行政相对人名称黑龙江省恒增盛医药连锁有限公司克山一分店行政相对人代码(统一社会信用代码)91230229MA1C80U63P法定代表人高允秋行政处罚决定书文号克山市监处罚〔2025〕69号违法行为类型药品零售企业未按规定凭处方销售处方药的行为违法事实黑龙江省恒增盛医药连锁有限公司克山一分店，构成未按规定凭处方销售处方药逾期不改正的行为。处罚依据《药品经营和使用质量监督管理办法》 / 第七十二条 / 第一项　　　　药品零售企业有以下情形之一的，由药品监督管理部门责令限期改正；逾期不改正的，处五千元以上五万元以下罚款；造成危害后果的，处五万元以上二十万元以下罚款：　　（一）未按规定凭处方销售处方药的；处罚类别罚款处罚内容对当事人处以1,000.00元罚款的减轻行政处罚罚款金额（万元）0.1处罚决定日期2025-04-08处罚有效期2027-04-08公示截止期2025-07-08处罚机关克山县市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Robert E. LogueOwnerEpiCare Acquisitions, LLC11 Princess Rd Ste CLawrenceville,NJ08648-2319United StatesIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 702493March 21, 2025Dear Mr. Logue:During an inspection of your firm located in Lawrenceville, NJ, US, on November 12, 2024, through December 13, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the EpiCare-Zenith™ Family of Laser Systems. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. In addition, under section 531(2) of the Act, 21 U.S.C. § 360hh(2), each of these products is an electronic product because it is (A) a manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) a manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation.This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response on January 9, 2025 from Bruce Wade, Quality Assurance and Compliance, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). Specifically,Your firm has not validated the design of the EpiCare-Zenith Family of Laser Systems per your established procedure, Product Design Validation (Document QSP-7307; Revision 00; Effective 08/13/2021). There is no evidence that a validation was performed to demonstrate that the EpiCare-Zenith™ Laser System’s (all models) hardware will consistently perform as intended when attempting specified treatment optimization parameters (wavelength, handpiece spot size, pulse duration, pulse fluence, pulse rate, and operating mode (continuous or countdown mode with number of shots to be delivered) under actual or simulated conditions, including challenging conditions such as procedures with(b)(4)and(b)(4)settings. There is also no evidence that a validation was performed under defined operating conditions (actual or simulated) on initial production batches or equivalents for each of the EpiCare-Zenith Family of Laser Devices.Your firm provided an undated document entitled: "Clinical Literature Review" as evidence of design validation. However, this document is a compilation of clinical literature summaries related to similar alexandrite 755nm and Nd:YAG 1064 lasers. None of the clinical literature provided utilized EpiCare-Zenith lasers.The response dated January 09, 2025 appears to be inadequate. We acknowledge that your firm initiated CAR 24-01 to address the observation. As part of this CAPA, we acknowledge that your firm intends to perform a post hoc validation by May 5, 2025. However, the list of promised validation processes does not indicate that EpiCare-Zenith devices will be utilized in this process. Please provide the results of your firm's planned corrective actions when they become available and if your firm intends to perform a validation utilizing EpiCare-Zenith lasers as part of your planned post hoc design validation processes.2. Failure to maintain complaint files and failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198. Specifically, your Customer Complaints and Concerns procedure (QSP-8202; Revision 00; Effective 01/27/2022) is not being implemented in that:a) Your firm is not processing complaints in a uniform and timely manner, as required by 21 CFR 820.198(a)(1). Specifically, section 4.12 of your Customer Complaints and Concerns procedure (QSP-8202; Revision 00; Effective 01/27/2022) is specific to closing complaints but does not address the timeliness of complaint closure.Specifically, all 52 complaints received in calendar year 2024 remain open; 20 of 63 complaints received in calendar year 2023 remain open; and 71 of 72 complaints received in calendar year 2022 remain open.b) Your firm has failed to review and evaluate complaints to determine whether an investigation is necessary. When no investigation is made, your firm failed to maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b).Specifically, section 4.7 of your Customer Complaints and Concerns procedure (QSP-8202; Revision 00; Effective 01/27/2022) requires complaint investigations. Your firm utilizes form QSF 8202-01 to document complaints received each calendar year. This document contains columns for "Investigation Required" and "Investigation or explanation". A review the last three years of complaint records found that these two columns were often left blank or indicate that no investigation is required without an appropriate record that includes the reason no investigation was made.c) Your firm is not evaluating complaints to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting, as required by 21 CFR 820.198(d).Specifically, section 4.6 of your Customer Complaints and Concerns procedure (QSP-8202; Revision 00; Effective 01/27/2022) requires any complaint or concern determined by the management representative or member of top management to be a reportable incident is immediately reported to the relevant regulatory authority. Your firm is not documenting the evaluation of each complaint for reportability under 21 CFR 803. Examples of complaints lacking an MDR reportability evaluation include:i) 22-058: The complaint stated, "Heard a loud pop and the patient developed a scab." The model laser was listed as "unknown".ii) 22-061: The complaint stated, "She feels the YAG side is running hot. She has treated 4-5 people and "burned" them. Treated at 30J/CM2, 30ms, 15mm