If your skin develops a rash or unpleasant redness after a day in the sun, your medication may be to blame. Experts say some drugs make the skin more sensitive to the sun, which can cause cellular damage and an unsightly appearance.

“These skin reactions are caused by the sun's UVA and UVB wavelengths, which cause photobiological reactions to drugs that are mostly free radicals. Free radicals and oxidative stress contribute to skin cell damage, causing redness and rashes on exposed skin, says Dr. Kelly Papantoniou, cosmetic dermatologist at Mount Sinai Health Center. "Studies have shown that certain medications can cause photosensitivity, and you should take good care of your skin when you're out in the sun and taking these medications."

Diuretics. Medicines that control high blood pressure and help reduce water retention—hydrochlorothiazide, bumetanide, and furosemide—sensitize the skin to sun exposure through photochemical activity. "A rash, like subacute lupus, can appear on exposed skin," says Papantoniou. - Sunscreen is very important in this case - it can prevent photodermatitis, also known as sun poisoning. Spend more time indoors if your skin is especially sensitive."

Antibiotics. Doxycycline and tetracycline are examples of antibiotics commonly used in the treatment of acne, which can also lead to phototoxicity when the skin is exposed to the sun. To avoid a potentially unpleasant reaction, apply sunscreen and avoid prolonged exposure to the sun.

Terbinafine. This popular antifungal medication, branded as Lamisil, is commonly prescribed to treat nail fungus. It can also make the skin extremely sensitive to the sun. Protect yourself with sunscreen.

Statins. Lovastatin and simvastatin, the two most commonly prescribed statins used to lower blood cholesterol, can make skin more sensitive to UVA and UVB.

Non-steroidal anti-inflammatory drugs. NSAIDs - naproxen, ibuprofen and ketoprofen - produce harmful free radicals when the skin is exposed to direct sunlight.

Hypoglycemic agents. Glipizide, glyburide, and sulfonylurea drugs are used to control blood sugar levels in people with diabetes. These medications also make the skin more sensitive to UV rays.

Antipsychotic drugs. Aaminazine and other phenothiazines cause photosensitivity through an oxidation process. Wear sunscreen to prevent skin damage.

Systemic retinoids. Isotretinoin and acitretin- systemic retinoids used to treat skin conditions, including acne and psoriasis. You must use sunscreen and take the necessary precautions.

Anti-aging creams. Extremely popular anti-aging creams that contain retinol and tretinoin can increase the skin's sensitivity to sunlight. For this reason, if you are using any of these products, stop taking them about a week before prolonged sun exposure, such as a trip to the beach. If you need them, be sure to use a broad-spectrum sunscreen containing titanium oxide or zinc oxide to protect your skin from UV radiation.

Alpha hydroxy acids. Although these drugs are not as strong, they can also sensitize the skin. In this case, apply SPF30 sunscreen every morning and repeat every two hours.

SBEI HPE "Kazan State Medical University"
Ministry of Health of the Russian Federation
Faculty of Pharmacy

Department of Pharmacy Economics Management

Medicines requiring protection from light.

Target: Familiarize yourself with the organization of storage of medicines that require protection from light.

Tasks:

• Acquainted with:
• a list of drugs requiring protection from light;
• storage features;
• reactions that occur during improper storage of drugs that require protection from light.
• Solve situational problems.
• Answer test questions.

Classification of drugs, depending on the impact on them of various environmental factors

All drugs, depending on the physical and physico-chemical properties, exposure to various environmental factors, are divided into:

Requiring protection from the light

Requiring protection from moisture,

Requiring protection from volatilization and drying,

Requiring protection from exposure to elevated temperatures,

Requiring low temperature protection,

Requiring protection from exposure to gases contained in the environment,

Odorous, coloring and a separate group of medicines - disinfectants.

Orders regulating the rules for the storage of medicines and medical products requiring protection from light

• Order of the Ministry of Health of the Russian Federation No. 330 dated November 12, 1997 "On measures to improve the accounting, storage, prescribing and use of narcotic drugs"
• Decree of the Government of the Russian Federation No. 1148 "On the Procedure for the Storage of Narcotic Drugs and Psychotropic Substances"
• Federal Law of the Russian Federation of June 22, 1998 No. 86-FZ "On Medicines"
• Order of the Ministry of Health of the Russian Federation No. 706-n dated 11/13/2010. "On approval of instructions for organizing storage in pharmacies of various groups of medicines and medical products"
• Order of the Ministry of Health of March 15, 2002 No. 80 “On approval of the industry standard “rules for the wholesale trade of medicines. Basic Provisions»
• Order of the Ministry of Health of the Russian Federation No. 214 of July 16, 1997 "On quality control of medicines manufactured in pharmacies"
• Order of November 1, 2001 No. 388 "On state standards for the quality of medicines"

