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‫سعادت‬‫فریده‬
‫تعریف‬ WHO ‫از‬ ADR • ‫وقتی‬ ‫از‬ ‫دارو‬ ‫استفاده‬ ‫می‬ ‫شود‬ ( ‫چه‬ ‫برای‬ ‫جلوگیری‬ ‫از‬ ‫چه‬،‫بیماری‬ ‫برای‬ ‫تشخیص‬ ‫و‬ ‫چه‬ ‫برای‬ ‫درمان‬ ) ‫اگر‬ ‫اتفاقی‬ ‫بیفتد‬ ‫که‬ ‫ما‬ ‫پیش‬ ‫بینی‬ ‫نکرده‬ ‫ایم‬ ‫به‬ ‫آن‬ ADR ‫می‬ ‫گویم‬ . ( ‫حتی‬ ‫ممکن‬ ‫است‬ ‫پیش‬ ‫بینی‬ ‫شده‬ ‫باشد‬ . ) • ADR ‫چهارمین‬ ‫تا‬ ‫ششمین‬ ‫علت‬ ‫مرگو‬
‫فارماکوویژالنس‬ • ‫یا‬ ‫شدن‬ ‫متوجه‬ ،‫ارزیابی‬،‫ردیابی‬ ‫چرا‬ ‫اینکه‬ ‫تفهیم‬ ADR ‫آمده‬ ‫وجود‬ ‫به‬ ‫در‬ ‫را‬ ‫آن‬ ‫از‬ ‫جلوگیری‬ ‫چگونگی‬ ‫و‬ ‫گوید‬ ‫می‬ ‫انسان‬ . • ‫ارتقاء‬ ‫ویژالنس‬ ‫فارماکو‬ ‫نهایی‬ ‫هدف‬ ‫است‬ ‫درمانی‬ ‫دارو‬ ‫کیفیت‬ .
‫ها‬‫و‬‫دار‬‫ناخواسته‬‫عوارض‬ ‫سی‬‫ر‬‫وبر‬‫ثبت‬ ‫مرکز‬ADR • ‫مرکز‬ ‫ثبت‬ ‫وبررسی‬ ‫عوارض‬ ‫ناخواسته‬ ‫داروها‬ ( ADR ) ‫به‬ ‫عنوان‬ ‫تنها‬ ‫مرکز‬ ‫ملی‬ ‫در‬ ‫سطح‬ ‫کشور‬ ‫به‬ ‫جمع‬ ‫آوری‬ ‫و‬ ‫ثبت‬ ‫گزارشهای‬ ‫عوارض‬ ‫دارویی‬ ‫مشاهده‬ ‫شده‬ ‫توسط‬ ‫جامعه‬ ‫محترم‬ ‫پزشکی‬ ‫می‬ ‫پردازد‬ . ‫این‬ ‫مرکز‬ ‫از‬ ‫سال‬ 1377 ‫به‬ ‫عنوان‬ ‫عضو‬ ‫کامل‬ ‫سازمان‬ ‫جهانی‬ ‫بهداشت‬ ‫در‬ ‫برنامه‬ ‫بین‬ ‫المللی‬ ‫پایش‬ ‫فرآورده‬ ‫های‬ ‫دارویی‬ ‫پذیرفته‬ ‫شده‬ ‫است‬ ‫و‬ ‫از‬ ‫آن‬ ‫زمان‬ ‫تاکنون‬ ‫با‬ ‫سازمان‬ ‫مذکور‬ ‫و‬ ‫سایر‬ ‫کشورهای‬ ‫عضو‬ ‫به‬ ‫تبادل‬ ‫اطالعات‬ ‫در‬ ‫زمینه‬ ‫عوارض‬ ‫دارویی‬ ‫می‬ ‫پردازد‬ . ‫هدف‬ ‫از‬ ‫بررسی‬ ‫عوارض‬ ‫دارویی‬ ‫دریافت‬ ،‫شده‬ ‫کاهش‬ ‫مرگ‬ ‫و‬ ‫میر‬ ‫ناشی‬ ‫از‬ ‫عوارض‬ ‫دارویی‬ ‫و‬ ‫پیشگیری‬ ‫از‬ ‫وقوع‬ ‫آنها‬ ‫می‬ ‫باشد‬ . ‫در‬ ‫بهمن‬ ‫ماه‬ ‫سال‬ 1385 ، ‫دستورالعمل‬ ‫ثبت‬ ‫عوارض‬ ‫وخطاهای‬ ‫دارویی‬ ‫از‬ ‫سوی‬ ‫معاونت‬ ‫محترم‬ ‫غذا‬ ‫ودارو‬ ‫با‬ ‫تائید‬ ‫وزیر‬ ‫محترم‬ ،‫بهداشت‬ ‫درمان‬ ‫وآموزش‬ ‫پزشکی‬ ‫به‬ ‫کلیه‬ ‫دانشگاههای‬ ‫علوم‬ ‫پزشکی‬ ‫و‬ ‫مراکز‬ ‫بهداشتی‬ ‫درمانی‬ ‫دولتی‬ ‫و‬ ‫خصوصی‬ ‫سراسر‬ ‫کشور‬ ‫ابالغ‬ ‫گردید‬
