/ Pentalgin-N

Pentalgin-N Pentalgin-N

Drops in pharmacies

over the counter

Manufacturer

Pharmstandard-Leksredstva, Russia

Pharmacological group

Analgesic

Active ingredient

metamizole sodium, codeine, phenobarbital, caffeine, naproxen (combination drug)

"Pentalgin-N" - effective drug, which has a strong analgesic and anti-inflammatory effect. Relieves pain of various etiologies. Particularly effective when severe pain, including postoperative. Dispensed from pharmacies by prescription, taken only according to indications; to prescribe, you must contact your doctor.

Application of Tempalgin

Tempalgin is a combined analgesic (painkiller) with an antipyretic and sedative effect. It is used for feverish conditions due to high temperature body, for toothache and headache, reducing pain after surgical interventions. When using Tempalgin, fear, anxiety, agitation go away and decrease blood pressure. Tempalgin is a fast-acting drug that has a sedative effect within half an hour, and an analgesic effect after an hour. It cannot be used as a course, but should be immediately canceled as soon as the opportunity arises.

Tempalgin for headaches and toothaches

Each person has his own threshold for pain sensitivity and sometimes it is simply impossible to endure pain, especially dental and headache pain. Tempalgin will help relieve pain medium degree and dull acute toothache. It contains analgesic and sedative substances, so the pain will go away within 10-15 minutes after taking the tablet, and the analgesic effect will last for several hours. The tablet should be taken after meals with plenty of water. Dosage for adults – 1-2 tablets three times a day (no more than 6 tablets per day). Children over 14 years of age can be given 1 tablet twice a day. Tempalgin should not be used for more than 5 days!

Composition of tablets of the drug "Pentalgin-N" and release form

Pentalgin-N is available in the form of tablets that are white or white with a yellowish or creamy tint, flat-cylindrical, with the abbreviated name of the drug PENT-N embossed on one side. One tablet contains:

• metamizole sodium 300 mg,
• caffeine 50 mg,
• naproxen 100 mg,
• codeine 8 mg,
• phenobarbital 10 mg,
• auxiliary components.

Pentalgin-N tablets You can buy 10 pieces in a blister pack. 1 or 2 blister packs along with instructions for use in a cardboard pack.

Pharmacological action

Pentalgin-N is a combination drug that has analgesic, anti-inflammatory and antipyretic effects. Naproxen and metamizole sodium have analgesic and anti-inflammatory effects. Codeine stimulates opioid receptors in various parts of the central nervous system, which leads to activation of the antinociceptive system and a change in the emotional perception of pain. Codeine and phenobarbital increase the analgesic effect of metamizole sodium and naproxen. Caffeine dilates blood vessels skeletal muscles, kidneys, heart, brain.

Pentalgin-N increases mental and physical performance, eliminates fatigue and drowsiness; increases the permeability of histohematic barriers and increases the bioavailability of non-opioid analgesics, thereby promoting increased therapeutic effect. The drug is biotransformed in the liver, excreted by the kidneys, and penetrates the placental barrier.

Indications for use

Pentalgin-N tablets are indicated for use in mild to moderate pain syndrome of various origins, including pain in joints, muscles, radiculitis, menstrual pain, neuralgia, dental pain and headaches (including migraines). They also help with post-traumatic and postoperative pain syndrome.

Contraindications

Pentalgin-N is contraindicated for use in following cases:

• Hypersensitivity to the components of the drug
• Portal hypertension, severe arterial hypertension
• Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase), gastrointestinal bleeding
• Bronchial asthma, bronchospasm
• Alcohol intoxication
• Glaucoma
• Liver and kidney dysfunction
• Severe organic diseases of the cardiovascular system (including acute myocardial infarction), arrhythmia
• Traumatic brain injury
• Anemia, leukopenia
• Glucose-6-phosphate dehydrogenase deficiency
• Children's age up to 12 years
• Pregnancy, lactation period

Take with caution when arterial hypertension light and moderate severity, in old age. A doctor's consultation is required.

Application of Pentalgin N during pregnancy and breastfeeding: the drug is contraindicated during pregnancy and lactation; it passes into breast milk.

Instructions for use

Pentalgin-N is taken orally. The drug is taken 1 tablet 1-3 times a day. The maximum daily dose is 4 tablets. It is not recommended to use the drug for more than five days as an analgesic and for more than three days as an antipyretic without a doctor’s prescription and supervision.

Side effects

Allergic reactions, including Steven-Johnson syndrome, Lyell's syndrome; bronchospasm.

Causes addiction and drug dependence when long-term use.

