Beyond the White Box: Why Patient Friendly IP Packaging Matters KRISTEN DEVITO Global Director, CSS Business Solutions Catalent Pharma Solutions Presented to 17 March 2015
Introduction The increasing complexity and global nature of clinical trial designs have been in part enabled by the developments of IRT (Interactive Response Technology) systems to manage the supply chain In response to the increasing complexity, the industry has applied lean practices to clinical supply to improve speed and efficiency and reduce overall cost Standardization of clinical supplies has resulted in a one-sizefits-all approach to the design of the medication kit and clinical label The result is often unfriendly medication kits delivered to the end-user, our patient volunteers 2
Voice of the Patient - IMP Kits Factors which heavily influence the medication kit and label design include Dosage Form and Delivery Method Clinical Protocol Regulatory Requirements Efficiency / Cost Time constraints There is often a disconnect between the groups which determine the kit design and the groups which interact most often with the patient volunteers Stakeholders within the Clinical Supply Chain recognize that the actual medication kit has impact upon both the patient experience and patient and site compliance, also potentially influencing patient retention 3 3
Patient Kits: Past, Present, Future Patient kits of Past Patient Specific Kits Site based Randomization Schemes Coloured labels to aid clinical site and patient compliance Titration/variable dose schemes required patient kits collated to all possible dose progressions Typically one or two languages, single or multi-panel labels Visit Specific Dispensing Cartons Design emphasis 4 Dispensing and Dosing compliance Country specific Patient No. 1006 Dose Level A Visit 5 Patient No. 1006 Dose Level A Visit 4 Patient No. 1006 Dose Level A Visit 3 Patient No. 1006 Dose Level A Visit 2 Patient No. 1006 Dose Level A Visit 1 Patient No. 1006 Dose Level B Visit 5 Patient No. 1006 Dose Level B Visit 4 Patient No. 1006 Dose Level B Visit 3 Patient No. 1006 Dose Level B Visit 2 Patient No. 1006 Dose Level C Visit 5 Patient No. 1006 Dose Level C Visit 4 Patient No. 1006 Dose Level C Visit 3 300 Patient Packs x 12 Visit Cartons =3600 Visit Cartons 4
Patient kits Today Standardised White cartons and labels Standard bottles, vial etc. Booklet labels Individual country pages with generic, coded cover panel Kit = a dispensable unit Multiple Kits may be dispensed at a single visit All look the same Design emphasis 5 Patient Kits: Past, Present, Future Regulations (getting all information on a label/booklet even if unreadable!) Cost effective packaging Flexibility of Supplies For same 5 dispensing visits 300 Patients x 5 Dispensing Kits =1500 Kits 5
Patient Feedback Survey on Clinical Trial Medicine Kits In response to industry desire to improve the patient volunteer experience, the International Society of Pharmaceutical Engineering (ISPE) in collaboration with the Center for Information and Study on Clinical Research Participation (CISCRP) and financial support of 11 industry sponsor and vendor companies, developed an online survey to solicit feedback directly from study volunteers on their experience with clinical medicine kits Distributed globally in 3 languages (English, French and Spanish) from May through September 2013 97% respondents from United States http://www.ispe.org/patientinitiative/2013novreport 1,425 responding study volunteers with recent experience in a Ph II or Ph III clinical trial and took medication home Good mix of age, gender and representation from various therapeutic studies Reference: C. Milligan, J Schults and K. Getz. Assessing Pa4ent Experience with Clinical Trial Medicine Kits. Pharmaceu)cal Engineering, Volume 23, Issue 8 6 6
Patient Survey Results Overall Satisfaction and compliance with Medicine Kits Majority of respondents stated kits were easy to use and easy to store Patient perception of compliance-enabling impact by kit type 60% responded that design/layout of the kit helped them to take their medicine on schedule 30% responded kit design did not have impact and 11% did not remember Though blister packs more difficult to open for some volunteers, they indicated greater impact of aid in adherence to schedule Volunteers suggest adding dates/times to blister packaging would help track dose intake and promote adherence to study protocol Reference: C. Milligan, J Schults and K. Getz. Assessing Pa4ent Experience with Clinical Trial Medicine Kits. Pharmaceu)cal Engineering, Volume 23, Issue 8 7 7
Role of Kit Design in Compliance Most Important medication kit factors 82% of respondents self reported they always take clinical trial medicine on schedule Over 50% felt at least one type of reminder very useful with youngest age group responding favorably to daily reminders Perceived Usefulness of adherence reminders Reference: C. Milligan, J Schults and K. Getz. Assessing Pa4ent Experience with Clinical Trial Medicine Kits. Pharmaceu)cal Engineering, Volume 23, Issue 8 8 8
Feedback on Clinical Labels Booklet Labels 12% never opened or reach booklet label 14% opened and read booklet label on only some containers Pictorial Instructions Agreement that pictograms are helpful However, must be easy to interpret and communicate correct message Further research globally on clarity of message on patient behavior could support expanded use Reference: C. Milligan, J Schults and K. Getz. Assessing Pa4ent Experience with Clinical Trial Medicine Kits. Pharmaceu)cal Engineering, Volume 23, Issue 8 9 9