‫ها‬‫و‬‫دار‬‫ناخواسته‬‫عوارض‬‫سی‬‫ر‬‫وبر‬‫ثبت‬‫مرکز‬‫عمده‬‫اهداف‬  ‫شناسایي‬ ‫سریع‬ ‫عوارض‬ ‫و‬ ‫تداخل‬ ‫هاي‬ ‫دارویي‬ ‫كه‬ ‫تا‬ ‫زمان‬ ‫ورود‬ ‫دارو‬ ‫به‬ ‫بازار‬ ‫شناخته‬ ‫نشده‬ ‫اند‬ .  ‫تشخیص‬ ‫افزایش‬ ‫ناگهاني‬ ‫در‬ ‫میزان‬ ‫وقوع‬ ‫عوارض‬ ‫ناخواسته‬ ‫شناخته‬ ‫شده‬ .  ‫شناسایي‬ ‫ریسك‬ ‫فاكتورها‬ ‫و‬ ‫مكانیسم‬ ‫هایي‬ ‫كه‬ ‫عوارض‬ ‫ناخواسته‬ ‫دارویي‬ ‫تحت‬ ‫آن‬ ‫شرایط‬ ‫رخ‬ ‫میدهند‬ .  ‫تخمین‬ ‫جنبه‬ ‫هاي‬ ‫كمي‬ ‫زیان‬ ‫هاي‬ ‫ناشي‬ ‫از‬ ‫مصرف‬ ‫داروها‬ .  ‫تحلیل‬ ‫و‬ ‫انتشار‬ ‫اطالعات‬ ‫مورد‬ ‫نیاز‬ ‫در‬ ‫تجویز‬ ‫داروها‬ ‫و‬ ‫مقررات‬ ‫دارویي‬ .  ‫پیشگیری‬ ‫از‬ ‫وقوع‬ ‫عوارض‬ ‫دارویی‬ ‫قابل‬
‫ارش‬‫ز‬‫گ‬‫ا‬‫ر‬ ‫ي‬‫ي‬‫و‬‫دار‬‫عوارض‬ ‫توان‬‫مي‬‫چگونه‬ ‫نمود؟‬  ‫به‬ ‫منظور‬ ‫جمع‬ ‫آوري‬ ‫گزارشهاي‬ ‫عوارض‬ ،‫دارویي‬ ‫فرم‬ ‫هاي‬ ‫زرد‬ ‫رنگي‬ ‫توسط‬ ‫این‬ ‫مركز‬ ‫تهیه‬ ‫شده‬ ‫است‬ ‫كه‬ ‫در‬ ‫صورت‬ ‫تماس‬ ‫با‬ ‫این‬ ‫مركز‬ ‫به‬ ‫تعداد‬ ‫الزم‬ ‫در‬ ‫اختیار‬ ‫كلیه‬ ‫حرف‬ ‫پزشكي‬ ‫قرار‬ ‫خواهد‬ ‫گرفت‬ . ‫پس‬ ‫از‬ ‫تكمیل‬ ‫فرم‬ ،‫ها‬ ‫مي‬ ‫توان‬ ‫آنها‬ ‫را‬ ‫به‬ ‫آدرس‬ ‫تهران‬ - ‫صندوق‬ ‫پستي‬ 948 - 14185 ‫ارسال‬ ،‫داشت‬ ‫هزینه‬ ‫پست‬ ‫ا‬ ‫قبال‬ ‫پرداخت‬ ‫شده‬ ‫است‬ . ‫هم‬ ‫چنین‬ ‫گزارش‬ ‫عوارض‬ ‫از‬ ‫طریق‬ ‫تلفن‬ ( 4 - 88923193 ) ‫و‬ / ‫یا‬ ‫نمابر‬ ( 88890857 ) ‫و‬ ‫یا‬ ‫از‬ ‫طریق‬ ‫سایت‬ ‫معاونت‬ ‫دارو‬ ‫و‬ ‫غذا‬ ‫نیز‬ ‫قابل‬ ‫ارسال‬ ‫می‬ ‫باشد‬ .  ‫چه‬ ‫مواردي‬ ‫را‬ ‫مي‬ ‫توان‬ ‫گزارش‬ ‫نمود؟