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Artikel dari : http://www.fda.gov/consumer/updates/compounding053107.html

The Special Risks of Pharmacy Compounding
photo of pharmacist in the back area of a pharmacy, adding a liquid to the contents of a small glass bottle with an eye dropper,

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On this page:

* A Troubling Trend
* Enforcement
* Red Flags
* What You Can Do

Pharmacy compounding is an age-old practice in which pharmacists combine, mix, or alter ingredients to create unique medications that meet specific needs of individual patients.

It's also a practice that is under FDA scrutiny—mainly because of instances where compounded drugs have endangered public health.

"In its traditional form, pharmacy compounding is a vital service that helps many people, including those who are allergic to inactive ingredients in FDA-approved medicines, and others who need medications that are not available commercially," says Kathleen Anderson, Pharm.D, Deputy Director of the Division of New Drugs and Labeling Compliance in FDA's Center for Drug Evaluation and Research (CDER).

Compounded medications are also prescribed for children who may be unable to swallow pills, need diluted dosages of a drug made for adults, or are simply unwilling to take bad-tasting medicine.

"But consumers need to be aware that compounded drugs are not FDA-approved," Anderson says. "This means that FDA has not verified their safety and effectiveness."

Steve Silverman, Assistant Director of CDER's Office of Compliance, says that poor practices on the part of drug compounders can result in contamination or in products that don't possess the strength, quality, and purity required. "And because patients who use these drugs may have serious underlying health conditions," he says, "these flawed methods pose special risks."

Unlike commercial drug manufacturers, pharmacies aren't required to report adverse events associated with compounded drugs. "FDA learns of these through voluntary reporting, the media, and other sources," says Silverman.

The Agency knows of more than 200 adverse events involving 71 compounded products since 1990. Some of these instances had devastating repercussions.

* Three patients died of infections stemming from contaminated compounded solutions that are used to paralyze the heart during open-heart surgery. FDA issued a warning letter in March 2006 to the firm that compounded the solutions.
* Two patients at a Washington, D.C., Veterans Affairs hospital were blinded, and several others had their eyesight damaged, by a compounded product used in cataract surgery. The product was contaminated with bacteria. In August 2005, FDA announced a nationwide recall of this Trypan Blue Ophthalmic Solution. Contaminated solution had been distributed to hospitals and clinics in eight states.
* In March 2005, FDA issued a nationwide alert concerning a contaminated, compounded magnesium sulfate solution that caused five cases of bacterial infections in a New Jersey hospital. A South Dakota patient treated with the product developed sepsis and died.

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A Troubling Trend

The emergence over the past decade of firms with pharmacy licenses making and distributing unapproved new drugs in a way that's clearly outside the bounds of traditional pharmacy is of great concern to FDA.

"The methods of these companies seem far more consistent with those of drug manufacturers than with those of retail pharmacies," says Silverman. "Some firms make large amounts of compounded drugs that are copies or near copies of FDA-approved, commercially available drugs. Other firms sell to physicians and patients with whom they have only a remote professional relationship."

FDA highlighted these concerns in August 2006, when it warned three firms to stop manufacturing and distributing thousands of doses of compounded, unapproved inhalation drugs nationwide.

Inhalation drugs are used to treat diseases including asthma, emphysema, bronchitis, and cystic fibrosis. "These are potentially life-threatening conditions for which numerous FDA-approved drugs are available," says Silverman. "Compounded inhalation drugs may be distributed to patients in multiple states, and patients and their doctors may not understand that they are receiving compounded products."

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Enforcement

"FDA historically hasn't directed enforcement against pharmacies engaged in traditional compounding," says Anderson. "Rather, we've focused on establishments whose activities raise the kinds of concerns normally associated with a drug manufacturer and whose compounding practices result in significant violations of the new-drug, adulteration, or misbranding provisions of the Federal Food, Drug, and Cosmetic Act."

FDA counts compounded drugs among the new drugs that are covered under the Act. "We consider them new because they're not generally recognized among experts as safe and effective," says Anderson.

She adds that FDA recognizes that states have a central role in regulating pharmacy compounding. "We refer complaints to the states, support them when they request it, and cooperate in investigations and follow-up actions. But there are cases when states are unable to act, and we proceed without them," Anderson says.

