In the material, we will consider the features of subject-quantitative accounting in medical institutions, PKU journals, order 378n, and also highlight in detail the issues and subtleties of filling out PKU documentation.
Subject-quantitative accounting of individual medicines is mandatory in all medical institutions. The rules for maintaining drug registers were approved by order of the Ministry of Health of the Russian Federation No. 378n dated June 17, 2013.
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Let us consider in more detail the intricacies of filling out PKU logs.
From the article you will learn:
Order 378n: subject-quantitative accounting of drugs
According to order 378n, subject-quantitative accounting of medicines is carried out both in medical institutions and in pharmacies. However, filling out the PKU journal in a healthcare facility has its own nuances.
First of all, the head issues an internal order for the institution, by which he appoints an employee responsible for the implementation of the PKU and to record the receipt and consumption of drugs in the accounting and reporting documentation.
The PKU journal form is the same for all medical organizations, therefore the responsible officer must strictly follow the rules for its maintenance.
The circulation of medicines in a medical organization: what the head nurse needs to know
- Checkout local acts responsible for work with medicines and places of storage of medicines.
- Don't complicate your drug record keeping process by requiring you to fill out unnecessary forms.
- Clean up medicine storage areas and instruct staff on how to avoid mistakes in handling medicines.
- A complete algorithm of actions, as well as a form of journals ready for download and a memo to a health worker on storing medicines in departments, are available to customers and the Chief Nurse magazine.
The PKU journal is started for a period of 1 year. It ends at the end of December, and a new document starts in January. It is acceptable to keep a journal both on paper and in electronic format.
There are two options for managing paper magazine PKU:
- Order and buy a finished document at the printing house;
- Independently type, print and sew the journal from separate sheets, which are then numbered and sealed with the seal of the institution and the signature of the head physician.
The electronic accounting journal is kept differently - accounting is carried out on electronic media, and the completed pages of the journal are printed and stapled every month. When calendar year comes to an end, the bound sheets are numbered and drawn up in a journal, which is then sealed and certified by the signatures of the responsible person, the head physician and the seal of the medical institution.
Person responsible for the accounting of medicines:
- every day records in the journal all income and expenditure transactions with them;
- brings in daily accounting documentation consumption of medicines;
- upon receipt of new medicines in the department, enters into the journal entries for each of them in accordance with the invoices (the number of the invoice and the date of receipt of the drugs are indicated).
How to make corrections to the journal and reconcile
It has already been mentioned above that normative document, regulating the maintenance of PKU journals - order No. 378n dated 06/17/2013. According to it, after each calendar month, all records of the remaining medicines are reconciled with their actual number in the PKU journal, information about the reconciliation is entered in the journal. If there is an error in the log, responsible person should make corrections.
This is done in the following way:
- incorrect entry is neatly crossed out;
- the correct entry is written next to it;
- the correction is certified with the mark “corrected to believe” and the signature of the responsible employee.
Uncertified corrections and erasures in the document are not allowed.
How to store the PKU log
The current log of subject-quantitative accounting is stored in a safe or a metal cabinet, the keys to which are kept by an authorized person. In the same place with it, originals and copies of invoices should be stored - they are stapled together in chronological order.
After a year, the completed PKU journal is transferred to the archive of the institution - it is stored here for 3 years.
How to mark the release of drugs to inpatients in the journal
Information about the medicine prescribed to the patient is noted in his card.
It states:
- The name of the medicine.
- At what time or with a frequency of how many hours you need to take the drug.
- Dosage.
- How long does the patient need to take this drug.
Information about medicines dispensed to patients is also recorded in the PKU journal - the date of prescription, the patient's surname and initials, his medical record number, and the amount of medicine dispensed. If medicines are dispensed to patients on a daily basis, then records should also be made every day.
How to properly record the reconciliation act in the PKU journal
All transactions with medicines are recorded for each individual item, including the receipt and consumption of individual lekforms and dosages.
If the PKU journal is maintained in electronic format, and reconciliation data is entered at the end of each month, the maintenance of journal sheets will be incorrect.
It's better to do it like this:
- on the last day of the month, reconciliation of drug balances is carried out based on the data of accounting documents and the actual number of drugs;
- a reconciliation entry is entered in the PKU journal itself - it will be the next after the last entry on income and expenditure transactions with the drug (including dosage and dosage form).
