"On approval of vacation rules medicines For medical use, including immunobiological medicinal products, pharmacy organizations, individual entrepreneurs with a license for pharmaceutical activities"
Revision dated 07/11/2017 - Valid from 09/22/2017
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
ORDER
dated July 11, 2017 N 403n
ON APPROVAL OF THE RULES FOR THE DISCLAIMER OF MEDICINES FOR MEDICAL USE, INCLUDING IMMUNOBIOLOGICAL MEDICINES, BY PHARMACY ORGANIZATIONS, INDIVIDUAL ENTREPRENEURS HAVING A PHARMACEUTICAL LICENSED UY ACTIVITY
1. Approve the rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities, in accordance with the appendix.
2. To recognize as invalid:
dated December 14, 2005 N 785 “On the Vacation Procedure medicines" (registered by the Ministry of Justice Russian Federation January 16, 2006, registration N 7353);
Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302 “On amendments to the order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785” (registered by the Ministry of Justice of the Russian Federation on May 16, 2006, registration N 7842);
Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 109 "On amendments to the Procedure for the dispensing of medicines, approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785" (registered by the Ministry of Justice of the Russian Federation March 30, 2007, registration N 9198);
Order of the Ministry of Health and Social Development of the Russian Federation dated August 6, 2007 N 521 "On amendments to the Procedure for the dispensing of medicines, approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785" (registered by the Ministry of Justice of the Russian Federation August 29, 2007, registration N 10063).
Minister
IN AND. SKVORTSOVA
RULES FOR THE DISTRIBUTION OF MEDICINES FOR MEDICAL USE, INCLUDING IMMUNOBIOLOGICAL MEDICINES, BY PHARMACY ORGANIZATIONS, INDIVIDUAL ENTREPRENEURS HAVING A PHARMACEUTICAL ACTIVITY LICENSED NOST
I. General requirements for the dispensing of medicinal products for medical use
1. These rules determine the procedure for the dispensing of medicinal products for medical use, including immunobiological medicinal products (hereinafter referred to as medicinal products), by pharmacies and individual entrepreneurs with a license for pharmaceutical activities (hereinafter referred to as retail entities), without a prescription<1>and (or) according to a prescription for a medicinal product issued in accordance with the established procedure<2>medical workers, as well as according to the invoice requirements of the organization carrying out medical activities(hereinafter referred to as a medical organization), or an individual entrepreneur with a license for medical activities (hereinafter referred to as a prescription, demand invoice).
2. Dispensing of medications without prescriptions is carried out:
pharmacies;
pharmacy points;
pharmacy kiosks;
individual entrepreneurs with a license for pharmaceutical activities (hereinafter referred to as individual entrepreneurs).
3. Dispensing of prescription drugs is carried out:
pharmacies;
individual entrepreneurs (except for vacation narcotic drugs and psychotropic substances included in 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<3>(hereinafter referred to as the List).
<3>Collection of Legislation of the Russian Federation, 1998, No. 27, Art. 3198; 2004, N 8, art. 663; N 47, art. 4666; 2006, N 29, art. 3253; 2007, N 28, art. 3439; 2009, N 26, art. 3183; N 52, art. 6572; 2010, N 3, art. 314; N 17, Art. 2100; N 24, Art. 3035; N 28, art. 3703; N 31, art. 4271; N 45, art. 5864; N 50, art. 6696, 6720; 2011, N 10, art. 1390; N 12, art. 1635; N 29, art. 4466, 4473; N 42, art. 5921; N 51, Art. 7534; 2012, N 10, art. 1232; N 11, art. 1295; N 19, Art. 2400; N 22, art. 2864; N 37, art. 5002; N 48, art. 6686; N 49, Art. 6861; 2013, N 9, art. 953; N 25, art. 3159; N 29, art. 3962; N 37, art. 4706; N 46, art. 5943; N 51, Art. 6869; 2014, N 14, art. 1626; N 23, art. 2987; N 27, art. 3763; N 44, art. 6068; N 51, Art. 7430; 2015, N 11, art. 1593; N 16, art. 2368; N 20, art. 2914; N 28, art. 4232; N 42, art. 5805; 2016, N 15, art. 2088; 2017, N4, art. 671; N 10, art. 1481.
The dispensing of narcotic and psychotropic drugs according to prescriptions is carried out by pharmacies and pharmacy points that have a license to operate in the circulation of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants.
Immunobiological drugs are dispensed according to prescriptions by pharmacies and pharmacy points.
4. N 107/u-NP<4>, narcotic and psychotropic drugs included in the List of Narcotic Drugs and Psychotropic Substances, the circulation of which is limited in the Russian Federation and in respect of which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List II), the List (hereinafter - narcotic and psychotropic drugs of list II), with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.
<4>Appendix No. and to Order No. 54n.
According to prescriptions written for prescription forms forms N 148-1/у-88, issued<5>:
<5>Clause 9 of the procedure for prescribing and prescribing medications, approved by Order N 1175n.
psychotropic medicinal products included in the List of psychotropic substances, the circulation of which is limited in the Russian Federation and in respect of which certain control measures may be excluded in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List III), the List (hereinafter referred to as psychotropic medicinal products of List III );
narcotic and psychotropic drugs of list II in the form of transdermal therapeutic systems;
medicinal products included in the list of medicinal products for medical use subject to subject-quantitative accounting<6>, with the exception of the medicines specified in paragraphs one and three of this paragraph, and medicines sold without a prescription (hereinafter referred to as medicines subject to subject-quantitative accounting);
<6>Order of the Ministry of Health of the Russian Federation dated April 22, 2014 N 183n “On approval of the list of medicines for medical use subject to subject-quantitative registration” (registered by the Ministry of Justice of the Russian Federation on July 22, 2014, registration N 33210) as amended by the order Ministry of Health of the Russian Federation dated September 10, 2015 N 634n (registered by the Ministry of Justice of the Russian Federation on September 30, 2015, registration N 39063).
drugs with anabolic activity (in accordance with the main pharmacological action) <7>and according to the anatomical-therapeutic-chemical classification recommended by the World Health Organization (hereinafter referred to as ATC), they are classified as anabolic steroids (code A14A) (hereinafter referred to as drugs with anabolic activity);
<8>Registered by the Ministry of Justice of the Russian Federation on June 1, 2012, registration N 24438, as amended by orders of the Ministry of Health of the Russian Federation dated June 10, 2013 N 369n (registered by the Ministry of Justice of the Russian Federation on July 15, 2013, registration N 29064), dated August 21, 2014 N 465n (registered by the Ministry of Justice of the Russian Federation on September 10, 2014, registration N 34024), dated September 10, 2015 N 634n (registered by the Ministry of Justice of the Russian Federation on September 30, 2015, registration N 39063).
medicinal products manufactured according to a prescription for a medicinal product and containing a narcotic drug or psychotropic substance included in List II of the List, and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that the combination drug is not a Schedule II narcotic or psychotropic drug.
According to prescriptions written on prescription forms, form N 148-1/u-04 (l) or form N 148-1/u-06 (l), medications are dispensed and prescribed to citizens entitled to free receipt medicines or receiving medicines at a discount (hereinafter referred to as medicines dispensed free of charge or at a discount).
According to prescriptions written on prescription forms of form N 107-1/u, other medications not specified in paragraphs one, three through nine of this paragraph are dispensed, with the exception of medications sold without a prescription.
5. The dispensing of medications not specified in paragraph 4 of these Rules, in accordance with the instructions for their medical use, is carried out without prescriptions.
6. Medicines are dispensed during the validity period specified in the prescription when a person contacts a retail trade entity.
If a retail trade entity does not have the medicinal product specified in the prescription, when the person contacts the retail trade entity, the prescription is accepted for servicing within the following terms (hereinafter referred to as deferred servicing):
a prescription marked “statim” (immediately) is served within one business day from the date the person contacts the retail trade entity;
a prescription marked “cito” (urgent) is served within two working days from the date the person contacts the retail trade entity;
prescription for a drug included in minimum assortment medicinal products for medical use necessary to provide medical care <9>, serviced within five working days from the date the person contacts the retail trade entity;
<9>Order of the Government of the Russian Federation of December 26, 2015 N 2724-r (Collected Legislation of the Russian Federation, 2016, N 2, Art. 413).
a prescription for a medicinal product that is dispensed free of charge or at a discount and is not included in the minimum range of medicinal products for medical use required for the provision of medical care is serviced within ten working days from the date the person contacts the retail trade entity;
prescriptions for medications prescribed by decision of the medical commission are serviced within fifteen working days from the date the person contacts the retail trade entity.
Do not fill expired prescriptions unless the prescription expired while it was on deferred maintenance.
If a prescription expires while it is under deferred servicing, the medicinal product for such a prescription is dispensed without reissuing it.
7. Medicines are dispensed in the quantity specified in the prescription, except in cases where the maximum permissible or recommended quantity for prescribing per prescription is established for the medicine<10>.
