Tuesday, October 6, 2009

U.S. Seniors Want OTC Acetaminophen Saved, Survey

According to a new survey of U.S. senior citizens, mild-to-severe pain is a common occurrence and most of them rely on over-the-counter acetaminophen for relief. They believe that education, not government regulation that would limit access, is the best solution for addressing any safety concerns regarding this analgesic.

The survey was commissioned by The Alliance for Aging Research to better understand U.S. seniors’ attitudes, perceptions, and concerns regarding age-related pain management and changes to over-the-counter (OTC) acetaminophen availability being considered by the Food and Drug Administration (FDA). We have previously discussed how the FDA is considering making higher-dose OTC acetaminophen products (eg, 500 mg. or more) available only by prescription and possibly banning all Rx acetaminophen-opioid combination products. In our blogpost (see 7/8/09) we described how available data does not support such actions.

According to the just-released survey, nearly half (46%) of U.S. seniors suffer pain — from headaches, arthritis, joint/muscle problems, backache, or colds — at least several times a week, with a third of them (34%) reporting pain every day. In most cases, the pain is moderate (46%), with 31% suffering mild pain and 17% experiencing severe pain. More than two-thirds (68%) rely on OTC pain relievers; only about 1-in-5 also sometimes use prescription analgesics. Acetaminophen-containing products are by far the most popular OTC analgesics, with most persons using extra-strength formulations. Here are some conclusions from the survey:
  • Most seniors interviewed were unaware of the FDA’s considering changing the rules on the availability of OTC pain relievers, and 78% expressed opposition to such restrictions.

  • By more than an 8-to-1 margin, seniors believe consumer education is a much better way to protect people from abusing or overdosing on pain relievers than government restrictions.

  • Most seniors believe that changing the availability of 500 mg. acetaminophen pain relievers would make it harder and more expensive to get safe and effective pain relief. Respondents were generally uncertain about what they would do, but half (52%) said they would use more of the lower dose formulation to make up the difference.

  • By very wide margins, seniors believe it would be a bad idea if the FDA required a doctor’s prescription to buy extra-strength acetaminophen products. They do not believe it is necessary or practical to make such a change —preferring individual responsibility over government regulation — and fear the added cost and inconvenience that could result.
Comment: In fair balance, roughly 1-in-5 respondents thought it would be a good idea for the FDA to require prescriptions for extra-strength acetaminophen products, with most saying it would help keep people from abusing the drug and that doctors should determine what people take for pain. However, even after being informed of the potential for liver damage due to excessive use of acetaminophen, more than three-quarters (76%) of survey respondents believed it should continue to be readily available OTC. Therefore, the message from senior citizens to government seems clear: We would welcome education on safe drug use, but leave our acetaminophen alone!

The nationwide survey was conducted via telephone by the Clarus Research Group during September 14-18, 2009, on behalf of the Alliance for Aging Research (http://agingresearch.org/). This private, non-profit organization was founded in 1986 to promote medical and behavioral research into the aging process, and to advocate for improving the health and independence of Americans as they age. The survey included a random sample of 801 U.S. adults aged 65 and older; however, the accuracy of such surveys in truly representing the entire population of interest must be cautiously considered. Support for the survey was provided by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., makers of Tylenol®.

Reference: Nationwide Survey of U.S. Seniors: Pain Management and the FDA. Alliance for Aging Research. September 2009. PDF document available here.