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 named after. 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 Russian Federation" and defines the following.
1. For single-component preparations 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 preparations are applied (i.e. for single-component medicines control measures are independent of the quantity of the substance).
2. For combined preparations with a low content of narcotic drugs, psychotropic substances and their precursors (i.e. containing, in addition to narcotic drugs, psychotropic substances or their precursors, other pharmacological active substances), the following control measures are applied:
· prohibition of sending in postal items, including international ones, as well as sending under the guise of humanitarian aid, with the exception of cases when, in 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;
· vacation individuals specified drugs intended for medical use, in the manner established by the Ministry of Health of Russia in agreement with Federal service drug control; in this case, drugs with low codeine content 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 containing small amounts of codeine are medicines with extremely permissible quantity 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 medicines It has been revealed that more than 20 positions of combination drugs with low codeine content are currently registered, both Russian (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, Caffetin, Unispaz, Codelmixt, Nurofen plus, Solpadein) produced.
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 an analgesic and 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 combined 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 acute respiratory viral infections).
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 that excite the respiratory center and stimulate the vomiting center; has a pronounced expectorant effect, manifested in increased secretory function of the bronchial glands, increased activity of the ciliated epithelium and accelerated evacuation of secretions, increased 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 an expectorant, anti-inflammatory and bactericidal effect due to increased activity of the ciliated epithelium of the mucous membranes - the upper parts of the 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. IN this letter, in particular, the rules regarding the dispensing of codeine-containing drugs are clarified:
· 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 with prescriptions written out on prescription forms Form 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
Question:
How did they change to this moment rules for dispensing codeine-containing drugs from a pharmacy? Dispensing rate per prescription, keeping a subject-quantitative journal? If the doctor prescribes “according to special purpose» is it possible to dispense more than two packages in one prescription and how should the doctor fill out this prescription?
Answer:
So-called codeine-containing drugs are not narcotic or psychotropic drugs, but are considered combination drugs containing, in addition to a small amount of narcotic drugs, other pharmacological active substances. Section III, approved by Order of the Ministry of Health of the Russian Federation dated April 22, 2014 N 183n, of the “List of Medicines for Medical Use Subject to Substantive and Quantitative Accounting” includes combination medicines containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances listed in 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, including 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). Thus, codeine-containing drugs are subject to subject-quantitative accounting. According to subparagraph 4 of paragraph 9 approved by Order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n “The procedure for prescribing and prescribing drugs” (as amended on June 30, 2015), the drugs specified in paragraph 5 of the “Procedure for the dispensing of drugs for medical use to individuals, 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, are prescribed on a prescription form, form N 148-1/u-88. According to paragraph 5 “a” and 5 “z2” approved by Order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 N 562n “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” (in as of August 21, 2014) combination medicinal preparations containing codeine or its salts (in terms of pure substance) in an amount of up to 20 mg (per 1 dose of solid dosage form) or in an amount of up to 200 mg (per 100 ml or 100 g of liquid dosage form for internal use), as well as phenobarbital in amounts up to 15 mg inclusive in combination with codeine (or its salts), regardless of the amount (per 1 dose of solid dosage form) are subject to prescriptions written out on prescription forms of form N 148-1 /у-88. According to clause 2.5 of the “Procedure for Dispensing Medicines” approved by Order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 (as amended on April 22, 2014), medicines are dispensed by pharmacies (organizations) in the quantities specified in the prescription, with the exception of medicines, dispensing norms which are specified in clause 1.11. to the approved Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110 “Instructions on the procedure for prescribing medications and issuing prescriptions and invoice requirements” and Appendix No. 1 to it. However, in accordance with Order of the Ministry of Health of the Russian Federation dated February 26, 2013 N 94n, paragraph 1.11 of this Instruction does not apply from July 1, 2013 to legal relations related to the prescription and prescription of medicines and medical devices. Consequently, at present one should be guided by the norm of paragraph 15 of the above “Procedure for Prescribing and Prescribing Medicines”, according to which the number of prescribed medicines subject to specific...
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 medications written on prescription forms form No. 107-1/u (with the exception of prescriptions valid for up to 1 year in accordance with paragraph 1.17 of the Instructions) must be redeemed with the stamp of the pharmacy organization “Medicine dispensed” and returned to the patient’s hands.
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 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 issued 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 box
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.
