J.9 - Example Pharmacy Plan Template.pdf

Attachment J.9 – Solicitation 75D301-20-R-67869 TBTC Study 37/TBESC PART D Pharmacy Plan -- Version 23-Feb-2018

TBTC/TBESC Site Specific Pharmacy Plan

Study 37/Part D

When there is a significant change in related personnel or administration process at a site (e.g. hiring of a new supervising coordinator), the Pharmacy Plan will need to be updated and submitted. The necessary approvals will be required for all submissions. Provide submission date below.

Submission Date: _____ _____ - _____ _____ _____ - _____ _____ _____ _____

D D M M M Y Y Y Y

Background

Name, address, and site number of the clinical research site for this pharmacy plan, to be monitored for compliance during Westat site visit.

1) Name, degree, title or position, site mailing address, email address, telephone, and fax numbers of the

Pharmacist of Record (or Study Drug Manager) who is responsible for this pharmacy plan. (Note: all pharmacy related correspondence will be sent to the contact provided below.)

2) Provide shipping address where study products are to be shipped.

3) Name, degree, titles or position, and contact information for the Back-Up Pharmacist (or Back-Up Study Drug Manager) who will assume these responsibilities when the Pharmacist of Record (or Study Drug Manager) is not available.

4) Please initial and date here, to indicate that the contact information (name, address, phone number, and email) of the pharmacist (or Study Drug Manager) has been added to the TBTC2 Member Module and is correct and complete. This is necessary for study drug supply communications and shipments

Initials Date

Receipt of Study Products Shipments

Rifapentine will be provided by Sanofi/CDC Drug Service. Site Pharmacist (or Study Drug Manager) will receive a notification which contains the quantity of Rifapentine boxes to be shipped prior to receipt of study drugs. Upon receipt of drug shipment, site must verify that the number of available boxes received are the same as the expected number of boxes shipped. International sites, must complete page 2 of form IPSO2, indicating receipt of shipment and any temperature deviations during shipment. If there is a temperature deviation outside the specified guidelines, sites must complete a Temperature Deviation Report. Temperature guidelines for Rifapentine provide for temperature deviation from +15°C (59°F) to +25°C (77°F). Deviations are to be reported if there are temperature excursions below +15°C (59°F) or above +30°C (86°F). All correspondence, shipping invoices, and supporting documentation should be filed and available for monitoring.

1) Does the pharmacy have written policies and procedures for handling investigational agents? If yes, attach.

2) For study drugs not provided by Sanofi/CDC Drug Service, please describe how site is prepared to ensure that proper drug supply is available on site, to allow continued enrollment, and completion of treatment.

3) Describe the system for organizing protocol information, (for example, the current IRB approved version of the protocol (and amendments if applicable), participant treatment assignment lists, order forms, packing slips, accountability records, written prescriptions, return records, letters and memos from TBTC, Investigator Brochures, etc.) the process for keeping this information up to date, where it will be located and who will have access.

4) How will the Pharmacist of Record (or Study Drug Manager) be informed of the IRB approval, continuation, or termination of the protocol?

5) How will authorized prescribers be identified, to the Pharmacist of Record (or Study Drug Manager), for a protocol so as to prevent the unauthorized prescribing of investigational agents?

6) What procedures will be followed by the Pharmacist of Record (or Study Drug Manager) to maintain confidentiality of a participant's pharmacy file and the investigational agent accountability records?

Investigational Agent Control

Temperature guidelines for Rifapentine provide for temperature deviation from +15°C (59°F) to +25°C (77°F).

Deviations are to be reported if there are temperature excursions below +15°C (59°F) or above +30°C (86°F). Sites are responsible for obtaining and maintaining a supply of all study drugs used by the site in this study. This includes rifapentine not being used in the experimental arm. Each of the following questions must be answered.

1) Room Temperature Storage

a) Where will investigational agents be stored?

b) Will the investigational agents be stored according to manufacturer’s specifications?

c) Will a temperature monitoring device be used? If yes, will documented results be maintained?

d) Initial and annual certifications from the manufacturer(s) that temperature monitoring devices have been calibrated is not required. However, the site is required to conduct testing, at least annually, to ensure that temperature monitoring devices are working.

Please indicate whether the site plans to have their temperature monitoring devices certified and calibrated by the manufacturer or a third independent party. If not, describe the approach that will be taken (e.g. cross-checking temperatures with another device, “ice bath” test, etc.) to ensure the temperature monitoring devices are working accurately.

e) How will temperature excursions outside of the manufacturer’s specifications be managed? Please describe the site’s procedure as it pertains to study drugs used in both the experimental and comparator arm.

f) There will be a “Last Allowable Enrollment Date”, after which sites will not be allowed to enroll participants using a batch of study drugs that will soon expire. How will outdated study drugs be separated from unexpired study drugs?

g) How and when will expired investigational agents/study drugs be disposed?

h) Who will have access to investigational agents?

i) How will access to investigational agents be limited to only those listed in item (1h) above?

j) If prescriptions are prepared prior to a participant’s visit, where will they be stored and for how long can they be stored before being given to the participant?

k) Is the access limited in this storage area?

l) Who will handle the investigational agents/study drugs in between the time they leave the Pharmacist of Record’s (or Study Drug Manager’s) possession and the time they are dispensed to the participant? If applicable, explain how the study drugs will be protected from possible exposure to extreme temperatures during the transfer?

m) For study drugs not provided by Sanofi/CDC Drug Service (i.e. study drugs used in the comparator arms), please describe how the site is prepared to ensure the proper storage of the local drug supply.

