Not All Isotretinoin Prescribing Meets Safety Standards

Not all dermatologists comply with recommendations for use of isotretinoin in females of childbearing potential, according to a study in the September issue of the International Journal of Dermatology. The finding was especially significant in countries with restrictions on abortion.

Dr. Khalid M. AlGhamdi of King Saud University in Riyadh, Saudi Arabia, and colleagues looked at the practices and safety concerns of dermatologists in Saudi Arabia, including whether they followed necessary precautions when prescribing isotretinoin to females of childbearing potential (FCBP) (Int. J. Dermatol. 2011;50:1094-8).

For the cross-sectional study, the investigators distributed a self-administered questionnaire to 160 dermatologists attending a national conference in Riyadh during 2008. Of the dermatologists, 134 completed the survey (82 female and 52 male), for a response rate of 84%. The physicians ranged in age from 25 to 66 (mean age 39). They were in practice for a mean of 11 years, though 32% were residents. Of the 160 dermatologists, 70% worked in government hospitals, 15% were in private practice, and 15% worked in both sectors.

Using the questionnaire, the researchers gathered the following information:

• Isotretinoin prescriptions. Respondents prescribed isotretinoin during the previous 12 months for an estimated 792 FCBP.

• Pregnancy. Of these 792 FCBP, there were 7 reported pregnancies, for an estimated rate of 8.8 per 1,000. "Such a rate of pregnancy may be an underestimate of the true rate, because there are no registries at the present time of such incidents on a local/national scale," the researchers reported.

Three women (43%) terminated their pregnancies, one miscarried, two were lost to follow-up, and one gave birth to a normal baby.

• Pregnancy tests. Of the responding dermatologists, 71% reported performing a pregnancy test for patients before initiating treatment with isotretinoin, while 22% reported asking for a monthly pregnancy test.

• Informed consent. The questionnaire asked whether the dermatologists obtained informed consent from their female patients before starting isotretinoin treatment, if they discussed the potential teratogenic risk of using the drug, and if they educated patients about how to prevent pregnancy. Of the questionnaire respondents, 79% asked patients to sign a consent form, and 99% discussed teratogenic effects.

• Instructions. Of the dermatologists, 91% advised patients to continue contraception for 1 month after the last dose, 44% provided written guidelines about teratogenic risks, and 36% provided written information about contraception. Also, 73% advised patients to use two effective contraception methods, and 72% advised patients to begin effective contraception 1 month before starting isotretinoin,

• Attitudes. About two-thirds, 63% reported generally avoiding isotretinoin therapy in FCBP. This was irrespective of the dermatologist’s gender, years of experience, or any previous incident of having a patient become pregnant while on isotretinoin, the researchers reported.

"This study was the first, to our knowledge, to examine trends and practices of dermatologists from their perspective in this significant area," Dr. AlGhamdi and his colleagues wrote. "Saudi Arabia is among the countries where there are certain limitations on abortion, which renders this study of great importance."

Contraception is easily accessible in Saudi Arabia, but Islamic law makes abortion difficult to obtain. "In view of restricted and diverse jurisprudence regarding abortion on fetal impairment grounds, one should be very vigilant in prescribing such a teratogenic drug in FCBP and take all necessary precautions to avoid the tragedy of exposing the embryo to a highly teratogenic medication such as isotretinoin."

The strengths of the study, the researchers noted, were its large sample size and that it may be the first to examine pregnancy prevention from the perspective of prescribing dermatologists rather than patients. One weakness may be recall bias as dermatologists may have been inaccurate in remembering the exact number of female isotretinoin users.

Isotretinoin, used to treat extensive and nodulocystic acne and moderate acne that is unresponsive to conventional treatment, can cause severe birth defects when used during pregnancy (even as little as one dose). In March 2006, the four drug companies in the U.S. that market isotretinoin jointly launched iPLEDGE, a computer-based risk management program, to prevent female patients from beginning therapy while pregnant or becoming pregnant during therapy. Three previous programs failed to prevent pregnancies in patients using isotretinoin.

The iPLEDGE program requires FCBP to commit to using two forms of contraception, and to have a negative urine or serum pregnancy test before receiving the initial dose and every month before receiving a new prescription. Prescribing physicians must enter pregnancy results and the two forms of contraception in the system, counsel patients about the risks of isotretinoin each month before providing a prescription, and document the counseling in the system.