Samvel Grigoryan talks about the new document regulating the procedure for dispensing medicines and coming into force on September 22
IP and IBLP
In general, in order No. 403n the topic of IBP release is spelled out separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when dispensing an IBP, it is indicated on the prescription or prescription counterfoil, which remains with the buyer exact time of this very vacation, in hours and minutes.
Violation of secondary
With the entry into force of Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.
Order No. 403n, which replaced it, is in this regard more specific and more consistent modern requirements, medical practice and consumer requests. Paragraph 8 of the order determines that violation of secondary packaging and dispensing of a medicinal product in primary packaging is permitted in cases where the amount of the drug indicated in the prescription or required by the consumer (for over-the-counter dispensing) is less than the amount of the drug contained in the secondary packaging.
In this case, the buyer must be provided with instructions for use or a copy thereof, and tampering with the original packaging is prohibited. By the way, the new order does not contain the rule that in case of violation of the secondary order, the drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory batch, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.
"The medicine has been released"
Clause 4 of Order No. 403n of the Ministry of Health of the Russian Federation regulates the topic of prescription forms and the list of drugs dispensed on them. In particular, narcotic and psychotropic drugs of List II are dispensed using Form No. 107/u-NP, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.
The remaining prescription drugs, as is known, are dispensed using forms No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases it is allowed to set the validity period of the prescription form No. 107-1/у within up to one year and exceed the recommended amount of the drug for prescribing per prescription, installed by application No. 2 of this order.
Such a prescription, which also indicates the periods and quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. He also determines that the next time the patient comes to the pharmacy with the same prescription, the chief must take into account the notes on the previous dispensing of the drug.
The prescription remains at the pharmacy
There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order establishes that the retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:
within 5 years prescriptions for:
within 3 years prescriptions for:
within 3 months recipes for:
Order No. 403n of the Russian Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not specified in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.
The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is also reflected in the new order on the rules of dispensing. According to the current procedure, prescriptions for such drugs are returned to the patient (with a “dispensed” stamp); under the new order, they must remain in the pharmacy organization.
To avoid getting caught
The procedure for working with incorrectly written prescriptions is now described in a little more detail (clause 15 of order No. 403n). In particular, when they are registered by a pharmacist in the journal, it is necessary to indicate the identified violations in the execution of the prescription, the full name of the health worker who wrote it, the name medical organization, in which he works, the measures taken.
Paragraph 17 of Order No. 403n contains the rule that a pharmacist does not have the right to provide false or incomplete information about the availability of drugs in the pharmacy product range - including drugs that have the same INN - and also to hide information about the availability of drugs that have more low price. Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (Order of the Ministry of Health of the Russian Federation dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on vacation rules.
This was a review of the order, so to speak, “on fresh trail.” Readers will probably find in it other points and norms that deserve special attention. Write to the editors of Katren-Style magazine about them, and we will address your questions to leading industry experts. We'll also ask them about the issue of "disposable" prescriptions with a two-month validity period, which was mentioned above, as well as the issue of dispensing ethyl alcohol and alcohol-containing preparations in the light of the provisions of the new order No. 403n.
Materials about the order of the Ministry of Health No. 403n:
What could be more important for a pharmacy organization than the order in which medications are dispensed. Pharmacists barely had time to return from their summer vacation and look around when a new order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n was published with appendices “On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations, individual entrepreneurs with license for pharmaceutical activities" Order No. 403n on the vacation procedure was registered with the Ministry of Justice of the Russian Federation on September 8; its validity begins on September 22 of the current year.
The first thing I want to say in this regard is that now forget the number “785”. New order 403n with amendments and additions recognizes that the well-known order of the Ministry of Health and Social Development of December 14, 2005 No. 785 “On the procedure for dispensing medicines”, as well as the orders of the Ministry of Health and Social Development No. 302, No. 109 and No. 521 that amended it, have become invalid. At the same time, many points of the new normative -legal act repeat - sometimes almost verbatim - the corresponding fragments of the predecessor order. But there are also differences, new provisions, on which we will focus more, setting out the first observations and notes in the margins of the freshly issued order of the Ministry of Health No. 403n.