<10>Appendices No. 1 and No. 2 to the procedure for prescribing and prescribing medications, approved by Order No. 1175n.
When a prescription is presented that exceeds the maximum permissible or recommended amount of a medicinal product for prescribing per prescription, the pharmacist informs the person who submitted the prescription about this to the head of the relevant medical organization and releases to the specified person the correspondingly established maximum permissible or recommended amount of the medicinal product for prescribing per prescription. by putting the appropriate mark in the recipe.
If a retail trade entity has a medicinal product with a dosage different from the dosage of the medicinal product specified in the prescription, dispensing of the existing medicinal product is permitted if the dosage of such medicinal product is less than the dosage specified in the prescription. In this case, the amount of the drug is recalculated taking into account the course of treatment specified in the prescription.
If the dosage of a medicinal product available to a retail trade entity exceeds the dosage of the medicinal product specified in the prescription, the decision to dispense the medicinal product with such dosage is made by the medical professional who wrote the prescription.
8. The medicinal product is sold in primary and secondary (consumer) packaging, the labeling of which must meet the requirements of Article 46 Federal Law dated April 12, 2010 N 61-FZ "On the circulation of medicines"<11>, and packaging for narcotic and psychotropic drugs of List II - the requirements of paragraph 3 of Article 27 of the Federal Law of January 8, 1998 N 3-FZ "On Narcotic Drugs and Psychotropic Substances"<12>.
<11>Collection of Legislation of the Russian Federation, 2010, No. 16, Art. 1815; N 42, art. 5293; 2014, N 52, art. 7540.
<12>Collection of Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2012, N 53, art. 7630; 2013, N 48, art. 6165; 2015, N 1, art. 54.
Tampering with the primary packaging of the medicinal product when dispensing it is prohibited.
Violation of the secondary (consumer) packaging of the medicinal product and dispensing of the medicinal product in the primary packaging is permitted if the amount of the medicinal product indicated in the prescription or required by the person purchasing the medicinal product (for over-the-counter dispensing) is less than the amount of the medicinal product contained in the secondary (consumer) packaging. ) packaging. In this case, when dispensing a medicinal product, the person purchasing the medicinal product is provided with instructions (a copy of the instructions) for the use of the dispensed medicinal product.
9. When dispensing drugs according to a prescription, the pharmacist puts a mark on the prescription about the dispensing of the drug indicating:
names pharmacy organization(last name, first name, patronymic (if any) of the individual entrepreneur);
trade name, dosage and quantity of the drug dispensed;
last name, first name, patronymic (if available) medical worker in the cases specified in paragraph four of clause 7 and paragraph three of clause 10 of these Rules;
details of the identity document of the person who received the medicinal product, in the case specified in paragraph 20 of these Rules;
surname, name, patronymic (if any) of the pharmaceutical worker who dispensed the medicinal product, and his signature;
date of release of the drug.
10. When dispensing medications according to a prescription written out on prescription form Form N 107-1/u<13>, and which indicates the periods and quantity of dispensing of the medicinal product (in each period), the prescription is returned to the person purchasing the medicinal product with a note containing the information specified in paragraph 9 of these Rules.
The next time a person contacts a retail trade entity with this prescription, the notes on the previous dispensing of the medicinal product according to such a prescription are taken into account and in the event that the person purchased a quantity of the medicinal product corresponding to the maximum quantity specified by the medical professional in the prescription, as well as after the expiration of the prescription, on the prescription a stamp “The drug has been dispensed” is affixed and the prescription is returned to the person.
One-time dispensing of a medicinal product according to a prescription written out on prescription form Form N 107-1/у, which is valid for one year<13>, and which indicates the periods and quantity of dispensing of the drug (in each period), is allowed only in agreement with the medical professional who wrote the prescription.
13. When dispensing an immunobiological medicinal product, the prescription or prescription counterfoil, which remains with the person purchasing (receiving) the medicinal product, indicates exact time(in hours and minutes) dispensing of the drug.
The release of an immunobiological medicinal product is carried out to the person purchasing (receiving) the medicinal product, if he has a special thermal container in which the medicinal product is placed, with an explanation of the need to deliver this medicinal product to a medical organization, subject to storage in a special thermal container for a period not exceeding 48 hours after its acquisition.
14. Recipes (with the mark “The medicinal product is dispensed”) remain and are stored by the retail trade entity for:
narcotic and psychotropic drugs of list II, list III - for five years;
medicines dispensed free of charge or at a discount - for three years;
combined medicinal products containing narcotic drugs or psychotropic substances included in the lists and III List, manufactured in a pharmacy organization, medicinal products with anabolic activity, medicinal products subject to subject-quantitative accounting - for three years;
medicines in liquid dosage form, containing more than 15% ethyl alcohol of the volume of finished products, other drugs classified according to ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives(code N05C), antidepressants (code N06A) and not subject to subject-quantitative accounting - within three months.
15. Prescriptions not specified in paragraph 14 of these Rules are marked with the stamp “The medicinal product is dispensed” and are returned to the person who received the medicinal product.
Prescriptions written in violation of established rules<14>, are registered in a journal in which the identified violations in the execution of the prescription are indicated, the last name, first name, patronymic (if any) of the medical worker who wrote the prescription, the name of the medical organization, the measures taken, are marked with the stamp “The prescription is invalid” and are returned to the person who submitted the prescription. The retail trade entity informs the head of the relevant medical organization about facts of violation of the rules for filling prescriptions.
<14>Order N 1175n and order N 54n.
16. When dispensing a medicinal product, the pharmacist informs the person purchasing (receiving) the medicinal product about the regimen and doses of its administration, storage rules at home, and interactions with other medications.
17. When dispensing a medicinal product, a pharmaceutical worker does not have the right to provide unreliable and (or) incomplete information about the availability of medicinal products, including medicinal products that have the same international generic name, including hiding information about the availability of medicines that have more low price <15>.
II. Requirements for the dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting
19. The dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, drugs subject to subject-quantitative accounting is carried out by pharmaceutical workers holding positions included in the list of positions of pharmaceutical and medical workers in organizations that are granted the right to dispense narcotic drugs and psychotropic drugs individuals, approved by order of the Ministry of Health of the Russian Federation dated September 7, 2016 N 681n (registered by the Ministry of Justice of the Russian Federation on September 21, 2016, registration N 43748).
20. Narcotic and psychotropic drugs of list II, with the exception of drugs in the form of transdermal therapeutic systems, are dispensed upon presentation of an identification document to the person specified in the prescription, his legal representative<17>or a person who has a power of attorney issued in accordance with the legislation of the Russian Federation for the right to receive such narcotic and psychotropic medications.
<17>In relation to the person specified in part 2 of Article 20 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26, Art. 3442, 3446; 2013, N 27, Art. 3459, 3477; N 30, Art. 4038; N 39, Art. 4883; N 48, Art. 6165; N 52, Art. 6951; 2014, N 23, Art. 2930; N 30, Art. 4106, 4206, 4244, 4247, 4257; N 43, Art. 5798; N 49, Art. 6927, 6928; 2015, N 1, Art. 72, 85; N 10 , Art. 1403, 1425; N 14, Art. 2018; N 27, Art. 3951; N 29, Art. 4339, 4356, 4359, 4397; N 51, Art. 7245; 2016, N 1, Art. 9, 28; N 15, Art. 2055; N 18, Art. 2488; N 27, Art. 4219).
21. Narcotic and psychotropic drugs of List II (with the exception of drugs in the form of transdermal therapeutic systems), intended for citizens entitled to receive free drugs or receive drugs at a discount, are dispensed upon presentation of a prescription written out on the prescription form Form N 107/u-NP, and a prescription written out on a prescription form, form N 148-1/u-04 (l) or form N 148-1/u-06 (l).
Medicines specified in paragraphs three to eight of clause 4 of these Rules, intended for citizens entitled to receive medicines dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written out on a prescription form, form N 148-1/у-88, and a prescription written out on a prescription form, form N 148-1/u-04 (l) or form N 148-1/u-06 (l).
22. After dispensing narcotic and psychotropic drugs of List II, including in the form of transdermal therapeutic systems, psychotropic drugs of List III, the person who received the drug is given a signature with a yellow stripe at the top and the inscription “Signature” on it in black font, which indicates:
name and address of the pharmacy or pharmacy;
number and date of the prescription;
last name, first name, patronymic (if any) of the person for whom the drug is intended, his age;
number medical card patient receiving medical care outpatient setting for which the medicinal product is intended;
last name, first name, patronymic (if any) of the medical worker who wrote the prescription, his contact phone number or the phone number of the medical organization;
last name, first name, patronymic (if available) and signature of the pharmaceutical worker who dispensed the drug;
date of release of the drug.
23. Ethyl alcohol is dispensed according to a prescription, taking into account the established requirements for the volume of containers, packaging and completeness of medicines<18>.
