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In this episode, we discussed eight essential strategies to prevent prescription drug fraud and abuse:
Verify the prescriber's identity.Know the prescriber's DEA number.Know your patient thoroughly.Verify prescription dates for validity; ensure prescriptions are current.Communicate directly with prescribers if any concerns arise.Request identification when necessary.Act decisively if fraud is suspected—never dispense suspicious prescriptions and report incidents promptly.Recognize and report misuse patterns to appropriate authorities for swift action and prevention.Tune in to DarshanTalks for more insights on healthcare compliance and safety.
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In this episode we're joined by Heather McFalls, Director of Promotion Compliance at Otsuka Pharmaceutical Companies to discuss the evolving role of ad promo executives and the regulatory landscape in the pharmaceutical industry. Dive into the conversation as we explore the impact of regulatory bodies like the FDA, FTC, and NAD, and the importance of compliance in avoiding legal pitfalls. Plus, learn valuable insights on the role of legal and compliance in navigating the complexities of ad promo. Don't miss out on this enlightening discussion!
Points discussed:
1. How has the concept of regulatory evolved?
2. Is legal essential in MLR?
3. How do we define the roles of legal, compliance, and regulatory?
4. How does a company's history and risk tolerance affect PRC committee interactions?
5. How much flexibility should be given to regulatory consultants?
6. How to manage pushback within PRC team dynamics?
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Saknas det avsnitt?
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Today, we discuss four legal pathways to acquire unapproved drugs.
First, over-the-counter drugs offer a route as some bypass FDA approvals, relying instead on a nomograph.
Second, compounded drugs crafted by pharmacists provide an alternative despite lacking FDA approval.
Third, the FDA's new policy allows for state-imported drugs, provided certain protocols are adhered to.
Lastly, individuals can legally import drugs for personal use from abroad within specified limits.
For further insights, consult with legal and medical professionals.Support the Show.
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We discuss the essential elements to ensure that your pharma marketing plan aligns with AI use:
1. Define Clear Goals: Establishing clear objectives is crucial for developing a comprehensive compliance plan for AI use. Without clear goals, executing a successful strategy becomes challenging.
2. Establish Policies and Procedures: Clearly defined policies and procedures are necessary to understand and adhere to compliance standards. They provide guidelines for ensuring ethical and legal AI usage.
3. Implement Training Programs: Training programs are essential for ensuring compliance with policies and procedures. They educate employees on AI usage protocols and help align their actions with organizational goals.
4. Conduct Continuous Quality and Audit Checks: Regular quality and audit checks are vital for ensuring adherence to policies, achieving goals, and maintaining ethical AI usage. Continuous monitoring helps identify and address any deviations from established guidelines.
For assistance in aligning your marketing plan with AI use and ensuring compliance, feel free to reach out to us.
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In this short, we explore four key reasons to get involved in clinical research.
First, it offers potential access to cutting-edge therapies, though it's important to note you might only receive the standard of care.
Second, participation ensures closer monitoring by healthcare professionals.
Third, it provides an opportunity to contribute to medical progress, benefiting others with similar conditions.
Lastly, while financial compensation is a factor, it's controversial as it may impact informed consent.
Tune in to hear more about these considerations and their implications.Support the Show.
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In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee .
Darshan and Andrew discuss MedSpas. MedSpas combine beauty treatments with medical procedures, blurring the lines between pampering and healthcare. To navigate this complexity, they talk about MSOs, which are basically middlemen. MSOs let non-physicians handle the business side of a MedSpa, while a licensed physician oversees the actual medical services.
What are medspas?
Different kinds of medspas
How medspas are structured
Qualifications for running a medspa
Services offered by medspas
Can non-physicians run a medspa?
Setting up a Management Service Organization (MSO)
How can pharmacists get involved?Support the Show.
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Darshan explains why you shouldn’t Trust Celebrities When Choosing Your Drugs!
Hidden Agendas: They're paid to promote, not give unbiased advice.
Not Medical Experts: Trust your doctor's knowledge, not a celebrity's opinion.
Oversimplified Info: 30-second ads can't tell the whole story.
Not Personalized: Your doctor can give you the right advice for your needs.
Ditch the Hype, Talk to Your Doctor!Support the Show.
