Healthcare professionals working together on documentation; medical affairs audits concept

Why Life Sciences Companies Need Regular Medical Affairs Audits

Industry leaders tend to agree that life sciences companies benefit from periodic medical affairs audits.

An audit performed every two to three years can help ensure an MA team has the tools and support it needs to perform at its best. Incorporating a comprehensive medical information platform can help the audit — and any resulting changes — proceed smoothly.

The Benefits of Medical Affairs Audits

Audits are commonplace in the medical industry. Healthcare providers focus primarily on audits of their billing, coding, and charting practices. Life sciences companies tend to audit a broader range of functions, including their medical affairs teams.

Because MA teams handle communications between life sciences companies and the world at large, many MA audits are essentially communication audits. Communication audits fulfill a number of purposes, writes Molly Southern at Oak Engage.

For example, communication audits reveal where information fails to reach the right audience, or where key information is missing. In the MA context, an audit can also reveal whether your teams are meeting regulatory requirements and best practices for communicating and sharing medical and scientific information.

Setting Expectations Before a Medical Affairs Audit

Audits often raise tension or concern among MA team members.

Audits do not indicate a suspicion of wrongdoing, nor do audits invariably uncover errors. Rather, audits are an opportunity to evaluate whether the MA team’s processes and methods are optimizing progress toward its goals.

In fact, sharing the results of an audit tends to reduce uncertainty rather than create it, researchers Owen Hargie, Dennis Tourish, and Noel Wilson write. By treating the audit as a means to produce insights rather than as an end in itself, MA teams can gain more information about their own efforts. Proper planning can manage early uncertainty, while proper communication can boost confidence and focus.

Healthcare professionals looking at information materials; medical affairs audits concept

Planning a Medical Affairs Audit

Applicable regulations don’t tell life sciences companies when to audit their medical affairs efforts. Neither do regulations let these companies off the hook for audits, either.

On average, most life sciences organizations audit their MA functions every three to five years. At the 41st Annual Conference for the Association of Healthcare Internal Auditors (AHIA), PYA’s Tynan Kugler and Katie Garmon identified four key areas to consider when planning a medical practice audit. Their advice applies just as well to medical affairs:

  • Identify the purpose of the audit. Audits can identify areas of risk and non-compliance. They may also reveal what works well when it comes to meeting essential goals.
  • Choose the right type and scope of audit to fulfill the audit’s purpose. Auditing everything at once may result only in confused team members and overwhelmed auditors. Use the purpose of the audit to narrow the audit’s scope and focus.
  • Prepare both the team and the auditors with clear, objective guidelines. A written handbook or guide for the audit process and practices can help both MA team members and auditors stay on the same page.
  • Create an action plan. The action plan includes audit strategies, a to-do list prioritizing various tasks, and guidelines for reporting audit findings. Like the audit guidelines, the action plan helps keep everyone coordinated before, during, and after the audit.

Several types of audits are commonly used in medical affairs communications, each with its own specific scope. Kivi Leroux Miller, founder and CEO of Nonprofit Marketing Guide, identifies five types of communications audits that, though written for a nonprofit audience, apply to medical affairs as well:

  • A channel-mix audit examines the channels used for communication and how communications are handled in each channel.
  • A content or messaging audit reviews the topics and approach to topics the team most often addresses.
  • A brand audit explores the world in which content or messaging is couched, including its visual presentation, verbiage, and other brand elements.
  • A strategic objective audit asks whether the team’s communications are meeting its broader goals and, if so, how these goals are achieved.
  • A tactical best practices audit analyzes whether the team’s use of each communication channel is optimized for that channel, audience, and content.

Choosing key performance indicators (KPIs) during the audit process can help an audit team quantify its findings. Quantifiable findings can more easily be compared across audit years. They can also provide benchmarks for ongoing improvements.

One key place for auditors to focus is on MA teams’ abilities to generate and disseminate real-world medical data and communications. Medical affairs’ role in pharmaceutical communications and research-sharing is gaining prominence as providers turn away from pharmaceutical representatives and toward scientific and technical sources of information, write Loic Planetvin, Christoph Schlegel, and Maria Gordian at Bain & Company.

As interest in scientific sources continues to grow, medical affairs teams increasingly become the focus and source of medical information for providers, payers, and patients.

Healthcare professionals looking at document; medical affairs audits concept

Choosing Digital Tools to Support Auditing and Compliance Efforts

Like many MA functions and tasks, auditing shifted from an in-person job to a virtual or remote one during the COVID-19 pandemic. Virtual audits can provide the same benefits as in-person audits if the specific challenges of the virtual format are addressed early.

Alena Galante and Denise Dixon of Diligent Health Solutions identify four key challenges to address when planning a virtual audit:

  • Relationship building. Building connections between auditors and the MA team is more challenging in a virtual context than it is in person.
  • Planning and communication. Because the audit is done remotely, more thought must go into the planning process ahead of the audit itself. Creating and maintaining regular communication channels is a must.
  • Scheduling. Auditors tend to shift between speaking to the MA team and spending time alone reviewing documents. In a remote context, teams will need to prepare for a schedule in which meetings may be interrupted by the need for auditor concentration.
  • Addressing technical demands. Connecting through technology also poses the risk of having that communication disrupted by technical issues. Having IT staff on standby and setting expectations for technology use can reduce the risk that a technical problem will disrupt the audit process.

Whether an audit is conducted virtually or in person, digital communications will almost certainly be part of the audit process. “If you have a digital communications platform in place, collecting these insights will be much easier,” writes Patrick Icasas at Nudge. Digital tools can help auditing teams better generate metrics, review tool use and access, and test regulatory compliance demands.

Medical affairs audits can be a powerful tool for improving communications, meeting compliance standards, and boosting the efforts of an MA team toward greater success. The right digital tools provide further support for MA teams and their goals.

Images by: kaew6566/©, peopleimages12/©, stockasso/©

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