MTN Regional Meeting Pharmacy Session October 29-30, 2013 Tuesday - PowerPoint PPT Presentation

MTN Regional Meeting Pharmacy Session October 29-30, 2013

Tuesday October 29th 12: 30 P M to 1: 30 P M LUNCH (Restaurant Thirty7) 1 : 3 0 P M t o 2 : 0 0 P M Welcome and Objectives 2 : 0 0 P M t o 2 : 3 0 P M Ring manufacturing and supply chain Kathie Windle 2 : 3 0 P M t o 3 : 0 0 P M ASPIRE Progress Update Cindy Jacobson 3 : 0 0 P M t o 3 : 3 0 P M BREAK (Old Harbour Lobby) 3 : 3 0 P M t o 4 : 0 0 P M Pharmacists Site 4 : 0 0 P M t o 4 : 3 0 P M Role in ASPIRE Presentations 4 : 3 0 P M t o 5 : 0 0 P M Cont. Site Presentations 5 : 0 0 P M Meeting adjourned

Wednesday October 30th 12: 30 P M to 1: 30 P M LUNCH (Restaurant Thirty7) 1 : 3 0 P M t o 2 : 0 0 P M Welcome and Objectives 2 : 0 0 P M t o 2 : 3 0 P M Product complaint Kathie Windle 2 : 3 0 P M t o 3 : 0 0 P M Used Rings to Lab Group Discussion 3 : 0 0 P M t o 3 : 3 0 P M BREAK (Old Harbour Lobby) 3 : 3 0 P M t o 4 : 0 0 P M Dispensing >1 ring Protocol Deviations Group discussion 4 : 0 0 P M t o 4 : 3 0 P M Cindy Jacobson Off-Site visits Site Presentation 4 : 3 0 P M t o 5 : 0 0 P M Wrap-up Cindy Jacobson 5 : 0 0 P M Meeting adjourned

Pharmacy Session Overview Day 1  Dapivirine Ring: Kathie Windle (IPM) Manufacturing & Supply Chain Process Next plans/future  ASPIRE Progress Update Enrollment  Pharmacists Role in ASPIRE Site Presentations

Pharmacy Session Overview Day 2  Product Complaint Review Reporting Process Summary of Reports  Used Ring Clinic to Lab vs. Destruction Process  Protocol Deviation Reporting  Off-Site Visits: Site Presentation  Wrap up

Kathie Windle  International Partnership for Microbicides (IPM)  Materials Planning and Supply Chain Lead  Extensive experience in trial supply management including forecasting, packaging and global distribution.  Prior to joining IPM Kathie was with Human Genome Science Inc.

Kathie Windle  Currently manages drug supply chain from drug substance, manufacturing and drug product through packaging and distribution.  Clinical drug supply management and oversight.

Pharmacists Role in ASPIRE  What was discussed last year  What is really happening - Site presentations  Discussion – what changes can we make at our site?

Pharmacists Role in ASPIRE  Education Participant meetings Waiting room Dispensing 2 rings Information about non-study products Review product use instructions

Pharmacists Role in ASPIRE  Counseling ● Provide ring adherence counseling. ● Conduct counseling and ● Provide information regarding contraception and/or STI treatments.

Pharmacists Role in ASPIRE  Other Periodic check-ins with pharmacists during specified follow-up visits to maintain relationship. Participant may accompany clinic staff to pharmacy or pharmacist may accompany participant to clinic staff when study product is dispensed.

Pharmacists Role in ASPIRE  Other Reminder calls to participants between Enrollment and Month 1 (and/or other study visits) to answer questions, gather information, and remind of next appointment.

Pharmacists Role in ASPIRE Uganda - Prior to start: Participants will be referred to pharmacists by clinic staff when questions arise that could be best answered by pharmacy staff. Pharmacists will educate participants about relevant issues, such as results from other related studies, during any participant meetings held on site. RM 2012 Ordering, proper storage, dispensing, information/education when called upon, and product destruction.

