Innovative medicines on the Russian pharmaceutical market: key players and main areas of development


General recommendations

To ensure that the first aid kit is always at hand, it is necessary to properly organize the storage of medications. For them you need to select a plastic box, a container that closes tightly and does not allow sunlight to pass through. Most medications are sensitive to bright light and require storage at room temperature. Therefore, the box should be placed in a cabinet so that it can be easily reached if necessary. High humidity is dangerous for medications; storing them in the bathroom is not recommended.

Suppositories, interferon preparations and some other medications are stored in the refrigerator. In a warm room they can melt, and drugs with protein components can be inactivated. The box with the home first aid kit is stored in a place that small children or animals cannot reach. Medicines are a source of danger for them.

In order not to confuse which medicine is in the container at home, you do not need to take them out of the original packaging and pour them into jars. For each drug, keep the package insert, even if it is familiar. In an emergency, this will help you quickly decide in what dose to take the medicine.

Original packaging is necessary to control expiration dates. The expiration date of the product must be duplicated on the cardboard box and on the individual blister, bottle or ampoule. Expired medications are dangerous and should not be used.

List of necessary medications in a home medicine cabinet

The composition of a first aid kit is individual in each home, but there are certain groups of drugs that every person should have on hand. They will help provide first aid until the doctor arrives or wait until the morning to contact specialists. But your home medicine cabinet should not include products that are used very rarely.

A first aid kit for use at home should include three main groups of medications:

  • means for treating wounds and dressings;
  • necessary medications;
  • auxiliary medical products.

The last group includes tweezers, clean scissors that can be used to cut a bandage or plaster. The necessary components include a thermometer, mercury or electronic, and a tonometer. If you have a small child at home, you can purchase an infrared thermometer.

Normative base

The general norm establishing the basic requirement for the prescription of drugs is fixed in Part 15 of Art. 37 of the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation.” Thus, from this norm it follows that drugs must be prescribed in accordance with the standards of medical care and clinical recommendations. If the drug is not included in the relevant standard of medical care or is not provided for by the corresponding clinical recommendation, then its prescription is allowed in the case of medical indications (individual intolerance, for health reasons) by decision of the medical commission.

The main regulation of the issues of prescribing medications is established by Order of the Ministry of Health of Russia dated January 14, 2019 No. 4n (hereinafter referred to as Order No. 4n).

The said order approved:

  • The procedure for prescribing medicines (hereinafter referred to as the Procedure for Prescribing Medicines) (establishes the rules for prescribing medicines for medical use and processing their prescription when providing medical care in medical organizations);
  • Forms of prescription forms for drugs: No. 107-1/u
  • No. 148-1/u-88
  • No. 148-1/u-04 (l)
  • The procedure for preparing prescription forms for medications, their recording and storage (hereinafter referred to as the Procedure for registration of RB).
  • Let us recall that the procedures and forms introduced by Order No. 4n began to be applied on April 7, 2021 and replaced the previously valid similar documents, which were approved by Order of the Ministry of Health of Russia dated December 20, 2012 No. 1175n (hereinafter referred to as Order No. 1175n). Order No. 1175n, accordingly, became invalid on April 7, 2021.

    Note: detailed information on the differences in the requirements of Order No. 4n and Order No. 1175n is presented in the article by the Faculty of Medical Law “New procedure for prescribing drugs for medical use.”

    The rules of Order No. 4n are also supplemented by other regulatory legal acts that relate to more specific cases, for example:

    • Order of the Ministry of Health and Social Development of Russia dated February 12, 2007 No. 110 “On the procedure for prescribing and prescribing medicines, medical products and specialized medical nutrition products” (in accordance with this order, or rather in accordance with the Instructions approved by it on the procedure for prescribing medicines and processing prescriptions and requirements - invoices, medications are prescribed when providing medical care in a hospital setting in the invoice requirements sent to pharmacy organizations, which are structural divisions of the medical organization in which medical care is provided);
    • Order of the Ministry of Health of Russia dated 08/01/2012 No. 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as registration rules” (hereinafter referred to as Order No. 54n) (in In accordance with this order, a special prescription form for narcotic drugs and psychotropic substances is issued (according to Form No. 107/u-NP)).

    Wound treatment products

    Minor household injuries, abrasions, cuts and minor burns can be treated independently without seeking help from a doctor. To do this, it is enough to make a home first aid kit properly. It necessarily includes several types of antiseptics and preparations for treating the skin. It is best to have hydrogen peroxide, iodine solution, and brilliant green at home. For washing wounds in adults and children, chlorhexidine, miramistin, and furacillin can be included in the list. Any of these antiseptics will help get rid of pathogenic bacteria on the skin. They are also used to treat the oral mucosa for colds.

