The US law requires that drugs that could not be used safely without professional supervision, are dispensed only by prescription. Those are drugs, which can cause the development of addiction, be toxic, pose a high risk of side effects, or intended for use in conditions that may not be in the majority of cases diagnosed by the patient alone.
All other medications can be dispensed without a prescription, that is, may have a non-prescription status. The process of changing the status of drugs in the US is called the Rx-to-OTC switch. As a rule, drugs may change the status by two procedures: review of OTC drugs or providing additional information to the manufacturer of the original NDA application.
Procedure for reviewing with OTC drugs is carried on since 1972 in the form of continuous monitoring (evaluation) safety and efficacy of OTC medicines. The first stage of the status change process involves the review of the active ingredients (active substances) by the non-governmental experts to determine whether they can be attributed to safe and effective drugs.
The Commission is also reviewing the components of a prescription drug, to determine whether they are suitable for OTC use.
The second common mechanism of changing the status of the drug is to amend manufacturer in a certificate of registration (NDA) of the drug. Under this procedure, the producers send information to the FDA, which demonstrates (proves) that the drug is suitable for self-treatment. This information is provided by drawing up a new NDA application, or as a supplement to the approved registration dossier New Drug Application (NDA).
Often the submission of an application includes research data, which shows that labeling can be read and understood by consumers, which will allow the patient to adequately apply the drug (without the help of a doctor).
FDA reviews the presented data, along with all the available information about the history of the use of prescription medication. Despite the fact that the US law allows to assign OTC status to a drug as the initial approval (for market introduction of innovative medicines), in most cases, the original drug hits the market in prescription status. Over time, with the appropriate data on its safety and efficacy, along with expert judgment that the drug can be used for self-medication, prescription medication can change the status.
Since there is no perfect formula for uniquely evaluate the risk / efficiency correlation, the review of the FDA drug status change is individual for each case. As a rule, the decision making process involves experts, who are members of the relevant professional health committees.
If the status-change making decision experts suspect possible adverse reactions, they can recommend to reduce the dose of the active ingredient. In such case the medicine should demonstrate effectiveness.
Undoubtedly, one of the most important componentsof proper quality, efficacy and safety drug provision to patient is to collect data on adverse reactions from the use of drugs, by the the pharmacovigilance system.
WAR OF THE WORLDS: OBTAINING THE OTC STATUS
CIALIS THREATENS TO SHAKE THE POSITION OF VIAGRA
Perhaps soon, millions of men around the world will sigh with relief: at last they will be able to acquire the coveted tadalafil without prescription, thereby eliminating such an embarrassing procedures as a visit to the andrologist. Multinational pharmaceutical company Eli Lilly, the owner of Cialis trademark, has signed an agreement with one of the world’s leading pharmaceutical companies Sanofi, according to which the two companies will create a united front in order to lobby the drug’s OTC status. In accordance with the agreement, Sanofi will prepare the necessary documents and submit the request for exclusion of Cialis in the list of prescription drugs in the United States, Canada, Australia, Europe, and after the expiry of patent protection will begin selling this wonderful means to combat erectile dysfunction, total revenue from the sale of which in the past year counted with slightly less than 3 bln. dollars.
CIALIS IS PREPARING TO ENCROACH ON THE SACRED
If Cialis acquire OTC status, it will be a devastating blow to the hitherto unshakeable positions of Viagra, Pfizer’s (pharmaceutical company) “child”. The lack of the prescription barrier is a powerful competitive advantage in the battle for the minds, or rather, for … well, you know what. But do not rush to give Cialis its palm of victory in advance: it is still unclear how this initiative will be considered by the regulators, who will review the request. Especially since Pfizer had a negative experience in this field: in 2008, the company had applied for assign the OTC drug status, and the European Medicines Agency refused. But officials Eli Lilly simply exude optimism. “Millions of people today having no alternative trust Cialis in the most difficult situations, – says David E. Ricks, head of one of the company’s department which makes the laboratory and clinical studies. – We are very pleased to work with Sanofi to achieve our common goal: to help men suffering from erectile dysfunction tadalafil drugs and make much more accessible than it is now.”