Pharmacist role at the Kampala site Rebecca Sakwa

What does the pharmacist do?  Orders for study product and the zip lock bags  Maintains the study product at the recommended (15-30) ° C  Prepares and dispenses study product to the filing clerk or designee on receipt of a prescription from an authorized prescriber  Maintains study product accountability records

What does the pharmacist do?  The pharmacist carries out quality control activities by performing real time review of study product preparations by another pharmacist before the study product leaves the pharmacy  The pharmacist does quality assurance through review of all participant specific pharmacy files before they are placed back in the cabinets after the day’s work is done

What does the pharmacist do?  The pharmacist maintains an adequate supply of male condoms for issue to the participants  The pharmacist participates in weekly team meetings

Has the role of the pharmacist changed since the last visit? The pharmacist role has not changed

Is there anything that could be done differently in the study and if so why? No, nothing could be done differently

How does the pharmacist impact adherence/retention? There is a plan for different team members to talk to participants in the waiting area on a rotational basis and the pharmacists have a slot in the future

What works well in the study and what should be changed for future studies? The double check system works well; no need for any changes

How often has the pharmacist dispensed more than one ring to a participant? This has happened once at our site

Thank you

Pharmacists Role in ASPIRE MRC – Prior to start Pharmacists may be involved in the counseling of participants for whom a second ring is dispensed (e.g. how to store the second ring or what to do with the used ring until the participant returns to the clinic). Pharmacists could also be involved in counseling and providing information regarding damaged rings and procedure to be followed. RM- 2012 Study Product Management and Accountability QA/QC STIs and emergency drugs, destruction, temperature monitoring

ASPIRE PHARMACY BREAKOUT SESSION Presented by Faeeza Arbee Pharmacist – Chatsworth CRS HIV Prevention Research Unit South African Medical Research Council MTN Regional Meeting Cape Town October 2013

ROLE OF PHARMACY IN ASPIRE Study Non Product Investigational Drug Management • • Centralized Procurement Order, receipt, storage, • Contraception Tracking randomization, maintain blinding, • dispensing IUCD coordination of insertions • Study Product Accountability (Pharmacist Assistant) • • Condoms: centralized function Temperature control & monitoring ROLE OF • • Dispensing - STI, contraception Request Slips: Order; store; distribute PHARMA Destruction Equipment CY IN ASPIRE • • Calibration and maintenance Unused rings Assist Internal Clinical Staff Pharmacy QC • Training of staff – pharmacy SOPs • Self QC Clinic QC • Destruction of used rings • Check by 2 nd pharmacist • Provide pharmaceutical information • QC of clinic accountability • IC & screening files • Counseling of participants procedures • Co-enrolment prevention

HOW HAS PHARMACIST’S ROLE CHANGED FROM VOICE Role is more participant centered and we are part of the team focusing on :  Retention  Adherence  Product coverage  Data Quality 30

WHAT WE WOULD DO DIFFERENTLY & WHY • Adherence :  Restrict ring insertion/removal training – this can encourage manipulation by some participants  Document ring appearance per participant over time (e.g. on clinic accountability record).  Identify adherence support for each participant - “buddy system”  Objective measures of adherence from study start – PK analysis at each visit, validated ring inspection procedures  Adherence monitoring – starts at month 1, with intense counseling support for all participants with <80% adherence  Provide demo ring to participants at screening to determine acceptability for long term use  Regular adherence workshops where participants share strategies and discuss problems regarding adherence 31

ROLE ON ADHERENCE & RETENTION Retention and product Waiting Room coverage Education • Posters • Retention tracking – create a • Address anonymous queries weekly list of expected participants for follow up • Address comments on HIV • Ring use tracking – prior to ribbons LoA#2 – decreased the number of PD’s. Adherence Social Events • Partner testing and treatment Counselling • Women’s Day/ Heritage Day • Clearly Non-adherent ppt Celebration • Difficult cases • Singing Competition; Fashion Show • Refreshments served • Participant tokens 32

ASPIRE – WHAT WORKS • Pharmacy System - works well  Dispensing process:  Well thought-out  Label concept (on PSDR):  Excellent idea  Minimizes dispensing errors • Study Product Request Slip  Covers all scenarios 33

FUTURE TRIALS • Worked well in VOICE Randomization • Lowers chance of errors Envelopes • PSDR self-separated in ASPIRE Randomization Tracking • Include Bin codes: Ease of summary Record • Include on flip-side of participant Randomization dispensing record number • Quick reference 34

FUTURE TRIALS Product Use • Pharmacist involvement – team approach to improve adherence Counselling • Pharmacist involvement in ring inspections Ring Use • Document trends per participant over time 35