Rules for the dispensing of medicines from pharmacies and enterprises. Rules for dispensing prescription drugs

In accordance with the requirements of the legislation on licensing of pharmaceutical activities, employees of pharmacy organizations engaged in the retail trade of medicines and their dispensing are responsible for compliance with the rules for the circulation of medicines. Pharmacy employees need to know the modern procedure for prescribing medications and the rules for preparing prescription forms, and know the algorithms for conducting a pharmaceutical examination of a prescription in order to avoid errors when dispensing medications.

He talks about the legal requirements for preparing prescription forms for medicines. Natalia Zolotareva, Ph.D., Associate Professor, Department of Management and Economics of Pharmacy, St. Petersburg State Chemical-Pharmaceutical Academy.

Decree of the Government of the Russian Federation dated December 22, 2011 No. 1081 “Regulations on licensing of pharmaceutical activities” is a key document defining the list of licensing requirements and conditions that the state currently imposes on licensees engaged in retail trade in medicinal products for medical use, namely for pharmacy organizations , individual entrepreneurs with a license for pharmaceutical activities.

These licensees must comply with the rules for the dispensing of medicinal products for medical use. The same document defines the concept of “gross violation of licensing requirements and conditions,” which includes issues related to the dispensing of medicines. If the established vacation rules are violated, the control authorities have the right to regard the identified violations as gross, with all the ensuing consequences, ranging from quite serious penalties and including suspension of the licensee’s activities.

WHAT ARE THE HOLIDAY RULES DETERMINED TODAY?

Let's start with legal regulation in order to figure out how to correctly accept prescriptions, namely with Federal Law 04/12/10 No. 61-FZ “On the Circulation of Medicines” (Chapter 10 “Pharmaceutical Activities”, Article 55), which reads: “The rules for the dispensing of medicinal products (medicines) for medical use by pharmacies and individual entrepreneurs are approved by the authorized federal executive body.” What legislative acts have been approved regulating the procedure for dispensing medicines?

• Federal Law No. 323-FZ "On the fundamentals of protecting the health of citizens in the Russian Federation";
• Federal Law of 02/07/92 No. 2300-I “On the Protection of Consumer Rights”;
• Decree of the Government of the Russian Federation dated January 19, 1998 No. 55 “On approval of the rules for the sale of certain types of goods...”;
• Order of the Ministry of Health of the Russian Federation dated August 31, 2016 No. 647n “On approval of the Rules of Good Pharmacy Practice for Medicinal Products for Medical Use” (came into force on March 1, 2017);

and departmental regulations - orders of the Russian Ministry of Health:

• No. 1175n from 2012.12 (came into force on July 1, 2013), which determines the procedure for prescribing and prescribing medications, as well as prescription forms;
• No. 54n dated 01.08.12 (came into force on July 1, 2013), dedicated to a special prescription form for narcotic drugs and psychotropic substances;
• No. 785 of December 14, 2005 “On the procedure for dispensing medicines”;
• No. 157n dated March 16, 2010 “On approval of the maximum permissible amount of narcotic drugs, psychotropic substances and their precursors contained in drugs.”

The process of dispensing drugs according to a prescription involves close interaction between a medical and pharmaceutical worker. The responsibility of the first one includes prescribing the drug if the necessary requirements are met, and the second one must, before dispensing the drug according to a prescription, carry out its pharmaceutical examination, if necessary, transfer it for manufacturing, and then dispense the drug. The requirement for feedback between pharmaceutical and medical organizations remains important. Literally, the regulatory requirement involves regularly sending information about all incorrectly written prescriptions to the medical organization. Such feedback, regular and properly established, eliminates a number of questions regarding identified violations from the point of view of prescription drug dispensing.

FIVE RECIPES FORMS

Two key regulatory documents are directly related to the procedure for prescribing drugs and the forms of the prescription form - these are order No. 1175n and order No. 54n (both came into force on July 1, 2013).

Traditionally existing regulatory documents have determined the forms of prescription forms. Today there are 5 forms of prescription forms: No. 107-1/u, 148-1/u-88, 148-1/u-04 (l), No. 148-1/u-06 (l), special prescription form . From January 1, 2016, by order No. 385n, separate changes were made to the forms of prescription forms 148-1/u-88, 107-1/u. But in order for stocks of previously purchased prescription forms to be used for their intended purpose, it was allowed to use old-style forms before the entry into force of the order of the Ministry of Health of Russia dated June 30, 2015 No. 385n "On amendments to the order of the Ministry of Health of the Russian Federation dated August 1, 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", i.e. until July 1, 2016. After this, pharmacy workers must require those forms prescription forms, the structure of which has been changed in accordance with current regulatory documents.

Order No. 1175n introduced a lot of new things into the procedure for prescribing and prescribing medications. The first place in importance of innovation can be given to the paradigm of drug prescription itself. If previously a health worker could use any drug name: INN, group name or trade name, as it was convenient for him, then in connection with the entry into force of this regulatory document, the priority is clearly established in prescribing drugs according to the INN. If it is missing, then the group name should be used, and if both names are missing, the trade name should be used.

The list of those who have the right to prescribe and write prescriptions now includes specialists with secondary medical education: paramedics and midwives. Only if such powers are assigned to them by the relevant order of the head of the medical organization. Individual entrepreneurs traditionally also have the right to prescribe drugs and write prescriptions, but there are certain restrictions, for example, related to the fact that medical specialists engaged in private medical activities do not have the right to prescribe narcotic and psychotropic drugs from Schedules 2 and 3.

If a recipe comes under a trade name, what should you do with it? Can it be rejected, or is it written out correctly? The answer to this question is in the order of the Ministry of Health No. 1175n - a health worker has the right to use a trade name when prescribing in case of individual intolerance and/or for health reasons, but this decision must be confirmed by a medical commission, as evidenced by the corresponding stamp on the back of the prescription.

DIFFERENCES IN RECIPES FORMS

What is the difference between these forms of prescription forms and how can health workers fill them out correctly in order to prevent incorrect pharmaceutical examination in the pharmacy?

√ Special prescription form(the most complex - in terms of the composition of the details, structure, although from the point of view of its use there is only one case when a health worker can and should use this form). This strict accounting form has several degrees of protection and is intended for prescribing narcotic and psychotropic drugs from List 2 of the List approved by Decree of the Government of the Russian Federation dated March 21, 2011 No. 181 “On the procedure for importing into and exporting from the Russian Federation narcotic drugs, psychotropic substances and their precursors" (for example, morphine, promedol, prosedol, etc.). List 2 is updated regularly. Working with narcotic drugs from Schedules 2 and 3 requires a separate license, unlike working with highly toxic drugs.

All prescription forms differ in purpose of use, structure, composition of details, validity period and shelf life.