Groups of drugs requiring protection from light

Medicines that require protection from light include :

• antibiotics
• herbal preparations (tinctures, extracts, concentrates from plant materials)

		Name			Additional storage conditions
		Adrenaline hydrotartrate B
		Adrenaline hydrochloride 0.1% solution			cool place
		Amidopyrine			dry place
		Amicazole
		Aminazin
		Anestezin
		Antipyrine
		Vitamin C
		Ascorbic acid 5% injection			cool place
		Aceclidine			dry place
		Henbane sheet
		Benzohexonium
		Benzonal
		Bilygnost 20% and 50% for injections
		Bromisoval
		Bromocamphor
		Butadion
					dry place
		Bismuth nitrate basic
		Galascorbin			cool dry place
		Gesamidin			dry place
		Hydroperite			Dry place at t not higher than 20C
		Histidine hydrochloride
		Dermatol
		Diazolin
		Digalen-neo
		Diiodotyrosine
		Dikolina solution 1% for injections
		Dicoumarin
		Diphenhydramine
		Dimecolin
		Diprazine
		Diprazine solution 2.5% for injection
		Diethylstilbestrol
		Diethylstilbestrol propionate
		Diethylstilbestrol propionate solution 0.1% and 0.5% in oil
		Natural gastric juice			The same at t 2-10С
		Lime chloride
					cool dry place
					cool place
		calcium iodine			dry place
		Camphor solution in oil 20% for injection
		carbacholin
		Glutamic acid
		Nicotinic acid
		Salicylic acid
		Codeine Phosphate
		Collargol			cool dry place
		Collodion			Cool dry place away from fire
					dry place
		Korglikon solution 0.06% for injections
		Cordiamin
		Corticotropin for injection
		belladonna leaf
		Lanolin Anhydrous
		Magnesium peroxide			dry place
		Fatty oils			cool place
		Bleached butter
					dry place
		Metacin solution 0.1% for injection
		Miarsenol
		Morphine hydrochloride			dry place
		Morphine hydrochloride solution 1% or 5% for injection
		foxglove leaf
		sodium nitrite
		Neomycin sulfate			Dry place at t up to 20C
		Nicotinamide solution 1%, 2.5% or 5% for injection
		Nicotinic acid solution 1% for injections
		Novarsenol			cool place
		Novobiocin sodium salt			dry place
		Novocaine solution 0.5%, 1% or 2% for injection
		Novocaine
		Norepinephrine Hydrotartrate
		Norepinephrine hydrotartrate solution 0.2% for injection			cool place
		Oxaphenamide			dry place
		Oxytetracycline hydrochloride
		Omnopon solution 1% or 2% for injection
		Pentamine			dry place
					Dry place at t 2-15C
		Hydrogen peroxide solution			cool place
		Perhydrol			The temperature is not higher than 25C, the stopper to the vessel must contain a gas outlet pipe
		Pyridoxine Hydrochloride (Vitamin B6)			Dry place at t 12-15C
		Progesterone			dry place
		Progesterone solution in oil 1% or 2.5% for injection
		Prozerin
		Propazine
		Salicylamide
		Saluzid soluble			Dry place at t 18-20C
		Scopolamine hydrobromide			dry place
		Spasmolitin
		Thiamine chloride (vitamin B1)			Without contact with metals
		Tetacin-calcium solution 10% for injections
		Tetracycline hydrochloride			dry place
		Trypsin crystalline			Dry place up to 10C
		Quinine hydrochloride			dry place
		Chloral hydrate
		Chloramine B
		Chlorazicin			dry place
		Chlorbutin			cool dry place
		Chloroethyl			cool place
		Celanide solution 0.02% for injection			cool place
					dry place
		Cyanocobalamin (vitamin B12)
		belladonna extract
		male fern extract
		Emetine hydrochloride
		Emetine hydrochloride injection
					Temperature not higher than 5C
		Erythromycin			dry place
		Etazol-sodium solution 10% or 20% for injection
		Etazol sodium
		Eufillin
		Eufillina solution 24% for injections
		Eufillina 0.15 (tablets)
		Ephedrine hydrochloride			dry place
		Ephedrine hydrochloride solution 5% for injection

• herbal medicinal raw materials
• organ preparations
• vitamins and vitamin preparations
• corticosteroids
• essential and fatty oils
• coated preparations
• salts of iodide and hydrobromic acids
• halogenated compounds
• nitro and nitroso compounds
• nitrates and nitrites
• amino and admido compounds
• phenolic compounds
• phenothiazine derivatives

They should be stored in containers made of light-shielding materials (orange glass containers, metal containers, aluminum foil packaging or polymeric materials painted black, brown or orange), in a dark room or in cabinets painted black on the inside with tightly fitting doors or in tight-fitting boxes with tight-fitting lids.

