Assessing the availability of the teratogenic drug isotretinoin outside the pregnancy prevention programme: a survey of e-pharmacies.
OBJECTIVE
The increase in online purchasing of medications raises safety concerns regarding teratogenic drugs. The use of the teratogenic drug 'isotretinoin' for women of childbearing age requires strict adherence to the Pregnancy Prevention Programme (PPP), a risk minimisation measure imposed on prescribers and users. We sought to determine how readily consumers can purchase isotretinoin online and the associated safety procedures and information.


METHODS
A descriptive cross-sectional survey was conducted of 50 e-pharmacies identified from commonly used search engines. E-pharmacy characteristics and isotretinoin PPP specific criteria were evaluated. Purchases of isotretinoin from seven e-pharmacies not bearing authentication logos and not requiring a prescription were assessed for PPP policy adherence, purchasing procedures and compound quality.


RESULTS
Forty-three (86%) of the e-pharmacies did not have an authentication seal/logo. Isotretinoin could be purchased from 42 sites without a valid prescription. Information on isotretinoin causing birth defects was lacking in 25 of the 50 sites, on not taking isotretinoin in pregnancy in 24 sites and not taking isotretinoin if planning or at risk of a pregnancy in 33 sites. Of the eight attempted purchases, seven arrived, all without any patient information leaflet. All were verified as isotretinoin.


CONCLUSIONS
The Internet provides a loophole for purchasing of medications known to cause congenital abnormalities, which needs to be addressed by medicines regulatory agencies worldwide. The current PPP for isotretinoin may be failing to protect mothers and babies from preventable harm-clinicians need to be aware of this, and the public needs to be educated about the potential risks.
University of Ulster, Northern Ireland, UK.
Briege M
BM
Lagan
Helen
H
Dolk
Bronagh
B
White
Donald R A
DR
Uges
M
M
Sinclair
D000014:Abnormalities, Drug-Induced / Q000517:prevention & control*; D003132:Commerce / Q000592:standards / Q000706:statistics & numerical data; D003430:Cross-Sectional Studies; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011307:Drug Prescriptions; D005260:Female; D019983:Guideline Adherence; D019538:Health Care Surveys; D006801:Humans; D020407:Internet; D015474:Isotretinoin / Q000008:administration & dosage* / Q000009:adverse effects; D010353:Patient Education as Topic / Q000379:methods / Q000706:statistics & numerical data; D060946:Pharmaceutical Services, Online / Q000592:standards / Q000706:statistics & numerical data*; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000592:standards; D011247:Pregnancy; D013723:Teratogens / Q000633:toxicity
D003879:Dermatologic Agents; D013723:Teratogens; D015474:Isotretinoin
e-pharmacies; isotretinoin; online purchasing; pharmacoepidemiology; pregnancy prevention programmes