Current regulatory documents require that if a narcotic drug or psychotropic substance is prescribed for privileged categories of citizens, in addition to the special prescription form, it is necessary to provide forms 148-1/u-04 (l), No. 148-1/u-06 (l) . The special prescription form has undergone changes - it has become larger, and from June 30, 2015, the validity period of this prescription form has been significantly increased - from 5 to 15 days from the date of prescription. The stamp of the medical organization must be clearly legible (its name, address and telephone number). The form has a series, number, date of prescription, indication “child” or “adult” (underlined); The patient's full name, age (number of completed years (children under one year old - number of months), series and number of the compulsory medical insurance policy, number of the outpatient medical card. In Latin, according to the INN, indicating the dosage, packaging and quantity, the corresponding medicinal product is indicated. Only in In this form of the prescription form, the number of prescribed psychotropic and narcotic drugs from List 2 must be indicated not only in numbers, but also in words.

All this is certified by the personal signature of the doctor, as well as the personal seal of the health worker. This form must indicate the full name of the authorized person, who can be the head or deputy head of a medical organization, structural unit, or a designated authorized person who certifies these forms (full name, signature). It is additionally certified by the seal of the medical organization or the seal for prescriptions. Next on the prescription form is a note from the pharmacy organization about the dispensing of the drug. If the pharmacy worker is satisfied with everything in the design of the prescription form, he indicates what is dispensed, dosage, and packaging. Certified by full name (full name), date of issue and seal of the pharmacy organization.

√ Prescription form 148-1/у-88- the form of which is simpler in terms of the composition of the details, but if we talk about the purposes of the form, there are 5 options for use.

1. Narcotic and psychotropic drugs from Schedule 2, but in the form of transdermal therapeutic systems, i.e. any other dosage form of a narcotic drug or psychotropic substance classified as Schedule 2 must be prescribed on a special prescription form. Traditionally, this form is used to prescribe and prescribe psychotropic drugs from List 3.
2. Other medications are subject to subject-quantitative accounting, but there is an addition - with the exception of drugs sold without a doctor's prescription.
3. To prescribe drugs with anabolic activity (anabolic steroids).
4. Also, since 2012, the procedure for dispensing combination drugs containing small amounts of narcotic and psychotropic substances and their precursors, and other pharmacologically active substances has changed. We are talking about combinations that are indicated in clause 5 of the order of the Ministry of Health of Russia dated May 17, 2012 No. 562 “On approval of the Procedure for the dispensing to individuals of medicinal products for medical use, containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances” .
5. When prescribing individually manufactured medicinal products that contain narcotic drugs and psychotropic substances from List 2 of the List of Resolution No. 681, provided that the narcotic and psychotropic content in these combined drugs does not exceed the highest single dose, and the drug itself is not included in List 2.

This form is valid for 15 days. Since August 2016, either the patient’s full address with a zip code, or the patient’s medical card number, has been indicated on the prescription form.

√ Prescription form 107-1/у- the simplest form of a prescription form. At the same time, regulatory documents indicate the following: this form must be used for prescribing and prescribing combination drugs containing small doses of narcotic, psychotropic substances, their precursors and other pharmacologically active substances, but those combinations that are indicated in clause 4 of Order No. 562 of the Ministry of Health of Russia .

The form must contain a stamp of the medical organization, name (in full), address, telephone number, date, indication of “adult” or “children”, full name of the patient (in full), his age, full name of the doctor (in full), name of the medicinal product in Latin according to INN with indicating dosage, packaging and dosage.

Up to three names of drugs can be written out on this prescription form (unlike other forms, where only one name can be indicated). Personal signature and stamp of the doctor on the form. Valid up to 60 days. For chronic patients, an extension of up to 1 year is possible.

MAJOR VIOLATIONS WHEN COMPLETING RECIPES

The St. Petersburg State Chemical-Pharmaceutical Academy conducted a study in which recipes placed in the journal of incorrectly written prescriptions were analyzed. Sometimes health workers do not indicate the validity period of the prescription, incorrectly fill out the “full address” details, do not fully indicate the full name of the doctor and the patient, the stamps are not clearly readable, incorrectly fill out the details regarding the patient’s age, there are no notes from the medical commission when the prescription is written out under a trade name, there are extra seals and inscriptions exceed the drug supply norm.

The last one is a frequently occurring error. Current regulatory regulations establish maximum permissible dispensing rates and recommended quantities per prescription. But any rule allows for an exception; it is marked by order No. 1175n (clause 15, clause 22, clause 23), which makes it possible to legally exceed the established norms for drug supply.

Based on materials from an online seminar organized by the St. Petersburg Union of Doctors

Registered with the Ministry of Justice of the Russian Federation on January 16, 2006.
Registration N 7353

In accordance with Article 32 of the Federal Law of June 22, 1998 N 86-FZ “On Medicines” (Collection of Legislation of the Russian Federation, 1998, N 26, Art. 3006; 2003, N 27, Art. 2700; 2004, N 35 , article 3607) I order:

1. Approve the attached Procedure for dispensing medicines.

2. Recognize as invalid Appendix 3 “List of medicines subject to subject-quantitative accounting in pharmacies/organizations, drug wholesalers, medical institutions and private practitioners**” and Appendix 4 “Procedure for dispensing medicines in pharmacies” /organizations", approved by order of the Ministry of Health of the Russian Federation dated August 23, 1999 N 328 "On the rational prescribing of medicines, the rules for writing prescriptions for them and the procedure for their dispensing by pharmacies (organizations)" (registered with the Ministry of Justice of the Russian Federation on October 21, 1999 N 1944), with amendments and additions made by order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 206 (registered with the Ministry of Justice of the Russian Federation on June 5, 2003 N 4641) and by order of the Ministry of Health and Social Development of the Russian Federation dated March 16, 2005 N 216 (registered with the Ministry of Justice of the Russian Federation on April 8, 2005 N 6490).

Minister M. Zurabov

Procedure for dispensing medicines

I. General provisions

1.1. This Procedure determines the requirements for the dispensing of medicines by pharmacies (organizations)*, regardless of their organizational and legal form, form of ownership and departmental affiliation.

1.2. Medicinal products, including narcotic drugs, psychotropic, potent and toxic substances registered in the Russian Federation in accordance with the established procedure, are subject to dispensing by pharmacies (organizations).

1.3. Medicines are dispensed with a doctor's prescription and without a doctor's prescription by pharmacies (organizations) licensed for pharmaceutical activities.

1.4. Medicines prescribed by doctor are subject to dispensing by pharmacies and pharmacy points.

Medicines in accordance with the List of medicines dispensed without a doctor's prescription, approved by order of the Ministry of Health and Social Development of the Russian Federation dated September 13, 2005 N 578 (registered with the Ministry of Justice of the Russian Federation on September 29, 2005 N 7053) (hereinafter referred to as the List medicines dispensed without a doctor's prescription) are subject to sale by all pharmacies (organizations)*.

