Frequency rate of temperature control in refrigerators with medicines. New SanPiNs: fog in the refrigerator

16.03.2019

Many are interested in the question: how many thermometers should be in the refrigerator for storage drugs?

You will find the answer in our article.

At least 2 in the absence freezer and at least 3 if available.

The placement of two thermometers (temperature recorders, thermal indicators) on the upper and lower shelves of refrigerators was prescribed by clause 6.9.1 SP 3.3.2.1248-03 "Conditions for the transportation and storage of medical immunobiological preparations." Resolution of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 No. 19 "On Approval of Sanitary and Epidemiological Rules of the Joint Venture 3.3.2.3332-16" Conditions for the Transportation and Storage of Immunobiological Medicines " two autonomous thermometers and two thermal indicators (temperature recorders). The readings of each thermometer are monitored twice a day (at the beginning and at the end of the working day). Thermometer readings are recorded in special journal temperature monitoring, which is filled separately for each unit of refrigeration equipment. Thus, the requirement to place two thermometers in refrigerators applies only to refrigerators in which immunobiological preparations are stored. This requirement is due to the fact that, depending on the load of the refrigerator, free air exchange cannot always be ensured throughout the entire refrigerating chamber, and, accordingly, the storage temperature at the top and bottom may differ from the specified one. In the order of the Ministry of Health and Social Development of 23.08.2010 No. 706n "On the approval of the rules for storing medicines" there is no requirement for a thermometer in the refrigerator, however, paragraph 32 says that the storage of thermolabile medicines should be carried out in accordance with the temperature regime indicated on the primary and secondary (consumer) packaging of the medicinal product in accordance with the requirements of regulatory documents. For these purposes, pharmacies use different kinds refrigerators, in which it is possible to control the temperature only with a thermometer. Hence, it becomes necessary to place a thermometer in the refrigerator and maintain a "Register temperature regime refrigerator ". In addition, we inform you the following: Resolution of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 No. 19 "On the approval of sanitary and epidemiological rules of the joint venture 3.3.2.3332-16" Conditions for the transportation and storage of immunobiological drugs "determines the following: In addition to the built-in thermometer, the refrigerator is equipped with two autonomous thermometers and two thermal indicators (temperature recorders). Autonomous thermometers and thermal indicators (temperature recorders) are placed next to each other directly on the boxes with medical devices or directly on the shelves at two control points of each refrigerator chamber: the "warmest" (farthest from the cold source) and the most "cold" (susceptible to probable freezing, but not closer than 10 cm to the source of cold). Autonomous thermometers are placed in the "coldest" and "warmest" points of refrigeration equipment. outside the middle shelves of the racks. How many thermometers should I put in the vaccine refrigerator? To monitor the temperature in the entire volume of the refrigerating chamber, several indicators should be used: at least 2 in the absence of a freezer and at least 3 in the presence of one.

We remind you that you can buy thermometers for pharmaceutical refrigerators from us at the best price.

Important documents:

DECISION of October 12, 2017 No. 130 On the suspension of retail trade in alcohol-containing non-food products, alcohol-containing food additives and flavors A.Yu. POPOVA
LETTER dated October 24, 2017 No. 3095 / 25-4 On additional clarifications of the norms of the order of the Ministry of Health of Russia dated July 11, 2017 N 403n E.A. MAKSIMKINA, Director of the Department of Pharmaceutical Provision and Regulation of the Circulation of Medical Devices of the Ministry of Health of Russia
ORDER dated September 1, 2017 No. 585n ON THE APPROVAL OF THE ADMINISTRATIVE REGULATIONS FOR THE EXECUTION OF THE FEDERAL SERVICE FOR SUPERVISION IN THE SPHERE OF HEALTHCARE OF THE STATE FUNCTION FOR THE IMPLEMENTATION OF LICENSE CONTROL OF PHARMACEUTICAL ACTIVITIES Minister V. I. SKVORTSOVA

What is ILP?

The topic of immunobiological drugs (hereinafter also - IL drugs or ILP) in early autumn is more than relevant. The transition from warm to cold, from sun to cloudy and rainy, from rest to hard work is a risky period for immunity. Summer bliss gives way to autumn colds, which are especially susceptible to weakened organisms.

To begin with, let's answer the question, what is ILP? This is far from an idle question, because pharmaceutical specialists working in the pharmacy and distribution segments often ask how to determine whether a particular drug belongs to the drug.

According to clause 7 of the conceptual art. 4 Federal law"On the Circulation of Medicines" (No. 61-ФЗ dated 12.04.2010), this concept means medicinal products intended for the formation of active or passive immunity or diagnostics of the presence of immunity or diagnosing a specific acquired change in the immunological response to allergenic substances. Accordingly, they are used for therapeutic, prophylactic and diagnostic purposes.

According to the aforementioned clause of Law No. 61-FZ, IL drugs include vaccines, toxoids, toxins, sera, immunoglobulins and allergens... In this matter, between the Law "On the Circulation of Medicines" and There is a contradiction in the General Pharmacopoeia Monograph "Immunological Medicines" (OFS.1.8.1.0002.15)... The latter classifies other medicinal preparations of biological nature as the main groups of ILP: bacteriophages, probiotics, cytokines, including interferons, microbial enzymes, etc., as well as preparations produced by biotechnological processes, including those using the method of genetic engineering.

