NHC Issues 'Prescription Review Guidelines', Empowering Pharmacists to Enable Prescription Sharing and Extension

VCBeat (WeChat ID: vcbeat) has learned that the National Health Commission, the State Administration of Traditional Chinese Medicine, and the Logistics Support Department of the Central Military Commission recently jointly issued the "Specifications for Prescription Review in Medical Institutions." For the first time, these specifications clearly define the following aspects regarding prescription supervision in medical institutions:

1. Conduct reviews of prescriptions for legality, standardization, and appropriateness.

2. All prescriptions must be reviewed and signed by a pharmacist before they can proceed to the pricing, billing, and dispensing stages; prescriptions that have not passed review shall not be billed or dispensed.

3. Medical institutions shall actively promote the informatization of prescription review and may utilize information systems to facilitate this process.

4. The name of the drug shall use the generic name approved and published by the drug regulatory authority.

5. Pharmacists are the primary persons responsible for prescription review.

This represents another major authoritative standard and basis pertaining to prescriptions, following the Measures for the Administration of Prescriptions and the Specifications for the Management of Hospital Prescription Review. The Standard explicitly sets forth requirements regarding the objectives and processes of prescription review, as well as the final quality assurance system. It can be said that, against the current backdrop of the separation of prescribing from dispensing and tiered diagnosis and treatment, this is the most practical, operable, and enforceable standard.

The head of Beijing Kuai Xingfang Enterprise told VCBeat that the release of the “Specifications” is of great significance for enhancing the effectiveness of prescription supervision, promoting the separation of prescribing and dispensing, and strengthening the role of pharmacists.

First, under the vigorous promotion of tiered diagnosis and treatment, medical services are being decentralized to primary care institutions. To effectively absorb the patient flow transferred from large hospitals, these grassroots facilities must improve their quality of care, including prescription management. Services such as secondary prescriptions and chronic disease prescriptions should be manageable at the primary level. However, in this context, errors such as incorrect prescribing, dispensing mistakes, and operational mishaps occur frequently. This is precisely because the staffing, professional expertise, and proficiency of pharmacists at the primary level fail to meet the standards required by secondary and tertiary hospitals; in some cases, there are no qualified pharmacists at all.

In this context, the level of prescription review at primary care institutions can be improved through a combination of computer-assisted auditing and manual verification. The currently known regional cloud-based prescription review platform, KuaiXingFang (by Kuaima Medical), along with regional prescription review centers, enables clinical pharmacists from secondary and tertiary hospitals to provide rational drug use guidance and conduct prescription reviews for primary healthcare institutions, thereby effectively enhancing the quality of prescriptions at the primary care level.

Secondly, against the backdrop of the separation between medical services and pharmaceutical sales, a portion of prescriptions has been diverted to social pharmacies and drugstores. Implementing billing, pricing, and pharmaceutical distribution only after prescription review serves as a real-time constraint mechanism. This approach effectively mitigates the risks associated with sharing prescriptions in the community and addresses the deficiency of lack of oversight by enabling effective interception and control at the prescription issuance stage.

“The Guidelines” specify that drug names shall use the generic drug names, patented drug names of new active compounds, and combination product names approved and published by the drug regulatory authorities, or the customary drug names published by the former Ministry of Health; hospital preparations shall use the names formally approved by the drug regulatory authorities. These measures help break the practices of physician kickbacks and funding healthcare through drug sales by promoting the use of generic names, de-branding, and reducing physicians’ discretion in drug selection, while simultaneously accelerating the outflow of prescriptions from hospitals.

The "Guidelines" also enhance pharmacists' engagement and functional role in medication safety. By underscoring the importance and involvement of pharmacists, the Guidelines recognize them as a critical component throughout the global prescription lifecycle and its related processes, even extending to prescribing privileges. The Guidelines clearly establish pharmacists' primary responsibility for prescription review, aiming to transform the traditional practice where medications are dispensed immediately upon physicians' prescribing. This shift is expected to address the historical undervaluation of pharmacists across various stages of clinical pharmaceutical services, strengthen the pharmacist workforce, and significantly advance talent development within the pharmacy profession.