1.5. To ensure an uninterrupted supply of medicines to the population, pharmacies (organizations) are required to have in stock a minimum range of medicines necessary to provide medical care, approved by Order of the Ministry of Health and Social Development of the Russian Federation dated April 29, 2005 N 312.

II. General requirements for the dispensing of medicines

2.1. All medicines, with the exception of those included in the List of medicines dispensed without a doctor's prescription, must be dispensed by pharmacies (organizations) only according to prescriptions filled out in the prescribed manner on prescription forms of the relevant accounting forms.

2.2. According to prescriptions written on prescription forms, the forms of which are approved by order of the Ministry of Health of the Russian Federation of August 23, 1999 N 328 (registered with the Ministry of Justice of the Russian Federation on October 21, 1999 N 1944), pharmacies (organizations) dispense:

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 N 681 (Collected Legislation of the Russian Federation, 1998, N 27, Article 3198; 2004, No. 8, Article 663; No. 47, Article 4666) (hereinafter referred to as the List), written out on special prescription forms for a narcotic drug;

Psychotropic substances included in List III of the List, prescribed on prescription forms, form N 148-1/u-88;

Medicines subject to subject-quantitative accounting in pharmacies (organizations), drug wholesale trade organizations, medical institutions and private practitioners, the List of which is provided in Appendix No. 1 to this Procedure (hereinafter referred to as medicines subject to subject-quantitative accounting) , written out on prescription forms, form N 148-1/u-88;

Medicines included in the List of medicines dispensed on prescription from a doctor (paramedic) when providing additional free medical care to certain categories of citizens entitled to receive state social assistance, approved by order of the Ministry of Health and Social Development of the Russian Federation dated September 28, 2005 N 601 (registered with the Ministry of Justice of the Russian Federation on September 29, 2005 N 7052) (hereinafter - medicines included in the List of medicines dispensed according to prescriptions from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount, prescribed for prescription forms form N 148-1/u-04 (l);

Anabolic steroids prescribed on prescription forms, form N 148-1/u-88;

Other medicines not included in the List of medicines dispensed without a doctor's prescription, prescribed on prescription forms, form N 107/u.

2.3. Prescriptions for narcotic drugs and psychotropic substances included in List II of the List are valid for five days.

Prescriptions for psychotropic substances included in List III of the List; medicines subject to subject-quantitative accounting; anabolic steroids are valid for ten days.

Prescriptions for medicines included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount, with the exception of prescriptions for narcotic drugs and psychotropic substances included in List II of the List, for psychotropic substances , included in List III of the List, for medicines subject to subject-quantitative registration, for anabolic steroids are valid for one month.

Prescriptions for other medicines are valid for two months from the date of issuance of the prescription and up to one year in accordance with paragraph 2.19 of the Instructions on the procedure for prescribing medicines and writing prescriptions for them, approved by order of the Ministry of Health of the Russian Federation dated August 23, 1999 N 328 ( further - Instructions).

2.4. Pharmacy establishments (organizations) are prohibited from dispensing drugs on expired prescriptions, with the exception of drugs on prescriptions that expired while the prescriptions were on deferred service.

2.5. Medicines are dispensed by pharmacies (organizations) in the quantities specified in the prescription, with the exception of medicines, the dispensing rates of which are specified in Appendices 1 and 3 to the Instructions.

2.6. When dispensing medicines according to a doctor's prescription, an employee of a pharmacy institution (organization) makes a note on the prescription about the dispensing of the drug (name or number of the pharmacy institution (organization), name and dosage of the drug, quantity dispensed, signature of the dispenser and date of dispensing).

2.7. If a pharmacy institution (organization) has medications with a dosage different from the dosage prescribed in the doctor’s prescription, the employee of the pharmacy institution (organization) may decide to dispense the available medications to the patient if the dosage of the drug is less than the dosage specified in the prescription doctor, taking into account recalculation for the course dose.

If the dosage of a medicinal product available in a pharmacy institution (organization) exceeds the dosage specified in the doctor’s prescription, the decision to dispense the medicinal product to the patient is made by the doctor who wrote the prescription.

The patient is provided with information about changing the single dose of the drug.

2.8. In exceptional cases, if it is impossible for a pharmacy institution (organization) to fulfill the doctor’s (paramedic’s) prescription, violation of the secondary factory packaging is allowed.

In this case, the medicinal product must be dispensed in a pharmacy package with the obligatory indication of the name, factory batch, expiration date of the medicinal product, series and date according to the laboratory packaging register and providing the patient with other necessary information (instructions, package insert, etc.).

Tampering with the original factory packaging of medicines is not allowed.

2.9. When dispensing medicines according to a doctor’s prescription valid for one year, the prescription is returned to the patient indicating on the back the name or number of the pharmacy institution (organization), the signature of the employee of the pharmacy institution (organization), the quantity of the drug dispensed and the date of dispensing.

When the patient next contacts a pharmacy institution (organization), notes on the previous receipt of the medicine are taken into account. Upon expiration of the validity period, the prescription is canceled with the stamp “Prescription is invalid” and left at the pharmacy institution (organization).

2.10. In exceptional cases (the patient leaves the city, the inability to regularly visit a pharmacy institution (organization), etc.), pharmaceutical workers of a pharmacy institution (organization) are allowed to make a one-time dispensing of a medicine prescribed by a doctor according to prescriptions valid for one year, in an amount necessary for treatment for two months, with the exception of medicines subject to subject-quantitative accounting.

2.11. If a pharmacy institution (organization) does not have a medicinal product prescribed by a doctor, with the exception of a medicinal product included in the List of Medicines Dispensed on the Prescription of a Doctor (Paramedic), as well as other medicinal products dispensed free of charge or at a discount, the employee of the pharmacy institution (organization) ) can carry out its synonymous replacement with the consent of the patient.

When dispensing a medicinal product included in the List of Medicines Dispensed on the Prescription of a Doctor (Paramedic), as well as another medicinal product dispensed free of charge or at a discount, an employee of a pharmacy institution (organization) can make a synonymous replacement of the medicinal product in agreement with the doctor who wrote the prescription. .

2.12. Prescriptions for medicines marked “statim” (immediately) are processed within a period not exceeding one working day from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines marked “cito” (urgent) are processed within a period not exceeding two working days from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines included in the minimum range of medicines are processed within a period not exceeding five working days from the moment the patient contacts the pharmacy institution (organization).

2.13. Prescriptions for medicines included in the List of medicines dispensed by prescription from a doctor (paramedic) and not included in the minimum range of medicines are serviced within a period not exceeding ten working days from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines prescribed by decision of a medical commission approved by the chief physician of a medical institution are processed within a period not exceeding fifteen working days from the moment the patient contacts the pharmacy institution (organization).

2.14. Prescriptions for medicines subject to subject-quantitative accounting; medicines included in the List of medicines dispensed on prescription from a doctor (paramedic), as well as other medicines sold free of charge or at a discount; anabolic steroids remain in the pharmacy institution (organization) for subsequent separate storage and destruction after the expiration of the storage period.

