Compliance-Enabled SMS in Pharma: Engaging HCPs and Patients Through Innovation

by Brian Fitzgerald | Last Updated: September 12, 2024 | 1 min read

Are compliance worries preventing your organization from exploring innovative ways to engage with Healthcare Professionals (HCPs) and patients? If so, you're not alone. 83% of pharmaceutical executives surveyed say they face this challenge, particularly when it comes to ensuring compliant communication. This issue becomes even more pronounced in specific contexts like off-label promotions in the U.S. or public advertisements encouraging prescription-only medicine (POM) requests in the U.K., where noncompliance can lead to hefty fines and public scrutiny.

Consider the example of antipsychotic medications in the U.S. Initially approved for treating specific conditions like schizophrenia and bipolar I disorder, these drugs were later marketed for a variety of unapproved uses. This led to federal lawsuits alleging the promotion of atypical antipsychotics for off-label conditions such as aggression, anxiety, ADHD, dementia, depression, PTSD, and sleeplessness. Settlements for these off-label marketing claims have ranged from $300 million to $1.4 billion. Some companies admitted guilt, while others denied any wrongdoing.

In the U.K., it's not just off-label marketing that can lead to trouble; marketing prescription medications directly to patients can also create issues. Recently, a single LinkedIn post about a drug's authorization in Great Britain resulted in a complaint to the Prescription Medicines Code of Practice Authority (PMCPA). The complaint was referred to the Medicines and Healthcare Products Regulatory Agency (MHRA) because it potentially breached U.K. regulations prohibiting ads encouraging patients to request specific POMs. Although no fines were issued, the MHRA emphasized that future social media posts should be appropriately targeted and free of promotional language.

Given these examples, it’s understandable why compliance teams in both the U.S. and the U.K. might be overly cautious about information sharing. Unfortunately, this necessary caution often hampers growth, causing many to stick to safer methods rather than pushing the boundaries of what's possible. But it doesn’t have to be that way. Instead of viewing compliance as a barrier, pharmaceutical executives should see it as a framework within which to innovate and rise above the competition.

With the right engagement strategy, there's immense potential waiting to be unlocked, and the role of technology in this process is crucial. Not only can technology enhance the connection between HCPs, patients, and pharmaceutical companies, but it can also increase sales and improve healthcare outcomes. But before we dive into this topic a bit deeper, let’s first explore what compliant HCP and patient engagement is.

What is Compliant HCP and Patient Engagement?

Compliant HCP and patient engagement goes beyond just adhering to legal standards; it is a strategic approach essential for upholding a company's integrity and reputation. Additionally, it is a wise business practice. By implementing compliant HCP and patient engagement strategies, companies can mitigate risks and foster valuable relationships that enhance sales. Therefore, it is crucial for pharmaceutical leaders to grasp the intricacies of compliant HCP and patient engagement.

Let's explore this in more detail:

Compliant HCP Engagement: HCP engagement involves interactions between pharmaceutical companies and healthcare providers, encompassing educational initiatives, clinical trial collaborations, product detailing, patient support, and more. Effective HCP engagement informs HCPs about the latest medical advancements, ultimately improving patient outcomes. Compliance in these interactions is essential, as regulations ensure transparency and uphold ethical standards, free from undue influence or conflicts of interest.
Compliant Patient Engagement: Patient engagement focuses on involving patients in their healthcare decisions through educational resources, access to product information, clinical trials, treatment feedback, and much more. When done effectively, patient engagement empowers individuals to actively participate in their healthcare, leading to better health outcomes. Compliance is equally vital in patient engagement, with regulations ensuring that interactions are ethical and transparent while protecting patient privacy.

When aligned with the multifaceted network of laws, industry codes, and guidelines that govern the pharmaceutical industry, these engagements ensure ethical conduct and regulatory adherence, which can, in turn, enhance a company's reputation and drive meaningful business growth.