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Recent pharmacy walkouts and closures at major chains highlight a critical issue: staffing shortages. Independent pharmacies are also at risk.
Here are 5 tips for pharmacy owners and managers to prepare for potential temporary closures:
Cross-Train Staff: Train front-end staff on basic pharmacy procedures (depending on state regulations) so they can assist with paperwork like taking in prescriptions and completing end-of-day tasks.Stock Up on Prescriptions: Anticipate closures by keeping a surplus of routine prescriptions filled. This ensures patients don't miss important doses.Notify Patients & Physicians: Develop a call list to efficiently notify patients and local doctors of a potential closure. This gives them time to make alternative medication arrangements.Post Signage & Update Messages: Prepare clear signage indicating closure dates and times. Update voicemail messages to explain the situation.Offer Prescription Transfers: Contact nearby pharmacies to see if they can take prescription transfers during a closure. This allows patients seamless access to their medications.Support the Show.
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In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee.
Darshan and Andrew discuss MedSpas. MedSpas combine beauty treatments with medical procedures, blurring the lines between pampering and healthcare. To navigate this complexity, they talk about MSOs, which are basically middlemen. MSOs let non-physicians handle the business side of a MedSpa, while a licensed physician oversees the actual medical services.
Points discussed:
What are medspas? Different kinds of medspas How medspas are structuredQualifications for running a medspa Services offered by medspas Can non-physicians run a medspa? Setting up a Management Service Organization (MSO) How can pharmacists get involved?Support the Show.
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We dive deep into 5 uses of Ozempic, a drug known for managing diabetes, but with surprising potential beyond! Here are 5 intriguing uses you might not have heard of:
Liver Support: Early research suggests Ozempic could benefit liver health, but more studies are needed.
Weight Loss Weapon: Ozempic has a weight-loss version, offering a powerful tool many don't know exists.
Addiction Fighter: Ozempic might hold promise in combating alcohol and substance abuse (this one might surprise you!).
Heart Health Hero: Studies show Ozempic could help reduce the risk of heart problems.
Cancer Prevention & Treatment: Emerging evidence suggests Ozempic's potential role in preventing and treating certain cancers.
Alzheimer's Hope: Early research hints at Ozempic's possible use in managing Alzheimer's disease, although further investigation is crucial.Support the Show.
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In today's episode, we discuss AI-generated content in the pharmaceutical industry. AI has revolutionized content creation, but it's not without its legal and ethical dilemmas. Take, for instance, the New York Times' lawsuit against OpenAI, highlighting the contentious issue of data ownership. As pharma companies increasingly rely on AI for content generation, they must navigate murky waters to ensure compliance with existing regulations and respect for intellectual property rights.
Controlling AI output presents another challenge. Unlike human creators, AI can produce content that may not align with intended guidelines or quality standards. For pharma, where precision and compliance are paramount, this unpredictability poses risks. It's crucial for companies to implement robust review processes, involving both legal and regulatory teams, to mitigate potential errors and ensure content accuracy.
Moreover, the issue of ownership looms large. Both legal and regulatory bodies have expressed concerns about the ownership of AI-generated content. The US Patent and Trademark Office requires human oversight to verify accuracy and compliance with existing rules. Similarly, the US Copyright Office has stringent criteria for copyright protection, requiring human authorship. This raises questions about how much human intervention is necessary before AI-generated content can be considered owned or copyrighted.
In conclusion, while AI offers immense potential for innovation in content creation, pharma companies must navigate a complex legal and ethical landscape. By staying informed, implementing robust review processes, and seeking legal guidance, companies can harness the power of AI while ensuring compliance and ethical use. For tailored advice on integrating AI into your content strategy, reach out to us at the Kulkarni Law Firm.
Stay tuned for more insights on navigating the evolving landscape of AI in pharma.
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In today’s short, Darshan discusses why drugs cost so much. It takes around 10 to 15 years and roughly $2.3 billion to bring a drug to market. That means a drug company spends between $420,000 and $630,000 daily during this process. Imagine going to a casino every day, betting that much money without knowing the outcome, for 10 to 15 years. What kind of return would you expect on that investment? That's why drugs are so expensive.
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Join Darshan Kulkarni, a Food and Drug attorney, as he explores the dynamic intersection of artificial intelligence, drug and device promotion, and the law.
