Section 9.4: Poison Prevention Packaging Act & Child-Resistant Containers

Section 9.4: Poison Prevention Packaging Act & Child-Resistant Containers

The Poison Prevention Packaging Act of 1970 (PPPA) is a federal law aimed at protecting young children from accidental poisoning by household substances, including prescription and over-the-counter medications. Enforced by the Consumer Product Safety Commission (CPSC), the PPPA mandates the use of child-resistant (CR) packaging for most oral medications. Because the PPPA is a federal statute, compliance is enforced at both the federal level and by the Texas State Board of Pharmacy (TSBP) during routine pharmacy inspections.

Child-Resistant Packaging Standards and Testing

To be classified as "child-resistant," packaging must undergo rigorous testing using specific panels of children and adults. The standards are defined as follows:

• Child Testing Panel: A panel of children aged 42 to 51 months is given 5 minutes to attempt to open the package. They are then given a visual demonstration of how to open it, and another 5 minutes. The packaging is considered child-resistant if at least 85% of the children cannot open it during the first 5 minutes, and at least 80% cannot open it after the demonstration.
• Adult Testing Panel: A panel of adults aged 50 to 70 years is given 5 minutes to open and, if applicable, properly reclose the package. To ensure that child-resistant packaging does not prevent seniors from accessing their medications, at least 90% of the adult panel must be able to open and close the package successfully.

PPPA Drug Coverage and Exemptions

The PPPA applies to all oral prescription (legend) drugs and several categories of over-the-counter (OTC) medications. However, the law provides a comprehensive list of exemptions. These exemptions exist because certain medications are needed in acute emergencies where any delay in opening the container could result in severe harm or death, or because the drug has an extremely low toxicity profile.

Pharmacists must memorize the major exemptions for the MPJE:

1. Sublingual Nitroglycerin: All strengths of sublingual nitroglycerin tablets must be dispensed in non-child-resistant containers (typically the manufacturer's original glass bottle) because patients experiencing an acute angina attack must have immediate access to the drug.
2. Isosorbide Dinitrate: Sublingual and chewable forms of isosorbide dinitrate in strengths of 10 mg or less are exempt.
3. Methylprednisolone Tablets: Dosepacks containing not more than 84 mg of methylprednisolone (e.g., Medrol Dosepack) are exempt.
4. Oral Contraceptives: Estrogen-progestin oral contraceptives dispensed in manufacturer mnemonic (dialpack) dispenser packages are exempt.
5. Conjugated Estrogens: Tablets dispensed in mnemonic dispenser packages containing not more than 32 mg of conjugated estrogens are exempt.
6. Norethindrone Acetate: Tablets dispensed in mnemonic dispenser packages containing not more than 50 mg of norethindrone acetate are exempt.
7. Medroxyprogesterone Acetate: Medroxyprogesterone acetate tablets are exempt.
8. Potassium Supplements: Unit-dose forms (effervescent tablets, unit-dose liquids, and powders) containing not more than 50 mEq of potassium per unit dose are exempt.
9. Erythromycin Ethylsuccinate (EES):
   • Oral suspensions in packages containing not more than 8 grams of equivalent erythromycin are exempt.
   • Tablets in packages containing not more than 16 grams of equivalent erythromycin are exempt.
10. Anhydrous Cholestyramine: Powdered forms of anhydrous cholestyramine are exempt.
11. Colestipol: Powdered colestipol in packages containing not more than 5 grams of colestipol is exempt.
12. Sodium Fluoride: Liquid and tablet preparations containing not more than 264 mg of sodium fluoride per package are exempt.
13. Pancrelipase Preparations: All forms of pancrelipase (enzymes) are exempt.
14. Mebendazole: Tablets in packages containing not more than 600 mg of mebendazole are exempt.
15. Sacrosidase (Sucrase): Preparations in a solution of glycerol and water are exempt.
16. Hormone Replacement Therapy (HRT): Products that rely solely upon the activity of one or more progesterone or estrogen substances are exempt.

Note that non-oral dosage forms (e.g., topical ointments, creams, transdermal patches, eye drops, ear drops) are not covered by the PPPA's oral medication requirements, though they may be subject to other child-resistant regulations depending on their ingredients (e.g., iron-containing products).

Requests for Non-Child-Resistant Packaging

Under the PPPA, a pharmacy may dispense a covered oral medication in a non-child-resistant container under two specific circumstances:

1. Patient Requests

A patient or the patient's authorized representative can request that their medications be dispensed in non-child-resistant (easy-open) containers.

• Individual vs. Blanket Request: A patient may request that a single prescription be dispensed in non-CR packaging, or they can issue a blanket request covering all current and future prescriptions filled at that pharmacy.
• Documentation: A blanket request does not legally have to be in writing under federal law, but the TSBP and risk-management best practices strongly advise pharmacies to obtain a signed, written statement from the patient. The pharmacy must document the request on the patient's profile.

2. Practitioner Requests

A prescribing practitioner can request that a prescription be dispensed in non-child-resistant packaging.

• Individual Request Only: A prescriber can only make a request for a single prescription and its refills. A practitioner cannot make a blanket request for all prescriptions written for a patient, nor can they make a blanket request for all patients in their practice.
• Refills: The prescriber’s request is valid for the life of that specific prescription (including refills). Once the prescription expires and a new one is written, the prescriber must request non-CR packaging again if desired.

Reusing Prescription Containers

The PPPA establishes strict rules regarding the physical reuse of prescription vials and caps when refilling a prescription. The goal is to prevent wear and tear from compromising the child-resistant mechanism.

• Plastic Vials and Caps: Must not be reused. Every time a prescription is filled or refilled, a brand new plastic vial and a brand new plastic cap must be used.
• Glass Containers: May be reused, but the plastic safety cap must still be replaced with a new one.

Common Exam Traps and Legal Nuances

• Institutional Exemptions: Medications dispensed to inpatients of hospitals or long-term care facilities are exempt from PPPA requirements, provided that the facility's personnel administer the medications directly to the patients. However, if a resident in a nursing home keeps their own medications at their bedside, those medications must be in child-resistant packaging.
• OTC Products in Non-CR Packaging: The PPPA allows manufacturers of OTC products to package one size of an OTC product in non-child-resistant packaging, provided that the package bears the statement: "This package for households without young children" or "Package Not Child-Resistant", and the manufacturer also offers the product in popular child-resistant sizes.
• Nitroglycerin Forms: Only sublingual nitroglycerin tablets are exempt under the cardiac exception. Oral nitroglycerin sustained-release capsules or tablets are not exempt and must be dispensed in child-resistant packaging.
• Civil Liability: Dispensing a medication in violation of the PPPA (e.g., failing to use a CR container without a request) is a federal violation and can lead to severe civil liability (malpractice) if a child is poisoned, in addition to TSBP disciplinary action.