If there were no operations for any drug during the month, then the reconciliation record in the printed electronic journal at the end of the month will be the only one.
Entering reconciliation marks in the journal after the last entry greatly simplifies the order of document maintenance, while making such marks at the end of the journal makes the procedure more complicated.
Question: Please provide clarifications in accordance with Order No. 378n dated June 17, 2013: 1) when (specify the date) it is necessary to keep a register of operations related to the circulation of medicines for medical use; 2) Is it necessary to have the same journal to account for ethyl alcohol in a production pharmacy?
Answer: In accordance with part 3 of Article 58.1 federal law RF dated 04/12/2010 N 61-FZ "On the circulation of medicines" (as amended on 07/02/2013) subject-quantitative accounting of medicines for medical use is maintained by manufacturers of medicines, organizations wholesale trade medicines, pharmacies, individual entrepreneurs licensed for pharmaceutical activities or a license for medical activities, and medical organizations that circulate medicines for medical use, by registering any operations related to their circulation, in which their number and (or) condition changes, in special transaction registers, associated with the circulation of medicines for medical use.
This provision of the Law entered into force on June 25, 2013 and, formally, it was from this date that the obligation to maintain accounting journals was established. medicines subject to PKU.
However, the Ministry of Health of the Russian Federation, as always, did not approve the Rules for maintaining such journals in time.
Order of the Ministry of Health of the Russian Federation of June 17, 2013 N 378n approving the "Rules for registration of operations related to the circulation of medicinal products for medical use, included in the list of medicinal products for medical use subject to subject-quantitative accounting, in special registers for registering transactions related to the circulation of medicinal products for medical use" and "Rules for the maintenance and storage of special registers of transactions related to the circulation of medicinal products for medical use", was registered by the Ministry of Justice of the Russian Federation only on August 15, 2013 and was officially published in Russian newspaper No. 190 August 28, 2013.
In accordance with paragraph 12 of Decree of the President of the Russian Federation of 05.23.1996 N 763 "On the procedure for publishing and entry into force of acts of the President of the Russian Federation, the Government of the Russian Federation and regulatory legal acts of federal executive bodies" (as amended on 02.02.2013), this order entered into force ten days after the day of their official publication, i.e. September 8th, 2013.
Thus, it was from this date that the obligation of the organizations listed in Part 3 of Article 58.1 of the Law "On the Circulation of Medicines" to keep records of medicines subject to PKU began, in accordance with the rules approved by Order No. 378n.
Ethanol (Ethyl alcohol, Medical antiseptic solution) is included in section 5 "Other medicines" approved by the Order of the Ministry of Health and Social Development of the Russian Federation of December 14, 2005 N 785 "List of medicines subject to quantitative accounting in pharmacies (organizations), drug wholesalers , medical institutions and private practitioners" (as amended on 08/06/2007), therefore, operations related to the circulation of ethyl alcohol intended for medical use should be taken into account in accordance with the "Rules for registration of transactions related to the circulation of medicines for medical use, included in the list of medicines for medical use subject to subject-quantitative accounting, in special registers for registering transactions related to the circulation of medicines for medical use" and "Rules for maintaining and storing special registers for registering transactions related to the circulation of medicines for medical use", approved by the Order of the Ministry of Health of the Russian Federation of June 17, 2013 N 378n, including in the industrial pharmacy.
Registration N 29404
In accordance with paragraph 5.2.171 (3) of the Regulations on the Ministry of Health of the Russian Federation, approved by the Decree of the Government of the Russian Federation of June 19, 2012 N 608 (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2012, N 26, Art. 3526; 2013, N 16, article 1970), order:
Approve:
rules for registration of transactions related to the circulation of medicinal products for medical use included in the list of medicinal products for medical use subject to subject-quantitative accounting in special registers of operations related to the circulation of medicinal products for medical use, in accordance with Appendix No. 1;
rules for maintaining and storing special registers for registering operations related to the circulation of medicines for medical use, in accordance with Appendix No. 2.