To store medicinal substances that are especially sensitive to light (silver nitrate, prozerin, etc.), glass containers are pasted over with black opaque paper.

There are medicinal substances that need exposure to light, for example, ferrous iron preparations should be stored in a small glass container of light glass in bright light. exposure to direct sunlight is allowed.

List of additional storage conditions for a number of medicinal products to be stored in a place protected from light

List of medicines to be stored in a place protected from light

Description of the chemistry of reactions that occur during improper storage of medicinal products that require protection from light

CHEMISM

Antibiotics, galenic preparations, herbal medicinal raw materials, organ preparations, vitamins and their preparations, corticosteroids, essential and fatty oils, sugar-coated preparations, salts of hydrobromic and iodic acids, halogenated compounds, nitro and nitroso compounds, nitrates, amino and amido compounds, phenolic compounds , phenothiazine derivatives.

They are stored in orange glass containers, metal containers, aluminum foil packaging, polymeric materials painted black, brown or orange inside, in a dark room or cabinets painted black inside. medicinal substances especially sensitive to light: silver nitrate, prozerin - are stored in a container covered with black paper.

1. Argenti nitras. Silver nitrate.
List A is stored in a well-closed container with a ground stopper, pasted over with black paper, in a place protected from light.
Under the influence of light, it decomposes with the formation of a black precipitate of metallic silver and the release of nitrogen oxide with a characteristic odor and brown color.

2. Proserium. Prozerin.
List A, stored in a dry place, hygroscopic, turns pink in the light.

3. Phenolumpurum. Phenol is pure.
List B.

4. Thymolum. Thymol.
List B.
Under the influence of light and in the presence of atmospheric oxygen, it oxidizes, while the solution acquires a pink color.

5. Solutio Hydrogenii peroxidy diluta. Hydrogen peroxide solution 3%.
Store in bottles with a ground stopper, in a cool, dark place.
Under the influence of light, it decomposes with the formation of water and gaseous oxygen.

6. Natrii nitris. Sodium nitrite.
List B.
It is hygroscopic, easily oxidized by atmospheric oxygen, stored in a place protected from light, in tightly closed orange glass jars.

7. Bismuthi subnitras. Bismuth nitrate basic.
Store in a well-closed container, protected from light, moisture, as it undergoes hydrolysis.
Under the influence of light, it decomposes with the formation of nitric acid, during the decomposition of which nitrogen oxides are formed, which are noticeable by smell.

8. Hydrargyri oxydum flavum HgO, Hydrargyri amidochloridum.
List B. Store in a place protected from light, in tightly closed orange glass jars.

Hydrargyri dichloridum HgCl 2
List A.
Under the influence of light, a black precipitate of metallic mercury precipitates and chlorine with a characteristic odor is released.

9. Chloroform for anesthesia.
Store in well-corked and filled to the top orange glass bottles of small volume, in a dry, cool, dark place. As a stabilizer, anhydrous ethanol 0.6-1%.
In the presence of oxygen, the poisonous gas phosgene is formed, which is further oxidized to gaseous chlorine.
Stabilization of chloroform is carried out by adding ethanol to chloroform, which neutralizes the toxic decomposition products of chloroform.

10. Chloralum hydratum. Chloral hydrate.
List B. Store in a dry, cool place, in a well-closed container, protected from light, because it is hygroscopic, especially when wet and slowly volatilizes in air.
Under the influence of light and in the presence of moisture, it decomposes, and an odor appears.

11. Aether medicinalis. Ether medical.
List B.
Store in well-corked orange glass bottles, protected from light, away from fire. The flasks are sealed with cork stoppers with a parchment lining and filled with a special zinc-gelatin mass, insoluble in ether, since rubber stoppers swell from ether vapors, glass ones do not create proper tightness.
Ether for anesthesia - the action of atmospheric oxygen is excluded and the formation of peroxide compounds is not allowed. Orange bottle of 150 ml, sealed with a cork stopper with a metal foil gasket filled with mastic. The foil restores the formed impurities of peroxides and aldehydes.

12. Dimedrol. Dimedrol.
List B, hygroscopic, gradually. Store in a well-closed container, protected from light and moisture.
Under the influence of light and in the presence of moisture, it decomposes, and the color changes - a yellow tint appears.

13. Nitroglycerine. Nitroglycerine.
List B is stored in a well-closed container, in a cool place, protected from light, away from fire. On impact or on shaking, it explodes due to the formation of gas.
Under the influence of light, it decomposes, and gaseous nitrogen, carbon dioxide and oxygen are formed.

Spilled nitroglycerin is poured with alkali, and the reaction of the formation of glycerol and potassium nitrate occurs.

14. Bromisovalum. Bromised.
List B is stored in well-sealed orange glass jars.
In case of improper storage - in the light and in the presence of moisture and oxygen it decomposes - in this case, a characteristic smell of ammonia appears and carbon dioxide is released.

