OTC and RX drugs are the most common drugs. Their share in the pharmaceutical market is about 80%, and in terms of stock quantity they include more than one and a half thousand items. These drugs are one of the most highly profitable components of the production and marketing of drugs, but their release is fraught with some safety requirements for the patient. Next, we try to explain in simple words what it is.
OTC drugs: what is it?
All medicines that are on sale can be divided into 3 large groups:
- prescription (RX, from the Latin word recipe, - “take”) - sold only by prescription;
- OTC - dispensed to consumers in the pharmacy network freely;
- hospital - used, as a rule, only in stationary conditions (for example, blood and plasma substituting solutions, chemotherapeutic drugs and others).
The first group of drugs is characterized by the fact that they can have an undesirable effect on the health of the patient, even when used correctly. This is due to high toxicity, the risk of disruption of vital processes, the formation of dependence with prolonged use and a high level of interaction with other drugs, accompanied by adverse reactions.
After completing the course of treatment with the prescription drug, the patient may experience a deterioration in well-being, the appearance of new symptoms and conditions caused by changes in the receptor pool, which is affected by the active components. Therefore, only a doctor can prescribe such a medicine, after evaluating the possible risks to the patient’s health. Most often, all new pharmaceutical preparations in the first five years of implementation belong to this group of drugs.
The interpretation of OTC drugs is associated with the abbreviation formed from the English words over the counter, which means "without a prescription." Among them, there are also many of those drugs that cause side effects, especially when used improperly. However, they are characterized by common parameters that they must satisfy.
Criteria
OTC drugs are a large group of drugs that can be purchased for self-medication in a pharmacy (and in foreign countries - and in supermarkets). There are the following main criteria, on the basis of which they can be attributed to OTC:
- low level of general toxicity;
- lack of carcinogenicity, genotoxicity, effects on the reproductive system;
- wide experience of use in therapeutic practice;
- the absence of pronounced adverse reactions when interacting with other commonly used drugs;
- good knowledge (lack of components whose effect on the human body is not well understood).
The final decision on the distribution of drugs in the OTC and RX groups of drugs is made by the health authorities of each state.
Disadvantages of OTC Drugs and Pharmaceutical Trusteeship
The disadvantages of OTC OTC drugs include the effect of an indirect health threat. It lies in the fact that when taking the medicine, a situation may arise when the elimination of symptoms "masks" the main cause of the disease. As a result, the correct diagnosis and adequate therapy will be appointed later, and the possibility of successful treatment is lost.
Therefore, in modern medicine, the term "OTC drugs" is inextricably linked with pharmaceutical care. In 1994, the role of pharmacists was revised by the World Health Organization and a new resolution was adopted. A change in the pharmacist's function in a pharmacy is due to several reasons:
- the rapid growth of the range of drugs and the large amount of information that the attending physicians do not have time to master;
- a significant increase in the cost of services in the health care system and, in connection with this, a decrease in state regulation, a decrease in the national budget;
- improving the educational and living standards of patients, which contributes to independent decision-making on their part;
- active advertising of over-the-counter drugs in the media;
- propaganda of an active approach to maintaining one’s health.
Thanks to these factors, pharmacists in pharmacies begin to occupy a key position in the self-medication system. Customers are increasingly turning to them, bypassing the doctor. In order to avoid the negative consequences of this phenomenon, the instructions for the use of OTC drugs indicate complete information in which cases you can self-medicate, and when you need to see a doctor. Most often, this is indicated in the form of the duration of symptomatic treatment, as well as a description of threatening signs. The pharmacist should also state the risks of using the products sold.
Additional security measures
Since OTC drugs are funds intended for self-medication, additional safety measures are provided for them:
- the size of the package is selected so that it corresponds to no more than 1 course of treatment;
- the design of the lids and containers protects the medicine from children's access;
- in the annotation to the drug indicates the maximum daily and single dose.
