GPP

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Hướng dẫn chi tiết quy trình mở nhà thuốc GPP
Chiến lược xây dựng nhà thuốc đạt chuẩn GPP
Phân biệt thuốc Generic và Biệt dược
Bí quyết tăng doanh thu từ khách hàng hiện thời – Bí kíp kinh doanh P.2

Các Nhà thuốc mở ra đều muốn hướng tới đạt chuẩn GPP, để việc thẩm định GPP thành công thì việc chuẩn bị rất quan trọng, sau đây là một số câu hỏi thẩm định Nhà thuốc GPP thường gặp như sau:

1. Hồ sơ Nhà thuốc

Dược sĩ Nhà thuốc cần chuẩn bị đầy đủ hồ sơ gồm các giấy tờ như:

  • Giấy Đăng ký kinh doanh gốc
  • Chứng chỉ hành nghề gốc
  • Hồ sơ nhân sự

2. Mô tả công việc của nhân viên

Chuẩn bị sẵn mô tả công việc của nhân viên.

3. Hồ sơ đào tạo?

Với câu hỏi này, Dược sĩ hãy lấy phần đào tạo ra cho đoàn kiểm tra xem, có luôn phần kế hoạch đào tạo, đánh giá đào tạo.

4. Quy trình thao tác chuẩn

  • Có bao nhiêu Quy trình?
  • Các phụ lục kèm theo SOP là phụ lục gì?

Trả lời: Thường Có 11 SOP (trong đó có 7 SOP bắt buộc) và phải nắm các phụ lục là các Sổ ví dụ như khi được yêu cầu xem “Sổ theo dõi đơn thuốc không hợp lệ…” phải biết phụ lục nằm trong SOP nào và lấy Sổ cho Đoàn xem. Đặc biệt lưu ý ” SOP thuốc kiểm soát đặc biệt” và Sổ theo dõi thông tin BN, mẫu báo cáo định kỳ của SOP kiểm soát ĐB.

5. Có được thay đổi thuốc trong đơn hay không? Ai là người có thẩm quyền?

Trả lời: Được, Dược sĩ Đại học có thẩm quyền.

6. Việc thực hành tốt Nhà thuốc hiện tại (Thông tư 02/2018/TT-BYT) khác trước đây điểm nào?

Trả lời: Có thêm phần thuốc kiểm soát đặc biệt, Nhiệt ẩm kế tự ghi, phần mềm kết nối mạng.

7. Đơn thuốc như thế nào là hợp lệ, không hợp lệ?

Trả lời: Theo thông tư 52/2017/TT-BYT, Đầy đủ tên họ, địa chỉ BN, bệnh lý kèm, ghi tên Genegic ( Tên thương mại) vd paracetamol (panadol) 500mg….và bên cạnh đó còn nhiều thứ nữa.

8. Quy chế kê đơn hiện tại thực hiện theo các thông tư nào?

9. Khi có đơn thuốc không hợp lệ thì nhân viên Nhà thuốc phải làm gì?

Trả lời: Dược sĩ điều hành liên hệ với người kê đơn, được quyền từ chối bán.

10. Làm sao phân biệt được thuốc kê đơn, không kê đơn?

Trả lời: Thông tư 07/2017 có kèm danh mục thuốc không kê đơn, các thuốc ngoài danh mục này đều phải kê đơn.

11. Nhiệm vụ Quản lý chuyên môn của Dược sĩ là gì?

Dược sĩ Nhà thuốc có nhiệm vụ:

  • Có mặt tại Nhà thuốc hoặc ủy quyền.
  • Giám sát hoặc trực tiếp tham gia bán thuốc kê đơn.
  • Liên hệ với bác sĩ kê đơn trong trường hợp cần thiết.
  • Thường xuyên cập nhật kiến thức chuyên môn.
  • Đào tạo hướng dẫn nhân viên quy chế, kiến thức chuyên môn.
  • Tham gia kiểm soát chất lượng thuốc khi nhập về và trong quá trình bảo quản tại nhà thuốc.
  • Hướng dẫn nhân viên theo dõi các tác dụng không mong muốn và báo cáo với cơ quan y tế.

12. Nhiệt độ độ ẩm tiêu chuẩn?

Trả lời: Nhiệt độ dưới 30 độ C, độ ẩm dưới 75%.