Overdose

Symptoms of drug overdose: nausea, vomiting, gastralgia, drowsiness, tachycardia, cardiac arrhythmias, respiratory depression, delirium, weakness.

Treatment for overdose: induction of vomiting, gastric lavage through a tube, administration of adsorbents (activated carbon), symptomatic therapy aimed at maintaining vital functions.

Interaction with other drugs

Concomitant use of Pentalgin N with other non-opioid analgesics may lead to increased toxic effects. Sedatives and tranquilizers enhance the analgesic effect of the drug. The simultaneous use of metamizole with cyclosporine reduces the level of the latter in the blood. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effects of metamizole sodium. Tricyclic antidepressants, contraception for oral administration, allopurinol increases the toxicity of metamizole sodium included in the drug.

Special instructions

During treatment you should avoid drinking alcohol. With long-term use (more than 5 days), it is necessary to monitor the peripheral blood picture and liver function indicators. The use of the drug may change the results of doping control of athletes.

In some cases, a decrease in concentration and speed of psychomotor reactions is possible, therefore, during the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Taking the drug may make it difficult to establish a diagnosis for acute abdominal pain syndrome.

Release from pharmacies

Pentalgin-N is released strictly according to prescription. Form 148-1/у-88. There is a dispensing norm for 1 prescription, taking into account an indivisible package of 20 tablets.

Storage conditions

In a dry place, at a temperature not exceeding 25 C. Keep out of the reach of children! Do not use the drug after the expiration date indicated on the package.

Analogues of Pentalgin-N

You can replace Pentalgin-N with the following analogue drugs:

• "Piralgin" (Belarus) - tablets No. 10.

Question:
According to Order No. 1175n, how to calculate the number of packages in one prescription for codeine-containing drugs, in terms of codeine, if this order allows for a two-month prescription for special purposes?

In accordance with paragraph 5 “a” of the “Leave Procedure” approved by the Order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 N 562n individuals medicines for medical use, containing in addition to small quantities narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances» combination medicinal products containing codeine or its salts (in terms of pure substance) in amounts up to 20 mg (per 1 dose of solid dosage form) or in an amount up to 200 mg (per 100 ml or 100 g of liquid dosage form for internal use), are subject to dispensing according to prescriptions written out on prescription forms of form N 148-1/у-88.
Clause 13 of the Order of the Ministry of Health of the Russian Federation of December 20, 2012 N 1175n “Procedure for prescribing and prescribing drugs” approved when writing a prescription for a drug containing codeine (codeine phosphate) in powder form, it is prohibited to exceed the maximum permissible amount medicinal product for prescribing for one prescription, in the amount of 0.2 g, and it is also not recommended to exceed the established amount of a combination medicinal product of any form of release containing codeine (codeine salts) for prescribing for one prescription, in the amount of 0.2 g, except in cases specified in paragraph 15 of the Procedure.
At the same time, paragraph 23 of the “Procedure for Prescribing and Prescribing Medicines” prescribes prescriptions for combination drugs containing codeine (its salts) for the treatment of patients with chronic diseases it is allowed to prescribe for a course of treatment up to two months, provided that the inscription “For special purposes” is applied to the prescription, separately signed medical worker and seal medical organization"For recipes."
Thus, upon receipt from the buyer of a prescription on form N 148-1/u-88 for a combined medicinal product containing codeine (its salts), with the inscription “For special purposes”, separately signed by a medical worker and the seal of the medical organization “For prescriptions”, there is no need to calculate the number of packages of the drug in terms of codeine, but the drug should be dispensed to the buyer in strict accordance with the doctor’s prescription.

Letter of the Ministry of Health of the Russian Federation dated January 13, 2014 No. 25-4/10/2-79 On the requirements for the circulation of codeine-containing drugs and the dispensing of drugs containing small amounts of phenobarbital

Ministry of Health Russian Federation informs about the adoption by the Government of the Russian Federation of Decree No. 1159 of December 16, 2013 “On amendments to certain acts of the Government of the Russian Federation on issues related to the circulation of narcotic drugs and psychotropic substances” (hereinafter referred to as the resolution).

The resolution amends 5 resolutions of the Government of the Russian Federation.

In particular, the resolution introduced changes to the section “Narcotic Drugs” of List II of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 No. 681 (hereinafter referred to as the list).

The changes concern the harmonization of two norms regulating the establishment of control measures in relation to drugs containing codeine (its salts).

The first norm is defined by paragraph 4 of Article 2 Federal Law dated January 8, 1998 No. 3-FZ “On Narcotic Drugs and Psychotropic Substances” and regulates that drugs containing narcotic drugs (including codeine) are subject to measures similar measures control provided for the narcotic drugs contained in them.

