Risks and precautions you should pay attention to when purchasing mirikizumab

Mirikizumab is a humanized anti-IL-23p19 monoclonal antibody. It is currently mainly used to treat autoimmune diseases such as moderate to severe ulcerative colitis and psoriasis. The drug has been approved for marketing in some European and American countries and has shown good efficacy and tolerability in clinical trials. However, as of now, militizumab has not been officially approved for marketing in mainland China, and domestic hospitals cannot directly prescribe the drug. In order to meet their treatment needs, many patients choose to purchase the drug from abroad through cross-border medical channels. However, there are many potential risks and traps in this process. Patients must be vigilant and make scientific judgments to ensure that the drug purchase is formal, safe and effective. This article will provide a detailed analysis of the main risks and response strategies when purchasing Militizumab overseas for reference.

1. Risks of counterfeit and substandard drugs: Be wary of fraud through illegal channels

Since Militizumab is a high-priced biological agent, a box (300mg/15ml) of the European version of the original drug costs about more than RMB 10,000 in overseas markets. Therefore, it is easy to find counterfeit, adulterated or expired drugs in the second-hand market or informal platforms. Some purchasing agents attract patients by exaggerating the effectiveness of medicines, fictitious sources of goods, and falsely using official packaging pictures. In fact, they sell drugs of "unknown origin" without any regulatory guarantee. This not only seriously affects the efficacy, but may also endanger life safety.

When choosing purchasing channels, patients must adhere to the three principles of "regular channels, traceable sources, and transparent processes" It is recommended to give priority to purchasing through formal cross-border medical platforms or institutions with international drug procurement qualifications. These platforms usually have direct cooperation with European pharmacies or pharmaceutical companies and can provide customs clearance documents, drug batch numbers, drug purchase invoices, etc., ensuring that drugs can be tracked from procurement to transportation. At the same time, you should check the manufacturer, expiry date, registration number and batch number on the product packaging before purchasing, and verify the authenticity through the official website of the original drug.

2. Transportation and storage issues: special requirements for biological agents

Milizumab is a monoclonal antibody biologic and has extremely high requirements for the storage environment. It usually needs to be transported and stored in a cold chain environment of 2~8℃. If it encounters overtemperature, repeated freezing and thawing, strong light irradiation, etc., the structure and activity of the drug may be irreversibly damaged, eventually leading to a decrease in efficacy or inducing adverse reactions.

During the purchase process, you should know whether the supplier has professional cold chain transportation qualifications and whether it uses packaging that meets pharmaceutical transportation standards. Formal channels generally use cold chain transport boxes with built-in temperature control recorders, and monitor the transportation temperature throughout the process to ensure that the drugs are always kept within the safe storage range before reaching the patients. After receiving the goods, patients should promptly transfer the medicines to special medicine boxes in the refrigerator to avoid mixing them with food and prevent cross-contamination.

3. Insufficient guidance on medication: the risk of breaking away from doctor’s supervision

Since militizumab has not yet been marketed in China, patients often cannot obtain detailed medication regimens, dosage adjustment recommendations, and guidance on adverse reaction management at local hospitals. Some patients use it on their own without the guidance of a professional doctor, which may cause dosage errors, improper injection methods, confusing medication intervals, etc., which will affect the treatment effect and even cause safety hazards.

Before using militizumab, patients should seek help from doctors or professional medical institutions with international drug knowledge background as much as possible. Cross-border medical platforms should also provide services including pharmacist consultation, medication plan formulation, injection method guidance and other services to assist patients in scientific medication use. In addition, if abnormal reactions such as fever, allergies, redness and swelling at the injection site, or digestive discomfort occur during medication, you should seek medical treatment immediately and report to the platform to obtain a timely treatment plan to avoid delayed treatment.

4. Legal and policy risks: the gray area of cross-border drug purchase

Currently, mainland China has not completely banned personal overseas drug purchases “for personal use,” but this type of cross-border drug use still exists in a legal gray area. Once the medicine is detained or returned due to transportation, customs, declaration and other issues, patients will face the risk that the medicine will not be delivered on time and treatment will be interrupted. In addition, if a drug has quality problems or causes adverse events, it will be difficult to safeguard rights because it is not supervised by domestic drug regulatory authorities, and it will be difficult to protect the interests of patients.

Therefore, it is recommended that when choosing a platform or drug supplier, patients should confirm whether they have legal customs declaration capabilities and drug import and export qualifications to avoid legal disputes caused by smuggling, entrainment, and failure to declare. Patients who have been using such overseas drugs for a long time should also pay attention to the progress of domestic drug registration and medical insurance negotiations. Once the drug is approved for marketing in China, it should be transferred back to the supervision of local doctors as soon as possible to reduce subsequent risks.

Conclusion: Safety first, formality first

Militizumab, as a new biological agent that has been approved abroad, provides new treatment hope for patients with moderate to severe ulcerative colitis. However, because it is not yet on the market in China, is expensive, and has complicated procurement channels, it faces many risks during the purchase and use process. In order to ensure medication safety and treatment continuity, patients must purchase drugs from formal channels, strictly control the quality of cold chain transportation, and always receive treatment under the guidance of professional doctors.

In the future, as the domestic approval process for rare diseases and high-end innovative drugs accelerates, Militizumab is expected to enter the Chinese market as soon as possible and be included in medical insurance coverage, truly benefiting more patients. Until then, rational judgment, scientific purchase, and safe use of medicines are the basic responsibilities of every patient who needs to use this medicine.

Reference materials:https://www.drugs.com/