on a Latino. She also treated someone at 20J/CM2-40ms,15mm." The model laser was listed as the dual laser "-ZTH".The response dated January 09, 2025 appears to be inadequate. We acknowledge your firm initiated CAR 24-02 to address the observation. As part of this CARA, we acknowledge that your firm intends to conduct a comprehensive review and revision of your complaint procedure to ensure compliance along with training all associated personnel by March 3, 2025. However, your response did not indicate if a retrospective review of previously received complaints will be conducted to determine if an investigation is required or if a review for reportability under 21 CFR 803 will be performed.3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your Corrective Action procedure (QSP-8502; Revision 00; Effective 08/12/2021) is not being implemented in that:a) Your firm failed to analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems, as required by 21 CFR 820.100(a)(1).Specifically, section 4.2.5 of your Corrective Action procedure (QSP-8502; Revision 00; Effective 08/12/2021) states that "Corrective action may be initiated in response to analysis of data including, but not limited to: Post-market surveillance of EpiCare-Zenith products in use including customer concerns and minor complaints" and "A series of minor nonconformances identified in EpiCare-Zenith products in the field." Your firm has not analyzed complaints received since January 2022 to identify existing and potential causes of nonconforming product, or other quality problems.Complaints were received reporting the following failures:o 23 complaints related to power drops/losso 8 complaints for overheated handpieceo 13 complaints for calibration issues.b) Your firm failed to implement and record changes in methods and procedures needed to correct and prevent identified quality problems, as required by 21 CFR 820.100(a)(5).Specifically, section 4.7.1 of your Corrective Action procedure (QSP-8502; Revision 00; Effective 08/12/2021) states that “Corrective actions are taken per planned arrangements as agree[sic] to by the Director of Engineering, Director of Manufacturing, and the Quality Assurance Manager.” Your firm opened Corrective Action Request (CAR) 22-01 as a result of the previous FDA inspection to ensure completeness and accuracy of past DHRs along with making changes, as necessary, to DHR forms. One of the listed corrective actions was “The Quality Manager will continuously work to improve the graphic layout of the forms to improve transmission of information to interested parties.” CAR 22-01 was closed on 04/15/2022 with two DHR documents reviewed and operator training conducted. The updated DHR forms are still in draft and have not been implemented. As listed in item 4 below, your firm failed to update DHR records to remove sections that are no longer used or outdated.The response dated January 09, 2025 appears to be inadequate. We acknowledge that your firm plans to reassess a previous corrective action request opened from a previous FDA establishment inspection as well as review and revisions as necessary to your current Corrective Action procedure. However, your response did not address if additional corrective actions (CARs) would be initiated based on your review of quality data. Please provide our office with the results of the reassessment of previous CARs and revisions made to relevant procedures.4. Failure to maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184.Specifically, your firm does not have a procedure for the creation or maintenance of device history records. Additionally, per your Regulatory/QA Director the DHRs contain sections that are no longer valid or used. He stated any sections related to EpiCare-Zenith model Ta2, testing for the previous design of the water coolant pump, various test equipment no longer used, 7mm / 9 mm handpiece standoff size testing, sound level testing, and all labeling bearing the previous company logo/name. These sections are continually crossed out when creating new DHRs. No document or procedure exist which specify which sections are supposed to be performed and which are to be crossed out. The following are examples:Device serial number(b)(4)o Handwritten note in section 4 -(b)(4)Burn in Test (755nm ALEX) of the Optical Module Final Test Report that reads "No burn in after(b)(4)."o Added digital voltage of(b)(4)and(b)(4)in sections 4-(b)(4)Burn in Test (755nm ALEX) and 5-(b)(4)Burn in Test (1064nm YAG) in the Optical Module Final Test Report.o Additional Picture and measurements of handpiece burn pattern in section 12-Spatial Profile of Handpiece of the Optical Module Final Test Report.Device serial number(b)(4):o Section 2 Laser Output Power/Energy vs. Digital Voltage and Actual Voltage Readings (755nm ALEX), in the 1.6Hz Pulse Rate with Pulse duration=(b)(4), the(b)(4)is crossed out and not performed.o Section 2 Laser Output Power/Energy vs. Digital Voltage and Actual Voltage Readings (755nm ALEX), in the 1.6Hz Pulse Rate with Pulse durations of(b)(4), and(b)(4)the(b)(4)is crossed out and changed to(b)(4).o Section IV-(b)(4)Inspection of the Optical Module Final Test Report was not reviewed and signed.Device serial number(b)(4)o Section 3-Test Results of the Power Supply Test Report was not completed.o Test process step 6 on the Electrical Checkout to "Record hardware shot count starting value shown in the Tech Mode screen for YAG was lined out. This model is a Duo, which contains both ALEX and YAG lasers.o Section 1-Identification of Unit Under Test in the Optical Module Final Test Report is missing the PFN S/N#.o Section 2 Laser Output Power/Energy vs. Digital