Manufacturer Bulk Patient Assistance Programs

A manufacturer bulk replacement program or PAP allows the pharmacy to maintain a segregated bulk supply of product(s) available for immediate dispensing. The program is largely governed by individual contracts with specific manufacturers. Contract with manufacturer will determine patient eligibility requirements. 

From a patient standpoint, the shipping time is eliminated when product is in stock at the pharmacy. On the pharmacy side, the pharmacy, rather than the manufacturer, accepts responsibility for verifying patient eligibility. Policies approved by the manufacturer include patient eligibility, acceptable forms of identification and income documentation, product receipt, storage, recall and destruction, and adverse event reporting. (See PAP policies) Patient and product dispensed information are usually reported monthly. Audits are annually, usually with one to two months preparation time to collect data for the auditor.

Though time consuming to manage, a bulk replacement program may be a valuable source of branded medication for charity patients, filling therapeutic gaps not available with generic meds.

Helpful tips for incorporating a bulk replacement program:

  • Record keeping and documentation are paramount 
  • Trained staff following manufacturer-accepted policies and processes make reporting and auditing easier 
  • Product labeling and dispensing are the same as other prescriptions from the pharmacy
  • Add the manufacturer as a third party in pharmacy software for reports 
  • Adapt pharmacy prescription software to provide other information needed for monthly reports, including provider state license number and patient FPL 
  • Segregate prescription pick-up or use other designation to ensure collection of all necessary signatures for monthly reporting and audits
  • Add alerts in pharmacy software and on prescription pick-up label for communicating with the patient about missing documentation or in need of renewing for next fill
  • Tag and store charts for patients utilizing the bulk program separately, reducing time tracking charts for eligibility documentation 
  • Use well trained students and/or volunteers in audit preparation.