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TWI756789B - 醫藥針劑管理系統 - Google Patents

醫藥針劑管理系統 Download PDF

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TWI756789B
TWI756789B TW109128674A TW109128674A TWI756789B TW I756789 B TWI756789 B TW I756789B TW 109128674 A TW109128674 A TW 109128674A TW 109128674 A TW109128674 A TW 109128674A TW I756789 B TWI756789 B TW I756789B
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injection
information
medical
patient
pharmaceutical
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TW109128674A
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TW202209345A (zh
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何彥毅
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香港商智慧生醫材料有限公司
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Priority to TW109128674A priority Critical patent/TWI756789B/zh
Priority to US17/189,424 priority patent/US11455505B2/en
Priority to EP21164501.5A priority patent/EP3957294A1/en
Priority to JP2021093729A priority patent/JP2022035980A/ja
Priority to CN202110664389.XA priority patent/CN114078575A/zh
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Abstract

一種醫藥針劑管理系統，其中醫藥針劑管理系統用於追蹤一醫藥針劑之一藥廠製造端訊息、一物流運送端訊息和一醫院病人注射端訊息。該醫藥針劑包括一晶片組，該晶片組包括一識別標籤及一區塊鏈模組，該區塊鏈模組包括一運算晶片及一無線通訊晶片或通訊天線，藉此將該醫藥針劑的資料記錄於一區塊鏈網路。