Minister V. Skvortsova
Appendix N 1 to the Order
Rules for registration of transactions related to the circulation of medicinal products for medical use included in the list of medicinal products for medical use subject to subject-quantitative accounting in special registers of transactions related to the circulation of medicinal products for medical use
1. These Rules establish the requirements for registration of operations related to the circulation of medicinal products for medical use included in the list of medicinal products for medical use subject to subject-quantitative accounting 1 (hereinafter referred to as medicinal products), as a result of which their quantity and (or ) state.
2. Registration of transactions related to the circulation of medicinal products that are narcotic drugs, psychotropic substances or their precursors included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation 2 is carried out by the subjects of drug circulation funds in special journals in the forms provided for in Appendix No. 1 to the Rules for maintaining and storing special journals for registering transactions related to the circulation of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of November 4, 2006 N 644 3, and the Appendix to the Rules for Keeping and storage of special registers for registering transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by the Decree of the Government of the Russian Federation of June 9, 2010 N 419 4 .
3. Registration of transactions related to the circulation of medicines (with the exception of medicines specified in paragraph 2 of these Rules) is carried out in special registers for registering transactions related to the circulation of medicines (hereinafter referred to as registers):
1) manufacturers of medicinal products and wholesalers of medicinal products in the form in accordance with Appendix No. 1 to these Rules;
2) pharmacy organizations and individual entrepreneurs licensed for pharmaceutical activities, in the form in accordance with Appendix No. 2 to these Rules;
3) medical organizations and individual entrepreneurs licensed for medical activities, in the form in accordance with Appendix No. 3 to these Rules.
4. Registration of transactions related to the circulation of medicinal products is carried out for each trade name medicinal product (for each individual dosage and dosage form) on a separate expanded sheet of the log book or in a separate log book on paper or in in electronic format.
5. Registration of transactions related to the circulation of medicines is carried out by persons authorized by the head legal entity for the maintenance and storage of registers, or an individual entrepreneur who has a license for pharmaceutical activities or for medical activities.
2 Decree of the Government of the Russian Federation of June 30, 1998 N 681 "On approval of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation" (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 1998, N 27, art. 3198; 2004, N 8, item 663, N 47, item 4666; 2006, N 29, item 3253; 2007, N 28, item 3439; 2009, N 26, item 3183, N 52, item 6572; 2010, N 3, Article 314, No. 17, Article 2100, No. 24, Article 3035, No. 28, Article 3703, No. 31, Article 4271, No. 45, Article 5864, No. 50, Article 6696, Article 6720; 2011, N 10, item 1390, N 12, item 1635, N 29, item 4466, item 4473, N 42, item 5921, N 51, item 7534; 2012, N 10, item 1232, No. 11, article 1295, No. 19, article 2400, No. 22, article 2864, No. 37, article 5002, No. 48, article 6686, No. 49, article 6861; 2013, No. 9, article .953).
Appendix N 2 to the Order
Rules for the maintenance and storage of special registers of transactions related to the circulation of medicines for medical use
1. These Rules establish the requirements for the maintenance and storage of special registers for transactions related to the circulation of medicinal products for medical use included in the list of medicinal products for medical use subject to subject-quantitative accounting 1 (hereinafter, respectively - registers, medicines).
2. These Rules do not apply to the maintenance and storage of special registers of transactions related to the circulation of medicines that are narcotic drugs, psychotropic substances and their precursors included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation 2 .
3. The introduction and storage of special registers for transactions related to the circulation of medicines specified in paragraph 2 of these Rules is carried out in accordance with the Rules for maintaining and storing special registers for registering operations related to the circulation of narcotic drugs and psychotropic substances, approved by a decree of the Government of the Russian Federation dated November 4, 2006 N 644 3 , and the Rules for maintaining and storing special logs for registering transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by the Decree of the Government of the Russian Federation dated June 9, 2010 N 419 4 .
4. Accounting logs filled in on paper are bound, numbered and sealed with the signature of the head of the legal entity (individual entrepreneur) and the seal of the legal entity (individual entrepreneur) before they are kept.
Accounting journals are issued for the calendar year.
5. Sheets of accounting journals filled in electronic form, are monthly printed out, numbered, signed by a person authorized to maintain and store accounting logs, and are brochured according to the names of the medicinal product, dosage, dosage form.