15. Paracetamolum. Paracetamol.
List B is stored in a well-closed orange glass container.
Under the influence of light and in the presence of moisture, it decomposes, and the smell of acetic acid appears.

16. Phenothiazine derivatives.
List B, hygroscopic, easily oxidized in the light, especially drug solutions.
- Aminazin, Triftazin, Etmozin - darken;
- Chloratsizin - blushes;
- Propazine - blue-green coloration

17. Phenyl salicylate.
Store in a well-closed orange glass container.
Under the influence of light and in the presence of moisture, it decomposes, and a precipitate and a smell of phenol appear.

18. Methilenum coeruleum. methylene blue.
Store in a well-closed container, protected from light.
In the light there is a redox reaction in the solution of the drug.
When standing in air -> blue coloration again.

19. Bromcamphora. Bromocamphor.
Store in well-closed orange glass jars, protect from light.
Under the influence of light, it decomposes, and a yellow precipitate of molecular bromine appears.

20. Chinini hydrochloridum. Quinine hydrochloride.
Store in jars and orange glass, protect from light.
Decomposes in the light - while the substance turns yellow.

21. Papaverini hydrochloridum. Papaverine hydrochloride.
List B is stored in a well-closed container, as oxidation occurs under the action of light and moisture.
The substance oxidizes if stored improperly.

22. Morphini hydrochloridum. Morphine hydrochloride.
List B is stored in a well-closed container, protected from light.
If stored incorrectly, it loses crystal water, which can cause overdosing.

23. Acidum ascorbinicum. Ascorbic acid.
Stored in a well-sealed container, protected from light and atmospheric oxygen, stable in crystalline form (in the absence of moisture), rapidly oxidizes in solutions, especially in the presence of traces of metals, in an alkaline and acidic environment. Sodium metabisulfide and sodium sulfite are used as a stabilizer.
If stored incorrectly, it is oxidized by oxygen in the air.

24. Tocopheroli acetas. Tocopherol acetate.
Store in hermetically sealed jars filled to the top, in a cool, dark place.

25. Thimini bromidum, chloridum. Thiamine bromide, chloride.
Store in a hermetically sealed container, protected from light, without contact with metals.
Loses crystal water if stored incorrectly

26. Adrenalini hydrochloridum. Adrenaline hydrochloride.
If stored incorrectly, it is oxidized by atmospheric oxygen and turns red.

27. Acidum folicum. Folic acid.
Store in a well-closed container, in a dry, dark place. Hygroscopic, decomposes on exposure to light. Solutions are more stable at pH 5-10.
If stored improperly in the light, it is oxidized by oxygen in the air.

28. Riboflavinum. Riboflavin.
Store in well-corked orange glass jars.
If stored incorrectly, it is oxidized by atmospheric oxygen and turns yellow.

29. Iodoformium. Iodoform.
Store in a well-closed dark glass container, in a cool, dark place.
In case of improper storage, it is oxidized by oxygen in the air, and a brown precipitate of molecular iodine is formed, while carbon monoxide and carbon dioxide are released.

30. Halides.
Store in a dry place (hygroscopic), in tightly closed jars, protected from light (orange glass).
If stored improperly, they decompose in the light with the formation of molecular halogens, with the formation of a yellow precipitate of bromine or a brown precipitate of iodine.

Photo bank of storage places for medicines and medical devices

Storage of dosage forms on the trading floor

Storage of dressings on the trading floor

Dressing storage

Storage of medicinal plant materials

Medicinal herbal preparations

Storage boxes for parapharmaceuticals

Showroom hygrometer

Warehouse hygrometer

Showroom hygrometer

Storage of medical devices

Storage of rubber products

Storage of rubber products

Storage of patient care products on the sales floor

Safe for storing potent substances

Shelf of a safe for storage of medicines subject to PPKN

Situational tasks

1. Phenol was poured into a light-colored glass rod and forgot to be put in a closet. What will happen to phenol? What visible changes can be observed?

2. After making the dosage form with silver nitrate, the residue was wrapped in parchment paper and left on the turntable. What storage conditions have been violated? What will happen to silver nitrate?

3. When taking ergocalciferol as prescribed by a doctor, the patient developed signs of intoxication (in the absence of an allergic reaction to this drug in the patient). What caused the patient's reaction?

4. A pharmacist, releasing eye drops with riboflavin to a patient, forgot to tell about the storage conditions of the drug. What are the consequences of a pharmacist's mistake?

5. When checking, black spots were found in the vial of mercury dichloride. What could have caused such changes?

6. A woman, leaving a pharmacy, dropped a bottle of hydrogen peroxide solution. The bottle cracked. At home, she poured the solution into another bottle of light glass and a smaller volume, filling it almost 100%. What storage conditions did the woman violate? What can this lead to?