IP and IBLP
Order of the Ministry of Health of the Russian Federation No. 403n consists of three appendices. The first approves new rules for the dispensing of medicinal products, including immunobiological medicinal products (IBP); the second is the requirements for the dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting (SQR). The third appendix establishes the rules for the dispensing of medicines according to the invoice requirements of medical organizations, as well as individual entrepreneurs(IP) with a license for medical activities.
Under the new order, the dispensing of over-the-counter drugs will be allowed both to pharmacies and pharmacy points, as well as individual entrepreneurs and pharmacy kiosks. For the rest, if we summarize points 2 and 3 of order No. 403n and the list of drugs, the following picture emerges.
- The dispensing of narcotic and psychotropic drugs can only be carried out by pharmacies and pharmacy points that have the appropriate license.
- The remaining prescription drugs are dispensed by pharmacies, pharmacy points and individual entrepreneurs (of course, those with a license for pharmaceutical activities - this clarification will be further considered accepted by default and omitted).
- The dispensing of immunobiological prescription drugs is carried out by pharmacies and pharmacy points. Individual entrepreneurs are not mentioned in this provision of paragraph 3, which means that they cannot dispense drugs of this group, which we advise you to pay special attention to.
In general, in order No. 403n the procedure for dispensing IBP drugs is prescribed separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.
IBLP can be released if two conditions are met. Firstly, if the buyer has a special thermal container in which the required mode of transportation and storage of these thermolabile drugs can be observed. The second condition is an explanation (from the pharmacist to the buyer) of the need to deliver this drug to a medical organization, despite the fact that it can be stored in the mentioned container for no more than 48 hours.
Let us recall in this regard that this topic is also regulated by subclause 8.11.5 of the Sanitary and Epidemiological Rules “Conditions of transportation and storage immunobiological preparations"(SP 3.3.2.3332–16), which are approved by the Resolution of the Chief State Sanitary Doctor of the Russian Federation dated February 17, 2016 No. 19. It obliges the pharmacy employee to instruct the buyer on the need to comply with the “cold chain” when transporting IBPs.
The fact of this instruction is recorded with a mark on the drug packaging, prescription or other accompanying document. The mark is certified by the signature of the buyer and the chief clerk (or another representative of the pharmacy organization) and also includes the date and time of dispensing. However, SanPiN does not specify that the time in in this case must be entered in hours and minutes.
Violation of secondary
With the amendments and additions to Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.
The order No. 403n that replaced it with a list of drugs in this regard is more specific and more in line with modern requirements, medical practice and consumer demands. Paragraph 8 of the order determines that violation of secondary packaging and dispensing of a medicinal product in primary packaging is permitted in cases where the amount of the drug indicated in the prescription or required by the consumer (for over-the-counter dispensing) is less than the amount of the drug contained in the secondary packaging.
In this case, the buyer must be provided with instructions for use or a copy thereof, and tampering with the original packaging is prohibited. By the way, in the new order of the Ministry of Health of the Russian Federation No. 403n there is no provision that in case of violation of the secondary drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory series, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.
What does this mean in practice? Let's assume two situations: first - drug X tablets (or dragees) No. 56, primary packaging - blister; the second is drug N tablets No. 56, in a bottle. And in both cases, the question arises about its release to the patient who has presented the chief of staff with a prescription on which, say, 28 tablets or 42 tablets (dragées) are prescribed.
It is clear that in the first case this is acceptable, since it is possible to dispense 28 or 42 tablets without breaking the primary packaging (blister), and in the second case it is unacceptable, since the primary packaging in this situation is a bottle, and breaking it is strictly prohibited. So count out tablets or dragees from the bottle, as they do in some pharmacies foreign countries, our leaders have no rights.
"The medicine has been released"
Clause 4 of Order No. 403n of the Ministry of Health of the Russian Federation regulates the topic of prescription forms and the list of drugs dispensed on them. In particular, narcotic and psychotropic drugs of Schedule II are dispensed using Form No. 107/u-NP, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.
According to form No. 148–1/у-88 the following are issued:
- Schedule III psychotropic drugs;
- narcotic and psychotropic drugs of Schedule II in the form of transdermal therapeutic systems;
- drugs included in the list of drugs subject to PCU, with the exception of those drugs that are dispensed in form No. 107/u-NP;
- drugs with anabolic activity and classified according to the anatomical-therapeutic-chemical classification (ATC) recommended by the World Health Organization as anabolic steroids(code A14A);
- drugs specified in paragraph 5 of the “Procedure for the dispensing to individuals of drugs containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances” (order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 No. 562n);
- preparations manufactured according to a prescription for a medicinal product and containing a narcotic drug or psychotropic substance included in Schedule II and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that the combination drug is not a Schedule II narcotic or psychotropic drug.