13. Trong quá trình hoạt động.

 Trong quá trình hoạt động, Nhà thuốc GPP cần đảm bảo:

Về các hồ sơ, giấy tờ:

  • Có hồ sơ, tài liệu hoặc máy tính để theo dõi dữ liệu liên quan đến bệnh nhân: Tên người kê đơn và cơ sở hành nghề; Đơn thuốc của bệnh nhân có đơn thuốc hoặc bệnh nhân cần lưu ý, đơn thuốc gây nghiện, thuốc tiền chất, thuốc hướng thần.
  • Có hồ sơ các nhà cung ứng thuốc có uy tín gồm: Bản sao Giấy chứng nhận đủ điều kiện kinh doanh thuốc, có danh mục các mặt hàng cung ứng, nhà cung cấp uy tín, đảm bảo được lựa chọn.
  • Lưu hóa đơn mua hàng hợp lệ.
  • Kiểm tra đối chiếu số lượng thuốc phải kiểm soát đặc biệt trên sổ sách và thực tế khớp.

Về quá trình mua bán thuốc:

  • Nhân viên nhà thuốc nắm được quy chế kê đơn và biết cách tra cứu danh mục thuốc không kê đơn.
  • Khi bán thuốc, người bán thuốc cần hỏi người mua các thông tin về triệu chứng bệnh, về tình trạng người sử dụng thuốc để tránh rủi ro khi dùng thuốc
  • Có kiểm tra đơn thuốc trước khi bán. Nếu đơn thuốc không hợp lệ, người bán thuốc có: Hỏi lại người kê đơn, Thông báo cho người mua,Từ chối bán
  • Khi bán thuốc, người bán thuốc cần tư vấn cho người mua: Lựa chọn thuốc phù hợp nhu cầu điều trị và khả năng tài chính. Cách dùng thuốc. Các thông tin về thuốc: Tác dụng phụ, tương tác thuốc, các cảnh báo. Hướng dẫn sử dụng thuốc vừa bằng lời nói, vừa ghi nhãn theo quy định.
  • Khi giao thuốc cho người mua, người bán thuốc có kiểm tra đối chiếu các thông tin sau: Nhãn thuốc; Chất lượng thuốc bằng cảm quan; Chủng loại thuốc.

14. Thực hành tốt bán lẻ thuốc (GPP) là gì? Mục đích?

  • Là bộ nguyên tắc, tiêu chuẩn trong hành nghề tại cơ sở bán lẻ thuốc
  • Nhằm đảm bảo cung ứng, bán lẻ thuốc trực tiếp đến người sử dụng thuốc và khuyến khích việc sử dụng thuốc hợp lý, an toàn và hiệu quả.

15. Căn cứ thực hiện GPP?

  • Thông tư 02/2018/TT-BYT ngày 22.01.2018 quy định về thực hành tốt bán lẻ thuốc

16. Căn cứ chấm điểm GPP?

  • Dựa trên CHECKLIST gồm 9 mục kèm theo TT 02

17. Hãy cho biết về diện tích, nhiệt độ và độ ẩm cần có theo chuẩn GPP của nhà thuốc?

  • Diện tích: tối thiểu 10m2
  • Nhiệt độ: không quá 30 độ C
  • Độ ẩm: không quá 75%
  • (Nếu độ ẩm vượt quá mức quy định phải tiến hành giảm độ ẩm bằng cách thông gió, chất hút ẩm…)

 18. Hãy cho biết cách ghi nhãn đối với bao bì ra lẻ đối với thuốc kê đơn và thuốc không kê đơn theo chuẩn GPP?

  • THUỐC KÊ ĐƠN (Rx) THUỐC KHÔNG KÊ ĐƠN (OTC)
  • Tên thuốc Tên thuốc
  • Dạng bào chế Dạng bào chế
  • Nồng độ /Hàm lượng Nồng độ /Hàm lượng
  • Liều dùng
  • Cách dùng
  • Số lần dùng /ngày

19. Các SOP cần thiết đối với nhà thuốc chuẩn GPP

– SOP về mua thuốc và kiểm tra chất lượng (*)

– SOP về bán thuốc kê đơn (*)

– SOP về bán thuốc không kê đơn (*)

– SOP về giải quyết với thuốc bị khiếu nại hoặc thu hồi (*)

– SOP về bảo quản và theo dõi chất lượng thuốc (*)

– SOP về đào tạo nhân viên nhà thuốc

– SOP về vệ sinh nhà thuốc

– SOP về quy trình ghi chép nhiệt độ, độ ẩm

– SOP về sắp xếp trình bày

– SOP về theo dõi tác dụng phụ của thuốc

(*): Bắt buộc

20. Phân biệt thuốc kê đơn và không kê đơn?

  • Thuốc kê đơn: Theo hướng dẫn số 1571/BYT-KCB
  • (Danh mục 30 thuốc kê đơn)
  • Thuốc không kê đơn: Theo thông tư 07/2017/TT-BYT ngày 03.05.2017 danh mục thuốc không kê đơn
  • (Có 243 hoạt chất)