Description

醫藥針劑管理系統
本發明係關於一種醫藥針劑管理系統，特別是一種可追蹤藥廠製造端訊息、物流運送端訊息和醫院病人注射端訊息且具有醫藥針劑之防偽、定位、溫控、可追蹤等功能之醫藥針劑管理系統。
不論是治療疾病、施打疫苗都需要使用醫藥針劑，為確保醫藥針劑的藥物活性與用藥安全，需要妥善的保存與運輸醫藥針劑並防止偽造、假藥、假針劑，目前仍未出現可追溯醫藥針劑的來源、儲存與運送歷程(從製造端到醫院醫師使用的歷程)的系統，因此，有必要提供一種醫藥針劑及醫藥針劑管理系統，其可以追溯醫藥針劑的來源、儲存與運送歷程，以並避免因運送溫度感控不良造成藥物或疫苗成分變質，而使得病人使用造成過敏或其他不良反應，進而能釐清責任在於製造商或物流運送商或是醫院注射儲存，同時有必要提供一套完整可追溯，將整體運送資訊，注射資訊及病人資訊，解決現有技術存在的問題。
本發明之主要目的係在提供一種具有防偽、可追蹤流通、定位、溫控歷程等功能的醫藥針劑管理系統。
為達成上述之目的，本發明提供一種醫藥針劑管理系統，用於追蹤醫藥針劑之流通歷程，醫藥針劑包括晶片組，晶片組包括識別標籤及區塊鏈模組，醫藥針劑追蹤系統包括標籤讀寫器，其係用以讀取識別標籤內之流通歷程或將流通歷程輸入識別標籤並透過區塊鏈模組將流通歷程資訊記錄於區塊鏈網路。本發明之醫藥針劑及醫藥針劑管理系統可追蹤醫藥針劑的製造來源、儲存與運送歷程，以加強病人與醫療院所的用藥安全，並可於醫療糾紛發生時，釐清因醫藥疫苗針劑之過敏、不良反應中之醫療糾紛相關責任，並提供問題醫藥疫苗針劑召回之程序與效率，提供醫療糾紛之責任歸屬釐清，確定責任端之歸屬為藥廠製造端、藥品物流端、醫院醫師端，做為藥害救濟時之依據，保障病人用藥之安全。
1:醫藥針劑
10:瓶本體
20:晶片組
21:識別標籤
22:區塊鏈模組
23:定位模組
200:針筒
30:蓋體
40:鋁封條
50:電池
120:管理伺服器
110:標籤讀寫器
400:醫藥針劑管理系統
300:區塊鏈網路
24:防偽模組
25:溫控模組
100:第三方機構
圖1係本發明之醫藥針劑之一實施例之爆炸圖。
圖2係本發明之醫藥針劑之一實施例之立體示意圖。
圖3係本發明之醫藥針劑之一實施例之使用狀態示意圖。
圖4係本發明之醫藥針劑管理系統之一實施例之硬體架構圖。
為能更瞭解本發明之技術內容，特舉較佳具體實施例說明如下。以下請一併參考圖1至圖4關於本發明之醫藥針劑之一實施例之爆炸圖、立體示意圖、使用狀態示意圖及本發明之醫藥針劑管理系統之一實施例之硬體架構圖。
在本實施例中，如圖1至圖4所示，本發明之醫藥針劑1包括瓶本體10、晶片組20、蓋體30、鋁封條40及電池50，其中晶片組20為一可撓式晶片，其係設置於瓶本體10，蓋體30覆蓋於瓶本體10，鋁封條40將蓋體30密封於瓶本體10。本發明之醫藥針劑1可盛裝一液體藥品，醫護人員可用針筒200刺穿蓋體30以便將液體藥品取出後注射至病患體內。在此須注意的是，本發明之醫藥針劑1可以是藥品或疫苗。
如圖1與圖4所示，本發明之晶片組20包括識別標籤21、區塊鏈模組22、定位模組23、防偽模組24以及溫控模組25，其中識別標籤21儲存醫藥針劑1之一藥廠製造端訊息、一物流運送端訊息和一醫院病人注射端訊息，區塊鏈模組22訊號連接識別標籤21與一區塊鏈網路300以便將藥廠製造端訊息、物流運送端訊息和醫院病人注射端訊息以及注射該醫藥針劑之病人的電子病歷記錄於區塊鏈網路300。根據本發明之一具體實施例，識別標籤21是射頻標籤(Radio Frequency Identification；RFID)或一近距離無線通訊(NFC)標籤，區塊鏈模組22包括一運算晶片及一無線通訊晶片或通訊天線，藉此將醫藥針劑1來源和歷程以及注射該醫藥針劑之病人的電子病歷記錄於區塊鏈網路300，藉由區塊鏈網路300可追溯且記錄不易被竄改的特性，來記錄並追蹤醫藥針劑1之藥廠製造端訊息、物流運送端訊息以及醫院病人注射端訊息。藥廠製造端訊息包括該醫藥針劑生產與製造訊息， 如：該醫藥針劑之國家藥品驗證號(NDC；National Drug Code)、序號、批號、效期等訊息。物流運送端訊息包括該醫藥針劑運送全程溫控紀錄、全程定位紀錄、物流車號資料、物流人員資料等訊息。醫院病人注射端訊息包括使用該醫藥針劑之醫療院所的名稱、注射該醫藥針劑之醫師、施打該醫藥針劑的時間、注射該醫藥針劑病人的資料、注射該醫藥針劑病人的出生年月日、注射該醫藥針劑病人注射時之生命徵象(如：血壓、心跳、呼吸、體溫、體重)、注射該醫藥針劑病人過去過敏反應、注射該醫藥針劑病人過去注射記錄、注射該醫藥針劑病人的家族病史、注射該醫藥針劑病人的現病史及基因序列。定位模組23是一全球定位系統(Global Positioning System)晶片，利用定位模組23對醫藥針劑1定位，以確定醫藥針劑1當下的位置並全程記錄運送過程與時間點的關係，確認運送時間之地點、行車軌跡的紀錄。在本實施例中，防偽模組24是一防偽標籤，溫控模組25是具有溫度感應功能的晶片，溫控模組25偵測並監控醫藥針劑1的溫度，藉此，可以監控醫藥針劑1是否處於適宜的溫度，以避免過熱的環境影響醫藥針劑1的藥物活性。根據本發明之一具體實施例，醫藥針劑1更包括電池50，電池50設置在瓶本體10並提供電力給晶片組20，以確保電力給晶片組20可以正常運作。