Medicines containing ethyl alcohol, including those manufactured according to a prescription by a retail trade entity that has a license for pharmaceutical activities with the right to manufacture medicines, are dispensed taking into account the established requirements for the volume of containers, packaging and completeness of medicines<18>.
24. Separate dispensing of medicinal products included in a medicinal product manufactured by a retail trade entity is prohibited.
25. It is prohibited for a retail trade entity to dispense medicinal products specified in paragraph 4 of these Rules according to prescriptions from veterinary organizations.
III. Requirements for the dispensing of medicinal products according to the invoice requirements of medical organizations and individual entrepreneurs with a license for medical activities
26. The demand-invoice for the dispensing of medicines is drawn up in accordance with the Instructions on the procedure for prescribing medicines and issuing prescriptions and demands-invoices, approved by order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110 “On the procedure for prescribing and prescribing medicines, medical devices and specialized products therapeutic nutrition"(registered by the Ministry of Justice of the Russian Federation on April 27, 2007, registration No. 9364)<19>.
<19>As amended by orders of the Ministry of Health and Social Development of the Russian Federation dated August 27, 2007 N 560 (registered by the Ministry of Justice of the Russian Federation on September 14, 2007, registration N 10133), dated September 25, 2009 N 794n (registered by the Ministry of Justice of the Russian Federation on November 25, 2009, registration N 15317), dated January 20, 2011 N 13n (registered by the Ministry of Justice of the Russian Federation on March 15, 2011, registration N 20103), by orders of the Ministry of Health of the Russian Federation dated August 1, 2012 N 54n (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration N 25190), dated February 26, 2013 N 94n (registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration N 28881).
It is allowed to dispense medicines according to the requirements of invoices of medical organizations and individual entrepreneurs with a license for medical activities, issued in electronic form, if the medical organization, an individual entrepreneur with a license for medical activities, and a retail trade entity are respectively participants in the information exchange exchange system information.
29. When dispensing medicines, the pharmacist checks the proper execution of the demand invoice and puts a note on it about the quantity and cost of the medicines dispensed.
30. All invoice requirements for which medications are dispensed must be left and stored with the retail trade entity:
for narcotic and psychotropic drugs of list II, psychotropic drugs of list III (in relation to pharmacies and pharmacy points) - for five years;
for medicinal products subject to subject-quantitative accounting - for three years;
for other drugs - for one year.
31. Violation of the primary packaging of a medicinal product when dispensing it upon request-invoice is permitted by a retail trade entity that has a license for pharmaceutical activities with the right to manufacture medicinal products. In this case, the medicinal product is dispensed in a package prepared in accordance with the established procedure.<21>, with the provision of instructions (copies of instructions) for the use of the drug being dispensed.
<21>Order of the Ministry of Health of Russia dated October 26, 2015 N 751n “On approval of the rules for the manufacture and dispensing of drugs for medical use by pharmacy organizations and individual entrepreneurs licensed for pharmaceutical activities” (registered by the Ministry of Justice of the Russian Federation on April 21, 2016, registration N 41897 ).
Samvel Grigoryan talks about the new document regulating the procedure for dispensing medicines and coming into force on September 22
IP and IBLP
In general, in order No. 403n the topic of IBP release is spelled out separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.
Violation of secondary
With the entry into force of Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.
Order No. 403n, which replaced it, is in this regard more specific and more consistent modern requirements, medical practice and consumer requests. Paragraph 8 of the order determines that violation of secondary packaging and dispensing of a medicinal product in primary packaging is permitted in cases where the amount of the drug indicated in the prescription or required by the consumer (for over-the-counter dispensing) is less than the amount of the drug contained in the secondary packaging.
In this case, the buyer must be provided with instructions for use or a copy thereof, and tampering with the original packaging is prohibited. By the way, the new order does not contain the rule that in case of violation of the secondary order, the drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory batch, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.
"The medicine has been released"
Clause 4 of Order No. 403n of the Ministry of Health of the Russian Federation regulates the topic of prescription forms and the list of drugs dispensed on them. In particular, narcotic and psychotropic drugs of Schedule II are dispensed using Form No. 107/u-NP, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.
The remaining prescription drugs, as is known, are dispensed using forms No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases it is allowed to set the validity period of the prescription form No. 107-1/у within up to one year and exceed the recommended amount of the drug for prescribing per prescription, installed by application No. 2 of this order.
Such a prescription, which also indicates the periods and quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. He also determines that the next time the patient comes to the pharmacy with the same prescription, the chief must take into account the notes on the previous dispensing of the drug.
The prescription remains at the pharmacy
There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order establishes that the retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:
within 5 years prescriptions for:
within 3 years prescriptions for:
within 3 months recipes for:
Order No. 403n of the Russian Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not specified in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.
The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is also reflected in the new order on the rules of dispensing. According to the current procedure, prescriptions for such drugs are returned to the patient (with a “dispensed” stamp); under the new order, they must remain in the pharmacy organization.
To avoid getting caught
The procedure for working with incorrectly written prescriptions is now described in a little more detail (clause 15 of order No. 403n). In particular, when they are registered by a pharmacist in a journal, it is necessary to indicate the identified violations in the execution of the prescription, the full name of the health worker who wrote it, the name of the medical organization in which he works, and the measures taken.
Paragraph 17 of Order No. 403n contains the rule that a pharmacist does not have the right to provide false or incomplete information about the availability of drugs in the pharmacy’s assortment - including drugs that have the same INN - and also to hide information about the availability of drugs that have a lower price. Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (Order of the Ministry of Health of the Russian Federation dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on vacation rules.
This was a review of the order, so to speak, “on fresh trail.” Readers will probably find in it other points and norms that deserve special attention. Write to the editors of Katren-Style magazine about them, and we will address your questions to leading industry experts. We will also ask them about the problem of “disposable” prescriptions with a two-month validity period, which was mentioned above, as well as the dispensing of ethyl alcohol and alcohol-containing drugs in the light of the provisions of the new order No. 403n.
Materials about the order of the Ministry of Health No. 403n:
What could be more important for a pharmacy organization than the order in which medications are dispensed. Pharmacists barely had time to return from their summer vacation and look around when a new order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n was published with appendices “On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations, individual entrepreneurs with license for pharmaceutical activities." Order No. 403n on the vacation procedure was registered with the Ministry of Justice of the Russian Federation on September 8; its validity begins on September 22 of the current year.
The first thing I want to say in this regard is that now forget the number “785”. New order 403n with amendments and additions recognizes that the well-known order of the Ministry of Health and Social Development of December 14, 2005 No. 785 “On the procedure for dispensing medicines”, as well as the orders of the Ministry of Health and Social Development No. 302, No. 109 and No. 521 that amended it, have become invalid. At the same time, many points of the new normative -legal act repeat - sometimes almost verbatim - the corresponding fragments of the predecessor order. But there are also differences, new provisions, on which we will focus more, setting out the first observations and notes in the margins of the freshly issued order of the Ministry of Health No. 403n.
IP and IBLP
Order of the Ministry of Health of the Russian Federation No. 403n consists of three appendices. The first approves new rules for the dispensing of medicinal products, including immunobiological medicinal products (IBP); the second is the requirements for the dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting (SQR). The third appendix establishes the rules for the dispensing of medicines according to the invoice requirements of medical organizations, as well as individual entrepreneurs (IP) with a license for medical activities.
Under the new order, the dispensing of over-the-counter drugs will be allowed both to pharmacies and pharmacy points, as well as individual entrepreneurs and pharmacy kiosks. For the rest, if we summarize points 2 and 3 of order No. 403n and the list of drugs, the following picture emerges.
- The dispensing of narcotic and psychotropic drugs can only be carried out by pharmacies and pharmacy points that have the appropriate license.
- Vacation of the rest prescription drugs are carried out by pharmacies, pharmacy points and individual entrepreneurs (of course, those with a license for pharmaceutical activities - this clarification will be further considered accepted by default and omitted).
- The dispensing of immunobiological prescription drugs is carried out by pharmacies and pharmacy points. Individual entrepreneurs are not mentioned in this provision of paragraph 3, which means that they cannot dispense drugs of this group, which we advise you to pay special attention to.
In general, in order No. 403n the procedure for dispensing IBP drugs is prescribed separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.
IBLP can be released if two conditions are met. Firstly, if the buyer has a special thermal container in which the required mode of transportation and storage of these thermolabile drugs can be observed. The second condition is an explanation (from the pharmacist to the buyer) of the need to deliver this drug to a medical organization, despite the fact that it can be stored in the mentioned container for no more than 48 hours.
Let us recall in this regard that this topic is also regulated by subclause 8.11.5 of the Sanitary and Epidemiological Rules “Conditions of transportation and storage immunobiological preparations"(SP 3.3.2.3332–16), which are approved by the Resolution of the Chief State Sanitary Doctor of the Russian Federation dated February 17, 2016 No. 19. It obliges the pharmacy employee to instruct the buyer on the need to comply with the “cold chain” when transporting IBPs.
