Minimum assortment in a pharmacy list for 2018 - how has it changed, and for which organizations is it mandatory? What drugs are included in the list? How does the list compare? minimum assortment and Vital and Essential Drugs
Minimum assortment in a pharmacy list for 2018 - how has it changed, and for which organizations is it mandatory?
What drugs are included in the list? How does the list of minimum assortment compare with vital and essential drugs?
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Important in the material
Minimum assortment: what changed in 2018
The 2018 list of minimum assortment in a pharmacy is an official list of medications that are necessary in order to provide medical care.
List of medications in the pharmacy range
The minimum pharmacy assortment for 2018 has changed.
The main changes are as follows:
- Min assortment in the pharmacy 2018 is supplemented with fluconazole capsules and amlodipine tablets;
- for a drug with the international nonproprietary name oseltamivir, the dosage form in the form of a suspension for internal use. The remaining form of the drug is in the form of capsules;
- The conditions for the availability of atorvastatin tablets in the pharmacy assortment have been changed. Pharmacies can purchase both conventional and film-coated tablets.
So, current list VED is valid in accordance with the order of the Government of the Russian Federation No. 2724-r dated December 26, 2015.
The appendix to the document contains a list of 646 drugs. How do these two lists relate - VED and minimum assortment? medicines 2018 for pharmacies?
The law does not say that vital drugs must be present in the pharmacy assortment, which seems illogical. This situation is dangerous due to the artificial removal from the pharmacy range of those drugs that for some reason are “inconvenient” for its owners.
For example, many pharmacies try to avoid purchasing drugs that have additional storage costs and accounting requirements.
Also “inconvenient” are drugs from a low price category, since investments in their sale may be much higher than their real cost.
Presence of Vital and Essential Drugs in the minimum pharmacy assortment in 2019
The law does not stipulate the mandatory presence of vital and essential drugs in the minimum list medicines. Only some items on the list are included in the mandatory assortment list. Which ones will be determined by a separate regulatory legal act.
The national oncology program will begin operating in 2019. In this regard, the list of vital and essential drugs will necessarily include antitumor drugs.
On this moment The minimum range of drugs for 2019 includes 90 such drugs, of which 42 are targeted. The Ministry of Health commission on the formation of lists of drugs recommended that 11 new INN anticancer drugs be included in the List of Vital and Essential Drugs in 2019.
Drugs (onco) in the List of ONLS
In February 2016, the district prosecutor's office conducted an inspection at a pharmacy owned by an individual entrepreneur. During the inspection, it was revealed that there was no Loratadine syrup, which is included in the minimum range of drugs for the provision of medical care. However, the drug arrived at the pharmacy during the day, meaning it was only out of stock for a few hours.
Explain whether this violation is legally classified as gross violation licensing requirements.
M.R. Zaripova,
magazine expert
"Pharmacy: accounting and taxation"
In addition, the court indicated that administrative offense cannot be considered insignificant, since the offense, liability for which is provided for in the above-mentioned article, is formal, which is expressed in the failure to provide consumers with a minimum range of medicines. The absence of consequences and the further elimination of the violation are not in themselves grounds for the application of insignificance.
