What medications can give out with that medical prescription and to what extent could this benefit the health system and the patient?
Although this possibility exists, a series of potential risks that could worsen the patient's health (counting with factors such as self-medication) must be taken into account, and therefore the pharmacist's role is essential for the use of these medications. , thus guaranteeing the criteria of efficacy and safety.
Throughout history, we found great examples of medications that initially required a prescription and that suddenly changed their prescription and are now distributed freely in pharmacies and at the discretion of the patient and the pharmaceutical board. This is the case of the known ibuprofen for acute pain or Paracetamol for duration of fever. We also find antihistamines for the treatment of allergies (such as cetirizine or loratadine), proton pump inhibitors (omeprazole), antivirals for the treatment of cold sores (penciclovir or acyclovir) 2 or, more recently, hormonal contraceptive treatment with levonorgestrel, known as the morning after pill, with its non-prescription sale since 2009.
This type of change in legislation is known as a "switch", and is carried out not only in Europe, but also worldwide. This proposal originated in the United States, where Rx (medical prescription) and OTC drugs began to be differentiated for the first time in 1951 with the Durham-Humphrey Amendment. It defined the criteria according to which prescription medications could be used only under the supervision of a doctor, while all other medications could be sold as "over the counter", outside the counter. In 1962, the Kefauver-Harris Drug Amendments introduced more severe controls. At that time, manufacturers had to prove not only the safety of the products, but also their effectiveness in the indications that were planned for them.
Currently, the World-Self Medical Industry tells us for which conditions they could initially be considered non-prescription medications, due to their capacity for self-diagnosis and self-care
Regulatory criteria
Even so, what are the regulatory criteria that a medicine must meet to consider its otc to RX switch? The Agency for Medicines and Health Products postulates that a medicine not subject to medical prescription should consider processes or conditions that do not require an accurate diagnosis and whose toxicological evaluation, clinical data or its use and route of administration do not require a medical prescription .
In addition, it should be noted that such medication:
• Cannot be financed with public funds.
• May not contain psychotropic or narcotic substances.
• Both its composition and its objective should be intended for use without the intervention of a doctor who makes the diagnosis, prescription or follow-up of treatment.
Of course, this option is not applicable to every otc drug development medication that requires a medical prescription, since all the safety and efficacy factors of its possible use without medical control must be taken into account, since there are drugs that can generate a dependency or whose levels of toxicity and adverse effects can be high, even with the administration of other medications due to the different interactions that could lead to.
In turn, also when assessing its availability we must take into account the route of administration and the consequences that may arise from its excessive use (maximum daily dose). The marketing time of the product registered over the years is also assessed, as well as the number of cases reported by pharma co vigilance, both of interactions and adverse effects, taking into account that, the greater the number of reported cases, the lower It will be acceptance as a future candidate for a switch .
In turn, also when assessing its availability we must take into account the route of administration and the consequences that may arise from its excessive use (maximum daily dose). The marketing time of the product registered over the years is also assessed, as well as the number of cases reported by pharma co vigilance, both of interactions and adverse effects, taking into account that, the greater the number of reported cases, the lower It will be acceptance as a future candidate for a switch . Also before lunch of medicine in market it must be approved by FDA.
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