Does It Matter Where I Store Medications?

In order to ensure the safety of patients, in addition to understanding the contraindications of patients' medication, the quality of the drugs should also be guaranteed. To ensure the quality of medicines, medicines must be stored reasonably, correctly and strictly.

In order to ensure the safety of patients, in addition to understanding the contraindications of patients' medication, the quality of the drugs should also be guaranteed. To ensure the quality of medicines, medicines must be stored reasonably, correctly and strictly.

The reserve that is formed after many stays in the distribution process of pharmaceuticals from the production to the consumption field is an essential and important link in the distribution process of medicines. Conservation of drugs: the use of modern science and technology and methods to study the technology of drug storage and conservation and the quality of stored drugs Change the law, prevent the deterioration of medicines, ensure the quality of medicines, and ensure that the medication is safe and effective.

Drug storage

Medicines are an important means to prevent, treat, and diagnose diseases. The quality of medicines is directly related to the health of patients and even the safety of their lives. The stability of a drug is not only related to its own properties, but also to a large extent affected by many external factors, such as temperature, humidity, light, oxygen in the air, carbon dioxide, microorganisms, storage time, packaging containers, etc. These factors often cause changes in medicines such as decomposition, volatilization, precipitation, deliquescent, rancidity, and mildew. In order to ensure the quality of medicines, the correct storage of medicines is particularly important.

Drug storage

( 1 ) Color label management

In order to effectively control the quality of drug storage, drugs should be managed by district according to their quality status, and in order to prevent storage errors of stock drugs, color label management must be implemented for drugs in stock.

The color standard for drug quality status is:

Qualified drugs-green; unqualified drugs-red; drugs with unclear quality status-yellow.

According to the actual needs of the warehouse management, the unified standard for color division of the warehouse management area is: the drug store (or area) to be tested, the returned drug store (or area) are yellow; Pick-up (or district) and pending drug warehouse (or district) are green; unqualified drug warehouse (or district) is red. The three-color sign is based on the background color, and the text can be expressed in white or black to prevent color label confusion ^[1] .

( 2 ) Requirements for handling and stacking

Strict compliance with the requirements for the graphical marking of drug packaging and standardize operations. Drugs that are afraid of being pressed should control the stacking height to prevent squeezing deformation of the packaging box. Drugs should be stacked in a relatively concentrated manner according to the variety and batch number, and stacked separately. Drugs of different varieties or different batches of the same type must not be stacked to prevent accidents caused by wrong hair.

( 3 ) Drug stacking distance

There should be corresponding distances or isolation measures between the drug stacks and the floor, walls, ceilings, and radiators between the warehouses. A sufficient width of goods passages should be set up to prevent the facilities in the warehouse from affecting the quality of the drugs and ensure effective storage and maintenance management. Carry out. The distance requirements for medicine stacks are: the distance between the medicine and the wall, the medicine and the roof (house beam) is not less than 30 cm, the distance from the warehouse radiator or heating pipe is not less than 30 cm, and the distance from the ground is not less than 10 cm. In addition, the width of the main channel between the warehouses should be no less than 200 cm, and the width of the auxiliary channel should be no less than 100 cm.

( 4 ) Classified storage management

There should be warehouses suitable for the classification and management of drugs, which should be stored in accordance with the management requirements, uses, and properties of the drugs. Drugs that can be stored in the same warehouse, but should be separated in different positions are: non-drugs, drugs for internal use and external drugs for drugs and food and health products. Drugs that should be kept in stock and should not be mixed with other drugs in the same warehouse include medicines that are easy to smell, Chinese medicinal materials, Chinese medicine decoction pieces, specially managed drugs, and dangerous goods.

( 5 ) Temperature and humidity conditions

Drugs should be stored in the corresponding warehouses according to the temperature and humidity requirements of the drugs, and all types of drug storage warehouses of drug distributors should be kept at a constant temperature. For each drug, it should be stored in cold storage (2-10 ° C), cool storage (below 20 ° C) or normal temperature storage (0-30 ° C) according to the storage conditions of the drug. The relative humidity of each storeroom should be Keep it between 45% and 75%.

The required temperature range of the cold storage, cool storage and normal temperature storage should be based on the principle of ensuring the quality of the drug and meeting the storage conditions specified by the drug, and set it scientifically and reasonably, that is, the temperature and humidity of the drug should be stored. Then, a warehouse with a corresponding temperature and humidity range should be set up. If the medicine is stored at 15-25 , a thermostatic storage room at 15-25 should be set up.

For drugs with two or more different temperature and humidity storage conditions, they should generally be stored in a relatively low-temperature warehouse. For example, the storage conditions for a drug label are: 3 years below 20 ° C and 1 year at 20-30 ° C. Store the medicine in a cool store.

