US Pharm. 2013;38(11):12-15.
Childhood poisoning is an eternal issue that never seems to cease. Pharmacists receive phone calls from worried parents who do not know what to do. Parents also come to the pharmacy with the child, asking for advice. It is critical to know what course of action to take in these cases.
The Scope of the Problem
For an overview of the national poisoning problem, the best resource is the annual report of the American Association of Poison Control Centers.1 The latest one is the 29th annual report. In 2011, the National Poison Data System (NPDS) logged a total of 3,624,063 poisonings, but some of these were in animals and others were only calls for information. There were actually 2,334,004 calls in which humans were exposed to a poison. The percentage of human exposures with more serious outcomes (e.g., moderate or major patient harm or death) increased by 6.8% over the previous report.1
The five most common poisons in the time covered were analgesics (11.7%), cosmetics/personal care products (8%), household cleaning substances (7%), sedatives/hypnotics/antipsychotics (6.1%), and foreign bodies/toys/miscellaneous (4.1%). The greatest increase in poisoning incidents over the previous 11-year period was in the analgesics group.1
The agency separated out poisonings in children aged 5 years and younger for special scrutiny. The most common poisons in this group were cosmetics/personal care products (14%), analgesics (9.9%), household cleaning substances (9.2%), foreign bodies/toys/miscellaneous (6.9%), and topical preparations (6.6%). NPDS data revealed that there were 2,765 human exposures that resulted in the death of the subject, and that 1,995 of those were related to the intoxicant.1
The FDA and OTC Poisoning Products
The FDA OTC Review has considered poison treatment products quite extensively, but it has not yet been completed.2 During the review, the FDA tentatively classified two ingredients
as safe and effective for nonprescription sales: syrup of ipecac and activated charcoal. Each presents unique challenges for the pharmacist to consider.
Syrup of Ipecac: This product (hereafter referred to as ipecac) has had a long and troubled history. The FDA described the early controversy in a set of discussion points prior to a meeting of the Nonprescription Drugs Advisory Committee (NDAC) in 2003.3 In this document, the FDA stated that prior to 1965 there was medical disagreement as to whether ipecac should be available to consumers without a prescription. The FDA obtained the views of the American Academy of Pediatrics (AAP), the American Association of Poison Control Centers, the American Medical Association, and its own Medical Advisory Board. There was unanimous agreement that ipecac should be given non-prescription status. As a result, the FDA created a formal regulation, effective in 1965, that allowed OTC sales. The justification was that ipecac should be “readily available in the house-hold for emergency treatment of poisonings.”3
The FDA OTC Review covered ipecac in two separate documents, later including activated charcoal for purposes of the review, as a group of products titled “Poison Treatment Drug Products.” In a 1985 Tentative Final Monograph, the FDA classified both ingredients as being safe and effective for nonprescription treatment of poisoning.4 Nevertheless, a final monograph for these ingredients was never issued. Despite the fact that the FDA never finished its review of ipecac and charcoal, 2003 was to be a fateful year for continued nonprescription status of ipecac. Two events coincided to make further marketing of ipecac virtually unfeasible.
The first event was in June 2003. The FDA convened a meeting of NDAC to explore the continued use of ipecac.3 Two issues had emerged that were of serious import. One was an ongoing question of whether ipecac was actually effective, and the other concerned its abuse potential. After hearing the evidence, the NDAC voted 6 to 4 to make ipecac prescription only.5
The second event was a research study in the prestigious journal Pediatrics in November 2003.6 The paper was titled, “Home Syrup of Ipecac Use Does Not Reduce Emergency Department Use or Improve Outcome.” The author (Bond) examined the American Association of Poison Control Centers’ Toxic Exposures Surveillance System Database, specifically exploring poisoning incidents in children under 6 years of age. Bond was able to report on data from 2000 to 2001, determining whether ipecac was used at home, the rate of referral to emergency departments, the actual rate of emergency department usage, and the eventual outcome of the case. The author discovered that 1.8% of patients in the study were given syrup of ipecac at home. The mean rate of referral to an emergency department was 9% of ingestions. Only 0.6% of patients had an adverse outcome. In comparing those who ingested ipecac to those who did not, it became clear that administration of ipecac did not affect referral to an emergency department, nor did it affect the rate of adverse outcomes.6
In the same 2003 issue of Pediatrics, the AAP Committee on Injury, Violence, and Poison Prevention issued a policy statement on poison treatment in the home.7 It discussed the organization’s former policy recommending that households with young children keep a 1-oz bottle of ipecac in the home to be used only on the advice of a physician or poison control center. The AAP further elaborated that the study cited above had forced a policy update. The AAP advised its members that the new policy recommended against keeping ipecac in the home, and that any ipecac in the home be disposed of safely. The AAP also cited several concerns about ipecac, including7:
• Ipecac does not completely remove toxins from the stomach. Tablets often remain in the stomach after the patient has endured ipecac-induced vomiting.