These factors prevent the misuse of the drug, its overdose and contribute to more timely access to medical care. In some cases, the same active substance can be positioned as a prescription and over-the-counter in the OTC drugs market. To a greater extent, this depends on the type of disease and the concentration of the active compound.
Appointment
OTC drugs are drugs for symptomatic treatment. They do not affect the cause of the pathology and serve for reception in a short period of time. Their main purpose is as follows:
- self-elimination of mild conditions and symptoms;
- reducing the burden on medical institutions;
- increasing the availability of treatment in remote areas where it is difficult to obtain medical care.
If we consider the economic aspect, then expanding the transfer of drugs from the prescription category is currently very profitable, since sales are significantly increasing. Back in the 80s. XX century, large companies in the market of OTC and RX drugs did not show interest in OTC drugs, since their profitability was lower. The situation changed diametrically in the 90s. It has become more profitable for the patient to consult a pharmacist directly when buying a medicine than to spend time and money on a visit to the doctor.
Brand name drugs and generics
As market research shows, over 70% of over-the-counter drug brands are over 10 years old. The most successful ones may be over 50 years old (for example, Bayer Aspirin, which has a 100-year history of branding). In the practice of choosing the most suitable drug, it is necessary to take into account not only its effect on the human body, but also the cost.
To address this issue, the concepts of original and generic drugs are introduced. The former are characterized by legislative protection in the field of intellectual rights to the active substance, that is, the presence of a patent confirming exclusive rights to manufacture and sell the product. Such drugs are the most studied, and their cost is high.
Generics are drugs containing an active substance that has expired patent protection. They can be sold both under the original name, and under another. Deciphering OTC drugs, classifying them as generics or original drugs for ordinary consumers presents certain difficulties, since there can be several tens of analogues at a lower price.
Since expensive drugs are highly marginal, this market segment requires regulation by the state. According to the legal act “Development of Competition in Health Care”, developed by the Federal Antimonopoly Service of the Russian Federation, pharmacists are required to provide consumers with information about cheaper counterparts.
Generics are produced by many pharmaceutical companies in all countries of the world. The main advantage of their production is that the effectiveness of the original products is comparable to generic OTC drugs. Sanfarma Ranbaxi (India) is one of such companies whose products occupy a leading position in the pharmaceutical market of Russia. Many of its brands have been known to Russians since the 90s. XX century ("Faringosept", "Ketanov", "Coldact" and others). The medicines of this company are sold in more than 150 countries of the world. Sanfarma Ranbaksi is one of the five best global pharmaceutical manufacturers of generics.
Classification
OTC drugs are drugs represented by various pharmacological groups. Based on 40 studies in various countries, the following most common conditions are distinguished for the treatment of which they are used:
- fever (high fever);
- cough;
- rhinitis (runny nose);
- sore throat;
- muscle, headache, and joint pain;
- stomach ache;
- indigestion, constipation, diarrhea;
- acne
- cuts, scratches;
- conjunctivitis;
- burns.
Features of the reception
The use of OTC drugs according to the classification indicated above is justified only in those cases that are not severe: fever as a result of acute respiratory illness; rhinitis due to allergic reactions or ARI; sore throat associated with “colds”, hypersensitivity to certain foods, pain in the stomach due to a violation of the diet and others.
Consulting a doctor is necessary when the patient has the following symptoms:
- body temperature is more than 40 ° C, remains at 38 ° C for more than 2 days or is not accompanied by typical symptoms of a cold (runny nose, sore throat, cough, headache and muscle pain);
- lack of improvement within 48 hours or the appearance of additional symptoms;
- persistent cough (more than a week) and cough, with symptoms such as shortness of breath, asthma attacks, chest pain when breathing, thick green or profuse sputum, streaks of blood in it, weight loss, profuse sweating, sudden severe attacks, skin itching ;
- enlarged nasopharyngeal tonsils, the appearance of plaque, sores on them;
- runny nose, in which the following symptoms occur: purulent or bloody discharge from the nose, temperature above 38 ° C, pulling pain in the nose when the body is tilted forward, swelling of the eyelids, pain in the occipital region, secretion with an unpleasant odor, a combination of rhinitis and cough more than a week;
- sore throat with angina, tonsillitis, laryngitis, pharyngitis, and also accompanied by symptoms: difficulty breathing, bright redness in the throat, swelling of the neck, painful lymph nodes, skin rash, dark urine, severe pain in the abdomen, ears, head;
- with joint pain in combination with other signs: the duration of the condition is more than 1 week, fever, swelling, redness of the skin, rash, stiffness of movements in the morning, deformation of the joint;
- vomiting of the color of coffee grounds, with blood, bile, dark stools, heartburn for more than 3 days and other life-threatening symptoms.