根據本發明之一具體實施例，本發明之醫藥針劑1可包括設置於晶片組20外表面之一二維條碼，以供病人或醫療院所掃描二維條碼後讀取該醫藥針劑的藥廠製造端訊息、物流運送端訊息和醫院病人注射端訊息，以確保病人注射疫苗或藥物針劑全程之安全與紀錄。
如圖1和圖4所示，根據本發明之一具體實施例，本發明之醫藥針劑1可與一區塊鏈網路300訊號連接，以便紀錄醫藥針劑1之一藥廠製造 端訊息、一物流運送端訊息和一醫院病人注射端訊息以及注射該醫藥針劑之病人的電子病歷，且一第三方機構100可透過區塊鏈網路300查詢醫藥針劑1之一藥廠製造端訊息、一物流運送端訊息和一醫院病人注射端訊息以及注射該醫藥針劑之病人的電子病歷。根據本發明之一具體實施例，第三方機構100包括藥廠、醫療院所以及trace-link®公司提供的供應鏈平台管理伺服器。根據本發明之一具體實施例，醫藥針劑1搭配一標籤讀寫器110使用而形成一醫藥針劑管理系統400，以便將醫藥針劑1的藥廠製造端訊息、一物流運送端訊息和一醫院病人注射端訊息輸入識別標籤21或讀取識別標籤21中醫藥針劑1的藥廠製造端訊息、一物流運送端訊息和一醫院病人注射端訊息，以管理並追蹤醫藥針劑1之一藥廠製造端訊息、一物流運送端訊息和一醫院病人注射端訊息，在本實施例中，標籤讀寫器110為一射頻標籤(Radio Frequency Identification；RFID)讀寫器或一近距離無線通訊(NFC)標籤讀寫器。根據本發明之另一具體實施例，標籤讀寫器110更可與管理伺服器120訊號連接，以便管理伺服器120將醫藥針劑1的藥廠製造端訊息、物流運送端訊息和醫院病人注射端訊息傳送至標籤讀寫器110，再利用標籤讀寫器110將藥廠製造端訊息、物流運送端訊息和醫院病人注射端訊息寫入識別標籤21，或管理伺服器120接收標籤讀寫器11讀取的藥廠製造端訊息、物流運送端訊息和醫院病人注射端訊息。根據本發明之一具體實施例，標籤讀寫器110可直接設於醫療院所、藥廠及trace-link®公司提供的供應鏈平台管理伺服器作為全球藥品供應鏈追蹤之資料，藉由標籤讀寫器110掃描識別標籤21讓醫護人員得知該醫藥針劑1之一藥廠製造端訊息、一物流運送端訊息和一醫院病人注射端訊息，以確保病人的用藥安全，並將醫院病人 端、注射端之訊息透過標籤讀寫器110寫入識別標籤21並上傳至管理伺服器120。此外，根據本發明之一具體實施例，注射該醫藥針劑之病人的電子病歷亦可上傳至管理伺服器120。
本發明之醫藥針劑1及醫藥針劑管理系統可管理並追蹤醫藥針劑的來源、儲存與運送歷程，以加強病人與醫療院所的用藥安全。本發明之醫藥針劑1滿足處方針劑標示最小銷售包裝，能提升供應鏈效率、排除非法偽藥、提升問題處方針劑召回之程序與效率，釐清醫療糾紛、藥物救濟之責任歸屬。本發明之醫藥針劑1及醫藥針劑管理系統400滿足處方針劑標示最小銷售包裝，能提升供應鏈效率、排除非法偽藥、提升問題處方針劑召回之程序與效率，釐清醫療糾紛、藥物救濟之責任歸屬。此外，藉由本發明之醫藥針劑1及醫藥針劑管理系統400可蒐集全球使用本發明之醫藥針劑1藥物/疫苗針劑注射病人病歷資訊，其係包括使用該醫藥針劑之醫療院所的名稱、注射該醫藥針劑之醫師、施打該醫藥針劑的時間、注射該醫藥針劑病人的資料、注射該醫藥針劑病人的出生年月日、注射該醫藥針劑病人注射時之生命徵象(如：血壓、心跳、呼吸、體溫、體重)、注射該醫藥針劑病人過去過敏反應、注射該醫藥針劑病人過去注射記錄、注射該醫藥針劑病人的家族病史、注射該醫藥針劑病人的現病史及基因序列，作為藥物疫苗針劑之大數據資料庫，提供疫苗/藥物與基因序列相關性之比對，將資料庫上傳，藥廠(製造端)、物流商(物流端)、醫院(醫師端)及第三方公正異地備份資料端之儲存分析，及病人個人注射針劑、電子病例之個人儲存，符合區塊鏈電子病例精神。
應注意的是，上述諸多實施例僅係為了便於說明而舉例而已，本發明所主張之權利範圍自應以申請專利範圍所述為準，而非僅限於上述實施例。
1:醫藥針劑
10:瓶本體
20:晶片組
30:蓋體
40:鋁封條
50:電池
120:管理伺服器
110:標籤讀寫器
400:醫藥針劑管理系統
300:區塊鏈網路
24:防偽模組
25:溫控模組
100:第三方機構
21:識別標籤
22:區塊鏈模組
23:定位模組