2.15. The pharmacy institution (organization) must ensure conditions for the safety of prescriptions left for storage for medicines that are subject to subject-quantitative accounting; medicines included in the List of medicines dispensed on prescription from a doctor (paramedic), as well as other medicines sold free of charge or at a discount; anabolic steroid.

2.16. The shelf life of prescriptions in a pharmacy institution (organization) is:

For medicines included in the List of Medicines dispensed on prescription from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount - five years;

For narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List - ten years;

For medicines subject to subject-quantitative registration, with the exception of narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List; anabolic steroids - three years.

After the expiration of the storage period, the recipes are subject to destruction in the presence of the commission, about which acts are drawn up, the form of which is provided for in Appendices No. 2 and No. 3 to this Procedure.

The procedure for the destruction of prescriptions left in a pharmacy institution (organization) after the established storage period has expired, and the composition of the commission for their destruction may be determined by the health care or pharmaceutical authorities of the constituent entity of the Russian Federation.

2.17. Medicines of good quality purchased by citizens are not subject to return or exchange in accordance with the List of non-food products of good quality that cannot be returned or exchanged for a similar product of a different size, shape, size, style, color or configuration, approved by the Decree of the Government of the Russian Federation dated January 19, 1998 No. 55 (Collection of Legislation of the Russian Federation, 1998, No. 4, Art. 482; No. 43, Art. 5357; 1999, No. 41, Art. 4923; 2002, No. 6, Art. 584; 2003, No. 29, Art. 2998; 2005, N 7, Art. 560).

It is not permitted to re-dispense (sell) medicines recognized as goods of inadequate quality and returned by citizens for this reason.

2.18. Prescriptions for tranquilizers that are not subject to subject-quantitative accounting; antidepressants, neuroleptics; industrially produced alcohol-containing medicines are canceled with the stamp of the pharmacy institution (organization) “Medicine dispensed” and returned to the patient’s hands.

To re-dispense the drug, the patient must consult a doctor for a new prescription.

2.19. Incorrectly written prescriptions remain in the pharmacy institution (organization), are canceled with the stamp “Prescription is invalid” and are registered in a journal, the form of which is provided in Appendix No. 4 to this Procedure, and are returned to the patient.

Information about all incorrectly prescribed prescriptions is brought to the attention of the head of the relevant medical institution.

2.20. Pharmacy institutions (organizations) carry out separate accounting of medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), dispensed to citizens living in the territory of the corresponding subject of the Russian Federation, and to citizens temporarily staying in the territory of this subject of the Russian Federation.

III. Requirements for the supply of narcotic drugs and psychotropic substances; medicines subject to subject-quantitative accounting; anabolic steroids

3.1. Drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List are subject to dispensing by pharmacies (organizations).

3.2. The right to work with narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List, are only available to pharmacy institutions (organizations) that have received the appropriate licenses in the manner prescribed by the legislation of the Russian Federation.

3.3. Dispensing narcotic drugs and psychotropic substances to patients. included in List II of the List, and psychotropic substances included in List III of the List, are carried out by pharmaceutical workers of pharmacy institutions (organizations) who have the right to do so in accordance with the order of the Ministry of Health and Social Development of the Russian Federation dated May 13, 2005 N 330 (registered in the Ministry of Justice of the Russian Federation on June 10, 2005 N 6711).

3.4. In a pharmacy institution (organization), the dispensing of narcotic drugs and psychotropic substances included in List II of the List is carried out by patients assigned to a specific outpatient clinic, which is assigned to the pharmacy institution (organization).

The assignment of an outpatient clinic to a pharmacy institution (organization) can be carried out by the health care or pharmaceutical management body of a constituent entity of the Russian Federation in agreement with the territorial body for control over the circulation of narcotic drugs and psychotropic substances.

3.5. Narcotic drugs and psychotropic substances included in List II of the List prescribed by a doctor are dispensed to the patient or the person representing him upon presentation of an identity document issued in the prescribed manner.

3.6. Narcotic drugs and psychotropic substances included in List II of the List and included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as those dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written out on a special prescription form for a narcotic medicine, and prescription written out on prescription form form N 148-1/u-04 (l).

Psychotropic substances included in List III of the List, medicines subject to subject-quantitative recording, anabolic steroids included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as those dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written on a prescription card. form N 148-1/у-88, and a prescription written out on the prescription form form N 148-1/у-04 (l).

3.7. Pharmacy institutions (organizations) are prohibited from dispensing narcotic drugs and psychotropic substances included in List II of the List; psychotropic substances included in List III of the List; medicines subject to subject-quantitative accounting; anabolic steroids according to prescriptions from veterinary medical organizations for the treatment of animals.

3.8. Separate dispensing of medicinal products subject to subject-quantitative accounting and other medicinal products included in the composition of a combination medicinal product manufactured according to an individual prescription (hereinafter referred to as an extemporaneous medicinal product) is not allowed.

3.9. A pharmacist at a pharmacy institution (organization), upon receipt of a prescription for an individually manufactured medicinal prescription, is obliged to dispense a medicinal product subject to subject-quantitative recording in half the highest single dose in the event of a doctor’s failure to comply with the established rules for filling out a prescription or in the case of a doctor prescribing medicinal products in a dose exceeding highest single dose.

3.10. When producing extemporaneous medicinal products containing medicinal products subject to subject-quantitative accounting, in accordance with prescriptions written by a doctor, the pharmacist of the pharmacy institution (organization) signs on the prescription for issuance, and the pharmacist of the pharmacy institution (organization) - on receipt of the required quantity of medicinal products .

3.11. Ethyl alcohol is released:

According to prescriptions written by doctors with the inscription “For applying compresses” (indicating the required dilution with water) or “For treating the skin” - up to 50 grams in pure form;

According to prescriptions written by doctors for individually prepared medicinal prescriptions - up to 50 grams in the mixture;

According to prescriptions written by doctors for individually prepared medicinal prescriptions, with the inscription “For special purposes”, separately certified by the doctor’s signature and the seal of the medical institution “For prescriptions”, for patients with a chronic course of the disease - up to 100 grams in the mixture.

3.12. When dispensing narcotic drugs and psychotropic substances included in List II of the List; psychotropic substances included in List III of the List; extemporaneous medicinal products containing medicinal products subject to subject-quantitative registration, instead of a prescription, patients are given a signature with a yellow stripe at the top and the inscription in black font on it “Signature”, the form of which is provided for in Appendix No. 5 to this Procedure.

IV. Control over the dispensing of medicines by pharmacies (organizations)

4.1. Internal control over compliance by employees of a pharmacy institution (organization) with the procedure for dispensing medicines (including those subject to subject-quantitative accounting; medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount) is carried out by the head (deputy head) of a pharmacy institution (organization) or a pharmaceutical employee of a pharmacy institution (organization) authorized by him.

