Presentation on theme: "SAFE HANDLING OF HAZARDOUS DRUGS"— Presentation transcript:
1 SAFE HANDLING OF HAZARDOUS DRUGS Presented byPh Waël ABI GHANEMChief PharmacistSaint George HospitalUniversity Medical Center
2 Hazardous DrugsCarcinogenicity in animal models, in patient population or both.Teratogenicity in animal studies or in treated patients.Fertility impairementGenotoxicity (mutagenicity)Evidence of serious organ, or other, toxicity at low doses.
3 Hazardous DrugsEach facility or hospital should create its own list of hazardous drugs based on specific criteria.Examples :All Antineoplastic agentsImmunosuppressant agentsAntiviral agents
4 Routes of Exposure Via the lungs (Inhalation) Via the digestive tract (Ingestion of contaminated food stuffs)Via the skin and mucous membranes (Mouth contact with hands)Via injection due to needle stick injuries
5 Possibility of Exposure Reconstituting powdered dugsAdministering hazardous drugsCounting uncoated oral dosesHandling unused hazardous drugsDecontaminating and cleaning drug preparation or clinical areasRemoving and disposing PPE
6 Types of toxicity Immediate : Delayed : Personnel involved in preparationPersonnel involved in administrationPatientDelayed :Personnel
7 Evidence of toxicity exposure Case reports in the literature range from skin-related and ocular effects to flu-like symptoms and headache.Reproductive studies on health care workers have shown an increase in fetal abnormalities, fetal loss, and fertility impairment resulting from occupational exposure.A study done by Sessink et al. estimated that Cyclophosphamide causes an additional 1.4 – 10 cases of cancer per million workers each year.
8 Evidence of toxicity exposure 39 year old pharmacist suffered episodes of painless hematuria and was found to have cancer (papillary cell carcinoma). 12 years before her diagnosis, she had worked full time for 20 months in a hospital IV preparation of Cytotoxics. She used a horizontal laminar flow hood. Because she was a nonsmoker and had no other known occupational or environmental risk factors, her cancer was attributed to her exposure to antineoplastic drugs.(Levin et al. 1993)
9 NIOSH ALERT 2004Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.
10 NIOSH ALERTWARNING!Working with or near hazardous drugs in health care settings may cause skin rashes, infertility, miscarriage, birth defects, and possibly leukemia or other cancers.
11 RecommendationsPolicies and Procedures for the safe handling of Hazardous Drugs must be in place for all situations in which these drugs are used throughout a facility.
12 Recommendations Protect and secure packages of hazardous drugs Developing a “Safety Program” with the following goals:Protect and secure packages of hazardous drugsInform and educate all involved personnel about hazardous drugsDo not let the drugs escape from containers when they are manipulatedEliminate the possibility of inadvertent ingestion or inhalation and direct skin or eye contact with the drug
13 Recommendations TWO GOALS: Maintaining physical integrity of packages Safe Handling Procedures
14 GOAL 1 : Maintaining physical integrity of packages Access to all areas where hazardous drugs are stored is limited to specific authorized staffA method should be present for identifying to personnel those drugs (WARNING LABEL )Methods for identifying shipping cartons required from distributorsWritten procedures for handling damaged packagesFacilities for storing hazardous drugs are designed to prevent breakageMethods for transporting
21 5- Rooms and Equipment (ct’d) B) Make ready roomMaterials needed for the preparationSolutions ready for dispatchC) Air LockOne roomTwo separate roomsWindows integrated in the doorSliding mechanism to open the window to the preparation room
22 5- Rooms and Equipment (ct’d) D) Preparation room (1)Room size : min 10 m²Height : min 2.50mWalls, ceilings and floorsCleanness of the roomE) Preparation room (2)Safety workbenchTwo way intercomStorage facilities for limited quantities of drugsCleaned seatingsWaste containersDecontamination kitPossibility of direct documentation of the preparation
23 F) Safety work Benches Biological safety cabinets (Ventilated
24 Biological safety cabinets (1) Different classes: I, II, IIIIsolatorsClass II : A,B1,B2,B3
25 Biological safety cabinets (2) A- DifferencesType II A : recirculating to the work roomType II B : outside exhaustB1 : exhaust 70 %B2-B3 : exhaust 100 %Hepafilters, UV lightsB-CertificationC-Cleaning : water for injectionD-Disinfecting : 70 % alcoholE-Decontamination
27 What is recommended?BSC Type II B Class B2 or B3Isolators
28 6- Personal Protective Equipment It is the third measure to be taken in addition to organizational measures and the technical equipment
29 Personal Protective Equipment A) Overall/Protective gownUsed for: compounding, administration, spill control, waste managementClosed up to neckLong sleeves with close-fitting cuffsLint freeLiquid repellentSingle-use
30 Personal Protective Equipment B) Single-use glovesTo be worn at all timesSuitable gloves or glove combinationsSterile, powder freeCriteria for selecting gloves:Material propertiesSize and fitSafety during use (grip)Tested for freedom from holesDetectability of any damageHealth of the personnel
31 Personal Protective Equipment C) Additional PPEEye & Face protection: Face shieldRespirators: Fit tested, based on OSHA standards.Shoe & Hair covering
35 7- Technical Equipment 3-layer work underlay Sterile compresses and swabsSingle-use syringesCannulas (needles)Container for discarded cannulasWaste containerClosed system, Drug-transfer devices (Mixing adaptor, phaseal,…)
36 8- Manipulative Procedures General Techniques (Use of luer-lock syringes….)Aseptic & Negative pressure TechniquesValidation:Rooms with respect of cleaning and hygieneCytostatics workbenchWork materialsStarting materialsAseptic Technique: Demonstration of Competence
39 9-Requisition of cytostatic solutions Requisition form:Name & genderBody weight, height and /or BSACytostatic prescribedDosageType of carrier solutionVolume of the ready-to-administer solutionRequired administration timeSignature of doctor, dateEtc….
