PCI Pharma Services is happy to congratulate Vertex Pharmaceuticals and Mannkind Corporation for their recent awards in the Healthcare Compliance Packaging Council’s (HCPC) 2015 Compliance Package of the Year competition. HCPC recognized Vertex as the overall winner for the ORKAMBI package while also naming MannKind Afrezza as second runner-up in the prestigious awards programme.
ORKAMBI (lumacaftor/ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene. Submitted for the HCPC award by PCI on behalf of Vertex, the ORKAMBI packaging offers a number of compliance-prompting features for patients.
ORKAMBI is provided in convenient daily blister units, with graphics clearly highlighting the AM and PM dosing requirements. Individual blister units are file-packed into a weekly organiser carton, with individual days neatly arranged to illustrate the daily regimen. Dosing instructions are positioned to educate the patient, reminding patients to take the AM and PM doses 12 hours apart and to take their medicine with fat-containing foods. Four weekly packs are provided in an outer monthly carton, which contains graphics that further reinforce dosing instructions as well as the FDA-approved labelling.
Prescription Afrezza, a rapid-acting inhaled insulin breathed through the patient’s lungs, is used to control high blood sugar in adults with type 1 and type 2 diabetes. Submitted by PCI on behalf of MannKind, Afrezza is provided to patients delivered in colour-coded prefilled cartridges. Individual cartridges are blister-packed in quantities of 15 based on a colour-coding system to indicate the strength: 4-unit strength cartridges are blue, 8-unit strength cartridges are green, and 12-unit strength cartridges are yellow. Indication of the strength of each cartridge is also moulded in the plastic of the individual cartridge.
Two 15-count cartridge blisters are provided in an overwrapped pouch. The pouched unit reinforces the colour-coding methodology by utilising the drug strength colours in the package graphics, in addition to providing detailed instructions for refrigeration of the product as well as equilibration requirements prior to dosing, bringing the product up to room temperature. Furthermore, the pouch graphics identify that once a blister strip is opened to access the cartridges, it must be used within 72 hours.
Also provided to the patient are two prewrapped inhalers in a prepackaged carton, protecting the inhaler from dust, particulate, etc. Carton artwork provides detailed dosing instructions, a colour-coded dosing chart based on the number of units needed per dose, as well as a calendar to guide the patient for the timely replacement of the disposable inhaler unit. The carton also reinforces the storage requirements for Afrezza.
The individual pouches and inhaler carton are combined with regulatory literature in the dispensing carton. Package graphics highlight the www.AFREZZA.com website, where patients can find additional resources including videos, storage and dosing instructions, prescription savings information, and social support for patients, as well as other resources.
PCI has a distinguished history in the adherence packaging design competition. PCI has supported winning packages in previous years, most recently being recognised in 2015 for the Eli Lilly Strattera Physician Sample and Novartis Exforge HCT and in 2014 for the Noven Therapeutics Brisdelle and Depomed’s Gralise designs.