无论您是否将其称为流行病或称之为危机，据美国人部有关的情况，阿片类药物相关药物过量每天损失估计的130多人。“infographic。
Packaging has a unique opportunity to help complement the comprehensive reform effort in addressing opioid abuse. That’s certainly one goal for outsourcing biopharmaceutical services providerPCI Services。Though based in Rockford, IL, the company maintains an international focus, supporting medications destined to more than 100 countries. It partners with customers in product, packaging and supply chain innovation for everything from opioids and orphan drugs to medical marijuana to e-commerce shipments. Its responsibilities clearly extend beyond the traditional role of yesteryear’s contract packager/manufacturer.
“The role of an outsourced biopharmaceutical services provider is evolving in today’s market,” says Justin Schroeder, PCI’s Senior Executive Director, Global Marketing & Design. As a strategic partner, PCI aims to deliver value to the relationship, “impacting innovation, speed-to-market, regulatory guidance, and patient-centric considerations, in addition to price efficiency. The company helps brand owners navigate and avoid obstacles, develop and implement breakthrough ideas, and has helped launch more than 50 products a year across a broad portfolio of drug delivery forms.”
For example, PCI partnered withCSP Technologies (now owned by Aptar) for the commercialization of ActivBlisterTM。“这提供了定制的解决方案来控制各个泡罩腔内的内部大气，”他说。“它有可能显着影响产品稳定性，增强保质期。PCI将于2019年3月在第一台机器上运行其第一个客户稳定[学习]。为客户真正突破技术。“
Financial implications
Ever-evolving industry changes require outsourcing/contract packaging firms to adjust, particularly as the value of advanced biologic, oncology, pain management and orphan disease treatments skyrocket.
“A single dose of certain drugs we support may have a manufactured value in the hundreds or thousands of dollars, notwithstanding its exponentially higher retail value at the consumer level,” says Schroeder. “For investigational clinical study medicines, they are simply invaluable.
International regulatory complexities
With its global market, PCI engages daily with international regulatory agencies. Schroeder notes, “This sometimes involves reconciling the demand and areas of focus of the FDA or EU/MHRA agencies versus those of emerging market governmental agencies in Russia, Brazil, Turkey or others.
“监管标准继续提高,in prescription and OTC medicines, as well as medical devices and consumer products. The rising regulatory expectations are felt in the industry as FDA has more resources to inspect and enforce requirements in places like India and China, which has led to the shift from offshoring to large-scale in-shoring for outsourced drug manufacturing and packaging activities.”
Unit-dose packaging
PCI通过投资人，设施，包装机械，控制和材料来解决全球挑战。例如，今年年初，它宣布进一步扩展其费城和罗克福德设施的受控物质储存，以帮助建立其泡罩的包装能力来支持新的包装变化opioid legislation。
“There has been considerable discussion about the opportunity for utilizing blister packaging as one tool to positively influence the misuse of opioid and pain management medications in the U.S.,” noted PCI’s Phil DiGiacomo, Senior Vice President of Sales & Marketing. “A critical factor in that narrative is to ensure safety in the home. This child-resistant packaging protects younger people in the home and provides an adherence platform supporting the user to take medication as prescribed.”
Schroeder elaborates: “Opioids, and controlled substances more broadly, [represent] a great example of where PCI has been engaged with various industry organizations, understanding the stringent manufacturing and supply chain requirements as well as some of the nuanced regulatory requirements from the DEA, FDA as well as the CPSC for child-resistant and senior-friendly needs, an often-overlooked element of the discussion. It is a complex area and we have tried to ensure that the FDA and legislators grasp both the challenges at the consumer level, as well as those of the highly regulated supply chain, so the solutions they bring forth in regulation can realize a positive impact.”
limited dosages/patient adherence
PCI continues to push for change in unit-dose formats. Schroeder notes, “It is well documented by FDA, DEA and many other organizations that opioids are overprescribed. Through our participation with industry working groups, theHealthcare Compliance Packaging Counciland PBOA for example, PCI has advocated the advancement of unit-dose formats for prescribing limited days of therapy. Rather than the automatic prescribing of a 30- or 60-day bottle, for example, a doctor or pharmacist could provide medicines in limited three- or five-day packs.
“Calendarized adherence-style packaging has proven to support patient compliance, helping patients take medication as prescribed and as intended,” he continues. “Unit-dose packaging provides a clear demonstration of when a prescription has been consumed, helping mitigate the opportunity for diversion in the household. With the unit-dose packaging format, tablets are separated and provide more difficultly to access for children. A recent statistic showed that opioid death in children has tripled over the past two decades.”
Schroeder admits, “Unit-dose packaging is not a silver bullet in addressing the opioid crisis in our country, but it is a positive step as part of a comprehensive approach to changing our prescribing practices.”
近年来，PCI为其耐抗儿童/高级友好包装赢得了荣誉。该公司支持来自诸如此本的公司的几个专有的单位剂量包装设计Westrock-MPSandKeystone折叠盒CO。“除了安全方面，这些格式还提供了一种平台，可以更好地向患者提供日历化，补充文献，患者教育以及许多其他支持工具来实现更好的健康结果的患者，”Schroeder说。“
SIDEBAR:
医疗大麻
医疗大麻继续受到更加传统治疗疼痛方法的选择。在此问题上，PCI的Justin Schroeder解释说：“我们正在支持大麻基衍生物的临床研究以进行道德药用用途。目前，那些药物是联邦治理的安排我控制物质，因此我们实际提交并收到了批准，以扩展我们的DEA牌照II-V目前包括进度I的药物。这些临床研究由FDA监督。
“在国家一级更广泛地使用大麻疗法的合法性方面，个人州法律仍然与联邦法律相冲突，因此这不是我们此时追求的领域。正是我们期望曾经在国家一级定居，法规将包括这些药物，他们将由同等国家合规则，监管标准和童药的国家标准。
SIDEBAR:
电子商务和亚马逊
Another “hot-button” topic PCI is watching closely is the role of e-commerce on life sciences packaging and logistics. Justin Schroeder notes, “Amazon raised significant interest in the industry with their recentacquisition of PillPack, leaving the market pondering how that may influence distribution of prescription medicines via an e-commerce/mail-order type platform, in addition to how it could help drive medication adherence in unitizing multiple medications for patients.
“亚马逊也有一个重要的机会，也有机会影响场外市场，特别是在定义包装设计标准时围绕消费者友好的设计和可持续性的地位。处方和OTC市场都很快就会看到零售交付的新渠道，这将对包装设计和相关的供应链产生影响。亚马逊对解决医疗保健成本的上升成本也是相当的声音。鉴于亚马逊的影响亚马逊已经在其他类别中，我们相信这绝对是一个观看的空间。“
