, to undertake chronic therapy, even if a recent comment, signed by Cesare Sirtori in the Lancet, believed that there were sufficient elements, from public health point of view, to recommend such a strategy. The point, however, remains that OTC is still considered the go-to resource for acute and ultimately self-limiting conditions. In practice, without the discomfort of the symptom, it is difficult for the patient, in the absence of the doctor, to develop adequate compliance and adherence. Unless, and perhaps in Italy this would be the right moment, we rely on pharmaceutical care.
Paradoxically, the arrival of molecules with more problematic management would encounter fewer difficulties in a situation such as the European one where even the f