( 6 ) Storage of Chinese medicinal materials and decoction pieces

Corresponding storage warehouses should be set up according to the nature of Chinese medicinal materials and Chinese medicine decoction pieces to properly control the temperature and humidity conditions. For varieties that are susceptible to insect worms, mildew, oil, and discoloration, sealed, dry, cool, and clean warehouses should be set up; for species that have a small business volume and are liable to discoloration, volatilization, and melting, they should be equipped with light and heat Storage equipment, such as refrigerators and freezers.

Special drugs, special accounts, special warehouses (or cabinets), and double locks should be used for the storage of poisonous hemp Chinese medicine.

Drug storage

1. Poor drug storage conditions in drug warehouses and pharmacies Most factories, mines, hospitals, college clinics, and township-level medical institutions have no heat insulation devices, indoors, and no air conditioners or exhaust fans. Some need to be stored in a cool store (temperature (Above 20 ° C) medicines such as penicillin and cefuroxime sodium injection for injection are stored at normal temperature (0-30 ° C). There are no facilities such as a tripod and an insect-proof device. The medicine directly contacts the ground or the wall, and it is easy to absorb moisture and mildew in wet and rainy seasons. Various medicines of village-level medical institutions are randomly placed and not classified according to requirements.

2. Insufficient refrigeration equipment Only factories and mine hospitals, college outpatient departments, and medical institutions at or above the county level are equipped with refrigerators, or a refrigerator is used with biochemical reagents. Village-level medical institutions do not have dedicated refrigerators, and those with refrigerators are also mixed with families.

3. Insufficient temperature and hygrometer equipment Some basic medical institutions are equipped with temperature and hygrometer, but there is no record. When the temperature and humidity exceed the specified range, effective measures cannot be taken. Village-level medical institutions are basically not equipped with temperature and hygrometer, and they cannot grasp medicines in time. The storage conditions, temperature and humidity regulation became an empty word.

4. Awareness of laws and regulations Talking about the drug management personnel of thin- level medical institutions do not store drugs in accordance with laws and regulations. Although the "Drug Management Law" and "Implementing Rules for the Implementation of Goods Management Quality Management Regulations" have made corresponding provisions for drug storage conditions, Provision for storage of medicines ^[2] .

5. Poor management or low quality of pharmaceutical technicians Some medical institutions do not even have pharmaceutical technicians. Some warehouse managers failed to strictly follow the rules and regulations, and incorrectly stacked them, which led to the phenomenon of odor, moisture, and insects.

6. Periodic inspection is in the form of the warehouse management staff is not serious and responsible during the regular inspection, only routine inspections in the form will inevitably cause the accumulation and spread of hidden dangers ^[3] .

Drug storage

1. Raising awareness of safe storage is a prerequisite

The storage of drugs is the last procedure before use. The quality of the storage directly determines the quality of the drugs after they go out of the warehouse. If the storage process is not strengthened, it will affect the development and efficiency of the enterprise, and endanger life and safety. . Enterprises not only need to increase investment in warehouse infrastructure, but also strengthen personnel audits, actively conduct business training, and carry out regular inspections to ensure that each link runs in an orderly manner.

2. Scientific and reasonable storage is the foundation

2.1 Strengthening the construction of drug storage facilities in medical institutions Drugs are affected by factors such as temperature, moisture, and light. Drugs are stored at room temperature, low temperature, frozen, refrigerated, and protected from light. Add refrigeration equipment in pharmacies and drug warehouses, improve the current situation of drug storage without air-conditioning, and ensure that drugs stored at room temperature are controlled below 30 ° C; Equipped with a refrigerator to ensure that drugs stored in cold places are controlled below 10 ° C; In a cool warehouse, ensure that the temperature of the medicines stored in the shade and protected from light is controlled below 20 ° C; Install an exhaust fan to ensure the flow of air; Equip with a thermo-hygrometer to regulate the temperature and humidity of the pharmacy and warehouse.

2.2 Classified storage according to the nature and management requirements of drugs. Drugs and non-drugs must be stored separately. This is because drugs are special commodities for life-saving treatment, and their quality must be foolproof. Dedicating drugs to stocks is to prevent drugs from being contaminated by other non-drugs or causing errors. Drugs refer to substances used to prevent, treat, and diagnose human diseases, purposefully regulate human physiological functions, and provide indications for usage and dosage, including Chinese medicinal materials, Chinese medicine pieces, proprietary Chinese medicines, chemical raw materials and their preparations, and antibiotics , Biochemical drugs, radioactive drugs, serum vaccines, blood products and diagnostic drugs. According to the "Drug Administration Law", a drug must also have a drug production approval number, registered trademark, and production batch number (except for Chinese medicinal materials), otherwise it is a non-drug. In addition, medicines that affect each other or are susceptible to taint should be stored separately to prevent contamination or affect safety; internal and external medicines should be stored in separate warehouses or partitions to prevent contamination or errors; varieties that are easily confused by product names or packaging shapes It should be stored in zones to prevent errors; dangerous goods must be stored in dangerous goods warehouses.