The arguments of the complaint that the drug was ordered on time and was only out of stock for a few hours cannot lead to the reversal of court decisions. Similar conclusions of the courts are set out in the decisions of the AS DO
1 ELECTRONIC SCIENTIFIC JOURNAL “APRIORI. SERIES: HUMANITIES" UDC 339 ANALYSIS OF THE MANDATORY MINIMUM RANGE OF PHARMACY ORGANIZATIONS FROM THE POSITION OF IMPORT SUBSTITUTION ON THE RUSSIAN PHARMACEUTICAL MARKET Samoshchenkova Irina Fedorovna senior teacher Buvina Irina Vasilievna student Orlovsky State University them. I.S. Turgeneva, Orel Garankina Rimma Yurievna Candidate of Pharmaceutical Sciences First Moscow State medical University them. THEM. Sechenov, Moscow Abstract. A complex of theoretical and practical issues related to import substitution is considered, as well as the relationship between the list of vital and essential drugs and the minimum range of drugs. When writing the article, we took into account statistical indicators of the availability of local and imported drugs, as well as indicators taken into account when compiling a minimum list of drugs. This work examined the changes that came into force on March 1, 2016 on the basis of Order of the Government of the Russian Federation dated December 26, 2015 No. 2724-r. Keywords: pharmaceutical market, import substitution of drugs, minimum range, list of vital and essential drugs, ABC analysis, pharmacy segment, pharmacy organizations. 1
2 THE ANALYSIS OF THE COMPULSORY MINIMUM RANGE OF THE PHARMACEUTICAL ORGANIZATIONS FROM AN IMPORT SUBSTITUTION POSITION ON THE RUSSIAN PHARMACEUTICAL MARKET Samoshchenkova Irina Fedorovna senior lecturer Buvina Irina Vasil`evna student I.S. Turgenev Oryol state university, Oryol Garankina Rimma Yur evna candidate of pharmacy I.M. Sechenov First MGMU, Moscow Abstract. In the article the complex of theoretical and practical issues connected with import substitution, as well as interrelations of the list of vital and essential medicines and the minimum range of medicines are examined. Statistical indicators of availability of local and import medicines, and also the indicators taken into account by drawing up the minimum list of medicines are considered. In this work the changes that have come into force on 1 March 2016 by the order of the Government of the Russian Federation dated 26 December are taken into account. Key words: pharmaceutical market, import substitution of medicines, the minimum range, the list of vital and essential medicines, ABC-analysis, pharmaceutical segment, pharmaceutical organizations. 2
3 The assortment of a pharmacy organization is a list of goods located in the pharmacy and intended for sale. In accordance with paragraph 6 of Art. 55 of the Federal Law of the Year 61-FZ “On the Circulation of Medicines”, pharmacy organizations and individual entrepreneurs licensed to pharmaceutical activities, are obliged to provide the minimum range of medicines necessary for the provision of medical care, approved by the Government of the Russian Federation and formed in the manner established by it. The minimum list is being developed in order to ensure that patients have access to the most popular and necessary medications for the provision of medical care, the availability of which is mandatory in pharmacies. On March 1, 2016, Order No. 2724-r of the Government of the Russian Federation came into force on December 26, 2015, which approved: a list of vital and essential drugs for medical use for 2016, as well as the minimum range of drugs necessary for the provision of medical care and a list of drugs intended to provide persons with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms lymphoid, hematopoietic and related tissues, multiple sclerosis, persons after organ and (or) tissue transplantation. As before, the new list of the Minimum Range of Medicines Necessary for the Provision of Medical Care is divided into two sections: Section I for pharmacies (ready-made dosage forms, production, manufacturing with the right to manufacture aseptic medicinal products); 3
4 section II for pharmacy points, pharmacy kiosks and individual entrepreneurs having a license for pharmaceutical activities. At the same time, the minimum range does not include: medications that are on the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation; included in the list of medicinal products subject to subject-quantitative accounting; included in the lists of potent and toxic substances; medicines in dosage forms for injection, infusion administration, implantation, except solvents; medicines, the use of which is intended to provide specialized medical care. The new minimum range additionally includes two drugs (they have Russian manufacturers), number of international generic names medicines increased from 68 to 70 items. The formation of a mandatory list is largely determined by legal restrictions and requirements, established laws and other regulatory legal acts regulating the circulation of medicines and other goods medical purposes. When forming a minimum range of medicines, the following principles are taken into account: state registration of medicines; the effectiveness and safety of drugs when used to prevent and alleviate the symptoms of the disease, as well as the treatment of mild, uncomplicated forms of diseases that do not require complex diagnostic methods and treatment when used by everyone age groups population; 4