8. A pharmacy received a solution of epinephrine hydrochloride in ampoules from a warehouse, the secondary packaging of which was damaged. Can I leave this product in the pharmacy for sale? Why?

9. During the analysis, it was found that the preparation exceeds the content of morphine hydrochloride, despite the fact that the technologist accurately weighed the right amount. What could have caused the overdose?

10. The pharmacy received a large amount of motherwort tincture. Half of the delivery did not fit in the refrigerator and was left on the table. What consequences can be expected?

1. Phenol oxidizes under the action of oxygen and light, acquiring a pink color. It must be stored in a place protected from light.

2. Silver nitrate is stored in a well-closed container with a ground stopper, pasted over with black paper, in a place protected from light. It belongs to medicinal substances that are particularly sensitive to light. The world turns brown. Sp. And they keep it in a safe.

3. Ergocalciferol was exposed to light as a result of storage, resulting in the formation of toxic compounds of toxisterol and suprasterols. This drug should be stored in orange glass bottles, protected from light.

4. Riboflavin must be stored in well-closed dark glass jars in a place protected from light, given its ability to easily oxidize and decompose under the action of light to form biologically inactive lumichrome and lumiflavin. If stored incorrectly, the patient will not receive the desired effect from the treatment.

5. In light, mercury dichloride is reduced to metallic mercury, which is black in color. Therefore, mercury preparations must be stored in well-closed orange glass jars in a place protected from light.

6. In light, hydrogen peroxide decomposes to form water and oxygen, the accumulation of which can cause an explosion. The drug must be stored in a dark glass bottle in a place protected from light.

7. Given that the drug is hygroscopic and easily oxidized in air, store it in a dark place, with caution (Sp B), in well-corked orange glass bottles. If the storage conditions are not observed, the preparation blurs and turns yellow due to the release of nitrogen dioxide.

8. Adrenaline hydrochloride is easily changed by light and air oxygen. It must be stored in a hermetically sealed orange glass container, protected from light. Damaged secondary packaging does not provide adequate protection from light, which can lead to oxidation if the ampoules are exposed to light for a long time. Since it is not known how long ago the secondary packaging was damaged and under what conditions the drug was stored and transported, it must be returned back to the supplier.

9. In case of improper storage (leaky capping, exposure to light), the drug can lose crystallization water, which can lead to overestimation of doses.

10. Tinctures should be stored in a cool, dark place. If these requirements are not observed, biologically active substances are inactivated and precipitated.

7. When hanging the sodium nitrite powder, it was found that the top layer of the powder in the vial turned yellow and blurred. What caused these changes? What storage conditions have been violated?

To prevent spoilage of medicines in pharmacies, it is necessary to strictly observe the conditions for their storage, taking into account the influence of various external factors. According to the storage conditions, all medicines are divided into the following groups.

Medicines that react negatively to light (photosensitive drugs). This group includes a very large number of drugs, some of which do not withstand direct sunlight, while others change even with diffused light. Store such drugs should be in orange or dark glass bottles in cabinets protected from light. In some cases, for the storage of drugs that are especially sensitive to light, barbells are used, completely pasted over with black opaque paper. Only preparations containing ferrous oxide should be stored in direct sunlight.

moisture sensitive drugs. A fairly significant group of drugs lose their activity or deteriorate under the influence of moist air. Store these drugs in well-closed containers in a dry place.

Medicines that require protection from exposure to low temperatures. These drugs include those whose physicochemical state changes after freezing and is not restored upon subsequent heating to room temperature (solution of formaldehyde, insulin, glacial acetic acid).

Medicines that change under the influence of oxygen and other gases. Some medicines can react chemically with oxygen, carbon dioxide and other gaseous substances in the air, and as a result of this interaction lose activity or deteriorate. For example, under the influence of moisture and carbon dioxide in the air, magnesium oxide can turn into magnesium carbonate. Open contact with air deteriorates urethane and some other medicines.

The preparations exposed to gases are stored in well stoppered bottles and in cabinets protected from light.

Medicines stored at low temperatures. Many preparations require a lower temperature for better preservation. For example, sera and vaccines should be stored in a dark place between 2°C and 10°C. Organ preparations and hormonal preparations are usually stored at a temperature of 10-15°C. Antibiotics, medical fats and oils, fat-based ointments, dosage forms with insulin, etc. should also be stored at a low temperature. However, the temperature should not be lower than 0 ° C, as this entails freezing and deterioration or inactivation of drugs.

Drugs requiring protection from volatilization. These agents include: actually volatile substances (camphor, chloral hydrate, etc.); drugs containing a volatile solvent (alcohol concentrates, etc.); solutions in a mixture of volatile substances; vegetable raw materials containing essential oils; drugs - crystalline hydrates; medicinal substances that decompose with the formation of volatile products.

