WHAT WE HAVE LEARNED?? ONCOLOGY CLERKSHIP GROUP B LIM KOK HAN

1. WHAT WE HAVE LEARNED?? ONCOLOGY CLERKSHIP GROUP B LIM KOK HAN MD HASHIMIE BADDRUDIN BIN MAT HASSAN SURESKUMAR A/L HARISKRISHANAN CHAI YEE YIEN CHUA SUE HOON NABILAH BINTI JAMALUDIN NIK NUR NASEELA FATHIN BINTI NIK MOHD SABRI NUR FADHILAH ARSHAD NUR HAIDAR BT AKBAR TAN SIN YEIN MOHAMAD SYAHIR BIN FADZIL MOHD JAUZE BIN KOMA RUDIN MUHAMMAD IMADUDDIN BIN CHE MOHD NASIR LECTURER: Assoc Prof Saad Othman

2. What I have learned??? By LIM KOK HAN (95298) Group B ONCOLOGY PHARMACY CLERKSHIP 2010

3. What I have learned about cleanroom? • A Cleanroomis"a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, e.g., temperature, humidity, and pressure, are controlled as necessary.“ • A “Cleanroom” is a controlled environment in which the concentration of airborne particles is controlled to specific limits- so that a desired level of cleanliness can be achieved. The level to which these particles need to be removed depends upon the standards required. • To control the contamination, the only way is to control the total environment. Air flow rates and direction, pressure, temperature, humidity etc. all need to be controlled carefully. The sources of these particles need to be controlled or eliminated whenever possible. These sources are facilities, people, tool generated, fluids and products generated. • Cleanrooms are planned and manufactured using strict protocol and methods. Cleanroomsare specifically used in many areas such as electronics, pharmaceutical, biopharmaceutical, medical device industries, operating rooms and other critical manufacturing environments, which need the product to be produced at certain level of “cleanliness”.

4. Cont… • Types is based on the airflow pattern, either • Horizontal • Vertical • Mixed • Classification based on the particles count in the room air • Clean room have to be evaluated based on some parameters such as air particulate count, air velocity / air changes, temperature, humidity, pressure differences in order to ensure all the controlling parameters are within the normal range.

5. KEY ELEMENTS OF CLEANROOM 1)HEPA FILTERS- These filters are important for maintaining contamination control. They filter particles as small as 0.3 microns with a % 99.9995 (H14) minimum efficiency. Used with central system or stand alone 2)AIRLOCK- An airlock is a passage which permits the people to pass from non-controlled environment to controlled environment and vice versa. 3)PASSBOX-Passbox is a device which enables objects, parts, tools and other work items to be passed to and from the cleanroom 4)PANEL WALLS, FLOORS, CEILINGS, LIGHTS etc :Made of non contaminant, dust proof materials

6. MAINTENANCE OF THE CLEANROOM • Maintenance of the cleanroom involves daily cleaning, weekly cleaning, and monthly cleaning, where all the cleaning work must be done properly based on the established standard cleaning procedure of cleanroom • Wearing proper equipment while handling the sample that require sterile environment is highly necessary (example: TPN product , cytotoxic drug-PPE must be worn)

7. Parameters need to be controlled • For example air particulate count here at clinical lab is done every 6 month & an acceptable result should shows that the Number of particles larger than 0.5 mcm should not be more than 10,000/ft3 or 350/l of air • The air velocity should be maintained at 0.45 m/sec ±20% Air changes should be more than 20 times/hour. • Temperature should be maintained at 18oC ± 2oC • Humidity should be maintained at 50% - 60% • Pressure differences should be maintained at 15 pascal or more

8. What I had learned at HPP?

9. CYTOTOXIC DRUG REQUEST FORM(HPP)

10. Example of real cytotoxic drug request * This is meant for educational purposes only…

11. Request form for cytotoxic drug reconstitution • Requested by the physician/doctor via a form(as shown) and to be sent to the CDR unit for screening and cytotoxic drug preparation • Pharmacist at CDR unit will do prescription screening from left right style. • In the request form, the physician(prescriber) has to fill up some of the details required, which includes: General information on patient demographic data Information about the requested drug(s)

12. 1)General information on patient demographic data that need to be filled by prescriber: • Chemo administration date: • Ward& Bed. No : • Patient’s Name & I/C: • Gender • Age • Weight(kg) • Height(cm) • BSA(m2)-to be calculated by the pharmacist based on patient’s weight and height • Diagnosis • Chemotherapy Protocol/Regimen • Interval: Days or Week • Cycle Number • Case : Old or New • *BSA formula used : (Body weight(kg) x height(cm)/ 3600)^0.5