5 possibility of safe self-use medications by patients in outpatient and home settings without the need for regular consultations and supervision by a doctor (or paramedic). The formation of a minimum assortment is based on an assessment of the effectiveness of drugs that are included in this list, and is carried out using the following analysis methods: 1. ABC analysis / volume-cost, 2. VEN analysis. Russian economy Today is not going through the most stable times. This is largely due to the high dependence of certain sectors of the national economy on foreign suppliers. In this regard, import substitution becomes especially relevant in the pharmaceutical sector of the economy. We have analyzed the list of vital and essential drugs. Today it consists of 567 INN drugs, of which 93 (16% in quantitative terms) are produced only by local companies, 207 (37%) only by foreign ones, and 267 (47%) are produced both locally and abroad. The existing mandatory assortment list contains 60 INNs, 102 positions of dosage forms, 398 trade names 148 of which are domestically produced, 276 are imported, 28 are produced in neighboring countries, 17 items of the mandatory assortment list are not produced in Russia, 16 items of dosage forms are presented on Russian market exclusively from domestic producers. Approaching the main issue, let us dwell on the research of the analytical company DSM Group on the leading imported items and leading importers based on the results of 2015. 5
6 Table 1 TOP-10 corporations-manufacturers of OTC drugs by share in pharmacy sales in Russia (in value terms) for 2015 Based on Table 1, imported enterprises predominate in number, which indicates the commitment of consumers to these corporations and their manufactured drugs. The share of domestic and imported manufacturers in the pharmaceutical sector of sales of drugs of the minimum range for 2014 50.90% 49.10% Russia Foreign countries Rice. 1. Share of domestic and imported manufacturers in the pharmaceutical sector of sales of drugs of the minimum range for 2015 6
7 0% If we take into account the change in the economic policy of the state, the social orientation of the activities of pharmacy organizations is lost, and the commercial interests of the owners increasingly come first. In this regard, it is possible to compare the minimum range with the list of vital and essential drugs (VED). The list of vital and essential drugs is approved annually by the Government of the Russian Federation in order to drug provision healthcare institutions and the population of the Russian Federation. After spending this analysis, we can conclude that the drugs included in the Vital and Essential Drugs list are completely duplicated in a minimal range. Analysis of the minimum assortment with the list of vital and essential drugs 100% Share of drugs included in the list of vital and essential drugs Other drugs Fig. 2. Analysis of the minimum assortment with a list of vital and essential drugs This suggests that despite the importance of vital and essential medicines for ensuring accessibility medicinal assistance, for pharmacy organizations there is no obligation for their presence in the minimum list of medicines, which cannot lead to the removal from the range of pharmacy organizations of “inconvenient” goods, for which additional costs are envisaged for organizing their storage and accounting, drugs 7
8 with low cost, the costs of promotion and implementation, which significantly exceed the income from their sale. Thus, the availability of vital and essential drugs for the population will not decrease. But, in order to ensure full accessibility of medicinal care to the population, it is advisable to create a list of vital and essential drugs, in which it is important to make notes regulating the use of drugs (for example, “for inpatient medical care”, “for outpatient medical care”, “minimum range for pharmacies, pharmacy points, pharmacies kiosks, for individual entrepreneurs”, etc.), combining the purpose of two lists of the list of vital and essential drugs and the minimum range of medicines mandatory for pharmacy organizations and individual entrepreneurs. The pharmaceutical audience today is experiencing difficult times, which is due to dependence on foreign suppliers. To this end, pharmaceutical structures approve and support the market displacement of foreign medicines Russian analogues. Moreover, the most well-known domestic manufacturers are already implementing programs to replace imported products with drugs Russian production. However, to date there is no sufficiently clear picture and balanced analysis of import substitution trends. Import substitution is a process at the level national economy, which ensures the production of goods necessary for domestic consumers by producers operating within the country. This process can be proactive or reactive. In the first case, import substitution goods are produced in order to prevent competing foreign suppliers from entering the market. In the second, foreigners are forced out of the corresponding segments. 8