The listed substances should be stored in hermetically sealed containers in a cool place.

Flammable and explosive preparations. Flammable substances in a pharmacy include alcohol, ether, turpentine, collodion, etc. They are stored in well-closing vessels, cans, flasks in a cool, dark place. Often, specially equipped rooms or niches in basements are used for this, and in rural pharmacies - independent cellars. Places where such substances are stored should be provided with fire-fighting measures and good ventilation.

Explosive substances include a solution of nitroglycerin, potassium permanganate in powder, and some other strong oxidizers.

In order to properly fulfill all the requirements for the storage of the listed groups of medicines, pharmacy workers must be well aware of the chemical properties of drugs and their ability to react with other substances, water vapor and gases in the air.

Recently, in the pharmacies of Belarus, instead of medicines, signs with the names of medicines began to appear in the windows more and more often.

Previously, only licorice root syrup was “exhibited” in this way (it requires storage “in a place protected from light”, but the manufacturer did not take care of this, packaging this syrup in ordinary transparent plastic). Since licorice root syrup is included in the mandatory list of Belarusian goods that should always be presented in a pharmacy window, pharmacies had to contrive with its display on the window. Someone put up a sign with the name of the syrup and the price, someone put up an empty (drunk) bottle, etc.

However, today in the pharmacies of Belarus there are sharply more such plates. On this occasion, we give you a quote from the recommendation letter of the Ministry of Health:

“With regard to medicinal products, on the packaging and in the instructions for medical use of which it is indicated: “to store in a place protected from light”, we clarify that this instruction means that the packaging does not provide complete protection of the medicinal product from the harmful effects of “actinic” light. In practice, such medicines should be stored in cabinets with non-transparent doors.”

It turns out that medicines that need to be “stored in a place protected from light” are recommended by the Ministry of Health to be hidden even from the light of lamps.

Moreover, this letter does not answer the question: what kind of packaging does not protect the medicine from actinic light? Primary packaging or secondary? And if the primary packaging is “made of dark glass”? And if the secondary packaging is made of durable cardboard? Does it let light through too? Questions, questions...

According to the “new” storage rules, from the list of medicines of Belarusian (Russian) production, which are mandatory for availability in pharmacies of all forms of ownership, it is now necessary to store:

• Hematovit(in assortment) Exon RUP
• Glucose chewable tablets(in assortment) 2000 mg per pack. #15 Exon RUP
• Ginseng tincture in a bottle of 50 ml Belmedpreparaty RUP
• Magnesium sulfate 20g №1 package RUP Belmedpreparaty
• Hydrogen peroxide 3% 40ml №1 Belmedpreparaty RUP
• Licorice roots syrup 100ml Dialek UP
• Furadonin tablets 100mg in pack №10х2
• Furazolidone, tab. 50mg #10 Borisov Plant of Medical Preparations
• Cefazolin-Belmed 1.0 powder d / adj. r-ra d / in Belmedpreparaty RUP
• Cefotaxime sodium salt 1.0g powder d / adj. r-ra d / in Belmedpreparaty RUP
• Ceftriaxone sodium salt 1.0 g powder d / adj. r-ra d / in Belmedpreparaty RUP
• Citramon-Borimed, pills №6 Borisov Plant of Medical Preparations

Etc. (if you find more - write).

Instead of medicines from this list, there should be signs with the name and price on the windows. Just in case, think about the suitability of your plates for wet cleaning, otherwise you will get a fine from the sanitation station.

Key takeaways from this article:

From the United States Pharmacopoeia (USP-NF): "if the product documentation states storage conditions in a 'sheltered place', this always means that measures should be taken to prevent exposure to direct sunlight, any other bright light, and ultraviolet rays , for example, by using dishes made of special glass or other opaque material, working in a darkened room, and even using furniture painted black on the inside, etc..”

The World Pharmacopoeias (USP, Eur.Ph.) and the WHO and ICH guidelines state the following rule: “photosensitive drugs must be packaged in light-protective consumer packaging and (or) stored in a place protected from light.” The responsibility for protecting the medicinal product from light always lies with the owner of the registration dossier.

The phrase "in a place protected from light" remains necessary for the text of regulatory documents that establish the requirements and rules for the acceptance, storage, shipment and transportation of medicines. It means that it is impossible to allow a long stay of the drug (regardless of the type of its packaging) in the sun, including near windows in a warehouse or in receiving and / or shipping areas, as well as near other light sources that generate strong thermal radiation.

In other words, in world practice, the responsibility for protecting a drug from light lies with the manufacturer (pharmaceutical plant) and relates more to the problem of working with pharmaceutical substances and packaging of finished drugs.

