Heparin Sodium Price Hike (BM)

(Bahasa Malaysia Translation)

Kebelakangan ini, harga cecair Heparin Sodium yang banyak digunakan didalam rawatan dialisis telah naik dengan mendadak. Untuk membantu kami memahami sebab-sebab kenaikkan harga ini, kami perlu meninjau kembali perstiwa-peristwa lampau tertentu.

Pada tahun 1986 penyakit “Bovine Spongiform Encephalopathy” atau juga dikenali sebagai penyakit “Lembu Gila” telah dikesan di UK. Punca penyakit yang dikesan ialah bijiran makanan ternakan lembu yang diimpot dari Europa telah dicampuraduk dengan cebisan daging lembu yang berjangkit digunakan sebagai protin tambahan. Manusia apabila makan daging lembu berjangkit itu akan dijangkiti penyakit yang dikenali sebagai penyakit “Creutzfeldt-Jacob”.

Pada tahun 2004, seramai 157 pesakit di UK dikesan telah dijangkiti penyakit ini dan telah menyebabkan industri berkaitan terjejas. Pada tahun 2005, 5 kes penyakit yang sama telah dikesan di AS dan oleh itu telah juga menjejaskan industri berkenaan di AS dengan teruk. Pada masa yang sama, terdapat ramai yang bimbang dengan pemcemaran produk-produk ternakan lembu dari AS dan Europa, khasnya cecair Heparin Sodium yang dipercayai boleh mengakibatkan penjangkitan penyakit tersebut.

Pembekal-pembekal di AS dan Europa mula mencari punca baru untuk bahan mentah Heparin Sodium yang membawa mereka ke Negara China. Heparin Sodium – Khinzir adalah punca baru Heparin Sodium sebagai penganti punca Heparin Sodium – Lembu yang telah dicemari di AS dan Europa.

Akan tetapi, dari November 2007 hingga Februari 2008 ratusan pesakit di AS dan Europa mengalami reaksi alahan akibat penggunaan Heparin Sodium – Khinzir berkenaan. Di AS seramai 81 kematian yang dikaitkan dengan penggunaan Heparin Sodium – Khinzir berkenaan telah dilaporkan. Banyak negara-negara lain yang mendapatkan bekalan Heparin Sodium – Khinzir dari pembekal-pembekal dari AS dan Europa juga mengalami masalah yang sama.

Penyiasatan pihak berkuasa AS (The Food and Drug Authority – FDA) telah mengesahkan bahawa pencemaran “over-sulphated chondroitin” adalah punca utama berlakunya reaksi alahan berkenaan. Pencemaran ini dipercayai berlaku kerana kekurangan bahan mentah Heparin Sodium – Khinzir ketika itu. Penyakit khinzir “Blue Ear” di Negara China pada masa itu telah menjejaskan bekalan bahan mentah berkenaan. Adalah dipercayai bahawa ketika itu, kerana keinginan untuk memenuhi permintaan pasaran atau sifat tamak mencari keuntungan berlebihan, bekalan dengan sengaja atau tidak sengaja telah dicemari.

Perstiwa ini telah menyebabkan FDA and pihak berkuasa kesihatan seluruh dunia mewajibkan pemeriksaan makmal tambahan dijalankan semasa pembuatan cecair Heparin Sodium.

Permintaan untuk bahan mentah berkenaan telah sekali lagi meningkat pada tahun 2009 dan dengan pelaksanaan tindakan memperketatkan pengawalan pengeluaran Heparin Sodium – Kindzir di Negara China, pengeluaran bahan mentah berkenaan melebihi 155% berbanding dengan tahun sebelum itu dan harga telah meningkat ke paras USD4,354/kg iaitu kenaikkan 100% berbanding dengan tahun 2008.

Ini telah menyebabkan tekanan yang sengit ke atas negara-negara pengeluar Heparin Sodium - Lembu yang tidak terjejas dengan penyakit “Lembu Gila” untuk memenuhi permintaan yang meningkat secara mendadak dan secara tidak langsung ia telah menyebabkan harga bahan mentah itu turut melambung tinggi.

