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From Signals to Policies: Academic and Regulatory Perspectives in the Philippines

Abstract

A signal is a suspicion of a relationship between a reaction and a drug, and an indication that no regulatory action has yet been taken. It is an initial lead that, when reported, triggers a warning. A practitioner suspects and reports an adverse drug reaction (ADR), and health authorities determine whether a warning and health policy statement should be issued. The process by which the Philippine government with the help of the Adverse Drug Reactions Monitoring Programme (ADRMP) evaluates problem drugs or problem drug use is discussed. Steps in pharmacovigilance for translating ADR signals into health policies will be proposed. Examples of cases reported to the ADRMP—defective devices, unregistered herbal medicines and antimicrobial drugs, slimming formulations, body building pills, mood altering health foods, dosage labeling confusion, suspected therapeutic inefpcacy, dangerous drug product advertisements, and deregulation of prescription drugs into over-the-counter products—and the lessons learned are highlighted.

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References

  1. 1.

    Kare A, Kacukarslan S, Birdwell S. Consumer perceived risk associated with prescription drugs. Drug Inf J. 1996;30:465–472.

  2. 2.

    Edwards IR, Hugman B. The challenge of effectively communicating riskbenefit information. Drug Safety. 1997;17:216–227.

  3. 3.

    Routledge RA, Bialas MC, Houghton JE, Woods, F. Adverse drug reactions: The great masqueraders. Drug InfJ. 1998;32:79–84.

  4. 4.

    Edwards IR. Who cares about pharmacovigilance. Eur J Clin Pharmacol. 1997;53:83–88.

  5. 5.

    Bateman DN, Sanders GL, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol. 1992;34:421–426.

  6. 6.

    Belton KJ, Lewis SC, Payne S, et al. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol. 1995;39:223–226.

  7. 7.

    Hartigan-Go K. Working methods for adverse drug reaction monitoring program in the Philippines. Drug InfJ. 1998;32:85–92.

  8. 8.

    Fucik H, Edwards IR. Impact and credibility of WHO adverse reaction signals. Drug InfJ. 1996;30:461–463.

  9. 9.

    Meyboom RH, Egberts AC, Edwards IR, et al. Principles of signal detection in pharmacovigilance. Drug Safety. 1997;16:355–365.

  10. 10.

    Hartigan-Go K. ADR monitoring: Experiences in the Philippine General Hospital. Acta Medica Philippina. 1992;28:164–166.

  11. 11.

    Ines-Cuyekeng E. Adverse Drug Reaction Reporting, Philippine Experience. Med Toxicol. 1986;1:99–104.

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Author information

Correspondence to Dr. Kenneth Hartigan-Go MD, FPCP, FPSECP.

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Hartigan-Go, K. From Signals to Policies: Academic and Regulatory Perspectives in the Philippines. Ther Innov Regul Sci 33, 949–954 (1999) doi:10.1177/009286159903300336

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Key Words

  • ADR
  • Drug safety
  • Pharmacovigilance
  • Philippines
  • Policies