New Plan B rules cause confusion for NYC pharmacists

By Erick Arzate, Shemaiah Clarke, Miguel Diaz and Hunter Richards
with the staff of The Princeton Summer Journal

Confusion On The Morning AfterThis June, in response to a federal judge’s ruling, the Obama administration made the emergency contraceptive pill Plan B One-Step available over the counter to people of all ages and genders.

But an investigation by The Princeton Summer Journal revealed that the vast majority of pharmacists interviewed in New York City did not know about this recent change regarding the rules for access to Plan B One-Step, the most common “morning-after” pill.

Of 49 pharmacists interviewed Wednesday in Manhattan, Brooklyn, Queens and the Bronx, only 16 were even aware that Plan B One-Step was now available to everyone without age or point-of-sale restrictions.

And of those 16 pharmacists, only 11 were actually selling Plan B One-Step without any restrictions. Several of the pharmacists interviewed said they were still enforcing the now-defunct age restrictions and cited lack of guidance from the Food and Drug Administration (FDA) and the pill’s manufacturer, Teva Pharmaceuticals, as a cause of confusion.

In addition, several pharmacists interviewed said that, despite the lack of age restriction, they would continue to demand identification. Many said that they were concerned that making the pill available without restriction represented a risk to public health.

“I hate it,” said Hening Kwan, a pharmacist at a Walgreens in the Bronx, who said that he would continue to sell the drug only to consumers who provided him with identification.

“I feel like everybody’s not educated enough [to buy the pill over the counter]. I just don’t want anybody to abuse the medication,” he said.

Evolving Legal Landscape

In April, a federal judge in Brooklyn ruled that anyone, regardless of age, could purchase emergency contraceptives without a doctor’s prescription. In response, the FDA lowered the age restriction for Plan B One-Step from 17 to 15 in April, and then eliminated it altogether in June, making it the only morning-after pill that can be purchased regardless of age.

Many pharmacists complained, however, that four months after the ruling, they have received little or no guidance regarding the change.

Joseph Thomas, a pharmacist at Rite Choice Pharmacy in Brooklyn, said that he found out about the new policy by word of mouth, rather than through a formal notification from the FDA or Teva. “The state and federal government should be more clear . . . about informing pharmacies and sending updated information regarding the new regulation,” he said.

Packaging Problems

Some pharmacists said they believed that the duty to clarify the rules regarding Plan B One-Step should fall upon the manufacturer, Teva, which has begun shipping Plan B One-Step with new labeling that will allow it to be sold “in aisle” (meaning not behind a pharmacist’s counter).

But many of the pharmacists interviewed said they had not yet begun to receive the newly packaged pills. They continued to sell Plan B One-Step with the old packaging and were still following the original sales restrictions that are printed on the labels themselves.

At a Rite Aid in Queens, there was an empty space on the shelf where Plan B One-Step was usually stocked. Pharmacist Wai Yin Mak explained that there were no Plan B One-Step pills on the shelves because the store had not yet received any with the updated labels.

When asked about the availability of the newly packaged Plan B One-Step pills, Teva spokeswoman Denise Bradley said in an email that they were “widely available in-aisle at major national retailers.”

Bradley said that Teva worked “in partnership with pharmacies to ensure that they have up-to-date information about when to expect the new packaging and to provide clarification regarding the shelving status.”

However, Bradley conceded that other retailers may be continuing to sell the originally labeled pill. “[T]he timing of when this product will no longer be available may vary across retailers,” she said.

According to the FDA, the manufacturer should resolve any confusion regarding the rules for Plan B One-Step. “Manufacturers are responsible [for] providing stores with appropriately labeled product,” FDA spokeswoman Erica Jefferson said in an email.

Dazed and Confused

The lack of guidance from the FDA and Teva has left many of the pharmacists who were interviewed confused about when they are permitted to sell the drug, how the labeling affects the sales rules, and to whom they should be selling.

“I have no idea. They change it all the time. It’s hard to keep up with it,” said Ronald Zenger of Mercedes Pharmacy in the Bronx when asked about the rules on who can buy Plan B One-Step.

Pharmacists at smaller stores were particularly vulnerable to this uncertainty.

Of the 35 smaller pharmacies visited by the Summer Journal, most had pills only with the old packaging, and many of the pharmacists at those stores said they were unsure when the newly labeled shipments would arrive. Indeed, pharmacists in only six of those smaller stores knew about the change in policy regarding Plan B One-Step, and only four were strictly following it.

In the Bronx, Alexandros Argyris from Pharmore Pharmacy said, “Now they’re saying 15. I’ve seen other documents saying it’s 17 years old. I’m not sure that it’s accurate.”

“Everything is in limbo. I haven’t even seen the Plan B script as yet,” Argyris added.

Confusion was not limited to labeling for the new packages. Ana Nunez of Rite Choice Pharmacy in the Bronx incorrectly said that to obtain the pill, “You have to be accompanied by a female if you’re a male, and she has to have ID.”

By comparison, out of 14 pharmacists interviewed at big-chain pharmacies, 10 were familiar with the new point-of-sale policy regarding Plan B One-Step, and seven were actively selling the pill under the new rules.

Still, not even all the large-chain pharmacies were up-to-date on the new policy regarding Plan B One-Step.

“As far as we’re concerned here, you’ve got to be 18 because we haven’t seen the other one on paper [the actual text of the new regulation],” said Faye Godwin, a pharmacist at a CVS in the Bronx.

In contrast, a pharmacist at a Brooklyn Walgreens, who declined to give his name because he said he was not authorized to be quoted in the newspaper, said that his corporate headquarters sent out frequent updates on their medications, including Plan B One-Step, and that his store was sold out of the newly packaged medication, which had been made available in-aisle.

Source of Discontent

While the level of awareness regarding the new Plan B One-Step sales policy varied from pharmacy to pharmacy, so did the pharmacists’ personal views. Of the 32 pharmacists who agreed to comment on their personal opinion regarding making Plan B One-Step more widely available, 20 said they viewed the change negatively.

One pharamacist at Town Drug Pharmacy in Manhattan said he believes that the change in Plan B One-Step’s point-of-sale rules will increase the chances of the drug being abused. He said that the FDA should have kept the age restriction. He planned to wait until his inventory “phases out” to get the new packaging.

At County Pharmacy in Brooklyn, a pharmacist who declined to give his name said that he was personally against the change, which he said “sucked.” He added that he had called the FDA to complain.

“I could think of 50 to 100 medications that were safer than Plan B One-Step that currently were not over the counter,” he said. That pharmacist said that despite the FDA’s newly released policy, he would continue to demand identification before dispensing Plan B One-Step.

Opie Malla, a pharmacist from a Rite Aid in Queens, said that she believed that the increased availability of Plan B One-Step was part of an effort to lower health care costs, but that it would promote unsafe sex and lead to more people contracting sexually transmitted diseases.

Still, the new policy had some supporters. “Women should be able to buy it, because it’s their choice,” said Lenny, a pharmacist at Sugar Hill Pharmacy in Manhattan who declined to give his last name.

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