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 , art. 3607) I order:
1. Approve the attached Procedure for dispensing medicines.
2. Recognize as invalid Annex 3 “List of medicines subject to subject-quantitative accounting in pharmacies/organizations, drug wholesalers, medical institutions and private practitioners**” and Annex 4 “Procedure for dispensing medicines in pharmacies” /organizations", approved by order of the Ministry of Health of the Russian Federation of 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, Art. 3198; 2004, No. 663; No. 47, Art. 4666) (hereinafter referred to as the List), prescribed on special prescription forms for narcotic drugs;
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 the prescription was issued 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 whose dispensing rates 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 (a patient leaving 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 carry out 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 by 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 periods have 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.
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 redeemed with the stamp of the pharmacy institution (organization) “Medicine dispensed” and returned to the patient.
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. Narcotic 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 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 combined 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.
Order of the Ministry of December 14, 2005 N 785
"On the procedure for dispensing medicines"
1.5. For the 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 and Social Development of the Russian Federation dated February 12, 2007 N 110, pharmacy institutions (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, Art. 3198; 2004, No. 663; No. 47, Art. 4666) (hereinafter referred to as the List), prescribed on special prescription forms for narcotic drugs;
Psychotropic substances included in List III of the List, prescribed on prescription forms, form N 148-1/у-88;
Other medicinal products 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 other medicinal products subject to subject-quantitative recording registration), 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 18, 2006 N 665 (registered with the Ministry of Justice of the Russian Federation on September 27, 2006 N 8322) (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 of form N 148-1/у-04 (l) and form N 148-1/у-06 (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, other medicines subject to subject-quantitative registration, and 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 other 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 their issuance and up to one year in accordance with paragraph 1.17 of the Instructions on the procedure for prescribing medicines and issuing prescriptions and invoice requirements, approved by order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110 (hereinafter referred to as the 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 paragraph 1.11 of the Instructions and Appendix No. 1 to the Instructions.
Medicines containing narcotic drugs, psychotropic substances and their precursors, and included in the List of Medicines Dispensed Without a Prescription, are subject to dispensing by pharmacies in quantities of no more than 2 packages to the consumer.
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 (a patient leaving 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, the List of which is provided in Appendix No. 1 to this Procedure.
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 Medicinal Products dispensed on prescription from 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.
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 recording, the list of which is provided in Appendix No. 1 to this Procedure; 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, anabolic steroids remain in the pharmacy institution (organization) for subsequent separate storage and destruction after the expiration of the shelf life.
2.15. A pharmacy institution (organization) must ensure conditions for the safety of prescriptions left for storage for medicines subject to subject-quantitative recording, the List of which is provided in Appendix No. 1 to this Procedure, medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic ), as well as other drugs sold free of charge or at a discount, anabolic steroids.
2.16. The shelf life of prescriptions in a pharmacy institution (organization) is:
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 - five years;
For narcotic drugs and psychotropic substances included in List II of List III of the List - ten years;
For other medicines subject to subject-quantitative registration, with the exception of narcotic drugs and psychotropic substances included in List II of 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 periods have 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.
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 quantitative accounting, antidepressants, neuroleptics, and alcohol-containing drugs of industrial production 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 are canceled with the stamp “Prescription is invalid” and registered in a journal, the form of which is provided in Appendix No. 4 to this Procedure, and 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 dispensing of narcotic drugs and psychotropic substances, medicines subject to subject-quantitative accounting, anabolic steroids
3.1. Narcotic 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. The dispensing to patients of narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List, is 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 13 May 2005 N 330 (registered with the Ministry of Justice of the Russian Federation on June 10, 2005, registration 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, other 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 issued for prescription form form N 148-1/у-88, and a prescription written 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 List III of the List, other medicines subject to subject-quantitative accounting, anabolic steroids according to prescriptions of 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 combined 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 if a doctor prescribes medicinal products in a dose exceeding the 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 a mixture and in pure form .
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 drugs containing drugs that are subject to subject-quantitative recording, instead of a prescription, patients are given a signature with a yellow stripe at the top and the inscription in black font on it is “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
Appendix No. 3
to Order
approved by order of the Ministry
healthcare and social development of the Russian Federation
dated December 14, 2005 N 785
(as amended on April 24, 2006,
August 6, 2007)
* The act is issued monthly.
