Corpus ID: 74513859

European Association of Hospital Pharmacists (EAHP) Guidance on the Pharmacy Handling of Gene Medicines

@inproceedings{Vulto2007EuropeanAO,
  title={European Association of Hospital Pharmacists (EAHP) Guidance on the Pharmacy Handling of Gene Medicines},
  author={Arnold G. Vulto and Nicola S Stoner and Dip Clin Pharm and Ana Cerc{\'o}s and Torsten Hoppe-Tichy and Per Nydert and Andr{\'a}s Vermes and Andrea Wolfsberger},
  year={2007}
}

Tables from this paper

Clinical pharmacists’ services, role and acceptance: a national Swedish survey
TLDR
Clinical pharmacists’ patient-centred clinical pharmacy work in a clinical setting as part of the care team is well established, accepted and important. Expand
GMO Medicines and hospital pharmacy practice: a review
TLDR
Current literature concerning the management of GMO medicines in a hospital setting is explored and pharmacists need to be aware of the safety risks surrounding the use of GMOs and implement procedures to handle these medicines safely. Expand
Gene therapy and hospital pharmacy: the experience of the Hospital Pharmacy unit of L. Vanvitelli university hospital
TLDR
This example confirms the importance of close collaboration in a multidisciplinary team between hospital pharmacists, ophthalmologists experienced in the treatment of patients with hereditary retinal dystrophies and surgeons experienced in subretinal surgery to ensure the correct management of gene therapy with voretigene neparvovec, through compliance with shared operating procedures. Expand
Moving somatic gene editing to the clinic: routes to market access and reimbursement in Europe
TLDR
It is argued that alternative routes should be considered for products developed for a market of large groups of patients versus unique personalized treatments, and a balance between scientific evidence for safety and effectiveness, affordability, and fast access may demand a range of alternative solutions. Expand
Patients perspectives on drug shortages in six European hospital settings – a cross sectional study
TLDR
Although drug shortages led to serious medical consequences, the findings show that most of the patients did not perceive shortages as a problem and good hospital management practices by healthcare professionals helped to mitigate the perceived impact of shortages. Expand
Time spent by hospital personnel on drug changes: A time and motion study from an in-and outpatient hospital setting
TLDR
Investigating time spend by hospital personnel in a drug change situation when dispensing medicine to in- and outpatients in a hospital setting in the Capital Region of Denmark finds that implementing drug changes do require extra time, thus, hospital management should encounter this and ensure that additional time is available for the hospital personnel to ensure a safe drug dispensing process. Expand
Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing
Introduction: This article aims to identify best practices, improve risk controls, and aid regulatory agencies in developing guidance for environmental and biosafety risk assessment forExpand
Multi-stakeholder consensus on a target product profile for an HIV cure
TLDR
Three distinct therapeutic modalities for a target product profile for an HIV cure were identified and it was found that an acceptable cure need not be as safe and effective as optimally delivered antiretroviral therapy. Expand
Drug change: ‘a hassle like no other’. An in-depth investigation using the Danish patient safety database and focus group interviews with Danish hospital personnel
TLDR
Patient safety challenges related to DCs are identified and described to explore potential facilitators to improve patient safety in the medication process in Danish hospital setting, especially related to drug shortage. Expand
Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene–drug interaction of DPYD and fluoropyrimidines
TLDR
This guideline describes the starting dose optimization of three anti-cancer drugs to decrease the risk of severe, potentially fatal, toxicity (such as diarrhoea, hand-foot syndrome, mucositis or myelosuppression) and directs DPYD testing prior to initiating fluoropyrimidines. Expand
...
1
2
...

References

SHOWING 1-10 OF 15 REFERENCES
Appendix 6 : Gene therapy
  • Quality Assurance of Aseptic Preparation Services
  • 2006
Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust.
TLDR
Key elements were Trust-wide communication and involvement of staff in a pro-active approach to risk management, with specific emphasis on staff training and engagement, waste management, audit and record keeping. Expand
The risks of handling cytotoxic drugs
TLDR
Results of various biological and physical/chemical tests of the urines or blood of health-care personnel working with cytotoxic drugs are discussed and protective measures have to be taken in order to lower the risk as much as possible. Expand
Inactivation of adenovirus types 5 and 6 by Virkon S.
TLDR
It is shown that the level of organic content in the inactivation sample matrix has a significant impact on Virkon S activity, and it is proposed that Virk on S liquid decontamination procedures for adenovirus types 5 and 6 use 0.9% VirkOn S for contact times greater than five minutes. Expand
Inactivation of human adenovirus genome by different groups of disinfectants.
TLDR
The genomes of human adenoviruses show considerably more chemical resistance than the complete viral particle, and the molecular resistance of individual serotypes also varies, but there was no clear correlation between the differences in the effect of disinfectants on infectivity of thecomplete viral particle and destruction of the viral genome. Expand
Development of procedures to address health and safety issues in the administration of gene therapy within the clinical setting
TLDR
The aim of this paper is to highlight the procedures used throughout the clinical trial process, including storage, handling and disposal of the vectors, to minimize the health and safety risk to staff, patients and the environment. Expand
Gene therapy: applications to pharmacy practice.
Despite few clear-cut successes thus far, gene therapy holds great promise for easing or curing a wide variety of protein-deficiency disorders.
Hospital and Pharmacy Departmental Policies and Procedures for Gene Therapy at a Teaching Institution
TLDR
These preliminary guidelines identify the standards of practice at one institution in 1999 and will be refined as systems of practice develop, which exemplify the types of precautions necessary for safely utilizing gene therapy. Expand
Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets
Emergency management/Emergency preparedness; Emergency management/Emergency response; Terrorism and threats/Biological terrorism
Virucidal efficacy of a combination of 0.2% peracetic acid and 80% (v/v) ethanol (PAA-ethanol) as a potential hand disinfectant.
TLDR
The broad antimicrobial spectrum including a high virucidal activity, short exposure time and no toxic or allergenic decomposition products are favourable prerequisites for the medical use of PAA-ethanol and it warrants further investigation as a hand disinfectant. Expand
...
1
2
...