Chapter 1.27-37.edited.docx

Poison Prevention Packaging Act of 1970 (PPPA) Administered by the Consumer Product Safety Commission (CPSC). Requires child-resistant containers for all prescription drugs and for the following nonprescription drugs, drug classes, preparations, or dietary supplements: Aspirin—Any aspirin-contain...

Poison Prevention Packaging Act of 1970 (PPPA) Administered by the Consumer Product Safety Commission (CPSC). Requires child-resistant containers for all prescription drugs and for the following nonprescription drugs, drug classes, preparations, or dietary supplements: Aspirin—Any aspirin-containing preparation for human use in dosage form intended for oral administration. Methyl Salicylate (oil of wintergreen)—Liquid preparation5 containing more than 5% by weight of methyl salicylate unless packaged in pressurized spray containers. Controlled Drugs Note: There are some Schedule V controlled substances available without a prescription under federal law, but this doesn't apply in Texas. See Chapter Three in this book. Methyl Alcohol (methanol)—Household substances in liquid form containing 4% or more by weight of methyl alcohol unless packaged in a pressurized spray container. Iron-Containing Drugs—With the exception of animal feeds used as vehicles for the administration of drugs, noninjectable animal and human drugs providing iron for therapeutic or prophylactic purposes, which contain a total amount of elemental iron equivalent to 250 mg. Dietary Supplements Containing Iron—With the exception of those preparations in which iron is present solely as a colorant, dietary supplements that contain an equivalent of 250 mg or more of elemental iron in a single package. 56 Copyright 0 2023 Gary Cacciatore Scanned with CamScanner Acetaminophen—Preparations for human use in a dosage form intended for oral administration and containing more than 1 g of acetaminophen in a single package. Exemptions: Acetaminophen-containing effervescent tablets or granules containing less than 10% acetaminophen with a median lethal dose greater than 5 g/kg of body weight and that release at least 85 ml of carbon dioxide per grain of acetaminophen when placed in water. Unflavored acetaminophen-containing preparations in powder form, other than those intended for pediatric use, that are packaged in unit doses with no more than 13 grains of acetaminophen per unit dose and that contain no other substance subject to the special packaging requirements. Diphenhydramine HCl—Preparations for human use in oral dosage forms containing more than the equivalent of 66 mg of diphenhydramine base in a single package. Ibuprofen—Preparations for human use in oral dosage forms containing 1 gram or more of ibuprofen in a single package. Loperamide—Preparations for human use in oral dosage forms containing more than 0.045 mg of loperamide in a single package. Lidocaine—Products containing more than 5 mg of lidocaine in a single package (includes all dosage forms, including creams, sprays, and transdermal patches). Dibucaine—Products containing more than 0.5 mg of dibucaine in a single package (includes all dosage forms, including creams, sprays, and transdermal patches). Naproxen—Preparations for human use in oral dosage forms containing 250 mg or more of naproxen in a single package. Ketoprofen—Preparations for human use in oral dosage forms containing more than 50 mg of ketoprofen in a single package. Fluoride—Products containing more than 50 mg of elemental fluoride and more than 0.5% fluoride in a single package. Minoxidil—Preparations for human use containing more than 14 mg of minoxidil in a single package (includes topical products that must continue to meet requirements once the applicator is installed by the consumer). 57 Copyright & 2023 Gary Cacciatore Imidazolines—Products containing 0.08 mg or more in a single package. Imidazoline is a drug class that includes tetrahydrozoline, naphazoline, oxymetazoline, and xylometazoline, often found in ophthalmic and nasal products. Any drug switched from Rx to OTC status. Exemptions: Reque5t of patient or physician. STUDY TIP: Only the patient can provide a blanket request for all future prescriptions. The prescriber can only request a non-child-resistant container on an individual prescription. The request is not required to be in writing, although it is good practice to have it in writing. Bulk containers are not intended for household use. Drugs are distributed to institutionalized patients. Prescription drugs are packaged for residents of LTCFs and other institutional settings if the facility personnel will administer the medications to the patients. s. One package size of OTC drugs designed for the elderly. Specific prescription and nonprescription drug exemptions include: Oral contraceptives, conjugated estrogens, and norethindrone acetate are in the manufacturer's dispenser package. Medroxyprogesterone acetate tablets. Sublingual nitroglycerin and sublingual and chewable isosorbide dinitrate of 10 mg or less. Aspirin and acetaminophen in effervescent tablets or granules. Potassium supplements in unit-dose packaging. Sodium fluoride containing no more than 264 mg of sodium fluoride per package. Anhydrous cholestyramine and colestipol packets. Erythromycin ethyl succinate granules for oral suspension and oral suspensions in packages containing no more than 8 g of erythromycin. Erythromycin ethyl succinate tablets in packages containing no more than 16 g erythromycin. Prednisone tablets containing no more than 105 mg per package. Methylprednisolone tablets containing no more than 84 mg per package. 