At the end of the calendar year, bound sheets are drawn up in a journal, sealed with an indication of the number of sheets and certified by the signature of a person authorized to maintain and store accounting journals, the head of a legal entity (individual entrepreneur) and the seal of a legal entity (individual entrepreneur).
6. Entries in the registers are made by a person authorized to maintain and store the register with a ballpoint pen (ink) at the end of the working day on the basis of documents confirming the completion of incoming and outgoing transactions with the medicinal product.
7. The receipt of the medicinal product is reflected in the register for each receipt document separately, indicating the number and date. Medication consumption is recorded daily. Pharmacy organizations and individual entrepreneurs who have licenses for pharmaceutical activities record the daily consumption of the medicinal product, indicating separately for prescriptions issued medical workers, and according to the requirements medical organizations.
8. Corrections in the accounting logs shall be certified by the signature of the person authorized to maintain and store the accounting logs. Erasures and uncertified corrections in accounting journals are not allowed.
9. On last number Every month, the person authorized to maintain and store the registers checks the actual availability of medicines with their balance in the register and makes appropriate entries in the register.
10. The accounting log is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting log.
Receipt and expenditure documents (their copies) are filed in the order of their receipt by date and are stored together with the accounting journal.
11. Completed accounting books are stored in the archive of a legal entity (individual entrepreneur).
1 Article 58.1 of the Federal Law of April 12, 2010 N 61-FZ "On the Circulation of Medicines" (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815, N 31, Art. 4161, N 42, Art. 5293, No. 49, article 6409; 2011, No. 50, article 7351; 2012, No. 26, article 3446; No. 53, article 7587).
2 Decree of the Government of the Russian Federation of June 30, 1998 N 681 (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 1998, N 27, Art. 3198; 2004, N 8, Art. 663, N 47, Art. 4666; 2006, N 29, Art. 3253; 2007, N 28, item 3439; 2009, N 26, item 3183, N 52, item 6572; 2010, N 3, item 314, N 17, item 2100, N 24, item 3035 , N 28, item 3703, N 31, item 4271, N 45, item 5864, N 50, item 6696, item 6720; 2011, N 10, item 1390, N 12, item 1635, N 29, Article 4466, Article 4473, No. 42, Article 5921, No. 51, Article 7534; 2012, No. 10, Article 1232, No. 11, Article 1295, No. 19, Article 2400, No. 22, 2864, No. 37, 5002, No. 48, 6686, No. 49, 6861; 2013, No. 9, 953).
3 Collection of Legislation of the Russian Federation, 2006, N 46, art. 4795; 2008, N 50, Art. 5946; 2010, N 25, Art. 3178; 2012, N 37, Art. 5002.
4 Collection of Legislation of the Russian Federation, 2010, N 25, art. 3178; 2011, N 51, Art. 7534; 2012, N 1, art. 130, no. 41, art. 5623, No. 51, art. 7235.
"On Approval of the Rules for Registration of Operations Related to the Circulation of Medicinal Products for Medical Use, Included in the List of Medicinal Products for Medical Use Subject to Quantitative Accounting, in Special Registers of Operations Related to the Circulation of Medicinal Products for Medical Use, and the Rules for Maintaining and storage of special registers of transactions related to the circulation of medicines for medical use"
Edition of 04/05/2018 - Valid from 05/14/2018
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MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
ORDER
dated June 17, 2013 N 378n
ON THE APPROVAL OF THE REGISTRATION REGULATIONS OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE SUBJECT TO QUANTITATIVE REGISTRATION IN SPECIAL JOURNALS COUPLE OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINAL PRODUCTS FOR MEDICAL USE AND THE RULES OF MANAGEMENT AND STORAGE OF SPECIAL JOURNALS OF ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE
(As amended by the Orders of the Ministry of Health of the Russian Federation dated October 31, 2017 N 882n, dated April 5, 2018 N 149n)
Approve:
rules for registration of transactions related to the circulation of medicinal products for medical use included in the list of medicinal products for medical use subject to subject-quantitative accounting in special registers of operations related to the circulation of medicinal products for medical use, in accordance with Appendix No. 1;
rules for maintaining and storing special registers for registering operations related to the circulation of medicines for medical use, in accordance with Appendix No. 2.