• Administration of ipecac is not free of risk, as it can cause persistent vomiting, lethargy, and diarrhea. Ipecac-induced lethargy is particularly dangerous in patients who have also ingested medications that cause lethargy (e.g., sedatives).
• Parents and caregivers often fail to call a health professional prior to administering ipecac. As a result, it had been given to at least 61% of children whose ingestants were nontoxic.
• If the patient suffers persistent ipecac-induced vomiting, he or she may not be able to retain such valuable additional interventions as activated charcoal, N-acetylcysteine, or whole-bowel irrigations.
• Ipecac abuse was rising in two areas. One was by the group of anorexics/bulimics who took ipecac to keep their weight down. Another abuse was administration of ipecac to children by caregivers/parents with Munchausen syndrome by proxy. People with this mental disorder enjoy the resulting attention from medical personnel.
As a result of the increasing scrutiny and criticism of ipecac, its availability has slowly decreased over the past decade.8 Few pharmacies even stock the product. Pharmacists are well advised to check their shelves to see if a few bottles of ipecac remain. If they are out of date, they should be discarded, and even those that are in date should be disposed of safely. The best advice is to pour the ipecac down the sink or toilet. The pharmacist could also simply dump the contents of the bottles into a grassy area where they cannot be retrieved.
It appears almost impossible to purchase ipecac on the Internet, and discussion boards contain posts from disgruntled patients who wish to purchase ipecac and cannot find it. While some posters seem to want it to relieve poisoning, others may seek it for abuse reasons.
Activated Charcoal: The only other ingredient considered safe and effective for nonprescription purchase in poisoning emergencies is activated charcoal. It has a long list of use precautions and instructions. However, the companies that sell activated charcoal prefer not to actively market it to community pharmacies for a variety of reasons. As a result, few pharmacies stock it, and patients looking for the product will waste valuable time driving from one pharmacy to the next in a fruitless exercise to locate it.
What Can the Pharmacist Do?
At this time, the community pharmacist is not a primary location to purchase either ipecac or activated charcoal. Thus, when patients call the pharmacy, the pharmacist should instead serve as an information resource. The most vital thing to communicate to a concerned caller is the national poison control hotline number: 1-800-222-1222.9 Patients anywhere in the U.S. can call this number any hour of the day or night. Poisoning experts will give free and confidential advice. It is a good idea to have this number posted prominently at several locations in every pharmacy, especially next to each phone. It is easy to forget a number during a situation of high stress. Having it right before one’s eyes by the phone can be a lifesaver.
Pharmacists can also disseminate this issue’s PATIENT INFORMATION, which provides numerous tips on the prevention of poisoning. Another activity for pharmacies is to take part in National Poison Prevention Week 2014, which will be observed March 16-22, 2014.10 Pharmacies can participate in a poison prevention event and can obtain further information by calling the toll-free hotline number.
Pharmacies may also wish to host a poison prevention event. If this is the case, they may contact the Health Resources and Services Administration to obtain a National Poison Prevention Week Planner.11 It gives a wealth of assistance, such as a handout of tips for making the activity successful.12 For instance, the pharmacy should coordinate its efforts with other groups to maximize success, including local radio and TV stations, and all types of community organizations (e.g., religious and civic groups, fraternities and sororities), and should target the activities to the specific audience (e.g., bilingual presentations, age-appropriate youth activities).
What Can a Parent Do to Prevent Poisoning?
As soon as your baby is able to move around on its own, you must take swift steps to ensure that the child does not reach poisons. What can you do?
