Pharmacovigilance is a pivotal part of a pharmacist’s responsibilities. It requires a thorough system to monitor medication safety, which involves reporting any adverse events (AE) that occur among patients taking medication.
The Philippine Food and Drug Administration (FDA) has a pharmacovigilance section that works closely with the World Health Organization (WHO) in processing reports of suspected adverse drug reactions (ADR) from pharmaceutical industries, hospitals, healthcare professionals, patients or consumers, and public health programs.
What should be reported?
Every medication comes with a product label (i.e., package insert, patient information leaflet or PIL) that lists all known ADRs that may arise from taking a certain medicine. Patients may react differently to the same medication while some may experience ADRs not previously discovered during drug development process. It is equally vital to identify and report these previously unknown ADRs in order to help reduce the risk of drug-related morbidity. Beyond what is stated in the product label, the following instances must also be reported to the FDA:
- Serious adverse reactions (i.e., any untoward medical event which results in death; is life-threatening; requires hospitalization or prolongation of hospital stay; involves disability, permanent damage, or permanent impairment; or involves a congenital anomaly/birth defect)
- All adverse reactions related to newly introduced medicines or vaccines
- Medication errors, lack of efficacy, overdose, or off-label use (when medication is used in a manner not specified in the approved label) that resulted in serious adverse reactions
- Adverse reactions suspected to be related to a product defect
If in doubt on what to report, it is better to err on the side of caution and report any suspected adverse reaction.
How to report an adverse drug reaction to the Philippine FDA
Pharmacists may report any suspected adverse reactions identified among patients through various means:
- via FDA’s Online Adverse Drug Reporting portal
- by accomplishing FDA’s suspected side effects reporting form and e-mailing it to pharmacovigilance@fda.gov.ph or directly mailing it to FDA’s Pharmacovigilance Section
- by calling FDA at (02) 8809-5596
Pharmacists must report the following details as completely and accurately as they can:
- Description of the ADR with symptoms and findings
- Temporal relationship between the administration of medicine or vaccine and the onset of reaction
- Outcome of the reaction, whether symptoms have resolved or improved after stopping therapy
- Details of all medicines administered, including start and stop date
- Details of other possible factors that may influence clinical picture, such as diagnosis or other non-drug related factors
- Lot or batch number of the suspected medicinal product
The Pharmacovigilance System at Unilab
As early as 2005, Unilab established its own pharmacovigilance system in an effort to enhance medication safety monitoring and processing. In 2011, the importance of pharmacovigilance was further emphasized by the Department of Health (DOH) through an Administrative Order (AO) requiring pharmaceutical companies to establish their own pharmacovigilance system.
At Unilab, great care is taken to make sure that any untoward medical event resulting from medicine intake is monitored and addressed. As part of its strict protocols on medicine safety monitoring, the following instances must be reported to the Unilab’s Pharmacovigilance Unit:
- Suspected AEs and ADRs from using a medication, whether or not it was used as indicated
- Unexpected reactions regardless of severity (i.e., experienced reaction is not listed in the package insert/patient information leaflet)
- Expected or unexpected serious AEs or ADRs
- Drug interactions (i.e., drugs taken with other drugs, herbal products, food, or food supplements)
Special situations which, may or may not result in an adverse reaction, must also be reported. This includes use of products during pregnancy or while breastfeeding, medicine misuse or abuse, accidental/occupational exposure, medication error, off-label use, lack of therapeutic efficacy, overdose, withdrawal reaction, and any unexpected beneficial reactions.
Suspected AEs or ADRs are reported to Unilab’s Pharmacovigilance Unit (by calling 8-UNILAB-1, by e-mailing productsafety@unilab.com.ph, or through https://www.unilab.com.ph/report-an-adverse-event/) within 24 hours upon one’s knowledge of the AE or ADR. This report must include four minimum information, listed as follows:
- An identifiable patient (i.e., initials, age, age group, OR sex)
- An identifiable reporter (i.e., initials, contact details, AND qualification—such as pharmacist)
- A suspected product (should include generic name, brand name, dosage strength, and form)
- An AE/ADR
Investigation and collection of information in compliance with the Data Privacy Act of 2012 happens within 24 to 48 hours upon receipt of the AE or ADR report. The Unilab Pharmacovigilance Unit then reviews and approves the report before it is submitted to the Philippine FDA.
Unilab ensures rigorous processes are in place to ensure the safety and efficacy of medicines before being released to the market. Despite this, there can be no assurance that medicines and vaccines are 100% safe and free of undesirable effects, especially as this will still depend on how patients use the products or if they have underlying conditions.
Any patient may encounter an adverse reaction with a certain medication. It is through the collective effort of patients, healthcare professionals, public health officials, and pharmaceutical companies that these undesirable effects are responsibly reported and diligently monitored. Unilab is committed to providing the country with trusted quality healthcare in safeguarding the quality of life for every Filipino.
Sources:
https://www.fda.gov.ph/pharmacovigilance/
https://www.fda.gov.ph/pharmacovigilance-reportinghcp/
