Adverse event/ Product quality Complaint reference guide

© Janssen Pharmaceuticals, Inc. 2015

May 2015

031843-150324

DETERMINING

Remember Report a complaint immediately. When in doubt, report.

Whom do I contact for medical information inquiries?

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For medical information requests, you may use the ENCOURAGING same contact information listed on the following pages. What safety information should be reported?

You have just completed adverse event (AE) and product quality complaint (PQC) training. The following information is a supplement to this training.

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You are responsible for reporting all safety information applicable to your program. Reportable safety information may include: Adverse Event (AE):

The Johnson & Johnson/Janssen product and

 n AE is any untoward or undesirable medical A occurrence in a patient linked in time with the use of a Johnson & Johnson/Janssen product.

event description must be reported to meet

Special Situation:

the minimum criteria of a complaint.

A Special Situation involves safety information that may not meet the definition of an adverse event; however, all of the same rules and reporting time frames for adverse events apply. Examples include: • Pregnancy (maternal or paternal* exposure) • Suspected abuse/misuse • Overdose of a Johnson & Johnson/Janssen medicinal product *Paternal—occurs when there is a possibility of intrauterine exposure to a drug via semen from the male partner who is taking the Johnson & Johnson/Janssen product at the time of conception, thereby possibly exposing the fetus to the product. For example, a male patient’s partner becomes pregnant while the male patient is using a Johnson & Johnson/Janssen product.

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• Inadvertent or accidental exposure to a Johnson & Johnson/Janssen product (eg, breast-feeding) • Any failure of expected pharmacological action (eg, lack of effect) of a Johnson & Johnson/Janssen product • Medication error involving a Johnson & Johnson/Janssen product, with or without an AE or patient exposure to a Johnson & Johnson/Janssen product (eg, name confusion) • Suspected transmission of any infectious agent via a Johnson & Johnson/Janssen product (eg, patient becomes ill after exposure to a contaminated product) • Unexpected therapeutic or clinical benefit from use of a Johnson & Johnson/Janssen product • Report of death • Off-label use of a Johnson & Johnson/Janssen product • Occupational exposure

Product Quality Complaint (PQC):  PQC is related to a potential quality issue A during manufacturing, release testing, stability monitoring, dose preparation, storage or distribution of the product or delivery system. In addition, it includes any reports in which a suspicion of counterfeit/tampering exists. It is important to note that not all PQCs involve a patient.  otential needle issues or product misuse P to be reported within 24 hours of receipt: • Needle detaches from syringe and remains in patient’s body (deltoid/gluteal muscle). Additionally, if the healthcare professional (HCP) administering the injection inadvertently gets stuck while extracting the needle, this also needs to be reported • Needle (device) breaks and only some of the dose was administered to the patient OR the dose is completely missed • Deltoid needle blocks (clogs), and the HCP changes the needle to a different needle other than the one supplied in the kit • White collar of syringe breaks and needle remains in patient’s arm

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en • Drug leaked from syringe and got onto HCP’s skin (partial dose could have been received and drug leaked on HCP) • Syringe separates from needle and patient could not receive dose; therefore, patient is missing prescribed dose

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• Syringe separates from needle and HCP receives a needle stick (before injecting patient)

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• Product microspheres do not mix well with diluents, resulting in a missed dose • Deltoid needle was used in the gluteal region of the patient (or vice versa) • When attempting to mix diluents with medication, the SmartSite® leaked, resulting in the patient missing his or her dose • HCP administers diluents only (mistakenly did not mix drug with syringe) • Issues with packaging or instructions • Janssen long-acting injectable atypical antipsychotic was stored incorrectly (based on storage requirements found in Prescribing Information)

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How do I report an AE, PQC, or Special Situation? All AEs, PQCs, and Special Situations must be reported within 24 hours of initial complaint awareness. Please use the following contact information, and be sure to provide program number RRA#: 4299 when calling:

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Reporting Methods Verbal AE/PQC MIC Business Hours Monday–Friday: 9 am–8 pm ET Weekends: 9 am–5 pm ET There is 24/7 support for urgent inquiries (eg, AE/PQC reporting).

Call 1-609-730-2898*

Written AE/PQC MIC Business Hours Monday–Friday: 9 am–8 pm ET Weekends: 9 am–5 pm ET There is 24/7 support for urgent inquiries (eg, AE/PQC reporting).

Fax to 1-609-730-3138

*Unless another number is provided in accordance with the program procedure documents.

NOTE: Contact numbers subject to change upon written notice. Reporting may be done electronically only upon written approval by the company, which approval must acknowledge that the electronic transmission is in an acceptable encrypted email format.

If unable to determine if a reportable safety event has occurred, or when in doubt, report the event to the company intake unit for final determination.

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Janssen Scientific Affairs Medical Information Center

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enrollment Who is responsible for reporting an AE, PQC, or Special Situation? PDF

All employees of JANSSEN CONNECT® Injection Centers are responsible for reporting all AE, PQC, or Special Situation from anyone, anywhere, at any time to the company, when such a complaint relates to any Johnson & Johnson/Janssen product.

ENCOURAGING What information should be provided when calling? The Johnson & Johnson/Janssen product name and event description must be reported to meet the minimum criteria of a complaint. Collect as much information as possible about the product, AE, PQC, or Special Situation, and the reporter (even if you have some, but not all, of the key identifiers for an identifiable patient). enrollment Some of the key identifiers are: 1. Reporter, if different from patient (name and PDF contact information, including phone number). 2. Patient information* (eg, age; age category; gender; initials; birth date; medical record/ patient/hospital number; full email address or screen name). 3. Johnson & Johnson/Janssen product name (and strength/lot number, if available). 4. Brief description of the AE, PQC, or other Special Situation and outcome (in reporter’s exact words). 5. Your name and the company for which you work (vendor name). 6. Trial Master Source number (also referred to as the Related Research Activity/RRA number). *If patient identifiers are NOT available, the reporter can confirm that a single patient exists (eg, “a patient experienced” a specific product safety event); therefore, sufficient information exists to believe there is a real patient. Where multiple patients are mentioned, there should be an attempt to obtain one of the key identifiers, as listed on the previous page, for each patient.

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COORDINATING

When should I report an AE, PQC, or Special Situation? The clock starts ticking as soon as the first employee of a JANSSEN CONNECT® Injection Center learns of an AE, PQC, or Special Situation, which is why all AEs, PQCs, and Special Situations must be reported immediately (within 24 hours of initial complaint awareness) to the Medical Information Center at 1-609-730-2898.* This includes after hours and during weekends and holidays. Twenty-four-hour coverage is maintained by the company. NOTE: Any AE, PQC, or Special Situation reported after the 24-hour time frame must be accompanied by an explanation of lateness. *Unless another number is provided in accordance with the program procedure documents.

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Who should complete AE/PQC training? All HCPs administering injections need to complete this training, depending upon their scope of work and involvement in the respective program/project (eg, involvement in collecting and/or assessing data). DETERMINING How frequently should I complete this training? This training is valid for a 12-month period. Retraining is required on an annual basis, as appropriate (eg, vendor is still actively supporting a company program/project), as well as whenENCOURAGING enrollment there is a change in governing contracts and/or Janssen processes. PDF

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