The fact of this instruction is recorded with a mark on the drug packaging, prescription or other accompanying document. The mark is certified by the signature of the buyer and the chief clerk (or another representative of the pharmacy organization) and also includes the date and time of dispensing. However, SanPiN does not specify that the time in in this case must be entered in hours and minutes.
Violation of secondary
With the amendments and additions to Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.
The order No. 403n that replaced it with a list of drugs in this regard is more specific and more in line with modern requirements, medical practice and consumer demands. Paragraph 8 of the order determines that violation of the secondary packaging and dispensing of the medicinal product in the primary packaging is allowed in cases where the amount of the drug indicated in the prescription or required by the consumer (for over-the-counter dispensing) is less than the amount of the drug contained in the secondary packaging.
In this case, the buyer must be provided with instructions for use or a copy thereof, and tampering with the original packaging is prohibited. By the way, in the new order of the Ministry of Health of the Russian Federation No. 403n there is no provision that in case of violation of the secondary drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory series, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.
What does this mean in practice? Let's assume two situations: first - drug X tablets (or dragees) No. 56, primary packaging - blister; the second is drug N tablets No. 56, in a bottle. And in both cases, the question arises about its release to the patient who has presented the chief of staff with a prescription on which, say, 28 tablets or 42 tablets (dragées) are prescribed.
It is clear that in the first case this is acceptable, since it is possible to dispense 28 or 42 tablets without breaking the primary packaging (blister), and in the second case it is unacceptable, since the primary packaging in this situation is a bottle, and breaking it is strictly prohibited. So count out tablets or dragees from the bottle, as they do in some pharmacies foreign countries, our leaders have no rights.
"The medicine has been released"
Clause 4 of Order No. 403n of the Ministry of Health of the Russian Federation regulates the topic of prescription forms and the list of drugs dispensed on them. In particular, narcotic and psychotropic drugs of Schedule II are dispensed using Form No. 107/u-NP, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.
According to form No. 148–1/у-88 the following are issued:
- Schedule III psychotropic drugs;
- narcotic and psychotropic drugs of Schedule II in the form of transdermal therapeutic systems;
- drugs included in the list of drugs subject to PCU, with the exception of those drugs that are dispensed in form No. 107/u-NP;
- drugs that have anabolic activity and are classified as anabolic steroids according to the anatomical-therapeutic-chemical classification (ATC) recommended by the World Health Organization (code A14A);
- drugs specified in paragraph 5 of the “Procedure for dispensing to individuals medicinal products containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances” (order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 No. 562n);
- preparations manufactured according to a prescription for a medicinal product and containing a narcotic drug or psychotropic substance included in Schedule II and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that this combined medicinal product is not a narcotic or psychotropic drug Schedule II drug.
The list of other prescription drugs, as is known, is dispensed on form No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1/u within up to one year and exceed the recommended amount of the drug for prescribing per prescription, established by Appendix No. 2 of this order.
Such a prescription, which also indicates the periods and quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. It also determines that the next time the patient comes to the pharmacy with the same prescription for a list of drugs, the chief must take into account the notes on the previous dispensing of the drug.
When the maximum quantity specified in the prescription is purchased, it must be stamped “Dispensed.” And a one-time release of the entire quantity, according to the same paragraph, is allowed only in agreement with the doctor who wrote this prescription.
The prescription remains at the pharmacy
There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order No. 403n of the Ministry of Health establishes that the retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:
within 5 years prescriptions for:
- narcotic and psychotropic drugs of Schedule II, psychotropic drugs of List III (according to the outgoing 785th order, they are stored for 10 years);
within 3 years prescriptions for:
- drugs dispensed free of charge or at a discount (according to forms No. 148–1/u-04 (l) or No. 148–1/u-06 (l));
- combination drugs containing narcotic drugs or psychotropic substances included in Schedules II and III, manufactured in a pharmacy, drugs with anabolic activity, drugs subject to PCU;
within 3 months recipes for:
- drugs in liquid dosage form containing more than 15% ethyl alcohol by volume of the finished product, other drugs classified by ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives (code N05C), antidepressants (code N06A ) and not subject to PCU.
Note that Order 785 does not contain this group of recipes for three-month storage.
Order No. 403n of the Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not listed in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.
The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is also reflected in the new order on the procedure for dispensing drugs. According to the current procedure, prescriptions for such drugs are returned to the patient (with a “dispensed” stamp); under the new order, they must remain in the pharmacy organization.
To avoid getting caught
The procedure for dispensing incorrectly written prescriptions is now described in a little more detail (clause 15 of order No. 403n). In particular, when they are registered by a pharmacist in a journal, it is necessary to indicate the identified violations in the execution of the prescription, the full name of the health worker who wrote it, the name of the medical organization in which he works, and the measures taken.
According to this paragraph, when medicinal holiday the pharmacist informs the buyer not only about the regimen and doses, but also about the rules for storing at home and interactions with other medications.
In theory this means the following. The pharmaceutical inspector can approach the first table in the guise of an ordinary buyer - so to speak, make a test purchase. And if the chief captain, dispensing the medicine, does not inform him, for example, that this medicine must be stored at a temperature not exceeding 25 °C, or will not ask if he is taking in given time other medications, then the inspector can “drop the mask” and draw up an administrative violation report. So the norm in paragraph 16 is serious and fraught. And, of course, it requires that the chief captain be thoroughly versed in the complex and voluminous topic of drug interactions.
Paragraph 17 of Order No. 403n, as amended, contains the rule that a pharmacist does not have the right to provide false or incomplete information about the availability of drugs in the pharmacy product range - including drugs that have the same INN - and also to hide information about the availability of drugs that have a lower price . Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law dated November 21, 2011 No. 323 Federal Law “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (Order of the Ministry of Health of the Russian Federation dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on the vacation procedure.
These were explanations of order No. 403n, so to speak, “on a fresh trail.” Readers will probably find in it other points and norms that deserve special attention. Write to the editors of Katren-Style magazine about them, and we will address your questions to leading industry experts. We will also ask them about the problem of “disposable” prescriptions with a two-month validity period, which was mentioned above, as well as the dispensing of ethyl alcohol and alcohol-containing drugs in light of the provisions of the new Order No. 403 of the Ministry of Health.
On October 5, a webinar by Larisa Garbuzova, Ph.D. will be held on our website. Sc., Associate Professor, Department of Management and Economics of Pharmacy, Northwestern State University medical university(St. Petersburg), dedicated, and on October 25, executive director of the National Pharmaceutical Chamber Elena Nevolina on the same topic. Register for both webinars.
Materials on the order of the Ministry of Health No. 403n.
The norms for the dispensing of medicines are approved by order of the Ministry of Health of the Russian Federation No. 1175. The norms for prescribing and dispensing ethanol (ethyl alcohol, medical antiseptic solution approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 No. 785 “On the procedure for dispensing medicines.”
The rates for prescribing and dispensing drugs may be increased by following cases:
1. The number of prescribed narcotic and psychotropic drugs of lists II and III of the List, other drugs subject to subject-quantitative recording, when providing palliative care to patients, can be increased by no more than 2 times compared to the maximum permissible number of drugs for prescription per prescription, or the recommended number of drugs to be prescribed per prescription.
2. Prescriptions for medications written out on prescription forms Form N 148-1/u-04 (l) and Form N 148-1/u-06 (l) are valid for one month from the date of prescription. Prescriptions for medications written out on prescription forms Form N 148-1/u-04 (l) and Form N 148-1/u-06 (l), for citizens who have reached retirement age, disabled people of the first group and disabled children are valid for three months from the date of issue. For the treatment of chronic diseases, these categories of citizens can be issued prescriptions for medications for a course of treatment of up to 3 months.
3. When a medical worker prescribes prescriptions for finished medicinal products and individually manufactured medicinal products for patients with chronic diseases on prescription forms of form N 107-1/u, it is allowed to set the validity period of the prescription within up to one year and exceed the recommended amount of the medicinal product for prescribing by one recipe. When writing such prescriptions, the medical professional makes a note “For a patient with a chronic disease”, indicates the validity period of the prescription and the frequency of dispensing medications from the pharmacy or individual entrepreneur, who has a license for pharmaceutical activities (weekly, monthly and other periods), certifies this instruction with his signature and personal seal, as well as the seal of the medical organization “For prescriptions”.
4. Prescriptions for barbituric acid derivatives, ephedrine, pseudoephedrine in pure form and in a mixture with other drugs, drugs with anabolic activity, combination drugs containing codeine (its salts) for the treatment of patients with chronic diseases can be prescribed for a course of treatment of up to two months. In these cases, the prescriptions are marked “For special purposes”, separately signed by the medical worker and the seal of the medical organization “For prescriptions”.