PER ASPERA AD ASTRA
Another circumstance which suggests that Cialis’s road on the way to OTC “paradise” will not be awashed with roses, is that this drug does not lack of certain side effects. Suppose they are not critical and do not pose an immediate threat to health. Nevertheless, like any representative of the group of phosphodiesterase-5 inhibitors, Cialis is not compatible with nitrates – drugs for the treatment of breast-pang. This pharmacological combination threatens the considerable blood pressure decrease down to the collapse. For this reason, the official representative of the Office of the Food and Drug US agents said that in the near future they will work out a list of studies to be made before the review of assigning the OTC status to Cialis.
PROTECTION FROM GENERICS
It is quite common when pharmaceutical companies are beginning to fuss and push their most popular drugs in nonprescription field shortly before the expiry of patent protection. This tactic is clear to be financially motivated, because after the original drug loses the exclusivity of its pharmaceutical substance companies specializing in the production of generic drugs can start (and always will) to use it. Assigning the OTC status to the original drug allows to mix the financial losses caused by the entry of cheaper generic drugs into the market. For example, a story about the drug “Prilosec” which all the heartburn sufferers know. This original omeprazole created by Swedish pharmaceutical company Astra Zeneca, was sold strictly on prescription until 2003. However, after the expiry of patent protection the company was able to lobby their medication’s OTC status, thereby avoiding substantial financial losses caused by the issuance of copies of generic omeprazole by several companies. Then the same thing happened with the drug Nexium (esomeprazole original), rights on the OTC implementation of which have been sold … to whom do you think? To Pfizer Group.
All the experts agree that if not for the prescription status, the already high sales of Cialis, Viagra and similar drugs would have ascended to heaven. Indeed, the social stigma of erectile dysfunction hinders many men from visiting the andrologist. To some extent, online pharmacies help to solve this problem. Same Pfizer in 2012 began selling Viagra online on its website. The most inquisitive of our readers may exclaim: “What are you pushing to me here?! Never bought I your Cialis without a prescription!”. Indeed, the Russian doctors often do not consider it necessary to prescribe drugs to increase potency and pharmacies in order to improve implementation deliberately release them without proper medical prescription. Yet once again we caution our readers: if you purchase Cialis in order not to diversify your sex life, but as the only hope to defeat erectile dysfunction – see your doctor: Is it possible that there is a much more serious pathology than the blood circulation disturbance in the genital area.
American Regional WHO Office proposed a criteria for the classification of drugs.
OTC drug is medicine that meets the following criteria:
- The drug is proved to be efficacious and safe in use for the prevention and relief of symptoms of disease, as well as for the treatment of mild cases, not requiring complex diagnostic and treatment methods.
- The drug possess a high degree of safety, and the conscious or unintentional exceeding the recommended dosage is not seriously dangerous to the patient’s life and health.
- The drug has a wide dosage range that allows to choose the needed dosage to patients of different age and weight.
- Does not cause tolerance or addiction.
- When used according to instructions does not mask the symptoms of serious illnesses, and also does not hinder diagnosis and timely treatment of pathological states requiring medical intervention.
- The drug is proved to be safe for using by all age groups.
- Can be used by patients themselves at home and does not require special regimen and storage.
- The active components were broght to the market and made available to the consumer, at least 5-10 years ago, and during this time the drug demonstrated high safety and efficacy level.
- Since its release to the market of drug’s active ingredients adverse or unwanted reactions in response to the use of this drug were not detected.
- Active components of the drug previously were included in the list of OTC drugs. In Europe and throughout the Western world now there is a tendency to increase the number of OTC drugs. It is connected with the desire:
- To make the costs of the distribution of medicines the responsibility not of the state but of the consumer.
- To expand the rights of the consumer and to encourage self-treatment, improve access.
- To extend the market life of products, which have their patent term coming to end.
In many countries, pharmacists step towards expanding the range of OTC drugs, as it expands the range of drugs available to them in consultations on the treatment of symptoms of mild cases and diseases that run their course. This original function of pharmacists was increasingly important for them at a time when the technical aspects of medicines dispense were standard, and the ability considered in the past to be essential to cook extemporary preparation is in little demand. However, the need of pharmacists professionalism which is required in pharmaceutical assistance programs and in the optimal drugs use, which connects pharmacist with patient and a doctor, is increasing.