Appendix No. 4
to the Procedure for Dispensing Medicines,
approved by order of the Ministry
healthcare and social development of the Russian Federation
dated December 14, 2005 N 785
Ministry of Health and Social Development of the Russian Federation _____________________________________ (name of institution (organization)
Magazine registration of incorrectly prescribed prescriptions
Note.
Information about violations in the issuance of prescriptions is brought to the attention of the head of the relevant medical institution at least once a month.
Appendix No. 5
to the Procedure for Dispensing Medicines,
approved by order of the Ministry
healthcare and social development of the Russian Federation
dated December 14, 2005 N 785
______________________________
* To repeat the dispensing of the drug, a new doctor's prescription is required.
Note.
The signature must have a size of 80 mm x 148 mm and a yellow stripe at least 10 mm wide.
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 and 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?
and departmental regulations - orders of the Russian Ministry of Health:
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 the rules for registration", 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, grouping 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 should health workers fill them out correctly in order to prevent incorrect pharmaceutical examination in the pharmacy?
√ Special prescription form(the most difficult one is in terms of the details and 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 - 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.
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
OrderMedicines according to List 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 of medicines sold without a prescription doctor), subject to sale by all pharmacies (organizations)<*>.
<*>Pharmacies, pharmacy points, pharmacy kiosks, pharmacy stores.
1.5. For the uninterrupted supply of medicines to the population, pharmacies (organizations) are required to have available minimum assortment medicines necessary for the provision of 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 medicines2.1. 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 the Order of the Ministry of Health of the Russian Federation dated August 23, 1999 N 328(registered with the Ministry of Justice of the Russian Federation on October 21, 1999 N 1944), pharmacy institutions (organizations) dispense:
Narcotic drugs and psychotropic substances included in List II 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, Art. 3198; 2004, N 8, Art. 663; N 47, Art. 4666) (hereinafter referred to as the List), written out on special prescription forms for narcotic drugs;
Psychotropic substances included in List III Lists written out on prescription forms form N 148-1/у-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/у-88 ;
Medicines included in Scroll medicines dispensed according to prescriptions 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 of September 28, 2005 N 601 (registered with the Ministry of Justice Russian Federation September 29, 2005 N 7052) (hereinafter - 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, prescribed on prescription forms form N 148-1/u-04 (l));
Anabolic steroids prescribed on prescription forms form N 148-1/у-88 ;
Other medicines not included in Scroll medicines sold without a doctor's prescription, prescribed on prescription forms form N 107/у.
2.3. Prescriptions for narcotic drugs and psychotropic substances included in List II The list is valid for five days.
Prescriptions for psychotropic substances included in List III List; medicines subject to subject-quantitative accounting; anabolic steroids are valid for ten days.
Prescriptions for medicines included in Scroll medicines dispensed according to prescriptions 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 the List II List of psychotropic substances included in List III The list for medicines subject to subject-quantitative accounting, for anabolic steroids, is valid for one month.
Prescriptions for other drugs are valid for two months from the date the prescription was issued and up to one year in accordance with clause 2.19 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 (hereinafter referred to as the 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 the appendices and 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 (a patient leaving 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 the pharmacy institution (organization) does not have a medicine prescribed by a doctor, with the exception of the medicine included in Scroll medicines dispensed according to prescriptions from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount, an employee of a pharmacy institution (organization) can carry out its synonymous replacement with the consent of the patient.
When dispensing a medicinal product included in Scroll of medicines prescribed by a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount, an employee of a pharmacy institution (organization) can carry out a synonymous replacement of the medicine 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 Scroll medicines prescribed by 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 Scroll medicines prescribed by 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 Scroll medicines prescribed by 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 Scroll medicines dispensed according to prescriptions 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 List III List - ten years;
For medicines subject to subject-quantitative registration, with the exception of narcotic drugs and psychotropic substances included in List II List III 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 periods have 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 appropriate quality purchased by citizens are not subject to return or exchange in accordance with List non-food products of good quality that cannot be returned or exchanged for a similar product of a different size, shape, dimension, style, color or configuration, approved by Decree of the Government of the Russian Federation of January 19, 1998 No. 55 (Collection of Legislation of the Russian Federation, 1998, No. 4, Art. 482; Art. 1999, Art. 4923; Art. 2003, 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 redeemed with the stamp of the pharmacy institution (organization) “Medicine dispensed” and returned to the patient.