Voltage and Actual Voltage Readings (755nm ALEX), in the 1.6Hz Pulse Rate with Pulse durations of(b)(4), and(b)(4), the(b)(4)is crossed out and changed to(b)(4).o Section 3 Laser Output Power/Energy vs. Digital Voltage and Actual Voltage Readings (1064nm YAG), in the 1.6Hz Pulse Rate with Pulse duration(b)(4)was added.o Section 3 Laser Output Power/Energy vs. Digital Voltage and Actual Voltage Readings (1064nm YAG), in the 1.6Hz Pulse Rate with Pulse durations of(b)(4)and(b)(4), the(b)(4)was changed to(b)(4).o Section 3 Laser Output Power/Energy vs. Digital Voltage and Actual Voltage Readings (1064nm YAG), in the 1 Hz Pulse Rate with Pulse duration=(b)(4), the(b)(4)was changed to(b)(4).o Section 4-(b)(4)Test (755nm ALEX),(b)(4)was added to the test and the(b)(4)occurrences of(b)(4)were changed to(b)(4).o Section 5-(b)(4)Test (1064nm YAG),(b)(4)was added to the test and the(b)(4)occurrences of(b)(4)were changed to(b)(4).The response dated January 09, 2025 appears to be inadequate. Your response promises to review and revise all DHR forms by March 3, 2025. However, your response does not address if your firm plans to establish a DHR procedure. In your response, provide the revised DHRs and DHR procedure or a justification for not creating one.5. Failure to maintain device master records (DMR's), as required by 21 CFR 820.181. Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;d) Packaging and labeling specifications, including methods and processes used; ande) Installation, maintenance, and servicing procedures and methods.Specifically, the device master record for your firm's EpiCare-Zenith Laser System (all models) does not contain appropriate processes and specifications for your current line of laser systems. The DMR consists of a blank device history record with sections that are no longer valid or used. These include any sections related to EpiCare-Zenith model Ta2, testing for the previous design of the(b)(4)pump, various test equipment no longer used,(b)(4)standoff size testing, sound level testing, and all labeling bearing the previous company logo/name.We reviewed your January 09, 2025 response and the adequacy cannot be determined. Your response promises to perform a post hoc device validation to confirm or revise all manufacturing specification for manufactured devices. Additionally, your response promises to develop a separate DMR for each family of laser product by July 7, 2025. In your response, please provide any revisions made to your manufacturing specifications and examples of each device DMR.6. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).Specifically, section 4.4.9 of your Human Resources: Training, Awareness, and Competence procedure (QSP-6200; Revision 00; Effective 03/05/2022) requires documentation of training outcomes utilizing QSF 6200-04 Training Record or documented by an Internal Audit of the trainee performing the task independent of instruction or guidance. However, during the inspection you were unable to provide documentation of any training completed by employees at your firm.We reviewed your January 09, 2025 response and the adequacy cannot be determined. Your response promises to develop and effectively deliver training to be given(b)(4)for existing employees and upon hiring of new employees by February 2, 2025. In your response, please provide evidence that training was conducted.Failure to Have Compliant Electronic Product Radiation Control (EPRC) LabelingOur inspection also revealed that your firm failed to comply with labeling requirements applicable to electronic products. Section 538(a)(1) of the FD&C Act, 21 U.S.C. 360oo(a)(1), prohibits manufacturers from introducing, or delivering for introduction, into commerce, or importing into the United States, any electronic product which does not comply with an applicable standard prescribed pursuant to section 534 of the FD&C Act, 21 U.S.C. 360kk.21 CFR 1010.3(a)(2)(ii)—which is an applicable standard prescribed pursuant to section 534 of the Act, among other provisions—requires that the month and year of manufacture be provided clearly and legibly, without abbreviation, and with the year shown as a four-digit number, in the format “Manufactured: (Insert Month and Year of Manufacture.).”. Alternatively, a manufacturer may utilize a manufacturing symbol and date format that conforms with an applicable FDA recognized consensus standard.The identification label used on the EpiCare-Zenith laser model ZTH with serial number(b)(4)and located on the rear lower panel, does not accord with 21 CFR 1010.3(a)(2)(ii) because it does not provide the month of manufacture without abbreviation and in the format “Manufactured: (Insert Month and Year of Manufacture.),” nor does it utilize a manufacturing symbol and date format that conforms with an applicable FDA recognized consensus standard. Instead, it reads "2024-11" as an abbreviation for November 2024.The response dated January 09, 2025 appears to be inadequate. We acknowledge that your firm initiated CAR 24-10 to address the observation. As part of this CAR, we acknowledge that your firm intends to confirm that the labeling for your firm's medical lasers conforms with the requirements of 21 CFR 801. However, according to 21 CFR 801.18(b)(2), if the device is an electronic product to which a standard is applicable under 21 CFR Chapter I, subchapter J, the date of manufacture shall be presented as required by 21 CFR 1010.3(a)(2)(ii). In your response, please provide examples of any revisions made to the identification labels for our review.Failure to Have Compliant Medical Device Reporting (MDR) ProceduresOur inspection also revealed that your firm has failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.For example: during the inspection, your firm presented a procedure titled "Medical Device Records and Product Recalls", QSP-8303, Rev. 00, dated 08/13/2021, as its guideline for MDR reporting. After reviewing the procedure, the following deficiencies were noted:1. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1).a) The procedure omits definitions of the terms "become aware" and "serious injury" from 21 CFR Part 803.3, as well as the definition of "reasonably suggests" found in 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).b) The procedure, as written, combines language from the requirements of other regulatory or competent authorities with the requirements in 21 CFR Part 803 in a manner that will result in incomplete, inadequate, or even non-reporting of adverse events that meet the reportability requirements under 21 CFR Part 803. For example, Section 3.1 interchangeably uses the same reporting determination criteria for both U.S. MDR reporting and the non-U.S. reporting processes, which could lead to confusion and noncompliance.2. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, your procedure does not include:a) Instructions for how to obtain and complete the FDA 3500A form.b) A process for submitting initial and supplement or follow-up reports to FDA in an electronic format that FDA can process, review and archive in accordance with 21 CFR 803.12(a).c) Although the procedure references supplement or follow-up report, it does not specify the requirement to submit these reports within 30 calendar days of the day that your firm receives applicable information, as required by 21 CFR 803.56.d) How your firm will ensure that all information reasonably known to you is submitted for each event. Specifically, which sections of the Form 3500A will need to be completed to include all information found in your firm's possession and any information that becomes available as a result of a reasonable follow-up within your firm.3. The procedure does not describe how your firm will address documentation and record-keeping requirements, as required by 21 CFR 803.17(b), including:a) Documentation of adverse event related information maintained as MDR event files.b) Information that was evaluated to determine if an event was reportable.c) Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable, as required under 21 CFR 803.18(b)(1)(i).A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, which includes adverse event reports required under 21 CFR Part 803, respecting the device.In response to this letter, please provide any completed actions taken by your firm to address this item or your planned actions and the timeframe for when these actions will be completed.Failure to Have Compliant LabelingThe inspection revealed that the EpiCare-Zenith Laser System devices are misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of section 519 of the Act, 21 U.S.C. § 360i, to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a) - which was promulgated under authority of section 519 of the Act, among other provisions - requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. The labels of the EpiCare-Zenith Laser System devices do not bear such a UDI.Specifically, the labels for the EpiCare-Zenith Laser System do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, and there is no UDI presented in easily readable plain-text on the label of the EpiCare-Zenith Laser System (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses automatic identification and data capture (AIDC) technology on the label of EpiCare-Zenith Laser System (see 21 CFR 801.40(a)(2)).The response dated January 09, 2025 appears to be inadequate. Your firm promised to obtain UDIs for the EpiCare-Zenith Family of Laser Devices and indicated that you have made initial contact with GS1 for obtaining UDIs for devices. However, you have not provided evidence of obtaining UDIs from GS1, any revisions to device labels to include valid UDIs, or evidence of implementation of those revised device labels.Failure to Submit Required Information to GUDIDIn addition, the EpiCare-Zenith Laser System devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting these devices. In particular, 21 CFR 830.300(a) and 830.320(b) - both of which were promulgated under section 519 of the Act, among other provisions - require that the labeler of a device submit electronically to FDA's Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI. FDA has determined that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. EpiCare Acquisitions, LLC. is therefore a "labeler" within the meaning of 21 CFR 830.3 and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these devices.The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).The response dated January 09, 2025 appears to be inadequate. Your firm promised to register with GUDID and make required entries for the EpiCare-Zenith Family of Laser Devices. However, there are no entries in GUDID for Epicare Acquisitions, LLC. or for devices with the trade names Epicare-Zenith Laser System or any other powered laser surgical instrument associated with Epicare Acquisitions, LLC.Your firm should take prompt action to correct the violations addressed in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing, within fifteen business days from the date you receive this letter, of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which should address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to Establishment Assessment Team 1 Assistant Director, Gina Brackett, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case # 702493” when replying. If you have any questions about the contents of this letter, please contact: Sean Moynihan, Compliance Officer at sean.moynihan@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility or associated with your firm’s devices and electronic products. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.Sincerely,/S/RDML Sean Boyd, M.P.H., USPHSDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCc: Islam Hafez, Owner, Lasetech LLCBruce Wade, Regulatory and QA Director