In this podcast series, we'll dive deep into AI's role in promotional and non-promotional communications within the pharmaceutical and medical device industries. From regulatory compliance and ethical considerations to the latest FDA guidance, we'll cover it all. Whether you're a legal professional, an industry insider, or simply curious about the future of AI in healthcare, this series will provide the insights and expert analyses you need to stay ahead of the curve. Let's get started!
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Speaker programs are events sponsored by drug and device companies where a physician or other healthcare professional (HCP) delivers a speech or presentation to fellow HCPs regarding a specific drug, device product, or disease state on behalf of the sponsoring company. Typically, the company compensates the speaker with an honorarium and may also provide remuneration, such as free meals, to attendees. Between 2017 and 2020, drug and device companies reportedly paid nearly $2 billion to HCPs for services related to speaker programs. It's important to note that some iterations of these events are referred to as drug dinners.
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We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.
We discuss the following:
What does off-label mean from a reimbursement standpoint? Lessons from the US v. Eli Lilly 2009 case How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid? How are compounded drugs reimbursed? Could a company be held accountable for off-label use of a drug due to compounded products? Are weight loss drugs exempted from reimbursement?Support the Show.
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Buying a Drug or Device Company? 6 Compliance Must-Knows
Thinking of acquiring a drug or device company? Buckle up! This deal requires serious compliance considerations. Here's a quick rundown:
The DOJ offers a 6-month "safe harbor" for confessing past compliance issues. Use it!
The DOJ demands strong compliance programs with thorough risk assessments, effective training, and clear reporting channels.
Companies can now claw back bonuses from employees who break compliance rules.
Accurate risk assessments, comprehensive training, and clear misconduct reporting are key for HHS compliance.
Disclosing payments to doctors and hospitals is crucial too, with details readily available online.
Don't forget about mandatory clinical trial disclosures on ClinicalTrials.gov. Skipping this can lead to hefty fines and hinder future research.
Need Help Navigating M&A Due Diligence? We can help!Support the Show.
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We discuss how recent shortages of chemotherapy drugs like cisplatin and carboplatin have caused delays and changes in treatment plans for some cancer patients. While the situation is improving, shortages still exist for some drugs. Staying informed is crucial, and the FDA is actively tracking drug shortages to mitigate them.
It's important to communicate with your doctor, who can provide the latest information and discuss alternative treatment options tailored to your needs.Support the Show.
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We discuss how failure to register with the appropriate state boards of Pharmacy as a drug or device manufacturer can lead to severe consequences. These consequences include
1. Hefty fines, revoked licenses, and even legal charges, potentially ruining your business.
2. Additionally, non-compliance can result in reputational damage, eroding public trust and deterring potential partners.
3. Moreover, loss of distribution rights could leave you unable to serve customers in entire states.
To avoid this nightmare scenario, ensure registration with state boards of Pharmacy. For
assistance, contact us at [email protected]Support the Show.
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We discuss six critical errors in the informed consent process:
1. Exclusion of Principal Investigator: PI was not allowed to engage in the informed consent process.
2. Lack of Detailed Discussion: Staff members did not take the time to thoroughly discuss the study's potential benefits and risks with prospective subjects.
3. Inadequate Training: Coordinators lacked knowledge about the study and lacked a research background, leading to insufficient information provided to participants.
4. Unauthorized Handling of Paperwork: Unqualified individuals would sign required forms without proper understanding or expertise.
5. Lack of oversight: Subjects were allegedly denied meetings with sponsors, FDA, or IRB, citing privacy laws as a barrier.
6. Signature Verification Issues: Signatures were not compared with subjects' identification, posing challenges in ensuring the authenticity of informed consent.
For assistance with clinical trial compliance, contact Darshan at 302-252-6959Support the Show.
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Informed consent is a crucial aspect of clinical trials, ensuring that prospective subjects understand the benefits, risks, and potential harms of participating in a study. This process involves full disclosure of information, allowing subjects to ask questions and address
concerns with a knowledgeable medical professional. For minors, parental involvement is required, and subjects have the right to withdraw consent at any time. It's not merely a form but an ongoing process that starts before the research begins and continues until the study concludes or the subject withdraws.
Need assistance with your clinical trial compliance program? Email us at [email protected]Support the Show.
- Visa fler