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Why Compliance is Important

Adhering to regulatory compliance frameworks is not merely an ethical obligation but a strategic necessity. Ensuring compliance is crucial for safeguarding public health, maintaining industry credibility, and promoting transparency. Additionally, non-compliance can lead to severe repercussions, such as hefty fines, reputational damage, legal penalties, and, in extreme cases, the suspension or revocation of marketing authorizations. Conversely, strict adherence to these guidelines ensures that pharmaceutical companies' marketing practices remain transparent, truthful, and responsible.

Here are four more reasons why compliant engagement is so critical:

Safeguards Public Health: Providing a safe and effective environment for patients is of the utmost importance. Abiding by industry standards, regulations, and ethical guidelines helps protect the public's health and ensures that patients receive the best possible care. Inadequate compliance can lead to serious harm to the patient and cause severe damage to the reputation of pharmaceutical companies.
Protects Against Legal Risk: Failure to comply with industry regulations can result in fines, prosecution, and even imprisonment of individuals. As knowledge about these laws increases, regulatory bodies are taking stricter measures to enforce compliance. Therefore, compliance is crucial to avoid legal consequences.
Improves Brand Reputation: Pharmaceutical companies rely on their brand reputation for long-term success. Negative publicity can harm sales and profits and, in some cases, result in the discontinuation of a particular product. Since a customer’s trust is essential, companies must comply with the law and ethical guidelines. Failure to adhere to such policies can lead to a loss of reputation, consumer trust, and sales.
Ensures Ethical Responsibility: Pharmaceutical companies must ensure business survival while providing the public with safe and effective healthcare solutions. Compliance fosters this moral responsibility, ensuring that companies maintain the highest standards of professionalism, ethics, and behavior.

Compliance Challenges

Despite the importance of compliance in HCP and patient engagement, the landscape is fraught with numerous challenges that complicate efforts to ensure adherence to regulatory standards. These challenges range from the complexities of the regulatory landscape to the rapid evolution of digital marketing platforms and the disparities in regulatory standards across regions. Following is a closer look at some of these challenges.

Complex Regulatory Landscape: One of the primary compliance challenges is the complexity of the regulatory landscape. Pharmaceutical companies must navigate a myriad of laws, regulations, and guidelines issued by government agencies and industry bodies, each with its own set of requirements and interpretations. The sheer volume of regulations and frequent updates and amendments can pose significant compliance burdens for companies operating in multiple jurisdictions.
Rapidly Evolving Digital Platforms: Digital marketing has revolutionized how pharmaceutical companies engage with healthcare professionals and patients. However, this rapid evolution brings its own set of compliance challenges. Digital marketing platforms, including social media, websites, and mobile applications, offer unparalleled opportunities for reaching target audiences with tailored messaging. Yet, navigating the regulatory requirements governing online promotion can be daunting.
Differing Regulatory Standards Across Regions: In an increasingly globalized pharmaceutical market, companies often face the challenge of complying with differing regulatory standards across regions. What may be acceptable promotional practices in one country may be prohibited or restricted in another. Harmonizing compliance efforts across regions while accommodating local regulatory nuances requires careful coordination and resources.
Balancing Innovation with Compliance Requirements: Pharmaceutical companies constantly innovate to stay competitive in a crowded market. However, innovation in marketing strategies must be balanced with compliance requirements to ensure that promotional activities remain ethical, transparent, and compliant with regulatory standards. Striking this balance can be challenging, particularly when novel marketing techniques push the boundaries of traditional compliance frameworks.

Regulatory Bodies that Govern Pharmaceutical Companies

The regulatory landscape for pharmaceutical companies is intricate and varies across jurisdictions. A few of the world’s key regulatory bodies include:

United States: Food and Drug Administration (FDA)
Europe: European Medicines Agency (EMA)
Japan: Pharmaceutical and Medical Devices Agency (PMDA)
Australia: The Therapeutic Goods Administration (TGA)

These agencies enforce regulations such as the Federal Food, Drug, and Cosmetic Act (US FD&C Act), the Medicines Act (UK), the Pharmaceutical and Medical Device Act (Japan) and the Therapeutic Goods Act (Australia). Additionally, industry associations like the Pharmaceutical Research and Manufacturers of America (PhRMA) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) provide guidelines to ensure compliance.