So which of these regulations should be guided by? Here, pharmacists can be advised to adhere to the primacy of Law No. 61-FZ, since the rest of the regulatory legal acts, including the State Pharmacopoeia, are being developed and adopted for the implementation of its norms. Therefore, the requirements imposed by legislation on the storage and transportation of medical immunobiological preparations - they will be discussed below - do not apply to probiotics, bacteriophages, cytokines, including interferons, microbial enzymes.

Surely the Ministry of Health is working to bring the norms and terms of various regulatory legal acts in accordance with the provisions of Federal Law No. 61-FZ. But if we switch from the dry language of jurisprudence to a living human language ... In an amicable way, it would be easier for pharmaceutical practitioners if each package of an ILP were marked with some sign that identifies this group of drugs or at least the abbreviation “ILP”.

ILPs are produced in different dosage forms: tablets, capsules, granules, powders, lyophilisates, solutions, suspensions, suppositories, ointments. IL-drugs are very labile, so it is difficult and responsible to work with them. Violation of storage conditions, for example, vaccines is one of the main reasons for the development of post-vaccination complications. This alone speaks of the importance of the topic of proper handling of this group of drugs at all production, logistic stages, as well as during storage in medical and pharmaceutical institutions.

Four levels of cold

Let's start with where these very rules for storing ILS are spelled out. In the order of the Ministry of Health and Social Development of the Russian Federation of 23.08.2010 No. 706n "On the approval of the rules for storing medicines" they are never mentioned. Clause 32 of this regulatory legal act contains only a general indication that thermolabile medicinal products should be stored in accordance with the temperature regime indicated on the primary and secondary packaging. Immunization drugs, of course, belong to this group of drugs, but even among thermolabile drugs they make up special group, so this instruction is clearly not enough to organize their proper storage.

More informative and detailed norms governing the storage conditions of immunobiological preparations can be found, in particular, in the State Pharmacopoeia of the Russian Federation. Let's select from OFS.1.1.0010.15 "Storage of medicines" what concerns the topic under consideration. This monograph primarily notes that proper quality ILP, safety and efficiency of their use is ensured by the "cold chain" system in a complex, that is, all four of its levels. They are listed in section II of the above Sanitary and Epidemiological Rules(Further - rules).

The first level of the "cold chain" is the delivery of medical products from the manufacturer to the wholesale link, including the stage of customs clearance. The second is the storage of drugs in this group by drug wholesalers and their delivery to pharmacy and medical organizations (including individual entrepreneurs licensed for pharmaceutical or medical activities), as well as other pharmaceutical distributors. The third level is the storage of ILP by these same pharmacy, medical organizations and entrepreneurs, their retail sale, as well as delivery to other medical organizations or their separate divisions (district hospitals, polyclinics, outpatient clinics, maternity). Accordingly, the fourth level is the storage of immunobiological preparations in a pharmacy and medical organizations.

Two to eight ... Celsius

From OFS.1.1.0010.15 and OFS.1.8.1.0002.15, as well as from pp. 3.2 and 3.5 of the Rules, it follows that the storage of IL-preparations must be carried out at a temperature from +2 ° C to +8 ° C, unless otherwise specified in the instructions for use or other regulatory documentation... That is, we are talking about ensuring the storage regime, which is called the "cold place" in the State Fund. With regard to transportation, OFS.1.8.1.0002.15 emphasizes that its temperature and other conditions should not differ from those for storage of ILP. Thus, the conditions of transportation and storage of immunobiological preparations coincide.

The rooms in which refrigerators for storing ILS are located should not overheat above +27 ° C. OFS.1.1.0010.15 also defines that access of cooled air must be provided to each package of medical supplies in the refrigerator... Let us recall in this connection that modern pharmaceutical refrigerators are equipped with appropriate air circulation systems. In addition, in order to comply with this norm, the packaging of IL-preparations should not be piled on top of each other.

It should also be borne in mind that OFS.1.1.0010.15 and clause 6.19 of the Rules do not allow storing ILS on the door panel of the refrigerator... The logic of this prohibition is clear - the air temperature in this part of the refrigerating device is higher than in other parts of it, respectively, and there is a higher risk of going beyond +8 ° C. But, this norm for those who use not conventional, but pharmaceutical refrigerators of little relevance.

Let the fog go

The following pharmacopoeial norm OFS.1.1.0010.15 must be quoted verbatim: "Joint storage in the refrigerator of immunobiological medicinal products with other medicinal products is not allowed"... The similar indication of clause 8.12.1 of the Rules almost echoes this norm: "joint storage of vaccines in a refrigerator with other drugs is not allowed."

As you know, our legislation contains many vague rules that can be interpreted this way and that. Even lawyers sometimes find it difficult to explain them. And the auditors can take advantage of this ambiguity. If you do this, they will say that it was necessary to do it this way; Well, if you do that, it turns out that it should be like this.

