CT/GC PDPT Distribution Program FAQ

What is the source for this FAQ?

The source for much of the information in this FAQ is the California Department of Public Health's "Patient-Delivered Partner Therapy (PDPT) for Chlamydia, Gonorrhea, and Trichomoniasis: Guidance for Medical Providers in California" (2012). For more information and to reference this document directly, please visit www.std.ca.gov.

Who can I contact if I have questions about my order?

If you have a question about your order, you can contact stdprograms@essentialaccess.org.

How can I change my order once I have already placed it?

Email stdprograms@essentialaccess.org with a detailed description of changes to the previously placed order. Essential Access Health will accommodate order modifications as necessary and/or appropriate.

Some PDPT medication expired before my clinic could use it. How should I account for expired medications?

The web-based CT/GC PDPT Distribution Program order form includes fields to indicate the number of chlamydia (CT) and gonorrhea (GC) doses that have expired at the ordering site since the last order was placed. Submit the number of expired doses on the order form next time you place an order for that site. Please dispose of the expired medications properly.

What if I do not have medication log data to submit with my order?

Medication log data is required to be submitted for every order placed by a Title-X funded clinic/local health jurisdiction (TXFC/LHJ) that has previously participated in the Chlamydia/Gonorrhea (CT/GC) PDPT Distribution Program. Medication log data is not required for TXFCs/LHJs that are placing their first CT/GC PDPT Distribution Program order. For TXFCs/LHJs requesting their first order, please indicate zero doses of free CT and GC medication currently in stock and indicate zero patients seen and zero doses dispensed since last order.

How do I submit medication log data?

Aggregate site-specific data, including medication log data, must be submitted online each time medication from the Chlamydia/Gonorrhea (CT/GC) Patient-Delivered Partner Therapy (PDPT) Distribution Program is requested. The web-based order form contains text boxes in which to enter and submit the data electronically. Do not email/fax medication logs to Essential Access Health.

Why must a license number be provided to register for the CT/GC PDPT Distribution Program?

Essential Access Health must submit the license number of the medical director or physician overseeing EPT/PDPT dispensing practices to the CT/GC PDPT Distribution Program’s medication repackager each time a clinic site or local health jurisdiction (LHJ) orders medication. The medication repackager maintains the CT/GC PDPT Distribution Program medication supply and upon Essential Access Health’s request, ships medication directly to the ordering clinic site or LHJ. A valid license number must be on file for the medication repackager to be able to ship medications to the clinic site or LHJ.

What is the 340B Drug Pricing Program and how do I enroll in it?

The 340B Drug Pricing Program requires drug manufacturers to provide outpatient medications to eligible organizations at significantly reduced prices. Only non-profit health care organizations that have certain federal designations or receive support from specific federal programs are eligible to enroll and purchase discounted drugs through the 340B Drug Pricing Program. These include Federally Qualified Health Centers (FQHCs), Ryan White HIV/AIDS Program grantees and specialized clinics such as STD Clinics and Title X Family Planning Clinics.

To participate in the 340B Drug Pricing Program, eligible organizations must register with the program and comply with all program requirements. Once enrolled, covered entities are assigned a 340B identification number that vendors verify before allowing an organization to purchase 340B discounted drugs for their eligible patients.

If you think your organization may be eligible for the STD 340B Drug Pricing Program, please contact Laura Douglas at laura.douglas@cdph.ca.gov.

Will I be held liable if a partner receiving PDPT has an adverse reaction to the drugs I provide?

Current legislation allowing patient-delivered partner therapy (PDPT) for sexually transmitted diseases (STDs) does not protect healthcare providers from lawsuits resulting from adverse outcomes related to the practice. However, this liability is no different from the liability of any other action taken by a health care provider. To date, the STD Control Branch has not received any reports of adverse reactions to PDPT medications.

Will PDPT contribute to antibiotic resistance at the population level?

Currently, there is no evidence to suggest that patient-delivered partner therapy (PDPT) leads to increased microbial resistance. However, PDPT should only be used for individuals who are unable or unlikely to be treated within a clinic setting.

Is PDPT appropriate as a first-line treatment approach?

Patient-delivered partner therapy (PDPT) is not appropriate as a first-line treatment approach. PDPT is intended to benefit individuals who would not otherwise seek timely clinical care.

Is there a limit to the number of doses of PDPT that can be dispensed / prescribed to a patient?

There is no limit to the number of doses of patient-delivered partner therapy (PDPT) medication a patient can receive to give to known sexual partners within the past 60 days. If the last sexual encounter was more than 60 days prior to diagnosis, PDPT can be given for the most recent sexual partner. See "Who are the most appropriate patients for PDPT?"

Why is there a patient treatment requirement?

Onsite sexually transmitted disease (STD) treatment for patients, through direct onsite dispensing (including direct observed therapy (DOT)) or at an onsite pharmacy, is important for participation in the Chlamydia/Gonorrhea (CT/GC) Patient-Delivered Partner Therapy (PDPT) Distribution Program.