The authors did not declare having any conflicts of interest.

Not all dermatologists comply with recommendations for use of isotretinoin in females of childbearing potential, according to a study in the September issue of the International Journal of Dermatology. The finding was especially significant in countries with restrictions on abortion.

Dr. Khalid M. AlGhamdi of King Saud University in Riyadh, Saudi Arabia, and colleagues looked at the practices and safety concerns of dermatologists in Saudi Arabia, including whether they followed necessary precautions when prescribing isotretinoin to females of childbearing potential (FCBP) (Int. J. Dermatol. 2011;50:1094-8).

For the cross-sectional study, the investigators distributed a self-administered questionnaire to 160 dermatologists attending a national conference in Riyadh during 2008. Of the dermatologists, 134 completed the survey (82 female and 52 male), for a response rate of 84%. The physicians ranged in age from 25 to 66 (mean age 39). They were in practice for a mean of 11 years, though 32% were residents. Of the 160 dermatologists, 70% worked in government hospitals, 15% were in private practice, and 15% worked in both sectors.

Using the questionnaire, the researchers gathered the following information:

• Isotretinoin prescriptions. Respondents prescribed isotretinoin during the previous 12 months for an estimated 792 FCBP.

• Pregnancy. Of these 792 FCBP, there were 7 reported pregnancies, for an estimated rate of 8.8 per 1,000. "Such a rate of pregnancy may be an underestimate of the true rate, because there are no registries at the present time of such incidents on a local/national scale," the researchers reported.

Three women (43%) terminated their pregnancies, one miscarried, two were lost to follow-up, and one gave birth to a normal baby.

• Pregnancy tests. Of the responding dermatologists, 71% reported performing a pregnancy test for patients before initiating treatment with isotretinoin, while 22% reported asking for a monthly pregnancy test.

• Informed consent. The questionnaire asked whether the dermatologists obtained informed consent from their female patients before starting isotretinoin treatment, if they discussed the potential teratogenic risk of using the drug, and if they educated patients about how to prevent pregnancy. Of the questionnaire respondents, 79% asked patients to sign a consent form, and 99% discussed teratogenic effects.

• Instructions. Of the dermatologists, 91% advised patients to continue contraception for 1 month after the last dose, 44% provided written guidelines about teratogenic risks, and 36% provided written information about contraception. Also, 73% advised patients to use two effective contraception methods, and 72% advised patients to begin effective contraception 1 month before starting isotretinoin,

• Attitudes. About two-thirds, 63% reported generally avoiding isotretinoin therapy in FCBP. This was irrespective of the dermatologist’s gender, years of experience, or any previous incident of having a patient become pregnant while on isotretinoin, the researchers reported.

"This study was the first, to our knowledge, to examine trends and practices of dermatologists from their perspective in this significant area," Dr. AlGhamdi and his colleagues wrote. "Saudi Arabia is among the countries where there are certain limitations on abortion, which renders this study of great importance."

Contraception is easily accessible in Saudi Arabia, but Islamic law makes abortion difficult to obtain. "In view of restricted and diverse jurisprudence regarding abortion on fetal impairment grounds, one should be very vigilant in prescribing such a teratogenic drug in FCBP and take all necessary precautions to avoid the tragedy of exposing the embryo to a highly teratogenic medication such as isotretinoin."

The strengths of the study, the researchers noted, were its large sample size and that it may be the first to examine pregnancy prevention from the perspective of prescribing dermatologists rather than patients. One weakness may be recall bias as dermatologists may have been inaccurate in remembering the exact number of female isotretinoin users.

Isotretinoin, used to treat extensive and nodulocystic acne and moderate acne that is unresponsive to conventional treatment, can cause severe birth defects when used during pregnancy (even as little as one dose). In March 2006, the four drug companies in the U.S. that market isotretinoin jointly launched iPLEDGE, a computer-based risk management program, to prevent female patients from beginning therapy while pregnant or becoming pregnant during therapy. Three previous programs failed to prevent pregnancies in patients using isotretinoin.

The iPLEDGE program requires FCBP to commit to using two forms of contraception, and to have a negative urine or serum pregnancy test before receiving the initial dose and every month before receiving a new prescription. Prescribing physicians must enter pregnancy results and the two forms of contraception in the system, counsel patients about the risks of isotretinoin each month before providing a prescription, and document the counseling in the system.

