Doctors, dentists and pharmacists can claim continuing education points for reading each issue of the HSA ADR News Bulletin.
- Doctors can apply for 1 x non-core Continuing Medical Education (CME) point under category 3A,
- Dentists can apply for 1 x Continuing Professional Education (CPE) point under category 3A, and
- Pharmacists can apply for 1 x patient-care Continuing Professional Education (CPE) point under category 3A per issue of the bulletin.
Bulletin Highlights:
- Isotretinoin is associated with reported risks of psychiatric disorders and sexual dysfunction, though causality is challenging to establish definitively.
- Healthcare professionals are advised to consider counseling, screening for depressive symptoms, and potential referral to specialists when prescribing isotretinoin.
- Medication Information Leaflets (MILs) can aid in communicating risks to patients and caregivers.
- Despite international reviews, the Health Sciences Authority (HSA) concludes that the benefit-risk profile of isotretinoin remains favorable for approved indications.
- Local sales data shows stable isotretinoin exposure, with few local reports of adverse events.
- HSA emphasizes the importance of healthcare professionals being aware of and managing potential risks during isotretinoin prescription.
2. Reports of severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), associated with the use of modafinil and armodafinil.
- Modafinil and armodafinil are used to treat conditions involving excessive somnolence, such as narcolepsy and obstructive sleep apnea.
- Both medications are not currently registered in Singapore but can be imported and supplied locally under the special access route (SAR).
- Despite low usage, three cases of SJS have been reported locally, prompting HSA to emphasize closer monitoring.
- Healthcare professionals are advised to consider the possibility of SCARs, including SJS, in patients showing prodromal symptoms.
- Clinical trials and worldwide post-marketing experience indicate a higher reporting rate of TEN and SJS associated with modafinil use compared to the background incidence rate.
- HSA has issued press releases alerting the public to serious adverse reactions with these drugs and advises healthcare professionals to report any suspected adverse events.
3. AE Case in Focus 1: Test Yourself – What could have cause the rash in this patient?
What might be responsible for the skin rash in this 60-year-old Chinese male with a retrovirus infection, who recently underwent a treatment regimen involving allopurinol, etoricoxib, and colchicine, and is now presenting with painful rashes accompanied by mucosal involvement?
4. AE Case in Focus 2: Test Yourself – What was the likely cause of the musculoskeletal symptoms in this patient? What treatment options were available for his hyperlipidaemia?
What could be the reason behind the musculoskeletal symptoms in this 60-year-old Chinese male who had been on simvastatin and later switched to atorvastatin for hyperlipidemia? Additionally, what treatment alternatives exist for managing his hyperlipidemia?
5. HSA participated in WHO-UMC #MedSafetyWeek 2023 global social media campaign on adverse event reporting
- HSA joined the global #MedSafetyWeek campaign led by Uppsala Monitoring Centre and WHO.
- Campaign theme for 2023 is “Who can report,” emphasizing contributions of patients, pharmacists, and doctors to pharmacovigilance.
- HSA posted animations on Twitter, LinkedIn, and YouTube from Nov 6 to 12, 2023, emphasing that adverse effects from medicines can happen unexpectedly, and encouraged patients and caregivers to report the adverse effects to their healthcare providers.
- Reporting adverse effects enhances patient safety by enabling HSA to detect and investigate potential safety issues.
- HSA also collaborated with Pharmaceutical Society of Singapore and Health Promotion Board for wider outreach during this week-long campaign.
- Healthcare professionals urged to report suspected adverse effects through the HSA website via this link: https://www.hsa.gov.sg/adverse-events
- Read more about how your report can enhance the safety of medicines at https://www.hsa.gov.sg/consumer-safety/articles/details/AEreporting-medicinesafety
HSA: Health Sciences Authority; MILs: Medication Information Leaflets; SCARs: Severe Cutaneous Adverse Reactions; SJS: Stevens-Johnson syndrome; SAR: special access route; WHO: World Health Organization; UMC: Uppsala Monitoring Centre;
Link to the HSA announcement: https://www.hsa.gov.sg/announcements/adverse-drug-reaction-news-bulletin/adr-news-bulletin-2023-december-(volume-25-number-3)
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