This ensures that an STD-positive patient leaves the clinic site with treatment for themselves in addition to treatment for their sex partners. At clinic sites where patients receive PDPT for their partner but a prescription for their own STD treatment to fill at an offsite pharmacy, it is possible that patients will instead use the free medication from the CT/GC PDPT Distribution Program for their own STD treatment, rather than pick up their prescription at an offsite pharmacy. This practice reduces the opportunity to treat the sex partners with PDPT, therefore negating the intention, effectiveness and outcomes of Essential Access Health CT/GC PDPT Distribution Program.

Furthermore, onsite dispensing improves treatment compliance among STD-positive patients. A data analysis of chlamydia-positive patients enrolled in Family PACT showed that one-third of patients (33%) who received a prescription for chlamydia treatment did not fill their CT prescription; non-fill rates were higher among clients aged 18 and younger. (source: 1Douglas et al. “Are patients filling chlamydia treatment prescriptions? Using administrative data to validate treatment in California Title X clinics.” CDC STD Prevention Conference, June 2014.  Atlanta, GA.)

Providing medication to patients via DOT is considered a best-practice in STD care. If your agency or LHJ is interested in free resources to support onsite dispensing of STD treatment please contact stdprograms@essentialaccess.org.

How is PDPT medication given to patients?

The preferred method is to dispense patient-delivered partner therapy (PDPT) medication directly to the patient in a pre-packaged partner pack that includes medication, informational materials (available on the Resources page) and a clinic referral.

What about partners who are pregnant?

Although patient-delivered partner therapy (PDPT) is available for pregnant partners, providers should assess whether the pregnant partner is receiving pregnancy services or prenatal care. Every effort should be made to contact the pregnant partner and ensure appropriate care and PDPT should only be used as a last resort. The need of a test-of-cure (i.e., repeat testing three–four weeks after completing treatment) for chlamydia and gonorrhea during pregnancy should be emphasized. All three recommended PDPT regimens are considered safe in pregnancy. Doxycycline, a potential alternative to azithromycin for treating chlamydia, should not be used during pregnancy.

Can our clinic use PDPT medications to treat the patient?

Medication from the Chlamydia/Gonorrhea (CT/GC) Patient-Delivered Partner Therapy (PDPT) Distribution Program cannot be used to treat patients in the clinical setting.

Agencies and local health jurisdictions (LHJs) participating in the CT/GC PDPT Distribution Program may qualify for the federal 340B Drug Pricing Program, which allows eligible health care organizations/covered entities to purchase sexually transmitted disease (STD) treatment and other medications for their STD patients at a significantly discounted rate. See "What is the 340B Drug Pricing Program and how do I enroll in it?"

LHJs using the medication for other methods of expedited partner treatment (EPT), such as field-delivered treatment (FDT), are permitted to provide the medication to the patient as appropriate.

Who should not be given PDPT medication?

Patient-delivered partner therapy (PDPT) is not recommended for the treatment of syphilis or for patients who are co-infected with a sexually transmitted disease (STD) that is not treatable by PDPT medications. Partners with known severe allergies to antibiotics should not be given PDPT.

PDPT is not appropriate for cases of suspected child abuse, sexual assault, intimate partner abuse, or situations in which the patient’s safety is in question.

Caution should be exercised when providing PDPT for gonorrhea to partners of men who have sex with men (MSM) who have a known oral exposure. If provided in this circumstance, the need for a gonorrhea test-of-cure two weeks after treatment should be emphasized. Using PDPT to treat MSM may also increase the risk of missing a concurrent STD or HIV diagnosis, both of which are more common among MSM, and therefore should not be used as a first-line strategy for this population.

Is PDPT safe?

The 2012 California Patient-Delivered Partner Therapy (PDPT) Guidelines cite several research studies, including randomized clinical trials, that have demonstrated that expedited partner treatment (EPT), including PDPT, is safe. Such treatement is as effective as - or more effective than - other partner management strategies in facilitating partner notification and reducing recurrent infection.

Who are the most appropriate patients for PDPT?

The Chlamydia/Gonorrhea (CT/GC) Patient-Delivered Partner Therapy (PDPT) Distribution Program is for sex partners of patients diagnosed with CT and/or GC who are uninsured/underinsured, or would otherwise be unable or unlikely to seek timely care.

As PDPT for GC includes medications that may not be as effective in treating pharyngeal infection, caution should be exercised if providing PDPT for gonorrhea to men who have sex with men (MSM) who have indicated oral exposure risk. If provided in this circumstance, the need for a gonorrhea test-of-cure two weeks after treatment should be emphasized. PDPT may increase the risk of missing a concurrent STD or HIV diagnosis, and therefore should not be used as a first-line strategy.

Is PDPT legal in California?

Yes, patient-delivered partner therapy (PDPT) is legal. Since 2001, California law has allowed medical providers the option of using PDPT for treatment of sex partners of patients diagnosed with chlamydia. In 2007, California legislation was expanded to permit the use of PDPT for gonorrhea and trichomoniasis as well. PDPT is allowed through California Health and Safety Code §120582.