10.2 Pharmaceuticals

Part II: Guidelines for Client Services and Clinic Management

  1. Prescriptive Methods for Transfer Clients:
  2. Pharmaceutical Purchasing and Inventory:
  3. 340 B Drug Pricing Program:
  4. Family Planning Cooperative Purchasing Program (FPCPP):

Delegate agencies must operate the family planning program in accordance with Federal and State laws relating to security and record keeping for drugs and devices.

The Illinois Title X Family Planning Program operates under the auspices of the Illinois Medical Practice Act. It is, therefore, the interpretation of the program that the physician must insure the patient is aware they have the option to have their prescriptive medications filled by a provider of his or her choice. It is further the interpretation of the IDHS that this does not require that a written prescription be extended to each client. Compliance is judged through standard DHS annual clinical evaluation measures including review of written protocols and direct observation of clinic practices.

The Medical Practice Act indicates that all persons licensed under this Act shall maintain a book or file of prescriptions as required in the Pharmacy Practice Act of 1987. This file has been determined to be the client's medical record. A separate file of the original written prescription is not required. Refer to Appendix I for DHS interpretation regarding prescriptive medications. The written prescription must include all standard prescription components.

 It is essential that each delegate facility maintain an adequate supply and variety of drugs and devices to effectively manage the contraceptive needs of its clients. A listing (formulary) of all drugs must be kept and annually revised. Purchase and use of generic drugs should be based on therapeutic equivalence as published by the FDA or in the Formularies of Therapeutic Equivalence accepted by the State Board of Pharmacy.

Delegates must have written protocols and operating procedures for the distribution, security and record keeping of all pharmaceuticals and supplies that include the following elements:

  • The medical director of the family planning program is responsible for all policies and procedures pertaining to the general handling of pharmaceuticals.
  • Prescription of pharmaceuticals is done under the direction of a physician as directed by the Medical Practice Act (who must have a drug control license to dispense medications). The physician may dispense indirectly under his/her delegated authority to a R.N. via standing orders or an APN via collaborative agreement and standard protocols. Pre-labeled, pre-packaged oral contraceptives may be distributed by trained staff, if so delegated by a dispensing prescriber.
  • All medications must be prepackaged. Refer to the Pharmacy Practice Act related to repackaging of medications.
  • All prescriptions vials/packages (including samples) must be labeled and contain the following information:
    1. Name/address of dispensing agency
    2. Date dispensed
    3. Name of client
    4. Name, dosage and quantity of drug dispensed
    5. Directions for use, including frequency of use
    6. Prescriber's name.
    7. Expiration date
    8. Lot number
  1. All clients must receive verbal and written instructions for each drug. The nature of drug education should be documented in the medical records.
  2. At a minimum, each site that provides medical services must have the following:
    • Emergency drugs and supplies for treatment of vasovagal reaction.
    • Emergency drugs and supplies for treatment of anaphylactic shock.
  3. There must be documentation that in-service education pertaining to the nature and safety aspects of pharmaceuticals is provided to staff involved in the provision of medications to clients.

Prescriptive Methods for Transfer Clients:

  1. Title X agencies are not allowed to operate as a pharmacy. Clients who received a full exam within the last six months at another provider, may request that records be sent to the Title X clinic. A new client history must be completed and an informed consent form must be obtained. If the client does not return for the next annual exam, the prescription may not be extended without a full annual exam by the delegate agency. If the clients' last exam occurred over six months ago, the client should be treated as a new client with clinical protocols followed accordingly.
  2. Delegate agencies must insure that all Title X education, counseling and clinical service requirements were met and provide any required services not documented in the records received from the previous provider. The clinician will review the transfer records and decide if current prescription can be continued. The clinician must document the prescription in the client's record.

Pharmaceutical Purchasing and Inventory:

The purchasing, inventory, supply and provision of pharmaceuticals may be delegated to an appropriately qualified health professional, however, all family planning staff members are to be trained in all aspects of pharmaceutical and supply distribution. Delegate policies for purchase, inventory and storage of pharmaceuticals must include the following:

  • Contraceptive and therapeutic pharmaceuticals must be kept in a secure place, either under direct observation or locked.
  • Access to pharmaceuticals must be limited to health care providers responsible for distributing these items.
  • A system must be in place to monitor the expiration date on drugs and ensure disposal of all expired drugs. Check with pharmaceutical companies to see if outdated stock may be exchanged.
  • A system must be in place for client notification in case of drug recall must be in place.

340 B Drug Pricing Program:

The 340B Drug Pricing Program resulted from enactment of Public Law 102-585, the Veterans Health Care Act of 1992, which is codified as Section 340B of the Public Health Service Act. Section 340B limits the cost of drugs to federal purchasers and to certain grantees of federal agencies. Significant savings on pharmaceuticals may be seen by those entities that participate in this program.

Delegate agencies contracted for family planning by IDHS are eligible to participate in the 340B Drug Pricing Program and benefit from reduced costs for supplies for their family planning program. IDHS Family Planning is directly responsible for sign-up with and notification to the Office of Pharmacy Affairs when there are clinic additions, moves, or deletions. IDHS must also forward written approval of new and moved sites to DHHS Region V prior to such notification by the delegate agency. See Appendix O for IDHS Policy and Procedure for 340B Drug Pricing Registration. Visit the 340B website at http://bphc.hrsa.gov/opa/howto.htm.

Family Planning Cooperative Purchasing Program (FPCPP):

The family planning purchasing cooperative has been in existence since 1992 and assists Title X funded agencies in managing their higher cost/higher usage products and services. The Cooperative strives to:

  • Maximize cost savings and increase participant buying power through combined purchasing contracts
  • Standardize specifications and encourage consistent quality in product availability
  • Provide a single location for vendor sales presentations, contract negotiations and general information.

Delegate agencies contracted for family planning by IDHS are eligible to participate in the Family Planning Cooperative Purchasing Program and benefit from reduced costs for clinical supplies, office supplies and other services for their family planning program. Delegate agencies must keep their address current with the FPCPP. For more information, visit the FPCPP website at http://www.fpcpp.org.

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