21. Trong nhóm thuốc kê đơn cần lưu ý gì?

– Nhóm NSAID kê đơn trừ Aspirin 325mg với chỉ định giảm đau hạ sốt kháng viêm thì không kê đơn (nhưng với Aspirin 81mg với chỉ định chống huyết khối phải kê đơn)

Nhóm thuốc nội tiết tố kê đơn trừ thuốc tránh thai không kê đơn

Vaccin và sinh phẩm y tế kê đơn trừ men vi sinh không kê đơn

22. Trong danh mục thuốc không kê đơn cần lưu ý gì?

– Một số phối hợp với Pseudoephedrin, Ephedrin, Codein… phải kê trong sổ theo dõi

– Một số thuốc giới hạn ngày sử dụng (Omeprazol ≤14 ngày, Ranitidin ≤15 ngày…)

23. Nếu gặp đơn thuốc không hợp lệ thì phải làm sao?

– Hỏi lại người kê đơn (liên hệ trực tiếp với người kê đơn hoặc nói bệnh nhân trở lại nơi đã khám để sửa chữa, bổ sung cho đầy đủ)

– Thông báo cho bệnh nhân biết

– Từ chối bán

24. Đơn thuốc hợp lệ khi nào?

– Đơn thuốc đúng mẫu Thông tư

– Ghi đầy đủ nội dung đơn thuốc (Tên – Địa chỉ – Chẩn đoán – Tên thuốc – Dạng bào chế – Nồng độ/Hàm lượng – Số lượng – Cách dùng… Ký và ghi rõ họ tên người kê đơn)

– Đối với trẻ em dưới 72 tháng tuổi thì ghi số tháng tuổi và họ tên cha hoặc mẹ

– Đơn thuốc được kê chưa quá 5 ngày

25. Khi giao thuốc cho khách phải đối chiếu các thông tin gì?

  • Nhãn thuốc – Chủng loại thuốc – Số lượng thuốc – Hạn dùng – Chất lượng thuốc bằng cảm quan

26. Cách sắp xếp thuốc như thế nào?

  • Theo khu vực: Kê đơn – Không kê đơn – Thực phẩm chức năng…
  • Theo tác dụng Dược lý và điều kiện bảo quản ghi trên nhãn
  • Sắp xếp gọn gàng, dễ lấy tránh nhầm lẫn
  • FIFO (Thuốc nhập trước xuất trước), FEFO (Thuốc hạn dùng ngắn xuất trước)

27. Thuốc cận hàng dùng là như thế nào?

  • Có hạn dùng ≤ 6 tháng (Phải kiểm soát và ghi sổ hàng tháng)

28.  Bao nhiêu lâu kiểm tra chất lượng thuốc 1 lần? Kiểm tra như thế nào?

– Kiểm tra đột xuất và định kỳ ít nhất 3 tháng 1 lần

– Kiểm tra 100% thuốc có tại nhà thuốc, chú ý:

+ Các thuốc cận hạn

+ Thuốc dễ biến đổi chất lượng: Vitamin C, Aspirin, Thuốc nhỏ mắt, Dịch truyền…

29. Cách xử lý với bệnh nhân dị ứng thuốc?

  • Ngừng ngay thuốc đang sử dụng
  • Chuyển đến cơ sở y tế phù hợp để xử lý
  • Phối hợp với y tế địa phương làm báo cáo có hại của thuốc

30. Giải quyết đối với thuốc bị khiếu nại hoặc phải thu hồi

  • Tiếp nhận và lưu thông tin hoặc lưu các thông báo
  • Thu hồi và lập hồ sơ thu hồi, kiểm kê
  • Thông báo thu hồi cho khách hàng (đối với thuốc phải kê đơn)
  • Trả lại nơi mua hoặc hủy đúng quy định
  • Báo cáo các cấp
  • Lưu trữ vào sổ theo dõi

31. Khi phát hiện có thuốc khiếu nại hoặc thu hồi tại cơ sở ta phải làm gì?

  • Cho thuốc vào ngăn “chờ xử lý” , báo cho công ty hoặc nhà cung cấp thuốc để thu hồi, báo cho phòng y tế biết để nắm tình hình có thuốc bị thu hồi trên địa bàn

32. Tủ biệt trữ dùng để làm gì?

  • Để các thuốc hư hỏng vỡ, thuốc thu hồi, thuốc hết hạn dùng… và chờ quyết định xử lý

Cám ơn các bạn đã theo dõi bài viết của Thuocsi.vn. Chúc các bạn một ngày tốt lành.

NGUỒN: Sưu tầm.

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