58 Copyright B 2023 Gary Cacciatore J. Mebendazole tablets containing no more than 600 mg per package. Betamethasone tablets containing no more than 12.6 mg per package. Preparations in aerosol containers intended for inhalation. Pancrelipase preparations. Sucrose preparations in a solution of glycerol and water. Hormone replacement therapy products that rely solely upon the activity of one or more progestogen or estrogen substances. STUDY TIP: It is important to know all of the products that are exempt from the Poison Prevention Packaging Act, including details as to strengths and dosage forms. BONUS STUDY TIP: For pharmacies, the law requires the dispensing of medications in a new vial/bottle and safety cap with each prescription filled. A pharmacy is permitted to reuse a glass container if a new safety cap is provided with each fill. EXTRA BONUS STUDY TIP: When a pharmacist does not comply with PPPA, in addition to violating PPPA (CPSC enforces), it is also a misbranding violation of FDCA (FDA enforces). Other Federal Laws and Regulations Federal Hazardous Substances Act of 1966 The Consumer Product Safety Commission administers and enforces this act, which is intended to protect consumers from hazardous and toxic substances. Requires the label on the immediate package of a hazardous product and any outer wrapping or container that might cover up the label on the package to have the following information in English: The name and business address of the manufacturer, packer, distributor, or seller; The common or usual or chemical name of each hazardous ingredient; 59 Copyright B 2023 Gary Cacciatore The signal word “Danger” for products that are corrosive, extremely flammable, or highly toxic; The signal word “Caution” or “Warning” for all other hazardous products; An affirmative statement of the principal hazard or hazards that the product presents (e.g., “Flammable,” "Harmful if Swallowed,” “Causes Burns,” “Vapor Harmful,” etc.); Precautionary statements telling users what they must do or what actions they must avoid to protect themselves; g• Where it is appropriate, instructions for first aid treatment if the product injures someone; The word “Poison” for a product that is highly toxic, in addition to the signal word “Danger”; If a product requires special care in handling or storage, instructions for consumers to follow to protect themselves; and j• . The statement “Keep out of the reach of children.” If a hazardous product such as a plant does not have a package, it still must have a hang tag that contains the required precautionary information. That information must also be printed in any literature that accompanies the product, and that contains instructions for use. The act does not apply to drugs regulated by the FDA but may apply to other products sold in a pharmacy, such as bleach, cleaning fluids, antifreeze, etc. Federal Hazard Communication Standard The Occupational and Safety Health Administration (OSHA) administers and enforces this regulation, which requires employers (including pharmacies) that deal with hazardous materials to meet the Hazard Communication Standard. See 29 CFR 1910.1200. The standard requires chemical manufacturers and importers to classify the hazards of chemicals they produce or import and to prepare appropriate labels and Safety Data Sheets (SDS), which were formerly known as Material Safety Data Sheets (MSDS). Drugs in solid, final dosage form for administration to patients (such as tablets or capsules) are exempt from these requirements. However, hazardous drugs such as those subject to USP 800, chemicals, or products not in solid, final dosage form for administration (such as liquid products used 60 Copyright 0 2023 Gary Cacciatore in compounding) may be covered. Generally, a pharmacy may rely on the manufacturer to determine if a product is considered hazardous and will supply an SDS for that product. If a pharmacy has any such products, it is required to have a written Hazard Communication Plan. The plan must include a list of hazardous chemicals in the workplace, must ensure all such products are appropriately labeled and have a Safety Data Sheet and must include training for all workers on the hazards of chemicals, appropriate protective measures, and where and how to obtain additional information. Note: Additional details can be found in OSHA's publication “Small Entity Compliance Guide for Employers that Use Hazardous Chemicals.” Centers for Medicare and Medicaid Services (CMS) Requirements Tamper-Resistant Prescriptions—CMS requires that all written prescriptions meet certain tamper-resistant requirements to prevent unauthorized copying and to prevent counterfeiting (with some exceptions). The tamper-evident features must include: One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form; One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription pad by the prescriber; and One or more industry-recognized features designed to prevent the use of counterfeit prescription forms. Pharmacy Services at Long-Term Care Facilities Medication Regimen Reviews—CMS regulations require a consultant pharmacist to perform a Medication Regimen Review for all long-term care patients every 30 days. The pharmacist must report any irregularities to the attending physician, the facility's medical director, and the facility's director of nursing, and these reports must be acted upon. Each resident's drug therapy must be free of unnecessary drugs. This includes avoiding drugs at excessive doses or durations and limiting psychotropic drugs to diagnosed and documented conditions. 