But what makes things even more complicated when it comes to HCP and patient engagement in the US is that there are dozens of laws and regulations that pharmaceutical sales teams must abide by, including the Federal Communications Commission’s (FCC) Telephone Consumer Protection Act (TCPA) and the Federal Trade Commission’s (FTC) CAN-SPAM Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), FCPA (Foreign Corrupt Practices Act), The Physician Payments Sunshine Act (PPSA) and the US Department of Justice’s (DOJ) Evaluation of Corporate Compliance Programs (ECCP).

Of particular note is an essential update to the DOJ’s ECCP related to HCP and patient engagement using personal devices, communications platforms, and messaging applications, including ephemeral messaging applications, during the course of business. Sales teams often use personal devices to communicate with doctors and other healthcare providers. The new guidance emphasizes the need for companies to have policies and procedures in place to retain all business-related communications while ensuring that employees are not using unapproved applications and devices to conduct business.

The Importance of Retaining Business-Related Communications

Several industry-related regulatory guidelines emphasize the need for pharmaceutical companies to have stringent policies and procedures to retain all business-related communications. Such practices are designed to ensure that employees are not using unapproved applications and devices to conduct business, which could lead to compliance breaches and severe penalties—ranging from hefty fines to loss of licenses and irreparable damage to the company's reputation. Hence, implementing a robust system to manage and retain these communications is indispensable.

However, despite there being clear guidelines around the retention of business-related communication, many pharmaceutical companies need help with compliance. One reason for this is that the proliferation of digital communication tools has complicated matters, making it challenging to monitor and retain communication accurately. Employees might use unapproved apps or devices, inadvertently compromising the company's compliance posture.

Furthermore, ensuring that communications content aligns with regulatory requirements is another significant challenge. Inappropriate or off-script messages can result in compliance issues and endanger the company. Fortunately, there is a solution to these challenges. We call it the ZING Engagement Suite!

ZING is a comprehensive platform designed to facilitate HCP and patient engagement while addressing complex compliance requirements set by regulatory bodies. ZING ensures that every message sent through its platform is preapproved, retained, and fully auditable, providing an all-encompassing solution to business communication retention needs. Key features of ZING include:

Comprehensive Audit Trail: With ZING, every piece of communication data—from messages exchanged by representatives, HCPs, and patients to details like date, time, location, browser, operating system, and device used—is meticulously recorded and securely stored. This robust logging mechanism ensures a complete audit trail, significantly simplifying compliance reporting and oversight. All necessary data can be swiftly retrieved upon request, whether for legal requirements or compliance audits.
Automated Compliance Checks: ZING automatically reviews communications for compliance, ensuring that every message meets regulatory standards before it is sent.
Data Protection: Leveraging state-of-the-art encryption, ZING protects sensitive information, adhering to stringent data security regulations.
Compliance Preapproval: Every message, digital asset, and reply can be quickly preapproved by the compliance team and preloaded into the system. This guarantees that HCPs and patients never receive content that isn’t approved.
Customizable Templates: ZING provides customizable templates that help ensure only appropriate content is sent. These templates are designed to meet regulatory requirements and can be tailored to specific needs.
AI-Powered Content Moderation: ZING’s built-in, AI-powered content moderation tools act as an added layer of protection. These tools help ensure reps never send off-script messages that could put the company at risk.

How ZING Can Mitigate Compliance Risks for Your Teams

Despite dedicated efforts to maintain regulatory compliance, pharmaceutical companies often face a myriad of compliance challenges in their interactions with HCPs and patients. These challenges range from off-label promotion violations to adverse event reporting difficulties, data retention issues, and privacy concerns. Below are several use cases illustrating how ZING can assist your teams in navigating common compliance pitfalls.

