PharmWatch Jamaica: reporting GLP-1 side effects and fake pens

When a patient in Jamaica turns up with pancreatitis after a semaglutide pen bought abroad, or a tirzepatide vial that "didn't work", the case usually ends in the chart. It should also end in PharmWatch, the national drug-monitoring scheme of the Ministry of Health and Wellness. The current form, revised in May 2022, is titled "Report drug failure and adverse reactions with medications and suspected counterfeit product"¹. That last part matters now that GLP-1 drugs reach Jamaican patients through pharmacies, couriers and social media.

How PharmWatch works in Jamaica

The form describes PharmWatch as "a collaborative effort between the Ministry of Health and Wellness and the Pharmacology Section of the University of the West Indies"¹. It is issued by the Ministry's Standards and Regulation Division, Pharmaceutical and Regulatory Affairs Branch¹. Completed forms go to the Division at the REIT Building, 52-60 Grenada Crescent, Kingston 5, or by email to pharmwatch@moh.gov.jm, or to the UWI Pharmacology Section¹.

Who can report is broad: "Any health care professional (Physician, Pharmacist, Dentist, Nurse)" and "Any patient who has experienced an adverse drug reaction"¹. The form defines an adverse reaction by outcome, including death, hospitalisation, disability, allergic reactions and "gastrointestinal distress"¹. It also asks for the batch number of the suspected drug, the indication, and all other drugs taken¹.

Reports are confidential, causality is assessed by the Ministry, and the Ministry says it will give the relevant pharmaceutical company "a summary of its findings and subsequent decision regarding intervention"¹. Jamaica's reports also feed the global system: the country has been a full member of the WHO Programme for International Drug Monitoring since 2012².

The under-reporting problem

Spontaneous reporting only works if clinicians use it, and the Jamaican evidence says many do not. In a study of community pharmacists published in Pharmacy Practice, "the majority (67%) were not aware of the PharmWatch programme"³. The UWI pharmacologist named as the university contact on the PharmWatch form¹ wrote in the West Indian Medical Journal that the active involvement of Caribbean health professionals "at the national level is imperative" to weigh benefit against harm⁶.

UWI has tried to start earlier: a special study module introduced first- and second-year medical students at Mona to pharmacovigilance in 2019, with nine of ten students producing posters with more than 80% compliance with the content guidelines⁴. A 2022 review by UWI Mona authors argued that poor adherence in non-communicable diseases is linked to adverse drug reactions, that reporting of this in the pharmacovigilance process "is inadequate", and that Jamaican cultural and religious beliefs should be built into the process⁵.

The system does respond when there is public pressure. In April 2021, the Chief Medical Officer, Dr Jacquiline Bisasor-McKenzie, told a Ministry briefing there were no local reports of the rare blood clots linked to the AstraZeneca vaccine and urged the public to report any such event to their doctor⁷. GLP-1 drugs have not had that kind of campaign.

GLP-1 safety signals that came after approval

The randomised trials already showed the common problems. In STEP 1, nausea and diarrhoea were the most common adverse events with semaglutide, and more people stopped treatment because of gastrointestinal events than on placebo (4.5% vs 0.8%)⁹. Rarer harms surfaced later, through large databases and case reports.

• Gastrointestinal events. In a US claims database, GLP-1 receptor agonists used for weight loss were associated with a higher risk of pancreatitis (HR 9.09; 95% CI 1.25-66.00), bowel obstruction (HR 4.22) and gastroparesis (HR 3.67) than bupropion-naltrexone⁸.
• Optic neuropathy. A matched cohort from one US neuro-ophthalmology service found a higher risk of nonarteritic anterior ischemic optic neuropathy (NAION) in patients prescribed semaglutide, with hazard ratios of 4.28 in type 2 diabetes and 7.64 in overweight or obesity; the authors said causality still had to be tested¹².
• Regulatory action. In June 2025 the European Medicines Agency's safety committee recommended adding NAION to the product information of semaglutide medicines as a "very rare" side effect, affecting up to 1 in 10,000 people, and said treatment should be stopped if NAION is confirmed¹⁰.
• Compounded products. The US Food and Drug Administration reports adverse events, some requiring hospitalisation, that may be related to dosing errors with compounded injectable semaglutide, and lists 990 reports for compounded semaglutide and more than 730 for compounded tirzepatide¹¹.

None of these signals came from a single physician. They came from many small reports and large datasets put together, which is the point of a national centre.

Fake pens and 'drug failure' reports

The PharmWatch form has a tick box for "Failure of therapy"¹. For GLP-1 drugs, that box can be the first sign of a falsified product. In June 2024, WHO warned of falsified batches of Ozempic detected in Brazil, the United Kingdom and the United States, and said its surveillance had seen rising reports of falsified semaglutide in all regions since 2022¹³. Its Medical Product Alert told health professionals to report adverse effects, "lack of effectiveness and suspected falsification" to "the National Regulatory Authorities/National Pharmacovigilance Centre"¹⁴. In Jamaica, that centre is the Standards and Regulation Division¹.

What a useful GLP-1 report contains

The form already asks for what investigators need¹. For a GLP-1 case, the details that make a report useful are:

• the exact product name on the package, the strength and the batch number (field 16), and whether it was a pen, a vial or something else;
• where it came from: a registered pharmacy, a courier, a social-media seller or abroad;
• the event, its dates, the action taken and the outcome, with relevant laboratory results such as lipase or glucose;
• every other drug taken, since GLP-1 drugs are often combined with insulin or sulfonylureas in diabetes;
• a photo of the packaging and the device, kept with the chart, in case the Ministry asks for it.