Abstract
Background
Off-label and unlicensed drug use is common in Europe and the US; however, information about this issue in China is limited.Objective
To determine the scope and scale of off-label and unlicensed drug use in general hospitals in Shanghai, China, and to evaluate the varying levels of supporting evidence.Methods
A total of 493 cases of discharge history were randomly sampled. Off-label uses were defined according to package inserts, the China Pharmacopeia Clinical Medication Notice (2010), and New Pharmacology (16th edition). All drugs administered were assessed to determine whether their use was unlicensed and off-label.Results
There were 459 cases (93.10%) of off-label drug use, and 47.64% of total therapeutic drugs prescribed were off-label. Of these cases, 8.72% of patients received 1 off-label drug, and 9.94% of patients received 2 off-label drugs. Use of multiple off-label medications per patient was also common, and the percentage of patients receiving 3, 4, 5, 6, 7, 8, 9, and ≥10 medications was 9.74%, 9.74%, 8.72%, 7.91%, 12.58%, 7.10%, 5.88%, and 12.78%, respectively. Categories of off-label drugs used most frequently were vitamins, cardiovascular drugs, and gastroenteric drugs. The most common off-label use was that the indication for which a drug was prescribed was not approved (83.49%); other off-label uses involved disregard for contraindications and drug incompatibility (6.37%), dose exceeding approved amount (4.76%), unapproved route of administration (4.65%), and unapproved dosing intervals (0.73%). Vitamins and nutritional supplements are the drugs most frequently prescribed off-label, while off-label use of vasodilators, lipid-lowering drugs, and adjuvant therapy medications for cardiovascular and cerebrovascular conditions is also common.Conclusion
Unlicensed and off-label prescribing of drugs may be common in China.