Expanding Role of Technologies in Compliance Study volunteers asked their perception of usefulness of receiving label information via various technologies Overall, respondents favorable to alternative methods to receive labeling information Younger respondents more open to using smartphone technologies and digital communication Similar responses when asked about receiving reminders via same technologies Reference: C. Milligan, J Schults and K. Getz. Assessing Patient Experience with Clinical Trial Medicine Kits. Pharmaceutical Engineering, Volume 23, Issue 8 10 10
Medication Kits Delivered to Patients Homes Interest in having repeat dispensing kits delivered to patients home 78% indicated it would be very helpful or somewhat helpful to have refills of study medications delivered directly to their home Respondents had also indicated within survey that ability to connect with site study personnel is important to satisfaction and compliance Maintaining connectivity to site while employing remote study execution will be important to success Reference: C. Milligan, J Schults and K. Getz. Assessing Patient Experience with Clinical Trial Medicine Kits. Pharmaceutical Engineering, Volume 23, Issue 8 11 11
Key Takeaways from Survey Results Study volunteers have a genuine intent to comply with the study and want the study to succeed Though generally satisfied with their medicine kits, with blister card designs a preference for aiding compliance, there are opportunities to improve upon their design and the delivery of information which would affect positively patient experience and compliance Study volunteers would like to have options to customize their experience There are quick wins we can employ now to improve New models are currently developing which improve the patient experience Future technologies supported by regulatory framework to further customize delivery of IMP to the patient 12 12
Improvements to Readability of Labels Label example- how do get label text from sponsors? Protocol No.: 123456 Catalent tab 4 mg or Matching Placebo Content: 20 Tablets Lot Number: Exp Date: Patient Number: XXXXXXXXXX XXXXXXXXXX EudraCT No.: 2014-002338-29 Directions: For Oral Use Only. Take one tablet three times daily Investigational Drug. To be used by qualified investigators only. Store in original packaging to protect contents from light. Do not store over 25 Keep out of reach of children. Sponsor: Catalent Pharmaceuticals, Unit 107, Tenth Avenue, Deeside; Tel: 01244 555666 XXXX Investigator Name: Site ID: Patient ID: 13 13
Improvements to Readability of Labels Key site/patient information larger and bolder Peel off label for site to fix to other face of box to assist site storage Text not all left justified, different font sizes and bolding used 14 14
Patient kits Tomorrow The supply of clinical materials is becoming a two-way street, with information flowing upstream from the patients and sites to drive the downstream flow of user focused products and services Patient friendly to aid compliance Use of colour / Smaller / Simplified kits Easy to transport (inc. cold chain solutions) Use of pictograms On-demand models will enable patient kit to be customised to level of country, site and ultimately patient preference Single language labels High visibility of the Kit ID number customised for Clinical Site convenience Link to other formats for accessing label information e-labels / videos Direct to Patient (DTP) shipments Design emphasis 15 Patient Kits The Future Include Patient & Clinical Site input Tailored to Therapeutic solution 15
Catalent Direct to Patient Value Proposition PATIENTS CLINICAL SITE TRIAL - Prevents missed treatments/doses - Supports pa4ents with long/difficult travel to site - Assists those with disabili4es or other health issues that can impact travel - Can eliminate needs and burden of transpor4ng returns - Supports pa4ent lifestyle e.g. vaca4on - Reduced travel costs - Simplified processes - Reduced storage burden - Travel fees eliminated - Could be possible to increase visit windows - Increased Pa4ent reten4on/reduced drop out - Improved pa4ent compliance - Final mile control of product stability - Op4mized drug accountability and returns - Reduced waste Pa4ent feels valued and more likely to comply and complete trial 16 16
Will be key Apps for patients Technology - PUSH information - Expiry updates - Label updates - Visit reminders - Delivery reminders - Dosing reminders - PULL information - Compliance information - Diary information - Confirmation of receipts for home delivery 17 17
E-labeling Concept E-labeling: the labeling of secondary medicine packs/kits with non-country specific labels but with serialized barcode or RFID chip which will enable delivery of information to the site and to the patient Delivery of custom information delivered for each pack Local language translation of clinical label Real-time expiry information Instructions videos specific to dispensed pack Dosing reminders Cumulative temperature excursion data Not currently within regulatory framework Reference: K. Gram, H. Heessakers, R. Lauwers and S. Sonnenberg. Patient Centric Innovations in the Clinical Supply Chain. Pharmaceutical Engineering, Volume 34, Issue 3 18 18
Summary The patient volunteer experience and perceptions of an improved supply chain for clinical trials must be taken into account in order to recruit and retain this essential resource Patient-centric considerations and improvements in medicine kit design and the overall supply chain can be implemented now within current technology and regulatory constraints Leveraging available technologies and best practices within the clinical supply chain do not need to increase costs in order to achieve patient focus, but may re-distribute the cost Younger populations as current and future study volunteers will set new expectations on the definition of a positive study volunteer experience in regard to their study medications Increase opportunities for change by training on concepts learned from patient and site feedback up through the supply chain 19 19