Hazardous Medicines: Hazardous Medicines: Current Issues & Future Current Issues & Future Challenges Challenges Graham Sewell Graham Sewell Professor of Clinical Pharmacy, Professor of Clinical Pharmacy, Kingston University Kingston University and and Assistant Director of Pharmacy, Assistant Director of Pharmacy, Plymouth Hospitals Trust Plymouth Hospitals Trust
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Hazardous Medicines: Current Issues & Future Challenges
Hazardous Medicines: Current Issues & Future Challenges. Graham Sewell Professor of Clinical Pharmacy, Kingston University and Assistant Director of Pharmacy, Plymouth Hospitals Trust. NIOSH Definition of Hazardous Drugs. Carcinogenicity - PowerPoint PPT Presentation
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Contamination detected in 75% pharmacy Contamination detected in 75% pharmacy and 65% administration areasand 65% administration areas
Pharmacy; highest levels on work surface Pharmacy; highest levels on work surface and airfoil of BSC and floor in front of BSCand airfoil of BSC and floor in front of BSC
Clinic; highest levels on floor by bedClinic; highest levels on floor by bed
Connor etal, Am J H-S Pharm (1999),56,1427Connor etal, Am J H-S Pharm (1999),56,1427
Isolators: Total Protection?Isolators: Total Protection?
Simulation in aseptic clean room, Simulation in aseptic clean room, Kingston UniversityKingston University
Experienced technicians, Experienced technicians, 25 batches over 4 days25 batches over 4 days
Sample before and after cleaningSample before and after cleaning
Cross-Contamination with Cross-Contamination with Biological Agents: A Real Risk?Biological Agents: A Real Risk?
““Meningitis due to iatrogenic BCG infection Meningitis due to iatrogenic BCG infection in 2 immunocompromised children”in 2 immunocompromised children”
Stone M Stone M et alet al N Engl J Med, 1995, N Engl J Med, 1995, 333333, 561, 561
Closed System for Cytotoxic Closed System for Cytotoxic HandlingHandling
Summary: Risk of ContaminationSummary: Risk of Contamination
Risk Risk isis real real
High frequency, low amountsHigh frequency, low amounts
Clear evidenceClear evidence
Contamination arises from drug vials, Contamination arises from drug vials, manipulation of drugs, isolator surfacesmanipulation of drugs, isolator surfaces
Risk of Equipment and Protection Risk of Equipment and Protection FailureFailure
Isolators become contaminated and Isolators become contaminated and contaminate product. contaminate product. Can we clean isolators?Can we clean isolators?
Isolators leakIsolators leak
How effective is Personal Protective How effective is Personal Protective Clothing (PPE)? Clothing (PPE)? Are they likely to fail to protect?Are they likely to fail to protect?
- Gloves?Gloves?
- Gowns?Gowns?
Cleaning Effectiveness: No. Wipes to Remove Drug (<LOD)
Test
Detergent
5-FU
(WFI)
5-FU
(N/S)
CP
(WFI)
CP
(N/S)
DOX
(WFI)
DOX
(N/S)
WFI 1 3 1 1 1 1
Criti-Klenz 1 1 1 1 2 2
CIP 150 1 1 1 1 3 3
CIP 100 1 1 1 1 2 2
Renu -Klenz 1 1 1 1 1 1
NpH-Klenz 1 1 1 1 1 1
Cage-Klenz 1 1 1 1 1 1
CIP 220 1 1 1 1 1 1
CIP 200CIP 200 1 1 1 1 1 1
IMSIMS 1 1 1 1 1 1
PPE : Are Gowns and Gloves PPE : Are Gowns and Gloves Effective ?Effective ?
Penetration study on 6 protective gownsPenetration study on 6 protective gowns
- 2/6 allowed penetration of 10 and 4 drug - 2/6 allowed penetration of 10 and 4 drug solutions over a 1 min test period solutions over a 1 min test period
- quality & comfort varied between gowns- quality & comfort varied between gowns
P. Scheepers , Nijmegen :P. Scheepers , Nijmegen :
Oncology nurses; 229 live births.Oncology nurses; 229 live births.
