Safe Handling of Hazardous Drugs — Part 4: Medical Surveillance, Training, Reproductive Health, and Special Topics
Medical surveillance program design and components, biological monitoring, reproductive health counseling and alternative duty policies, training and competency assessment requirements, documentation and record-keeping, non-antineoplastic hazardous drug considerations, home administration guidance, and quality assurance.
12. Medical Surveillance Program
A medical surveillance program is a systematic approach to monitoring the health of workers who are exposed to hazardous drugs. The program serves multiple purposes: early detection of adverse health effects, identification of workers at increased risk, evaluation of the effectiveness of engineering and administrative controls, and documentation of exposure history for legal and regulatory purposes.1
12.1 Workers Who Require Medical Surveillance
Medical surveillance must be offered to all employees who handle hazardous drugs or work in areas where hazardous drugs are handled. This includes, but is not limited to:
- Pharmacists and pharmacy technicians who compound, dispense, or verify hazardous drug preparations
- Nurses who administer hazardous drugs or care for patients receiving them
- Physicians who administer or directly handle hazardous drugs
- Environmental services workers who clean HD handling areas or manage HD waste
- Shipping and receiving personnel who handle HD shipments
- Maintenance workers who service equipment in HD areas (BSCs, ventilation systems, plumbing)
- Research personnel who handle hazardous drugs in investigational settings
- Any worker who responds to HD spills
12.2 Medical Surveillance Components
Baseline Assessment (Pre-Placement)
A baseline health assessment must be completed before a worker begins handling hazardous drugs or working in HD areas. This establishes the worker’s health status prior to occupational exposure.2
| Component | Details |
|---|---|
| Health history questionnaire | Comprehensive medical and reproductive history; history of prior HD or chemical exposure; current medications; allergies; baseline symptoms review (skin, respiratory, reproductive, hepatic, renal, hematologic) |
| Physical examination | General physical examination with focus on skin (baseline dermatologic assessment), respiratory system (baseline pulmonary function), hepatic function, renal function, and reproductive system |
| Laboratory studies | Complete blood count (CBC) with differential; comprehensive metabolic panel (including liver function tests and renal function); urinalysis. Additional studies per clinician judgment based on history |
| Reproductive health assessment | Current pregnancy status (pregnancy test for female workers of childbearing potential, with informed consent); discussion of reproductive plans; baseline reproductive history |
| Exposure history documentation | Record of prior occupational exposure to hazardous drugs, radiation, or other genotoxic agents |
Periodic Surveillance
| Component | Frequency |
|---|---|
| Health questionnaire update | Annually — updated symptom survey, reproductive history update, review of any new health conditions or exposures |
| Physical examination | Annually or as clinically indicated based on questionnaire findings |
| CBC with differential | Annually; more frequently if baseline abnormalities or clinical indication |
| Comprehensive metabolic panel | Annually |
| Urinalysis | Annually |
| Symptom monitoring | Ongoing — workers should be educated to report new or worsening symptoms promptly (skin changes, respiratory symptoms, menstrual irregularities, unusual fatigue, persistent headaches) |
Post-Exposure Assessment
Following an acute exposure event (spill on skin, needlestick, eye splash, significant inhalation exposure):
- Immediate first aid (see Part 3, Section 9.5)
- Medical evaluation within 24 hours (preferably immediately) by occupational health or emergency medicine
- Exposure-specific assessment:
- Identify the drug(s) involved, route of exposure, estimated quantity, and duration
- Focused physical examination of the exposed area
- Laboratory studies as clinically appropriate based on the drug’s known toxicity (e.g., CBC if exposure to a myelosuppressive agent; liver function tests if exposure to a hepatotoxic agent)
- Biological monitoring (urine drug assay) if a validated assay exists for the implicated drug — obtain sample as soon as possible after exposure (within 24 hours; some drugs are cleared within hours)
- Follow-up assessment at 48–72 hours and again at 1–2 weeks, with additional follow-up as clinically indicated
- Documentation of the exposure and all follow-up in the worker’s occupational health record
Exit Assessment
When a worker permanently leaves a position involving hazardous drug handling:
- Updated health questionnaire
- Physical examination
- Final laboratory studies (CBC, metabolic panel)
- Documentation of total duration and estimated intensity of HD exposure
- Counseling regarding any ongoing health monitoring recommendations
12.3 Biological Monitoring
Biological monitoring involves the measurement of hazardous drug concentrations or their metabolites in biological specimens (typically urine) of exposed workers. This directly measures internal dose and can detect exposure that is not prevented by engineering controls and PPE.3
| Parameter | Details |
|---|---|
| Specimens | Urine is the preferred matrix; samples are collected at the end of a work shift or at the end of the work week for best sensitivity |