‬  ‫كلیه‬ ‫عوارض‬ ‫مشكوك‬ ‫به‬ ‫مصرف‬ ‫فرآورده‬ ‫هاي‬ ‫درماني‬ ‫از‬ ‫جمله‬ ‫داروها‬ ، ‫فرآورده‬ ‫هاي‬ ،‫خوني‬ ‫واكسن‬ ،‫ها‬ ‫مواد‬ ،‫حاجب‬ ‫مواد‬ ‫مورد‬ ‫استفاده‬ ‫در‬ ‫دندانپزشكي‬ ‫یا‬ ،‫جراحي‬ ‫فرآورده‬ ‫هاي‬ ‫گیاهي‬ ‫و‬ ‫محلولهاي‬ ‫لنز‬ ‫قابل‬ ‫گزارش‬ ‫به‬ ‫این‬ ‫مركز‬ ‫مي‬ ‫باشند‬ .  ‫جهت‬ ‫گزارش‬ ‫یك‬ ،‫عارضه‬ ‫اطمینان‬ ‫از‬ ‫وجود‬ ‫ارتباط‬ ‫قطعي‬ ‫میان‬ ‫مصرف‬ ‫فرآورده‬ ‫و‬ ‫بروز‬ ‫عارضه‬ ‫ضروري‬ ‫نیست‬ ‫بلكه‬ ‫تردید‬ ‫به‬ ‫ایجاد‬ ‫عارضه‬ ‫نیز‬ ‫قابل‬ ‫گزارش‬ ‫مي‬ ‫باشد‬ . ‫همچنین‬ ‫كلیه‬ ‫عوارض‬ ‫مشاهده‬ ‫شده‬ ‫اعم‬ ‫از‬ ‫خفیف‬ ‫یا‬ ،‫شدید‬ ‫گذرا‬ ‫یا‬ ‫پایدار‬ ‫توسط‬ ‫این‬ ‫مركز‬ ‫پذیرفته‬ ‫مي‬ ‫شود‬ .  ‫توجه‬ ‫مهم‬ :  ‫هنگام‬ ‫گزارش‬ ‫یك‬ ‫عارضه‬ ‫حتي‬ ‫االمكان‬ ‫نام‬ ‫شركت‬ ‫سازنده‬ ‫و‬ ‫شماره‬ ‫سري‬ ‫ساخت‬ ‫را‬ ‫جستجو‬ ،‫نموده‬ ‫گزارش‬ ‫نمایید‬ .  ‫هرگز‬ ‫به‬ ‫دلیل‬ ‫نامعلوم‬ ‫بودن‬ ‫برخي‬ ‫اطالعات‬ ‫درخواستي‬ ‫در‬
‫ارشات‬‫ز‬‫گ‬‫کاهش‬‫باعث‬‫که‬‫دالیلی‬ ADR ‫گردد‬‫می‬ 1 - ‫برای‬ ‫موجود‬ ‫مکانیزم‬ ‫از‬ ‫اطال‬ ‫عدم‬ ‫گزارش‬ ‫ارسال‬ 2 - ‫مربوطه‬ ‫فرم‬ ‫به‬ ‫دسترسی‬ ‫عدم‬ 3 - ‫نظر‬ ‫از‬ ‫عارضه‬ ‫اهمیت‬ ‫عدم‬ ‫گزارشگر‬ 4 - ‫وقت‬ ‫نداشتن‬ 5 - ‫کارهای‬ ‫در‬ ‫درگیری‬ ‫از‬ ‫اجتناب‬ ‫اداری‬ 6 - ‫کبفری‬ ‫حقوقی‬ ‫شکایات‬ ‫از‬ ‫ترس‬
Medication Error‫ی‬‫ی‬‫و‬‫دار‬ ‫اشتباهات‬ • ‫اشتباهات‬ ‫ی‬‫ی‬‫و‬‫دار‬ ،‫پزشکی‬ ‫ی‬‫جزی‬ ‫از‬ adverse event ‫ها‬ ‫هستند‬ ‫که‬ ‫به‬ ‫مرکز‬ ADR ‫ارش‬‫ز‬‫گ‬ ‫می‬ ‫گردند‬ . ‫این‬ ‫اشتباهات‬ ‫به‬ ‫دلیل‬ ‫قابل‬ ‫ی‬‫پیشگیر‬ ‫ب‬ ‫ودن‬ ‫حائز‬ ‫اهمیت‬ ‫هستند‬ . • ‫ادامه‬‫ر‬‫د‬ ‫چند‬ ‫نمونه‬ ‫عملی‬ ‫از‬ ‫اشتباهات‬ ‫ی‬‫ی‬‫و‬‫دار‬ ‫پزشکی‬ ‫ائه‬‫ر‬‫ا‬ ‫می‬ ‫شود‬ .