    The necessary components of a home first aid kit include various types of fixing and dressing materials. What minimum set should all homes have:

    • large wide sterile bandage;
    • small bandage;
    • cotton wool or sterile non-woven bandages;
    • elastic bandage;
    • several types of patches.

    If you have a child at home, you can buy a children's patch with funny pictures to cheer up after an abrasion. Special types of fixing bandages and patches against calluses and corns are purchased in the required quantity when injuries occur. It is not necessary to always keep them at home.

    A necessary item in the home first aid kit is lidocaine anesthetic spray. It can be applied topically to bruises and sprains to reduce pain. Burn spray is also added to the list of preparations for treating wounds and dressings. It usually contains panthenol, which helps reduce pain and burning and accelerates skin recovery. But if the required drug is not included in the first aid kit, it is prohibited to apply oil or fat to the burn site.

    Accounting and storage of prescription forms

    Let us note that in each medical organization, by order of the head, a person must be appointed who is responsible for storing and recording all types of prescription forms.

    For different forms of prescription forms, there are their own log books containing information regarding a given (specific) prescription form.

    The rules for recording prescription forms in forms No. 107-1/u, No. 148-1/u-88 and No. 148-1/u-04(l) and information to be included in the log books of such prescription forms are established in clause 23, 24, 25 and 27 of the Procedure for Registration of the Republic of Belarus, approved. Order No. 4, and in relation to prescription forms in form No. 107/u-NP - in Appendix No. 4 to Order No. 54n.

    The rules for storing prescription forms in forms No. 107-1/u, No. 148-1/u-88 and No. 148-1/u-04(l) are defined in clauses 28, 29, 30, 31, 32, 34 of the Registration Procedure RB, approved Order No. 4, and in form No. 107/u-NP - as well as the accounting rules for the latter - in Appendix No. 4 to Order No. 54n.

    Please note that prescription forms to be recorded must be stored under lock and key in a metal cabinet (safe) or metal box.

    Medicines

    If there are no people in the family with chronic diseases, then a large first aid kit for the home is not needed. The list of essential drugs should include only those that have a universal effect and can be used without a doctor’s recommendation.

    A simple home first aid kit consists of the following groups of medications:

    • Painkillers are non-steroidal anti-inflammatory drugs, the most popular drugs include paracetamol, ibuprofen, aspirin, nimesulide. They help not only relieve pain, but also reduce temperature.
    • Antispasmodics are medications that relieve spasm of the smooth muscles of the intestines, blood vessels, and uterus, and also help eliminate pain. These include drotaverine, papaverine, papazole.
    • Remedies for diarrhea - they consist of sorbents that help remove toxins and harmful bacteria from the body. Everyone should have at least one of these products at home: smecta, activated carbon, polysorb, enterosgel. And for recovery after diarrhea - rehydron.
    • Antiallergic - antihistamines are added to the contents of the first aid kit, even if there have never been any allergy symptoms. They will help reduce nasal swelling during colds and relieve itching after insect bites.
    • Cold medicines - to reduce a runny nose, simple vasoconstrictor drops and saline solutions are needed. For a sore throat, you can have lozenges or a simple spray on hand.
    • Sedatives - to reduce anxiety and unexpected experiences, you need to have valerian tablets, validol or corvalol at home.

    General requirements for prescribing medications and filling out prescriptions

    The general requirements for the prescription of drugs are established in clauses 2 – 26 of the Procedure for prescribing drugs. Note that the most important of them include the following:

    • Registration of drug prescription
      , incl. subject to manufacture and dispensing by pharmacies (hereinafter referred to as individually manufactured drugs),
      carried out
      by a medical professional in the name of the patient* for whom the drug is intended,
      on a prescription form drawn up on paper with your signature, and (or) with the consent of the patient or his legal representative
      on a prescription form
      in the form of an electronic document using an enhanced qualified electronic signature of a medical worker
      (clauses 3 and 7 of the Procedure for Prescribing Medicines).

      Please note that a prescription in the form of an electronic document containing the prescription of narcotic drugs or psychotropic substances must be signed not only using an enhanced qualified electronic signature of a medical worker, but also using an enhanced qualified electronic signature of the relevant medical organization.

      An electronic prescription must be generated using the state information system in the healthcare sector of a constituent entity of the Russian Federation, the medical information system of a medical organization (clause 7 of the Procedure for Prescribing Medicines).

      It should be taken into account that the registration of prescriptions in the form of electronic documents can only be carried out if the authorized executive body of a constituent entity of the Russian Federation makes a decision on the use in the territory of this subject of prescriptions for medicines generated in the form of electronic documents (clause 3 of the Procedure for prescribing medicines) . That is, without the corresponding regional regulatory legal act, electronic prescriptions cannot be used on the territory of the corresponding constituent entity of the Russian Federation.