Minister
IN AND. SKVORTSOVA
1. These Rules establish the requirements for registration of operations related to the circulation of medicinal products for medical use included in the list of medicinal products for medical use subject to quantitative accounting<1>(hereinafter referred to as medicinal products), as a result of which their quantity and (or) state changes.
<2>Decree of the Government of the Russian Federation of June 30, 1998 N 681 "On approval of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation" (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 1998, N 27, art. 3198; 2004, N 8 , item 663; N 47, item 4666; 2006, N 29, item 3253; 2007, N 28, item 3439; 2009, N 26, item 3183; N 52, item 6572; 2010, N 3 , item 314; N 17, item 2100; N 24, item 3035; N 28, item 3703; N 31, item 4271; N 45, item 5864; N 50, item 6696, item 6720 ; 2011, N 10, item 1390; N 12, item 1635; N 29, item 4466, item 4473; N 42, item 5921; N 51, item 7534; 2012, N 10, item 1232 ; N 11, item 1295; N 19, item 2400; N 22, item 2864; N 37, item 5002; N 48, item 6686; N 49, item 6861; 2013, N 9, item 953; N 25, item 3159; N 29, item 3962; N 37, item 4706; N 46, item 5943; N 51, item 6869; 2014, N 14, item 1626; N 23, item 2987; N 27, item 3763; N 44, item 6068; N 51, item 7430; 2015, N 11, item 1593; N 16, item 2368; N 20, item 2914; N 28, 4232, No. 42, 5805; 2016, N 15, art. 2088; 2017, N 4, art. 671, no. 10, art. 1481, no. 23, art. 3330; No. 30, Art. 4664; No. 33, art. 5182). (As amended by the Order of the Ministry of Health of the Russian Federation of 04/05/2018 N 149n)
<3>Collection of Legislation of the Russian Federation, 1998, N 2, Art. 219; 2002, No. 30, Art. 3033; 2003, N 2, Art. 167; No. 27, Art. 2700; 2004, N 49, Art. 4845; 2005, N 19, art. 1752; 2006, N 43, Art. 4412; N 44, art. 4535; 2007, N 30, Art. 3748; N 31, art. 4011; 2008, N 30, art. 3592; No. 48, art. 5515; No. 52, art. 6233; 2009, N 29, Art. 3588, 3614; 2010, No. 21, art. 2525; N 31, art. 4192; 2011, N 1, art. 16, art. 29; No. 15, art. 2039; No. 25, Art. 3532; No. 49, Art. 7019, Art. 7061; 2012, N 10, art. 1166; No. 53, art. 7630; 2013, N 23, art. 2878; No. 30, Art. 4057; No. 48, Art. 6161, Art. 6165; 2014, N 23, Art. 2930; 2015, N 1, art. 54; No. 6, art. 885; No. 29, Art. 4388; 2016, N 1, art. 28; No. 15, art. 2052; No. 27, art. 4160; Art. 4238. (As amended by the Order of the Ministry of Health of the Russian Federation of 04/05/2018 N 149n)
<4>Collection of Legislation of the Russian Federation, 2006, N 46, art. 4795; 2008, N 50, Art. 5946; 2010, N 25, Art. 3178; 2012, N 37, Art. 5002; 2013, N 6, art. 558, N 51, art. 6869; 2015, N 33, art. 4837; 2017, N 2, art. 375. (As amended by the Order of the Ministry of Health of the Russian Federation of 04/05/2018 N 149n)
<5>Collection of Legislation of the Russian Federation, 2010, N 25, art. 3178; 2011, N 51, Art. 7534; 2012, N 1, art. 130, no. 41, art. 5623, No. 51, art. 7235; 2015, N 33, art. 4837; 2017, N 2, art. 375. (As amended by the Order of the Ministry of Health of the Russian Federation of 04/05/2018 N 149n)
3. Registration of transactions related to the circulation of medicines (with the exception of medicines specified in paragraph 2 of these Rules) is carried out in special ledgers for registering transactions related to the circulation of medicines (hereinafter referred to as registers):
1) manufacturers of medicines and wholesalers of medicines in the form in accordance with Appendix No. 1 to these Rules;
2) pharmacy organizations and individual entrepreneurs licensed for pharmaceutical activities, in the form in accordance with Appendix No. 2 to these Rules;
3) medical organizations and individual entrepreneurs licensed for medical activities, in the form in accordance with Appendix No. 3 to these Rules.