Another norm established by the list classified 7 items of drugs (currently not registered and not represented on the Russian pharmaceutical market) as narcotic drugs, containing codeine from 10 mg to 30 mg per 1 tablet/capsule, in combination with both pharmacologically active ingredients , and with neutral (pharmacological inactive) ingredients.

At the same time, a number of positions of medicinal products containing codeine up to 20 mg, in accordance with the norms of the order of the Ministry of Health and Social Development of Russia dated March 16, 2010 No. 157n “On approval of the maximum permissible amount of narcotic drugs, psychotropic substances and their precursors contained in drugs” (hereinafter - Order of the Ministry of Health and Social Development of Russia dated March 16, 2010 No. 157n) are classified as drugs containing small amounts of narcotic drugs.

For these drugs, control measures have been defined only in terms of:

— issuing prescriptions to individuals, as well as prohibiting mailing, including international ones (Resolution of the Government of the Russian Federation dated July 20, 2011 No. 599 “On control measures regarding drugs that contain small quantities of narcotic drugs, psychotropic substances and their precursors included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation”) (hereinafter referred to as Decree of the Government of the Russian Federation of July 20, 2011 No. 599);

— dispensing to individuals according to prescriptions written out on prescription forms form No. 148-1/u-88 (Order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n “On approval of the Procedure for dispensing to individuals medicinal products for medical use containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors and other pharmacological active substances”) (hereinafter referred to as Order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n).

Thus, the requirements for the circulation of codeine-containing drugs have not changed after the adoption of the resolution:

1) for narcotic drugs containing codeine (in an amount of more than 20 mg per 1 dose of solid dosage form and more than 200 mg per 100 ml/g of liquid dosage form for internal use), all control measures provided for by the legislation on narcotic drugs and psychotropic drugs remain substances in relation to codeine (including dispensing according to prescriptions written out on special prescription forms, form No. 107/u-NP, licensing of all types of circulation, establishing special storage requirements, etc.);

2) for medicinal products containing small amounts of codeine (up to 20 mg inclusive per 1 dose of solid dosage form and up to 200 mg inclusive per 100 ml/g liquid dosage form for internal use), in particular “Sedalgin”, “Pentalgin”, “ Terpinkod", "Codelac phyto", etc., the control measures provided for by Decree of the Government of the Russian Federation dated July 20, 2011 No. 599 and order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n remain (including dispensing on prescriptions issued on prescription forms, form No. 148-1/u-88).

In addition, the resolution introduced an amendment to the Rules for maintaining and storing special logs of transactions related to the trafficking of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of November 4, 2006 No. 644, in terms of simplifying the procedure for registering transactions related to the trafficking of narcotic drugs drugs and psychotropic substances, and granting the right to the manager legal entity establish the frequency of making entries in the register of transactions related to the circulation of narcotic drugs and psychotropic substances.

The introduced norm is aimed at improving the provision of medicines to citizens, including those containing narcotic drugs and psychotropic substances, in connection with significant expansion nomenclature of psychotropic drugs used in medical purposes, after the entry into force of the Decree of the Government of the Russian Federation of February 4, 2013 No. 78 “On amendments to certain acts of the Government of the Russian Federation.”

At the same time, in connection with incoming requests, we believe it is advisable to pay attention to compliance with the requirements for the dispensing of drugs containing small amounts of phenobarbital.

In accordance with the norms of the order of the Ministry of Health and Social Development of Russia dated March 16, 2010 No. 157n, medicinal products containing phenobarbital in amounts up to 50 mg inclusive per 1 dose of solid dosage form or up to 2 g inclusive per 100 ml/g liquid dosage form for internal use, in combination with other pharmacological active ingredients, are classified as drugs containing small amounts of psychotropic substances.

Thus, the specified medicinal products are subject to the dispensing requirements established by Order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n:

1) medicinal products containing phenobarbital in quantities exceeding 20 mg and up to 50 mg inclusive per 1 dose of solid dosage form (“Pagluferal 1”, “Pagluferal 2”, “Pagluferal 3”) are dispensed according to prescriptions written out on prescription forms No. 107-1/у;

2) medications containing phenobarbital in amounts up to 20 mg inclusive in combination with ergotamine hydrotartrate, regardless of the amount per 1 dose of the solid dosage form (“Bellataminal”), are dispensed according to prescriptions written out on prescription forms form No. 107-1/u;