13. 2) Information about the requested drug(s) need to be filled by prescriber based on the selected protocol • Name of the drug • Dosage & Frequency • Chemo Day • Route IVI/IVB • Diluent Final Volume • Duration(hrs) **At the bottom of this form, the prescriber must hand down their signature, name, chop(if any) and date the request has made

14. Particulars to be filled by the pharmacist in this form include • Reconstitution information -product batch no -no of ampoules/vial & strenght -reconstitution solution used & volume for cytotoxic drug that is available in powder form such cyclophosphamide -final volume of drug added -infusion solution used & volume : 2 types : 0.9% NS or D5W solution -expired date of final product

15. Cont..things to be filled by pharmacist 2) product information • -trade name/manufacturer • -batch no. • -expiry date Once the screening and all the particulars need to be calculated and written by the pharmacist have been completed, the pharmacist in-charge for processing this request need to hand down his/her signature, name and date it was done If there is any drug-related problem(s) detected in the cytotoxic request form, the pharmacist needed to contact the prescriber(the physician that make the order), inform them about the potential problems and recommend the intervention to be done. All form of communication between pharmacist and the physician regarding any changes to the prescription must be written in a box provided.

16. …. • Thus in regard to this request form, the pharmacist at Cytotoxic Drug Reconstitution(CDR) unit must provide the best pharmaceutical care to the patient which include the through screening on the prescription and check for any errors/discrepancies/doubtful • Thus, here screening process is still a part of the functions that pharmacist working at CDR unit . • To ascertain certain information and to clarify the values written, this prescription will be needed to be prepared by another pharmacist • Since this issue has involved pharmacokinetic formulas, thus as pharmacist we have to make sure that error is at minimal level while deliver the most effective drugs to the patient at safe recommended drug level.

17. THANK YOU… • Prepared by LIM KOK HAN • ( 95298) • ONCOLOGY PHARMACY CLERKSHIP 2010 • GROUP B

18. CDR CALCULATION MOHAMAD SYAHIR BIN FADZIL (UF 070007)

19. Patient’s Profile Name : ABC I/C : 07-5510 Gender : Male Weight : 63 kg Height : 123cm BSA :1.47m2 Diagnosis : Breast Cancer Protocol/Regime :FEC Chemo Administration Date : 29/9/2010 Ward & Bed No : C19 (In Patient) MOHAMAD SYAHIR BIN FADZIL (UF 070007)

20. FEC Regimens • All day 1 only • Recycle 3 weekly MOHAMAD SYAHIR BIN FADZIL (UF 070007)

21. Drug available in Penang GH. MOHAMAD SYAHIR BIN FADZIL (UF 070007)

22. Final Volume of Drug Needed 5FU Amount required in mg 600 mg/m2 x 1.47m2 = 882mg ≈ 880mg Volume need to withdrawn from vial stock solution = 880mg 1000mg = 17.6 mL ≈ 17.5 mL MOHAMAD SYAHIR BIN FADZIL (UF 070007)

23. Epirubicin Amount required in mg = 75 mg/m2 x 1.47m2 = 110.25mg ≈ 110 mg Volume needed to withdrawn from vial stock solution is 55 mL as shown in table below. MOHAMAD SYAHIR BIN FADZIL (UF 070007)

24. Cyclophosphamide Amount required in mg = 600mg/m2 X 1.47m2 = 882mg ≈ 880mg Volume needed to withdrawn from the vial stock solution = 880mg 1000mg = 44mL MOHAMAD SYAHIR BIN FADZIL (UF 070007)

25. Medical apparatus/devices used in the reconstitution of cytotoxic drugs Below are some of common apparatus used: • Syringe • Syringe filters/ Injection filter • Filter Straw • Vial’s spike/Vial’s adapter/ Reconstitution device • Needle • Vials • Ampoules • Bottle of infusion liquid such as normal saline, dextrose 5% • etc PREPARED BY: NABILAH JAMALUDIN

26. Syringe • It is a medical instrument used to inject or withdraw fluids • Types of syringes used in cytotoxic reconstitution: • Disposible syringes (three parts) luer slip • Disposible syringes (three parts) luer lock • Disposible syringes (two parts) • Packaging details: The syringes are packed individually in poly bag or blister package • Individual package is more easier to be handled as the syringe is sterilized. • The syringe that has been shown to us during clerkship is disposable syringes luer lock of 10 ml and 50 ml PREPARED BY: NABILAH JAMALUDIN

27. Available Size of Syringes Luer slip connector PREPARED BY: NABILAH JAMALUDIN

28. Luer lock PREPARED BY: NABILAH JAMALUDIN

29. PREPARED BY: NABILAH JAMALUDIN

30. Parts of syringe PREPARED BY: NABILAH JAMALUDIN

31. Needle • In cytotoxics reconstitution, needles is used to withdraw drug liquid from the vial • During clerkship, we have been shown the needles that been packed individually. Needle cap Luer connector PREPARED BY: NABILAH JAMALUDIN