      *Prescriptions on paper, drawn up on prescription forms No. 107-1/u, No. 148-1/u-88, No. 148-1/u-04 (l) and No. 107/u-NP, cannot be received without only by the patient himself and his legal representative, but also by a person who has a power of attorney from the patient for the right to receive such a prescription, issued in accordance with the civil legislation of the Russian Federation. The fact of issuing a prescription for a drug to a legal representative or authorized person is subject to recording in the patient’s medical records

      (Clause 7 of the Procedure for Prescribing Medicines).

    • Information about the prescribed drug
      (name of the drug, dosage, route of administration and use, dosage regimen, duration of treatment and justification for prescribing the drug)
      must be entered by a medical professional into the patient’s medical documentation
      (clause 3 of the Procedure for Prescribing Drugs).
    • The drug is prescribed
      medical worker
      by international nonproprietary name, and in its absence - by group or chemical name. In the absence of an international nonproprietary name and a generic or chemical name of the drug, the drug is prescribed by trade name
      .

      If there are medical indications (individual intolerance, for health reasons), by decision of the medical commission of the medical organization, the prescription and registration of the prescription of drugs that are not included in the standards of medical care, or by trade names are carried out (such a decision of the medical commission must be recorded in the patient’s medical documentation and in journal of the medical commission) (clause 6 of the Procedure for prescribing medications).

    • The composition of the drug, the dosage form and the request from the medical worker to the pharmacist about the dispensing of the drug are drawn up
      in Latin in the genitive case. When preparing prescription forms, the use of abbreviations is allowed (established in Appendix 2 to the Procedure for Prescribing Medicines). When prescribing a drug, it is not allowed to abbreviate the ingredients that make up the drug with similar names, which do not allow one to determine which drug is prescribed (clause 17 of the Procedure for Prescribing Drugs).
    • The method of administration of the drug
      is indicated indicating the dose, frequency, time of administration relative to sleep (morning, at night) and its duration, and for drugs that interact with food, the time of their use relative to meals (before meals, during meals, after meals ) (Clause 18 of the Procedure for Prescribing Medicines).
    • When registering a prescription for a finished drug, the amount of active ingredients in the prescription is indicated in accordance with the instructions for medical use of the drug. And when registering a prescription for an individually manufactured drug, the amount of solid and bulk pharmaceutical substances is indicated in the prescription in grams (0.001; 0.5; 1.0), liquid - in milliliters, grams and drops (clause 20 of the Procedure for Prescribing Drugs).
    • Medical workers are prohibited from issuing prescriptions for
      (clause 8 of the Procedure for Prescribing Medicines): medicines in the absence of medical indications;
    • Medicines not registered on the territory of the Russian Federation;
    • Medicines that, in accordance with the instructions for medical use, are used only in medical organizations;
    • for narcotic drugs and psychotropic substances included in List II of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved. By Decree of the Government of the Russian Federation of June 30, 1998 No. 681 (hereinafter referred to as the List), registered as medicines for the purpose of use for the treatment of drug addiction.

    Individual entrepreneurs carrying out medical activities, in addition to the prohibitions presented, are prohibited from issuing prescriptions for narcotic drugs and psychotropic substances included in Lists II and III of the List.

    Please note that a prescription issued in violation of the requirements established by the Procedure for Prescribing Medicines is considered invalid (clause 26 of the Procedure for Prescribing Medicines).

    Note: The procedure for prescribing medications separately regulates the specifics of prescribing medications:

    • when providing medical care in a hospital setting (clauses 27-31 of the Procedure for Prescribing Medicines);
    • in the provision of primary health care, emergency medical care and palliative care (clauses 32-35 of the Procedure for prescribing medications);
    • citizens who have the right to receive medicines free of charge or to receive medicines at a discount when providing primary health care (clauses 36-40 of the Procedure for prescribing medicines).

    Information about the most important features of prescribing drugs in these cases is presented in the article of the Faculty of Medical Law “New procedure for prescribing drugs for medical use.”

    Additional items in your home medicine cabinet

    An expanded list of medications in a home medicine cabinet is needed if there are children, people with chronic diseases, or elderly family members in the house. For a newborn baby, you need herbs for bathing, a baby syringe in case of constipation, and glycerin suppositories.

    Parents need to have antipyretic and antihistamine drugs in children's dosages. For children under 3 years old, you can store suppositories with paracetamol for fever in the refrigerator, and buy allergy medications in drops.

    For chronic diseases, a home first aid kit is collected individually. In case of pathology of the digestive tract, heartburn remedies are kept at home; in case of chronic constipation, simple laxatives are kept. People suffering from hypertension need to have plenty of high blood pressure pills recommended by their doctor. In old age, the main emergency medicine for heart pain is nitroglycerin. It is better to purchase other medications after consulting a doctor, rather than purchasing them in reserve.

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