3) medications containing phenobarbital in amounts up to 15 mg inclusive in combination with codeine (its salts), regardless of the amount per 1 dose of solid dosage form (“Pentalgin-N”, “Quintalgin”, “Piralgin”, “Sedal-M” , “Sedalgin-Neo”, “Tetralgin”, etc.), are dispensed according to prescriptions written out on prescription forms No. 148-1/u-88;

4) medications containing phenobarbital in amounts up to 20 mg inclusive in combination with ephedrine hydrochloride, regardless of the amount per 1 dose of the solid dosage form (“Neo-Teofedrin”, “Teofedrin-N”), are dispensed according to prescriptions written out on prescription forms No. 148-1/у-88;

5) medications containing phenobarbital in amounts up to 20 mg inclusive per 1 dose of solid dosage form (“Andipal”) or up to 2 g inclusive per 100 ml/g liquid dosage form for internal use (“Valocordin”, “Corvalol”, “ Valoserdin"), available without a prescription.

Document overview

In December 2013, changes were made to a number of acts of the Government of the Russian Federation on issues related to the circulation of narcotic drugs and psychotropic substances (Resolution No. 1159 of December 16, 2013).

It is clarified that the requirements for the circulation of codeine-containing drugs have not changed.

For narcotic medicinal products containing codeine (more than 20 mg per 1 dose of solid dosage form and more than 200 mg per 100 ml/g liquid form for internal use), all control measures provided for codeine remain (including dispensing prescriptions written out on special prescription forms, form N 107/u-NP, licensing of all types of turnover, establishment of special storage requirements).

For medications with a small amount of codeine (up to 20 mg inclusive per 1 dose of solid form and up to 200 mg inclusive per 100 ml/g liquid form for internal use) (in particular, “Sedalgin”, “Pentalgin”, “Terpinkod”, “ Codelac phyto") the following control measures remain. Provided for by Decree of the Government of the Russian Federation of July 20, 2011 N 599 (in relation to drugs that contain small amounts of narcotics, psychotropic substances and their precursors) and by Order of the Ministry of Health and Social Development of Russia of May 17, 2012 N 562n (including prescriptions , written out on prescription forms N 148-1/у-88).

Attention is drawn to the requirements for the dispensing of drugs containing small amounts of phenobarbital.

According to prescriptions written out on forms N 107-1/у, they are dispensed the following drugs. Containing phenobarbital in an amount from 20 mg to 50 mg inclusive per 1 dose of solid dosage form (“Pagluferal 1”, “Pagluferal 2”, “Pagluferal 3”). Containing phenobarbital in an amount of up to 20 mg inclusive in combination with ergotamine hydrotartrate, regardless of the amount per 1 dose of the solid dosage form (“Bellataminal”).

The following drugs are dispensed according to prescriptions written on forms N 148-1/u-88. Containing phenobarbital in amounts up to 15 mg inclusive in combination with codeine (its salts), regardless of the amount per 1 dose of solid dosage form (“Pentalgin-N”, “Quintalgin”, “Piralgin”, “Sedal-M”, “Sedalgin-Neo” ", "Tetralgin"). Containing phenobarbital in an amount up to 20 mg inclusive in combination with ephedrine hydrochloride, regardless of the amount per 1 dose of the solid dosage form (“Neo-Teofedrin”, “Teofedrin-N”).

Medicines containing phenobarbital in amounts up to 20 mg per 1 dose of solid dosage form (Andipal) or up to 2 g inclusive per 100 ml/g liquid dosage form for internal use (Valocordin, Corvalol, Valoserdin) ), available without a prescription.

Norms for dispensing codeine-containing drugs

Question:
Is it possible to dispense combination codeine-containing drugs prescribed on form No. 148-1/u-88 and additionally issued with the inscription “For special treatment” and certified by the doctor’s signature and seal and additionally stamped “For prescriptions” for a period of treatment of up to 1 month? What are the standards for dispensing codeine-containing drugs for “special treatment”?