4. Registration of transactions related to the circulation of medicinal products is carried out for each trade name of the medicinal product (for each individual dosage and dosage form) on a separate expanded sheet of the register or in a separate register on paper or in electronic form.
5. Registration of operations related to the circulation of medicines is carried out by persons authorized by the head of the legal entity to maintain and store accounting journals, or by an individual entrepreneur who has a license for pharmaceutical activity or medical activity.
________
| Month | Balance on the 1st of the month | Coming | Consumption | Total cost per month | Signature of authorized person | |||||||
| From whom received | N and document date | Quantity | Who is released | N and document date | Quantity | |||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
| January | ||||||||||||
| February | ||||||||||||
| March | ||||||||||||
| April | ||||||||||||
| May | ||||||||||||
| June, etc. | ||||||||||||
Appendix No. 2
medicines for medical use,
Russian Federation
dated June 17, 2013 N 378n
JOURNAL OF ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE
(name of medicinal product for medical use)
____________________________________________________________________________
(dosage, dosage form, unit of measure)
| Month | Balance on the 1st of the month | Coming | Just for a month upon arrival with the balance | Types of expense | Consumption | Cost per month for each type separately | Total per month for all types of expenses | Remainder according to the journal at the end of the month | Actual balance at the end of the month | Signature of authorized person | |||||
| Vendor, N and document date | Quantity | 1 | 2 | 3 | 4 | 5 etc. | |||||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 |
| January | prescription | ||||||||||||||
| according to requirements | |||||||||||||||
| February etc. | prescription | ||||||||||||||
| according to requirements | |||||||||||||||
Appendix No. 3
to the Rules for registering transactions related to circulation
medicines for medical use,
included in the list of medicines for medical
applications subject to subject-quantitative accounting,
in special journals for accounting for transactions related to circulation
medicines for medical use,
approved by order of the Ministry of Health
Russian Federation
dated June 17, 2013 N 378n
JOURNAL OF ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE
__________________________________________________________________________
(name of medicinal product for medical use)
__________________________________________________________________________
(dosage, dosage form, unit of measure)
(As amended by the Order of the Ministry of Health of the Russian Federation of October 31, 2017 N 882n)
| Month | Balance on the 1st of the month | Coming | Just for a month upon arrival with the balance | Consumption | Total cost per month | Account balance at the end of the month | Actual balance at the end of the month | Signature of authorized person | ||||
| From whom received | N and document date | Quantity | date of issue | N of the medical document (full name of the patient<*>) | Quantity | |||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
| (As amended by the Order of the Ministry of Health of the Russian Federation of October 31, 2017 N 882n) | ||||||||||||
| January | ||||||||||||
| February | ||||||||||||
| March | ||||||||||||
| April | ||||||||||||
| May | ||||||||||||
| June and (As amended by the Order of the Ministry of Health of the Russian Federation of 04/05/2018 N 149n) 1. These Rules establish requirements for the maintenance and storage of special registers of transactions related to the circulation of medicinal products for medical use included in the list of medicinal products for medical use subject to subject-quantitative accounting<1>(hereinafter, respectively - registers, medicines). <3>Collection of Legislation of the Russian Federation, 1998, N 2, Art. 219; 2002, No. 30, Art. 3033; 2003, N 2, Art. 167; No. 27, art. 2700; 2004, N 49, Art. 4845; 2005, N 19, art. 1752; 2006, N 43, Art. 4412; N 44, art. 4535; 2007, N 30, Art. 3748; N 31, art. 4011; 2008, N 30, art. 3592; No. 48, Art. 5515; No. 52, art. 6233; 2009, N 29, Art. 3588, 3614; 2010, No. 21, art. 2525; "N 31, item 4192; 2011, N 1, item 16, item 29; N 15, item 2039; N 25; item 3532; N 49, item 7019, item 7061; 2012, N 10 , item 1166; N 53, item 7630; 2013, N 23, item 2878; N 30, item 4057; N 48, item 6161, item 6165; 2014, N 23, item 2930; 2015, No. 1, article 54; No. 6, article 885; No. 29, article 4388; 2016, No. 1, article 28; No. 15, article 2052; No. 27, article 4160; article 4238. <1>Collection of Legislation of the Russian Federation, 2006, N 46, art. 4795; 2008, N 50, Art. 5946; 2010, N 25, Art. 3178; 2012, N 37, Art. 5002. <2>Collection of Legislation of the Russian Federation, 2010, N 25, art. 3178; 2011, N 51, Art. 7534; 2012, N 1, art. 130, no. 41, art. 5623, No. 51, art. 7235. 