During treatment, many patients often reach a point where standard medical treatments fail to work on them. Their families then look for alternative ways to help their loved ones. This is where expanded access and compassionate use programs come into play. They offer a lifeline for patients with serious or life-threatening conditions. They incorporate investigational treatments where traditional methods fail to bring results.
The process and pathway can be confusing for the families involved, but a proper understanding of the procedure can help them along with the patient. If you’re a family member of a patient seeking non-traditional healthcare options, check the points below for advice.
Understand Expanded Access Programs
Expanded access programs are a great way to treat patients who stop responding to regular treatment processes and available medicines. As the patient’s family member, you must first understand what it means. Expanded access programs help patients with life-threatening conditions to access investigational drugs that are still in clinical trials and not yet approved by regulatory agencies like the FDA. This treatment process might give you hope, but you’d still need specific regulations, paperwork, and approvals before you can begin. You must also understand the potential risks before you sign up your beloved family member for this treatment method.
Many healthcare service providers specialize in expanded access programs and can help you.
“We work directly with physicians in understanding all of the requirements to obtain an investigational drug for each patient expediting the overall process,” says a company called Early Access Care that provides expanded access services. You can contact them to understand the process better and make an informed decision.
Consult with Your Doctor
Non-traditional treatment methods can be confusing and untrustworthy, so having open communication with your doctor is important for the patient and their family members. The doctor knows your medical history and can understand whether the investigational drugs available through expanded access could benefit you or your loved one. They can also help you understand your eligibility and sort the required paperwork. Ask your doctor for clarification if you don’t understand the potential risks.
Explore Eligibility Criteria
As mentioned before, the expanded access program is available for patients with life-threatening conditions who have tried available approved treatments without success. However, not all such patients can enter this program, and you must meet the eligibility criteria. You must prove that other traditional and proven treatment methods have failed to bring you any results. You also must prove that the patient’s condition is severe and that applying a non-traditional treatment method or potentially risky drug wouldn’t make the situation any worse. These are common criteria, but the full list can have more, so consult your doctor to understand them.
Research Clinical Trials
Clinical trials can provide results if the patient has a condition without an approved treatment method. They can sign up for clinical trials that give them early access to investigational drugs. In return, the patients can become test subjects in their medical research. You can find many websites that can help you find studies on your specific condition. However, they come with strict eligibility criteria and protocols, so study them properly before opting.
Seek Support from Patient Advocacy Groups
Patient advocacy groups can help you find expanded access programs much faster. They also provide educational resources, guidance, and emotional support for patients and families. Many of these groups work directly with the healthcare service providers. They also have direct access to regulatory agencies and can help the patients understand their options better.
Reach Out to Early Access Care Services
Many organizations like Early Access Care specialize in helping patients access investigational drugs through compassionate use programs. They work as an intermediary among the patients, healthcare providers, and pharmaceutical companies to make the approval easier. Working with these service providers can help a patient deal with legal and regulatory hassles smoothly.
Understand the Risks and Benefits
Investigational medicines might seem like your only hope, especially when traditional and approved treatment methods fail to work on you. However, please remember that investigational medicines come with risks. These medicines are still under research and can have unknown side effects. Consult your doctor and the early access care services to understand what you’re signing up for. They can provide you with existing data and explain the benefits against the potential risks so that you can make an informed decision.
Prepare Documentation
Proper documentation is important for patients in every step of their treatment process, especially if they’re applying for the expanded access program. Collect and sort all documents related to test results, treatment history, and current diagnoses. They are required when requesting compassionate use of investigational drugs. Create a complete case that details your history with all details to maximize the chances of getting approved.
Work with a Legal or Ethical Advisor
Signing up for an expanded access program can result in complex legal and regulatory challenges. Even if you understand the basics, you might need help from a legal advisor who has experience in compassionate use and investigational treatments. They can interpret the laws for you, manage and guide the documentation, and help you navigate the application process. An ethical advisor also has a significant effect on the decision-making process. They will discuss the pros and cons of the process with the family members and list the potential risks for the patient. The family members can then decide whether to opt for this option. Both advisors ensure that all actions align with legal and ethical standards.
Stay Informed About Regulatory Requirements
And finally, stay informed about the regulatory requirements of your state or country, especially if you’ve made up your mind about it. Each country has its regulations for expanded access programs. Research them well and stay updated on changes and amendments. For example, in the U.S., you’ll need approvals from bodies, such as the FDA. But other countries may have different regulatory authorities. Knowing these guidelines ensures the process moves smoothly and reduces the risk of delays. Update your documentation regularly. Talk to your doctor or healthcare service provider to stay up-to-date about the regulatory requirements.
You could make all the healthy choices in life and still fall sick. While most of these diseases and conditions aren’t life-threatening, luck might not always be in our favor, and we get left with nothing but the option of going for a non-traditional mode of treatment to recover. The process can seem scary and confusing, but with access to the right team and services, you can ensure that you or your beloved family member can recover from the condition smoothly.