In accordance with paragraph 5 of the “Procedure for the dispensing to individuals of medicinal products for medical use, containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances”, approved by Order of the Ministry of Health and Social Development of the Russian Federation of May 17, 2012 N 562n, combination medicinal products containing codeine or its salts (in terms of pure substance) in an amount of up to 20 mg (per 1 dose of a solid dosage form) or in an amount of up to 200 mg (per 100 ml or 100 g of a liquid dosage form for internal use) are subject to dispensing prescriptions written out on prescription forms form N 148-1/у-88.
The validity period of such a prescription is established by the doctor (10 days, 1 month) in accordance with paragraph 13 “Instructions for filling out form No. 148-1/u-88” prescription form", approved by Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110 (as amended on January 20, 2011). At the same time, according to paragraph 12 of the specified Instructions, only one name of the medicinal product is allowed to be prescribed on one prescription form.
According to paragraph 6 of the above “Procedure for dispensing ...”, if the quantity of a combination drug prescribed in a prescription exceeds its maximum permissible quantity for prescribing for one prescription, specified in Appendix No. 1 to the “Instructions on the procedure for prescribing drugs and processing prescriptions and requirements – invoices”, approved by Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110, a pharmaceutical worker at a pharmacy (pharmacy point) dispenses a combined drug in the quantity established by this Appendix. In accordance with paragraph 15 of the specified Appendix No. 1 for combination medicinal products containing codeine, the maximum permissible amount medicines for prescribing per prescription is 0.2 g in terms of pure substance.
In conclusion, we note that in accordance with paragraph 9 of the above “Instructions for filling out form No. 148-1/u-88 “prescription form””, any prescriptions of this form are signed by a doctor and certified by his personal seal, and also additionally certified by the seal of the medical organization “For prescriptions” . However, current legislation does not provide for additional inscriptions on prescriptions “for special treatment.”

The procedure for dispensing and recording codeine-containing drugs

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Question:
How have the rules for dispensing codeine-containing drugs from pharmacies changed at the moment? Dispensing rate per prescription, keeping a subject-quantitative journal? If a doctor prescribes “for a special purpose,” is it possible to dispense more than two packages in one prescription and how should the doctor fill out this prescription?

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Dispensing codeine-containing order

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RELEASE OF CODEINE-CONTAINING DRUGS FROM PHARMACIES FROM JUNE 1

According to the Decree of the Government of the Russian Federation dated July 20, 2011 No. 599 (as amended on December 22, 2011) “On control measures regarding drugs that contain small quantities of narcotic drugs, psychotropic substances and their precursors included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation" set a standard for prescription combination medicinal products intended for medical use containing small amounts of codeine or its salts, which comes into force on June 1, 2012.
From June 1, 2012, all combination drugs containing codeine or its salts in amounts up to 20 mg per 1 dose of solid dosage form or up to 200 mg per 100 ml/100 mg of liquid dosage form for internal use are subject to release from pharmacies and pharmacies prescription items.

I. For dispensing medications

Use the prescription form: No. 107-1/у “Prescription form” (validity of the prescription is 2 months or 1 year) and No. 148-1/у-88 “Prescription form” (validity of the prescription is 10 days or 1 month).
Norm for dispensing medications: according to the prescription form form No. 107-1/u “Prescription form” = no more than 3 medications without any corrections, and according to the prescription form form No. 148-1/u-88 “Prescription form” = only one drug without any correction.

The following combination medications containing:
a) codeine or its salts in an amount of up to 20 mg (per 1 dose of solid dosage form), or up to 200 mg (per 100 ml or 100 g of liquid dosage form);
b) ergotamine hydrotartrate in an amount of up to 5 mg (per 1 dose of solid dosage form);
c) dextromethorphan hydrobromide in an amount exceeding 10 mg and up to 30 mg (per 1 dose of solid dosage form).

Prescriptions for combination drugs written out on prescription forms form No. 107-1/u (except for prescriptions valid for up to 1 year in accordance with paragraph 1.17 of the Instructions) must be redeemed with a stamp pharmacy organization“The medicine has been released” and are returned to the patient’s arms.

To re-dispense these medications, inform the patient about the need to contact a doctor (paramedic) for a new prescription.

When dispensing combined medications according to prescriptions from a doctor (paramedic), written out on prescription forms of form No. 107-1/u, and valid for 1 year, the prescription is returned to the patient indicating on the back the name or number of the pharmacy organization, signature of the pharmacy employee, quantity dispensed drug and date of release.

The next time a patient contacts a pharmacy, notes on the previous receipt of the drug 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.

ATTENTION: In connection with the clarifications issued by the Ministry of Health, codeine-containing drugs are dispensed only using prescription form 148-1/u-88.

II. The following drugs should be dispensed strictly according to a prescription filled out in accordance with all the requirements of the orders of the Ministry of Health, including the VALIDITY DURATION OF THE PRESCRIPTION.