Dear readers, you can always contact us with questions on the intricacies of pharmaceutical legislation, and our authors will give a competent answer to them in the Legal Blog. Write to us at [email protected]

Detecting a violation of the storage conditions of medicines is one of the inspectors' favorites. At the same time, this topic is the Achilles' heel of pharmacy organizations. Because the legislation regulating it is ambiguous, sometimes contradictory and somewhat incomplete.

Take, for example, the problem of storing drugs in a place protected from light, as prescribed by most instructions for their use. Pharmacists and pharmacists periodically have questions regarding certain aspects of this problem.

For example, they are interested in whether such preparations can be laid out on a pharmacy display case or stored in a refrigerator with a glass door. We will try to answer these and other questions.

Our expert

Elena Nevolina

Executive Director of the non-profit partnership "Pharmacy Guild"

Three storage points

Let's start with the general part. Here, first of all, one should be guided 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 the Storage of Medicines”. Section VI of the order contains a subsection entitled "Storage of Medicinal Products Requiring Protection from Light", which includes paragraphs 24-26. Here are his positions:

- medicines that require protection from the action of light must be stored in rooms or specially equipped places that provide protection from natural and artificial lighting (paragraph 24);

- pharmaceutical substances that require protection from light must be stored in containers made of light-protective materials, in a dark room or cabinets(paragraph 25). This item is relevant primarily for pharmacies with a prescription and production department. By "light-shielding materials" we mean orange glass containers, metal containers, packaging made of aluminum foil or polymeric materials painted in black, brown or orange;

- medicinal products for medical use requiring protection from light, packed in primary and secondary packaging, should be stored in cabinets or on racks, provided that measures are taken to prevent direct sunlight or other brightly directional light from reaching them(paragraph 26). This paragraph also contains an indication of how this can be prevented - through the use of reflective films, blinds, visors and other appropriate devices.

Room illumination

Next, let's turn to general pharmacopoeial monograph with the same name "Storage of medicines" (OFS 1.1.0010.15), first introduced in XIII edition of the State Pharmacopoeia of the Russian Federation. Let us single out from it what is directly related to the topic under consideration.

First, natural and artificial lighting in storage rooms must ensure that all work operations are carried out accurately and safely. In other words, each workplace must have appropriate lighting so that an employee of a pharmacy organization has enough of it to carry out his professional functions and duties.

How it should be can be found in Order of the Ministry of Health of the Russian Federation of October 21, 1997 No. 309 "On approval of instructions for the sanitary regime of pharmacy organizations (pharmacies)". Annex 3 of this order, in particular, shows the illumination standards (in lux) for various pharmacy premises - from the customer service hall to the storage rooms for medicines, containers, various pharmacy departments, assistant, packaging, etc. The application also indicates how there must be a light source in each of these cases (fluorescent lamp or incandescent lamp), type of lamps, acceptable discomfort indicator, etc.

The head of the pharmacy organization needs to ensure compliance with these requirements of Order No. 309 in order to successfully pass the certification of the workplaces of the facility for working conditions (in terms of lighting), the results of which he must send to the State Labor Inspectorate for the subject of the Federation. We add to the above that paragraph 3.6 of the Instructions on the sanitary regime of pharmacies determines that the premises of pharmacies should have both natural and artificial lighting, and general artificial lighting must be provided in all pharmacy premises; in addition, local lighting is also installed for individual workplaces.

Photosensitive theme

Let's go back to the Pharmacopoeia. According to the OFS 1.1.0010.15 mentioned above, if necessary, protection of medicines from solar radiation should be provided. For this, in particular, a sufficient number of cabinets, shelving, safes must be equipped in the storage rooms.

In the OFS section on the features of storage of certain groups of medicines, several paragraphs are devoted to the topic we are considering. The first indication is of a general nature - pharmacy workers are required to ensure the storage regime specified in the pharmacopoeial monograph or instructions for use. The disclaimer follows immediately: deviations from the regulated conditions are allowed once only for a short period (no more than 24 hours) unless otherwise specified otherwise.

Continuing to shed light on this topic, OFS 1.1.0010.15 recalls that some drugs under the influence of light energy can change their properties: oxidize or, conversely, recover, decompose, change color, etc. Such drugs are called photo- or light-sensitive . Their labeling, as noted in the monograph, as a rule, contains the instruction "Keep in a place protected from light."

Further provisions of the pharmacopoeia textually almost coincide with the norms of paragraphs 24–25 of Order No. 706n “On Approval of the Rules for the Storage of Medicines”, being, apparently, borrowed from it. The OFS contains a clarification that if glass containers are used as packaging for pharmaceutical substances that are especially sensitive to light (the color of the glass is not indicated here in the text of the Pharmacopoeia), then it must be pasted over with black opaque paper.

OFS 1.1.0010.15 also establishes that photosensitive medicinal products must be packed in light-protective secondary (consumer) packaging and/or should be stored in a place protected from light. Let us pay special attention to the presence of two unions here - not only “and”, but also “or”. This nuance will come up below when we try to answer common questions on the topic.