Claims (3)

  1. 一種醫藥針劑管理系統，用於一追蹤醫藥針劑之一藥廠製造端訊息、一物流運送端訊息和一醫院病人注射端訊息，該醫藥針劑包括一晶片組，該晶片組包括一識別標籤及一區塊鏈模組，該區塊鏈模組包括一運算晶片及一無線通訊晶片或通訊天線，藉此將該醫藥針劑的資料記錄於一區塊鏈網路，該醫藥針劑管理系統包括：一標籤讀寫器，其係用以讀取該識別標籤內之該藥廠製造端訊息、該物流運送端訊息和該醫院病人注射端訊息或將該藥廠製造端訊息、該物流運送端訊息和該醫院病人注射端訊息輸入識別標籤並透過該區塊鏈模組將該藥廠製造端訊息、該物流運送端訊息和該醫院病人注射端訊息記錄於該區塊鏈網路；其中該藥廠製造端訊息為該醫藥針劑生產與製造訊息，其係包括該醫藥針劑之國家藥品驗證號(NDC；National Drug Code)、序號、批號、效期；該物流運送端訊息包括該醫藥針劑運送全程溫控紀錄、全程定位紀錄、物流車號資料及物流人員資料；該醫院病人注射端訊息包括使用該醫藥針劑之醫療院所的名稱、注射該醫藥針劑之醫師、施打該醫藥針劑的時間、注射該醫藥針劑病人的資料、注射該醫藥針劑病人的出生年月日、注射該醫藥針劑病人注射時之一生命徵象、注射該醫藥針劑病人過去過敏反應、注射該醫藥針劑病人過去注射記錄、注射該醫藥針劑病人的家族病史、注射該醫藥針劑病人的現病史及注射該醫藥針劑病人的基因序列，該生命徵象包括血壓、心跳、呼吸、體溫及體重。
  2. 如請求項1所述之醫藥針劑管理系統，其中該標籤讀寫器為一射頻標籤(Radio Frequency Identification；RFID)讀寫器或一近距離無線通訊(NFC)標籤讀寫器。
  3. 如請求項1所述之醫藥針劑管理系統，其中該標籤讀寫器得與一管理伺服器訊號連接。
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勇奪百萬大獎，上海宜鏈將攜手螞蟻區塊鏈破解醫藥溯源難題，2019年10月10日/創業邦網站，https://www.mdeditor.tw/pl/p2Wq/zh-tw(最後點閱時間：2021年2月25日) *
秦曉峰，區塊鏈+醫療，解決醫藥溯源最後一公里監管難題，2019年09月30日/Odaily星球日報，https://twgreatdaily.com/qA2Ggm0BMH2_cNUgUevp.html(最後點閱時間：2021年2月25日) *

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