Use Case One - Safeguarding Against Off-Label Promotion: Off-label promotion involves marketing a pharmaceutical product for uses not approved by regulatory authorities. While healthcare professionals may prescribe medications off-label based on their clinical judgment, pharmaceutical companies are strictly prohibited from promoting such uses. Off-label promotion poses significant compliance risks, including potential patient harm, regulatory enforcement actions, and legal liabilities. ZING mitigates these risks through its compliance preapproval and content moderation capabilities, ensuring that promotional materials adhere to regulatory guidelines.
Use Case Two - Streamlining Adverse Event Reporting: Adverse event reporting is crucial for pharmacovigilance, enabling the timely identification and management of potential safety concerns associated with pharmaceutical products. Inadequate reporting of adverse events can lead to severe consequences, including regulatory sanctions, reputational damage, and litigation. Pharmaceutical companies must establish robust systems for capturing, documenting, and reporting adverse events in compliance with regulatory requirements. ZING assists with these efforts by facilitating real-time adverse event reporting, allowing company representatives to collect reports instantly and notify stakeholders promptly.
Use Case Three - Enhancing Transparency and Data Retention: Pharmaceutical companies frequently engage with healthcare professionals and patients to educate them about their products, conduct research, and provide scientific information. However, sometimes, the nature of these communications is called into question. But with ZING, transparency isn’t an issue. Every piece of communication data is meticulously recorded and securely stored, ensuring transparency and compliance with data retention regulations. Additionally, when needed, all necessary data can be swiftly retrieved upon request.
Use Case Four - Ensuring Data Protection: The digitization of marketing and the rise of data-driven strategies have heightened data privacy and security concerns. The collection, storage, and processing of personal and health-related data are subject to stringent privacy regulations, such as the Department of Justice’s Evaluation of Corporate Compliance Programs (ECCP), Health Insurance Portability and Accountability Act (HIPAA) in the United States, and the General Data Protection Regulation (GDPR) in the European Union. Non-compliance with these regulations can result in severe penalties and erode trust in the company. ZING employs state-of-the-art encryption technologies to safeguard sensitive information, ensuring compliance with rigorous data security standards.

By incorporating ZING into their compliance frameworks, companies can effectively manage and mitigate the risk of regulatory breaches. This not only protects an organization’s reputation but also contributes to its financial health. The following highlights how a top-tier brand achieved this.

How a Leading Brand Deployed ZING

A category-leading pharmaceutical brand sought a more effective way to send compliant messages and other digital assets to healthcare professionals (HCPs) and office staff. HCPs were not accessing the company’s physician engagement portal, and emails that contained valuable drug information weren’t being received or disseminated. In addition, in-person physician access was declining because of COVID-19. It was becoming almost impossible for reps to conduct office visits with their HCPs.

With all else failing, the client needed an innovative new solution—and they needed it quickly. However, it couldn’t be just any old solution. It had to be effective and frictionless, offering HCPs and office staff an easy user experience (UX) without burdening them. It also had to be compliant with corporate and legal guidelines.

With limited touchpoints, the idea of text messaging with HCPs surfaced within the organization. And that’s when the client turned to ZING as a potential remedy for its HCP engagement woes.

The Results of Implementing ZING

With ZING, the client has been able to significantly improve HCP engagement (>90% read, > 60% click-through). In addition, the company’s sales reps now have the ability to send approved messages and other resources instantly. The traditional email solutions used by the field team were lagging in terms of open rate and reach, and a high percentage of emails were flagged as spam. ZING removed all of these barriers and more.

In addition to better engagement, P360 was also able to meet the client’s legal and compliance restrictions. ZING was also able to navigate the client’s complex requirements related to data retention by giving them a full view of field operations with insights into usage. Historically, reps were allowed to use SMS text messaging for logistical text messages, but team leads couldn’t access the underlying data within those messages. ZING removed these blind spots and the risks associated with texting.

Since deployment, the client has made ZING its standard for providing compliant text messaging to HCPs for the category-leading brand team. The client is also in the process of deploying the solution across multiple brands and therapeutic areas.

