Drugs sold over the counter present dangers
Over-the-counter drugs offer a variety of cures for what ails the average college student, including problems such as coughs, yeast infections and headaches.
But college-aged students, especially women, need to be careful and critical of emerging OTC drugs, health officials warn. Some could have negative consequences, despite the fact that the Food and Drug Administration deems them safe for use without the consent of a doctor.
The FDA has no systematic way of tracking negative effects of OTC drugs yet, so patient responsibility is important, said David Brushwood, University of Florida professor in pharmacy health-care administration.
Concerns arise, for example, when looking at the new OTC drug, Alli, made available this summer. Alli, pronounced "ally," is the first FDA-approved, OTC weight-loss drug.
The drug, taken with meals, blocks intestinal enzymes from digesting one-fourth of food's fat.
"Let's face it. There is pressure in our society to be thin," said Mary Ann Burg, associate professor of Community Health and Family Medicine and former director of UF's Women's Health Research Center.
Weight-loss pills may seem like one route to get to that socially acceptable norm.
Yet, research shows that college-aged women diagnosed with bulimia can be frequent abusers of laxatives, or OTC stimulants that treat constipation, as a means to increase weight loss, Burg said.
Drugs treating more overt female concerns and problems have also made transitions from prescription to OTC, sometimes only after political pressure, said Phylis Craigcq, nurse practitioner at the Women's Clinic at the Student Health Care Center.
In 1991, women were allowed buy treatment for yeast infections over the counter. And last fall, the morning-after pill, or Plan B contraception, won approval for OTC use after the FDA duked it out with Congress and its own advisory board.
"We have a lot less girls sitting on our doorstep Monday morning, and our emergency calls sure have gone down," Craig said. "I don't miss those 2 a.m. phone calls."
Morning-after pills became available upon request in January, after the manufacturer re-packaged and re-labeled the drug - a major concern of the FDA, Craig said.
"The FDA is a label-oriented organization," health administration professor Brushwood said. "They say, 'Can we write a label so clear, so easy to understand that a consumer can use it without medical assistance?'Â "
Clear labels describing safe usage are one of the primary factors the FDA uses to decide if a drug should be offered over the counter, Brushwood said. If the drug company can't provide a legible label, its product becomes prescription only.
It has to have adequate directions, warnings and advice that consumers could understand and follow, he said.
Yet, even after precautions have been taken, the FDA could still have a problem on their hands.
"The truth is, every drug has side effects and the potential to cause harm," said Earlene Lipowski, an associate professor in the College of Pharmacy.
Both Lipowski and Brushwood agree that the FDA has no concrete, systematic method of catching abuse of OTC drugs.
The system in place now is completely voluntary, Brushwood said.
Here's how it works:
A patient takes a cough medicine, which gives him hives all over his body. Shocked and surprised, he goes to his doctor, explains what cough medicine he took and what happened to him.
The patient goes home, and the doctor has a choice. He can go about his day, or he can send a "moderator report" to the FDA, describing the patient's situation.
The FDA - if the patient isn't the only one with hives from this cough syrup - develops an aggregate of similar cases and if it becomes large enough, goes to the drug manufacturer to investigate what is happening.
Further research interprets whether that cough syrup stays on the market.
"You see, though, patients have a responsibility in all this as well. They have a responsibility to report adverse reactions" to a doctor, nurse, pharmacist or other health-care provider, Brushwood said.
The best way to use any drug - prescription or over the counter - is to check with a doctor first, women's health researcher Burg said.
Sometimes, going to a health practitioner, even if you know what you need, can help you in the future, as well, Craig said.
For instance, when the morning-after pill was only available by prescription, the Women's Clinic staff used to have ways of counseling sexual assault victims or setting up prescriptions for oral contraceptives so patients wouldn't need to use the morning-after pill again.
Even though she supports the drug being over the counter, it's harder to provide further help to patients who come in, pick up the drug and leave after only a minimal interaction with a pharmacist, Craig said.