4.2. External control of compliance by pharmacies (organizations) with the procedure for dispensing medicines is carried out by the Federal Service for Surveillance in Healthcare and Social Development and authorities for control of the circulation of narcotic drugs and psychotropic substances within their competence.

________________

* Pharmacies, pharmacy points, pharmacy kiosks, pharmacy stores.

1. The rules for dispensing medicines from pharmacies and enterprises (hereinafter referred to as the Rules) determine the procedure for dispensing medicines from pharmacies and enterprises (hereinafter referred to as pharmacies).

All medicines, with the exception of those approved by the Ministry of Health of the Republic of Belarus for dispensing without a doctor's prescription, must be dispensed from pharmacies according to prescriptions in established forms, written out in accordance with the Rules for Prescribing Medicines.

2. If the prescription contains poisonous, narcotic and potent medicines mixed with other ingredients, then it is prohibited to dispense them other than as part of the manufactured medicine.

3. If a doctor prescribes a poisonous, narcotic or potent drug in a dose exceeding the highest single dose without an appropriate prescription, the pharmacist (pharmacist) of the pharmacy is obliged to dispense this drug in half the dose that is established as the highest single dose.

4. Narcotic drugs are dispensed from pharmacies according to prescriptions from territorial health care institutions attached to these pharmacies.

The list of healthcare institutions and pharmacies is determined by a joint order of healthcare authorities and unitary enterprises "Pharmacia".

Pharmacies that dispense narcotic drugs according to prescriptions must be provided with samples of seals, stamps, and sample signatures of doctors prescribing narcotic drugs.

5. Psychotropic drugs, including combination drugs, subject to subject-quantitative accounting, and ethyl alcohol are dispensed by all pharmacies within the city and regions of the region according to prescriptions from medical institutions located on their territory.

6. Cancer patients are assigned to pharmacies to receive narcotic drugs by written order of the head of the treatment and prevention institution. Lists of patients are compiled by the medical institution annually at the beginning of the year and are changed as necessary by separate written orders of the medical institution, certified by the signature of the head of the institution.

7. Disabled people and participants of the Great Patriotic War and persons equal to them in terms of benefits, medications are dispensed according to free prescriptions written by doctors of medical institutions in any state pharmacy of the Republic of Belarus (regardless of the place where the prescription was issued), with the exception of narcotic drugs drugs, psychotropic drugs, including combination drugs, subject to subject-quantitative accounting, and ethyl alcohol.

8. Medicines listed in Appendix 7 to the Rules for Prescribing Medicines are dispensed from pharmacies in quantities not exceeding the permissible limits for one prescription.

It is permitted to increase the rate of one-time dispensing of prescription drugs in the cases specified in paragraphs 31, 32, 33 of the Rules for Prescribing Medicines.

9. Controlled psychotropic drugs, for which standards for one-time dispensing according to one prescription are not established, are dispensed from pharmacies in quantities not exceeding a course of treatment for a period of up to 1 month.

10. The dispensing of finished medicinal products containing codeine (pentalgin, solpadeine, spasmoveralgin and others), with the exception of the medicinal products specified in Appendix 7 to the Rules for Prescribing Medicines, is carried out according to doctor’s prescriptions in compliance with the one-time dispensing rate of no more than 0.2 codeine.

11. Dispensing of medicines containing ephedrine hydrochloride is carried out according to doctor’s prescriptions within the limits of the one-time dispensing rate (0.6) of ephedrine hydrochloride. An increase in the rate of one-time dispensing of medicines containing ephedrine hydrochloride is allowed in accordance with the conditions specified in paragraph 31 of the Rules for Prescribing Medicines.

12. When dispensing a medicinal product, including for free and preferential prescriptions, it is allowed to violate the original factory packaging, with the exception of contour cell (blister) and contour cell-free packaging, with the obligatory indication by the pharmacist (pharmacist) of the pharmacy number, name of the drug, dosage, manufacturer, series and expiration date of the drug on the pharmaceutical packaging. The total amount of the drug dispensed must correspond to the amount prescribed in the prescription, taking into account the dosage.

13. For external purposes, solutions of phenol, concentrated acids, perhydrol can be dispensed in the concentration prescribed by the doctor, with the obligatory indication on the prescription (requirement) of the concentration and method of use. The package must bear the label: “Handle with care.”

14. Ethyl alcohol is dispensed from pharmacies in pure form in weight measurement, and in a mixture with other ingredients - in volumetric measurement.

15. A pharmacist, with the consent of the patient, has the right, in the absence of a medicine prescribed in prescriptions on Form 1, to prescribe medicines dispensed from a pharmacy at full cost, and on Form 3, a prescription form, to prescribe and dispense medicines free of charge or on preferential terms. , replace it with its synonym.

16. Medicines are dispensed to the population on preferential terms and free of charge only from state pharmacies and enterprises upon presentation of a document confirming this right to patients. Children under 3 years of age and categories of patients for whom medications are dispensed free of charge during outpatient treatment according to the list of diseases approved by the Ministry of Health of the Republic of Belarus do not require presentation of documents.

17. When dispensing medicines, the price, number of packages, tablets (capsules, dragees, ampoules, etc.) must be indicated on the prescription.

The receipt of the prescription contains the amount to be paid by the medical institution, the surname, initials and signature of the dispenser, the surname, initials and signature of the person who received the medicine. The counterfoil with the necessary details filled in is sent with an invoice for payment to the medical institution.

18. When dispensing medicines for which prescriptions remain in the pharmacy, instead of a prescription, patients are given a signature with a yellow stripe or a label indicating the method of use of the medicine. The signature form is given in Appendix 1.

19. It is prohibited to dispense narcotic drugs for injection, anesthetic ether, chlorethyl, ketamine (calypsol, ketalar), fluorotane, sodium hydroxybutyrate in ampoules, lithium hydroxybutyrate in ampoules, barium sulfate for fluoroscopy to outpatients.

expiration of the prescription;

incorrectly written and executed prescriptions.

All incorrectly written prescriptions are canceled with the stamp “Prescription is invalid” and information about them is transferred to the heads of medical institutions for taking action against employees who violate the Rules for Prescribing Medicines.

21. Prescriptions for medicines remain in the pharmacy and are stored for the established periods in accordance with Appendix 2.

The counterfoils of Form 3 prescription forms received from pharmacy organizations are stored in the medical institution in the manner prescribed by law.

22. Upon expiration of the storage period, prescriptions are destroyed by a commission created by order of the head of the pharmacy, which includes at least 3 people, with the drawing up of an act in one copy, which is stored for 1 year, not counting the current one. The act indicates the pharmacological group of medicines, for what period the destruction is carried out and the date of destruction.

23. Packages in which medicines containing poisonous and narcotic medicines manufactured by pharmaceutical manufacturers are dispensed are issued with an additional label “Handle with care”, sealed by the person who checked the medicine, or sealed for rolling. They should be stored in a separate locked cabinet until vacation.