Secondary packaging as light protection

Some pharmacists and pharmacists say that in the course of control measures against their pharmacy organization there were claims from inspectors for the reason that the latter believed that drugs that, according to the instructions, should be stored in a place protected from light, should not be placed on the pharmacy showcase or store in a refrigerator with a glass door. The logic of the inspectors in such cases is as follows: on the showcase, these medicines are under the direct influence of artificial lighting; it also penetrates through any transparent glass.

Accordingly, such cases were often regarded as an administrative offense, that is, a gross violation of license requirements, and could result in the imposition of an appropriate administrative penalty. For officials, this is a fine from 5,000 to 10,000 rubles; for individual entrepreneurs (IP) - a fine from 4,000 to 8,000 rubles. or administrative suspension of activities (ADS) for up to 90 days; for legal entities - a fine from 100,000 to 200,000 rubles. or APD up to 90 days. From January 2017, these fines may increase significantly: for officials - from 25,000 to 35,000 rubles, for legal entities and individual entrepreneurs - from 200,000 to 300,000 rubles. or APD for up to 90 days.

In a word, the punishment for errors in the storage of photosensitive drugs is significant, almost ruinous. But is there an error in the above cases? Let us quote once again an excerpt from the Pharmacopoeia: vetosensitive medicinal products should be packed in light-protective secondary (consumer) packaging and / or should be stored in a place protected from light.

What does the presence of the union “or” mean here? It means that even if we consider a pharmacy display case or a pharmaceutical refrigerator with a glass door as a place not protected from light, then placing a medicinal product in a secondary package in these places is not a violation of the storage rules.

“If the medicine is stored in the manufacturer’s secondary packaging,” comments Elena Nevolina, Executive Director of the Pharmacy Guild Non-Commercial Partnership and the National Pharmaceutical Chamber Union, “this already indicates that the storage conditions (in terms of protection from light) are met.” Based on this provision of the Pharmacopoeia, Elena Nevolina considers the claims of the inspectors described above to be insufficiently substantiated and recommends that pharmacy organizations defend their position in such cases.

Up to and including a written request to the manufacturer with a question whether the cardboard of their secondary packaging provides light protection. The text of such a request, together with the cited provision of the OFS, may be presented when considering a case on an administrative offense.

Models on display

Some pharmacy workers offer the following way out of the situation - to place empty boxes of medicines on the showcase. Such a decision seems dubious. If these are dummies, then you can’t stock up on all preparations with a light-protective storage regime. Yes, and troublesome, costly to do this - a huge waste of time that could be spent more usefully, in particular, on serving visitors. And if you put empty secondary packaging on the windows, then this is even more wrong. After all, in this case, there is a problem of storing the primary packaging of this drug. And they just need to be stored in a place protected from light, because the primary packaging, as follows from the legislation, unlike the secondary one, does not provide a light-protective regime.

Elena Nevolina gives a relevant example. It is impossible to remove light glass ampoules, placed in transparent plastic, from the secondary packaging (which is “for showcase”) and place them in a refrigerator with a glass door for storage. In this case, it will be necessary to take additional measures to protect these ampoules from light, emphasizes Elena Nevolina, summarizing: "Any such removal from the manufacturer's secondary packaging violates the light protection guarantee it provides."

Manufacturer's Warranty

Of course, the inspectors - in an effort to justify their case - can refer to paragraph 26 of Order No. 706n, the provisions of which partially contradict the cited pharmacopoeial norm. This is the main problem of regulation of this topic.

To solve it, we can propose the following measure: to express the pharmacopoeial norm in the form of a short inscription "Consumer packaging guarantees protection from light" on each secondary (consumer) drug packaging. This inscription would be important not only for resolving contradictions between pharmacy workers and inspectors, but also for consumers.

Elena Nevolina recalls that at the time Non-profit partnership "Pharmacy Guild" made an inquiry on this topic to many pharmaceutical manufacturers. In response to it, in particular, it was emphasized that the instruction “Keep in a place protected from light” is written not only for pharmaceutical workers, but also for consumers - so that they do not throw away the secondary packaging, do not transfer the dosage form to other storage containers.

And the final aspect of the topic. Some drugs with the indication "Keep in a dark place" are formally released in primary packaging (for example, in blisters), without secondary. According to the above norms, they cannot be laid out on a display case, but should be stored in dark cabinets. Elena Nevolina in this regard, he notes that the manufacturer is primarily interested in ensuring that its packaging provides proper storage conditions. Otherwise, any violation - for example, during transportation - will inevitably lead to damage to the drug. “And here the reputational damage can be very high, much higher than the costs that go to providing secondary packaging,” concludes Elena Nevolina.