Generic selectors
Exact matches only
Search in title
Search in content
Search in posts
Search in pages
Filter by Categories
15th National Conference of the IAOMFP, Chennai, 2006
Abstract
Abstracts from current literature
Acne in India: Guidelines for management - IAA Consensus Document
Addendum
Announcement
Art & Psychiatry
Article
Articles
Association Activities
Association Notes
Award Article
Book Review
Brief Report
Case Analysis
Case Letter
Case Letters
Case Notes
Case Report
Case Reports
Clinical and Laboratory Investigations
Clinical Article
Clinical Studies
Clinical Study
Commentary
Conference Oration
Conference Summary
Continuing Medical Education
Correspondence
Corrigendum
Cosmetic Dermatology
Cosmetology
Current Best Evidence
Current View
Derma Quest
Dermato Surgery
Dermatopathology
Dermatosurgery Specials
Dispensing Pearl
Do you know?
Drug Dialogues
e-IJDVL
Editor Speaks
Editorial
Editorial Remarks
Editorial Report
Editorial Report - 2007
Editorial report for 2004-2005
Errata
Erratum
Focus
Fourth All India Conference Programme
From Our Book Shelf
From the Desk of Chief Editor
General
Get Set for Net
Get set for the net
Guest Article
Guest Editorial
History
How I Manage?
IADVL Announcement
IADVL Announcements
IJDVL Awards
IJDVL AWARDS 2015
IJDVL Awards 2018
IJDVL Awards 2019
IJDVL Awards 2020
IJDVL International Awards 2018
Images in Clinical Practice
In Memorium
Inaugural Address
Index
Knowledge From World Contemporaries
Leprosy Section
Letter in Response to Previous Publication
Letter to Editor
Letter to the Editor
Letter to the Editor - Case Letter
Letter to the Editor - Letter in Response to Published Article
LETTER TO THE EDITOR - LETTERS IN RESPONSE TO PUBLISHED ARTICLES
Letter to the Editor - Observation Letter
Letter to the Editor - Study Letter
Letter to the Editor - Therapy Letter
Letter to the Editor: Articles in Response to Previously Published Articles
Letters to the Editor
Letters to the Editor - Letter in Response to Previously Published Articles
Letters to the Editor: Case Letters
Letters to the Editor: Letters in Response to Previously Published Articles
Medicolegal Window
Messages
Miscellaneous Letter
Musings
Net Case
Net case report
Net Image
Net Letter
Net Quiz
Net Study
New Preparations
News
News & Views
Obervation Letter
Obituary
Observation Letter
Observation Letters
Oration
Original Article
ORIGINAL CONTRIBUTION
Original Contributions
Pattern of Skin Diseases
Pearls
Pediatric Dermatology
Pediatric Rounds
Perspective
Presedential Address
Presidential Address
Presidents Remarks
Quiz
Recommendations
Regret
Report
Report of chief editor
Report of Hon : Treasurer IADVL
Report of Hon. General Secretary IADVL
Research Methdology
Research Methodology
Resident page
Resident's Page
Resident’s Page
Residents' Corner
Residents' Corner
Residents' Page
Retraction
Review
Review Article
Review Articles
Revision Corner
Self Assessment Programme
SEMINAR
Seminar: Chronic Arsenicosis in India
Seminar: HIV Infection
Short Communication
Short Communications
Short Report
Special Article
Specialty Interface
Studies
Study Letter
Supplement-Photoprotection
Supplement-Psoriasis
Symposium - Contact Dermatitis
Symposium - Lasers
Symposium - Pediatric Dermatoses
Symposium - Psoriasis
Symposium - Vesicobullous Disorders
SYMPOSIUM - VITILIGO
Symposium Aesthetic Surgery
Symposium Dermatopathology
Symposium-Hair Disorders
Symposium-Nails Part I
Symposium-Nails-Part II
Tables
Technology
Therapeutic Guidelines
Therapeutic Guidelines - IADVL
Therapeutics
Therapy
Therapy Letter
View Point
Viewpoint
What’s new in Dermatology
View/Download PDF
Letter to the Editor
2010:76:4;412-413
doi: 10.4103/0378-6323.66586
PMID: 20657127

Prescribing and dispensing of isotretinoin: A survey

Shraddha R Anwikar1 , Mitali S Bandekar1 , Uday Khopkar2 , Nilima A Kshirsagar1
1 Department of Clinical Pharmacology, Seth G. S. Medical College and KEM Hospital, Parel, Mumbai - 400 012, India
2 Department of Skin, Seth G. S. Medical College and KEM Hospital, Parel, Mumbai - 400 012, India

