Oregon has done it. California is in the process of implementing it. Tennessee, Colorado, Washington, Missouri and a number of other states are at least considering it.
“It” is a pathway to allow women to receive oral and/or transdermal contraceptives with a visit to the pharmacy rather than the physician’s office.
Addressing changes to prescribing and dispensing laws, Tim Tucker, PharmD, the former president of the American Pharmacists Association (APhA), noted, “The biggest, most important message here is patient access. Anything the provider – anybody who is part of the healthcare team: physician, pharmacist, nurse practitioner, physician assistant – can do to improve access is where we have to go in today’s environment.”
Tucker, who owns City Drug Company in the small western Tennessee town of Huntingdon, continued, “I want every patient who can to have an OB/GYN.” However, he added, that isn’t always feasible as a matter of insurance, geography and other issues impacting access. “This is an alternative where pharmacists can help the OB/GYN or PCP.”
He added these new laws help women who are trying to be proactive in preventing unintended pregnancies.
A similar mindset was behind a new prescribing law in Oregon that went live Jan. 1, 2016. Rep. Knute Buhler, MD, worked with colleagues and the Oregon State Board of Pharmacy to expand access to self-administered oral and transdermal birth control products by allowing pharmacists who meet mandated requirements to prescribe these hormonal contraceptives.
Oregon State University College of Pharmacy played a key role in helping pharmacists meet those requirements through the creation of an education and certification program.
OSU Pharmacy Instructor Lorinda Anderson, PharmD, who was instrumental in crafting and rolling out the certification program, said the Board of Pharmacy approached OSU even before the law was passed to ensure a robust educational platform would be in place. Physician members of the American College of Obstetricians and Gynecologists (ACOG) provided input for both the patient screening tool and pharmacist coursework.
“Not only does the training program incorporate the guidelines for eligibility criteria but also the Oregon Board of Pharmacy’s rules they put into place,” said Anderson, noting there is a procedural algorithm that walks through conditions and exclusion criteria that would require a patient be referred to a physician to obtain a prescription for contraceptives.
“I’ve been really happy with how the training has turned out,” Anderson said. “Mostly because pharmacists have come out of this feeling prepared and comfortable to do this (prescribe), which is exactly what we had hoped.”
Paige Clark, RPh, who leads professional development efforts for OSU’s College of Pharmacy and is a member of APhA, said about 350 pharmacists had already completed the course and passed the certification examination. “We expect to have 1,200 pharmacists certified and prescribing by the end of June,” she added, noting that approaches the halfway mark of retail pharmacists in just six months.
While it’s too early for hard numbers, Clark said from anecdotal evidence, “We are seeing a 90 percent prescription rate and a 10 percent referral rate, which is exactly what ACOG physicians would hope to see.” She added individuals with an increased risk of stroke, high blood pressure or who simply want to explore other birth control options would be among those referred to a physician.
“We found Oregon patients were so excited to be able to access this service,” said Clark. “This can dramatically increase the availability of hormonal birth control therapies to women in every county of Oregon.”
She added, “We’ve had such a smooth rollout due to a lot of folks pulling together in a robust way. Patients are happy. Physicians are happy, and our public health officials are thrilled beyond belief because we’re already making an impact.”
Clark called pharmacists an “untapped resource” and pointed to the five-fold increase Oregon has seen in immunization rates since involving pharmacists in the process. As for concerns that patients might skip physician visits for recommended screenings with birth control now available at the pharmacy, Anderson noted the Oregon law tried to address this issue. She said pharmacists are routinely talking to patients about the importance of those visits.
“After three years, if the patient doesn’t have evidence of having a woman’s healthcare clinical visit, then the pharmacist can no longer write a birth control prescription for them,” Anderson added.
Although ACOG would much prefer birth control pills be available over the counter, Tucker, who is also a past president of the Tennessee Board of Pharmacy, said he is opposed to that move. “I think it’s so very important with contraceptives that there is some oversight by a healthcare team member.” He added that without a prescription, it would be impossible to track usage habits and changes in health that might impact the effectiveness or safety of oral contraceptives. “If we fill a prescription, we have a profile and can have a patient history,” he pointed out.
Why ACOG Thinks Good Isn’t Great
ACOG’s opposition to pharmacy prescribing laws for birth control pills stems not from an effort to protect physician territory but rather the belief that access to oral contraceptives should be even more open.
“I think it’s a mistake to go in that direction because it still creates a barrier,” AGOG President Mark S. DeFrancesco, MD, MBA stated of the current wave of state laws putting oral contraceptive prescribing power in the hands of pharmacists.
In terms of the new Oregon law and others that might follow, DeFrancesco noted, "Although ACOG members participated in the development of the patient screening tool and the pharmacist training program, this should not be interpreted as ACOG support for this concept. Once the new law was a reality, ACOG members did assist with implementation in order to assure that appropriate guidelines were followed."
However, he continued, “We’d like to see unfettered access. ACOG’s policy is we don’t want anybody to be between the patient and the pill. We feel like it is time for it to be available over the counter. The pill has been out long enough to be proven extremely safe.”
DeFrancesco added that many OTC options – ranging from medications for pain relief to those addressing gastric issues – have at least as much, if not more, potential to harm certain patients than hormonal contraceptives. As with current OTC medications, he said, “The things that are absolute contraindications for the pill could be outlined on the label.”
He also noted that his patients who have a condition that prevents taking oral contraceptives such as migraines or deep vein thrombosis (DVT) are typically keenly aware of the fact. In addition, the physician pointed out unintended pregnancies can also carry health risks for patients, including those with high blood pressure. Furthermore, DeFrancesco said he believed it was a fair assumption that if the number of unintended pregnancies was reduced, the nation would see a drop in the abortion rate.
As for the argument that requiring a physician visit to receive a birth control prescription is the impetus to get women through the doors for annual health screens, DeFrancesco said, “We shouldn’t be holding patients hostage to the pill prescription.”
While he said he recognizes the claim might have some limited merit and that a small percentage of women might, in fact, skip their annual OB/GYN appointment, DeFrancesco said, “That puts the onus on us to explain that the annual visit is more than just a pap smear and pelvic exam.”
And, he continued, ACOG is promoting that broader practice message not only to women … but to their own members, as well. “It’s time physicians and women separate the pill from the annual visit,” DeFrancesco stated, adding there are already many women who no longer require contraceptives that continue to come for an annual exam.
DeFrancesco said he suspects laws allowing women to seek oral contraceptives and transdermal patches from pharmacists are well meaning in their intent to allow broader access to birth control. Whereas moving hormonal birth control options to OTC status would most likely require individual manufacturers to apply for such a change with the U.S. Food and Drug Administration, state legislative action on prescribing laws broadens the reach without reclassifying the drugs.
Yet, DeFrancesco fears, this halfway step might unconsciously prove to be diversionary, diminishing the push for truly barrier-free access. “In that sense, the good would be the enemy of the perfect,” he said. “We might settle … and that’s not good enough.”
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