The authors did not declare having any conflicts of interest.

Not all dermatologists comply with recommendations for use of isotretinoin in females of childbearing potential, according to a study in the September issue of the International Journal of Dermatology. The finding was especially significant in countries with restrictions on abortion.

Dr. Khalid M. AlGhamdi of King Saud University in Riyadh, Saudi Arabia, and colleagues looked at the practices and safety concerns of dermatologists in Saudi Arabia, including whether they followed necessary precautions when prescribing isotretinoin to females of childbearing potential (FCBP) (Int. J. Dermatol. 2011;50:1094-8).

For the cross-sectional study, the investigators distributed a self-administered questionnaire to 160 dermatologists attending a national conference in Riyadh during 2008. Of the dermatologists, 134 completed the survey (82 female and 52 male), for a response rate of 84%. The physicians ranged in age from 25 to 66 (mean age 39). They were in practice for a mean of 11 years, though 32% were residents. Of the 160 dermatologists, 70% worked in government hospitals, 15% were in private practice, and 15% worked in both sectors.

Using the questionnaire, the researchers gathered the following information:

• Isotretinoin prescriptions. Respondents prescribed isotretinoin during the previous 12 months for an estimated 792 FCBP.

• Pregnancy. Of these 792 FCBP, there were 7 reported pregnancies, for an estimated rate of 8.8 per 1,000. "Such a rate of pregnancy may be an underestimate of the true rate, because there are no registries at the present time of such incidents on a local/national scale," the researchers reported.

Three women (43%) terminated their pregnancies, one miscarried, two were lost to follow-up, and one gave birth to a normal baby.

• Pregnancy tests. Of the responding dermatologists, 71% reported performing a pregnancy test for patients before initiating treatment with isotretinoin, while 22% reported asking for a monthly pregnancy test.

• Informed consent. The questionnaire asked whether the dermatologists obtained informed consent from their female patients before starting isotretinoin treatment, if they discussed the potential teratogenic risk of using the drug, and if they educated patients about how to prevent pregnancy. Of the questionnaire respondents, 79% asked patients to sign a consent form, and 99% discussed teratogenic effects.

• Instructions. Of the dermatologists, 91% advised patients to continue contraception for 1 month after the last dose, 44% provided written guidelines about teratogenic risks, and 36% provided written information about contraception. Also, 73% advised patients to use two effective contraception methods, and 72% advised patients to begin effective contraception 1 month before starting isotretinoin,

• Attitudes. About two-thirds, 63% reported generally avoiding isotretinoin therapy in FCBP. This was irrespective of the dermatologist’s gender, years of experience, or any previous incident of having a patient become pregnant while on isotretinoin, the researchers reported.

"This study was the first, to our knowledge, to examine trends and practices of dermatologists from their perspective in this significant area," Dr. AlGhamdi and his colleagues wrote. "Saudi Arabia is among the countries where there are certain limitations on abortion, which renders this study of great importance."

Contraception is easily accessible in Saudi Arabia, but Islamic law makes abortion difficult to obtain. "In view of restricted and diverse jurisprudence regarding abortion on fetal impairment grounds, one should be very vigilant in prescribing such a teratogenic drug in FCBP and take all necessary precautions to avoid the tragedy of exposing the embryo to a highly teratogenic medication such as isotretinoin."

The strengths of the study, the researchers noted, were its large sample size and that it may be the first to examine pregnancy prevention from the perspective of prescribing dermatologists rather than patients. One weakness may be recall bias as dermatologists may have been inaccurate in remembering the exact number of female isotretinoin users.

Isotretinoin, used to treat extensive and nodulocystic acne and moderate acne that is unresponsive to conventional treatment, can cause severe birth defects when used during pregnancy (even as little as one dose). In March 2006, the four drug companies in the U.S. that market isotretinoin jointly launched iPLEDGE, a computer-based risk management program, to prevent female patients from beginning therapy while pregnant or becoming pregnant during therapy. Three previous programs failed to prevent pregnancies in patients using isotretinoin.

The iPLEDGE program requires FCBP to commit to using two forms of contraception, and to have a negative urine or serum pregnancy test before receiving the initial dose and every month before receiving a new prescription. Prescribing physicians must enter pregnancy results and the two forms of contraception in the system, counsel patients about the risks of isotretinoin each month before providing a prescription, and document the counseling in the system.

The authors did not declare having any conflicts of interest.