3. Regular inspection of the quality of stock drugs is a guarantee

In terms of storage conditions, we try our best to meet the needs of the characteristics of the drug, but the quality of the drug in stock must be judged by regular quality inspection. This quality inspection should be a tour inspection. General medicines are inspected once a quarter, and the validity period is inspected once a month. The inspection is mainly based on visual inspection, and the internal quality inspection shall be supplemented. In addition, the enterprise should organize relevant departments to conduct two comprehensive quality inspections and inspections of storage conditions every year to find out problems and research and solve them in time, so that the inventory of drugs is always in a qualified state to facilitate market supply. Wholesale companies selling pharmaceuticals should keep good sales records, especially the batch number of the pharmaceuticals. If there are any problems, they can be tracked immediately.

4. Strengthen the legal awareness of drug regulators

To implement the drug management law to ensure the quality of drugs and the safety of patients' medication, we must strengthen the management of drug storage. First of all, it is necessary to increase the publicity of drug laws and regulations and improve the legal awareness of medical institutions and drug management personnel; The drug supervision department has stepped up efforts to correct the non-conformities in a timely manner. For drugs that are not stored as required, According to Article 49 (3) (6) of the Drug Administration Law, treat as inferior drugs.

Drug storage V. Basic requirements for drug storage and conservation

(I) Basic requirements for personnel

Qualifications

The person in charge of the quality management organization: According to the size of the enterprise, there should be full-time personnel who meet the qualifications of the company's quality leader. The working conditions can adhere to the principle. Practical experience can independently solve the quality problems in the actual work process. Quality management, inspection, acceptance, maintenance, and Staff for measurement: Wholesale enterprises should be no less than 4% of the total number of employees, and the minimum should not be less than 3; retail chain enterprises should be no less than 2% of the total number of employees, and the minimum should be no less than 3.

Health check-ups in direct contact with medicines: at least once a year

Quality management, drug acceptance, maintenance, storage: regular inspection

Diseases that are not allowed to be in direct contact with medicines: mental health, infectious diseases, other diseases that may contaminate medicines
Personnel training, education, quality management and acceptance personnel: should receive continuing education organized by the provincial drug regulatory department every year

Maintenance, measurement and other personnel: should continue to receive continuing education from enterprise organizations

Training and education content: 1. Drug laws, regulations, rules 2. Professional technology, drug knowledge, professional ethics

(II) Requirements for facilities and equipment

1.Warehouse area (building area)

500 m for small businesses 1000 m for medium businesses 1500 m for large businesses

2.Temperature and humidity conditions

Storehouses suitable for classified drug storage and meeting the requirements for drug storage: cold room temperature 2 -10 ; shady storeroom temperature: <20 ; room temperature storeroom temperature: 0 -30 ; storehouse humidity: 45% -75%

3. Drug inspection room

Area: Large Enterprise: 150m Medium Enterprise: 100m Small Enterprise: 50m

4. Acceptance and maintenance room

Area: Large Enterprise: 50 m Medium Enterprise: 40 m Small Enterprise: 20 m

Equipment: moisture-proof, dust-proof instruments: one-thousandth balance, clarity tester, standard colorimetric solution, disintegrator, Chinese medicinal materials, Chinese herbal medicine, moisture analyzer, ultraviolet fluorescent lamp, microscope

5.Other

Pharmaceutical wholesale and retail chain enterprises should have fixed packaging rooms for powdered Chinese medicine decoction pieces; drug retail chain enterprises should set up separate distribution places that are convenient for distribution activities.

Drug storage VI. Purpose and significance of drug storage and conservation

1.Objective: To ensure the safety of medicines during storage, to ensure the value of medicines, to strengthen the circulation of medicines, to meet the needs of people in preventing and treating diseases, to monitor the quality of medicines, to ensure the safety and effectiveness of medicines, and to protect the interests of medicine users

2. Significance: Instruct the storage staff to reasonably store the drugs, cooperate with the storage staff to manage the temperature and humidity, regularly check the stock of drugs, and sample the drugs that have doubts about the quality, and report the problems in time.

Drug storage

Aiming at different storage conditions and combining the requirements of the Good Manufacturing Practices, in the daily work, we should pay more attention to the storage and maintenance of medicines, strengthen the sense of work responsibility, be familiar with the physical and chemical characteristics of various medicines, and adopt scientific, Reasonable storage of medicines is a necessary measure to ensure the controllable quality of medicines, and it is also a prerequisite for medicines to give play to the essential attributes of healing and saving lives.