Hospital Pharmacy Management System

In order to standardize the hospital pharmacy management of our hospital and ensure the safety and effectiveness of medication, in accordance with the "Regulations on the Administration of Medical Institutions" and "Implementation Rules", "People's Republic of China**" *The Drug Administration Law of the People's Republic of China and its Implementation Regulations, the Regulations on the Use of Drugs in Shandong Province, the Good Quality Management Practices for Drug Use in Shandong Province, and the Emergency Response Measures for Drug Safety Emergencies in Shandong Province have formulated this system.

Chapter 1 Personnel Management

1. Personnel Files

Personnel engaged in drug quality management, purchase, acceptance, maintenance, storage, and deployment should establish Personal files include copies of ID cards, copies of relevant professional qualification certificates, copies of professional and technical titles, annual business assessment forms, etc.

2. Health Records

Staff who are engaged in drug quality management, preparation, acceptance, maintenance, storage, etc. and have direct contact with drugs shall be designated by the drug supervision and administration department every year as a medical record of level 2 or above. Institutions or disease prevention and control institutions conduct health examinations and establish health files.

3. Learning system

Personnel engaged in drug quality management, purchase, acceptance, maintenance, storage, and deployment should receive training on pharmaceutical laws, regulations, and professional knowledge every week The concentrated study time should be no less than 1 hour.

Chapter 2 Drug Management

1. Purchase and Acceptance of Drugs

Purchasing drugs should be based on quality assurance and should be obtained from legally qualified drug manufacturers. , Drug wholesale enterprises purchase drugs, strictly review the qualifications of supplier units, purchased drugs and sales personnel, and establish supplier unit files.

Establish and implement a purchase inspection and acceptance system. Acceptance personnel must verify the packaging, specifications, labels, instructions, certificates of conformity and other identifications of the drugs batch by batch; those that do not meet the prescribed requirements shall not be purchased.

Establish true and complete drug purchase and acceptance records to ensure that invoices, accounts and materials are consistent. Purchase acceptance records shall be kept for 1 year beyond the validity period of the drug, but not less than 3 years.

2. Storage of drugs

Set up pharmacies and drug stores that are suitable for the scope of diagnosis and treatment and the scale of medication, and are separate from the diagnosis and treatment area and treatment area. The inner walls, ceilings and floors of pharmacies and drug stores should be smooth and flat, and doors and windows should be tight.

Storage medicines at normal temperature (temperature 0-30℃), cool (temperature not higher than 20℃), refrigerated (temperature 2-10℃), with relative humidity maintained at 45-75% between. Drugs that have special requirements for storage should be stored in accordance with the conditions and relevant regulations marked on the drug instructions or packaging. Do a good job in monitoring and managing temperature and humidity. If the temperature and humidity exceed the specified range, it should be adjusted and recorded in a timely manner.

Drug maintenance personnel should conduct regular inspections and maintenance and keep records. Inventory drugs should be maintained quarterly, displayed drugs should be maintained monthly, and key varieties should be maintained every half month; hidden dangers that affect the quality of drugs should be maintained Exclude them in a timely manner; unqualified products such as expired, contaminated or spoiled products shall be dealt with in a timely manner in accordance with relevant regulations.

3. Dispensing of drugs

Personnel who prepare drugs must have relevant pharmaceutical professional and technical qualifications.

The drugs to be dispensed should be suitable for the scope of diagnosis and treatment, and must be carried out with a prescription or medical order issued by a registered practicing physician, practicing assistant physician or rural doctor. Drugs may not be dispensed without a prescription from a physician.

Drug distribution should follow the principles of “first in, first out”, “first out with the nearest expiration date” and distribution by batch number.

When dispensing and dismantling drugs, independent dispensing and dismantling places or special operating stations should be set up according to clinical needs and cleaned and disinfected regularly to keep the working environment clean and tidy; the containers and tools used should be cleaned and disinfected regularly to prevent contamination. Medicines; when disassembling, the medicines must not be touched directly with bare hands. Detailed records must be kept and kept for at least one year.