Ensure that these drugs are stored according to List B:

Glycodin syrup 100 ml
Grippex No. 10, No. 20, No. 100 tab.
Gripend No. 12, No. 24 tab., No. 6, No. 60 pack.
Caffetin No. 10, No. 12 table.
Caffetin cold No. 10 table.
Codelac No. 10 tablet.
Codelac syrup 100 ml
Codterpin No. 10 tab.
No-shpalgin TBL No. 12
Nurofen plus No. 12 tablet.
Pentalgin ICN No. 12 tab.
Pentalgin N No. 10 tablet.
Pentalgin plus No. 12 tablet.
Piralgin No. 10 tablet.
Sedal-M No. 10, No. 20 tab.
Sedalgin-Neo No. 10 tab.
Solpadeine No. 12 caps.
Solpadeine No. 12 tablet. plastic packaging
Solpadeine No. 12 tablet. soluble
Solpadeine No. 8 tablet.
Terpin code No. 10 table.
Tetralgin No. 10 tablet.
Toff plus No. 10 caps.
Tussin Plus syrup 118 ml
Unispaz No. 12 tab.

Subject: Medicine provision Source: Journal of Quality Management in Healthcare
Author: E.R. Zakharochkina, Ph.D. pharm. Sciences, Associate Professor Department of Management and Economics of Pharmacy, Faculty of Pharmacy, State Budgetary Educational Institution of Higher Professional Education "First Moscow State medical university them. THEM. Sechenov" of the Ministry of Health of Russia

The procedure for applying control measures in relation to these drugs is established by Decree of the Government of the Russian Federation dated July 20, 2011 No. 599 “On control measures in relation to drugs that contain small quantities of narcotic drugs, psychotropic substances and their precursors, included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation” and determines the following.

1. For single-component drugs with low contents of narcotic drugs, psychotropic substances and their precursors, the control measures provided for by the legislation of Russia regarding narcotic drugs, psychotropic substances and their precursors contained in the corresponding drugs are applied (i.e. for single-component drugs, control measures do not depend on the amount of substance).

2. For combined preparations with a low content of narcotic drugs, psychotropic substances and their precursors (i.e. containing other pharmacological active substances in addition to narcotic drugs, psychotropic substances or their precursors), the following measures control:

· prohibition of sending in postal items, including international ones, as well as sending under the guise of humanitarian aid, except in cases when emergency situations these drugs are sent to specific constituent entities of the Russian Federation in accordance with decisions of the Government of the Russian Federation;

· dispensing to individuals of the specified drugs intended for medical use in the manner established by the Ministry of Health of Russia in agreement with the Federal Service for Drug Control; in this case, drugs containing low codeine or its salts are dispensed to individuals according to a doctor’s (paramedic’s) prescription.

Order of the Ministry of Health and Social Development of Russia dated March 16, 2010 No. 157n “On approval of the maximum permissible amount of narcotic drugs, psychotropic substances and their precursors contained in drugs” established that combination drugs with a small amount of codeine are medicines with the maximum permissible amount of codeine and its salts in terms of pure substance:

· 20 mg per dose of solid dosage form;

· 200 mg per 100 ml liquid dosage form for internal use.

Order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n “On approval of the procedure for dispensing to individuals medicinal products for medical use containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances” establishes that dispensing according to prescriptions written out on prescription forms form No. 148-1/u-88, are subject to combination medicinal products containing, in particular:

· codeine or its salts (in terms of pure substance) in an amount up to 20 mg inclusive (per 1 dose of solid dosage form) or in an amount up to 200 mg inclusive (per 100 ml or 100 g of liquid dosage form for internal use);

· phenobarbital in an amount up to 15 mg inclusive in combination with codeine (or its salts) regardless of the amount (per 1 dose of solid dosage form).

As a result of the analysis of the State Register of Medicines, it was revealed that more than 20 positions of combination drugs with a low content of codeine as Russian are currently registered (Pentalgin ICN, Pentalgin-N, Pentalgin plus, Codelac, Codelac phyto, Terpinkod, Terpinkod N, Pentabufen, Tetralgin ), and foreign (Piralgin, Santoperalgin, Santotitralgin, Sedal-M, Sedalgin-Neo, No-shpalgin, Kaffetin, Unispaz, Codelmixt, Nurofen plus, Solpadein) production.

According to the pharmacotherapeutic classification for combination drugs with low codeine content, the following groups can be distinguished:

· analgesics combined with phenobarbital (Pentalgin ICN, Pentalgin-N, Pentalgin plus, Pentabufen, Tetralgin, Piralgin, Santoperalgin, Santotitralgin, Sedal-M, Sedalgin-Neo);

· combined analgesics (No-shpalgin, Caffetin, Unispaz, Codelmixt, Nurofen plus, Solpadeine);

· combined antitussives (Codelac, Codelac phyto, Terpinkod, Terpinkod N).

