Packaging Poison Prevention
Appreciate the Consumer Product Safety Commission's goal to protect children,
and accept the challenge to design senior-friendly, child-resistant packaging.
A few months ago, I attended the Consumer Product Safety Commission's (CPSC) forum, Understanding the Poison Prevention Packaging Act. Even though I have been packaging pharmaceuticals for years, I learned a lot at this forum. And much of what I already knew and believed was clarified and validated.
The objective of the commission was stated early and often to protect the safety of America's children. It was first mentioned during the welcoming address by Commissioner Mary Sheila Gall. It is also the purpose of the Poison Prevention Packaging Act of 1970 (PPPA). The act seeks to "to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting hazardous household substances." To accomplish that goal, the designation "special packaging" was created. This is where our responsibility begins as packaging professionals--to create special packaging that is both child resistant and adult friendly.
Pharmacists are required under law to distribute prescription drugs in child-resistant packaging and are under the scrutiny of the CPSC to do so. The act contains provisions to ensure that elderly or handicapped individuals unable to use special packaging can still obtain a regular package. A patient, just because he is elderly, can ask for an exemption from special packaging at the pharmacy. Pharmacists seldom, if ever, deny such a request. They are not allowed to make that substitution without first being asked by the patient. For the pharmacist to grant an exemption simply because there are no children in the home is not a valid reason.
The Code of Federal Regulations (CFR) lists all regulated and exempted pharmaceuticals. The CFR details the protection required for each drug or the situations when it is exempted, such as at a certain level or formulation, like powdered aspirin at a certain level. There are three justifications for an exemption: the product would not cause serious injury; the packaging is not technically feasible, practical, or appropriate; or child-resistant packaging would not function properly if the product were supplied in it. The fact that a pill is supplied in a numbered or calendar package is not justification alone for exemption.
Oral contraceptives, for example, are exempt because hormones would not cause serious injury to a child if accidentally ingested, not because they are supplied in a compliant package.
Although the procedure to file with the CPSC for specific product exemption is well documented, very few applications are received. One may wonder whether that is because drug makers are afraid of regulation or because they are ill prepared to defend their positions. The CPSC is more than willing to work with a pharmaceutical company and to consider reasonable arguments; available scientific, medical, and engineering data; manufacturing practices; and the nature and use of the substance.
Under the PPPA, regulated substances must be packaged in accordance with the act when the primary packaging contains a toxic amount of the drug. Samples and trial packs are therefore included if they hold a regulated substance containing a toxic amount over the regulated amount or otherwise can cause serious injury or illness to a 25-lb child.
CPSC regulates drugs, not packages. As a result, CPSC issues packaging performance guidelines, not design guidelines. It does not mandate package style, product count, or quantity. It can, however, prohibit packaging that is unnecessarily attractive to children. This could be a deterrent to implementing certain compliance-enhancing measures. Bright colors, for instance, are often used to enhance memory. But they may also be inviting to children.
Most times we accept blisters with numbers or days of the week on them to encourage compliance. Many times they do not. The rate of compliance is influenced strongly by diagnosis and drug type.
There has been little effort to use the tools of compliance within the realm of packaging. There are parking garages that do a better job of reminding us where we have parked than a package does of reminding us to take our medication, or that we already have. The inherent compliant nature of a blister is useful mainly when the product is dispensed from a package under the administration of a professional in a healthcare facility.
Dual-purpose closures are permitted by the CPSC. These are the reversible closures that can be applied in either a child-resistant or regular mode. They certainly are not favored, but are permitted. The pharmacist has a legal obligation to distribute this closure with the child-resistant feature activated. Blisters would be treated similarly if there were a blister that could be made reversible.
Other, random points made at the forum include:
--If the substance requires special packaging under the PPPA, the United States Post Office requires special packaging.
--It is prohibited to mail samples to multiple-tenant buildings.
--Many accidental ingestions are caused when pill reminders or calendar trays are used. When multiple drugs are placed in them, these unprotected trays become a source of "cocktail nightmares."
--If a physician prescribes a non-child-resistant package, he has made the determination that child-resistant packaging is not necessary for this particular patient. Therefore, he has accepted responsibility for whatever consequences may occur. Beyond that, the physician's insurance company has also been implicated from a liability standpoint. This is the primary reason why some pediatricians have refused to dispense non-child-resistant packages as samples.
In discussions with a number of attendees, I have learned that most feel encouraged by the direction CPSC has been taking. Many in industry are assertively pursuing the challenge of devising a child-resistant, senior-friendly package through science and technology. Vendors and packagers alike are attempting to make the process more transparent, from formulation to commercialization. This is a healthy approach, and it will go a long way toward protecting children.