40 10-Preparation A-Work Sheet for the Drug Name of cytostatic Kind and name of finished drug to be usedTypes and names of medical devicesMethod of proper preparationKind of packagingInformation on label
41 10-Preparation (ct’d) B-Documentation Time at which the preparation startedBatch number of the finished drug used ( cytostatics, solvents,..)Quantity of cytostatics usedUnusual incidents during the preparationName and signature of the personEtc…
42 10-Preparation (ct’d) C-Label Name of the pharmacy Name of the patient Ward, bed numberName and quantity of the cytostaticType and volume of carrier solutionMethod of administrationRequired time of administrationStorage conditionsDate of expiry
43 11- Administration General Recommendations IV Cytotoxic chemotherapy should be administered by nursing personnel who have received specialized education and training, and they should be able to demonstrate their competency on a regular basis.
44 11- Administration Oral Preparations PPE: Gloves, Gowns Number of tablets to be given should be shaken from the bottle into a medicine cup, without skin contact.Cytotoxic tablets and capsules must never be crushed, powdered or opened in any way, for ease of administration.
45 11- Administration IV Preparations PPE: Gloves, Gowns, Eye protection Staff should check the blood return in the catheter to confirm the patency prior to administration.On completion of administration, an appropriate solution should be infused to flush any remaining cytotoxic out of the line, then the line may be disconnected.
46 What to Check before Administration Review the Physician OrderRead the label on the infusion bag:Check for the name of the patientCheck for the name of drug (same as order)Check for the doseCheck for the Administration routeCheck for the rate of infusionCheck for any special handling conditions
47 What to Check before Administration Pre-Infusion parameters have to be metRequired laboratory testsEchocardiogramAll pre-medications are givenEtc…
48 Personnel Protection Strict adherence to safe working practices. Personal Protective EquipmentGown (of impermeable material)Gloves (the gloves must cover the gown on the wrist)MaskUse a new pair of gloves for each patient.Change the gloves if damaged or significant contamination occursAny cuts or scratches on the nurse’s hands should be covered with waterproof dressings to prevent infiltration of the site.
49 Personnel ProtectionNurses should take precautions to prevent skin contact with the Cytotoxic drug that they are administering without causing unnecessary alarm to patients.Always disinfect hands before the administration procedure.Wash hands with soap and water after finishing the drug administration.
50 General GuidelinesBe careful while giving injections in order to prevent extravasations.Be careful during the connection/disconnection of the bag or syringe to the administration device.Never remove the tubing from an IV bag containing a Cytotoxic drug, and don’t disconnect the tubing at other points in the system until the tubing has been flushed well with a non toxic solution.
51 12- Spill Management Policies & Procedures: To attempt to prevent spillsTo govern cleanup of spills (size, location,…)To define the responsibility of spill management
52 12- Spill ManagementA spill kit should be present at the nursing unit where administration takes place.The concerned personnel should be trained to the use of the kit.Do not forget to report any accidental spillage.
53 Decontamination Set-Spill kit Instructions for useEmergency signsSingle-use overall or gownOvershoesRespiratory protection maskProtective glovesDisposable clothesWater and ethanolWaste containersDocumentation forms
54 13-Waste ManagementCytotoxic waste is considered to be all those materials which have come into contact with cytotoxic drugs during reconstitution and administration:Syringes, needles, transfusion sets…Empty or partially used vialsPPEMaterials used for clean upAir filtersExpired drugs
55 13-Waste ManagementCytotoxic waste must be segregated, packaged and disposed of in a way that personnel and environment are not contaminated.Cytotoxic waste must be incinerated in a facility approved by an environmental protection authority.
56 Guidelines on hazardous drugs American society of health system pharmacists1985,19902005: guidelines on handling hazardous drugsNIOSH (Natl. Institutes of Occupational Safety and Health)2004:NIOSH Hazardous Drug AlertAppendix A: Sample listISOPP StandardsInternational Society of Oncology Pharmacy PractitionersOSHA (Occupational Safety and Health Administration)19861995: Controlling Occupational Exposure to Hazardous Drugs