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 Scroll medicines dispensed according to prescriptions from 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 steroids3.1. Narcotic drugs and psychotropic substances included in the list are subject to dispensing by pharmacies (organizations). List II List, and psychotropic substances included in List III List.
3.2. The right to work with narcotic drugs and psychotropic substances included in List II List, and psychotropic substances included in List III The list is available only 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 included in the list to patients List II List and psychotropic substances included in List III The list is 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 with 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 The list is carried out by patients assigned to a specific outpatient clinic, which is assigned to a 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 prescribed by a doctor and included in List II The list is issued 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 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 on a special prescription form for a narcotic drug, and a prescription written on a prescription form form N 148-1/u-04 (l).
Psychotropic substances included in List III List, medicines subject to subject-quantitative accounting, 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 form N 148-1/у-88, and the prescription written on the prescription form form N 148-1/u-04 (l).
3.7. Pharmacy institutions (organizations) are prohibited from dispensing narcotic drugs and psychotropic substances included in List II List III 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 combined 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 List; psychotropic substances included in List III 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 Scroll medicines dispensed according to prescriptions from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount) are carried out by the head (deputy head) of a pharmacy institution (organization) or a pharmaceutical worker authorized by him at a pharmacy institution (organization).
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.
ApplicationsAppendix No. 1
to Order
approved by the Order
Ministry of Health
and social development
Russian Federation
dated December 14, 2005 N 785
1. Narcotic drugs and psychotropic substances included in List II, and psychotropic substances included in List III 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, No. 27, Art. 3198; 2004, No. 8, Art. 663; No. 47, Art. 4666).
<*>Prohibited for use by private practitioners.
3. Medicines included in List No. 1 “Potent Substances” of the Standing Committee on Drug Control.
4. Medicines included in List No. 2 “Poisonous Substances” of the Standing Committee on Drug Control.
5. Substances of apomorphine hydrochloride, atropine sulfate, dicaine, homatropine hydrochloride, silver nitrate, pachycarpine hydroiodide.
6. Ethyl alcohol.
7. Medical antiseptic solution.
8. Clozapine (Leponex, Azaleptin).
9. Butorphanol (Stadol, Moradol).
Appendix No. 2
to Order
dispensing of medicines,
approved by the Order
Ministry of Health
and social development
Russian Federation
dated December 14, 2005 N 785
ACT \r\n on the destruction of prescriptions for \r\n narcotic drugs and psychotropic substances \r\n upon expiration of their storage periods<*>\r\n \r\nfrom "__" ___________ 200_ N ________ \r\n \r\nCommission consisting of: \r\n \r\n Chairman _____________________________________________________ \r\n (position and full name . in full) \r\n \r\nCommission members: _______________________________________ \r\n (position and full name) \r\n _______________________________________ \r\n (position and full name) \ r\n _______________________________________ \r\n (position and full name) \r\n \r\nmade "__" ___ 200_ seizure and destruction in _______________ \r\n (name \r\n of the organization ) \r\nprescriptions for narcotic drugs and psychotropic \r\nsubstances for _____________________: \r\n (month, year) \r\n
