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Should Viagra Be an Over-the-Counter Drug?

Posted On April 3, 2018 at 4:38 pm by / 1 Comment

Viagra will soon be available in the United Kingdom without a prescription. Should the U.S. do the same? And what about women’s contraceptives?

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Viagra may soon be available without a prescription in the United Kingdom.

In a recent announcement, the Medicines and Healthcare products Regulatory Agency (MHRA) said the erectile dysfunction drug will be reclassified from a prescription-only medicine to a pharmacy medicine.

It’s the first erectile dysfunction (ED) medication to be classified to pharmacy status in the United Kingdom.

Viagra Connect, containing 50 milligrams of sildenafil, will be available to men over age 18.

That doesn’t mean they can simply take it off the shelf and buy it.

They will be required to speak with the pharmacist, who will determine if they are good candidates for the drug.

If not, they will be referred to a physician.

Pharmaceutical company Pfizer plans to launch Viagra Connect in the United Kingdom in the spring of 2018.

Viagra tablets in 25-, 50-, and 100-milligram doses will remain available as a prescription medicine.

Should Viagra be sold over the counter in the U.S.?

Dr. Philip Werthman, urologist and director of the Center for Male Reproductive Medicine and Vasectomy Reversal in Los Angeles, sees both sides of the issue.

He told Healthline that Viagra is generally not a dangerous drug.

“It’s not like it needs to be a controlled substance from the standpoint of a huge amount of side effects. I’d like to see it over the counter (OTC) from that standpoint. And it would probably bring down the cost,” said Werthman.

But he noted that ED can sometimes be a sign of a potentially serious illness.

“From that perspective, I would want to see it in the hands of doctors,” he said.

“You can overdose and end up in the hospital. You don’t want people using it as a recreational drug. You don’t want 18- to 22-year-olds messing around with this stuff. There are many tradeoffs and I don’t know what the right answer is. The U.K. is doing it first, so we’ll get to see the unintended consequences,” he continued.

Why you might want to see a doctor

In the United Kingdom, pharmacists will be expected to provide information about ED, potential side effects of Viagra, and how to use the product safely.

Viagra Connect will not be sold to men taking certain interacting medications. Men with particular health conditions will have to go through a physician.

Werthman explained that Viagra can interfere with heart medications, especially nitrates, causing a rapid drop in blood pressure, fainting, and other complications.

He also noted that ED can be a symptom of an underlying condition such as vascular disease, heart disease, or diabetes.

“If you go to the drug store to get Viagra over the counter, what will prompt you to go to the doctor to get a checkup? If you go to your doctor for a prescription, you may uncover an underlying cause of ED and save your life,” said Werthman.

Dangers of black market Viagra

Among the reasons the MHRA reclassified the drug in the United Kingdom was an effort to discourage men from buying ED medicines from illegal websites.

In the past five years, the MHRA has confiscated over £50 million of unlicensed and counterfeit ED medicines.

Some men are embarrassed or reluctant to see their doctor about ED. Others may be trying to save time or money.

Whatever the reason, some men turn to the internet for ED medicines.

Werthman said there are ways to buy Viagra legally from an online pharmacy with doctor screening.

“But on the black market, you don’t know what you’re getting. Is it Viagra or is it laced with something else? There’s no quality control or assurance,” he cautioned.

“For some things, it’s just best to show up in person. I would go see a doctor, an internist, urologist — whoever you have a relationship with would be the best. If you take your health seriously, when you’re having an issue, the best thing is to discuss it with your physician. It’s more inconvenient and cumbersome, but has a potentially great benefit,” said Werthman.

Arrival of the generics

Viagra may not be available without prescription anytime soon in the United States, but change is coming.

Beginning this month, when its patent protection runs out, Pfizer will start selling a generic version of its own drug.

At the same time, Teva is introducing a generic form of sildenafil.

Both generic versions are expected to cost about half as much as Viagra.

Other generics are expected to hit the market next year.

Currently, many health insurance policies help cover the cost of Viagra and other ED drugs.

For uninsured men, or those whose insurance doesn’t cover Viagra, the cost is about $65 to $75 per pill. But Pfizer offers these customers a discount program to help defray costs.

All ED drugs still require a doctor’s prescription in the United States.

Should oral contraceptives for women be sold over the counter?

Dr. Rachel Perry, assistant professor of obstetrics and gynecology and director of the Women’s Options Center at the University of California Irvine Health in California, believes oral contraceptives should be available over the counter.

She told Healthline they are safe and effective.

“OTC oral contraceptives would remove barriers to women seeking effective birth control. It would save women time and money associated with physician visits, particularly those who lack insurance. Insured women may have a gap in contraception coverage if they change providers or insurance plans. OTC access would be a way for women who would otherwise have no coverage, or a gap in coverage, to continue using a method that is working for them,” she explained.

“There is the theoretical concern that women getting oral contraceptives OTC would be less likely to get preventive care like cervical cancer or STI screening, but because these services are not medically necessary to provide contraception, it is a barrier to require them before providing contraception,” she continued.

Perry noted there’s also concern that OTC access for oral contraceptives might affect insurance coverage for other contraceptives such as IUDs and implants.

“But it should not be an either-or scenario. Women should have affordable access to any effective method they choose,” she said.

As for potential harms, Perry said these would be the same as when oral contraceptives are prescribed by a physician. This includes the rare risks of blood clot or stroke. And some women with other risk factors for those complications should not use oral contraceptives that contain estrogen.

“However, it has been shown that women can use checklists to self-screen for contraindications to oral contraception use. Overall, serious complications from oral contraception are very rare,” she said.

Oral contraceptives are not widely available without a doctor’s prescription. Though the specifics of their policies differ, eight states and the District of Columbia do currently allow pharmacists to dispense them without a prescription.

“Longer-term outcomes from those states will shed light on the impact that not requiring a doctor’s visit has on women’s access and adherence to contraceptives. For oral contraceptives to be granted OTC status, generally a manufacturer would submit to the FDA in what is a fairly lengthy process,” explained Perry.

“It is important that any effort to make oral contraceptives OTC would not undermine women’s access to other methods of contraception, and that the cost of OTC oral contraceptives would continue to be covered by insurance programs,” she said.

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