Drug Names
The list below answers the question: "OTC drugs - which drugs are they?" Their complete list is reviewed in Russia every 5 years. The main groups of these drugs are presented in the following structure (trade names are indicated in parentheses):
- fever: acetylsalicylic acid (Aspirin, Anopiri n, Acesal, Elkapin), paracetamol (Acetaminophen, Coldrex, Panadol, Solpadein, Piranol), ibuprofen (" Solpaflex "," Nurofen "," Motrin "), mefenamic acid .;
- cough: Ambroxol hydrochloride (Ambrobene, Ambroxol, Lazolvan), bromhexine (Solvin, Bronchosan), acetylcysteine (ACC, Mukobene, Mukomist, Fluimucil), terpinghydrate ( Coldrex), licorice root (Liquiriton, Flacarbin, Glyciram);
- runny nose: oxymetazoline (Nazivin, Nazol, Fazin), naphazoline (Naphthyzin, Sanorin), tramazolin (Lazolnazal plus), xylometazoline (Galazolin, Otrivin, Rizaxil), pheniramine maleate (Fervex, Teraflu), physiological saline (for young children);
- allergic rhinitis: loratadine (Claritin, Cetirizine), cetirizine (Zirtek, Tsetrin), astemizole (Astemisan, Gismanal);
- sore throat: local anesthetics (Coldrex Lary Plus), antiseptics (Faringosept, Falimint, Septefril), combined drugs (Neoangin, Strepsils);
- muscle, joint, headache: paracetamol (Aldolor, Acetaminophen), acetylsalicylic acid (Anopyrin, Aspizol, Aspirin), diclofenac (Artrex, Veral, Voltaren), ketorolac ("Ketanov", "Ketalgin"), indomethacin ("Indomethacin", "Indomin");
- digestive upset (stomach pain, heartburn): antacids or enveloping agents (Phosphalugel, Almagel, Maalox), histamine H 2 receptor blockers (Cimetidine, Histodyl, Ranitidine);
- constipation: diphenylmethane derivatives (Dulcolax, Laxbene, Laxacodyl), phenolphthalein (Purgen), sodium picosulfate (Guttalax, Laxigal), lactulose (Dufalac, Normase), macrogol 4000 ("Forlax").
Market trends
The market for OTC drugs has a tendency to increase - every year it increases by 4-5%. In Russia, the share of OTC drugs is traditionally higher than in other European countries. The release of such drugs is regulated by the Federal Law "On the Circulation of Medicines" dated 04/12/2010 No. 61-FZ.
Analgesics, as well as drugs that regulate the metabolic processes in the human body (vitamins), gastroenterological, antimicrobial and cardiovascular drugs occupy the largest share in the structure of these drugs.
The largest manufacturers in the world market are the following chemical and pharmaceutical companies:
- Johnson & Johnson (USA).
- American HomeProducts (USA).
- SmithKlineBeecham (UK).
- Warner-LambertCompany (USA).
- Bayer (Germany).
Promoting a healthy lifestyle and respect for one's own health among the population contributes to an increase in demand for OTC drugs. Currently, the output of this sector is about 14% of the global market. In most countries, there is also a tendency to transfer drugs from the RX category to over-the-counter, as this generates income estimated at about $ 100 million per year (for each item of the item).