The cough, cold and allergy category has had a case of the hiccups.
First came the methamphetamine laws that pulled pseudoephedrine products off the shelves and put them behind the counter; then came concerns over abuse of dextromethorphan. Finally, this past fall, the U.S. Food and Drug Administration recommended that children ages 2 to 6 should not use cough and cold medicines. This has led to recalls, new labeling and increased consumer interaction with the pharmacist.
Not all the news has been bad. In recent weeks, the allergy medication Zyrtec switched to over-the-counter status, and private-label versions also are available. This is expected to boost sales.
Many retailers are still are working out what to do about children's cough and cold products. The FDA's expert advisory panel voted 13-9 that children ages 2 to 6 should not use these medicines, but the FDA has not acted beyond that vote.
“Most kids' cough and cold medicines have been pulled off store shelves,” said John Fegan, senior vice president of pharmacy, Ahold USA, Quincy, Mass. “In touring stores, I've seen customers come up and ask the pharmacist, ‘What do I do now? I've been depending on this Dimetapp for years,’ and so there is some added involvement of the pharmacists with the consumers. This is a good outcome, because it allows customers to ask questions and it puts pressure on us, the retailers, to make sure we have some replacement products in place.”
Although the FDA has not issued any further directives, manufacturers agreed to remove all cough and cold medicines for children under 2 in October after the FDA's advisory panel voted 21-1 that such products posed a high risk of misuse.
Many manufacturers also pulled medicines for children ages 2 to 6 off the shelves in a preemptive move, retailers told SN.
“A lot of the children's medicines were pulled due to manufacturers requesting they be taken off,” said Michele Snider, director of pharmacy for Save Mart Supermarkets, Modesto, Calif.
For instance, Wyeth Consumer Healthcare, Richmond, Va., recalled Children's Dimetapp Cold & Congestion because the dosage cup with the product does not have a half-teaspoon mark, which is the recommended dose on the label for children age 2 to under 6. The company says on its website, however, that this action is specific to the dosage cup and not related to the safety of the medication itself.
“In San Francisco, signs must be posted on shelves saying that certain cough and cold products for children are not recommended for ages 2 to 6,” Snider said. “The signs have a baby's face and a stop sign on them,” she said.
Wyeth Consumer Healthcare also points out on its website that it no longer recommends using cough and cold medicines for children under 2 years old.
In some cases, wholesalers have pulled kids' cough and cold products even if the manufacturer hasn't, said Bob Mueller, director of pharmacy, Schnuck Markets, St. Louis. “The FDA made the recommendations, but then they never said certain medications had to be removed. Some wholesalers decided to pull the products meant for kids age 2 to 6 anyway. In the meantime, some doctors are still recommending these products in the correct dosage, and many of our stores don't have them,” he said
In that case, Mueller said, Schnuck's pharmacists are usually asked for help, and those pharmacists will try to contact a patient's doctor to see if another product can be recommended.
At Minyard Food Stores, Coppell, Texas, pharmacists faced with questions from confused parents are referring them to their pediatricians, Ron Peters, vice president, pharmacy, told SN.
In some cases, the pharmacists can send the parents directly to Minyard's in-store clinics, run by MedBasics, Irving, Texas. “We can just recommend that the parent go over to the clinic,” Peters said.
Meanwhile, prescriptions for children's antibiotic and cough suppressant sales have gone up, but it is difficult to determine if the FDA announcement, which pertained to OTC items, had any bearing on sales, retailers told SN.
“It's hard to tell if more cough and cold medications have been prescribed to children since this announcement. It is masked this year, especially because of the rapid onset of cough and colds in February. We weren't seeing much difference in antibiotic and cough suppressant sales before that. But in February there was a rapid increase,” Fegan said.
Minyard's Peters said the OTC situation may have had some effect on increased prescriptions, but Snider did not think prescription volume had changed.
Further, no switches of cough and cold products from Rx to OTC are likely in the near future for a variety of reasons, sources said. “There aren't many scripts left, especially for pediatric cough and cold use, that would go over the counter,” Mueller said.
“I don't see a rapid change in cough and cold Rx-to-OTC switches,” Fegan said. The only recent change to many products is the federal legislation requiring the moving of products containing the decongestant pseudoephedrine to behind the pharmacy counter or a secure area in stores without a pharmacy, he said. “With that, every manufacturer has come out with a reformulated product that can stay on shelves, replacing pseudoephedrine with phenylephrine.”
BEHIND THE COUNTER
On its website, McNeil Consumer Healthcare, Fort Washington, Pa., said, “Tylenol is phasing out pseudoephedrine because of recent federal legislation placing pseudoephedrine-containing products behind the counter.” However, it also states that those products containing pseudoephedrine are still available behind the counter. Industry sources have raised concerns over the lack of efficacy of phenylephrine products.
Since the federal legislation was designed to curb abuse of drugs containing PSE, “if we have the problem of the continued abuse of over-the-counter products, that is going to force more over-the-counter products either off the market, or behind the pharmacy counter, which is a shame,” Peters said.
In November, the FDA held a public hearing to gather industry views on the merits of increasing behind-the-counter access to drugs. These drugs would not call for a doctor's prescription, but would require consultation with a pharmacist.
Although supermarket pharmacies already carry cough and cold products containing PSE behind the counter, marketing them with shelf tags — as well as carrying the emergency contraceptive Plan B — a new drug category would require significantly more planning, sources said.
The FDA has not made any ruling on the possibility.
One recently switched drug that is on the shelves is McNeil Consumer Healthcare's allergy medicine Zyrtec. So far, sales of the prescription version of the drug have dropped, retailers said. “We have seen a decrease in the number of prescription Zyrtec sales we are getting,” said Fegan.
The reason for this, Snider said, is that many insurance plan benefit managers have dropped their third-party coverage of the drug in light of the switch.
Additional reporting by Dan Alaimo