The Care Quality Commission (CQC) has issued a public alert following a serious incident involving a patient treated with Bisphosphonates who sustained bilateral atypical femoral fractures due to inadequate clinical monitoring. In response, the CQC has implemented a new set of prescribing safety searches within the medicines usage bundle aimed at reducing risks associated with long-term bisphosphonate therapy.
Understanding Bisphosphonates and Their Risks
Bisphosphonates are widely prescribed to treat or prevent osteoporosis, particularly in postmenopausal women and individuals on long-term corticosteroids. While effective at reducing fracture risk, these medications are associated with rare but serious side effects, including atypical femoral fractures and osteonecrosis of the jaw.
To ensure patient safety, Bisphosphonates must be taken correctly—typically on an empty stomach with water—and accompanied by strict adherence to monitoring protocols.
Recommended Monitoring Protocol
CQC emphasizes the importance of regular reviews and reassessments throughout the duration of treatment. Key recommendations include:
- Initial Review: 12–16 weeks after starting bisphosphonate therapy to evaluate side effects and ensure treatment compliance.
- Annual Reviews: Ongoing monitoring for any new symptoms, compliance issues, or emerging risk factors.
- Five-Year Reassessment: A full clinical reassessment should be conducted after five years, or sooner if a new fracture occurs or risk factors change. This may include consideration of a DEXA (dual-energy X-ray absorptiometry) scan to reassess bone mineral density.
🔍New Safety Searches Introduced
To aid clinicians in identifying patients at risk due to prolonged bisphosphonate use, the following automated searches have been added to the medicines usage bundle:
- On Bisphosphonate – Check as first issued >5 years ago
- On Bisphosphonate – Check as first issued >5 years ago + no DEXA in last 5y
These searches are designed to flag patients who may be overdue for review or reassessment, ensuring timely interventions and enhanced prescribing safety.
Conclusion
The CQC’s alert serves as a critical reminder for healthcare professionals to vigilantly monitor bisphosphonate therapy and proactively engage in patient reviews. Through improved awareness and the use of digital tools, clinical teams can mitigate risks and uphold high standards of patient care.