New Pyrimethamine Dispensing Program: What Pharmacists Should Know

Pyrimethamine (Daraprim) is an antiprotozoal medication with activity against Toxoplasmosis and Plasmodium species.

It exerts its mechanism of action through dihydrofolate reductase inhibition and can affect the patient’s folic acid stores. Therefore, it is recommended that leucovorin be administered to prevent hematologic complications.

The 3 main uses of pyrimethamine are treatment of Toxoplasmosis, prophylaxis against Pneumocystis jirovecii pneumonia (PJP), and treatment of malaria. In combination with sulfadiazine, pyrimethamine is the first-line therapy for Toxoplasmosis infections. In combination with either dapsone or atovaquone, it is an alternative for prophylaxis against PJP in patients with HIV. And, in combination with a sulfonamide, pyrimethamine may be an alternative for the treatment of uncomplicated malaria caused by non-falciparum plasmodia, although this regimen is not preferred.

While pyrimethamine may be used as malaria prophylaxis in theory, widespread resistance precludes its use in most cases. A G6PD level should be checked prior to starting the patient on therapy.

Pyrimethamine is available as 25-mg tablets and is only manufactured by Amedra Pharmaceuticals. As of June 15, 2015, its method of distribution has changed, which may lead to some confusion and delays in therapy.

As pyrimethamine is a rather low-use medication, finding information about this new distribution program is rather difficult. Searching for “pyrimethamine” or “Daraprim” through Google, Yahoo, or Bing does not return any information on the new distribution model. Only by entering “Daraprim Direct” does the pertinent reference appear. Likewise, neither UpToDate nor Micromedex currently provide this information.

For inpatient procurement, institutions can no longer order from their general wholesaler. Instead, they must set up an account with the Daraprim Direct program. Once enrolled, orders may be placed with the company until 6 pm Monday through Friday and will be delivered the next business weekday, because there is no weekend delivery at this time. To place an order through Integrated Commercial Services, institutions may call 1-800-554-6919 or email at daraprimdirect@icsconnect.com.

For outpatient procurement, patients can no longer obtain the medication from their community pharmacy. All prescriptions must be transmitted to a single dispensing pharmacy: Walgreens Specialty Pharmacy. Upon insurance verification and co-pay collection, the prescription will be mailed to the patient’s home, and most prescriptions can be mailed overnight. Prescribers may contact Walgreens Specialty Pharmacy by calling 1-844-463-2727. The prescription and enrollment form can be downloaded from the Daraprim Direct website.

As pyrimethamine is now a single-source and specialty pharmacy item, the cost of the medication has increased. The sole manufacturer has a Patient Assistance Program in place that may help uninsured, non-Medicare Part D patients cover the cost of their prescription. The turnaround time to provide the medication to the patient may take up to 1 week. More information may be found on the Daraprim Direct website.

This new distribution model potentially introduces a new layer of complicity to the care of the Toxoplasmosis, PJP, or malaria patient, as it is not a common method of dispensing prescriptions.

For hospitalized patients, a prescription cannot be handed to the patient upon discharge to fill as normal. Foresight and coordination must be undertaken to ensure that the pyrimethamine prescription was sent to the Walgreens Specialty Pharmacy and delivered to the patient’s home on time.

For both inpatients and outpatients, consideration must also be given to the place where the other components of combination treatment are dispensed. Does the patient fill the sulfonamide/dapsone/atovaquone and leucovorin at a local pharmacy, potentially forgetting to fill them, or can all prescriptions be filled through the Walgreens Specialty Pharmacy?

My institution recently encountered a difficult scenario in which pyrimethamine was attempted to be obtained through the Walgreens Specialty Pharmacy. The patient in question was currently homeless, and therefore did not have a home or address to which the medication could be delivered. Additionally, the manufacturer did not yet have a system in place to address the situation.

This could have been extremely problematic, but fortunately, my institution is affiliated with a Walgreens Specialty Pharmacy and contracted to provide bedside delivery to patients prior to discharge. The patient was able to receive the pyrimethamine as an inpatient.

As the procurement and distribution of low-use medications such as pyrimethamine are streamlined to the single-source or specialty pharmacy model, communication with prescribers is key, and consideration of various patient scenarios is crucial to ensure that patients receive the medications they require without a delay in therapy.

Important Contact Information:

Manufacturer

Amedra Pharmaceuticals

Daraprim Direct Website

www.daraprimdirect.com

Walgreens Specialty Pharmacy

(Outpatient Prescribing)

Phone: 1-844-463-2727

Fax: 1-844-325-6537

Integrated Commercial Services Inc

(Inpatient Prescribing)

Phone: 1-800-554-6969

E-mail: daraprimdirect@icsconnect.com

References:

1. Pyrimethamine (Daraprim) Prescribing Information. Amedra Pharmaceuticals LLC. Horsham, PA. Oct 2014. [Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3e4d5027-7939-480f-ae19-82e764d9fa97 Accessed: July 16, 2015]

2. www.daraprimdirect.com. Accessed: July 16, 2015