Product:DrugsRecipient:www.thesafepills.orgSingaporeIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesTO: www.thesafepills.orgFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: March 27, 2025WARNING LETTERThis is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.thesafepills.org and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].As discussed below, FDA has observed that www.thesafepills.org introduces into interstate commerce unapproved and misbranded opioid drug products. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.thesafepills.org cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Evidence obtained from your website establishes that certain products offered for sale by www.thesafepills.org are drugs intended for human use. Examples of claims that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs for human use include the following:Your description of tapentadol marketed as “Aspadol 100mg (Tapentadol),” “Aspadol® Tab,” “TAPENTADOL TABLET 100 MG,” and “Generic Nucynta” includes:“Aspadol 100mg is an opioid painkiller that helps to ease moderate to serious pain.”“Aspadol 100mg contains an active ingredient called Tapentadol that acts directly on opioid receptors in your central nervous system. It further decreases severity by inhibiting how nerve cells transfer pain between your brain and the body.”Your description of tapentadol marketed as “Typendol 100mg (Tapentadol),” “Typendol 100 mg,”“TAPENTADOL TABLET BP 100 MG,” and “Generic Nucynta” includes:“Tapentadol 100 mg is a medication that is an analgesic, which is prescribed in cases of acute pain that encompasses moderate to severe pain conditions. It works by changing the way the body responds to pain.”These products are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.For example, www.thesafepills.org offers tapentadol, an opioid, marketed as “Aspadol 100mg (Tapentadol),” “Aspadol® Tab,” “TAPENTADOL TABLET 100 MG,” “Typendol 100mg (Tapentadol),” “Typendol 100 mg,” “TAPENTADOL TABLET BP 100 MG,” and “Generic Nucynta.” While there are FDA-approved versions of tapentadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Aspadol 100mg (Tapentadol),” “Aspadol® Tab,” “TAPENTADOL TABLET 100 MG,” “Typendol 100mg (Tapentadol),” “Typendol 100 mg,” “TAPENTADOL TABLET BP 100 MG,” and “Generic Nucynta” offered by www.thesafepills.org. Currently, there are two tapentadol products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved tapentadol hydrochloride marketed under the brand name NUCYNTA is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved tapentadol hydrochloride marketed under the brand name NUCYNTA ER is indicated for the management of severe and persistent pain, including neuropathic pain associated with diabetic peripheral neuropathy, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. FDA-approved tapentadol products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when tapentadol is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.thesafepills.org is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].Additionally, FDA has observed that www.thesafepills.org offers prescription drugs for sale without a prescription. Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.thesafepills.org jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.thesafepills.org because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/S. Leigh Verbois, Ph.D.Director, Office of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

旭化成医疗器械（杭州）有限公司报告，由于三个批次的产品在加热盘中央部可能会发生剥落，存在使用管路时无法正常运行而延误患者治疗的可能，公司对该产品（注册证号：国械注准20173101867）主动召回，召回级别为三级。涉及产品在中国的销售数量54套/批，共162套，涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

湖南辰高医疗科技有限公司报告，由于受托生产企业生产许可证生产范围未与注册证同步进行变更等原因，湖南辰高医疗科技有限公司 对其生产的光脉冲睑板腺功能障碍（MGD）治疗仪（注册或备案号： 湘械注准20222160952 ）主动召回。召回级别为 三级 。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表.pdf湖南辰高医疗科技有限公司2025年4月7日相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

为全面反映2024年全省化妆品不良反应监测情况，提高公众用妆安全，湖北省药品监督管理局组织湖北省药品（医疗器械）不良反应监测中心（以下简称：省中心）编撰了《湖北省化妆品不良反应监测年度报告（2024）》。一、化妆品不良反应/事件报告情况（一）总体情况图1-1  2017-2024年度不良反应/事件报告总体情况2024年度全省共收到《化妆品不良反应/事件报告表》12402份，与2023年度相比，增长11.85%（见图1-1）。其中一般报告12390份，严重报告12份。每百万人口平均报告数214.74份。2017至2024年，报告总体呈递增趋势。（二）报告来源2024年报告来源以医疗机构为主，全年医疗机构上报8981份，占报告总数的72.42%，比2023年增加了9.56%；个人上报300份，占报告总数的2.42%，较去年有有大幅度提升（见表1-1）。表1-1 2023-2024年不良反应/事件报告来源情况报告单位类型2024年报告数（份）2023年报告数（份）较2023年增加数量（份）较2023年报告增长（%）医疗卫生机构898181758069.86经营单位2958260035813.77注册人/备案人119121-2-1.65个人30085215252.94受托生产企业1027-17-62.96其他（监测机构）3480-46-57.50 随着《化妆品监督管理条例》和《化妆品不良反应监测管理办法》的颁布实施，监测机构代报情况大幅度减少；医疗机构、经营单位、受托生产企业的报告数均有所提升。（三）质量评分2024年，全省化妆品报告质量评估平均得分为95.58，较2023年提高5.15%。其中，严重报告平均分为102.16，一般报告平均分为95.58。各市州化妆品报告质量均有较大的提高。见表1-2。表1-2  2023-2024年各市州化妆品报告质量评估得分表地区2024年报告质量评估得分2023年报告质量评估得分神农架林区105.40105.00荆州市101.41101.24鄂州市101.3293.57武汉市100.39100.49十堰市99.33101.31恩施州99.0397.65仙桃市96.5089.24天门96.1490.98黄冈市95.8985.47孝感市93.6583.36荆门市93.4288.85随州市92.3773.10咸宁市90.5286.71黄石市89.3678.48宜昌市89.1979.85襄阳市88.4583.52潜江市86.6870.95平均分95.5890.90（四）患者/消费者人口学信息1.性别分布情况2024年全省共收到12402份化妆品不良反应报告，其中涉及男性患者/消费者的报告1275份，占10.28%；涉及女性患者/消费者的报告11127份，占89.72%。女性数量远高于男性，该现象与化妆品使用人群以女性居多有关（见图1-2）。图1-2  2022-2024不良反应/事件涉及性别分布情况2.