24. Medicines listed in Appendix 3 are subject to special subject-quantitative accounting in pharmacies, pharmaceutical warehouses and healthcare institutions.

25. Payment for the cost of medicines dispensed by a pharmacy institution (enterprise) free of charge or on preferential terms according to prescriptions from doctors of state medical institutions is made at the expense of the budgetary allocations of the health care institution that issued the Form 3 prescription.

Annex 1
to the Vacation Rules
medicines from
pharmacies and enterprises

Photos from open sources

We are all accustomed to change. We are no longer so frightened by reports of another economic crisis, because in our memory there have already been several of them. Innovations in the educational standard of schools and higher educational institutions are not surprising. But news in the field of healthcare and access to medicines cannot but cause concern. There are practically no healthy people in the modern world. We all have some kind of chronic disease and are often forced to purchase certain medications. And when news feeds contain information that changes are coming in this process at some point, we experience anxiety.

From the beginning of 2017, a new order of the Ministry of Health on the rules for dispensing medicinal products from pharmacy chains comes into force. The new order will directly affect every citizen.

In particular, a ban is being introduced on the sale of a number of medicines in large quantities to one person. This restriction is introduced for alcohol-containing tinctures and syrups, the mass fraction of ethyl alcohol in which is higher than 15%. Now they will be sold per person in quantities of no more than two bottles. And it is with these means that many of us treat our own colds at home. We advise you to make sure you have them in advance, since during the peak of the disease you will have to frequently visit the pharmacy under the new conditions of dispensing. The advice is especially relevant given the long shelf life of the latter.

Fans of online shopping should also listen to the innovations, since starting from the new year, any online pharmacy in Moscow will follow them.

A pleasant change is that patients with chronic diseases will be able to purchase the necessary medications for future use using prescriptions. Today this can only be done for the next two months. In this case, it is necessary to provide documentary evidence of the fact of departure or inability to get to the pharmacy in the future. From January 2017, this period has been extended to a calendar year.

If the pharmacy does not have drugs on the list of vital and necessary drugs, it will have to purchase them and make them available for sale no later than a week after the patient’s request. Today this period is stated as five calendar days. But if the buyer needs to take the medicine immediately, which is indicated on the prescription by the doctor’s note “statim”, the pharmacy is obliged to provide this product on the day of application.

According to the new document, pharmacy workers are prohibited from advising the buyer of more expensive drugs when a cheaper analogue is available. Pharmacists will also be required to provide detailed advice on the properties and contraindications of a particular medicine, its expiration date, storage methods and doses used. Currently, such information is provided only at the request of the pharmacy employee and is not necessarily regulated in any way. Therefore, even when purchasing medications from an online pharmacy. In 2017, you can count on the professional participation of a specialist in choosing a particular product, and on advice on its use and storage.

We can only hope that all these innovations will be implemented and will benefit the interests of pharmacy customers.

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What medications will be available by prescription starting in 2017?

In-first, according to recipes in 2017 In 2016, all the drugs that were dispensed by prescription in 2016 will be dispensed in Russia. Unfortunately for buyers of medicines, no relaxations are planned in this list.

In-secondly, Rospotrebnadzor (its head) made a rather unexpected statement-proposal that it is very desirable to sell all drugs that are in pharmacies exclusively by prescription. That is absolutely everything. Maybe with the exception of those medications that are necessary to complete all kinds of first aid kits. Read about it. The Ministry of Health proposes to soften this proposal, and we will see to what extent this softening will occur.

In a word, drug consumers can expect, if not a revolution in the dispensing system, then at least a reformation of the list of prescription drugs in the direction of a clear increase. The list will be replenished with those medications that are not needed urgently, but have a negative effect on the body when self-medicated.

All new medications that contain narcotic drugs are psychotropic. And such funds are only increasing on the pharmaceutical market every year. Alas, people do not solve problems, but accept everything for years.

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The third group is combined drugs: narcotic drugs, psychotropic substances and their precursors. They decided to designate this group separately: antibiotics. We are used to prescribing them for ourselves, but sometimes there is no other way, especially if we got sick on the weekend. Many people send their relatives to the pharmacy for antibiotics.

We'll see how it turns out in practice.

Definitely, new tranquilizers and antidepressants will also join the ranks of prescription drugs.

Here are some drugs that will be sold by prescription.

What is sometimes surprising is that the drug remains the same, the same active ingredient, but the packaging is different 3D, and the price is already higher and they may ask for the recipe.

Many live without medication at all! Well done!

Currently, work is underway to compile such a list. The Ministry of Health of the Russian Federation was allocated enough time for such work, up to January thirty-first, 2017.

It is already known that the list will definitely include drugs on the prescription form with the following line:

Presumably, only thirty percent of the medicines offered for sale in pharmacies will be available without a prescription.

There is also the following list of medicines

Since January 2017, the dispensing of medicines in pharmacies has become more strict. Many medications that previously could be bought without a doctor’s prescription are now simply not sold. Most of these drugs include antibiotics, but there are also regular painkillers.

The instructions for these medications previously included the clause “dispensed with a doctor’s prescription.” But pharmacies sold them without any prescriptions. Now it is planned to organize unscheduled inspections, which will entail the issuance of fines to those pharmacies where drugs are sold without a prescription.

Another question arises: how should patients receive prescriptions? Everyone knows how long the queues are at the offices of local therapists. Therefore, this issue is now being actively addressed so that the “prescription-only medicine” system will work fully.

Already at the beginning of 2017, a list was posted in which a list of medications appeared that were prohibited from being released without a prescription.

People now really cannot live without medicines and pills, as they help us extend our lifespan when we are sick.

This year, only those medications that contain Khlopinin will be dispensed by prescription:

Also included in this list is the well-known Valocordin:

And here is a complete list of medications that will not be given to everyone, but only to those who have a special “prescription” paper from a doctor:

In 2017, changes occurred in the pharmaceutical field that are now being actively discussed.

The list of drugs that cannot be purchased without a prescription from a doctor has become longer. It contained medications with psychotropic effects and good old antibiotics. Some indignation was caused by the fact that the cardiac drug Valocordin was included in this list. Curantil, so often prescribed to pregnant women, was also there, as well as Nimesil, a well-known painkiller.

Most likely, the list will be replenished with new titles.

Since 2017, pharmacies will not be able to sell prescription drugs if instead of an official document with a doctor’s signature and seal there is a “handwritten piece of paper”

When going to the pharmacy to buy medicine, don’t be lazy, open the Internet. Type the required medication into a search engine and look at the instructions for it. If there is a note “Only with a doctor’s prescription,” it means that without this very prescription the product you need will not be sold.

Medicines are divided into those that can be freely purchased at a pharmacy and those that are available only with a doctor's prescription. For the latter, from January 1, 2017, the rules for their leave are being tightened. The “prescription only” stamp does not include medications that are freely available on pharmacy displays. You can easily purchase antivirals, many medicines for coughs and runny noses, some enzyme and painkillers.