The norm "joint storage in the refrigerator is not allowed ...", which we have just outlined, it seems, can be attributed to such "Andromeda nebulae". This requirement the storage of immunobiological preparations is perceived differently, some understand it as follows: ILP and others thermolabile drugs must be stored on separate shelves of the refrigerator. But some pay attention to another possible interpretation of this norm: a separate pharmacy refrigerator should be allocated for storing IL-preparations.

There are signals from pharmacy workers that the inspectors adhered to the second point of view during certain control activities. Therefore, it is possible to recommend pharmacists to follow it for greater reliability.

The problem here is that in many, if not most pharmacies, IL-drugs make up a very small part of the assortment (after all, the traditions of pharmacy participation in immunoprophylactic processes are not developed in our country). Sometimes there are only a few or even two or three names. After all, there are no ILS in the obligatory “minimum assortment”. It is very expensive to purchase and maintain a separate expensive pharmacy refrigerator for several assortment units - as a rule, not related to the best sellers. It is easier to refuse to purchase these “troublesome” assortment items altogether. Simpler, but not better. And it would be better if our regulators would clarify this norm.

Travel in a container

All the subtleties of the temperature regime for IL-drugs are set out in the Rules, to which we repeatedly refer. There are many of them, and within the framework of one article, such a large volume of norms cannot be covered. Therefore, it is possible to recommend that pharmaceutical specialists carefully study all the conditions for the transportation and storage of medical immunobiological preparations.

Sections IV – VII of the Rules contain requirements for refrigeration (freezing) equipment used to provide a cold chain during transportation of medical devices, as well as equipment for temperature control. For the proper transportation of medical supplies, refrigerated trucks, thermal containers - including ultra-small (up to 10 dm 3) and small (from 10 to 30 dm 3, including medical refrigerated bags) - as well as cold items should be used.

Hence, the recommendation to pharmacy workers receiving goods from a representative of the carrier company is not to take drugs of this group if they were delivered in a common box with other drugs (especially those requiring a different temperature regime) or if there are reasonable doubts that during transportation the temperature limits specified in the Global Fund and the Rules were violated.

Thermometers: how much and where?

The temperature regime must not only be maintained, but also checked and recorded. For these purposes, during the transportation and storage of ILS, the following are used: temperature measuring instruments, namely, autonomous or built-in electronic thermometers, thermographs, temperature recorders, as well as means of detecting violations of the temperature regime, that is, thermal indicators. Of course, they should be used all along the path of the IL-drug - from its insertion into the packaging container to the receipt by the user, to ensure end-to-end continuous temperature control, starting from the moment of production through all stages of transportation and all periods of storage.

We are primarily interested in the pharmacy aspect of the topic. According to clause 6.22 of the Rules, for the purposes of proper storage of medical products the refrigerator, in addition to a built-in thermometer, must be equipped with two independent thermometers and two thermal indicators. They are placed in pairs "one thermometer and one thermal indicator" next to each other directly on the shelves of the refrigerator or on boxes with ILS at two control points of each refrigerator chamber: the "warmest" and the "coldest".

The first of them is considered the one that is farthest from the source of cold. The second, according to the joint venture on the conditions of transportation and storage of immunobiological preparations, is the one that is most susceptible to freezing, with the proviso "not closer than 10 cm to the source of cold."

This paragraph of the Rules, it seems, is also not devoid of fog, since a simple mathematical calculation shows that a total of two autonomous thermometers and two thermal indicators will be needed per camera. But after all, pharmaceutical refrigerators are also two-compartment. But this circumstance is not reflected in any way in clause 6.22 of the Rules. In any case, it is possible to recommend that the managers of pharmacies equip the coldest and warmest points of each refrigerator chamber with a pair of "autonomous thermometer and thermal indicator".

According to clause 7.10 of the Rules, the readings of each thermometer are monitored twice a day, at the beginning and end of the working day. They are registered in a special temperature monitoring log, which is filled in separately for each refrigerator. In case of force majeure - a power outage, failure of the refrigerator in which the medicinal product is stored - it is necessary to have a thermocontainer (s) in the pharmacy with a supply of refrigeration elements.

In conclusion, we note that since the conditions for the transportation and storage of immunobiological preparations differ, it is necessary first to see for each IL-preparation whether it is prescribed or allowed for it other than the regime “from +2 ° C to +8 ° C. ", storage conditions. For example, there are such medical products that, according to the instructions for their use, must be stored frozen (clause 6.25 of the Rules). The rest must be protected from freezing - for example, do not place them on the path of a cold air stream with a temperature below +2 ° C.

As for the measures of administrative punishment for violation of the rules for storage and transportation of immunobiological preparations, it should be noted that this type of violation belongs to the category of gross violations of licensing requirements. Accordingly, today it entails the imposition: on individual entrepreneurs - an administrative fine (ASh) in the amount of 4,000 to 8,000 rubles. or administrative suspension of activities (APD) for up to 90 days; on officials- a fine from 5,000 to 10,000 rubles; on legal entities- from 100,000 to 200,000 rubles. or suspension of activities for up to 90 days (clause 4, article 14.1 of the Code of Administrative Offenses of the Russian Federation).