“The Standard” only stipulates the regulations for clinical pharmacists dispensing prescriptions within medical institutions, requiring that clinical prescriptions must be handled by individuals with at least three years of experience in dispensing outpatient, emergency, or inpatient ward prescriptions. It also provides further reference for the future regulation of licensed pharmacists in pharmacies.

In fact, prescription review was already stipulated in Article 33 of the Measures for the Administration of Prescriptions, which officially came into effect on May 1, 2007. “Pharmacists shall dispense prescribed medications in accordance with standard operating procedures: carefully review prescriptions, accurately dispense medications, and provide medication counseling and guidance, including instructions on the usage, dosage, and precautions for each medication.”

However, due to heavy workloads and ill-defined responsibilities, rights, and benefits for pharmacists, most hospitals have failed to implement these measures effectively. Currently, artificial intelligence has entered the pharmaceutical sector, particularly in areas such as intelligent imaging and smart pharmacy services. With the maturation of computer-assisted prescription review, the efficiency of this process has improved significantly. Companies such as Sichuan Meikang, Hangzhou Yiyao, and Kuai Xing Fang (Kuaima Medical) are continuously exploring this niche segment and have gained widespread recognition.

The Guidelines encourage the deployment of corresponding prescription review tools and the establishment of prescription review information systems in medical institutions; pharmacists are the primary persons responsible for prescription review. Pharmacists shall conduct a item-by-item review of all content in prescriptions. Medical institutions may utilize relevant information systems to assist pharmacists in conducting prescription reviews. For irrational prescriptions flagged by the information system and those portions that cannot be reviewed by the system, manual review by pharmacists is required. Information systems can provide necessary support for prescription review, thereby saving human and material resources during the process. Computer-assisted review generally includes:

1. Drug Interaction Review 2. Incompatibility Review 3. Compatibility Concentration Review

4. Review of Duplicate Medications 5. Review of Routes of Administration 6. Review of Dosage and Administration

7. Age-Based Medication Review 8. Medication Review During Lactation 9. Medication Review During Pregnancy

10. Gender-based Medication Review 11. Hepatotoxicity Medication Review 12. Renal Impairment Medication Review

13. Review of Medications with Contraindications 14. Review of Traditional Chinese Medicine Decoction Pieces 15. Review of Medical Insurance-Covered Medications

Dozens of real-time audits are conducted, with initial screening assisted by information systems followed by manual review by pharmacists. This approach significantly reduces the workload of prescription reviews, while improving both efficiency and timeliness. The integration of informatics and artificial intelligence assistance is a prevailing trend in contemporary society and will also define the future of prescription auditing.

The guidelines reflect the need for prescription review to return to pharmacists. Currently, in most medical institutions in China, prescription review remains a mere formality and has not been effectively implemented, particularly with regard to pre-prescription review. The guidelines mandate the implementation of pre-prescription review, which serves as an additional medication safety firewall for physicians, playing a positive role in preventing medical errors and improving healthcare quality. For pharmacists, real-time pre-prescription review not only demonstrates the value of reviewing pharmacists but also alleviates the prescription review burden on dispensing pharmacists. For patients, post-review prescriptions ensure greater medication safety and promote more rational drug use.

The release of the “Guidelines” will first enhance the value of intelligent prescription review tools offered by companies such as Sichuan Meikang, Kuai Xingfang, and Datong Pharmaceutical, thereby amplifying their commercial value. Secondly, within the prescription lifecycle, the importance of prescription review will be significantly elevated, as it serves as an essential pathway and component for processes like prescription outflow and prescription sharing. Ultimately, this will accelerate the separation of prescribing from dispensing, further promoting prescription outflow and expanding the market size for retail pharmacies and pharmaceutical e-commerce platforms, benefiting a number of retail terminal enterprises.