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Red Flags

In a May 29, 2002, Compliance Policy Guide devoted to human pharmacy compounding, FDA identifies factors that it considers in deciding upon enforcement action. These factors include instances where pharmacists are:

* compounding drug products that have been pulled from the market because they were found to be unsafe or ineffective.
* compounding drugs that are essentially copies of a commercially available drug product.
* compounding drugs in advance of receiving prescriptions, except in very limited quantities relating to the amounts of drugs previously compounded based on valid prescriptions.
* compounding finished drugs from bulk active ingredients that aren't components of FDA-approved drugs, without an FDA-sanctioned, investigational new-drug application.
* receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA-registered facility.
* failing to conform to applicable state law regulating the practice of pharmacy.

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What You Can Do

What can consumers do to protect themselves against inappropriate drug-compounding practices? Ilisa Bernstein, Pharm.D, J.D., Director of Pharmacy Affairs in FDA's Office of the Commissioner, offers these tips:

* Ask your doctor if an FDA-approved drug is available and appropriate for your treatment.
* Check with the pharmacist to see if he or she is familiar with compounding the product in your prescription.
* Get information from your doctor or pharmacist about proper use and storage of the compounded product.
* If you receive a compounded product, ask the pharmacist if the doctor asked for it to be compounded.
* If you experience any problems or adverse events, contact your doctor or pharmacist immediately and stop using the product.
* Report any adverse events experienced while using the product to FDA's MedWatch program at www.fda.gov/medwatch/

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Repost Gathering February

Undangan Pertemuan JPC Februari dilaksanakan pada:

Hari, Tanggal : Minggu, 15 Februari 2009
Jam : 09.00 - 11.00

Acara : Pertemuan Rutin JPC

Tema yang diangkat :
"MENDONGENG DENGAN ASYIK"
bintang tamu seorang pendongeng (nama masih di rahasiakan he he)

Tempat : Rumah Ibu Fitri Andyaswuri, perum minomartani, jl tengiri raya 15 Jogja.
(denah terlampir)

Semua ibu di undang ya....
ayoo ajakin moms yang lain
untuk yang belum pernah datang
dapat menghubungi Ibu Diani di (0274) 3224540
atau email dnajwa@gmail.com

pssstt..Insya Allah nanti ada doorprize...atau mungkin ada yg mau sumbang dp...di tunggu ya...

Denah rumah

Hati-hati Mengkonsumsi Suplemen

Selasa, 03 Februari 2009
TEMPO Interaktif, Jakarta: Tak ada secuil kekurangan yang kentara dari fisik Bulan, 13 bulan. Namun, kecemasan sang Bunda membuat bocah yang sering melontarkan senyum manis itu mendapat asupan multivitamin setiap hari. Apalagi di musim hujan seperti ini, Tanti, 28 tahun, begitu khawatir buah hatinya jatuh sakit. Ibu rumah tangga yang tinggal di Bekasi ini membayangkan kepanikan yang harus dialaminya jika kondisi itu terjadi. Maka, ia pun mengambil langkah sedia payung sebelum hujan. Agar tak sakit, bocah itu dicekoki suplemen multivitamin. Apalagi, ia terpesona berbagai iklan produk suplemen multivitamin di layar kaca.

Karena itulah, dr Purnamawati S. Pujiarto, SpAK, MMPed pun meminta para ibu untuk hati-hati. Spesialis anak ini menyebutkan, suplemen itu bermanfaat hanya untuk orang berusia 65 tahun ke atas. Atau orang-orang yang dalam kondisi tertentu, seperti menopause, mengalami gangguan makan, menjalani diet rendah kalori. Juga mereka yang perokok, mengkonsumsi minuman beralkohol, melakukan diet khusus, tengah merancang kehamilan, mempunyai kelainan metabolisme, atau penyerapan makanan dalam tubuh.

Ia mengungkapkan, anak dan perempuan sering kali menjadi korban dari berbagai produk suplemen. Dengan membidik pasar kaum Hawa, di pasar saat ini telah beredar berbagai produk yang bisa mencegah banyak hal, misal penuaan, osteoporosis. Padahal, penggunaan antioksidan--dengan kandungan vitamin A, E, dan lain-lain--secara berlebihan bisa berujung pada kematian.

