Medication errors. Impact of medication error guidance and regulation on drug-device combination products. June 2017 Dan Wozinski

Transcription

1 Medication errors Impact of medication error guidance and regulation on drug-device combination products June 2017 Dan Wozinski

2 Agenda Understand the management of medication errors within global requirements for combination product (drug/device) Discussion; Best practices in case management of medication error with combination products Master the challenges of varying requirements from multiple regions Best practices in defining risk and the related benefits 2

3 EU Requirements for Medication Error

4 What is a medication error* A medication error is an unintended failure/mistake in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. A failure in the drug treatment process does not refer to LOE of the drug, rather to human or process mediated failures. Level of mistakes MDs Nurses Caregivers Pharmacists Patients * /2015/11/WC pdf 4

5 Medication error classifications* * ocedural_guideline/2015/11/wc pdf

6 EU Requirements for medication error with combination products (drug/device) Good practice guide on risk minimization and prevention of medication errors (18 November 2015) 5.1 General principles of risk management planning and the tools used Continuous throughout the life-cycle of the product Requires Pharmacovigilance planning to monitor and further characterize risk, planning and implementation of risk minimization activities and measurements of the success of these activities Defects and device failures (pre-authorization) A combination product is covered under the pharmaceutical legislation However, in addition, the relevant essential requirements in Annex I of the Medical Device Directive 93/42/EEC also apply with respect to safety and performance related features of the device Compliance with harmonized standards is recommended. Applicants should systematically assess risks throughout development Medical errors resulting in harm during post-authorization use For device-related medication errors, MAHs should investigate whether the reports are substantiated, are isolated examples or are batch-wide and batchspecific Version 2.2

7 Regulatory Background: Europe (1) Good Practice guide on recording, coding, reporting and assessment of medication errors, dated October 2015 Marketing authorisation holders (MAH) should record medication errors associated with adverse reaction(s) in ICH E2B format in their pharmacovigilance database. It is good practice to also record cases of medication errors not associated with adverse reaction(s) in the format of an ICSR MAH may use alternative formats for recording medication errors that are not associated with adverse reaction(s) as appropriate (e.g. stakeholder database using other than ICH E2B standards). MAH should record, report and assess all medication errors which are brought to their attention regardless of whether associated with adverse reaction(s) in their pharmacovigilance system, or equivalent system for medication error reports not associated with adverse reaction(s). 7

8 Regulatory Background: Europe (2) Good Practice guide on recording, coding, reporting and assessment of medication errors, dated October 2015 Medication errors without suspected adverse drug reaction may be relevant for the scientific evaluation and interpretation of safety data and of the overall benefit-risk profile of the medicinal product and should be systematically recorded and assessed for pharmacovigilance purposes. In line with the recommendations of GVP Module VII patterns of medication errors regardless of whether associated with adverse reaction(s) should be included as summary information in the PSUR. Medication errors not associated with adverse reaction(s) may be included in the additional listings of individual cases of medication errors of special interest referred to in chapter 5.3. and Annex 2 to support the assessment of causes and circumstances. 8

9 FDA Requirements for Medication Error

10 Regulatory Background: USA FDA:Current Good Manufacturing Practice Requirements for Combination Products Final Rule Effective July 22, 2013 Provides that all constituent parts must be manufactured in accordance with the CGMP requirements that apply to them if they were not part of a combination product. Compliance with either CGMP for drugs (210/211) or QSR (820) will satisfy many, but not all, of the CGMP requirements If you are a combination product manufacturer using CGMPs, you must now also include Quality System Requirements: 21 CFR Management Responsibility 21 CFR Design Controls 21 CFR Purchasing Controls 21 CFR Corrective and Preventive Action 21 CFR Installation 21 CFR Servicing Version 2.2

11 Regulatory Background: USA 2.6 What is device user error and why do you want to know about events involving user error? We consider a device user error (or use error ) to mean a device-related error or mistake made by the person using the device. The error could be the sole cause of an MDR reportable event, or merely a contributing factor. Such errors often reflect problems with device labeling, the user interface, or other aspects of device design. Thus, FDA believes that these events should be reported in the same way as other adverse events which are caused or contributed to by the device. This is especially important for devices used in non-health care facility settings. If you determine that an event is solely the result of user error with no other performance issue, and there has been no device-related death or serious injury, you are not required to submit an MDR report, but you should retain the supporting information in your complaint files. FDA: Medical Device Reporting for Manufacturers, Issued Nov

12 Definitions Recap Medication Error a : An unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. (e.g., mistakes in the prescribing, dispensing, storing, preparation and administration of a medicine). Medication Error b : A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer Use Error c : Act or omission of an act, that has a different result to that intended by the Manufacturer or expected by the Operator of the medical device. a: EMA Good Practice guide on recording, coding, reporting and assessment of medication errors, Oct 2015: b: Division of Medication Error Prevention and Analysis (DMEPA) c: GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM, MEDDEV rev 8, Jan 2013.

13 Some challenges to consider FDA requires medication error to be part of your complaint file while EU guidance suggests ICSR format How to harmonize these different approaches Technical issues with combination products leading to medication error Technical investigations are not typically the role of Pharmacovigilance How to incorporate root cause analysis of technical issues into risk benefit MedDRA coding difficult to capture technical root causes How to incorporate into PSUR/PBRER format

14 Discussion: Best practices in case management of medication error with combination products How to master the challenges of varying requirements from multiple regions Best practices in defining risk and the related benefits