It is essential to keep the baby away from any poisons. Keep any potential poisons out of
the child’s sight and reach. Hazardous substances should be stored far away from food and medications. High cabinets are a better choice for storage than those under the sink, for instance. Locked cabinets are even better, and all hazardous substances and medications should be secured inside.
A toxic substance’s original container may be child-resistant, and will probably also have instructions for dealing with poisoning. Therefore, never remove any potential poison from its original container to place it in another.
The risk is even greater if you place the chemicals into a bottle that used to contain food or drink. Putting bleach or household cleaner in a soft-drink bottle is asking for trouble.
If you are in the middle of working with a potential poison, such as cleaning the house with an open bottle of household chemicals, be aware of where your child is at all times. If you are interrupted by a phone call or the doorbell, close all containers and place them out of reach before answering.
It is also a wise idea to take your child with you while you attend to this new business so that he or she does not have a chance to get into a hazardous substance you had not even thought about. Remember the old saying, “Kids act fast, but so do poisons.”
After you open anything with a child-resistant cap, remove the medication or substance immediately and replace the cap or closure as tightly and securely as possible.
Children imitate adult behaviors. Do not let them see you taking medications, as they may attempt to do the same when they find any medicine. When you need to give your child medication, never refer to it as “candy” in an effort to make it more appealing. This minimizes the hazardous nature of the drug.
When you have no further need of any possible poison or hazardous substance, remove it from your home. Take cleaners, paint thinners, paint, gasoline, fingernail polish, solvents, and similar dangerous chemicals to approved disposal facilities. Take medications to pharmacies with return programs so that the drugs can be disposed of through environmentally friendly methods that prevent others from reusing them.
Who Do I Call After a Poisoning?
If your child accidentally ingests a toxic substance, immediately call 1-800-222-1222. This national toll-free poison control hotline will direct you in the best steps to take. Follow the advice closely.
Remember, if you have questions, Consult Your Pharmacist.
1. Bronstein AC, Spyker DA, Cantilena LR, et al. 2011
annual report of the American Association of Poison Control Centers’
National Poison Data System (NPDS): 29th annual report. Clin Toxicol (Phila). 2012;50:911-1164.
2. Regulatory history for ipecac syrup. FDA. www.fda.gov/ohrms/dockets/ac/03/briefing/3962B1_02_Regulatory%20History.htm. Accessed September 24, 2013.
3. Nonprescription Drugs Advisory Committee meeting. June 12, 2003. FDA. www.fda.gov/ohrms/dockets/ac/03/briefing/3962B1_01_FDA-Ipecac%20syrup.htm. Accessed September 24, 2013.
4. Poison treatment drug products for over-the-counter human use; tentative final monograph. Fed Regist. 1985;50:2244-2259.
5. Levy S. Advisory committee to FDA: make ipecac Rx. Drug Topics. July 21, 2003. http://drugtopics.modernmedicine.com/drug-topics/news/advisory-committee-fda-make-ipecac-rx. Accessed September 24, 2013.
6. Bond GR. Home syrup of ipecac use does not reduce emergency department use or improve outcome. Pediatrics. 2003;112:1061-1064.
7. Committee on Injury, Violence, and Poison Prevention. Poison treatment in the home. Pediatrics. 2003;112:1182-1185.
8. Höjer J, Troutman WG, Hoppu K, et al. Position paper update: ipecac syrup for gastro-intestinal decontamination. Clin Toxicol. 2013;51:134-139.
9. Poison control center—emergency hotline number. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/002724.htm. Accessed September 24, 2013.
10. National Poison Prevention Week 2014. Poison Prevention Week Council. www.poisonprevention.org/poison.htm. Accessed September 24, 2013.
11. What can you do? Poison Prevention Week Council. http://poisonhelp.hrsa.gov/what-can-you-do/national-poison-prevention-week/index.html. Accessed September 24, 2013.
12. Tips for successful activity and event planning. Health Resources and Services Administration. January 2011. http://poisonhelp.hrsa.gov/uploads/nppw_2011_tips_for_successful_activity_and_event_planning.pdf. Accessed September 24, 2013.
13. Hyland’s Nausea and Vomiting, Ipecacuanha 30X, tablets. www.drugstore.com. Accessed September 24, 2013.
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