5. In accordance with the order of the Ministry of Health and Social Development of the Russian Federation No. 785, the supply of ethyl alcohol is carried out:
According to prescriptions written by doctors with the inscription “For application of compresses” (indicating required dilution with water) or “For leather treatment” - 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 chronic course diseases - up to 100 grams in a mixture and in pure form.
- Is it possible to dispense powders according to this recipe No. 30, No. 40?
No. 30 - yes, No. 40 - no, since the dispensing rate for ephedrine hydrochloride is 0.6 g (order No. 1175).
Problem No. 15
The pharmacy received the following drugs: morphine 1% 1.0 No. 5, potassium permanganate pore 3.0, theophedrine N tab.. To which groups from a legal point of view should these drugs be classified? The procedure for filling out a prescription for morphine 1% 1.0 No. 5, the validity period and shelf life of the prescription in the pharmacy. What documents must be used to register received drugs? Requirements for organizing the storage of these drugs. Regulatory justification.
Morphine 1% 1.0 No. 5 - according to PP No. 681, is included in List II of NS and PV, the circulation of which in the Russian Federation is limited and for which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation.
Morphine is prescribed on a prescription form, form 107-1/np, in accordance with Order No. 54 n of the Ministry of Health of the Russian Federation. Made on paper Pink colour with watermarks. The prescription form must be filled out legibly, clearly, in ink or with a ballpoint pen. Corrections when filling out the prescription form are not allowed. The prescription form is affixed with the stamp of the medical organization (indicating the full name of the medical organization, its address and telephone number) and the date the prescription for the narcotic (psychotropic) drug was issued. In the lines “Full name of the patient” and “Age” the full last name is indicated , first name, patronymic (last - if available) of the patient, his age (number of completed years). In the line "Series and number of the mandatory policy health insurance" indicates the number of the patient's compulsory health insurance policy. In the line "Number of the outpatient medical record (history of the child's development)" indicates the number of the outpatient medical record (history of the child's development). In the line "F.I.O. doctor (paramedic, midwife)" indicates the full last name, first name, patronymic (the latter - if available) of the doctor (paramedic, midwife) who wrote the prescription for a narcotic (psychotropic) drug. In the line "Rp:" on Latin the name of the narcotic (psychotropic) drug (international non-proprietary or chemical, or in their absence - trade name), its dosage, quantity and method of administration is indicated. One name of the narcotic (psychotropic) drug is written on one prescription form. The quantity of a narcotic (psychotropic) drug prescribed on a prescription form is indicated in words. The method of taking a narcotic (psychotropic) drug is indicated in Russian or national languages. When indicating the method of taking a narcotic (psychotropic) drug, it is prohibited to limit oneself to general instructions, such as “Internal”, “Known”. A prescription for a narcotic (psychotropic) drug is certified by the signature and personal seal of the doctor, the signature of the manager (deputy manager or manager structural unit) medical organization (indicating his last name, first name, patronymic (the latter - if available)), as well as the round seal of the medical organization, the imprint of which must identify the full name of the medical organization. In the line “Pharmacy organization’s mark on dispensing”, a mark from the pharmacy organization on the dispensing of the narcotic (psychotropic) drug is placed (indicating the name, quantity of the narcotic (psychotropic) drug dispensed and the date of its dispensing). of the drug is certified by the signature of the employee of the pharmacy organization who dispensed the narcotic (psychotropic) drug (indicating his last name, first name, patronymic (the latter - if available)), as well as the round seal of the pharmacy organization, the imprint of which must identify the full name of the pharmacy organization. The validity of the prescription is 5 days, the shelf life in the pharmacy is 10 years.
Rules for storing NS and PV approved by the Russian Federation GD dated December 31, 2009 No. 1148. Storage of NS and PV is carried out by legal entities that have a license for activities related to the circulation of NS and PV, as well as the right to store them (hereinafter referred to as legal entities). Storage of NS and PV is carried out in isolated premises, specially equipped with engineering and technical means security (hereinafter referred to as premises), and in places of temporary storage. Premises are divided into 4 categories . For premises of each category, basic requirements are established for their equipment with engineering and technical security equipment, as well as for the conditions for storing narcotic drugs and psychotropic substances in them. Category 2 includes premises of pharmaceutical establishments , intended for storing a month's supply of NS and PV used for medical purposes. The premises belonging to the 2nd category are equipped with security alarm systems consisting of at least 2 lines of protection and an alarm system with signals output to the central monitoring console of the police department private security with the internal affairs body of the Russian Federation, and if such a connection is not possible - with a signal output to the security post. Entrance door the room can be made of metal, wood (reinforced with upholstery on 2 sides with sheet iron or metal plates) or from another material that provides a protection class from destructive influences of at least 3. The entrance door has at least 2 locking devices of the 3rd class of protection against destructive influences. The doorway of the entrance to the room is protected with inside an additional metal lattice door with a locking device, having a protection class from destructive influences of at least 2, made of steel reinforcement. On the window structures of the 1st and last floors, metal gratings made of steel rods are installed on the inside or between the frames, or blinds equivalent in strength to metal grilles. Window structures must have a class of protection against destructive influences of at least 3. Narcotic drugs and psychotropic substances are stored in locked safes of at least 4 class of burglary resistance or metal cabinets. In the premises related to 4th category , narcotic drugs and psychotropic substances are stored in locked bulk or attached to the floor (wall) safes of at least class 3 burglary resistance. A safe weighing less than 1000 kilograms is attached to the floor or wall or built into the wall using an anchor. In other places of temporary storage, narcotic drugs and psychotropic substances are stored in locked safes of at least class 1 burglary resistance or metal or containers made of other high-strength materials.
In accordance with the order of the Ministry of Health and Social Development of the Russian Federation No. 397 n “On approval of special storage conditions for NS and PV, registered in the prescribed manner in the Russian Federation as drugs intended for medical use in pharmacies, medical institutions, research and educational organizations and organizations wholesale trade of drugs" storage of pharmaceutical substances of narcotic and psychotropic drugs in pharmacies should be carried out in bars indicating the highest single and highest daily doses. Storage of narcotic and psychotropic medications used during the working day in assistant rooms and prescription departments of pharmacies, in classrooms of educational organizations, as well as in laboratories of research organizations is carried out in safes (containers) of these premises or departments. At the end of the working day, narcotic and psychotropic medicines must be returned to the place of main storage of narcotic and psychotropic medicines. It is allowed to store narcotic and psychotropic medicines that require protection from elevated temperature, in pharmacies, medical and preventive institutions, research, educational organizations and wholesale trade organizations of medicines: in premises of the 1st and 2nd categories, specially equipped with engineering and technical security means - in locked refrigerators (refrigerators) or in a special area for placing refrigerators (refrigeration chambers), separated from the main storage area by a metal grill with a lockable lattice door, in rooms of the 4th category - in thermal containers located in safes; in places of temporary storage - in thermal containers placed in safes, or in metal or other high-strength materials containers placed in thermal containers.
The order of the head of the legal entity appoints persons responsible for the storage of NS and PV, authorized to work with NS and PV, and establishes the procedure for storing keys to safes, metal cabinets and premises, as well as those used for sealing (sealing) seals and sealing devices. List of persons, having the right to access the premises, is approved by order of the head of the legal entity.
in accordance with the requirements of the order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 No. 706n “On approval of the rules for storing medicines.” Medicines subject to subject-quantitative accounting are stored in metal or wooden cabinets, sealed or sealed at the end of the working day.
Problem No. 16
The pharmacy of a medical organization received an application from surgical department for a solution of magnesium sulfate for injection 25% - 10.0 in ampoules and a solution of promedol for injection 1% - 1.0 in ampoules.
- to which groups do these drugs belong from a regulatory perspective?
- on the basis of what documents does the pharmacy dispense such drugs to the departments?
What is the procedure for filling out invoice requirements for receiving these drugs by departments of a medical organization?
- Name the shelf life of the invoice requirements for these medications in the pharmacy of the medical organization.
- which of the Moscow Region personnel has the right to receive promedol injection solution 1% - 1.0?
How is the permission for an organization to work with promedol injection solution 1% - 1.0 documented and how is personnel allowed to work with this drug?
From a regulatory and legal position: magnesium sulfate solution belongs to other drugs dispensed by prescription; promedol for injection - NS list II in accordance with RF RF No. 681;
In accordance with Order of the Ministry of Health and Social Development of the Russian Federation No. 110, to ensure the diagnostic and treatment process, medical organizations receive medications from a pharmacy organization according to invoice requirements approved in the prescribed manner. The demand invoice for receiving medicines from pharmacy organizations must have a stamp, a round seal of the medical organization, and the signature of its head or his deputy for medical treatment. The demand invoice indicates the number, date of preparation of the document, sender and recipient of the medicinal product, name of the medicinal product (indicating the dosage, release form (tablets, ampoules, ointments, suppositories, etc.), type of packaging (boxes, bottles, tubes etc.), method of application (for injection, for external use, oral administration, eye drops etc.), the number of drugs requested, the quantity and cost of drugs dispensed. The names of medications are written in Latin. Invoice requirements for medicines subject to subject-quantitative accounting are written out on separate invoice requirements forms for each group of drugs. Requests and invoices from a structural unit of a medical organization (office, department, etc.) for medications sent to a pharmacy organization are drawn up in the prescribed manner, signed by the head of the relevant unit and issued with the stamp of the medical organization. When prescribing a medicinal product for an individual patient, his surname and initials and medical history number are additionally indicated. Requirements for poisonous medicines, in addition to the signature of the dentist or dentist, must have the signature of the head of the institution (department) or his deputy and the round seal of the medical organization.