But college-aged students, especially women, need to be careful and critical of emerging OTC drugs, health officials warn. Some could have negative consequences, despite the fact that the Food and Drug Administration deems them safe for use without the consent of a doctor.
The FDA has no systematic way of tracking negative effects of OTC drugs yet, so patient responsibility is important, said David Brushwood, University of Florida professor in pharmacy health-care administration.
Concerns arise, for example, when looking at the new OTC drug, Alli, made available this summer. Alli, pronounced "ally," is the first FDA-approved, OTC weight-loss drug.
The drug, taken with meals, blocks intestinal enzymes from digesting one-fourth of food's fat.
"Let's face it. There is pressure in our society to be thin," said Mary Ann Burg, associate professor of Community Health and Family Medicine and former director of UF's Women's Health Research Center.
Weight-loss pills may seem like one route to get to that socially acceptable norm.
Yet, research shows that college-aged women diagnosed with bulimia can be frequent abusers of laxatives, or OTC stimulants that treat constipation, as a means to increase weight loss, Burg said.
Drugs treating more overt female concerns and problems have also made transitions from prescription to OTC, sometimes only after political pressure, said Phylis Craigcq, nurse practitioner at the Women's Clinic at the Student Health Care Center.
In 1991, women were allowed buy treatment for yeast infections over the counter. And last fall, the morning-after pill, or Plan B contraception, won approval for OTC use after the FDA duked it out with Congress and its own advisory board.
"We have a lot less girls sitting on our doorstep Monday morning, and our emergency calls sure have gone down," Craig said. "I don't miss those 2 a.m. phone calls."
Morning-after pills became available upon request in January, after the manufacturer re-packaged and re-labeled the drug - a major concern of the FDA, Craig said.
"The FDA is a label-oriented organization," health administration professor Brushwood said. "They say, 'Can we write a label so clear, so easy to understand that a consumer can use it without medical assistance?'Â "
Clear labels describing safe usage are one of the primary factors the FDA uses to decide if a drug should be offered over the counter, Brushwood said. If the drug company can't provide a legible label, its product becomes prescription only.
It has to have adequate directions, warnings and advice that consumers could understand and follow, he said.
Yet, even after precautions have been taken, the FDA could still have a problem on their hands.
"The truth is, every drug has side effects and the potential to cause harm," said Earlene Lipowski, an associate professor in the College of Pharmacy.
Both Lipowski and Brushwood agree that the FDA has no concrete, systematic method of catching abuse of OTC drugs.
The system in place now is completely voluntary, Brushwood said.
Here's how it works:
A patient takes a cough medicine, which gives him hives all over his body. Shocked and surprised, he goes to his doctor, explains what cough medicine he took and what happened to him.
The patient goes home, and the doctor has a choice. He can go about his day, or he can send a "moderator report" to the FDA, describing the patient's situation.
The FDA - if the patient isn't the only one with hives from this cough syrup - develops an aggregate of similar cases and if it becomes large enough, goes to the drug manufacturer to investigate what is happening.
Further research interprets whether that cough syrup stays on the market.
"You see, though, patients have a responsibility in all this as well. They have a responsibility to report adverse reactions" to a doctor, nurse, pharmacist or other health-care provider, Brushwood said.
The best way to use any drug - prescription or over the counter - is to check with a doctor first, women's health researcher Burg said.
Sometimes, going to a health practitioner, even if you know what you need, can help you in the future, as well, Craig said.
For instance, when the morning-after pill was only available by prescription, the Women's Clinic staff used to have ways of counseling sexual assault victims or setting up prescriptions for oral contraceptives so patients wouldn't need to use the morning-after pill again.
Even though she supports the drug being over the counter, it's harder to provide further help to patients who come in, pick up the drug and leave after only a minimal interaction with a pharmacist, Craig said.