Reference group; 956 live births.Reference group; 956 live births.
Activity Odds RatioActivity Odds Ratio
Low Birth Wt. Cong. def.Low Birth Wt. Cong. def.
Caring/Nursing 1.8 1.4Caring/Nursing 1.8 1.4
Admin. chemo 1.4 1.8Admin. chemo 1.4 1.8
Prep. + Admin. 16.7 5.1 Prep. + Admin. 16.7 5.1
Pregnancy Category D or X Drugs in Pregnancy Category D or X Drugs in Current NIOSH AlertCurrent NIOSH Alert
USFDA
Category
No.
Agents
Definition
D 46
There is clear evidence of risk to the human fetus, but the benefits may outweigh the risk for pregnant women.
X 5
There is clear evidence that the medication causes abnormalities in the fetus. The risks outweigh any potential benefits for women who are pregnant.
Reproductive Outcomes Reproductive Outcomes (Health Care Workers)(Health Care Workers)
Endpoint No. Studies Pos/Total
No. Significant Studies
Spontaneous Abortions
4/5 2
Congenital malformations
3/4 2
Stillbirths 2/2 0(Dranitsaris et al, 2005)
Antineoplastic Drugs in Breast MilkAntineoplastic Drugs in Breast Milk
Detected in breast milk Cyclophosphamide Ifosfamide Cisplatin Doxorubicin Fluorouracil Methotrexate Gemcitabine
Not Recommended for nursing mothers Busulfan Chlorambucil Thiotepa Dactinomycin Epirubicin Ara-C
American Society of Health-System American Society of Health-System Pharmacists Guidelines (2006)Pharmacists Guidelines (2006)
“Until the reproductive risks (or lack thereof) associated with handling hazardous drugs within a safety program have been substantiated, staff who are pregnant or breast-feeding should be allowed to avoid contact with these drugs. Policies should be in effect that provide these individuals with alternative tasks or responsibilities, if they so desire. In general, these policies should encourage personnel to solicit recommendations from their personal physicians regarding the need for restricted duties. In the case of personnel actively trying to conceive or father a child, a similar policy should be considered, and a specific time period (e.g., three months) should be agreed upon. Legal counsel should be sought when establishing policies.”
Oncology Nursing Society Guidelines Oncology Nursing Society Guidelines (2005)(2005)
““Allow employees who are pregnant, actively trying to conceive, or breast-feeding or who have other medical reasons for not being exposed to cytotoxic agents to elect to refrain from preparing or administering those agents or caring for patients during their treatment with them.”
HSE GuidelinesHSE Guidelines“Employers must conduct a specific risk assessment after receiving the Med 3 [Medical Statement] and should take into account any medical advice you have been given. If risks are identified, which go beyond the level of risk found outside the workplace, but cannot be removed, employers should adjust the woman’s working conditions or hours. If there is still a risk, she must be offered suitable alternative work or if that is not possible, suspended on full pay for as long as is necessary to protect her and her child’s health.”
Conclusions Conclusions Evidence of risk of Evidence of risk of a) contamination and a) contamination and b) adverse health effects .b) adverse health effects .
Risks with new & biological agents requires Risks with new & biological agents requires greater understanding and research.greater understanding and research.Use simple, practical methods of control.Use simple, practical methods of control.Evaluate new technologies Evaluate new technologies e.g. Closed systemse.g. Closed systems
Recognise limitations of equipment and Recognise limitations of equipment and procedures procedures (e.g. cleaning)(e.g. cleaning)
Implement simple risk management and Implement simple risk management and validatevalidate
Key Information SourcesKey Information Sources
International Society of Oncology International Society of Oncology Pharmacy Practitioners Standards. Pharmacy Practitioners Standards. www.isopp.org
NIOSH Alert NIOSH Alert www.cdc.gov/niosh
MARCH Guidelines MARCH Guidelines www.marchguidelines.com