| Drugs commonly assayed | Cyclophosphamide (most common marker; validated urinary assay widely available), platinum compounds (urinary platinum as a marker for cisplatin/carboplatin/oxaliplatin exposure), methotrexate, 5-fluorouracil, ifosfamide |
| Analytical methods | LC-MS/MS (liquid chromatography–tandem mass spectrometry), ICP-MS (inductively coupled plasma mass spectrometry, for platinum), or equivalent validated methods |
| Interpretation | Any detectable level of a hazardous drug in the urine of a worker who is not receiving the drug therapeutically indicates occupational exposure. There are no established occupational exposure limits (OELs) for most hazardous drugs, so the goal is non-detectable levels |
| Frequency | Not routinely required in most jurisdictions; recommended as part of a comprehensive program at least annually for high-exposure workers, and after any known acute exposure event |
| Limitations | Negative results do not guarantee no exposure (the drug may have been cleared before sampling; the specific drug may not have a validated urine assay); positive results confirm exposure but do not quantify health risk |
12.4 Exposure Documentation and Record Retention
All medical surveillance records, exposure incident reports, and biological monitoring results must be maintained per applicable regulatory requirements:4
| Record Type | Retention Period |
|---|---|
| Medical surveillance records | Duration of employment plus 30 years (per OSHA medical records standard, 29 CFR 1910.1020) |
| Exposure incident reports | Duration of employment plus 30 years |
| Biological monitoring results | Duration of employment plus 30 years |
| Surface wipe sampling results | Per institutional policy; recommend retention for at least 5 years for trend analysis |
| Training records | Duration of employment plus 3 years (minimum); many institutions retain for duration of employment plus 30 years to match medical surveillance records |
| Spill reports | Per institutional policy; recommend retention for at least 5 years |
13. Reproductive Health Considerations
Occupational exposure to hazardous drugs poses specific risks to reproductive health. These concerns apply to both female and male workers and must be addressed proactively through counseling, alternative duty policies, and accommodations.5
13.1 Documented Reproductive Risks
| Risk | Evidence |
|---|---|
| Spontaneous abortion | Multiple studies have demonstrated an increased risk of spontaneous abortion among nurses and pharmacists who handle antineoplastic drugs without adequate protective measures, with odds ratios ranging from 1.5 to 3.5 in various studies |
| Congenital malformations | Some studies have reported increased rates of congenital malformations in offspring of workers exposed to antineoplastic drugs during pregnancy, although confounders make definitive causal inference challenging |
| Infertility | Both male and female infertility have been associated with occupational exposure to certain antineoplastic agents, particularly alkylating agents |
| Menstrual irregularities | Menstrual cycle disruptions have been reported among exposed female workers |
| Low birth weight | Some studies have associated HD exposure during pregnancy with lower birth weight in offspring |
| Ectopic pregnancy | Increased rates of ectopic pregnancy reported in some exposed populations |
| Male reproductive effects | Oligospermia, abnormal sperm morphology, and reduced fertility have been documented |
13.2 Institutional Policies for Reproductive Health
Every facility handling hazardous drugs must have a written policy addressing reproductive health, which should include the following elements:
- Disclosure of risk: All workers who handle hazardous drugs must be informed of the reproductive risks associated with occupational exposure during their initial training and annually thereafter
- Voluntary disclosure: Workers must be able to voluntarily disclose pregnancy, plans for conception, or breastfeeding status to their supervisor or occupational health without fear of retaliation or discrimination
- Alternative duty: The facility should have an alternative duty or temporary reassignment policy that allows workers who are pregnant, actively trying to conceive, or breastfeeding to be reassigned to duties that do not involve hazardous drug handling, without loss of pay, benefits, or seniority
- Timing of reassignment: Alternative duty should be available from the time the worker discloses pregnancy or intent to conceive and should continue through pregnancy and for a defined postpartum period (some institutions extend this through the breastfeeding period)
- Male workers: Alternative duty should also be available to male workers who are actively trying to conceive, as hazardous drug exposure can impair male fertility and may cause heritable genetic damage
- Confidentiality: All disclosures regarding pregnancy, fertility, and reproductive health must be maintained with strict confidentiality per applicable privacy laws
- Non-retaliation: Workers must not be subject to adverse employment actions for requesting alternative duty based on reproductive health concerns
13.3 Breastfeeding Considerations
Workers who are breastfeeding should not handle hazardous drugs, as absorbed drug can be secreted into breast milk. If alternative duty is not feasible, the worker should be informed of the potential risk so that an informed decision can be made.