4. Accounting logs filled in on paper are bound, numbered and sealed with the signature of the head of the legal entity (individual entrepreneur) and the seal of the legal entity (individual entrepreneur) before they are kept. Accounting journals are issued for the calendar year. 5. Sheets of accounting logs filled in electronic form are monthly printed out, numbered, signed by a person authorized to maintain and store accounting logs, and brochured by drug name, dosage, dosage form. At the end of the calendar year, bound sheets are drawn up in a journal, sealed with an indication of the number of sheets and certified by the signature of a person authorized to maintain and store accounting journals, the head of a legal entity (individual entrepreneur) and the seal of a legal entity (individual entrepreneur). 6. Entries in the registers are made by a person authorized to maintain and store the register with a ballpoint pen (ink) at the end of the working day on the basis of documents confirming the completion of incoming and outgoing transactions with the medicinal product. 7. The receipt of the medicinal product is reflected in the register for each receipt document separately, indicating the number and date. Medication consumption is recorded daily. Pharmacy organizations and individual entrepreneurs who have licenses for pharmaceutical activities record the daily consumption of the drug, indicating separately according to prescriptions issued to medical workers and according to the requirements of medical organizations. 8. Corrections in the accounting logs shall be certified by the signature of the person authorized to maintain and store the accounting logs. Erasures and uncertified corrections in accounting journals are not allowed. 9. On the last day of each month, the person authorized to maintain and store the registers shall reconcile the actual availability of medicines with their balance in the register and make appropriate entries in the register. 10. The accounting log is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting log. Receipt and expenditure documents (their copies) are filed in the order of their receipt by date and are stored together with the accounting journal. 11. Completed accounting books are stored in the archive of a legal entity (individual entrepreneur). | ||||||||||||
Letter from the Ministry of Health of the Republic of Tatarstan
dated October 21, 2013 N 09-01 / 11725
Heads of medical organizations regardless
from the organizational and legal form, form
ownership and departmental affiliation
Republic of Tatarstan
Heads of Health Departments
by years Kazan, Naberezhnye Chelny,
Nizhnekamsk, Almetievsk Ministry of Health of the Republic of Tatarstan
Heads of pharmaceutical organizations
The Ministry of Health of the Republic of Tatarstan sends you for guidance in the work the order of the Ministry of Health of the Republic of Tatarstan dated June 17, 2013 N 378n "On approval of the rules for registering transactions related to the circulation of medicines for medical use, subject to subject-quantitative accounting, in special registers of transactions related to with the circulation of medicinal products for medical use, and the rules for maintaining and storing special registers of transactions related to the circulation of medicinal products for medical use" (hereinafter - Order N 378n). The order came into force on September 8, 2013.
In accordance with the written explanation of the Ministry of Health of the Russian Federation, medical and pharmacy organizations, drug wholesalers, individual entrepreneurs holding a license for pharmaceutical activities or a license for medical activities are required to comply with the requirements of this order.
In connection with incoming requests from medical organizations on the procedure for issuing and maintaining new registers of transactions related to the circulation of medicines for medical use subject to subject-quantitative accounting (hereinafter referred to as PKU), we report the following.
The list of medicines subject to PKU is approved by order of the Ministry of Health and social development Russian Federation of December 14, 2005 N 785 "On the procedure for dispensing medicines" .
Please note that from this list drugs Butorphanol, Teaneptine and 21 potent substances were transferred to List III of psychotropic substances, Diethyl ether was transferred to List IV of precursors of the List of narcotic drugs, psychotropic substances and their precursors, approved by Decree of the Government of the Russian Federation of 30.06.1998 N 681 and require an accounting procedure approved for narcotic drugs, psychotropic substances and their precursors.