2) The Pharmacist of Record (or Study Drug Manager) is required to keep complete accountability records of all investigational agents/study drugs that are received from Sanofi/CDC Drug Service. The quantity of the investigational agents/study drugs that you have at your site must match the quantity on the accountability records (Drug Management Module) at all times.

a) Describe how the expected bulk supply of investigational agents/study drugs received will be verified against the actual bulk supply of investigational agents/study drug received.

b) If the site is participating in more than one clinical trial, or if investigational agents/study drugs are commercially available, describe the procedures in place so that the investigational agents/study drugs are not mixed with the general/program supply?

c) Once a participant is assigned to a specific regimen of investigational agents/study drugs, how will the participant be matched to the assigned regimen?

d) How often will the investigational agents/study drugs on the shelves be counted and compared with the accountability record (Drug Management Module)? If applicable, attach the pharmacy QA Plan.

e) If there is a discrepancy between the drug accountability record and the actual physical inventory, how will the reason(s) for the discrepancy be documented? Any discrepancies should be reported to the CDC Data Center.

f) For sites with several clinics, specify any differences in procedures for drug accountability and storage across clinics.

Investigational Agent Dispensing

If a Site Pharmacist (or Study Drug Manager) is responsible for dispensing an investigational agent to participants enrolled in the protocol at another institution, a letter describing the dispensing procedures must be co-signed by the

Director of Pharmacy at the second institution. Rationale: Make sure the process is consistent with the second institutions policies and to document the Director of Pharmacy of the second institution is aware the study is being conducted and agrees with the dispensing procedures.

1) An authorized prescriber listed on the FDA form 1572 must sign a written prescription at the time a participant is registered/randomized to the protocol, or when there is a change in treatment, in order for the pharmacist (or Study Drug Manager) to dispense medications. How will the Pharmacist of Record (or Study Drug Manager) receive this written prescription? Explain any anticipated delays from the time the prescription is signed until the time the investigational agents/study drugs are dispensed.

2) How will it be documented that the informed consent was signed prior to dispensing the investigational agents/study drugs?

3) How will the Pharmacist of Record (or Study Drug Manager) dispense the investigational agents/study drugs?

If applicable, also consider how investigational agents/study drugs will be dispensed from bulk supply to individual clinics.

4) How will the study treatment dispensed be matched with the study treatments indicated on the treatment assignment list?

5) If the dose must be calculated based on weight or body surface, what procedure would be used to ensure the dose is correctly calculated and dispensed? Also consider how the dose will be adjusted, if the participant’s weight changes over time.

6) How and when will unused investigational agents/study drugs assigned to participants, who have discontinued for any reason, be disposed? Explain how returned drugs will be stored and how storage/disposal of returned drugs will be documented. Disposition of returned study drugs are permitted only after study drug accountability has been conducted by a site monitor, and authorization has been given by DCC.

7) The administration of whole tablets is strongly preferred over crushed (or splitting) tablets. In the event that a participant can no longer swallow whole tablets, contact DCC personnel.

a) In what setting and conditions will study drug supplies (experimental and comparator arms), dispensed from the research pharmacy, be stored?

b) If site plans to repackage experimental study drugs for daily doses, please describe the packaging in detail.

c) Each site will determine whether the study medications will be administered via DOT or SAT (doses on weekends and on holidays included). If doses are self-administered, how will this be implemented and documented?

d) How will administration (either by DOT or SAT) of study drugs be managed and documented in the event of a participant being in a hospital setting?

8) Participants receiving a rifampin-containing regimen should take study drugs on an empty stomach; for participants on rifampin who have difficulty tolerating study drugs on an empty stomach, the administration with food is acceptable. Participants receiving a rifapentine-containing investigational regimen should ingest food within one hour before study drug administration. Sites are asked to confirm that if necessary, food (at least a light, locally appropriate snack) will be provided to participants receiving a rifapentine-containing investigational regimen, so as to ensure compliance with the requirement to take study drugs within one hour after ingesting food.

9) Please provide an estimate of your site’s monthly enrollment rate.

Approvals

Pharmacist of Record (or Study Drug Manager) _______________________________________________

Signature___________________________________________Date_____________

Institutional Pharmacy Director (Applicable only if the Pharmacist of Record is not an institutional pharmacist)

Signature___________________________________________Date_____________

Please check this box if Institutional Pharmacy Director is not applicable to this site.

TBTC/TBESC Site Specific Pharmacy Plan for Study 37/Part D Approved by Principal Investigator

Signature__________________________________________________Date ____________

Note: Pharmacy plans will not be approved without the Pharmacist of Record’s (or Study Drug Manager’s) dated signature. A copy of this completed Pharmacy Plan must be kept on file in the pharmacy.

TBTC/TBESC Site Specific Pharmacy Plan for Study 37/Part D Approved by CDC Data Center

Signature__________________________________________________Date ____________