SOLE SOURCE for Availability of National Level Poisoning Data in the United States for the Identification and Understanding of Adverse Drug Reactions, and Medication Errors Associated with Therapeutic Products

The Food and Drug Administration intends to award a purchase order on a sole source non-competitive basis to American Association of Poison Control Centers (AAPCC). The title of the project is: Availability of National Level Poisoning Data in the United States for the Identification and Understanding of Adverse Drug Reactions, and Medication Errors Associated with Therapeutic Products

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The AAPCC shall provide following services:



1) Customized national level data on acetaminophen poisonings, for the years 2002-2007. Provide the following data elements in an electronic searchable format:



Number of acetaminophen-related poisonings - unintentional and intentional by year and the outcomes. Provide a second similar summary for prescription versus over-the-counter acetaminophen-related poisonings (if possible break up by single ingredient and combination products)

Number of acetaminophen-related poisonings - unintentional and intentional by age (65) by year

Number of and reasons for unintentional deaths in the database where acetaminophen was the primary agent, and names of other drugs used concomitantly, if applicable. Exclude the year 2002 for this analysis only.

provide case narratives

For the thousands of exposures to acetaminophen that had a major effect, provide the number that were from unintentional exposures, how many had evidence of having a serious liver events, and the number that received N-Acetyl-Cysteine (NAC)

Ranking of the number of unintentional and intentional acetaminophen poisonings compared to other drugs for the year 2007



Provide customized national level data on dosing cup errors, for the last 5 years (i.e., 2003 -2007) for the top ten products. Provide the following data elements in an electronic searchable format:

Age groups by 19 years

Proprietary Name

Active Ingredient

NDC number

Dosage form

Container size

Outcome

Reason for medication error

Regulatory Status (i.e., Rx vs. OTC)

Provide the following, if available:

Dose intended to be administered

Dose actually administered

Intervention made

Self administration or caregiver administration

Type of Device (i.e., cup, syringe, household measuring device, etc.)

Was the dosing cup supplied with the product or purchased separately?

Location of event (e.g. home or health care facility)

Provide the narratives of all cases



3). Provide customized national level data on the following types of medication error scenarios from 2003 to 2007 for the top ten products.

Incorrect dosing route

More than 1 product containing the same active ingredient

Incorrect formulation concentration given

Incorrect formulation concentration dispensed

10-fold dosing error

Health professional iatrogenic error



Provide the following data elements for each scenario in an electronic searchable format.

Age groups by 19 years

Proprietary Name

Active Ingredient

NDC number

Dosage form

Container size

Outcome

Reason for medication error

Regulatory Status (i.e., Rx vs. OTC)



Provide the following, if available:

Dose, route or concentration intended to be administered

Dose, route or concentration actually administered

Intervention made

Self administration or caregiver administration

Location of event (home or health care facility)

Provide the narratives of all cases



4.) Provide customized national level data on all calls classified as information pertaining to how to correctly dose a medication and dosing device for the most current year for top ten products. Provide the following data elements in an electronic searchable format:

Age groups by 19 years

Proprietary Name

Active Ingredient

NDC number

Dosage form

Container size

Outcome

Reason for medication error

Regulatory Status (i.e., Rx vs. OTC)

Provide the following, if available:

Dose prescribed

Self administration or caregiver administration

Reason for inquiry

Provide the narratives of all cases



5). Provide customized national level data on events related to unintentional, non-therapeutic, non-malicious (i.e. self-administered) exposure to drugs for single ingredient opioid products and and certain acetaminophen opioid combination product for 2007. Provide data only on cases where attribution to the opioid is either certain, likely, or where the opioid was the only drug found. Drug product trade names are not necessary. Provide the following data elements in an electronic searchable format:



Age groups by
Attribution/causation

Outcome (e.g. death, major, moderate, minor, and none) [Question: do you want fatality reports? If so, there is an additional cost of $500/ report)

Drugs

Oxycodone

Morphine

Codeine

Propoxyphene (Suggest removing: note there are only 132 single exposures in 2007 report. Suggest capturing this info through the APAP combination because 2,428 single exposures.)

Tramadol

Meperidine

Methadone

Pentazocine (Suggest removing: note there are only 101 single exposures in the 2007 report)

Provide the following, if available in the other/unknown category for opioids:

Fentanyl

Diphenoxylate

Hydromorphone

Buprenorphine

Butorphanol

Nalbuphine

Oxymorphone

Difenoxin

Levorphanol

Alfentanil

Sufentanil

Remifentanil

Drug combination with acetaminophen

Hydrocodone

Codeine

Oxycodone

Propoxyphene

Drug Formulation (e.g. lozenge, transdermal patch)

6). Management Plan requirements:

All data shall be HIPAA-compliant. No patient, health care professional, or health care organizations identifiers will be required by FDA. It shall be solely the Contractors responsibility to de-identify the data for FDA use.



As part of its regulatory activities, FDA will, at times, require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data the Contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures and form found in Appendices E and F.



The FDA shall continue to require the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period for the period of Option Year 2 (year 3 of the contract). During Option Year 2, FDA shall not require data access service, but will require the services of processing clearance requests.



After option year 2, the FDA will notify the contractor of the aggregated data release and accept the Contractors requested revisions, but will not require formal approval for release.



Ongoing standard technical, analytical, and clinical support by phone or by e-mail shall be available during business hours (9:00-5:00) throughout the length of the contract.



E-mail exchange between the Contractor and the FDA will utilize the FDA secure electronic mail system



A management plan shall include timeframes for completion for each data request.



Type of Contract



The government anticipates a firm fixed price contract with a one (1) year base and two (2) option years.



THIS IS NOT A REQUEST FOR PROPOSAL (RFP). However, sources may submit descriptive literature, fully documenting their capabilities, which will be considered by the agency. A determination to compete this procurement based on response(s) to this notice is solely within the discretion of the Government. The FDA intends to make an award soon after the response date of this notice. All inquiries must be received by 4:30 PM (1630) EST on September 3, 2009 to the attention: Patricia Wright via email: patricia.wright@fda.hhs.gov.