Going Beyond ZING: Creating a Business Environment Focused on Compliance

While it’s clear that ZING offers numerous benefits, its effectiveness is significantly amplified when organizations adhere to the following compliance measures:

Provide Comprehensive Training: It's crucial that company representatives receive thorough training on pharmaceutical industry regulations. This training helps employees understand the boundaries of regulatory compliance and how to avoid violations, making them invaluable to the organization. Without proper education, pharmaceutical sales professionals may inadvertently engage in activities that expose their companies to legal and ethical risks.
Foster a Culture of Accountability: Establishing a culture of accountability within the company is another critical step to ensuring compliance. By prioritizing compliance within the organizational environment, employees are encouraged to report any ethical or legal violations promptly. This approach fosters a sense of shared responsibility, aligning employees with the organization's values.
Reinforce Personal Responsibility: Pharmaceutical representatives might bypass technological safeguards by initiating inappropriate conversations directly with clients or colleagues. Therefore, reinforcing a culture of personal accountability is essential to mitigate such risks.
Continuous Monitoring and Improvement: Pharmaceutical companies must implement systems to monitor and evaluate their compliance programs continuously. These systems should include regular risk assessments, audits, employee surveys, and ongoing dialogue with regulatory authorities. Employees should be consistently aware of their role in ensuring compliance programs remain effective and efficient.

The Future of Compliant HCP and Patient Engagement

As the pharmaceutical industry evolves, the regulatory landscape and compliance requirements will undoubtedly change. Therefore, staying ahead of these trends and fostering a culture of adaptability and agility around compliance will be essential for success. To help executives effectively manage this evolving landscape, here are a few key trends pharmaceutical leaders should monitor.

Stricter Enforcement and Oversight: Regulatory bodies must intensify their enforcement efforts and the oversight of pharmaceutical marketing practices. This means companies will face increased scrutiny and enforcement actions, making a proactive approach to compliance management and risk mitigation essential.
Greater Focus on Digital Marketing: With the rise of digital marketing channels, regulatory authorities will likely pay more attention to online promotional activities. Companies should prepare for specific regulations and guidelines targeting digital platforms like social media, websites, and mobile apps to address new compliance challenges.
Enhanced Transparency Requirements: There is growing pressure for greater transparency in pharmaceutical marketing, especially regarding financial relationships between companies and healthcare professionals. Expect expanded disclosure requirements and increased transparency in interactions with healthcare stakeholders.
Evolution of Emerging Technologies: Technologies like Machine Learning (ML) and Artificial Intelligence (AI) present opportunities to enhance compliance efforts. AI-powered tools can provide sophisticated monitoring, analysis, and predictive modeling of compliance risks, helping companies identify patterns, detect anomalies, and proactively address potential issues.
Necessity of Mobile Engagement: The way pharmaceutical companies engage with healthcare professionals (HCPs) and patients is rapidly changing. With Generation Z—the mobile-first digital natives—entering adulthood, pharma companies must adapt their engagement strategies. This generation, which spends an average of nine hours per day on devices, expects seamless mobile interactions. Companies that lack a mobile engagement strategy are already behind the curve.

By understanding and preparing for these trends, pharmaceutical executives can ensure their companies remain compliant while effectively engaging with HCPs and patients in an increasingly digital world.

Final Thoughts

For today’s pharmaceutical industry leaders, compliance isn’t just a box to tick—it's the foundation of ethical behavior, regulatory alignment, and public trust. It's also vital for business success, especially as industry regulations continue to tighten. That's why companies must prioritize compliance by investing in innovative tools and comprehensive programs.

By continuously updating their compliance structures and fostering a culture of ongoing education and collaboration, companies can exceed regulatory expectations and demonstrate their unwavering commitment to ethical practices and patient safety. However, this commitment must go beyond merely following rules to be truly effective. A culture of compliance should be deeply embedded within the company's ethical core.

One way to achieve this is by using technology platforms like ZING, which helps pharmaceutical teams elevate compliant HCP and patient engagement into a decisive business advantage. With ZING, companies can effectively manage regulatory risks, build stronger relationships with stakeholders, and protect their reputation and integrity. Every message sent with ZING is a step towards enhancing health outcomes and reinforcing compliant relationships that drive success.

To learn more about how top organizations use ZING to foster deeper, more impactful relationships with HCPs and patients, please visit our website at P360.com.

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