Cecair Heparin Sodium yang lazim digunakan di Malaysia adalah dari lembu kerana sensitiviti Agama. Akan tetapi, pencemaran “over-sulphated chondroitin” tidak berlaku kepada Heparin Sodium – Lembu. Walaubagaimanapun, pihak berkuasa kesihatan Malaysia (KKM) telah mewajibkan pemeriksaan makmal untuk “over-sulphated chondroitin” dijalankan semasa proses pembuatannya sebagai tindakan proaktif.

Memandangkan permintaan tinggi dan bekalan terhad, berlakunya pencemaran dan sifat berhati-hati terhadap satu punca bekalan dan permintaan tinggi pada punca yang lain serta kos pemeriksaan makmal tambahan telah menyebabkan kos pengeluaran cecair Heparin Sodium – Khinzir dan Lembu turut melambung tinggi. Ini telah menyebabkan harga pasaran cecair Heparin Sodium Khinzir dan Lembu pun terpaksa dinaikkan.

Sila maklum bahawa harga cecair Heparin Sodium - Khinzir atau Lembu akan terus meningkat melainkan punca baru dan lebih murah dapat dikenalpasti.

Heparin Sodium Price Hike

Of late we have seen prices of injection Heparin Sodium mainly used in dialysis treatment has shot through the roof. To help us understand some of the reasons for the increase we need to go back in history.

In 1986 “Bovine Spongiform Encephalopathy” or Mad Cow Disease was first realized in the UK and subsequently traced to cattle food imported from Europe. Cattle food was contaminated with infected cattle parts which were added as a source of protein for the cattle. Humans were infected with the human variant of the disease known as the Creutzfeldt-Jacob Disease when they consume the infected beef.

By 2004, a total of 157 patients in the UK were confirmed to have died from the disease which also affected UK and Europe’s cattle and its related industries. In 2005, 5 cases of the dreaded disease were discovered in the US which also saw the decline of the cattle and its related industries there. There were real concerns then that contaminated UK, European and US cattle by-products may be infected with the said disease.

A search for a new source for raw Heparin Sodium has lead European and US suppliers to China in the form of Porcine Heparin Sodium. But between November 2007 and February 2008, hundreds of patients in Europe and US experienced allergic reactions to the Heparin Sodium and in the US a total 81 suspected related deaths were reported. Many other countries were also affected when they imported the alleged Heparin Sodium from the US and European suppliers.

The Food and Drug Authority (FDA) of the US investigations recorded contamination of “over-sulphated chondroitin” to be the cause. This contamination is alleged to have occurred due to the drop in supply of raw Porcine Heparin Sodium due to the “blue ear” disease which affected the Chinese pigs then. It is alleged that due to either the urge to make a quick buck or make up for slack in supply, the supply were adulterated, intentionally or unintentionally.

This incidence resulted in FDA and Health Authorities worldwide to carryout additional tests in the manufacturing of Heparin Sodium.

After corrective measures in placed in 2009 and due to increase worldwide demand, China’s export of raw Heparin Sodium rose 155% year on year. This saw the increase of the average price to USD4,354/kg, an increase of 100% compared with 2008.

This sharp increased saw a tremendous pressure exerted on suppliers of Heparin Sodium from non “Bovine Spongiform Encephalopathy” infected areas to meet the sudden increased in demand, this resulted in an uncontrollable spiral skywards prices too.

Due to religious sensitivity, the Heparin Sodium available in Malaysia is mainly from the Bovine source. However contamination of “over-sulphated chondroitin” does not affect Bovine Heparin Sodium. But as a precaution and as a regulatory requirement, the Malaysian Health Authorities (KKM) has made it compulsory for testing of “over-sulphated chondritin sulphate” for the manufacturing of injection Bovine Heparin Sodium.

Due to the high demand and shortage of supply of raw Heparin Sodium, the incidences of contamination and caution of one source and increased demand on another, and regulatory requirement to add additional tests for manufacturing have all contributed to the spiral increase of manufacturing cost of injection Heparin Sodium.

Be forewarned that prices of injection Heparin Sodium will continue to rise with the demand outstretched supply, until and unless new and cheaper source is identified.

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