McNeil Consumer Healthcare temporarily suspends operations in Pa. facility
FORT WASHINGTON, Pa. In a statement released Tuesday, McNeil Consumer Healthcare stated: “The quality issues that [the Food and Drug Administration] has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate.”
McNeil Consumer Healthcare last week voluntarily recalled all lots that have not yet expired of certain over-the-counter children’s and infants’ liquid products in consultation with the Food and Drug Administration. The agency suggested that McNeil’s Fort Washington, Pa. plant may not be compliant with Good Manufacturing Practices.
“Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles,” the FDA stated on its Web site.
Both the FDA and McNeil suggested the risk for adverse events associated with the recalled products was relatively low.
Following the recall, McNeil has temporarily suspended production at its Fort Washington production facility. “We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there,” McNeil stated. “We will continue to work in close consultation with the FDA to take corrective action and ensure that our quality operations meet the high standards that consumers expect from us.”
APhA survey: Pharmacists recommend over-the-counter products to consumers
WASHINGTON Pharmacists believe that 82% of consumers purchase over-the-counter products that actually were recommended to them by a pharmacist, according to the most recent “Pharmacy Today Over-the-Counter Product” survey conducted by the American Pharmacists Association.
The survey, completed by more than 1,000 APhA member and nonmember pharmacists, also found that pharmacists counsel 29 patients on average per week around the use of nonprescription medicines. Patients who seek their pharmacist’s advice include patients requiring assistance in identifying the most appropriate product (90%), patients that are worried about using an OTC product with other prescription medications (80%), patients suffering from an acute or chronic condition (79%), and patients worried about taking OTC products with a specific disease/condition (65%).
“Pharmacists are the medication experts on the healthcare team,” stated Thomas Menighan, APhA CEO. “[They] are trained not only about prescription medications, but also nonprescription medications, supplements and herbals.”
One of APhA’s goals in conducting the annual “Pharmacy Today Over-the-Counter Product” survey is to educate consumers that pharmacists have the knowledge and training to help them select the right OTC medications. As part of the survey, pharmacists are asked to tabulate the OTC products they recommend per week in 76 different product categories.
As part of the survey, pharmacists were asked how many times per week they had recommended each product. Those brands that indexed higher than 60% among pharmacist recommendations included: Procter & Gamble’s Crest Whitestrips (87%); GlaxoSmithKline’s Breathe Right (74%); Amerifit Brands’ AZO Test Strips (UTI test) (72%); Church & Dwight’s First Response (ovulation test kits) (70%); McNeil Consumer’s Sudafed (70%); Omron blood pressure monitors (70%); Reckit Benckiser’s Mucinex family of products (63%).
FDA advisory committee to discuss curbing DXM abuse
BETHESDA, Md. The Food and Drug Administration on Tuesday announced through the Federal Register that a Sept. 14 meeting will be held with its drug safety and risk management advisory committee to ascertain the abuse potential of the cough-cold ingredient dextromethorphan as part of the over-the-counter cough suppressant’s benefit/risk ratio.
The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of abuse, especially among adolescents, the FDA reported.
It is not a fresh issue — the Consumer Healthcare Products Association has been raising awareness among parents around the potential of OTC and prescription-drug abuse among teens for several years. In addition, most if not all pharmacy retailers voluntarily require an age verification that a purchaser of DXM products be at least 18 years old at the point of sale.
According to survey data released in March by the Partnership for a Drug-Free America and MetLife Foundation, there was no significant increase in the abuse of over-the-counter cough medicines containing dextromethorphan. The 21st annual Partnership/MetLife Foundation Attitude Tracking Survey found that while lifetime abuse rates among teens for OTC cough medicines have remained relatively flat over the past few years, 12% of teens still report having abused an OTC cough medicine to get high at least once in their lives.
CHPA has been engaged in a long-term, comprehensive initiative to end this type of abuse with partners including the Partnership for a Drug-Free America, the Community Anti-Drug Coalitions of America, and D.A.R.E. America, and more recently, the National Association of School Nurses.
“While these medicines [containing dextromethorphan] are safe and effective when used as directed, they can be dangerous when abused in extreme amounts, especially when combined with alcohol, illicit drugs or certain prescription drugs,” stated Linda Suydam, CHPA president. “The makers of OTC medicines have been aggressive in their efforts to prevent cough medicine abuse among teens.”
NASN and CHPA last month announced the launch of “Home to Homeroom,” an educational program that teams parents with the medical expert in their teen’s school — the school nurse — to help prevent and address teen medicine abuse.