And although the innovation has caused a lot of controversy, it is by no means news for pharmacy workers. Order No. 785 “On the procedure for dispensing medicines” has been in effect since December 14, 2005. But now the very form of the “doctor’s note” is changing.

If previously a prescription was considered a banal piece of paper on which the doctor’s hand had scribbled the prescribed medicine, this “gag” will no longer pass in the new year. A prescription form is required (form No. 107/u). With the personal seal of the doctor, the seal of the medical institution, dosage and frequency of use.

Remember, recipes also have an expiration date. Now it is 60 days. For chronic patients, the validity period of the prescription may be longer.

There is no official list of all drugs that must be dispensed strictly according to a prescription. During January, the Ministry of Health will compile a list of medications that will be available only by prescription. In the meantime, they will focus on the instructions for the medications.

State Duma deputies plan to tighten control over pharmacies. For selling drugs without a doctor’s prescription, you can still face a fine, but people’s representatives propose increasing the administrative penalty to 10 thousand rubles. And as the most extreme measure, it is proposed to close the pharmacy for three months.

Starting from 2017, control over the sale of drugs will be strengthened. Is it worth purchasing drugs? (TV and radio company "Seim")

In recent years, they have had a mania to prohibit everything, limit punishing, etc. all laws are aimed at the negative; there is not a single law to give, provide, ensure, increase in favor of the people, even with authoritarianism, this is rarely seen, well, well, let's see where this curve will lead

Here you go. I've read a lot of nonsense) The comments are about nothing. Why stand in line with a blood pressure of 180, when there is an ambulance for such a situation. Although, in general, it is necessary to stock up on medications as soon as they come to an end, and not on the day of the crisis (. Someone wrote about an antibiotic, which should always be in the first aid kit . Are you sure? And what (read, for what) should be at home? Do you think one antibiotic cures everything? Nonsense! And they will do the right thing by not selling it. Otherwise, citizens drink a “harmful antibiotic for 2.5 days.. and so It is the bacteria that cause its resistance (addiction to the drug), the next time it no longer affects the microbe. This is how we returned tuberculosis to society, for which it became difficult to select drugs and the mortality rate increased. If you are afraid of the drug, do not start taking it.. it will be completely bad , then the doctor will write out a prescription, and in a difficult situation, you yourself will drink it to the end. And Valocordin is not a harmless drug at all, because it contains Phenobarbital (we read on Wiki), but it does not save you from death at all. Rather, from fear)) So, an ambulance and an ambulance again, if you really feel bad. PS. I ALWAYS get a coupon through the Internet, I’ve never sat at the office for 3 hours. strictly on time and almost always on time. Doctors are not interested in accepting 35 people instead of 15. Why is it “impossible to get in”?!

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Give me a piece of paper. Starting from the new year, the sale of drugs without a prescription will be tightened

In recent months, Kursk residents, while shopping at the pharmacy, have heard warnings from pharmacists that from January 1, 2017, most medications will be sold strictly according to prescriptions. But is this so and what barriers will now be put in front of patients?

Whose order?

On June 21, 2016, the State Duma adopted in the first reading government bill No. 1093620-6 “On amendments to the Code of the Russian Federation on Administrative Offenses in terms of improving administrative responsibility in the field of healthcare.” And in September, at a meeting with Roszdravnadzor of the Russian Federation, it was announced that from January 1, 2017, prescription drugs will be under special control of the department.

“Actually, the order of the Ministry of Health and Social Development of the Russian Federation No. 785 “On the procedure for dispensing medicines” is valid from December 14, 2005. It is he who regulates the procedure for dispensing medicines from pharmacies, regardless of the form of ownership. That’s why we still fine pharmacies for selling drugs without a prescription,” explained Lyudmila Ilyukhina, deputy head of the department of licensing, supervision and control in the field of medical and social activities of the regional Office of Roszdravnadzor.

Lethal injection. Kursk children are dying from a “harmless” drug

Let us remind you that 70% of drugs registered in the Russian Federation are sold strictly according to prescriptions, and only 30% are sold without it. But what then will change in the new year? Nothing but tougher legislation regarding control and supervision of pharmacies. Currently, Roszdravnadzor is constrained by current legislation and cannot effectively influence pharmacies for violations of the quality and safety of medical and pharmaceutical activities. It’s just that pharmacists did not always pay attention to these requirements, and the population did not see the problem and did not understand it.

How will they be punished?

The current version of the Code of Administrative Offenses does not establish administrative liability for a number of violations in the field of rules of laboratory and clinical practice when conducting clinical and preclinical studies of medicinal products for medical use, procedures for the provision of medical care in terms of non-compliance with the mandatory requirements established by them, procedures for conducting medical examinations, examinations and examinations , as well as the procedure for prescribing and prescribing medications. Therefore, changes have been made to the Code of Administrative Offenses of the Russian Federation (CAO).

The price of health. Do beneficiaries have enough medicine?

The new law proposes completely different fines and other types of punishment for violating drug trade regulations, including dispensing prescription drugs without a prescription.

So, from January 1, 2017, if it is discovered that a medicine is being sold without a prescription, Roszdravnadzor may fine the pharmacist who violated the law in the amount of 5 to 10 thousand rubles (now - from 1,500 to 3 thousand rubles); the official will have to pay from 20 to 30 thousand rubles (now - from 5 to 10 thousand rubles); legal - from 100 to 150 thousand rubles (now - from 20 to 30 thousand rubles). The apogee may be the closure of the pharmacy for 3 months (90 days).

Therefore, you understand, most pharmacies, if not all, will not want to take risks and will work strictly according to the letter of the law.

Self-medication is to blame

The impetus for the changes was the level of self-medication of the population, which has recently gone through the roof, and sometimes turns into very tragic consequences. Here it is already worth dealing with another problem - the shortage of doctors and queues in hospitals, which force people to go to the pharmacy and consult with a pharmacist about what medications should be taken for a particular disease.

“But the pharmacy must follow the doctor’s recommendation, draw the buyer’s attention to storage conditions and frequency of administration, nothing more. And the prescription itself is the doctor’s request to the pharmacist about what exactly he should give to the patient,” notes Ilyukhina. “And now it also happens that a person actually visited a doctor, but came to the pharmacy not with a prescription written on an official form, but with a piece of paper on which the doctor indicated the name of the drug. And pharmacists dispense medications based on these scraps. This whole situation must change."

The level of self-medication may be off the charts, but there is a logical explanation for this trend - how long will a person have to wait in line at a hospital for a prescription? Especially considering that the majority prefer not to go on sick leave with every cold, but to endure it on their feet, since the authorities do not favor sick leave, and many of us do not consider a sluggish ARVI to be a real disease, supporting our immunity with medications (not even antibiotics) from the nearest pharmacy. But now, before going to the pharmacy, you will have to go on a “crusade” to the hospital and sit in line there, most likely not for an hour or two.