Phenobarbital is an antiepileptic drug that has sedative, hypnotic, antispasmodic and muscle relaxant effects.

The most common analgesics combined with a small amount of codeine contain:

· Caffeine – stimulates the psychomotor centers of the brain, has an analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, increases physical and mental performance, improves the well-being of patients, reduces headache vascular origin (including migraine);

Paracetamol is a non-narcotic analgesic that blocks cyclooxygenase mainly in the central nervous system, affecting the centers of pain and thermoregulation, has an analgesic and antipyretic effect;

Metamizole sodium is a non-steroidal anti-inflammatory drug that has analgesic, antispasmodic effect on the smooth muscles of the urinary and biliary tract.

Analgesics combined with a small amount of codeine may also contain:

· Naproxen is a non-steroidal anti-inflammatory drug that has analgesic, antipyretic and anti-inflammatory effects associated with non-selective suppression of the activity of cyclooxygenase 1 and cyclooxygenase 2, which regulate the synthesis of prostaglandins (Pentalgin-N, Piralgin);

· Propyphenazone – has an analgesic and antipyretic effect (Pentalgin plus, Caffetin);

· Ibuprofen is a non-steroidal anti-inflammatory drug that has analgesic, antipyretic and anti-inflammatory effects due to the non-selective blockade of cyclooxygenase 1 and cyclooxygenase 2; the mechanism of action is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction; has an inhibitory effect on platelet aggregation (Pentabufen, Nurofen plus);

· Drotaverine – myotropic antispasmodic, isoquinoline derivative; inhibits phosphodiesterase (PDE) IV, which leads to the accumulation of intracellular cyclic adenosine monophosphate (cAMP) and, as a result, inactivation of the light chain of myosin kinase, resulting in relaxation of smooth muscles (No-shpalgin, Unispaz).

The main indications for use for combination analgesics with low codeine content are pain syndromes of various origins of weak and medium intensity, including: pain in joints, muscles, radiculitis, menstrual pain, neuralgia, neuritis, headache and toothache, migraine, pain from injuries, burns, pain after surgical interventions, colds accompanied by febrile syndrome (including ARVI).

The main indication for the use of combined antitussives with low codeine content is symptomatic treatment dry cough of any etiology in bronchopulmonary diseases (including bronchopneumonia, bronchitis, emphysema).

The composition of combined codeine-containing antitussives also includes the following pharmacological active ingredients:

· Thermopsis herb – contains isoquinoline alkaloids, stimulants respiratory center and stimulating the vomiting center; has a pronounced expectorant effect, manifested in increased secretory function bronchial glands, increasing the activity of the ciliated epithelium and accelerating the evacuation of secretions, increasing the tone of bronchial smooth muscles due to the central vagotropic effect;

· Licorice root – has an expectorant effect due to the content of glycyrrhizin, which stimulates the activity of the ciliated epithelium in the trachea and bronchi, and also enhances secretory function mucous membranes of the upper respiratory tract; has an antispasmodic effect on smooth muscles, because it contains flavone compounds;

· Thyme herb – contains a mixture essential oils, which have expectorant, anti-inflammatory and bactericidal effects due to increased activity of the ciliated epithelium of the mucous membranes - upper sections respiratory tract, increasing the amount of secretion of the bronchial mucosa, diluting sputum, accelerating its evacuation and loosening inflammatory plaques; has weak antispasmodic and reparative effects;

· Sodium bicarbonate – changes the pH of bronchial mucus to the alkaline side, reduces the viscosity of sputum, and to a certain extent also stimulates motor function ciliated epithelium and bronchioles;

· Terpinhydrate – enhances the secretion of bronchial glands, has an expectorant effect.

In connection with the adoption by the Government of the Russian Federation of the above-mentioned Resolution No. 1159, attention should also be paid to the letter of the Ministry of Health of Russia dated January 13, 2014 No. 25-4/10/2-79. This letter, in particular, clarifies the rules regarding the dispensing of codeine-containing drugs:

· for narcotic drugs containing codeine (in an amount of more than 20 mg per 1 dose of solid dosage form and more than 200 mg per 100 ml/g of liquid dosage form for internal use), all control measures provided for by the legislation on narcotic drugs and psychotropic substances remain in relation to codeine (including dispensing according to prescriptions written out on special prescription forms of form No. 107/u-NP, licensing of all types of circulation, establishing special storage requirements, etc.);