32. Needle gauge: Indicates the diameter of the needle. • Various needle lengths are available for any given gauge • Available needle gauge: Range from 7 G (largest in diameter) to 34 G (smallest in diameter) needles PREPARED BY: NABILAH JAMALUDIN

33. Syringe Filter/Injection filter • Use: To filter the solution or liquids from particles • There are also available type that use to filter gases, and remove bacteria. • It needs to be attached at the end of a syringe for use. • The liquid is filtered by drawing it out from the syringe through the filter into vials, bottles, etc • Most common sizes available: 0.2 or 0.22 µm and 0.45 µm pores. Membrane diameters of 10 mm, 13 mm, 25 mm are common as well. PREPARED BY: NABILAH JAMALUDIN

34. It may have luer lock fittings at one side to fit into the luer lock syringe. It consists of a plastic housing with a membrane which serves as a filter. Luer lock connector PREPARED BY: NABILAH JAMALUDIN

35. Using filter syringes PREPARED BY: NABILAH JAMALUDIN

36. PREPARED BY: NABILAH JAMALUDIN

37. PREPARED BY: NABILAH JAMALUDIN

38. Filter Straw • Use: To withdraw and filter fluids from the ampoules • Only be used to withdraw not to inject out the liquid • It enhance patient safety by reducing the potential for glass particle injection • It is a flexible straw, which can be angled for easy use, is needle-free and latex free promoting personnel safety PREPARED BY: NABILAH JAMALUDIN

39. Size of the Filter straw Short Filter straw Filter hub Long Filter straw PREPARED BY: NABILAH JAMALUDIN

40. Vials • Varies types of vials, such as screwed neck vials, vials with snap cap, crimp neck vials etc with or without rubber septa for the closure. • Available size/volume for injection vials (crimp neck vials) to store the cytotoxics: 2 ml, 4 ml, 5 ml, 10ml, 25 ml and 50 ml • The vials can be used to store liquids or soluble powders like cyclophosphamide. PREPARED BY: NABILAH JAMALUDIN

41. Vial’s spike/Vial’s adapter/ Reconstitution device • Used for withdrawal or addition of drug’s fluid from or into the vials in the reconstitution process. PREPARED BY: NABILAH JAMALUDIN

42. Ampoules • Ampoules are made of glass (clear or amber) or plastic. • An ampoules may comes with a break point or a circular line around the neck for the ease of breaking it (the weakest point). • Available sizes: Ranges from 1 ml to 25 ml. Break line Break point PREPARED BY: NABILAH JAMALUDIN

43. Bottle of infusion liquid • For IV infusion administration, the cytotoxics is directly injected into the bottle of infusion liquid such as normal saline or dextrose 5% for reconstitution • This IV infusion bottle already equipped with the hook at the bottom for hanging purposes • Usually, the bottle contains 500 ml of infusion liquid. PREPARED BY: NABILAH JAMALUDIN

44. Roles of oncology Pharmacist In Hospital Pulau Pinang, oncology pharmacy service is divided into two subunit: Cytotoxic Drug Unit ( CDR unit ) Clinical Unit by CHUA SUE HOON

45. Roles in CDR unit: • Receive prescription • Screening prescription • Calculation • Drug reconstitution • Labelling • Teaching – mostly the undergraduated nurses or pharmacy students from the college and university. • Provide information to the ward • Monitor stock level • Provide safety talk to the personnel

46. In Clinical part, most of the oncology pharmacist involved in: • Monitoring, mainly sign and symptom of the patient. • Ward round • Counselling - providing information, advice and assistance to help patient for better adherence towards their treatment • Give suggestion to the doctor

47. In general, oncology pharmacist play a significant roles in cancer treatment patient. They not just dispensing the drugs but also valuable information throughout the therapy; including counseling of side-effect and management of proper handling technique.

48. Cytotoxic Drugs • Cytotoxic drugs has a toxic effect on cells. It is often used in the chemotherapy and management of cancer patient. • It may also produce unpleasant side effects such as nausea, vomiting, hair loss and suppression of bone marrow function.

49. Colour of Cytotoxic Drugs During the clerkship, we have been exposed to few of the chemotherapy drugs. The preceptor emphasizes us on the importance of knowing the color of chemotherapy drugs. Most of the chemotherapy dugs are colorless. There are only few drugs that have special characteristic that oncology pharmacist should take note of.

50. Anthracyclines group such as doxorubicin, epirubicinhave red color of solution. Besides, idarubicin have a slightly red-orange colors of solution.