Family planning facilities meet the challenge of Lunelle syringe recall

Clinics scramble to issue alert, provide backup contraception

If a large segment of your patient population is using the monthly contraceptive injection Lunelle, chances are that the last few weeks have been filled with contacting patients, answering questions, and counseling on backup contraception after the manufacturer issued a voluntary recall of prefilled syringes of the product.

Pharmacia Corp. of Peapack, NJ, issued the recall on Oct. 10, 2002, due to what the company terms "a lack of assurance of full potency and possible risk of contraceptive failure."

As many as 100,000 women could be affected by the recall, according to the Food and Drug Administration.

The affected lots of the prefilled syringes were manufactured at a Pharmacia plant in Belgium and distributed in the United States, Puerto Rico, and the U.S. Virgin Islands during 2002. Pharmacia was alerted to the problem after a provider reported a prefilled syringe appeared suspect and testing indicated it might not have full potency.

Pharmacia has instructed providers who have administered Lunelle prefilled syringes to contact all patients and recommend the use of an additional barrier method of birth control, such as condoms, diaphragms, or spermicides for pregnancy prevention until they begin use of another form of hormonal birth control. The company also is recommending that providers perform a pregnancy test for patients on Lunelle; Pharmacia is providing free pregnancy test kits for use with these patients.

At Contraceptive Technology Update press time, affiliates of the New York City-based Planned Parenthood Federation of America (PPFA) were notifying all patients who had received at least one injection of Lunelle since January 2002, according to Vanessa Cullins, MD, MPH, MBA, PPFA vice president for medical affairs. What has been the immediate response from patients? According to Cullins, most women have been concerned upon learning about the recall.

"Most patients’ immediate response is to learn what can they do to prevent unintended pregnancy and to ensure that they are not pregnant at the current time," she notes. While the manufacturer is providing free pregnancy test kits, each PPFA affiliate has been advised to make its own decision about charging fees, says Cullins.

PPFA affiliates have taken a three-pronged approach to notifying patients: first alerting those women who received a Lunelle injection in the past four to six weeks, then informing those who received a Lunelle injection in the past two to four months who could possibly be pregnant and may not know it, and then contacting those clients who used Lunelle sometime earlier in the year. 

According to Pharmacia, vials of Lunelle are not affected by the recall. The concentration of estradiol cypionate and medroxyprogesterone acetate contained in the vials is sufficient to result in expected contraceptive efficacy, the company states. However, manufacture of vials had been temporarily halted about the time the prefilled syringes became available, so supply of vials is limited, says Bryant Haskins, Pharmacia director of communications for global supply.

PPFA is recommending that its affiliates refrain from use of the vials due to the supply issue. With the number of vials in limited supply, affiliates would have to devise criteria on who should receive the monthly contraceptive shots, as well as determine how to allocate stock, all of which could prove problematic, notes Cullins.

Continuing to use vials to keep women on Lunelle also may result in a possible quality perception problem, since most providers will have moved to take women off Lunelle completely due to the syringe recall and low supply of vials, notes the PPFA. Women who continue to get shots may perceive — incorrectly — that they are receiving "bad" product, because the prefilled syringes were recalled, notes the PPFA. The national organization suggests that affiliates who continue to supply Lunelle shots from vials have patients sign release forms noting that they have been informed that the vials are unaffected by the recall.

Negotiations are under way with Pharmacia as to what costs will be reimbursed as a result of the recall. The company has announced it will provide free pregnancy kits and condoms, in addition to reimbursement on returned product. In the meantime, PPFA is instructing its affiliates to keep a strict accounting of all expenses incurred due to the recall, including office visits, birth control methods dispensed, emergency contraceptive pills dispensed, and administrative and mailing costs.

What are the options?

Use of Lunelle has climbed since its spring 2001 U.S. introduction. Three-quarters of 2002 CTU Contraceptive Survey respondents indicated their facilities offer the contraceptive option, up 15% from the some 60% of respondents who gave similar answers in the 2001 survey.

