Officials Interpret Hubei Province's Drug Use Quality Management Regulations

If hospitals and pharmacies purchase inferior drugs, or fail to comply with the preservation regulations, leading to drug failure, all must bear legal responsibility!

Tomorrow, the Regulations on the Administration of the Quality of Pharmaceutical Use in Hubei Province will be formally implemented. As an important regulation for the safety of public drug use in Hubei, what impact will it have on citizens?

Yesterday, Xiao Hong, Deputy Director of Wuhan Food and Drug Administration, and Lin Xinghua, Director of the Department of Drug Safety Supervision received an exclusive interview with this reporter’s “People’s Inquiry”. They said that this new regulation starts with many details to protect the public. Medication safety.

Details: 80% of the people taking medicines from medical institutions must be aware of the "flowing accounts"

"80% of the total pharmaceutical product is provided to patients through medical institutions," Xiao Hong said. Therefore, regulating the use of drugs by medical institutions is the most critical.

The “Hubei Provincial Drug Use Quality Management Regulations” to be implemented on August 1 clearly stated that “drug use units must check the “Drug Production License” or “Pharmaceutical License” and “Business License” of the supplier for the purchase of drugs. 》, approval documents for the sales of medicines, etc., and verification of the original power of attorney held by the salesperson and the original ID card. The drug use unit should request and retain the legal bills of the supplier when purchasing drugs and establish purchases. Records, consistent with bills, accounts and drugs.”

The new regulations clearly stipulate the purchase channels for the use of drugs and acceptance of purchases.

"These accounts must be recorded for future reference."

The new regulations also “encourage and support units and individuals to report and complain about behaviors that affect the quality of drug use. The relevant departments should promptly investigate and handle complaints after receiving reports and complaints.”

Details II: Violations of the Law for Purchasing Substandard Drugs and Medical Institutions Are Subject to Severe Punishment Xiao Hong announced a case that had just been penalized: In March of this year, the Bureau's inspection branch conducted several on-site inspections of a hospital pharmacy and discovered several cephalosporins. Antibiotics were provided by Zhang, who had been punished as a result of unlicensed drugs for half a year ago.

After investigation, it was discovered that Zhang had used the name of a pharmaceutical company to conduct drug purchase and sales activities with the hospital. There were 3 kinds of medicines worth 33,000 yuan and the hospital had used 26,000 yuan of medicines. After inspection, it was determined that there was an oral antibiotic that was inferior and the value of the product was 6,000 yuan. It was used up. Subsequently, a staff member of the pharmacy department of the hospital admitted that because he was an acquaintance with Zhang, he only viewed and retained the photocopies submitted by him. Its qualifications have not been strictly reviewed.

After investigation and evidence collection, the hospital used an inferior drug to impose an administrative penalty of 6,000 yuan for confiscation of illegal income and a fine of 12,000 yuan. It also confiscates the remaining drugs, confiscates 26,000 yuan of illegal income and fines 66,000 yuan for illegally purchasing drugs (illegal channel purchases). Administrative penalties. Zhang handled the case separately.

Xiao Hong said that after the introduction of the new regulations, such illegal purchase of inferior drugs, medical institutions will be punished.

Details 3: Persons who come into contact with the drug must be medically checked for violations every year and must be "sold up".

Drugs are related to public health, but if the drugs are qualified, are those exposed to these drugs physically healthy?

Xiao Hong introduced that the new law has taken note of this detail and clearly requested that "drug users should organize direct contact with the drug every year to conduct health checks and establish health records."

In addition, once a drug-using unit has one of the following four illegal acts, if it fails to correct it within the time limit, it shall be fined between 2,000 yuan and 20,000 yuan. If the circumstances are serious, "the relevant department may revoke the practice license according to law."

These four kinds of behaviors are: Violating the regulations, arranging for persons with infectious diseases or other diseases that may contaminate drugs to engage in direct contact with drugs; failing to implement the purchase acceptance system as required, obtaining legal bills, and establishing a true and complete acceptance record; Storage and maintenance of drugs; failure to keep records of the purchase, acceptance, storage, maintenance, and deployment of drugs, as required.