Periodic report on special control drugs

The detailed regulations on certain provisions and implementation measures of the Law on Pharmacy were issued on May 8, 2017, and Circular 20/2017/TT-BYT: “Detailed regulations on certain provisions of the Law on Pharmacy and Decree No. 54/2017/ND-CP dated May 8, 2017, of the Government on drugs and drug ingredients subject to special control” was issued on May 10, 2017. In this article, SPHACY will provide a detailed analysis of the importance of periodic reporting, the implementation process, common challenges, and support solutions to help pharmacies complete this task effectively.

1. What are special control drugs?

1.1 Definition

Special control drugs are medications that are strictly regulated by health authorities and the government due to their high risk of abuse, addiction, or strong impact on human health.

1.2 Classification of special control drugs

• Addictive drugs

Addictive drugs include the following types:

a) Drugs containing one or more addictive substances, or drugs containing addictive substances combined with psychotropic substances, with or without precursors used as medicines as specified in Appendices I, II, and III attached to Circular 20/2017/TT-BYT.

b) Drugs containing addictive substances (with or without psychotropic substances, precursors used as medicines) combined with other substances that are not addictive substances, psychotropic substances, or precursors used as medicines, where the concentration or content of addictive substances exceeds the levels specified in Appendix IV attached to Circular 20/2017/TT-BYT.

• Psychotropic drugs include the following types:

a) Drugs containing one or more psychotropic substances, or drugs containing psychotropic substances combined with precursors used as medicines as specified in Appendices II and III attached to Circular 20/2017/TT-BYT.

b) Drugs containing psychotropic substances (with or without addictive substances, precursors used as medicines) combined with other substances that are not addictive substances, psychotropic substances, or precursors used as medicines, where the concentration or content of psychotropic substances exceeds the levels specified in Appendix V of this Circular, and the concentration or content of addictive substances (if any) is less than or equal to the levels specified in Appendix IV attached to Circular 20/2017/TT-BYT.

• Precursor drugs include the following types:

a) Drugs containing one or more precursors used as medicines as specified in Appendix III attached to Circular 20/2017/TT-BYT;

b) Drugs containing precursors used as medicines (with or without addictive substances, psychotropic substances) combined with other substances that are not addictive substances, psychotropic substances, or precursors used as medicines, where the concentration or content of precursors used as medicines exceeds the levels specified in Appendix VI attached to Circular 20/2017/TT-BYT, the concentration or content of addictive substances (if any) is less than or equal to the specified levels, and the concentration or content of psychotropic substances (if any) is less than or equal to the levels specified in Appendix V attached to Circular 20/2017/TT-BYT.

• Combination drugs containing addictive substances include drugs that simultaneously meet the following conditions:

a) Contain addictive substances; or addictive substances combined with psychotropic substances, with or without precursors used as medicines, where the concentration or content of addictive substances, psychotropic substances, and precursors used as medicines are all less than or equal to the levels specified in Appendices IV, V, and VI attached to Circular 20/2017/TT-BYT;

b) Contain other substances that are not addictive substances, psychotropic substances, or precursors used as medicines.

• Combination drugs containing psychotropic substances include drugs that simultaneously meet the following conditions:

a) Contain psychotropic substances, or psychotropic substances combined with precursors used as medicines, where the concentration or content of psychotropic substances and precursors used as medicines are all less than or equal to the levels specified in Appendices V and VI attached to Circular 20/2017/TT-BYT;

b) Contain other substances that are not addictive substances, psychotropic substances, or precursors used as medicines.

• Combination drugs containing precursors include drugs that simultaneously meet the following conditions:

a) Contain precursors used as medicines, where the concentration or content of precursors used as medicines is less than or equal to the levels specified in Appendix VI attached to this Circular;

b) Contain other substances that are not addictive substances, psychotropic substances, or precursors used as medicines.