· for medications containing small amounts of codeine (up to 20 mg inclusive per 1 dose of solid dosage form and up to 200 mg inclusive per 100 ml/g liquid dosage form for internal use), in particular Sedalgin, Pentalgin, Terpinkod, Codelac phyto, etc. . the control measures provided for by Decree of the Government of the Russian Federation dated July 20, 2011 No. 599 and Order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n remain (including dispensing on prescriptions written out on prescription forms No. 148-1/u-88);

· medications containing phenobarbital in amounts up to 15 mg inclusive in combination with codeine (its salts), regardless of the amount per 1 dose of solid dosage form (Pentalgin-N, Quintalgin, Piralgin, Sedal-M, Sedalgin-Neo, Tetralgin, etc. ), are dispensed according to prescriptions written out on prescription forms, form No. 148-1/u-88.<…>

Procedure for prescribing medications

The standards for the dispensing of medicines are approved by order of the Ministry of Health of the Russian Federation No. 1175. The standards 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 medications may be increased in the 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 medical care may be increased by no more than 2 times compared to the maximum permissible number of drugs for prescribing per prescription, or the recommended number of drugs for prescribing 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 worker makes a note “For a patient with a chronic disease”, indicates the validity period of the prescription and the frequency of dispensing medications from a pharmacy organization or an individual entrepreneur licensed to 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 mixtures 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 treatment for 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 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 .

- 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 color with watermarks. The prescription form must be filled out legibly, clearly, in ink or ballpoint pen. Corrections when filling out the prescription form are not allowed. The prescription form is affixed with a stamp from 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 patient's compulsory medical insurance policy number. In the line "Number medical card outpatient (history of child development)" indicates the number of the outpatient medical card (history of child 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) medicinal product (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) medicinal product 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 head (deputy head or head of a 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, it is established basic requirements to their equipment with engineering and technical security equipment, as well as to 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 a non-departmental police unit security at 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 medicinal product storage pharmaceutical substances 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 drugs 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 seals and sealing devices used for sealing (sealing). 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 the 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 with a doctor’s 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 the medical department. 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 DP, as well as activities related to the circulation of NS and DP 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 filing requirements-invoices for receiving this drug departments of a medical organization?

- 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 in accordance with the RF Regulation No. 681. From the staff of health care facilities, the right to receive NS and PV is assigned to an official (approved to work with NS and PV), authorized to do so by order of the head of the health care facility (chief physician, head of department, deputy head of department, senior 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 trafficking 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, a decision of the executive authority of a constituent entity of the Russian Federation determines 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 registration logs 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 recorded by the Federal Service for Surveillance in Healthcare and social development V state register 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 the last number in the completed log books. 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 of 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 pharmacy institutions”, 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 authority Federal service of the Russian Federation for drug control during 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 DP 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 PI, the dispensing and sale of NS and PI, 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

Question:
According to order No. 1175n dated December 20, 2012, the dispensing rate for phenobarbital is 30 tablets, and if the prescription states “special purpose,” how many can we dispense? And if there are 12 tablets in a package, what quantity do we have the right to dispense then, if there is 1 tablet in the package?

Answer:

Attention, you are using open access to outdated consultations. Current consultations for the last 5 years are available only to registered clients who have paid for access to the site.

The drug phenobarbital is a derivative of barbituric acid and is included in List III of psychotropic substances approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681 “List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation” (as amended on 07.11. 2013).
In accordance with paragraph 15 of the Order of the Ministry of Health of the Russian Federation of December 20, 2012 N 1175n “Procedure for prescribing and prescribing drugs” approved, the number of prescribed psychotropic drugs of List III of the List when providing palliative care to patients can be increased by no more than 2 times compared to with the recommended number of medications for prescribing per prescription, established by Appendix No. 2 to the specified Procedure.
Moreover, according to paragraph 23 of the Procedure, prescriptions for barbituric acid derivatives for the treatment of patients with chronic diseases can be issued 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”.
According to Appendix No. 2 to the above “Procedure for prescribing and prescribing medications,” the recommended amount of phenobarbital for prescribing per prescription is 30 tablets.
Therefore, when providing palliative care A doctor can prescribe up to 60 tablets of phenobarbital to a patient in one prescription without any special notes on it.
In addition, for the treatment of patients with chronic diseases, the doctor can prescribe in one prescription the number of phenobarbital tablets required for a course of treatment for 2 months. In this case, the prescription must bear the inscription “For special purposes”, sealed with the additional signature of a medical worker and the seal of the medical organization “For prescriptions”.
In both of the above cases, it is not the responsibility of the pharmacist to check the quantity of the prescribed drug. Responsibility for the correct prescription of the drug lies with the doctor who wrote the prescription, as well as with the medical organization.

26.12.13