Correspondence Address:
Shraddha R Anwikar
Department of Clinical Pharmacology, Seth G. S. Medical College and KEM Hospital, Parel, Mumbai - 400 012
India
How to cite this article:
Anwikar SR, Bandekar MS, Khopkar U, Kshirsagar NA. Prescribing and dispensing of isotretinoin: A survey. Indian J Dermatol Venereol Leprol 2010;76:412-413
Copyright: (C)2010 Indian Journal of Dermatology, Venereology, and Leprology

Sir,

Since the thalidomide disaster in the 1960s, physicians and patients have became aware of the teratogenic effects of drugs used during pregnancy. Isotretinoin is one such teratogenic drug and pregnancies exposed to isotretinoin are at severe risk of serious congenital malformations and have resulted in spontaneous or elective abortions, risk of depression, suicide, and liver damage. [1]

Several risk-management strategies like iPLEDGE have been implemented in the US to prevent pregnancy in females during the course of isotretinoin treatment. [2] In India, isotretinoin is widely prescribed by the dermatologists as well as general practitioners Hence, this study was done to find out whether care is taken while prescribing and dispensing teratogenic drugs like isotretinoin by healthcare professionals and pharmacists in one large and small city in Maharashtra. Package inserts of various companies marketing isotretinoin in India were assessed for their completeness of information.

This was a survey-based study carried out during the period from November 2008 to January 2009 in which a survey of physicians and pharmacists and analysis of package inserts were undertaken. Dermatologists and general practitioners were randomly selected by personal contact and were personally interviewed. A questionnaire was also circulated to them from which they were asked to tick the answer they thought appropriate and were assured anonymity.

The questionnaire was completed by a total of 38 healthcare professionals (28 dermatologists and 10 general practioners) from two different cities and their response is mentioned in [Table - 1].

The dispensing practices of pharmacists were assessed by sending ten female dummy patients of childbearing age, 10 married female patients with visible indicators of being married (like wedding chain in the neck) and 10 visibly pregnant women to pharmacies; they asked for isotretinoin without prescription and surprisingly, it was dispensed readily by the pharmacists to all patients without prescription and without giving any instructions about its teratogenic effect.

Package inserts of six different pharmaceutical companies marketing or manufacturing isotretinoin in India was assessed for their contents regarding precautions to be taken while on treatment.

All mention the need for a pregnancy test to be carried out twice before putting a female patient on this medication but the patient information sheet did not mention anything about double contraception i.e. one hormonal and one barrier method to be followed to avoid any remote chances of pregnancy.

Earlier, such studies have been carried out in the developed countries, which showed that prescriptions for teratogenic medicines are given to women of childbearing age without any documentation of contraceptive counselling. [3] Such studies are very important to India because we do not have an adequate pharmacovigilance program. It has been observed that prescribing instructions are not followed by most of the prescribers as there is a taboo to carry out pregnancy tests for unmarried women, physicians face a lot of difficulty to convince the families to get their daughter to do a pregnancy test even though it may be for the safe use of the drug.

In conclusion, all these factors put Indian women patients at risk but it is also one of the unavoidable facts that in a high-population country like India implementation of a risk minimization program like iPLEDGE become practically difficult. Thus there is not only a need for education and awareness among patients, prescribers and pharmacists about the potential preventable harm from teratogenic drugs but also a need for development of a simpler and practicable risk minimization method.

So we have come up with some recommendations to implement a simple risk minimization method shown in the chart below. In another article (under publication) detailed instructions to patients and physicians about pregnancy test and contraception are described.

[SUPPORTING:1]

References
1.
Abroms L, Maibach E, Lyon-Daniel K, Feldman SR. What is the best approach to reducing birth defects associated with isotretinoin. PLoS Med 2006;11:1978-83.
[Google Scholar]
2.
Cragan JD, Friedman JM, Holmes LB, Uhl K, Green NS, Riley L. Ensuring the safe and effective use of medications during pregnancy: planning and prevention through preconception care. Matern Child Health J 2006;10:S129-35.
[Google Scholar]
3.
Schwarz EB, Postlethwaite DA, Hung YY, Armstrong MA. Documentation of contraception and pregnancy when prescribing potentially teratogenic medications for reproductive-age women. Ann Intern Med 2007;147:370-6.
[Google Scholar]

Fulltext Views
150

PDF downloads
85
Show Sections