PHARMACY INVESTIGATIONAL DRUG SERVICE FEES
Service
Initial Protocol Setup
Includes:
Protocol review and assessment of pharmacy involvement
Preparation of drug forms, labels, SMS inclusion drug entries
Development of dispensing guidelines
Attend start-up meeting with investigator and study sponsor
Preparation of pre- printed order forms if needed.
Setup Fee Low $500
May require minimal staff training; first shift M-F only, simple randomization
Setup Fee Medium $1000
May require staff training 24 hour, 7 days week, randomization
Setup Fee High Intensity $2000
May require staff training 24 hours, 7 days week, randomization, possible call in.
If special equipment needed may be additional costs. (i.e. -180 F, -70 F, -20 F freezers, or will need to be provided.
MAINTENANCE FEES CHARGED (Annual)
Inventory Maintenance Fees $500
Limited stock, small no of subjects, any compounding required, simple randomization, and limiteddispensing.
Low Intensity Inventory Maintenance Fees $600
Multiple stocks;compounding; no special preparation or equipment needed; procedural randomization
Medium Intensity Inventory Maintenance Fees $700
Chemotherapy, controlled substances, special preparation or equipment or storage required; extensive staff in-servicing; pharmacokinetic monitoring, requires 24 hour enrollment coverage
High Intensity Inventory Maintenance Fees $1000
Extensive specialized training, Extensive special requirements for storage, handling, preparation involving multiple personnel. On call personnel 24 hour coverage. (I.e. Cryogenic studies)
All Maintenance Fees Include:
Ordering study medication
Receiving study medication
Storage
Inventory record maintenance
Meetings with research monitors
Quality assurance checks
Collection, reconciliation of storage returns
Destruction of used or expired drug
Study close-out
NEGOTIABLE SETUP AND INVENTORY MAINTENANCE FEES
Medical Staff Studies in House with Limited Budgets
Oncology Group low funded Study (i.e., ECOG)
Dispensing fees:
High intensity Study $400 dose
High intensity $600 per dose
1. Weekends
2. After 3pm if staff call in required
3. If required greater than 2 hr will be an additional $100 per hour.
Dispensing fees all other studies:
Potential fees include
IV syringes $15.00 per dose
IV Bags < 250 ml $30.00 per dose
IV Bags >250 ml $40.00 per dose
Chemotherapy
IV Bags/syringes $40.00 per dose
Extemporaneous compounding $75.00 per hr + cost of materials not provided
Dispensing fee Oral $5.00 per dose
Dispensing fee Rx Oral for home $10.00
Special handling or preparation $50.00
Dispensing fee Physician office use $15.00
Investigator Initiated (M.D. Student, Resident) $15.00
Materials and medication not provided by investigator or sponsor may be obtained by special order at an additional cost.
Annual renewal fee $300
4/02/12db