14. Training and Competency Requirements
14.1 Training Program Requirements
All personnel who handle hazardous drugs or work in areas where hazardous drugs are present must receive training before initial assignment and at regular intervals thereafter.6
| Training Element | Content |
|---|---|
| Hazard awareness | What hazardous drugs are; the six criteria for classification; where the institutional HD list can be accessed; which drugs in the facility’s formulary are classified as hazardous |
| Health risks | Exposure routes (dermal, inhalation, ingestion, injection); acute and chronic health effects; reproductive risks; evidence base for occupational risk |
| Facility policies and procedures | The institution’s written HD handling policies; standard operating procedures for all HD activities; location and use of Safety Data Sheets; reporting requirements for exposures and spills |
| Engineering controls | Proper use of BSCs and CACIs (including airflow principles, not disrupting laminar flow, work placement); proper use of CSTDs (connection, transfer, disconnection); ventilation system awareness |
| PPE | Correct selection for each activity; proper donning and doffing sequence; glove change frequency; inspection for defects; disposal |
| Safe handling procedures | Receiving and unpacking; storage; compounding (sterile and non-sterile); administration by all applicable routes; patient care (body fluids, linen); transport |
| Spill management | Spill kit location and contents; small spill vs. large spill response; personnel exposure first aid; decontamination procedures; documentation |
| Waste disposal | Waste categories (trace vs. bulk; RCRA vs. non-RCRA); proper container selection; segregation requirements; prohibited practices |
| Medical surveillance | What the program includes; how to access occupational health services; requirement to report symptoms, exposures, and reproductive status changes |
| Reproductive health | Risks and alternative duty policy |
14.2 Training Frequency
| Training Type | Frequency |
|---|---|
| Initial training | Before first assignment to HD handling duties; must be completed and documented before the worker handles any hazardous drug |
| Refresher training | At least every 12 months |
| Update training | When new drugs are added to the institutional HD list; when procedures change; when new equipment is introduced; after a significant incident |
| Just-in-time training | Before performing an infrequent or high-risk activity (e.g., spill cleanup for a worker who rarely encounters spills) |
14.3 Competency Assessment
Training alone is insufficient — competency must be demonstrated and documented. Competency assessment should include:7
| Method | Application |
|---|---|
| Written examination | Assess knowledge of HD classification, health risks, policies, and procedures |
| Direct observation | Observe the worker performing HD activities (donning/doffing PPE, compounding technique, administration, spill response) using a standardized competency checklist |
| Simulation exercises | Simulated spill response drills to assess procedural knowledge and performance under stress |
| Return demonstration | Worker demonstrates proper CSTD use, BSC technique, and PPE sequence to a qualified assessor |
| Documentation | All competency assessments must be documented, including the date, the activity assessed, the assessor’s name and credentials, and the outcome (competent/requires additional training) |
Competency reassessment must occur at least annually and whenever a worker transitions to a new HD handling role or activity.
