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Since last fall, the oral contraceptive rated as the top choice of family planning clinicians has been unavailable in a preferred form of packaging. Contraceptive Technology Update readers, who named Philadelphia-based Wyeth-Ayerst Laboratories’ Triphasil as their pill of choice in the newsletter’s 1996 annual pill survey, say the problems surrounding the lack of Triphasil clinic packs have been compounded by the company’s failure to share information about the reasons behind the shortage. (For more on the annual pill survey, see CTU, October 1996, beginning on p. 117.)
Almost all family planning sources contacted by CTU chose to remain anonymous rather than endanger their working relationship with Wyeth-Ayerst, one of the largest OC manufacturers. In an era of managed care, cost containment, and shrinking budgets, these sources say they have to walk a fine line with manufacturers to get needed contraceptives at an affordable price.
"We’ve got three major companies to deal with: Wyeth, Ortho, and Upjohn," says one Western program coordinator. "They know they have a captive audience. We can’t jeopardize our relationship."
"The worst thing is that Wyeth has never said anything about this," says an administrator for a Northeastern family planning clinic. "The first clear answer we got was in January from our purchasing service."
Although a Wyeth-Ayerst representative tells CTU the company is optimistic that it will be able to supply Triphasil clinic packs by the end of the second quarter, many clinicians say there is no guarantee.
Patients depend on their providers for straight answers, observes one Iowa clinician. With no corporate information readily available from Wyeth-Ayerst, clinicians have found themselves at a loss for words when patients confront them about the Triphasil shortfall.
"A big problem for us is the issue of credibility," says Rose Brady, ARNP, health services coordinator for North Iowa Community Action, a private nonprofit agency in Mason City, IA. "When we say we can’t get Triphasil, we get asked, What do you mean, you can’t get it?’ and we have no good answer."
The shortfall of Triphasil clinic packs began affecting one Northern facility as early as last August, reports one nurse practitioner. It was termed "a supply and demand problem," followed by an inability to get supplies through the facility’s regional pharmacy. Staffers then had to dispense packs one at a time, rather than providing women with their normal six-month supply. Some patients opted to have their prescriptions filled at retail pharmacies to alleviate the hassle of coming to the clinic each month, but for many women, this option was a luxury they could not afford, the clinician says.
For those facilities who serve disadvantaged patients, clinic packs are a program mainstay. One Southeastern clinician said the availability of Triphasil retail packs has helped maintain pill regimens for low-income women.
"We have been able to get Triphasil, but mainly through a lot of OB-GYNs in the community who donate their packs to us," she notes. "It’s the only way we can keep patients on it who need it."
Not every clinic, however, has been able to count on such generosity. Since many patients already have limited access to health care, no pills mean no compliance, clinicians say.
"The bottom line is that we have a lot of patients at risk, who say they won’t switch, don’t take anything, and are sexually active," says one Northern clinic administrator. "If they were doing well on Triphasil, then they had to switch, they’re more likely to be noncompliant."
A relocation of manufacturing and packaging processes for a number of products, including those for Triphasil clinic pack packaging, caused the shortage, says Wyeth-Ayerst spokeswoman Audrey Ashby. While Triphasil clinic packs have been unavailable since November 1996, she says, supplies of retail packs have been unaffected because they are packaged at a separate location.
Wyeth-Ayerst is in the validation process with the U.S. Food and Drug Administration for a new manufacturing line for the clinic packaging, Ashby says.
"We are optimistic regarding our ability to supply product to our clinic pack customers in the late second quarter," she says, adding that the new production line is one of several steps the company is taking to improve the future availability of Triphasil clinic packs.
"We remain committed to providing effective contraceptive products to our clinic customers and appreciate their patience in this matter as we seek to improve our ability to meet their future needs," she says.
While Wyeth-Ayerst says it has tried to work with customers by offering to replace their Triphasil orders with the company’s Nordette or Lo/Ovral brands in the clinic packaging, many clinicians say that option has not solved the problem. Replacing Triphasil, a 30/40/30 mcg triphasic, with either of Wyeth-Ayerst’s two 30 mcg monophasic pills can be problematic for patients due to changes in the estrogen dosage, they explain.
Administrators who decided to substitute Wayne, NJ-based Berlex Laboratories’ 30/40/30 mcg triphasic Tri-Levlen or Raritan, NJ-based Ortho Pharmaceutical’s 35 mcg Tri-Cyclen found both products in short supply due to the uptick in demand caused by the Triphasil shortage.
"There has been a domino effect here," says one Western regional coordinator. "We’ve had people switch. Wyeth said to substitute with Nordette, which isn’t a triphasic. In our clinics, we try to offer a triphasic, a biphasic, a monophasic, and a mini-pill. When Triphasil became unavailable, some went to Nordette or switched to Ortho Tri-Cyclen. Then Ortho went on back order."
Another administrator confirms, "We’ve tried to switch to Tri-Levlen as a generic version, but you can’t get either pill."
For patients, switching estrogen/progestin formulations can cause side effects, clinicians say. "Some patients have breakthrough bleeding with Tri-Levlen," observes a Northern nurse practitioner. "Loestrin [by Parke-Davis in Morris Plains, NJ] is a good choice, but it’s more expensive. We have Ortho products at the clinic, and I could use Ortho-Cept, but there’s the blood clot issue, so I’m reluctant to move to it," says the nurse practitioner, referring to the blood clots that may be caused by Ortho-Cept’s progestin, desogestrel, the subject of several studies. (For details, see CTU, December 1996, p. 149.)
All other available choices offer 35 mcg of estrogen, which may be unsuitable for estrogen-sensitive patients, notes the clinician.
While North Iowa Community Action has experienced few patient problems in switching to Ortho Tri-Cyclen, clinicians have had to take extra time with patients to re-educate them about the new pill’s risks, benefits, and side effects, Brady says. Finding that extra time has proven tricky for many family planners. Many have spent time tracking down the problem with the Triphasil clinic packs, at a cost that is hard to recoup.
"My clinic manager has probably lost a total of three workdays in hours trying to sort through all this," says a Northern clinic administrator. "She’s lost an incredible amount of time, with her phone calls unreturned, etc. This is extremely prohibitive, given the fact that we’re a Title X grantee."