Rx Sampling During COVID-19
While direct to practitioner pharmaceutical sampling has always played a critical role in the pharmaceutical industry, Rx sampling during COVID-19 presents unprecedented challenges. Representative access to practitioner offices is limited, as is access to samples. Healthcare Provider access to samples allows them to provide their patients with an immediate start to treatment and helps practitioners gain experience with the product. CCG’s integrations with client SFA systems and our internal 21CFR11 ordering portal has helped the industry shift from a hand-carried model to a rep-triggered model. Pharmaceutical sample management that prioritizes compliance, speed, and safety is essential in the timely development and distribution of life-saving and life-improving products.
Pharmaceutical Sample Management
Sampling contributes in a powerful way to pharmaceutical product development and public safety. At CCG, we speak from over 25 years of experience partnering with the pharmaceutical industry in managing sample distribution plans. We provide custom kitting, distribution, and order management. Additionally, we offer a suite of continually updated technology solutions designed to manage both rep sample allocations and direct to practitioner sampling initiatives. The more complete and streamlined the sample distribution plan, the easier it is to manage disruptions. Such disruptions include changes to in-office access and brand tactical planning. An effective plan assesses continually for potential improvement. As industry trends and access restrictions change, partnering with an experienced, compliant, and agile partner is critical.
Essentials of Pharmaceutical Sampling & Medical Device Fulfillment
As well as dedicated storage in the form of a secure, temperature-controlled warehouse, reliable pharmaceutical sampling for human and animal health features:
- OTC, Rx, Nutraceutical and Medical Device samples
- DEA Schedule 3 (III), IV and V
- Cold Chain Storage and Distribution
- Full HIPAA, PDMA, FDA and DEA compliance
Staying aligned with the FDA and other federal agencies and regulations is not a one-and-done enterprise. This is especially true during a pandemic. COVID-19 continues to impact distribution in unprecedented ways. For example, last year, the FDA altered its guidelines for how pharmaceutical samples could be received. Due to the global health emergency, the FDA concluded that pre-pandemic regulations made social distancing difficult. This difficulty, the department decided, jeopardized the health of delivery personnel as well as individuals who receive the delivery. Consequently, they now allow direct patient sampling so long as all current PDMA and state regulations are compliant.
This change in regulations is a specific response to COVID conditions, designed to be in effect only until the public health emergency has passed. When that day arrives, it will be necessary to adapt and update practices once again, to ensure an uninterrupted and safe supply chain.
Compliance + Integrated Technology = Solutions for RX Sampling During COVID-19
Nothing happens without compliance. Staying up to date on rapid-fire changes in regulatory policies and protocols requires advanced and nimble technology. From PDMA, HIPPA compliance to cGMP (Current Good Manufacturing Practice) certification; maintaining the capacity to manage and adapt to the shifting needs of pharmaceutical sampling plans takes vigilance and dedication.