The list of other prescription drugs, as is known, is dispensed on form No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1/u within up to one year and exceed the recommended amount of the drug for prescribing per prescription, established by Appendix No. 2 of this order.
Such a prescription, which also indicates the periods and quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. It also determines that the next time the patient comes to the pharmacy with the same prescription for a list of drugs, the chief must take into account the notes on the previous dispensing of the drug.
When the maximum quantity specified in the prescription is purchased, it must be stamped “Dispensed.” And a one-time release of the entire quantity, according to the same paragraph, is allowed only in agreement with the doctor who wrote this prescription.
The prescription remains at the pharmacy
There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order No. 403n of the Ministry of Health establishes that the retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:
within 5 years prescriptions for:
- narcotic and psychotropic drugs of Schedule II, psychotropic drugs of List III (according to the outgoing 785th order, they are stored for 10 years);
within 3 years prescriptions for:
- drugs dispensed free of charge or at a discount (according to forms No. 148–1/u-04 (l) or No. 148–1/u-06 (l));
- combination medicinal products containing narcotic drugs or psychotropic substances included in Lists II and III, manufactured in a pharmacy, drugs with anabolic activity, drugs subject to PCU;
within 3 months recipes for:
- drugs in liquid dosage form, containing more than 15% ethyl alcohol from the volume of finished products, other drugs classified according to ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives(code N05C), antidepressants (code N06A) and not subject to PCU.
Note that Order 785 does not contain this group of recipes for three-month storage.
Order No. 403n of the Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not listed in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.
The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is also reflected in the new order on the procedure for dispensing drugs. According to the current procedure, prescriptions for such drugs are returned to the patient (with a “dispensed” stamp); under the new order, they must remain in the pharmacy organization.
To avoid getting caught
The procedure for dispensing incorrectly written prescriptions is now described in a little more detail (clause 15 of order No. 403n). In particular, when they are registered by a pharmacist in a journal, it is necessary to indicate the identified violations in the execution of the prescription, the full name of the health worker who wrote it, the name of the medical organization in which he works, and the measures taken.
According to this paragraph, when medicinal holiday the pharmacist informs the buyer not only about the regimen and doses, but also about the rules for storing at home and interactions with other medications.
In theory this means the following. The pharmaceutical inspector can approach the first table in the guise of an ordinary buyer - so to speak, make a test purchase. And if the chief captain, dispensing the medicine, does not inform him, for example, that this medicine must be stored at a temperature not exceeding 25 °C, or will not ask if he is taking in given time other medications, then the inspector can “drop the mask” and draw up an administrative violation report. So the norm in paragraph 16 is serious and fraught. And, of course, it requires that the chief captain be thoroughly versed in the complex and voluminous topic of drug interactions.
Paragraph 17 of Order No. 403n, as amended, contains the rule that a pharmacist does not have the right to provide false or incomplete information about the availability of drugs in the pharmacy product range - including drugs that have the same INN - and also to hide information about the availability of drugs that have a lower price . Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law dated November 21, 2011 No. 323 Federal Law “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (Order of the Ministry of Health of the Russian Federation dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on the vacation procedure.
These were explanations of order No. 403n, so to speak, “on a fresh trail.” Readers will probably find in it other points and norms that deserve special attention. Write to the editors of Katren-Style magazine about them, and we will address your questions to leading industry experts. We will also ask them about the problem of “disposable” prescriptions with a two-month validity period, which was mentioned above, as well as the dispensing of ethyl alcohol and alcohol-containing drugs in light of the provisions of the new Order No. 403 of the Ministry of Health.
On October 5, a webinar by Larisa Garbuzova, Ph.D. will be held on our website. Sc., Associate Professor, Department of Management and Economics of Pharmacy, Northwestern State University medical university(St. Petersburg), dedicated, and on October 25, executive director of the National Pharmaceutical Chamber Elena Nevolina on the same topic. Register for both webinars.
Materials on the order of the Ministry of Health No. 403n.