9 Import substitution in the minimum range of domestic analogues 13% Non-replaceable drugs 87% Replaceable drugs Fig. 3. Import substitution in the minimum range with domestic analogues Analyzing the minimum range, we can say that it is possible to replace imported drugs with domestic ones by 87%. If the Russian government systematically creates favorable conditions for domestic drug manufacturers and supports high-tech production of pharmaceutical substances for the creation of drugs. Then even in a decade it will be possible to rise by high level. But it will take at least 20 years to completely replace imported medicines. Thus, import substitution is, according to a common interpretation, a process at the level of the national economy, which ensures the production of goods necessary for the domestic consumer by producers operating within the country. Having analyzed the minimum assortment, we can say that it is possible to replace imported drugs with domestic ones by 87%. Comparing the new minimum range with the list of vital and essential drugs, we can conclude that the drugs included in 9
10 list of vital and essential drugs are fully duplicated in a minimal assortment. This suggests that despite the importance of vital and essential medicines for ensuring the availability of medical care, pharmacy organizations are not required to have them in the minimum range of medicines necessary for the provision of medical care, which cannot lead to the removal from the range of pharmacies organizations of “inconvenient” product items, for which additional costs are envisaged for organizing their storage and accounting, drugs with low cost, the costs of promotion and sale of which exceed the income from their sale. 10
11 List of sources used 1. Burko R.A. The role of import substitution in the Russian economy Nevinnaya I.S. Pharmacy minimum Peregorodyeva L.N. Import substitution strategy in Russia // Economics Tarasevich V.N., Novikova N.V., Soloninina A.V. and others. Legal formation of the range of goods in pharmacy organizations // Contemporary issues science and education the federal law Russian Federation dated April 12, 2010 61-FZ “On the circulation of medicines”. 6. Analytical company DSM-group. URL: (access date:). 7. Information company Remedium. URL: (access date:). 8. Research Center IMS Health. Access mode: (date of access:). 9. Ministry of Health of the Russian Federation. URL: minzdravsoc.ru 10. Information and analytical newspaper: “Pharmaceutical Bulletin”. URL: (access date:). 11. Federal State Statistics Service. URL: (access date:). 12. Federal Service for Surveillance in Healthcare. URL: (access date:). eleven
Ministry of Health and social development published the minimum range of medicines that should be in every pharmacy in Russia. The list includes about 60 medications. We present this list.
1. Activated carbon* - capsules; pills
2. Algeldrat + Magnesium hydroxide * - tablets; suspension
3. Aminophylline - tablets
4. Amoxicillin - capsules; pills; powder for the preparation of suspension for oral administration
5. Ampicillin - capsules; pills
6. Arbidol - capsules; pills
7. Ascorbic acid* - dragee; pills
8. Atenolol - tablets
9. Acetylsalicylic acid* - pills
10. Acetylcysteine * - granules for the preparation of a solution for oral administration; powder for solution for oral administration
11. Acyclovir - cream *; ointment *; pills
12. Beclomethasone - aerosol for inhalation
13. Betaxolol - drops
14. Bisacodyl * - suppositories; pills
15. Diamond green * - alcohol solution for external use
16. Verapamil - tablets
17. Hydrocortisone * - cream; ointment
18. Hydrochlorothiazide - capsules; pills
20. Diclofenac * - tablets; gel; cream; suppositories; drops
21. Doxycycline - capsules; pills
22. Drotaverine * - tablets
23. Zanamivir - dosed powder for inhalation
24. Ibuprofen * - capsules; suspension; pills
25. Isosorbide mononitrate - capsules; spray; pills
26. Isosorbide dinitrate - capsules; pills
27. Ingavirin - capsules
28. Interferon alpha-2 * - gel; drops; lyophilisate for preparing a suspension for oral administration; lyophilisate for preparing a solution for intranasal administration; ointment; suppositories
29. Interferon gamma * - lyophilisate for the preparation of a solution for intranasal administration
30. Iodine + [Potassium iodide + Ethanol] * - alcohol solution for external use
31. Kagocel * - tablets
32. Captopril - tablets
33. Clotrimazole * - gel; cream; ointment; pills
34. Co-trimoxazole - suspension; pills
35. Loperamide * - capsules; pills
36. Loratadine * syrup; pills
37. Levomenthol solution in menthyl isovalerate * - tablets
38. Metoclopramide - tablets
39. Mint pepper oil+ Phenobarbital + Ethyl bromizovalerinate * - drops
40. Naphazoline * - drops
41. Nitroglycerin * - spray; pills
42. Nifedipine - capsules; pills
43. Omeprazole - capsules; pills
44. Oseltamivir - capsules; powder for the preparation of suspension for oral administration
45. Pancreatin * - capsules; pills
46. Paracetamol * - suspension; suppositories; pills
47. Pilocarpine - drops
48. Ranitidine * - tablets
49. Salbutamol - aerosol for inhalation; solution for inhalation
50. Sennosides A+B * - tablets
51. Spironolactone - capsules; pills
52. Sulfacetamide * - drops
53. Tetracycline * - ointment
54. Timolol - drops
55. Famotidine * - tablets
56. Furosemide - tablets
57. Chloramphenicol - tablets
58. Chloropyramine - tablets
59. Ciprofloxacin - drops; pills
60. Enalapril - tablets
* Medicines dispensed without a doctor's prescription and included in the minimum range of pharmacy kiosks and pharmacy stores.