Dokter yang bertugas di Kemang Medical Care, Jakarta Selatan, ini menyatakan, tak hanya anak-anak yang harus dicermati dari penggunaan suplemen, orang dalam kondisi tertentu pun harus lebih hati-hati. Misalnya, ibu menyusui, ibu hamil, atau menderita penyakit tertentu, seperti hipertensi, penyakit jantung, tiroid, diabetes, memiliki riwayat stroke, glaukoma, pembekuan darah, depresi, penyakit jiwa, epilepsi, parkison, pembesaran prostat, dan transplantasi organ.

Ia pun menyindir sebuah produk yang mengandung kolustrum. "Bayangkan, berapa sapi yang dibutuhkan untuk membuat produk tersebut," ujarnya. Menurut dokter yang biasa disapa Wati ini, vitamin dan mineral memang berperan penting dalam kelangsungan proses kegiatan sel-sel dalam tubuh. "Tapi, hanya dibutuhkan dalam jumlah kecil," ujarnya. Hanya ada beberapa gangguan yang muncul akibat kekurangan vitamin, tapi berlebihan juga bisa berbahaya.

Wati menjelaskan, kelebihan vitamin yang larut dalam air--vitamin B dan C--dapat membuat beban kerja ginjal berlebihan sehingga fungsinya terganggu atau menyebabkan penumpukan dan muncullah batu ginjal. Sedangkan kelebihan vitamin larut lemak--vitamin A, D, E, dan K--bisa membebani hati yang bisa memicu gangguan fungsi hati, problem pembekuan darah, serta keracunan vitamin.

Bayangkan bila kondisi tersebut harus dihadapi anak-anak akibat ia dijejali suplemen terus-menerus. Padahal, saat ini banyak ibu yang ingin anaknya doyan makan sehingga ia membeli suplemen khusus pendongkrak nafsu makan. Padahal, kata Wati, suplemen sejenis itu belum terbukti efektif meningkatkan nafsu makan. "Dalam dunia kedokteran, belum ada yang namanya perangsang nafsu makan," ia menegaskan. Lagi pula, suplemen bukan obat yang harus menjalani uji klinis sehingga kita tidak tahu persis efektivitas dan keamanannya.

Mayoritas ibu pun ingin anaknya memiliki daya tahan super sehingga membeli suplemen khusus yang diiklankan mempunyai kemampuan menaikkan kekebalan tubuh. Wati dengan tegas menyebutkan, tidak ada obat untuk sistem imun. "Kalau tidak, kan sudah digunakan buat (penanganan) HIV," ujarnya. Hal senada juga diungkapkan spesial anak dr Zakiudin Munasir dalam kesempatan berbeda.

Zaki menyebutkan, sistem kekebalan tidak bisa diatur dengan satu hal. Walhasil, anak itu tidak perlu diberi asupan untuk meningkatkan daya tahan tubuh karena yang penting ialah asupan bergizi dan seimbang. Kekebalan, seperti halnya organ tubuh lain, memerlukan modal untuk bekerja. Nah, sajian bernutrisi lengkap dan seimbanglah yang bisa mendongkrak sistem kerjanya. Wati pun menyarankan para ibu untuk menyediakan bahan-bahan makanan yang kaya vitamin dan berbagai zat yang berguna seperti tubuh, seperti serat, protein dan fitokimia. Ingat pula hasil penelitian American Academy Pediatrics (AAP) yang menyebutkan pemberian suplemen vitamin terlalu dini, justru dapat meningkatkan risiko timbulnya alergi dan asma pada anak. Walhasil, maunya anak selamat, malahan jadi menderita. Bukankah orang tua juga yang merana?

RITA

Gathering February

Undangan Pertemuan JPC Februari dilaksanakan pada:

Hari, Tanggal : Minggu, 15 Februari 2009
Jam : 09.00 - 11.00

Acara : Pertemuan Rutin JPC

Tema yang diangkat :
"MENDONGENG DENGAN ASYIK"
bintang tamu seorang pendongeng (nama masih di rahasiakan he he)

Tempat : Rumah Ibu Fitri Andyaswuri, perum minomartani, jl tengiri raya 15 Jogja.
(denah terlampir)

Semua ibu di undang ya....
ayoo ajakin moms yang lain
untuk yang belum pernah datang
dapat menghubungi Ibu Diani di (0274) 3224540
atau email dnajwa@gmail.com

pssstt..Insya Allah nanti ada doorprize...atau mungkin ada yg mau sumbang dp...di tunggu ya...

Denah rumah