15. Documentation and Record-Keeping
15.1 Required Documentation
Comprehensive documentation is essential for regulatory compliance, quality assurance, legal protection, and program evaluation.8
| Document | Content | Responsible Party |
|---|---|---|
| Institutional HD list | All hazardous drugs in the facility’s formulary, organized by classification (Table 1, 2, 3 equivalent); review date; approval signatures | Pharmacy; safety committee |
| Assessment of risk | Written assessment per Section 3.1; updated annually or when significant changes occur | Pharmacy; safety officer |
| Standard operating procedures | Written SOPs for every HD activity (receiving, storage, compounding, dispensing, administration, patient care, spill response, waste disposal, decontamination, transport) | Pharmacy; nursing; safety officer |
| Training records | Names, dates, content covered, assessment results, instructor qualifications | Education/training department; department managers |
| Competency assessments | Per Section 14.3 | Department managers; competency assessors |
| Medical surveillance records | Per Section 12.4 | Occupational health |
| Exposure incident reports | Per Section 9.3, Step 8 and Section 12.2 (post-exposure assessment) | Occupational health; safety officer |
| Spill reports | Per Section 9.3, Step 8 | Safety officer; department where spill occurred |
| Surface wipe sampling results | Per Section 11.5 | Pharmacy; safety officer |
| Engineering control certification | BSC and CACI certification reports (every 6 months); pressure monitoring logs; HEPA filter change records | Facilities/engineering; pharmacy |
| Waste disposal records | Manifests, disposal certificates, waste vendor contracts and compliance documentation | Environmental services; safety officer |
| Respiratory protection records | Fit testing results (annual), medical clearance documentation | Occupational health; safety officer |
15.2 Audit and Review
| Activity | Frequency |
|---|---|
| Policy and SOP review | At least annually; after any significant incident; when regulations change |
| HD list review | At least every 12 months |
| Engineering control certification verification | Every 6 months (coinciding with certification) |
| Training completion audit | Quarterly (verify all active HD handlers have current training) |
| Waste disposal compliance audit | At least annually |
| Surface contamination monitoring | At least every 6 months |
| Spill response drill | At least annually; more frequently in high-volume areas |
| Medical surveillance participation audit | Annually (verify all eligible workers have current surveillance) |
| Comprehensive program review | At least every 2 years; should involve pharmacy, nursing, safety, occupational health, administration, and environmental services |
16. Non-Antineoplastic Hazardous Drug Considerations
Non-antineoplastic hazardous drugs (Table 2 and Table 3 agents) require hazardous drug precautions, but the intensity of those precautions can be adjusted based on the facility’s assessment of risk and the specific activity being performed.9
16.1 Risk-Stratified Approach
| Dosage Form / Activity | Handling Approach |
|---|---|
| Intact oral solid forms (tablets, coated capsules) — not manipulated | May be received, stored, and administered with a single pair of chemotherapy-tested gloves and without additional engineering controls, provided the assessment of risk supports this approach and the dosage form is not altered in any way |
| Intact oral solid forms requiring manipulation (cutting, crushing, dissolving) | Must be manipulated within a BSC, CACI, or other containment device; double gloves and gown required |
| Oral liquid formulations | Double gloves and gown; use containment measures to prevent spills; administration technique should minimize splash |
| Topical formulations | Double gloves; gown if application area is large or splash risk exists; educate patients about secondary exposure to caregivers |
| Parenteral formulations requiring compounding | Full engineering controls (BSC or CACI) and PPE as for antineoplastic agents |
| Parenteral formulations — administration of commercially available ready-to-use products | Double gloves, gown; CSTD use determined by assessment of risk |
16.2 Common Non-Antineoplastic HD Scenarios
Ganciclovir and valganciclovir: Genotoxic and teratogenic; frequently handled in transplant and immunocompromised patient settings. Intravenous ganciclovir requires compounding precautions. Oral valganciclovir in intact form may be administered with a single pair of chemotherapy-tested gloves per risk assessment, but must never be crushed or manipulated outside of containment.
Mycophenolate mofetil: Teratogenic; commonly used in transplant medicine. Oral capsules should not be opened. If a liquid formulation is needed, it should be prepared in a containment device. Workers who are pregnant should not handle this drug.
Finasteride and dutasteride: Teratogenic; capsules must not be handled by women who are pregnant or may become pregnant due to risk of absorption through skin causing abnormal development of male fetus genitalia. Use gloves for all handling.