年龄分布情况图1-3  不良反应/事件涉及患者/消费者年龄分布2024年化妆品不良反应报告信息显示，患者/消费者年龄主要集中在16-44岁、45-64岁，其中16-44岁的患者/消费者8891例，占71.69%；45-64岁的患者/消费者2800例，占22.58%；化妆品重点使用人群为中青年女性（见图1-3）。（五）不良反应/事件表现1.初步判断 图1-4  不良反应/事件初步判断情况初步判断是根据不良反应症状选择的初步诊断结果,2024年度化妆品不良反应报告涉及初步判断12827例次，例次数居前5位的依次为化妆品接触性皮炎（11198例次，占87.30%）、化妆品荨麻疹（306例次，占2.39%）、化妆品毛发损害（277例次，占2.16%）、化妆品光感性皮炎（252例次，占1.96%）、化妆品痤疮（190例次，占1.48%）（见图1-4）。2.自觉症状自觉症状23776例次（自觉症状为患者的自我感受，一份化妆品不良反应/事件报告中可能含有两种或者两种以上自觉症状），表现为瘙痒有9366例次，占比39.39%；灼热感4842例次，占比20.37%；紧绷感3723例次，占比15.66%；干燥3546例次，占比14.91%（见图1-5）。图1-5  化妆品不良反应/事件自觉症状3.皮损形态皮损形态17954例次（一份不良反应/事件报告中可能含有两种或两种以上皮损形态），皮损形态为红斑有7294例次，占比40.63%；丘疹3896例次，占比21.70%；水肿1713例次，9.54%；斑块753例次，占比4.19%；粉刺666例次，占比3.71%；鳞屑627例次，占比3.49%；毛细血管扩张411例次，占比2.29%等。（六）产品信息分析1.化妆品类别2024年，化妆品不良反应/事件报告中涉及特殊化妆品的共有2324例次，占比18.62%；涉及普通化妆品10096例次，占比80.91%；涉及牙膏58例次，占比0.46%。普通化妆品属于日常肌肤护理保养类产品，报告数量多与其在日常中使用频繁、使用人群广泛有关。特殊化妆品主要集中在祛斑美白类、防晒类、染发类。普通化妆品主要为护肤类，包括面霜、乳液、面膜、化妆水、膏、化妆用油等；其次为洁肤类、发用类、美容修饰类（见表1-3）。表1-3   不良反应/事件报告的化妆品类别一级分类二级分类例次占比（%）特殊化妆品祛斑美白类94940.83防晒类73031.41染发类41117.69防脱发类562.41祛斑类421.81除臭类371.59脱毛类251.08美乳类190.82烫发类190.82宣称新功效类180.77育发类170.73健美类10.04合计2324100一级分类二级分类例次占比（%）普通化妆品护肤类735972.89洁肤类139013.77发用类7247.17美容5345.29香水类500.50脱毛类270.27除臭类100.10缺失20.02合计10096100牙膏580.462.产品来源情况12478例次怀疑化妆品不良反应中，产品主要来源于网购,共7069例次，占比56.65%，，比2023年增加了3.83%；其次商场（超市、专柜）4064例次，占比32.57%（见表1-4）。表1-4  化妆品不良反应/事件报告产品来源分布情况产品来源2024年2023年例次占比（%）例次占比（%）网购706956.65589952.82商场406432.57372333.33美容美发机构5584.476746.03其他6565.267276.51未填写产品来源1311.051461.31合计1247810011169100二、化妆品不良反应/事件报告监测趋势综合分析（一）报告总数平稳增长，报告质量进一步提升。2024年，全省共收集化妆品不良反应监测报告12402份，比2023年增长11.85%。每百万人口平均报告数达214.74份。质量评估平均得分为95.58,比2023年提高了5.15%。（二）监测哨点持续发挥积极示范带动作用。61家省级监测哨点医院共上报化妆品不良反应报告3166份，占上报总数的25.53%，比2023年增长了10.20%。9例严重风险信号来自哨点医院，占严重报告75%，为监测机构和监管部门提供了有力的技术支持。（三）化妆品商标名，类别和生产企业分布变化不明显。市场占有率较高的大品牌、大企业化妆品不良反应报告数量排名靠前。化妆品类别主要为普通化妆品，以护肤类为主，特殊化妆品主要集中在祛斑美白类、防晒类和染发类。化妆品商标名、类别和生产企业整体分布与2023年相比无明显变化。（四）网购化妆品引起不良反应仍占比最高，商场来源化妆品需加强关注。网购已连续七年成为化妆品不良反应涉及产品来源的主要渠道。对于儿童化妆品，2024年商场来源化妆品引起的不良反应占据首位，达到54.76%。对于染发类化妆品，网购来源引起的不良反应仍占比最高，为60.83%。疑似激素依赖性皮炎报告所涉及化妆品商场来源和网购来源分别达到了42.00%和38.00%，建议强化网购平台内化妆品经营者的守法意识，规范经营，并依法开展化妆品不良反应监测工作。三、有关说明（一）本年度报告中的数据来源于国家化妆品不良反应监测数据库中2024年1月1日至2024年12月31日湖北省收集上报的数据。（二）湖北省化妆品不良反应/事件报告是通过自发报告系统收集并录入到数据库中的，也存在自发报告系统的局限性，如漏报、填写不规范、信息不完善、无法计算不良反应发生率等。

为全面反映2024年湖北省医疗器械不良事件监测情况，提高公众安全用械水平，湖北省药品监督管理局组织湖北省药品（医疗器械）不良反应监测中心（以下简称湖北省中心）编撰了《湖北省医疗器械不良事件监测年度报告（2024年）》。一、 全省医疗器械不良事件报告总体情况（一） 报告数量情况2024年，湖北省中心通过国家医疗器械不良事件监测信息系统共收到医疗器械不良事件报告47769份，其中省内上报报告36085份，与2023年相比上升了6.49%。2014年至2024年，湖北省上报医疗器械不良事件报告数量总体呈逐年上升趋势（图1-1）。图1-1 2014-2024年全省上报医疗器械不良事件报告数量（二） 每百万人口平均报告数量情况2024年，我省每百万人口平均医疗器械不良事件报告数为617.5份，与2023年相比上升了6.24%。（三） 严重伤害及死亡不良事件报告情况2024年，全省上报严重伤害及死亡医疗器械不良事件报告4184份，报告数量较2023年上升了59.15%（图1-2）。严重伤害及死亡报告占比11.59%，较2023年上升49.36%。图1-2 2024年全省上报严重伤害及死亡事件报告数与2023年比较（四） 注册基层用户数量情况截止2024年12月31日，全省医疗器械不良事件监测在线使用基层用户13434家。其中，医疗器械注册人备案人1628家，占用户总数的12.12%；经营企业7806家，占用户总数的58.11%；使用单位（医疗机构）4000家，占用户总数的29.78%（图1-3）。图1-3 2024年全省医疗器械不良事件监测系统注册基层用户情况二、 医疗器械不良事件报告统计分析（一） 按报告来源统计分析2024年，全省上报的医疗器械不良事件报告中，使用单位（医疗机构）的报告有33503份，占报告总数的92.84%，为报告的主体；经营企业报告2336份，占报告总数的6.47%；注册人备案人报告241份，占报告总数的0.67%，其他5份，占比约0.01%（图2-1）。图2-1 2024年全省医疗器械不良事件报告来源情况（二） 按不良事件伤害程度统计分析2024年，全省上报的医疗器械不良事件报告中，伤害程度为严重伤害报告4184份，占比11.59%；死亡的报告3份，占比0.01%；其他报告31898份，占比88.40%（图2-2）。与2023年相比，严重伤害及死亡报告数量上升了59.15%，报告占比较2023年上升3.83%。图2-2 2024年全省医疗器械不良事件伤害程度情况（三） 按医疗器械管理类别统计分析2024年，全省上报的医疗器械不良事件报告中，涉及III类医疗器械的报告13719份，占报告总数38.02%；涉及II类医疗器械的报告18683份，占报告总数51.77%；涉及I类医疗器械的报告2258份，占报告总数6.26%；医疗器械类别不详的报告1425份，占报告总数3.95%。（图2-3）。图2-3 2024年全省医疗器械不良事件涉及医疗器械管理类别情况（四） 按医疗器械分类目录统计分析按现行《医疗器械分类目录》一级分类排序，报告数量排名前五位的分别为140000_注输、护理和防护器械，070000_医用诊察和监护器械，090000_物理治疗器械，220000_临床检验器械和080000_呼吸、麻醉和急救器械（表2-1）。表2-1按分类目录一级分类排名前十位排名产品分类报告数百分比（%）1140000_注输、护理和防护器械1555043.732070000_医用诊察和监护器械398211.203090000_物理治疗器械28277.954220000_临床检验器械18785.285080000_呼吸、麻醉和急救器械18145.106060000_医用成像器械14023.947180000_妇产科、辅助生殖和避孕器械11483.238100000_输血、透析和体外循环器械10743.029200000_中医器械7712.1710020000_无源手术器械7372.07按现行《医疗器械分类目录》二级分类排序，报告数量排名前五位的产品类别依次为140200_血管内输液器械，140100_注射、穿刺器械，070400_监护设备，070300_生理参数分析测量设备，090200_温热（冷）治疗设备/器具（表2-2）。表2-2按分类目录二级分类排名前十位排名产品分类报告数百分比（%）1140200_血管内输液器械737120.732140100_注射、穿刺器械22996.473070400_监护设备19025.354070300_生理参数分析测量设备16014.505090200_温热（冷）治疗设备/器具14254.016141000_创面敷料13703.857140500_非血管内导（插）管10753.028221100_采样设备和器具9062.559180600_妊娠控制器械7592.1310080600_呼吸、麻醉用管路、面罩6791.91按现行《医疗器械分类目录》三级分类排序，排名前五位的分别是140205_输液器，070401_病人监护设备，140102_无菌注射器，140212_药液用转移、配药器具，141001_创面敷贴（表2-3）。表2-3按分类目录三级分类排名前十位排名产品分类报告数百分比（%）1140205_输液器429812.092070401_病人监护设备18725.263140102_无菌注射器14214.004140212_药液用转移、配药器具13823.895141001_创面敷贴11193.156140207_血管内留置针9742.747140503_导尿管8682.448140101_注射泵7532.129070303_无创血压测量设备6951.9510180601_宫内节育器及取放器械6851.93（五） 按涉及使用场所统计分析产品使用场所为医疗机构的报告33272份，占92.20%；使用场所为家庭的报告2137份，占5.92%；使用场所为其他的报告676份，占1.87%（图2-4）。医疗机构仍然是医疗器械不良事件发生及报告的主要场所。图2-4 2024年全省医疗器械不良事件涉及使用场所情况三、2024年全省医疗器械不良事件监测评价重点工作（一） 夯基固本，报告数量质量双提升2024全省共收集医疗器械不良反应报告36085份，较上年同期上升7.02%；每百万人口平均报告数617.47份；严重伤害报告4158份，占同期报告总数的11.52%，报告占比较上年同期上升69.30%。制定《湖北省医疗器械不良事件报告表质量评分标准》，组织2024年全省医疗器械质量评估，2024年全省医疗器械质量评估平均得分为81.33分。（二） 风险挖掘，守牢医疗器械安全底线审核定期风险评价报告1308份，及时发现并妥善处置一次性使用静脉留置针、导光凝胶、腔镜关节头直线型切割吻合器及一次性钉仓、一次性使用无菌阴道扩张器、一次性使用精密过滤输液器（带针）等20个风险信号，其中导光凝胶、血液透析设备、注射泵3个产品不良事件风险信号被国家中心采纳，妥善开展预警评价处置，促使7家注册人修订了产品说明书，11家注册人改进产品工艺。（三） 主动作为，积极推动重点监测按照《”十四五”期间湖北省医疗器械不良事件重点监测实施工作方案》要求，继续推进高电位治疗设备重点监测工作。赴6家哨点医院开展报告质量核查，主动协助哨点医院开展医务人员重点监测培训。完成11家注册人高电位治疗仪重点监测技术档案建立。（四）分层分类，深入开展医疗器械不良事件专项检查根据国家局统一部署，按照省局要求，制定医疗器械不良事件专项检查实施方案，完成全省81家医疗器械注册人、备案人不良事件监测检查，共发现缺陷项目207条。其中三类医疗器械10家次，二类医疗器械36家次，一类医疗器械41家次。产品类别包含无菌医疗器械、有源医疗器械、体外诊断试剂、植入性医疗器械和其他医疗器械。专项检查期间，对未在国家药品不良反应监测系统注册的我省医疗器械企业进行梳理督导，截止到2024年底，系统中共注册1808家，维护品种9298个。为企业主动收集产品不良事件，充分评估产品风险，全面落实医疗器械不良事件监测主体责任夯实基础。（五） 宣传培训，共建共治共享良好环境举办全省医疗器械生产企业培训，引导企业主动上报医疗器械不良事件，强化企业主体责任意识。开展全省医疗机构医疗器械不良事件监测培训，进一步提升监测人员和医护人员的监测能力，推动医疗器械不良事件监测工作规范化高质量发展。完成2024年医疗器械安全科普宣传活动，制作儿童家庭雾化器使用安全、老年人理疗仪使用安全、光子嫩肤设备使用安全等科普视频，加强对老年、儿童、妇女的守护与关爱，提高公众用械安全意识。数据说明：1、与大多数国家一样，我国医疗器械不良事件报告通过自发报告系统收集并录入到数据库中，即当怀疑某种事件可能与医疗器械有关时，就可以上报。受报告者主观意识、经验水平、认知程度、甚至所持立场等影响，医疗器械不良事件的报告可能存在片面性和局限性，如伤害程度判读不准确、报告填写不规范、信息不完善等，甚至将与医疗器械无关的事件也按照不良事件上报，因此统计结果可能与实际发生的医疗器械不良事件情况存在偏差。2、不同医疗器械的不良事件报告数量受使用数量、风险程度、报告意识等诸多因素影响，因此报告数量的多少不直接代表医疗器械不良事件发生率的高低或者风险严重程度。3、上述统计数据来源于国家医疗器械不良事件监测信息系统中2024年1月1日至2024年12月31日湖北省收集的医疗器械不良事件数据。

