Literature Distribution: How to Ensure Compliant Pharmaceutical Marketing

August 18, 2020 by Leslie Barton

We’re all familiar with the expression “rules are made to be broken” – and maybe there are times when it’s okay to at least bend the rules a little. But, when it comes to pharmaceutical marketing, your best move is to stay compliant.

Pharma manufacturers and distributors are subject to a wide range of federal and state regulations governing how they advertise and promote their drugs. Penalties for violations include injunctions, civil penalties, seizures and even criminal prosecution that can affect individuals, as well as companies. Not good!

pharmaceutical-marketing-compliance-bigstockTo remain in compliance, pharmaceutical literature often requires a great deal of fine print, like footnotes and disclaimers. Keeping this information up to date and ensuring that it’s inserted where required can be a time-consuming, error-prone process.

Rx for Pharma Marketing Compliance

If you’re looking for ways to make it easier to stay on the government’s good side, Amware has the right prescription for your pharmaceutical marketing needs.

It starts with our online ordering and inventory management portal. In addition to cutting the cost and complexity of sales literature distribution, our system offers a host of features that help keep your materials in compliance. These include:

  • Permissions-based access so that sales reps can only order materials for drugs they’re allowed to sell.
  • The ability to set review and expiration dates for your materials, to prevent distribution of inaccurate or obsolete information. Flagging an item with a review date automatically generates an email to the person responsible for the document’s content, so he or she can revise it, mark it as expired or reflag it for review again at a later date. Setting an expiration date automatically removes the item from view at the set date.
  • A disclosure tool that allows you to enter, edit and automatically insert required wording into specified documents when they are ordered for digital printing. Our system keeps track of these in one dynamic database and automatically inserts the right copy each time a user places an order. No more accidental oversights.
  • A database that links your products and supporting documents (including those not produced, stored or fulfilled by Amware), so you can easily map, track and update relationships between documents and products or documents that must be ordered together. An order for one of these items will automatically generate an order for literature or forms that must ship with it. One of our clients uses this capability to generate Sunshine Act reporting notifications. If one of their sales reps orders 10 of an affected item, our system automatically prints and ships 10 sets of Sunshine Act forms and instructions with the item ordered.
  • A waiver tool that generates pop-up messages about usage or distribution restrictions for affected documents as they are ordered. Users have to acknowledge the message by clicking ‘agree’ before our system will let them proceed with their order. Their acknowledgements are saved in a searchable archive for compliance audit purposes.

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But That’s Not All…

Amware’s system – AMWARE 360 – can also capture, index and securely store both paper and electronic documents in a searchable archive, in case you ever need them for audits or compliance reviews. Every version of every document in your inventory is readily available until securely destroyed at a date you specify.

Another way Amware 360 helps keep pharma marketing clients in compliance is by capturing codes and dates from package inserts (PIs), which are commonly attached to or enclosed with sales literature distributed to physicians. This information ensures that the PIs are up-to-date and in compliance.

And, in cases where PIs have to be swapped out for an updated version, Amware can handle the literature reworking at the distribution center. No need to send it back to the printer.

In an increasingly competitive market, drug manufacturers and distributors need marketing communications that get results. Creativity is important, but so is compliance.

As your marketing literature fulfillment provider, Amware’s capabilities and experience can be an enormous help in keeping you compliant. To learn more about the solutions discussed in this blog, contact us today.

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Filed Under: Marketing/Sales Literature Fulfillment