Methotrexate (non-oncologic doses): Low-dose methotrexate for rheumatologic conditions is the same drug as antineoplastic methotrexate. Even at low doses, it meets HD criteria and requires appropriate handling. Intact tablets may be handled with gloves; injectable formulations require compounding precautions.
Ribavirin (aerosolized): Aerosolized ribavirin for treatment of respiratory syncytial virus (RSV) poses significant inhalation risk to healthcare workers. Administration requires:
- Negative-pressure room or room with specific engineering controls to prevent aerosol escape
- N95 respirator or PAPR for all personnel in the room
- Protective gown and gloves
- Minimize room entry during and for at least 2 hours after administration
17. Home Administration Considerations
Patients and their caregivers who administer or handle hazardous drugs in the home setting must receive comprehensive education on safe handling. The facility prescribing or dispensing hazardous drugs for home use is responsible for providing this education.10
17.1 Patient and Caregiver Education
| Topic | Key Points to Communicate |
|---|---|
| What hazardous drugs are | Explain that the medication requires special handling to protect the patient’s family and caregivers |
| PPE at home | Provide disposable chemotherapy-tested gloves; instruct on glove use for handling drug containers, oral medications, and topical applications; instruct caregivers to wear gloves when handling the patient’s body fluids during the excretion period |
| Oral medications | Do not crush, split, or chew unless instructed; handle with gloves; if the patient vomits shortly after taking the medication, clean up while wearing gloves and place materials in a sealed plastic bag |
| Topical medications | Apply with gloves or applicator; avoid skin-to-skin contact with caregivers; dispose of used applicators in sealed bags |
| Injectable medications (self-injection) | Use safety-engineered devices; place used syringes/needles immediately in a sharps container (not regular trash); return sharps containers to the dispensing facility or an authorized collection site |
| Body fluid precautions | Flush toilet twice with lid down for 48 hours after treatment; wash contaminated laundry separately, twice; wear gloves when handling soiled linen or diapers |
| Spills at home | Wear gloves; clean up with paper towels; double-bag and seal contaminated materials; wash the area with soap and water; contact the prescriber or poison control if a large spill or skin exposure occurs |
| Waste disposal | Return unused medications to the pharmacy or an authorized take-back program; do not flush (unless specifically instructed per FDA flush list); do not place in regular household trash |
| Storage | Keep out of reach of children and pets; store at appropriate temperature; keep in original container |
| Emergency contacts | Provide phone numbers for the prescriber, pharmacy, and poison control center |
17.2 Documentation of Home Education
The facility must document that the patient and/or caregiver received education on safe handling, including:
- Date of education
- Name of the educator
- Topics covered
- Understanding confirmed (teach-back or written acknowledgment)
- Written materials provided (the facility should provide a printed safe handling guide for the home setting)
18. Quality Assurance and Continuous Improvement
18.1 Program Performance Metrics
A comprehensive hazardous drug safety program should track the following metrics to evaluate effectiveness and drive improvement:11
| Metric | Target |
|---|---|
| Training compliance | 100% of HD handlers have current training documentation |
| Competency assessment completion | 100% of HD handlers have current competency documentation |
| Medical surveillance enrollment | 100% of eligible workers have completed baseline and current periodic assessments |
| BSC/CACI certification currency | 100% of units certified within the past 6 months |
| Respiratory protection fit testing | 100% of workers assigned N95 use have current annual fit test |
| Spill kit availability | 100% of designated locations have accessible, stocked, unexpired spill kits |
| Spill incident rate | Track and trend; target is reduction year over year |
| Exposure incident rate | Track and trend; target is zero preventable exposures |
| Surface contamination levels | Non-detectable or below institutional action level on wipe sampling |
| Waste disposal compliance | Zero instances of improper waste segregation per audit |
| Policy review currency | All SOPs reviewed within the past 12 months |
| Incident report completion | 100% of spills and exposures have a completed incident report |
18.2 Root Cause Analysis
Significant incidents (large spills, personnel exposure events, failed surface contamination testing, near-misses) should undergo root cause analysis (RCA) or a similar structured investigation to identify contributing factors and implement corrective and preventive actions.
18.3 Benchmarking
Facilities are encouraged to participate in multi-institutional benchmarking programs and to compare their surface contamination data, incident rates, and program metrics with peer institutions to identify best practices and areas for improvement.