When issuing new-style accounting journals approved by order N 378n, it is necessary to take into account:
- the transfer of the accounting balance of medicinal products subject to PKU from the "old" registers to the new ones is carried out according to the act by the commission, the composition of which is approved by order of the head of the legal entity;
- in the "old" registers, an entry is made: "The journal is completed, in connection with the entry into force of the order of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n");
- unused sheets of "old" registers are crossed out.
Registration of transactions is carried out for each trade name of the medicinal product (for each individual dosage and dosage form) on a separate expanded sheet of the register or in a separate register on paper or in electronic form.
Registration of operations in accounting journals is carried out by persons authorized by order of the head of the legal entity to maintain and store accounting journals.
Magazines filled out on paper are bound, numbered and sealed with the signature of the head of the legal entity and the seal of the legal entity before they are kept.
It is allowed to keep a record book in electronic form. In this case, the sheets filled in electronically must be:
- monthly print;
- to number;
- Brochure on the names of the medicinal product, dosage, dosage form;
- after the expiration of the calendar year, the bound sheets should be drawn up in a journal, which is sealed with an indication of the number of sheets and certified by the signatures of the person authorized to maintain and store the journals, the head of the legal entity and the seal of the legal entity.
Entries in the registers are made by an authorized person with a ballpoint pen at the end of the working day on the basis of documents confirming the completion of incoming and outgoing transactions with medicines.
The receipt of a medicinal product is reflected in the register for each receipt document, indicating the number and date of the document, each expenditure operation is not required to be recorded in the register, in medical organizations the expense is recorded daily. Pharmacy organizations and individual entrepreneurs also record daily consumption, but with indication separately according to doctors' prescriptions and according to the requirements of medical organizations.
Corrections in the accounting journals are certified by the signature of the person authorized to maintain and store the accounting journals. Erasures and uncertified corrections in accounting journals are not allowed.
On the last day of each month, the person authorized to maintain and store the registers checks the actual availability of medicines with their balance in the register and makes the appropriate entries in the register (columns 12 and 13 are filled in).
The accounting log is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting log.
Receipt and expenditure documents (their copies) are filed in the order of their receipt by date and are stored together with the accounting journal.
Completed accounting books are stored in the archive of the legal entity.
Accounting journals are issued for the calendar year. On December 31, 2013, the accounting journal must be completed, with the transfer of the balance to the accounting journal for 2014.
Additional columns or lines may be added to the forms of registers of medicines subject to PKU, approved by Order N 378n, in order to tighten accounting or adapt accounting to the medical process. All additions must be approved by order of the head of the legal entity. It is not allowed to exclude the columns of the accounting journals approved by order N 378n.
Taking into account the proposals of medical organizations, we recommend forms of registers for use in the offices of senior nurses and treatment rooms of departments of medical organizations (Appendices No. 1 and No. 2, additions to the forms of the register are in bold).
In accordance with paragraph 5 of Art. 58.1 of the Federal Law of 12.04.2010 N 61-FZ (as amended of 02.07.2013) "On the Circulation of Medicines" control over compliance with the rules for registering operations related to the circulation of medicines for medical use included in the list of medicines subject to subject- quantitative accounting, in special journals, as well as compliance with the rules for maintaining and storing special journals is carried out within the framework of license control.
Appendix No. 1
Appendix No. 1
Register of transactions related to the circulation of medicines for medical use (head nurse's office ____________________________________) name of the department
Balance on the 1st of the month | Total cost per month | Signature of authorized person |
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From whom received | N and document date | Quantity (series) | date of issue | N of the medical document (full name of the patient, requirement of the treatment room) | Quantity | |||||||
March, etc. | ||||||||||||
Appendix No. 2
Appendix No. 2
(name of medical organization)
Register of transactions related to the circulation of medicinal products for medical use (treatment room ____________________________) name of the department
Balance on the 1st of the month | Just for a month upon arrival with the balance | Total cost per month | Journal balance at the end of the month | Actual balance at the end of the month | Signature of authorized person | Balance at the end of the work shift |
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From whom received | N and document date | Quantity (series) | date of issue | N of the medical document (full name of the patient, | Quantity | ||||||||
