OBJECTIVE To assess the scientific rigor， clarity and feasibility of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis （hereinafter referred to as the Guideline） through external review， in order to further revise and improve the Guideline recommendations. METHODS This study employed a cross-sectional survey research design， a convenience sampling method was adopted to select frontline medical workers in the field of osteoporosis （including clinical doctors， clinical pharmacists， and nurses） as well as patients or their family members. External review was conducted through a combination of closed-ended and open-ended electronic questionnaires to get feedback from them on the appreciation，clarity and feasibility of the 32 preliminary recommendations in the Guideline. RESULTS A total of 90 external review subjects from 15 hospitals were collected， including 45 clinical doctors， 15 clinical pharmacists， 15 nurses and 15 patients or their family members. The overall appreciation degree of recommendations was 99.38%， the overall clarity degree of recommendations was 98.92%， and the overall feasibility degree of recommendations was 99.65%. At the same time， 111 subjective suggestions were collected， which provided an important reference for the further improvement of the Guideline recommendations. Based on the above feedback， the Guideline steering committee and core expert group revised the wording of 12 draft recommendations without deletion， and finally determined 32 recommendations. CONCLUSIONS The external review provides an important basis for the final formation of the Guideline， further improves the scientific rigor， clarity and feasibility of the recommendations， and ensures the standardization， practicality and implementability of the Guideline.

Objective:To explore the clinical safety of lopinavir/ritonavir (LPV/r) by mining the risk signals of adverse events (AEs) related to LPV/r for the safe application of the drug in the treatment of novel coronavirus pneumonia (COVID-19).Methods:The risk signals related to LPV/r in AE reports of US FDA Adverse Event Reporting System (FAERS) from the first quarter of 2010 to the third quarter of 2019 were mined by reporting odds ratio ( ROR). An AE with reports more than 3 and 95% confidence interval ( CI) lower limit of ROR greater than 1 was defined as a positive signal. AEs were counted and classified using the preferred system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA). The PTs of top 50 adverse event reports and signal strength were selected and analyzed. Results:From the first quarter of 2010 to the third quarter of 2019, a total of 13 335 AE reports with LPV/r as the primary suspicious drug were reported in the FAERS database. Four hundred and fifty-five AE risk signals with reports more than 3 and the 95 %CI lower limit of ROR greater than 1 were detected, involving 7 718 AE reports. The top 2 system organs involved in AE reports were "injury, poisoning and procedural complications" [13.6% (1 051/7 718)] and "pregnancy, puerperium and perinatal conditions" [11.7% (899/7 718)]. However, 998 (95.0%) of 1051 AE reports involved in "injury, poisoning and procedural complications" were related to drug exposure during pregnancy. The system organ with the highest signals was "congenital, familial and genetic disorders" [16.3% (74/455)]. In addition, 144 AEs caused by drug interactions were detected, which ranked the 7th in the AE reports. Conclusions:The risk signals of fetal, neonatal and infant abnormalities related to LPV/r during pregnancy were detected, suggesting that attention should be paid to the risk of using LPV/r in pregnant women and infants. The interaction between LPV/r and other drugs was also worthy of attention.

Objective:To explore the clinical safety of lopinavir/ritonavir (LPV/r) by mining the risk signals of adverse events (AEs) related to LPV/r for the safe application of the drug in the treatment of novel coronavirus pneumonia (COVID-19).Methods:The risk signals related to LPV/r in AE reports of US FDA Adverse Event Reporting System (FAERS) from the first quarter of 2010 to the third quarter of 2019 were mined by reporting odds ratio ( ROR). An AE with reports more than 3 and 95% confidence interval ( CI) lower limit of ROR greater than 1 was defined as a positive signal. AEs were counted and classified using the preferred system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA). The PTs of top 50 adverse event reports and signal strength were selected and analyzed. Results:From the first quarter of 2010 to the third quarter of 2019, a total of 13 335 AE reports with LPV/r as the primary suspicious drug were reported in the FAERS database. Four hundred and fifty-five AE risk signals with reports more than 3 and the 95 %CI lower limit of ROR greater than 1 were detected, involving 7 718 AE reports. The top 2 system organs involved in AE reports were "injury, poisoning and procedural complications" [13.6% (1 051/7 718)] and "pregnancy, puerperium and perinatal conditions" [11.7% (899/7 718)]. However, 998 (95.0%) of 1051 AE reports involved in "injury, poisoning and procedural complications" were related to drug exposure during pregnancy. The system organ with the highest signals was "congenital, familial and genetic disorders" [16.3% (74/455)]. In addition, 144 AEs caused by drug interactions were detected, which ranked the 7th in the AE reports. Conclusions:The risk signals of fetal, neonatal and infant abnormalities related to LPV/r during pregnancy were detected, suggesting that attention should be paid to the risk of using LPV/r in pregnant women and infants. The interaction between LPV/r and other drugs was also worthy of attention.

Medication safety officer (MSO) is an expert and manager of medication safety. Management of medication safety by MSO has been popularized and plays an important role in the medical institutions of the United States (US)and the United Kingdom (UK). The results of systematic search and analysis of literature showed that the setting of MSO in US and UK was mainly based on various characteristics of the adverse drug events (for example,the large number,high possibility for patient damage and economic loss,poor quality of the reports,inadequate management and preventability),and aimed to reduce its occurrence and then to guarantee the medication safety in patients. In US and UK,the MSOs mainly worked in large hospitals or large health care provider organizations,while the position level was not clearly defined. Responsibilities of MSOs mainly included the formulation and practice of a medication safety program,supervision and improvement of medication safety system,providing professional advice on medication safety,management and reporting of medication safety information in internal medical institution, receiving and transmitting medication safety information outside and carrying out medication safety training. In addition,the US put forward some specific qualification requirements for the position,including educational background,practicing qualification,related training experience,etc. The setting of MSO may be one of the effective measures to solve the problem of medication safety. It is suggested to set up a MSO management system in China′s medical institutions and actively explore a novel management mode of medication safety in China.

Medication safety officer (MSO) is an expert and manager of medication safety. Management of medication safety by MSO has been popularized and plays an important role in the medical institutions of the United States (US)and the United Kingdom (UK). The results of systematic search and analysis of literature showed that the setting of MSO in US and UK was mainly based on various characteristics of the adverse drug events (for example,the large number,high possibility for patient damage and economic loss,poor quality of the reports,inadequate management and preventability),and aimed to reduce its occurrence and then to guarantee the medication safety in patients. In US and UK,the MSOs mainly worked in large hospitals or large health care provider organizations,while the position level was not clearly defined. Responsibilities of MSOs mainly included the formulation and practice of a medication safety program,supervision and improvement of medication safety system,providing professional advice on medication safety,management and reporting of medication safety information in internal medical institution, receiving and transmitting medication safety information outside and carrying out medication safety training. In addition,the US put forward some specific qualification requirements for the position,including educational background,practicing qualification,related training experience,etc. The setting of MSO may be one of the effective measures to solve the problem of medication safety. It is suggested to set up a MSO management system in China′s medical institutions and actively explore a novel management mode of medication safety in China.