19. Regulatory and Professional Standards Summary
The following table summarizes the major regulatory and professional standards that inform hazardous drug handling practices. Facilities must comply with all applicable standards in their jurisdiction.12
| Standard / Guideline | Issuing Body | Key Focus Areas | Enforceability |
|---|---|---|---|
| General Chapter <800> | National compounding standards organization | Comprehensive handling requirements: engineering controls, PPE, compounding, administration, spill management, medical surveillance, training | Enforceable in jurisdictions that adopt USP standards as law (majority of US states) |
| Hazardous Drug List | Federal occupational safety research institute | Classification criteria; three-table drug list (antineoplastic, non-antineoplastic, reproductive risk) | Informational — the list itself is not regulation, but is referenced by enforceable standards |
| OSHA General Duty Clause | Federal workplace safety agency | Employers must provide a workplace free from recognized hazards; applies to HD exposure | Enforceable — OSHA can cite employers for failing to protect workers from HD exposure |
| OSHA Technical Manual, Section VI, Ch. 2 | Federal workplace safety agency | Detailed guidance on HD handling; serves as the basis for OSHA compliance inspections | Guidance document; informs enforcement but is not itself a regulation |
| Professional pharmacy society guidelines | National pharmacy professional organization | Comprehensive handling guidelines for health-system pharmacists | Voluntary professional standard; may be adopted by institutional policy |
| Oncology nursing professional standards | National oncology nursing organization | Safe handling focus on nursing activities: administration, patient care, patient education | Voluntary professional standard; informs nursing practice standards |
| International oncology pharmacy standards | International oncology pharmacy professional body | Global standards for cytotoxic drug handling; particularly influential outside the US | Voluntary international standard |
| EPA/RCRA regulations | Federal environmental protection agency | Hazardous waste classification, storage, transport, treatment, and disposal | Enforceable federal regulation for applicable waste streams |
20. Summary of Key Requirements by Role
| Role | Primary HD Activities | Minimum PPE | Required Training Topics | Medical Surveillance |
|---|---|---|---|---|
| Pharmacist / Pharmacy Technician | Compounding, dispensing, verification, storage | Double gloves (change q30min), chemo gown, hair cover, shoe covers (per policy), surgical mask (aseptic) | All topics; emphasis on compounding, engineering controls, CSTDs | Yes — full program |
| Oncology Nurse | Administration, patient care, body fluid handling, spill response | Double gloves, chemo gown, eye/face protection (if splash risk), CSTD (administration) | All topics; emphasis on administration, patient care, spills | Yes — full program |
| Physician | Administration (some settings), prescribing | Double gloves, chemo gown when directly handling drugs | Hazard awareness, PPE for direct handling, exposure reporting | Yes, if directly handling HDs |
| Environmental Services | Cleaning HD areas, waste handling, spill response | Double gloves, chemo gown; full spill PPE for spill response | Cleaning/decontamination, waste segregation, spill response, PPE | Yes — full program |
| Shipping / Receiving | Receiving, unpacking, transport | Single pair chemo gloves (minimum); full PPE if damage suspected | Receiving procedures, damaged shipment response, PPE | Yes — baseline plus periodic |
| Maintenance / Engineering | BSC service, plumbing repair in HD areas, ventilation work | Per activity — double gloves and gown minimum; full PPE for BSC decontamination | Equipment-specific hazards, PPE, decontamination | Yes — baseline plus periodic |
| Patient / Caregiver (home) | Home administration, body fluid handling | Gloves (provided by facility) | Home safe handling education per Section 17 | N/A |
References
United States Pharmacopeia. General Chapter <800> Hazardous Drugs — Handling in Healthcare Settings. Section: Medical Surveillance. American Society of Health-System Pharmacists (ASHP). “ASHP Guidelines on Handling Hazardous Drugs.” Am J Health-Syst Pharm. 63:1172-1193, 2006. Updated 2018. Section: Medical Surveillance. ↩︎