N p/p Appendix No. 3 Appendix No. 3. ACT ON THE DESTRUCTION OF RECIPES FOR OBTAINING MEDICINES SUBJECT TO SUBJECT-QUANTITATIVE ACCOUNTING, MEDICINES INCLUDED IN THE LIST OF MEDICINES DISCHARGED ACCORDING TO A DOCTOR’S (Paramedic’s) PRESCRIPTION, AND THE SAME OTHER MEDICINES DISCHARGED FOR FREE OR WITH A DISCOUNT AFTER EXPIRATION THEIR STORAGE LIFE ACT \r\n on the destruction of prescriptions for \r\n medicines subject to \r\n subject-quantitative accounting, \r\n medicines included in the List \r\n of prescription medicines \r\ n doctor (paramedic), as well as other medicines \r\n dispensed free of charge or at a discount, \r\n after their shelf life has expired<*>\r\n \r\n dated "__" ___________ 200_ N ________ \r\n \r\nCommission consisting of: \r\n \r\n Chairman _____________________________________________________ \r\n (position and full name O. in full) \r\n \r\nCommission members: _______________________________________ \r\n (position and full name) \r\n _______________________________________ \r\n (position and full name) \r\n _______________________________________ \r\n (position and full name) \r\n \r\nmade "__" ___ 200_ seizure and destruction in _______________ \r\n (name \r\n organization) \r\nthe following prescriptions for obtaining medicines \r\nsubject to subject-quantitative accounting, medicines \r\nincluded in Scroll medicines dispensed \r\naccording to prescriptions from a doctor (paramedic), as well as other medicines \r\ndispensed free of charge or at a discount: \r\n 1. Prescriptions for potent and toxic substances \r\nlists of the Standing Control Committee drugs for ___________ \r\n (month, \r\n year) \r\nin the amount of ______________________ pieces. \r\n (in numbers and words) \r\n 2. Prescriptions for medications included in \r\n Scroll medicines dispensed according to prescriptions from a doctor \r\n(paramedic), for ______________ in the amount of ______________________ \r\n (month, year) (in numbers and words) \r\npieces. \r\n 3. Prescriptions for medications dispensed \r\n free of charge or at a discount, for ______________ in the amount of _________ \r\n (month, year) \r\n______________________ pieces. \r\n (in numbers and words) \r\n 4. Recipes for obtaining apomorphine hydrochloride, atropine \r\nsulfate, dicaine, homatropine hydrochloride, silver nitrate, \r\npachycarpine hydroiodide (in pure form and in a mixture) for _____________ \r\n (month, year) \r\nin the amount of ______________________ pieces. \r\n (in numbers and words) \r\n 5. Recipes for obtaining ethyl alcohol and medical antiseptic solution for ______________ in the amount of _____ \r\n (month, year) \r\n________________________ pieces. \r\n (in numbers and words) \r\n 6. Prescriptions for clozapine and butorphanol for ___________ \r\n (month, \r\n year) \r\nin the amount of ______________________ pieces. \r\n (in numbers and words) \r\n 7. Prescriptions for obtaining anabolic steroids (indicating \r\n names) for ______________ in the amount of _____________________ \r\n (month, year) (in numbers and words) \r \npieces. \r\n \r\n Total according to the act, destroyed by burning or tearing and \r\nsubsequent soaking in a bleach solution (underline as necessary) __________________________________________ prescription \r\n (quantity in numbers and words) \r\nforms. \r\n \r\nChairman of the commission: ____________________________ \r\n (signature) \r\n \r\n Members of the commission: ____________________________ \r\n (signature) \r\n ____________________________ \r\n (signature) \ r\n ____________________________ \r\n (signature) \r\n \r\n \r\n<*>The act is issued monthly. \r\n \r\n \r\n Appendix No. 4 approved by the Order Ministry of Health and social development Russian Federation dated December 14, 2005 N 785Appendix No. 5. SIGNATURE Signature<*>\r\n \r\nName of the governing body \r\nhealthcare or \r\npharmaceutical activities of the \r\nsubject of the Russian Federation \r\n \r\nName or N of the pharmacy institution (organization) ......... ... \r\n................................... Recipe N .. ............... \r\nFull name and the age of the patient........................................ \r\n... ........................................................ ............. \r\nAddress or medical outpatient card number.................... \r\nFull name . doctor, telephone number of the medical institution....... \r\n................................. .................................. \r\nContents of the recipe in Latin........ .................... \r\n......................... ........................................ \r\n...... ........................................................ .......... \r\n.................................... ........................... \r\n ................ ........................................................ \r\n ........................................................ .................... \r\n......................... ........................................ \r\n...... ........................................................ .......... \r\nPrepared.................................... ................... \r\nChecked........................ ........................... \r\nLet go................ ......................................... \r\nDate..... ......... \r\nPrice.............. \r\n \r\n \r\n<*>To repeat the dispensing of the drug, a new \r\n doctor's prescription is required. \r\n \r\n Note. \r\nThe signature must have a size of 80 mm x 148 mm and a yellow stripe \r\nat least 10 mm wide. \r\n |