In pharmacy organizations, the invoice requirements of medical institutions for the dispensing of narcotic drugs and psychotropic substances of lists II and III are stored for 10 years, for the dispensing of other drugs subject to subject-quantitative accounting - for 3 years, for other groups of drugs drugs - within one calendar year. Requests-invoices of medical organizations must be stored in a pharmacy organization in conditions that ensure safety, bound and sealed and drawn up in volumes indicating the month and year. After the expiration of the storage period, the invoice requirements are subject to destruction in the presence of members of the commission created in the pharmacy organization, about which acts of the approved form are drawn up.
The release of NS and PV to the Moscow Region is carried out by employees of the Moscow Region, the list of whom is approved by order of the Ministry of Health and Social Development of the Russian Federation No. 330, these include: heads. doctor, head of department, deputy head of department, senior medical officer. sister. The admission of persons to work with NS and DP, precursors included in Table 1 of List IV is determined by RF PP No. 892 “On approval of the rules for the admission of persons to work with NS and DP, as well as to activities related to the circulation of NS and DP precursors.” Admission is carried out by the head of the organization and includes:
1. familiarization of persons with the legislation of the Russian Federation on NS and PV;
2. issuance of an order on the admission of persons to work with NS and DS, as well as activities related to the circulation of NS and DS precursors.
3. conclusion of a TD including mutual obligations of the organization and person related to the circulation of NS and DS and their precursors. Not allowed to work:
Under 18 years of age;
Those who have an outstanding or unexpunged conviction for crimes of moderate gravity, serious and especially serious crimes;
Those who have an outstanding or unexpunged conviction for crimes related to illegal trafficking NS and PV and their precursors;
Patients with drug addiction, substance abuse, and hron. alcoholism;
Recognized in accordance with the established procedure as unsuitable for performing work related to the circulation of NS and PV.
In order to obtain information about persons registered to work with NS and PV, the head of the organization:
1. gives the person a referral to the Moscow Region for medical treatment. examination and mandatory psychiatric examination (for NS and PV).
2. sends an application to the FSKN authorities with the attachment of employee questionnaires to obtain a conclusion that the employees have no outstanding or unexpunged convictions for crimes of moderate gravity, serious and especially serious crimes, for crimes related to the illicit trafficking of NS and DS and their precursors.
If there are no grounds preventing a person from being allowed to work with NS and PV, the manager issues an appropriate order and concludes a TD. The validity period of a person’s permission to work with NS and PV is limited to the validity period of the TD.
Problem No. 17.
The Moscow Region pharmacy received a request from the surgical department for a solution of promedol 1% 1.0 in ampoules.
- Which group of drugs does promedol solution belong to from a legal perspective?
What is the procedure for processing invoice requirements for departments of a medical organization to receive this drug?
- which of the Ministry of Defense personnel has the right to receive such drugs?
- who is responsible for monitoring the storage and use of such drugs in the departments of the Ministry of Defense?
- features of drug data accounting, reporting.
Promedol belongs to the NS and PV of List II according to the RF Regulation No. 681. From the staff of health care facilities, the right to receive NS and PV is assigned to executive(approved to work with NS and PV), authorized to do so by order of the head of the healthcare facility (head physician, head of department, deputy head of department, head nurse) in accordance with order No. 330.
Control over the storage of NS and PV in the divisions of health care facilities is assigned to an official authorized to do this by order of the head of the health care facility (head of department). By order of the head of the health care facility, persons responsible for the storage of NS and PV are appointed, authorized to work with NS and PV, and the procedure is established storage of keys to safes, metal cabinets and premises, as well as seals and sealing devices used for sealing. The list of persons who have the right to access the premises is approved by order of the head of the health care facility (Government of the Russian Federation dated December 31, 2009 No. 1148 “On the procedure for storing NS and PV.”
Order 397n – On approval of special requirements for storage conditions of NS and PV, registered in the prescribed manner in the Russian Federation as drugs intended for medical care in pharmacies, health care facilities, research institutions, account. Organizations, drug wholesale trade organizations.
Promedol 1% 1,0 – is subject to PKU as NS List II in the “Logbook of registration of transactions related to the turnover of NS and PV”.
The rules for maintaining and storing, as well as the forms of special logs for registering transactions related to the trafficking of narcotic drugs and psychotropic substances, were approved by Decree of the Government of the Russian Federation dated November 4, 2006 No. 644 “On the procedure for submitting information on activities related to the trafficking of narcotic drugs and psychotropic substances, and registration of transactions related to the trafficking of narcotic drugs and psychotropic substances” (as amended).
In quantitative terms, Schedule II narcotic drugs, Schedule II and III psychotropic substances are taken into account in a special “Logbook of registration of transactions related to the trafficking of narcotic drugs and psychotropic substances” .
Legal entities, as well as their divisions carrying out activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, are required to maintain registration logs in the form approved by Decree of the Government of the Russian Federation of November 4, 2006 No. 644 (as amended).
Registration of transactions related to the circulation of narcotic drugs and psychotropic substances is carried out for each name of narcotic drug and psychotropic substance on a separate, expanded sheet of the registration log or in a separate registration log.
Any operations that result in changes in the quantity and condition of narcotic drugs and psychotropic substances must be entered in the registration log. In pharmacies, these will be operations for the receipt and consumption of narcotic drugs and psychotropic substances, either in the form of substances or in the form of industrially manufactured drugs. In this case, the units of measurement will be different (grams, bottles, ampoules, patches, tablets, etc.). Registration books must be bound, numbered and sealed with the signature of the head of the legal entity and the seal of the legal entity. If necessary, by decision of the authority executive power of the constituent entity of the Russian Federation is determined by the body that certifies the “Logbook of registration of transactions related to the circulation of narcotic drugs and psychotropic substances.”
The head of a legal entity appoints persons responsible for maintaining and storing registration logs, including in departments.
Entries in the log books are made by the person responsible for their maintenance and storage, using a ballpoint pen (ink) in chronological order immediately after each operation for each name of a narcotic drug or psychotropic substance on the basis of documents confirming the completion of this operation. Documents or copies thereof confirming the completion of a transaction with a narcotic drug or psychotropic substance, certified in the prescribed manner, are filed in a separate folder, which is stored together with the corresponding registration log.
The registration logs indicate the names of narcotic drugs and psychotropic substances in accordance with the List of narcotic drugs, psychotropic substances and their precursors approved. by Decree of the Government of the Russian Federation of June 30, 1998 No. 681 (as amended), and other names of narcotic drugs and psychotropic substances under which they were received by a legal entity. Lists of names of narcotic drugs and psychotropic substances registered as medicines (international non-proprietary, patented, original names or, in their absence, chemical names) are entered Federal service for supervision in the field of healthcare and social development in the state register of medicines.
The numbering of entries in the registration logs for each name of a narcotic drug or psychotropic substance is carried out within a calendar year in ascending order of numbers. The numbering of entries in new log books begins with the number following last number in completed journals. Pages of the registration logs that are not used in the current calendar year are crossed out and are not used in the next calendar year.
An entry in the log books of each transaction performed is certified by the signature of the person responsible for their maintenance and storage, indicating the surname and initials.
Corrections in the registration logs are certified by the signature of the person responsible for their maintenance and storage. Erasures and uncertified corrections in log books are not permitted.
Legal entities carry out a monthly inventory of narcotic drugs and psychotropic substances in accordance with the established procedure by comparing their actual availability with accounting data (book balances). The registration logs must reflect the results of the inventory of narcotic drugs and psychotropic substances.
The inventory of narcotic drugs and psychotropic substances is carried out in accordance with the requirements of Article 38 of the Federal Law dated January 8, 1998 No. 3-FZ “On Narcotic Drugs and Psychotropic Substances”, Order of the Ministry of Finance of Russia dated June 13, 1995 No. 49 “On approval methodological instructions on inventory of property and financial obligations", Resolution of the State Statistics Committee of Russia dated 08/18/1998 No. 88 "On approval of unified forms of primary accounting documentation for recording cash transactions, recording inventory results" and order of the USSR Ministry of Health dated 01/08/1988 No. 14 "On approval specialized (intradepartmental) forms of primary accounting for self-supporting pharmacies”, with the creation of an inventory commission, with the preparation of descriptive inventory sheets. In the journal for registering transactions related to the circulation of narcotic drugs and psychotropic substances, a note is made about the inventory carried out (date of inventory, number of the matching sheet or inventory list).