Occupational Safety and Health Administration (OSHA). “Controlling Occupational Exposure to Hazardous Drugs.” OSHA Technical Manual (OTM), Section VI, Chapter 2. U.S. Department of Labor. Medical surveillance recommendations. National Institute for Occupational Safety and Health (NIOSH). “Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.” NIOSH Publication No. 2004-165 (NIOSH Alert). Medical surveillance components. ↩︎
Connor TH, DeBord DG, Pretty JR, et al. “Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers.” J Occup Environ Med. 52(10):1019-1027, 2010. Biological monitoring methodology. Turci R, Sottani C, Spagnoli G, Minoia C. “Biological and environmental monitoring of hospital personnel exposed to antineoplastic agents: a review of analytical methods.” J Chromatogr B. 789(2):169-209, 2003. ↩︎
Occupational Safety and Health Administration (OSHA). Access to Employee Exposure and Medical Records. 29 CFR 1910.1020. U.S. Department of Labor. Specifies 30-year retention for medical surveillance and exposure records. ↩︎
Dranitsaris G, Johnston M, Poirier S, et al. “Are health care providers who work with cancer drugs at an increased risk for toxic events? A systematic review and meta-analysis of the literature.” J Oncol Pharm Pract. 11(2):69-78, 2005. Fransman W, Roeleveld N, Peelen S, et al. “Nurses with dermal exposure to antineoplastic drugs: reproductive outcomes.” Epidemiology. 18(1):112-119, 2007. Lawson CC, Rocheleau CM, Whelan EA, et al. “Occupational exposures among nurses and risk of spontaneous abortion.” Am J Obstet Gynecol. 206(4):327.e1-8, 2012. ↩︎
United States Pharmacopeia. General Chapter <800> Hazardous Drugs — Handling in Healthcare Settings. Section: Personnel Training. Oncology Nursing Society (ONS). “Safe Handling of Hazardous Drugs,” 3rd ed. Pittsburgh, PA: ONS, 2018. Chapter on Education and Training. ↩︎
American Society of Health-System Pharmacists (ASHP). “ASHP Guidelines on Handling Hazardous Drugs.” Am J Health-Syst Pharm. 63:1172-1193, 2006. Updated 2018. Section: Training and Competency Assessment. International Society of Oncology Pharmacy Practitioners (ISOPP). “ISOPP Standards of Practice: Safe Handling of Cytotoxics.” J Oncol Pharm Pract. 13(Suppl):1-81, 2007. Training standards. ↩︎
Occupational Safety and Health Administration (OSHA). Access to Employee Exposure and Medical Records. 29 CFR 1910.1020. Hazard Communication Standard. 29 CFR 1910.1200. Record-keeping requirements applicable to hazardous drug programs. ↩︎
United States Pharmacopeia. General Chapter <800> Hazardous Drugs — Handling in Healthcare Settings. Section: Assessment of Risk — allows facilities to use professional judgment to adjust precautions for non-antineoplastic HDs based on dosage form and activity. The key principle is that intact dosage forms that are not altered may be handled with reduced precautions, while any manipulation that could generate aerosol or dermal exposure requires full containment. ↩︎
Oncology Nursing Society (ONS). “Safe Handling of Hazardous Drugs,” 3rd ed. Pittsburgh, PA: ONS, 2018. Chapter on Patient and Caregiver Education. International Society of Oncology Pharmacy Practitioners (ISOPP). “ISOPP Standards of Practice: Safe Handling of Cytotoxics.” J Oncol Pharm Pract. 13(Suppl):1-81, 2007. Section: Patient Information. ↩︎
American Society of Health-System Pharmacists (ASHP). “ASHP Guidelines on Handling Hazardous Drugs.” Am J Health-Syst Pharm. 63:1172-1193, 2006. Updated 2018. Quality assurance components. United States Pharmacopeia. General Chapter <800>. Sections on documentation and quality assurance. ↩︎
United States Pharmacopeia. General Chapter <800> Hazardous Drugs — Handling in Healthcare Settings. Enforceable in states that have adopted USP compounding standards into law or regulation. National Institute for Occupational Safety and Health (NIOSH). NIOSH Hazardous Drug List publications. Occupational Safety and Health Administration (OSHA). General Duty Clause, Section 5(a)(1) of the OSH Act. Environmental Protection Agency (EPA). Resource Conservation and Recovery Act (RCRA), 40 CFR Parts 260-272. ↩︎