为全面反映2024年湖北省药品不良反应/事件报告和监测情况，提高安全用药水平，促进临床合理用药，保障公众用药安全，湖北省药品监督管理局组织湖北省药品（医疗器械）不良反应监测中心编撰了《湖北省药品不良反应/事件监测年度报告（2024年）》。第一章 总论分析一、药品不良反应/事件报告总体情况2024年，国家药品不良反应监测系统收到湖北省药品不良反应/事件报告108321份，较2023年增长11.58%。（一）年度分布2007-2024年，国家药品不良反应监测系统湖北省报告数持续增长，目前累计数据收到91万份，详见图1。图1 2007-2024年湖北省药品不良反应/事件报告情况（二）新的和严重的不良反应/事件报告2024年，我省收到新的和严重的药品不良反应/事件报告42488份，占同期报告总数的39.22%，较2023年增长13.09%。其中，新的报告数为21801份，占同期报告总数的20.12%，较2023年同期增长7.95%；严重报告数为22286份，占同期报告总数的20.57%，较2023年同期增长10.88%。（三）每百万人口平均报告数每百万人口平均报告数是衡量各地区药品不良反应监测工作水平的指标之一。2024年，我省每百万人口平均报告数为1853.5份，与2023年相比增加11.31%。（四）县（区）级报告比例县（区）级药品不良反应/事件报告比例体现了地区间药品不良反应监测工作发展均衡性及覆盖程度。2024年，我省县（区）级报告比例达100%。（五）报告来源2024年，我省药品不良反应/事件报告主要来源仍然是医疗机构，占比98.06%；药品经营企业占比1.80%；其他途径（计生机构、监测机构）也有少量报告。详见图2。图2药品不良反应/事件报告来源（六）报告人职业2024年，我省药品不良反应/事件报告上报人职业主要为医生，占比63.25%；其次为药师和护士，占比分别为19.20%和14.69%。详见图3。图3药品不良反应/事件报告人职业构成（七）药品不良反应/事件涉及患者情况2024年药品不良反应/事件报告中，男女比例为0.79：1，女性多于男性。年龄分布从高到低依次是老年期、中年期、青壮年期和14岁以下儿童期。详见图4。图4药品不良反应/事件报告年龄分布（八）涉及药品情况按怀疑药品类别统计，化学药品占比89.56%，中药占比8.22%，生物制品占比2.22%。详见图5。图5药品不良反应/事件报告涉及药品分类按给药途径统计，静脉滴注依然是药品不良反应/事件报告的主要给药途径，占比63.51%，口服给药占比23.58%，其他注射给药途径（包括静脉注射、皮下注射、肌内注射、泵内注射等）占比7.37%，其他给药途径占比5.54%。详见图6。图6药品不良反应/事件报告涉及给药途径分布（九）药品不良反应/事件表现累及器官—系统情况将药品不良反应/事件表现按累及器官—系统分类，前5位依次是皮肤及皮下组织类疾病、胃肠系统疾病、各类神经系统疾病、全身性疾病及给药部位各种反应、免疫系统疾病。详见图7。图7药品不良反应/事件表现累及器官—系统（十）药品不良反应/事件报告总体分析2024年，全省药品不良反应/事件报告数量持续增长，较上年同期增长11.58%，每百万人口平均报告数增长11.31%，严重报告增长10.88%。全省药品不良反应监测网络基层机构用户数量持续增加，县（区）级报告达到全覆盖；报告来源方面，医疗机构仍然是报告主体，占比达98.06%；药品类别主要为化学药品，占比89.56%；给药途径主要是静脉滴注，其次为口服给药，两者共占比87.09%；年龄分布以老年患者和中年患者为主。小贴士：如何正确认识近年来药品不良反应/事件数量不断增长？答：药品不良反应/事件报告数量的增长是多重因素共同作用的结果。一方面，随着药品监管体系完善、监测技术提升及公众健康意识增强，医疗机构、药企和患者主动上报的积极性显著提高；另一方面，创新药上市加速、人口老龄化、慢性病用药需求持续扩大等，都会影响报告数量增长。药品不良反应/事件报告数量受药品的使用量和不良反应发生率等诸多因素的影响，报告数量上升并不等同于药品安全性下降，需结合用药基数、发生率及风险获益比综合评估。二、化学药品、生物制品监测情况（一）总体情况2024年药品不良反应/事件涉及怀疑药品114063例次（怀疑药品为多个药品的，按多例报告统计）。其中，化学药品102154例次，占比89.56%；生物制品2530例次，占比2.22%；中药9379例次，占比8.22%。相比于2023年，化学药品上升13.11%，生物制品下降5.42%。（二）药品情况化学药品类别前5位分别是抗感染药（占比46.03%），肿瘤用药（占比9.73%），心血管系统用药（占比6.55%），神经系统用药（占比5.24%）与镇痛药（占比4.73%），共占总报告数的72.28%。严重报告中，抗感染药（占比41.99%）居首位，其次是肿瘤用药（占比24.25%）、心血管系统用药（占比4.27%）、神经系统用药（占比3.72%）与消化系统用药（占比3.63%）。生物制品前5位分别是细胞因子（占比60.12%），抗毒素及免疫血清（占比12.49%），血液制品（占比4.78%），疫苗（含类毒素）（占比0.63%）和诊断用生物制品（占比0.16%）。按剂型分布统计，化学药品注射制剂报告占比74.86%，口服制剂报告占比21.46%；生物制品注射制剂报告占比95.81%，口服制剂报告占比1.46%。按给药途径统计，化学药品静脉给药、口服给药途径占比分别为70.93%和21.46%，其他给药途径占比7.61%；生物制品静脉给药、口服给药途径占比分别为51.70%和2.25%，其他给药途径（肌肉注射、皮下注射、泵内注射、皮内注射等）占比46.05%。（三）总体情况分析化学药品不良反应/事件报告排名前3位分别为抗感染用药、肿瘤用药和心血管系统用药，生物制品中以细胞因子居首位，与我国疾病谱的变化基本一致。其中口服制剂主要为心血管系统用药、精神障碍用药和抗感染用药，注射制剂主要为抗感染用药和肿瘤用药，提示除关注感染性疾病、肿瘤外，还应关注心脑血管疾病及精神类等慢性疾病的用药安全。小贴士：左氧氟沙星临床应用广泛，临床使用时应注意什么？答：左氧氟沙星是第三代喹诺酮类抗生素，通过抑制细菌DNA复制发挥广谱抗菌作用，常用于治疗呼吸道、尿路等敏感菌感染；禁忌人群包括对喹诺酮类过敏者、孕妇、哺乳期女性及18岁以下青少年（可能影响软骨发育）；严重不良反应有肌腱炎/断裂（尤其老年人）、QT间期延长（诱发心律失常）、光敏反应及神经系统症状（头晕、癫痫）等；该药品避免与含铝/镁/钙制剂同服（需间隔2小时），慎联用抗凝药或非甾体抗炎药；用药期间多饮水、避强光，若出现肌腱疼痛、心悸或皮疹需立即停药就医。特殊人群（老年人、肾功能不全者）需调整剂量，确保疗效与安全性平衡。三、中药监测情况（一）总体情况2024年，药品不良反应/事件报告涉及中药9379例次，总计1023个品种。其中，严重报告1176例次，占严重报告总例次数的5.27%。（二）药品情况根据中药功能分类，不良反应/事件报告药品分类排名前5位的依次为理血剂（占比34.10%）、补益剂（占比13.68%）、清热剂（占比12.50%）、祛湿剂（占比12.05%）与开窍剂（占比4.61%）。中药严重药品不良反应/事件报告药品分类排名前5位依次是理血剂（占比38.70%）、补益剂（占比15.69%）、清热剂（占比11.75%）、祛湿剂（占比8.30%）与开窍剂（占比4.93%）。按剂型分布统计，注射制剂报告占比34.24%，口服制剂报告占比49.85%，其他剂型报告占比15.92%；严重报告中注射制剂报告占比58.50%，口服制剂报告占比31.64%，其他剂型报告占比9.86%。按给药途径统计，静脉给药占比33.88%，口服给药占比49.50%，其他给药途径占比16.62%；严重报告中，静脉给药占比58.42%，口服给药占比32.54%，其他给药途径占比9.04%。（三）总体情况分析中药药品不良反应/事件报告主要为理血剂、补益剂、清热剂、祛湿剂。剂型和给药途径分析发现，严重报告排名前10的品种均为注射制剂，且中药注射制剂严重报告占比远高于其他剂型，提示中药注射剂依旧为中药不良反应的主要风险点，应继续加大对中药注射剂的监测和管控。小贴士：什么是联合用药？会有什么风险？答：联合用药是指为了达到治疗目的而采用的两种或两种以上药物同时或先后给药，这种方式常用于需要综合治疗的疾病。联合用药的作用机制可以是相互增强疗效，如抗生素联合使用提高抗菌效果；也可以是减少副作用，如使用保护胃黏膜的药物来降低抗炎药的刺激。但是不合理的联合用药会有一定风险，如导致药物疗效减弱，叠加药物的毒副作用，影响药物吸收、代谢或排泄等，临床应合理联合用药。第二章 各论分析一、国家基本药物监测情况分析（一）总体情况2024年，全省收到国家基本药物不良反应/事件报告52227份，占总报告数的48.22%，其中严重报告11173份，占国家基本药物报告数的21.39%。与2023年相比，国家基本药物不良反应/事件报告和严重报告数量分别上升10.85%和8.61%。患者男女比例为0.80:1，略高于总体报告。年龄分布构成比从高到低依次为中年期患者（占比33.56%）、老年期患者（占比33.32%）、青壮年期患者（占比21.29%）及14岁以下儿童（占比11.83%）。剂型分布中，注射制剂占比68.41%，口服制剂占比28.32%，其他制剂占比3.27%。（二）化学药品和生物制品监测情况《国家基本药物目录》（2018版）化学药品/生物制品部分25个类别，共417个（类）品种。2024年，我省收到国家基本药物化学药品/生物制品不良反应/事件报告47623份，占国家基本药物报告的91.18%，涉及50252例次（怀疑药品为多个药品的，按多例报告统计）、373个品种，其中严重报告10578份，涉及11723例次、302个品种。按药品类别统计，报告数量排名前5位的依次是抗感染药（占比51.95%）、肿瘤用药（占比9.16%）、心血管系统用药（占比6.03%）、代谢及内分泌系统用药（占比5.32%）与电解质、酸碱平衡及营养药（占比4.91%）。不良反应/事件表现累及器官—系统排名前5位的依次是皮肤及皮下组织类疾病（占比29.97%）、胃肠系统疾病（占比21.70%）、全身性疾病及给药部位各种反应（占比9.44%）、各类神经系统疾病（占比9.04%）与免疫系统疾病（占比6.85%）。（三）中成药监测情况《国家基本药物目录》（2018版）中成药部分7大类，共268个（类）品种。2024年，我省共收到国家基本药物中成药不良反应/事件报告4604份，占比8.81%，涉及4609例次、211个品种，其中严重报告595份，占国家基本药物严重报告数的5.32%，涉及595例次、98个品种。中成药主要以内科用药（占比67.57%）、骨伤科用药（占比19.19%）、妇科用药（占比4.96%）为主。不良反应/事件表现累及器官—系统排名前5位的依次是胃肠系统疾病（占比36.72%）、皮肤及皮下组织类疾病（占比30.17%）、全身性疾病及给药部位各种反应（占比8.82%）、各类神经系统疾病（占比6.72%）与免疫系统疾病（占比5.48%）。（四）安全性分析2024年，我省国家基本药物监测情况基本平稳，化学药品/生物制品主要以以抗感染药，肿瘤用药，心血管系统用药，代谢及内分泌系统用药与电解质、酸碱平衡及营养药为主，抗感染药远居首位。中成药主要以内科用药、骨伤科用药和妇科用药为主。小贴士：中药和西药一起吃，会不会增加不良反应?答:中药和西药一般是可以一起吃的，但是中西药配伍不当也会产生不良反应。中药里面有十八反、十九畏，指的就是药物之间配伍会协同增加疗效，相反也会相互抵消作用或者产生毒副作用而发生不良反应。中西药其实也是一样遵循这个配药原则。如酸性中药不能与氢氧化铝、胃舒平等同用，会降低或失去制酸药的治疗作用，而减弱疗效；中药桃仁、苦杏仁不能与西药麻醉剂、安定合用，有可能造成肝肾功能受到损害，增加毒性。所以在中西药配伍时需要了解药物性能，采取科学配伍，合理用药。二、抗感染药物监测情况分析（一）总体情况2024年，全省收到抗感染药不良反应/事件报告44649份，占总报告数的41.22%。其中严重报告9154份，占抗感染药报告总数的20.50%，占严重报告总数的41.08%。与2023年相比，抗感染药不良反应/事件报告数量和严重报告数量分别上升17.51%和15.04%。