After completing the prescription preparation, the prescription must be properly stored in accordance with relevant regulations.

IV. Management of Traditional Chinese Medicine Pieces

Personnel engaged in the procurement, storage, custody, and dispensing of Traditional Chinese Medicine pieces should undergo corresponding professional and technical training and obtain relevant qualification certificates.

The procurement, storage, storage, deployment and quality management of traditional Chinese medicine pieces shall comply with the relevant provisions of the "Hospital Management Specifications for Traditional Chinese Medicine Pieces".

When preparing prescriptions, personnel dispensing traditional Chinese medicine pieces should review prescriptions and prepare prescriptions in accordance with the relevant provisions of the "Prescription Management Measures" and the regulations for dispensing traditional Chinese medicine pieces. The weight error of each dose should be within ±5%.

5. Management of toxic drugs, narcotic drugs and psychotropic drugs for medical use

Manage in accordance with the relevant provisions of the "Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs"

Purchase Drugs subject to special management such as narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, etc., must be purchased from drug production or operating enterprises with corresponding qualifications.

Narcotic drugs, Class I psychotropic drugs, toxic drugs for medical use, and radioactive drugs should be stored in special warehouses or counters, so that two people can keep them, record them in special accounts, and keep the items in the accounts consistent.

The use of narcotic drugs and psychotropic drugs must be prescribed by a licensed physician, and the maximum dosage of a single prescription must comply with the regulations of the health authority of the State Council.

The dispenser and checker of the prescription shall carefully check, sign and register the prescription; if the prescription does not meet the requirements, the dispenser and checker of the prescription shall refuse to dispense the medicine.

Carry out special registration of narcotic drugs and psychotropic drug prescriptions and strengthen management. Prescriptions for narcotic drugs shall be kept for at least 3 years, and prescriptions for psychotropic drugs shall be kept for at least 2 years.

VI. Emergency response to drug safety emergencies

In accordance with the "Adverse Drug Reaction Reporting and Monitoring Management Measures", "Shandong Province Drug Safety Emergency Response Measures" and other relevant regulations for management.

The emergency response to drug safety emergencies should follow the policy of putting prevention first and being constantly prepared, and implement the principles of unified leadership, hierarchical responsibility, timely response, decisive handling, and handling in accordance with the law.

After a drug safety emergency occurs, it should be reported immediately to the local county-level food and drug administration department, and then to the provincial food and drug administration administration level by level.

After the occurrence of drug safety emergencies, actively cooperate with relevant departments to identify the causes of serious damage to public health, such as major drug quality incidents, mass drug harm incidents, serious adverse drug reactions, major manufacturing Cases of selling counterfeit and substandard drugs and other drug safety emergencies that seriously affect public health.

Chapter 3 Medical Device Management

Manage in accordance with the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices".

Purchase qualified medical devices from manufacturing enterprises that have obtained the "Medical Device Manufacturing Enterprise License" or operating enterprises that have obtained the "Medical Device Business Enterprise License" and verify the product qualification certificate.

Single-use medical devices shall not be reused; once used, they shall be destroyed in accordance with relevant national regulations and recorded.

For adverse reactions caused by medical devices, fill in the "Suspicious Medical Device Adverse Event Report Form" and report it in accordance with relevant regulations

Chapter 4 Related Files, Records and Voucher Management

1. Establish and improve a job responsibility system and strictly implement it.

2. The files of relevant personnel, drugs, and drug purchasing units shall be kept by dedicated personnel.

3. Physician prescriptions shall be kept by specialized personnel in accordance with relevant regulations.

4. After the authority to prescribe and the signature of the physician are reviewed and approved by the medical department, the signature and handwriting of the prescription should be recorded in the pharmacy.

Chapter 5 Others

1. Staff must have relevant professional qualification certificates.

2. The management of pharmacies and medicine warehouses shall be carried out in accordance with the relevant provisions of the "Regulations on the Management of Medical Institutions".

3. Medical waste shall be disposed of in accordance with the relevant provisions of the "Medical Waste Management Regulations"

4. This system will come into effect from the date of promulgation.