The stage preceding the opening of a pharmacy is research legislative framework. After all, violation of special rules can become a reason for deprivation of a license. A minimum assortment in a pharmacy is a prerequisite for legal activity; the availability of medicines used for first aid is checked by regulatory authorities. The minimum assortment in the pharmacy is formed in accordance with the approved list, changes to which are required to be monitored by authorized employees.
Violation of the rules for the formation of a minimum assortment is a gross violation of the law and entails administrative penalties for management.
The approved list includes drugs that can be sold with or without a prescription.
IN job description The pharmacy employee is assigned the responsibility of monitoring compliance with the standards governing the formation of the assortment.
Minimum assortment in a pharmacy - reasonable restrictions
The minimum assortment in the pharmacy is designed to eliminate difficulties in providing care and facilitate the purchase of funds for patients with chronic diseases.
The list is periodically revised, representatives medical institutions make suggestions regarding the administration of drugs. It is mandatory to have medications on which the lives of patients depend, medications prescribed by medical commissions.
A separate group consists of drugs used to treat chronic diseases, the pharmacy manager is obliged to ensure proper storage conditions: purchase special equipment, refrigerators, ensure control over maintaining a certain temperature regime, expiration dates. The minimum assortment in a pharmacy is divided into 2 sections, taking into account the specifics of the institution’s activities and its status.
Specific feature pharmacy business - the absence of the possibility of unlimited price increases; the state sets limits, violation of which may become a reason for deprivation of a license or the imposition of administrative penalties.
h2>Regulation of prices for medicines
Regulation of prices for medicines - ensures mutually beneficial relationships between consumers and pharmacies. Buyers are given the opportunity to purchase medicines in a timely manner and healthcare institutions to make a profit.
Special attention When checking pricing, medicines included in the list of the minimum range deserve; exceeding the cost fixed at the legislative level is a gross violation.
The analytical department monitors competitors' pricing and studies changes in the minimum assortment. Changing the cost of drugs that are in high demand is a common way to increase profits, but it is important to work in accordance with the law. Automation of pharmacies makes it easier to control the availability of medicines included in the minimum range. The pharmacist is responsible for monitoring the periodic updating of the assortment.
The pharmacy is obliged to provide the opportunity to purchase prescription drugs within 3 days.
Updating the assortment is profitable!
Availability of a minimum assortment in the pharmacy - business card, the list includes drugs that have been in demand for a long period. It is beneficial to update the assortment in a timely manner in accordance with legal requirements. Chronic diseases are accompanied by the need to regularly purchase medicines; the patient will become a regular customer, subject to decent service at the pharmacy. In parallel with the sale of drugs “from the minimum range,” the pharmacist is given the opportunity to sell expensive drugs.
Personal qualities pharmacists are a priority for customers who will regularly visit the pharmacy.
For the treatment of chronic diseases, it may be necessary to purchase an improved product; the patient prefers to discuss the benefits of the new product with a pharmacist whom he trusts. Compliance with generally binding rules in combination with the professionalism of employees is a guarantee of maintaining a stable position in pharmaceutical market in an increasingly competitive environment.
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