Shortages and queues

It is impossible to say right now exactly which medications will be dispensed only by prescription: in fact, there is no clear list; it was abolished in 2011 because it was too long and cumbersome. So you will have to focus on the packaging of the drug, which should indicate the name, dose, release form, manufacturers, expiration date, storage conditions and dispensing rules - with or without a prescription.

No. 55 “On the Circulation of Medical Products,” approved the rules for the sale of prescription drugs in pharmacies for their use in hospitals and clinics that are licensed to engage in pharmaceutical activities.

Basic provisions

Regulations on licensing activities in the field of pharmaceuticals No. 1081 dated December 22, 2011 is a key document that defines the list of requirements, as well as conditions imposed by the state on licensees. Licensees are legal entities that carry out retail trade in drugs intended for medical use, for example, pharmacy chains and individual entrepreneurs who have the right to do this activity. There is a specific list of prescription drugs.

What are the consequences of a violation?

All listed persons must comply with the rules for dispensing these products, which are intended for medical use. The same provision defines the concept of gross violation of licensing conditions and requirements, which include issues related to the dispensing of medicines. In the event that the established rules for the dispensing of drugs are violated, regulatory authorities have the right to regard the detected crime as gross with all the ensuing consequences, ranging from serious penalties to suspension of the licensee’s activities.

So, how do you properly dispense a prescription drug?

Legal regulation of the rules for dispensing drugs

Federal Law No. 55 “On the Circulation of Medicines” provides rules for the dispensing of drugs for medical use by pharmacies, as well as individual entrepreneurs.

In addition to this law, the following regulatory documents have been approved that regulate the procedure for dispensing medications:

• Law No. 323 “On the Fundamentals of Health Care”.
• Law No. 2300 “On the Protection of Consumer Rights”.
• Order of the Ministry of Health No. 647 "On approval of the rules of pharmacy practice of medicinal products."
• A number of departmental regulations.

Who is responsible?

The prescription drug dispensing process involves close collaboration between medical and pharmaceutical professionals. Physicians are responsible for prescribing medications within the framework of compliance with the necessary requirements. Pharmacy workers must conduct a pharmaceutical examination before dispensing a prescription. Therefore, an important requirement is the presence of feedback between medical and pharmaceutical structures. That is, regulatory requirements require regular sending of information about all incorrectly written prescriptions to a medical institution. This regular feedback process ensures that questions regarding prescription drug violations do not arise.

Who, according to the rules, has the right to write prescriptions?

Currently, five forms of prescription forms are valid. At the beginning of 2016, some changes were made to prescription forms. In order to use stocks of prescription forms purchased long ago for their intended purpose, it was allowed to use the old sample until Order No. 385 of the Russian Ministry of Health came into force. Now pharmacy workers are required to require those versions of forms, the structure of which has been changed in accordance with current regulatory documents.

Government Order No. 1175 introduced a lot of new things into the procedure for prescribing and prescribing medications. An important place in the significance of changes should be given directly to the paradigm of prescribing medications. Previously, a health worker had the right to use any name of the product, that is, group or trade. But in connection with the entry into force of Order No. 1175, priority is now given to prescribing drugs by international nonproprietary name. In the case where it is absent, the group option should be used. If both names are missing, then by trade type.

Who has been added to the list?

The list of those who have the right to prescribe and issue prescriptions now includes workers with secondary medical education, these include, in particular, midwives and paramedics, but only if such powers are assigned to them by a corresponding decree of the head of the medical institution. Individual entrepreneurs also traditionally have the right to prescribe medications and write prescriptions, albeit under certain restrictions. For example, the nuances are related to the fact that these entrepreneurs who carry out private medical practice cannot prescribe psychotropic and narcotic drugs from the pharmaceutical lists “2” and “3”. There are also cases where prescription drugs are dispensed without a prescription.

What about a prescription that comes under a trade name? Is it possible to reject it or is it considered to have been issued correctly? An explanation of this issue is found in the order of the Ministry of Health No. 1175. The bottom line is that a medical employee has the right to use a trade name when prescribing, subject to individual intolerance or according to health conditions. However, such a decision must be approved by a medical commission, which is confirmed by the presence of a stamp on the back of the prescription.

Rules for dispensing prescription drugs and differences in forms

What is the difference in the form of the forms and how should medical professionals fill them out correctly in order to avoid incorrect pharmaceutical examination? And what are the basic rules when dispensing drugs? Prescription forms can be distinguished by the purpose of use, their structure and composition of details, as well as by the period of validity and storage. Let us give an example of several options for prescription forms.

Special prescription form

It is the most complex in terms of the composition of the details, as well as the structure. However, from the point of view of use, there is only one case in which a health care worker should use it. This strict registration form is protected and is intended for prescribing psychotropic and narcotic drugs. Any such prescription must be certified by the doctor’s personal signature and seal. The form must necessarily indicate the last name, first name and patronymic of the authorized specialist, who can be the head or deputy of the medical institution. This person can also be the one who certifies the forms. In addition, certification with the seal of a medical organization is required. Next on the prescription form there is a note from the pharmacy structure about the dispensing of the medicine. If the pharmacy employee is satisfied with everything in terms of filling out the prescription, then he indicates information about what is dispensed, what is the dosage and packaging of the medicine. The prescription is certified by indicating the full name, date of issue, as well as the seal of the pharmacy.

Prescription form No. 107

It is a simplified form compared to the special form described above. According to regulatory documents, this option can be used when prescribing, as well as prescribing a list of prescription drugs that contain small doses of psychotropic and narcotic substances. This form must have the stamp of the medical organization, its full name along with the address, telephone number and date. In addition, a mark is placed on the patient’s age category: children or adults. The name of the patient, the name of the drug in Latin according to the international nonproprietary name along with packaging and dosage are also indicated. You can enter up to three types of medications into this prescription form, which cannot be done in other options. On the form, among other things, a personal signature is placed with the seal of the attending physician. Such a prescription is considered valid for up to sixty days, and for patients with chronic diseases an extension of up to one year is allowed. What other rules are involved in the dispensing of prescription drugs?

Additional rules

The legislation provides the following rules:

What drugs are prescription?

This list is fixed by order of the Ministry of Health No. 403 dated July 11, 2017.

Combination medications containing:

• ergotamine hydrotartrate in an amount of up to five mg;
• ephedrine hydrochloride up to 100 mg;
• pseudoephedrine hydrochloride 30 mg, 10 mg;
• dextromethorphan hydrobromide 10 mg;
• codeine or its salts 20 mg;
• pseudoephedrine hydrochloride 30 mg;
• pseudoephedrine hydrochloride from 30 mg to 60 mg, dextromethorphan hydrobromide in the amount of 10 mg;
• dextromethorphan hydrobromide 200 mg;
• ephedrine hydrochloride 100 mg;
• phenylpropanolamine 75 mg.