‫پزشکی‬‫ی‬‫ی‬‫و‬‫دار‬ ‫اشتباهات‬‫از‬‫عملی‬‫نمونه‬‫چند‬
102 : 29 / 3 / 1389 ADR : 1 . ADR 1421 . ( 51 ) . - . 2 . . . 3 . 0 . . 4 . . 5 . . ( )... . - / 3 - / 30 www.fdo.ir ( 88890857 ) ( - 88923193 ) ADR .
105 : 16 / 8 / 1389 ADR Sai Parenterals Pvt.Ltd. . . . . - / 3 - / 30 www.fdo.ir ( 88890857 ) ( - 88923193 ) ADR .
(ADR) ‫شماره‬‫نامه‬‫ر‬‫خب‬ 3 - 2 ‫ارش‬‫ز‬‫گ‬ Medication Error : ‫سندرم‬ Red-Neck ‫در‬ ‫اثر‬ ‫يون‬‫ز‬‫انفو‬ ‫يع‬‫ر‬‫س‬ ‫وانكومايسين‬ ‫از‬ ‫مرداد‬ ‫ماه‬ 81 ‫تاكنون‬ 4 ‫ارش‬‫ز‬‫گ‬ ‫مبني‬ ‫بر‬ ‫سندرم‬ Red-Neck ‫به‬ ‫مركز‬ ADR ‫ان‬‫ر‬‫اي‬ ‫ارسال‬ ‫شده‬ ‫است‬ . ‫سندرم‬ red-neck ‫يا‬ red-man ‫يك‬ ‫واكنش‬ ‫حساسيتي‬ ‫است‬ ‫كه‬ ‫با‬ ‫افت‬ ‫ناگهاني‬ ‫فشار‬ ‫خون‬ ‫بيمار‬ ( ‫به‬ ‫علت‬ ‫ريليز‬ ‫هيستامين‬ ‫در‬ ‫خون‬ ) ‫شروع‬ ،‫شده‬ ‫اغلب‬ ‫با‬ ‫گرگرفتگي‬ ‫و‬ ‫اش‬‫ر‬ ‫هاي‬ ‫ماكولوپاپوالر‬ ‫يا‬ ‫ار‬ ‫يتماتوز‬ ‫روي‬ ،‫صورت‬ ‫سينه‬،‫گردن‬ ‫و‬ ‫اندامهاي‬ ‫ي‬‫باالي‬ ‫بدن‬ ‫ادامه‬ ‫مي‬ ‫يابد‬ . ‫گاهي‬ ‫فقط‬ ‫اش‬‫ر‬ ‫و‬ ‫گرگرفتگي‬ ‫مشاهده‬ ‫مي‬ ‫گردد‬ ‫و‬ ‫افت‬ ‫فشار‬ ‫خون‬ ‫اتفاق‬ ‫نمي‬ ‫افتد‬ . ‫وقوع‬ ‫خس‬ ‫خس‬ ،‫سينه‬ ‫ديس‬ ‫پنه‬ ، ،‫نژيوادم‬‫ا‬ ‫كهير‬ ‫و‬ ‫خارش‬ ‫هم‬ ‫امكان‬ ‫پذير‬ ‫است‬ . ‫ايست‬ ‫قلبي‬ ‫و‬ ‫تشنج‬ ‫نيز‬ ‫تا‬‫ر‬‫ند‬ ‫اتفاق‬ ‫مي‬ ‫افتند‬ . ‫عليرغم‬ ‫تمامي‬ ‫عالئم‬ ،‫مذكور‬ ‫اين‬ ‫عارضه‬ ‫ا‬‫كامال‬ ‫قابل‬ ‫پيشگيري‬ ‫است‬ ‫و‬ ‫اگر‬ ‫انفوزيون‬ ‫داروي‬ ‫وانكومايسين‬ ‫طي‬ ‫حداقل‬ ‫يكساعت‬ ‫و‬ ‫به‬ ‫امي‬‫ر‬‫ا‬ ‫صورت‬ ،‫بگيرد‬ ‫اين‬ ‫عارضه‬ ‫اتفاق‬ ‫نمي‬ ‫افتد‬ . ‫فشار‬ ‫خون‬ ‫بيمار‬ ‫در‬ ‫طول‬ ‫انفوزيون‬ ‫بايد‬ ‫كنترل‬ ‫شود‬ ‫و‬ ‫داروهاي‬ ‫نتي‬‫ا‬ ‫هيستامين‬ ‫اي‬‫ر‬‫ب‬ ‫درمان‬ ‫واكنش‬ ‫احتمالي‬ ‫ماده‬‫ا‬ ‫باشند‬ . Reference: American Society of Health - system Pharmacists (AHFS) Drug Information, 2001. • •

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