（二）患者情况性别分布中，男女比例为0.79:1，与总体报告基本持平。年龄分布中，中年期患者占比居首位，占比达30.08%，其余依次为老年期（占比29.88%）、青壮年期（占比21.93%）和14岁以下儿童（占比18.11%）。（三）药品情况2024年抗感染药不良反应/事件报告涉及9大类别，抗生素居首位（占比63.06%），其次是合成抗菌药（占比29.53%）、抗分枝杆菌药（占比2.18%）、抗病毒药（占比2.17%）、天然来源抗感染药（占比1.40%）、抗真菌药（占比1.33%）、其他抗感染药（占比0.20%）、抗寄生虫药（占比0.09%）和消毒防腐药（占比0.04%）。在抗生素分类中，排名前5名依次是头孢菌素类、青霉素类、β-内酰胺酶抑制药、大环内酯类和林可霉素类；合成抗菌药主要为喹诺酮类、硝基咪唑类。剂型分布中，注射制剂占比89.10%，口服制剂占比8.70%，其他剂型占比2.21%。（四）累及器官—系统情况抗感染药物不良反应/事件表现累及器官—系统损害排名前5位依次是皮肤及皮下组织类疾病（占比42.49%）、胃肠系统疾病（占比18.80%）、免疫系统疾病（占比8.91%）、全身性疾病及给药部位各种反应（占比7.96%）与各类神经系统疾病（占比6.03%）。（五）安全性分析2024年，全省收到抗感染药物不良反应/事件报告44649份，较去年同期上升17.51%，排名前3位的依次是头孢菌素类、喹诺酮类和青霉素类，与临床用药较为广泛有关。其中注射制剂主要为头孢菌素类和喹诺酮类，口服制剂主要为青霉素类与抗病毒药。患者年龄分布中，中年期与老年期患者居首位，占比近60%；剂型分布中，注射制剂报告占比远高于口服制剂。抗感染药是临床上使用最为广泛的药物类别之一，不良反应/事件报告数长期位居各类药品之首，临床应加强抗感染药物的合理使用和安全性监测。小贴士：抗生素和退烧药是同一类别药物吗？答：抗生素和退烧药不属于同一类别，它们的作用和用途有所不同。抗生素是用来治疗由细菌引起的感染的药物，能够杀灭或抑制细菌的生长，常用于治疗像细菌性肺炎、尿路感染等病症。退烧药则主要是帮助缓解体温升高带来的不适，常见的如退烧药（如对乙酰氨基酚、布洛芬等），它们通过调节体温中枢来降低发烧。需要注意的是，退烧药并不治疗感染本身，而只是缓解发烧的症状，而抗生素是针对感染源进行治疗的。因此，退烧药不能代替抗生素，使用时应根据医生的建议使用。三、肿瘤用药监测情况分析（一）总体情况2024年，全省收到肿瘤用药不良反应/事件报告共7210份，严重报告3816份，严重报告占肿瘤用药报告的52.93%，占严重报告总数的17.12%。与2023年相比，肿瘤用药不良反应/事件报告数量和严重报告数量分别上升12.20%与19.47%。（二）患者情况性别分布中，男女报告比例为0.82:1。年龄分布中，中年期占比49.69%，其次为老年期（占比35.87%）、青壮年期（占比9.58%）和14岁以下儿童（占比4.85%）。（三）药品情况2024年，肿瘤用药不良反应/事件居前5位的品种依次为紫杉醇（占比15.23%）、奥沙利铂（占比9.28%）、顺铂（占比7.67%）、多西他赛（占比7.03%）与卡铂（占比6.11%），可能与临床用药量较大有关。剂型分布中，注射制剂占比88.54%，口服制剂占比10.91%，其他剂型占比0.56%。（四）累及器官—系统情况2024年肿瘤用药不良反应/事件表现累及器官—系统排名前5位的依次是血液及淋巴系统疾病（占比28.12%）、胃肠系统疾病（占比25.35%）、各类检查（占比13.41%）、全身性疾病及给药部位各种反应（占比7.89%）与皮肤及皮下组织类疾病（占比6.95%）。（五）安全性分析2024年，肿瘤用药不良反应/事件报告数量和严重报告数量较上年均有所上升。抗肿瘤药物不仅对肿瘤细胞具有选择性毒性，同时也可能影响正常细胞，常有很多副作用且较为严重，如骨髓抑制、胃肠道反应、肝肾功能损害等。因此，应加强肿瘤患者用药后监测，及时预防、发现和处置严重不良反应。小贴士：为什么注射制剂容易发生不良反应？答：与口服制剂相比，注射制剂直接进入血液循环系统，绕过了消化道和肝脏的代谢过程，药物能迅速高效地到达体内各个部位。由于这种快速进入血液循环，药物的浓度可能迅速升高，尤其在药物过量或不当注射的情况下，容易引起局部反应（如注射部位的红肿、疼痛）或全身反应（如过敏反应、血管损伤等）。注射制剂常含有一些辅料，如稳定剂或溶剂，这些成分可能在某些个体中引起过敏反应或免疫反应。另外，注射用药还可能导致感染风险增加，尤其是在无菌操作不当的情况下。因此，使用注射制剂时须严格遵循剂量和使用方法。四、心血管系统用药监测情况分析（一）总体情况2024年，全省收到心血管系统用药不良反应/事件报告共6372份，严重报告942份。心血管系统用药报告占年报告数的5.88%，严重报告占心血管系统用药报告的14.78%，占严重报告总数的4.23%。与2023年相比，心血管系统用药不良反应/事件报告数上升5.92%，严重报告数上升3.74%。（二）患者情况性别分布中，男女报告比例0.86：1，高于总体报告比例。年龄分布中，老年期和中年期患者占比超过90%，是心血管用药的主要人群。（三）药品情况按药品类别统计，心血管系统用药不良反应/事件报告前3位的类别依次是抗心绞痛药（占比32.03%）、血管活性药（占比22.66%）、降血压药（占比20.00%），与临床用药情况相符。剂型分布中，心血管系统用药报告和严重报告注射制剂占比分别为42.65%和49.90%；口服制剂占比分别为56.74%和49.58%。（四）累及器官—系统情况心血管系统用药不良反应/事件表现累及器官—系统排名前5位的是各类神经系统疾病（占比21.90%）、胃肠系统疾病（占比19.66%）、全身性疾病及给药部位各种反应（占比12.72%）、皮肤及皮下组织类疾病（占比11.99%）和心脏器官疾病（占比9.40%）。（五）安全性分析心血管系统用药是指用于心脏疾病治疗、血管保护、血压和血脂调节的药品。2024年，全省心血管系统用药不良反应/事件报告增长5.92%，已连续4年增长，与我国人口老龄化的加速以及心血管疾病患病人数的增长密切相关。年龄分布中，老年期患者和中年期患者是心血管用药的主要人群，两类人群占比超过90%；药品类别中，占比居前3位的品种分别为抗心绞痛药、血管活性药和降血压药，严重报告分别为抗动脉粥样硬化药、血管活性药和抗心绞痛药。心血管系统用药通常是一个长期的过程，且患者多是自行服药，应在医生的指导下合理用药，并注意药物的保存和使用细节。小贴士：常见的β受体阻滞剂有哪些？使用中有什么注意事项？答：β受体阻滞剂是一类常用于治疗高血压、心律失常、心绞痛和心力衰竭等心血管疾病药物。常见的β受体阻滞剂包括普萘洛尔、阿替洛尔、美托洛尔、比索洛尔和卡维地洛等。这些药物通过抑制肾上腺素对β受体的作用，减慢心率、降低心肌收缩力，从而达到降血压和减轻心脏负担的效果。β受体阻滞剂在治疗心血管疾病中需要注意以下几点：（1）突然停药可能导致病情反弹或加重，建议在医生指导下逐渐减量停药。（2）哮喘或慢性阻塞性肺病患者使用非选择性β受体阻滞剂时需谨慎，因为可能引起支气管痉挛。（3）糖尿病患者应注意，β受体阻滞剂可能掩盖低血糖症状，需密切监测血糖水平。（4）老年人和肝肾功能不全者使用时需遵循医嘱，调整剂量。五、老年人用药监测情况分析（一）总体情况2024年，全省收到65岁以上老年人不良反应/事件报告37633份，占总报告数的34.74%。其中严重报告8200份，占老年人用药报告的21.79%，占严重报告总数的36.79%。与2023年相比，老年人用药不良反应/事件报告数上升13.57%，严重报告数上升14.32%。（二）患者情况性别分布中，男女报告比例0.92：1，高于总体报告比例。年龄分布主要以65-74岁为主，占比60%以上，其次为75-79岁、80-84岁人群。（三）药品情况老年人用药不良反应/事件报告中，化学药品/生物制品排名前5位的依次是抗感染药（占比39.07%）、心血管系统用药（占比9.80%）、肿瘤用药（占比9.47%）、神经系统用药（占比7.28%）与镇痛药（占比5.38%）；中药排名前5位的依次是理血剂（占比43.79%）、补益剂（占比16.36%）、祛湿剂（占比9.98%）、清热剂（占比6.95%）与开窍剂（占比4.87%），与老年人的患病特征一致。剂型分布中，老年人用药不良反应/事件报告和严重报告中，注射制剂占比分别为72.28%和79.54%；口服制剂占比分别为23.58%和17.96%。（四）累及器官—系统情况老年人用药化学药品/生物制品累及器官—系统排名前5位的是皮肤及皮下组织类疾病（占比23.48%）、胃肠系统疾病（占比23.29%）、全身性疾病及给药部位各种反应（占比10.97%）、各类神经系统疾病（占比10.69%）与心脏器官疾病（占比6.31%）。中药累及器官—系统排名前5位的是胃肠系统疾病（占比31.40%）、皮肤及皮下组织类疾病（占比27.21%）、全身性疾病及给药部位各种反应（占比11.01%）、各类神经系统疾病（占比8.04%）与心脏器官疾病（占比6.69%）。（五）安全性分析2024年，老年患者用药不良反应/事件报告数较上年同期上升了13.57%，且已连续6年呈增长趋势。其中，化学药品主要为抗感染药、肿瘤用药、心血管用药、神经系统用药和镇痛药；中药主要为理血剂、补益剂、祛湿剂。老年人随着年龄增长，肝肾功能减退，药物代谢和排泄速度减慢，药品不良反应的发生风险增加，另外，老年人常伴有多种慢性疾病，需要长期服用多种药物，增加了药物相互作用的风险，须加强老年人安全用药的宣传教育，预防和降低不良反应的发生。小贴士：老年人用药有哪些需要格外注意的地方？答：（1）肝肾功能下降：老年人的肝脏和肾脏代谢能力减弱，药物更容易在体内积累，增加副作用风险，因此，用药剂量要合理。（2）用药种类多：很多老年人患有多种慢性病，需要服用多种药物，这容易引发药品不良反应，应充分听取医生的意见和建议，不可自行联合药。（3）服药依从性差：有些老年人记忆力下降，容易忘记吃药或重复用药，建议家人协助，或使用药盒、闹钟等工具提醒。（4）身体对药物更敏感：老年人对药物的耐受性较低，普通剂量可能引起强烈反应，如镇静类药物可能导致跌倒、抗胆碱类药物可能引起意识混乱等。老年人用药要在医生指导下进行，切勿自行更改剂量、换药和停药，同时要加强老年人用药的监护。有关说明（一）本年度报告中的数据来源于国家药品不良反应监测数据库中2024年1月1日至2024年12月31日我省上报的数据，不包含疫苗不良反应/事件的监测数据。（二）我国药品不良反应/事件报告是通过自发报告系统收集并录入到数据库中的，也存在自发报告系统的局限性，如漏报、填写不规范、信息不完善、无法计算不良反应发生率等。（三）每种药品不良反应/事件报告的数量受到该药品的使用量和该药品不良反应发生率等诸多因素的影响，故药品不良反应/事件报告数量的多少不直接代表药品不良反应发生率的高低或者严重程度。（四）本年度报告统计分析时采用的是监管活动医学词典（MedDRA）。MedDRA是在人用药品技术要求国际协调理事会（ICH）主持下编制的标准化国际医学术语集，用于与人用医疗产品相关的监管沟通和数据评估。各类检查是MedDRA中的一项系统器官分类，包括有限定词（例如：升高、降低、异常、正常）和没有限定词的检查名称。（五）本年度报告完成时，其中一些严重报告等尚在调查和评价的过程中，所有统计结果均为数据收集情况的真实反映，有些问题并不代表最终的评价结果。

依据年度抽检工作计划安排，江苏省药品监督管理局组织对部分药品生产、经营、使用单位进行了抽检。现将抽检中发现的5批次不符合规定药品信息予以通告（详见附件）。对不符合规定的药品，我省各级药品监督管理部门已要求相关企业和单位采取暂停销售、使用等风险控制措施，对不符合规定原因开展调查并切实进行整改。对不符合规定的药品，监管部门已依法组织开展对相关企业和单位的查处。附件：5批次不符合规定药品信息.pdf江苏省药品监督管理局2025年4月7日相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

为加强药品质量监督管理，规范市场秩序，保障公众用药安全，我局组织局属检查局和各区县药品监管部门开展药品抽检。经重庆市食品药品检验检测研究院检验，标示为湖南省自然堂中药饮片有限公司生产的人参片（批号：231101）和云南华优中药科技有限公司生产的铁皮石斛粉（批号：22071411）不符合规定，不符合规定项目为检查。对以上不符合规定的产品，重庆市药品监督管理局已责成有关单位采取查封、扣押、暂停销售、召回等必要的控制措施，依据相关法律法规进行查处。附件：2批次药品不符合规定名单重庆市药品监督管理局2025年4月7日附件 2批次药品不符合规定名单 序号药品名称标示生产企业批号规格抽样环节检品来源检验依据检验结论不符合规定项目检验机构备注1人参片湖南省自然堂中药饮片有限公司231101中药饮片经营单位重庆奇治阁药房有限公司《中国药典》2020年版一部不符合规定检查（五氯硝基苯、六氯苯）重庆市食品药品检验检测研究院2铁皮石斛粉云南华优中药科技有限公司22071411中药饮片经营单位重庆市永川区永沁堂平康药店 云南省食品药品监督管理局标准云YPBZ-0191-2013不符合规定检查（甘露糖与葡萄糖峰面积比）重庆市食品药品检验检测研究院相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。