According to Article 38 of the Federal Law of 01/08/1998 No. 3-FZ “On Narcotic Drugs and Psychotropic Substances”, information about discrepancies in the balance or discrepancy between the balance data and the results of the inventory carried out in three-day period after their detection, they are brought to the attention of the authorities for control over the circulation of narcotic drugs and psychotropic substances.
Discrepancies or inconsistencies in the results of reconciliation of precursors are brought to the attention of the relevant territorial body of the Federal Service of the Russian Federation for Drug Control within 10 days from the moment they are identified.
The register of narcotic drugs and psychotropic substances is stored in a metal cabinet (safe) in a technically fortified room. The keys to the metal cabinet (safe) and the technically fortified room are kept by the person responsible for maintaining and storing the registration log.
Completed registration logs, together with documents confirming the implementation of transactions related to the circulation of narcotic drugs and psychotropic substances, are handed over to the archives of a legal entity, where they are stored for 10 years after the last entry is made in them. After the specified period, the registration logs are subject to destruction according to an act approved by the head of the legal entity.
The rules for submitting reports to legal entities on activities related to the circulation of NS and PE were approved by the RF PP dated 04.11.06 No. 644 as amended by LE - holders of licenses to carry out activities related to the circulation of NS and PE are required to report on the quantity of each produced, manufactured, imported (exported), released and sold NS and PV, as well as their stocks as of December 31 of the reporting year.
Pharmacies and having pharmacies, health care facilities that carry out, in the prescribed manner, the manufacture of medicines containing NS and PIs, the dispensing and sale of NS and PIs, submit annually, no later than February 15, to the relevant territorial bodies of the Federal Service of the Russian Federation for Drug Control in the form according to the Appendix N 6:
· annual report on the number of manufactured, released and sold NS and PV;
The quantity and reserves of NS and PV are indicated in the reports in terms of current NS and PV.
Prescribing medications and processing prescriptions and invoice requirements approved by order 1175.
Problem No. 18
The pharmacy received a prescription for the preparation of a mixture of the following composition:
Rp.: Infusi rhizomatis cum radicibus Valerianae ex.................... 10.0
ORDER
DISPENDING OF MEDICINES
(as amended by Orders of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302, dated October 13, 2006 N 703, dated February 12, 2007 N 109, dated August 6, 2007 N 521, Order of the Ministry of Health of the Russian Federation dated April 22, 2014 N 183n)
I. General provisions
1.1. This Procedure determines the requirements for the dispensing of medicines by pharmacies (organizations)<*>regardless of the 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)<*>.
<*>Pharmacies, pharmacy points, pharmacy kiosks, pharmacy stores.
1.5. For uninterrupted supply population with medicines, pharmacies (organizations) are required to have in stock the minimum range of medicines necessary to provide medical care, approved by Order of the Ministry of Health and Social Development of the Russian Federation of April 29, 2005 N 312.
dated 04/29/2005 N 312 dated 09/15/2010 N 805n
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, pharmacies (organizations) dispense: dated 06.08.2007 N 521)
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/у-88;
In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place
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 registration) registration), written out on prescription forms, form N 148-1/u-88; (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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 on September 18, 2006 N 665 (registered with the Ministry of Justice of the Russian Federation on September 27, 2006 N 8322) (hereinafter referred to as 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, prescribed on prescription forms of form N 148-1/u-04 (l)) and form N 148-1/u-06 (l); (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 109, dated August 6, 2007 N 521)
In connection with the loss of force of the Order of the Ministry of Health and Social Development of the Russian Federation dated September 28, 2005 N 601, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated September 18, 2006 N 665 adopted in its place
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 accounting; anabolic steroid valid for ten days. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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 the 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). (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated August 6, 2007 N 521)
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 paragraph 1.11 of the Instructions and Appendix No. 1 to the Instructions. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302, dated August 6, 2007 N 521)
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. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 109)
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 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, the List of which is provided in Appendix No. 1 to this Procedure. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 109)
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 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. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
2.15. The pharmacy institution (organization) must ensure conditions for the safety of prescriptions left for storage that are 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 on prescription from a doctor (paramedic), as well as other medicines sold free of charge or at a discount; anabolic steroid. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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 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. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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 destroying prescriptions left in a pharmacy institution (organization) after the established storage periods, and the composition of the commission for their destruction may be determined by health authorities or pharmaceutical activities subject 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 of 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; alcohol-containing medicines 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. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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. 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 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 on the prescription form N 148-1/у-88, and the prescription written out on the prescription form N 148-1/у-04 (l). (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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 veterinary prescriptions medical organizations for treating animals. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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 if a doctor prescribes medicinal products in a dose exceeding the highest single dose. (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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 . (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302)
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.
ACT on the destruction of prescriptions for narcotic drugs and psychotropic substances after their shelf life has expired<*>dated "__" ___________ 200_ N ________ Commission composed of.
1 DISCHARGE OF MEDICINES FROM A PHARMACY ORGANIZATION
2 REGULATORY DOCUMENTS of the Federal Law “On the Circulation of Medicines” (Article 55 Procedure for Retail Trade of Medicines); Order of the Ministry of Health and Social Development of the Russian Federation dated 785 “On the procedure for dispensing medicines”
3 DISCHARGE OF MEDICINES FROM A PHARMACY ORGANIZATION Medicines prescribed according to a doctor’s prescription are subject to dispensing by pharmacies and pharmacy points
4 RELEASE OF BRLS FROM A PHARMACY ORGANIZATION Medicines dispensed without a doctor’s prescription are subject to sale by all pharmacies
5 VALIDITY DATES OF RECIPES Pharmacy organizations are prohibited from dispensing drugs on expired prescriptions, with the exception of drugs on prescriptions that expired while the prescriptions were on deferred maintenance
6 DEFERRED SERVICE OF RECIPES Prescriptions for medicines marked “statim” (immediately) are serviced within a period not exceeding one business 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).
7 DEFERRED SERVICE OF RECIPES Prescriptions for drugs included in the minimum range of medicines are serviced within a period not exceeding five working days from the moment the patient contacts the pharmacy
8 DEFERRED SERVICE OF RECIPES Prescriptions for drugs included in the List of drugs dispensed by prescription from a doctor (paramedic), and not included in the minimum range of drugs, are serviced within a period not exceeding ten working days from the date of the patient’s application to the pharmacy. Prescriptions for drugs prescribed by decision of the medical commission approved by the chief physician of the health care facility, are served within a period not exceeding fifteen working days from the date of the patient’s application
9 MARK ON THE PRESCRIPTION When dispensing a drug according to a doctor’s prescription, the employee of the pharmacy organization makes a mark on the prescription about the dispensing of the drug: name or number of the pharmacy organization, name and dosage of the drug, quantity dispensed, signature of the dispenser, date of dispensing
10 DOSAGE If a pharmacy organization has drugs with a dosage different from the dosage prescribed in the doctor’s prescription, the pharmacy employee may decide to dispense the existing drugs to the patient if the dosage of the drug is less than the dosage specified in the doctor’s prescription, taking into account the conversion to the course dose If the dosage of a drug available in a pharmacy exceeds the dosage specified in the doctor’s prescription, the decision to dispense the drug 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.
11 STANDARDS FOR DISPENSING medicinal products are dispensed by pharmacies in the quantities specified in the prescription to the maximum permissible quantity individual narcotic and psychotropic drugs for prescribing for one prescription were approved by order of the Ministry of Health of the Russian Federation 1175n dated. The recommended number of individual drugs for prescribing per prescription was approved by order of the Ministry of Health of the Russian Federation 1175n dated medicinal products containing narcotic drugs, psychotropic substances, precursors, and those available without a prescription doctor, are subject to release in quantities of no more than 2 packages to the consumer
12 STANDARDS FOR THE DISPOSAL OF ETHYL ALCOHOL 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 ; free for patients diabetes mellitus 100 g pure monthly
13 EXCEEDING THE STANDARD OF SUPPLY The number of prescribed narcotic and psychotropic drugs of lists II and III of the List, other drugs subject to subject-quantitative recording, when provided to patients in need of long-term treatment, primary health care and palliative care, can be increased by no more than 2 times compared to the maximum permissible quantity of drugs established by order 1175n. In these cases, the inscription “For special purposes” is written on the prescriptions, separately signed by a medical worker and seal of the medical organization "For prescriptions";
14 EXCEEDING THE DISTRIBUTION STANDARD Prescriptions for barbituric acid derivatives, combined drugs containing codeine (its salts), other combined drugs subject to subject-quantitative accounting, drugs with anabolic activity in accordance with the main pharmacological action, for the treatment of patients with chronic diseases can be prescribed for a course of treatment up to 60 days; In these cases, the prescriptions must bear the inscription “For special purposes,” sealed by the doctor’s signature and the seal of the healthcare facility “For prescriptions.”