Pharmacia has not set a time frame for reinstating the product, says Caroline Bullock, company spokeswoman.

"We want to bring it back, but right now we are focusing on eradicating the manufacturing issues," states Bullock. "We are working as hard and fast as we can to address them."

In the meantime, how should providers proceed with women who have been using Lunelle as their chosen method of contraception? Some women may opt to use oral contraceptives for a couple of months until the product is reinstated, observes Susan Wysocki, RNC, NP, president and chief executive officer of the Washington, DC-based National Association of Nurse Practitioners in Women’s Health. As for condom use, she believes it is counterintuitive that those women who chose Lunelle for the convenience of a monthly injection would move toward the inconvenience of condoms.

Women who have chosen Lunelle for birth control have indicated their preference for highly effective, long-acting contraception, agrees Andrew Kaunitz, MD, professor and assistant chairman of the department of obstetrics and gynecology at the University of Florida Health Science Center in Jacksonville.

"I am therefore not sure that recommending that current Lunelle users should use backup barrier contraception until new supplies of Lunelle become available meets the contraceptive needs of all Lunelle users," comments Kaunitz.

Current Lunelle users affected by this recall also should be given the opportunity, following a negative urine pregnancy test, to immediately begin combination oral contraceptives or injections of depot medroxyprogesterone acetate (DMPA), he says. Inform potential users of combination OCs that scheduled withdrawal bleeding may not occur with the first pack of pills, Kaunitz advises.

Lunelle is expected to eventually return to the market.

"I do not believe that [the recall] is an indication that the method does not work," states says David Archer, MD, professor of obstetrics and gynecology and director of the Clinical Research Center at the Eastern Virginia Medical Center in Norfolk. "This is important to convey to the consumer." 

Resources

For more information on the Lunelle recall, providers can contact the Pharmacia medical information service, (800) 323-4204. Patients may call the Pharmacia patient information service, (888) 691-6813. In addition, information is posted on the product’s web site, www.lunelle.com.

The company’s letters to physicians, pharmacists, and wholesalers are available at the Food and Drug Administration Medwatch site, www.fda.gov/medwatch. Click on "Lunelle Monthly Contraceptive Injection." Instructions for returning recalled product are covered in the Oct. 10, 2002, "Dear Physician" letter from Pharmacia.

For questions regarding the return of recalled product, Pharmacia has instructed providers to contact Indianapolis-based NNC Group. Telephone: (866) 264-9233.

Pharmacia has announced it will supply condoms to providers to give to Lunelle patients free of charge, as well as free pregnancy kits for provider user. To request pregnancy test kits or condoms, providers should call (866) 264-9233.

Did you receive the e-mail about the Lunelle recall?

As a subscriber to Contraceptive Technology Update, you should have received an e-mail on Oct. 14 that gave you the news that Pharmacia Corp. had issued a voluntary recall of Lunelle prefilled syringes. If you’d like to receive future e-mails regarding news events about contraceptives, please contact customer service with your e-mail address. Customer service can be reached at (800) 688-2421 or customerservice@ahcpub.com.

Talking Points for Lunelle Recall

  • Pharmacia, the manufacturer of Lunelle, is voluntarily recalling all prefilled syringes of Lunelle. The company is taking this step because a production error may have resulted in insufficient dosing.
  • We are pleased that Pharmacia has taken a responsible, proactive approach to educating women and health care providers about the voluntary recall.
  • The possible dosage issue is not dangerous to women. However, to reduce the risk of unintended pregnancy, Lunelle users also need to use a barrier method such as male or female condoms. They also should keep their next monthly appointment to receive counseling on other birth control options.
  • Women have several other options for birth control. These include the ring, the patch and the intrauterine device — in addition to the Pill and condoms. Lunelle is expected to eventually return to the market.
  • We are working closely with Pharmacia to notify Lunelle users and counsel them about their birth control options.
  • Birth control is basic health care. It’s not just good pregnancy prevention, it’s good medicine.

Source: Adapted from information from Planned Parenthood Federation of America, New York City.