DefinePK

Research Objective

To report on an event of visual impairment and loss in diabetic patients in Lahore, Pakistan, due to the off-label administration of diluted and contaminated Avastin injections, and to highlight the public health implications and necessary preventive measures.

Methodology

This is a letter to the editor reporting on a real-world event. It draws information from investigations by the Drug Regulatory Authority of Pakistan (DRAP), news reports, and existing literature on Avastin.

Methodology Flowchart

                        graph TD;
    A["Event of Vision Loss in Diabetic Patients"] --> B["Investigation by DRAP"];
    B --> C["Identification of Avastin Misuse"];
    C --> D["Discovery of Illegal Dilution and Contamination by Unregistered Company"];
    D --> E["Reporting of Cases and Public Concern"];
    E --> F["Regulatory Actions: Sealing Company, Recalling Batches, Halting Distribution"];
    F --> G["Analysis of Public Health Crisis and Recommendations"];                    

Discussion

The event highlights a critical healthcare crisis in Pakistan stemming from the proliferation of unregistered pharmaceutical companies and a shortage of qualified healthcare providers. The misuse of Avastin, a drug intended for cancer treatment, for off-label indications like diabetic retinopathy, compounded by illegal dilution and contamination, led to severe and irreversible vision loss. This situation underscores the urgent need for robust pharmacovigilance systems, strict regulation of pharmaceutical companies, and discouragement of off-label drug use without proper oversight. Healthcare professionals are urged to avoid locally manufactured or unregistered medications and to promptly report adverse drug events.

Key Findings

- In mid-September 2023, numerous diabetic patients in Lahore, Pakistan, experienced sudden vision loss or impairment.
- Investigations revealed that affected patients were administered Avastin (100mg/4mL inj), a cancer medication, instead of appropriate drugs for diabetic eye conditions.
- An unregistered pharmaceutical company, Genius, illegally procured Avastin, diluted it, and distributed it under unsanitary conditions, leading to contamination.
- At least 65 cases of severe vision loss were reported across Punjab province.
- DRAP sealed the local marketing company involved and initiated legal procedures.
- Roche Pharma recalled specific batches of Avastin, and its distribution and use were halted nationwide pending investigation.

Conclusion

The widespread visual impairment and loss among diabetic patients in Pakistan due to contaminated Avastin is a severe public health emergency. It necessitates immediate action to strengthen drug regulation, enhance pharmacovigilance, and educate healthcare providers and the public about the risks of using unregistered or improperly handled medications.

Fact Check

- Date of event: Mid-September 2023 (reported).
- Number of reported cases: At least 65 cases reported across Punjab province.
- Drug involved: Avastin (100mg/4mL inj).

Mind Map