• Medicines and substances in the List of medicines, substances in the List of banned substances for use in certain industries, fields:

The medicines and substances in the List of medicines, substances in the List of banned substances for use in certain industries, fields are selected according to the principles stipulated in Article 41(2) of Decree No. 54/2017/NĐ-CP dated May 8, 2017 detailing a number of provisions and measures for the implementation of the Pharmacy Law (hereinafter referred to as Decree No. 54/2017/NĐ-CP).

2. Why Should We Prepare Periodic Reports on Special Control Drugs?

2.1. Legal Compliance

Submitting periodic reports is a mandatory legal requirement. Failure to comply can lead pharmacies to face penalties such as fines, suspension of operations, or revocation of business licenses.

2.2. Effective Inventory Management

Periodic reporting helps pharmacies closely monitor the quantity of drugs received, dispensed, and remaining in inventory. This helps prevent shortages or excessive stockpiling of drugs, ensuring continuous and stable supply to customers.

2.3. Ensuring Safety for Users

Special control drugs often pose high risks of abuse and addiction. Close monitoring ensures that these drugs are used for their intended purposes, minimizing the risks of misuse or abuse.

3. Implementation Process of Periodic Reporting on Special Control Drugs

3.1. Data Collection 

Pharmacies need to meticulously record details of drug quantities received, dispensed, and remaining in inventory during the reporting period. This information includes drug names, batch numbers, expiration dates, and suppliers.

3.2. Verification and Data Validation 

After collecting information, pharmacies must verify the data to ensure accuracy and completeness. Errors in data can lead to report rejection or legal issues.

3.3. Completion of Reporting Forms 

Using standard forms provided by regulatory authorities, pharmacies fill out all necessary information required for the reporting. These forms typically demand detailed information about each type of special control drug.

3.4. Submission of Reports 

Pharmacies must submit the reports to the regulatory authority by the specified deadline, often before a specific date (e.g., July 15 annually). Timely submission ensures compliance with regulations and mitigates legal risks.

4. Challenges Often Encountered in Performing Periodic Reporting

4.1. Errors in Data Recording 

Manual recording and compiling of data can lead to errors. This not only consumes time but can also cause serious issues when the data is inaccurate.

4.2. High Workload 

Collecting and processing data demands considerable time and effort, especially for pharmacies with large-scale operations and a significant volume of special control drugs.

4.3. Lack of Understanding of Regulations 

Incomplete or incorrect reporting may result from a lack of understanding of regulatory requirements. This can lead to legal and administrative issues.

5. Solutions to Support Periodic Reporting

5.1. Use of Pharmacy Management Software 

Implementing pharmacy management software automates the data collection and processing process, minimizing errors and saving time. These software solutions often integrate automatic reporting features, making it easier for pharmacies to monitor and submit reports on time.

5.2. Employee Training 

Conduct training sessions to ensure staff understand the procedures and requirements of periodic reporting. Well-trained employees can reduce errors and enhance work efficiency.

5.3. Professional Consulting 

Seek assistance from experts or consulting services to ensure timely and accurate completion of reports. These services provide professional and optimized solutions for periodic reporting.

6. Benefits of Timely Submission of Periodic Reporting on Special Control Drugs

6.1. Legal Compliance 

Avoid penalties and legal risks, ensuring smooth and sustainable business operations for pharmacies.

6.2. Effective Management 

Help pharmacies manage inventory and use special control drugs efficiently, minimizing the risk of shortages or excess stock.

6.3. Enhanced Reputation 

Ensure credibility and trustworthiness of the pharmacy in the eyes of regulatory authorities and customers. Compliance with regulations and timely submission of reports help pharmacies build a professional and reliable image.

Conclusion

Periodic reporting on special control drugs is not only a mandatory task but also a crucial part of pharmaceutical management in pharmacies. Adhering to the correct procedures and deadlines helps pharmacies comply with legal regulations, manage inventory effectively, and ensure safety for users. Take proactive steps to complete periodic reports today to ensure regulatory compliance and enhance the quality of pharmacy services.