15 DISCHARGING OF medicinal products ACCORDING TO LONG-ACTING RECIPES When dispensing medicinal products according to doctor’s prescriptions valid for one year, the prescription is returned to the patient indicating on the back the name or number of the pharmacy organization, the signature of the pharmacy employee, the quantity of the medicinal product dispensed and the date of dispensing. When the patient next contacts the pharmacy the organization takes into account notes on the previous receipt of the drug. Upon expiration of the validity period, the prescription is canceled with the stamp “Prescription is invalid” and left in the pharmacy organization
16 DISCHARGE OF medicinal products ACCORDING TO LONG-ACTING RECIPES In exceptional cases (the patient leaves the city, the inability to regularly visit a pharmacy, etc.), pharmaceutical workers are allowed to make a one-time dispensing of medicinal products prescribed by a doctor according to prescriptions valid for one year, in the amount necessary for treatment for two months
17 STAMP “MEDICATION DISCLAIMED” Prescriptions for tranquilizers that are not subject to subject-quantitative accounting; antidepressants, neuroleptics; alcohol-containing drugs of industrial production are canceled with the stamp of the pharmacy organization "Medicine dispensed" and returned to the patient. To re-dispense the drug, the patient must consult a doctor for a new prescription
18 REQUIREMENTS FOR THE SUPPLY OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES; MEDICINES SUBJECT TO SUBJECT-QUANTITATIVE ACCOUNTING; ANABOLIC STEROIDS
19 DISPENDING OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES Narcotic drugs and psychotropic substances included in List II and psychotropic substances included in List III of the List are subject to dispensing by pharmacies (organizations) The right to work with NS and PD included in List II and List III of the List, have only pharmacy organizations that have received the appropriate licenses. Dispensing to patients of NS and PV included in List II and List III of the List is carried out by pharmaceutical workers of pharmacy organizations who have the right to do so.
20 DISCLOSURE OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES In a pharmacy organization, the dispensing of NS and PS included in List II of the List is carried out by patients assigned to a specific outpatient clinic institution, which is assigned to a pharmacy organization. Assignment of an outpatient clinic institution to a pharmacy organization can be carried out by a health care management body or pharmaceutical activities 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
21 DISCHARGE OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES Narcotic drugs and psychotropic substances prescribed by a doctor, included in List II of the List, are dispensed to the patient or the person representing him upon presentation of an identity document issued in the prescribed manner
22 DISCLOSURE OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES NS and NS, included in List II of the List and dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written on a special prescription form and a prescription written on a prescription form form N 148-1/u-04 ( k) Psychotropic substances included in List III of the List, other medicines subject to PCU, anabolic steroids dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written on prescription form N 148-1/u-88, and a prescription written on prescription form form N 148-1/у-04 (l).
23 LIST OF DRUGS SUBJECT TO PCU ORDER OF APRIL 22, 2014 N 183N 1. Medicines - pharmaceutical substances and drugs containing narcotic drugs, psychotropic substances and their precursors (their salts, isomers, stereoisomers), included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, in combination with pharmacologically inactive substances , as well as medicines containing narcotic drugs, psychotropic substances and their precursors in combination with pharmacologically active substances (subject to their inclusion in the list as a separate item)
24 LIST OF DRUGS SUBJECT TO PCU ORDER OF APRIL 22, 2014 N 183N 2. Medicines - pharmaceutical substances and drugs containing potent and toxic substances (their salts, isomers, ethers and esters, mixtures and solutions regardless of concentration), introduced to the lists of potent and toxic substances, in combination with pharmacologically inactive substances, as well as medicines containing potent and toxic substances in combination with pharmacologically active substances (subject to their inclusion in the list as a separate item)
25 LIST OF DRUGS SUBJECT TO PCU (ORDER DATED APRIL 22, 2014 N 183N AS AMENDED PR.MZ FROM N) 3. Combined drugs containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances (Clause 5 Order of the Ministry of Health of the Russian Federation dated May 17, 2012 N 562n 4. Other medicines subject to subject-quantitative accounting: Pregabalin (medicines) Tropicamide (medicines) Cyclopentolate (medicines)
26 PRESCRIPTION VALIATION FROM VETERINARY ORGANIZATIONS Pharmacy organizations are prohibited from dispensing prescriptions from veterinary medical organizations for the treatment of animals: narcotic drugs and psychotropic substances included in List II of the List; psychotropic substances included in List III of the List; other drugs subject to subject-quantitative accounting; anabolic steroids
27 SUPPLEMENT OF EXTEMPORAL MEDICINES Separate dispensing of medicines subject to subject-quantitative accounting and other medicines included in the composition of a combined medicinal product manufactured according to an individual prescription is not allowed.
28 SIGNATURE 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” 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 medicines subject to subject-quantitative accounting
29 ORDER OF THE MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIA 562N DATED MAY 17, 2012 (AS EDITED BY PR. FROM G. N 369N) On approval of the Procedure for the dispensing to individuals of drugs for medical use, containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances
30 Form form 107-1/у Broncholitin syrup Broncholin sage Bronchoton syrup Dispensing rate 6 fl. 125g 6 fl. 125g 6 fl. 125g each Form form 148-1/u-88 Caffetin tablet. Codelac Nurofen plus Dispensing rate 20 tablets. 25 tab. 20 tab. Toff plus n/a Pentalgin 25 tablets. Caffetin Cold tab. n/a Sedalgin-Neo Solpadeine Terpincode Coldrex Night syrup 20 tablets. 25 caps. 25 tab. Well
31 Tradename Broncholitin Caffetin Cold Caffetin Codelac Nurofen plus Pentalgin Sedalgin-Neo INN (grouped) Glaucine + Ephedrine + [Basil oil] Dextromethorphan + Paracetamol + Pseudoephedrine + [ascorbic acid] Codeine + Caffeine + Paracetamol + Propyphenazone Codeine + Sodium bicarbonate + Malt ki roots+ Thermopsis lanceolata herb Ibuprofen+ Codeine Codeine+ Caffeine+ Paracetamol+ Propyphenazone+ Phenobarbital Codeine+ Caffeine+ Metamizole sodium+ Paracetamol+ phenobarbital
32 ORDER OF THE MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT 562N DATED MAY 17, 2012. If the quantity of a combined drug prescribed in a prescription exceeds its maximum permissible quantity for prescribing for one prescription, the pharmacist dispenses the combined drug in the prescribed quantity. Prescriptions for combined drugs written out on Form 107 prescription forms -1/у, are canceled with the stamp “The drug is dispensed” and returned to the patient’s hands
33 ORDER OF THE MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT 562N OF MAY 17, 2012 When dispensing combined drugs according to prescriptions written out on prescription forms form 107-1/u, for which the period is set to 1 year, the prescription is signed by a pharmacist and returned to the patient with the name of the pharmacy indicated on the back, the quantity of the dispensed combined drug and the date of its dispensing. The dispensing of the combined drug is carried out by a pharmacist in accordance with the frequency of dispensing specified in the prescription.
34 ORDER OF THE MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT 562Н OF MAY 17, 2012. When the patient next visits the pharmacy, the pharmacist takes into account the notes on the previous dispensing of the combined drug. Upon expiration of the validity period, the prescription is canceled with the stamp “The drug has been dispensed” and returned to the patient’s hands. Prescriptions written on prescription forms Form 148 -1/у-88, after the release of the combined drug, they must be stored for three years
35 RULES FOR RETURN AND EXCHANGE OF MEDICINES Medicines of good quality purchased by citizens are not subject to return or exchange. Repeated dispensing (sale) of medicines recognized as goods of inadequate quality and returned by citizens for this reason is not allowed.
36 STORAGE PERIOD OF RECIPES IN A PHARMACY ORGANIZATION for drugs 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 - 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 - five years;
37 STORAGE TERMS OF RECIPES IN A PHARMACY ORGANIZATION for drugs subject to subject-quantitative recording, 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
38 PROCEDURE FOR DESTRUCTION OF RECIPES Upon expiration of the storage period, prescriptions are subject to destruction in the presence of a commission, about which acts are drawn up. The procedure for the destruction of prescriptions left in a pharmacy institution (organization) after the expiration of the established storage periods, and the composition of the commission for their destruction can be determined by health authorities or pharmaceutical activities subject of the Russian Federation
39 SYNONYMIC REPLACEMENT If the pharmacy does not have a prescribed drug, the pharmacist may perform a synonymous replacement with the consent of the patient
40 VIOLATION OF SECONDARY FACTORY PACKAGING 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.
41 Incorrectly written prescriptions are canceled with the “Recipe Invalid” stamp, recorded in a journal and returned to the patient.
42 Dispensing of medicines, payment for which is taken into account when determining the amount of social security tax deduction(See tutorial)
43 Dispensing medical immunobiological preparations to the population (See textbook)
