The Shandong Pharmaceutical Association (SPA) has released the “Shandong Province Expert Consensus on Off-label Drug Use” (2022 Edition), providing 247 recommendations across 156 drug varieties. The document covers antibacterial, antitumor, cardiovascular, psychiatric, renal, pediatric, and obstetrics drugs, serving as a reference for physicians and pharmacists.
Content Highlights
- Drug Categories: Includes 25 antibacterial, 15 antitumor, 14 cardiovascular, 16 psychiatric/neurological, 11 renal/rheumatism, 33 pediatric, and 35 obstetrics/reproductive drugs.
- Clinical Guidance: Aims to standardize off-label use, allowing new drug functions under legal and safety frameworks.
National Context
- Guangdong Update: The Guangdong Pharmaceutical Association added 37 new off-label drug entries in its 2022 list, including adalimumab and oxaliplatin.
- Hospital Involvement: Class 3A hospitals in 15 provinces and cities have issued 2022 off-label drug lists.
Legal Framework
China’s updated medical practitioners’ law, effective March 1, permits off-label use when no better treatment exists, provided physicians obtain patient consent. The move grants physicians autonomy while emphasizing patient safety.-Fineline Info & Tech