61 Copyright 0 2023 Gary Cacciatore When used PRN, psychotropic drugs must be limited to 14 days unless the practitioner documents the rationale for extending an order beyond 14 days. PRN orders for psychotropic drugs cannot be renewed unless the attending physician evaluates the patient for the appropriateness of that drug. To reduce medication waste, pharmacies may not dispense more than a 14-day cycle of medications to LTCF residents, with limited exceptions. Pharmacies must ensure routine and emergency drugs are provided in a timely manner to all residents. The use of emergency medication kits is permissible to help meet this requirement. DeliveringPrescriptions by U.S. Mail or Common Carrier Delivery by Mail (postal regulations administered by the U.S. Postal Service)—General postal regulations do not allow dangerous substances to be mailed; however, there are exceptions for prescription drugs. Non-controlled—Prescriptions containing non-controlled substances (Dangerous Drugs) may be mailed by a pharmacy to the ultimate user, provided that the medications are not alcoholic beverages, poisons, or flammable substances. Controlled substances may be mailed to patients under the following requirements: The prescription container must be labeled in compliance with prescription labeling rules; The outer wrapper or container in which the prescription is placed must be free of markings that would indicate the nature of the contents (including the name of the pharmacy as part of the return address on the mailing package, as that may alert individuals that drugs may be in the package); and No markings of any kind may be placed on the package to indicate the nature of the contents. Controlled substances may be mailed to other DEA registrants (practitioners, other pharmacies, distributors, or drug disposal firms), provided they are placed in a plain outer container or securely overwrapped in plain paper and all recordkeeping requirements are met. Delivery by Common Carrier—Any prescription drug may be delivered from a pharmacy to a patient by a common 62 Copyright O 2023 Gary Cacciatore carrier such as UPS or FedEx. This delivery includes all schedules of controlled substances and dangerous drugs. Common carriers are not subject to postal regulations. Federal Tax-Free Alcohol Regulations Pharmacies sometimes use 95% ethanol (190 proof) for compounding purposes. When used for scientific, medicinal, or mechanical purposes or to treat patients, such alcohol is considered “tax-free." s. The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates tax-free alcohol with the federal Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF). ATF is responsible for enforcement. A user permit must be acquired from TTB, and specific recordkeeping requirements must be met. Tax-free alcohol cannot be resold or used in any beverage product. Privacy—HIPAA, HITECH, and "Texas HIPAA" Most pharmacies are a “covered entity" under HIPAA and must be in compliance with these requirements. Notice and Acknowledgement Pharmacies must provide patients with a “Notice of Privacy Practices” and make a good faith effort to obtain a written acknowledgment of receipt of the Notice from the patient. The Notice must be provided upon first service delivery to the patient. The HIPAA privacy rule requires mandatory provisions in the Notice. Use and Disclosure of Protected Health Information (PHI) Protected Health Information (PHI) is the HIPAA term for patient-identifiable information. Pharmacies may use and disclose PHI to provide treatment for payment and for healthcare operations without authorization from the patient. Pharmacies may also use and disclose PHI for certain governmental functions without authorization from the patient. This includes uses and disclosures for public health activities such as reporting adverse events to the FDA, to health oversight agencies such as boards of pharmacies or state drug monitoring programs, and to law enforcement agencies. 63 Copyright 0 2023 Gary Cacciatore Scanned with CamScanner Other uses and disclosures, such as for marketing purposes, require a signed authorization from the patient. If the covered entity receives remuneration for the marketing, the authorization form must expressly inform the patient of such. S. Face-to-face communications about alternative drugs or health products are considered part of treatment and not marketing. 6. Refill reminders for a currently prescribed drug (or one that has lapsed for no more than 90 days) are not considered marketing as long as any payment made to the pharmacy in exchange for making the communication is reasonable and related to the pharmacy's cost of making the communication. 0. Business Associates (BAs) J. BAs are persons or entities, other than members of a pharmacy's workforce, who perform a function or service on behalf of the pharmacy that requires the use or disclosure of PHI (e.g., collection agencies and external auditors). Pharmacies are required to enter into business associate contracts with these B.A.s, which require the B.A.s to meet many of the same requirements for protecting PHI as a covered entity under HIPAA. Patient Rights and Administrative Requirements Patients have a right to access and obtain a copy of their PHI. Covered entities, including pharmacies, must comply with a request within 30 days but may extend time by no more than 30 additional days if they notify the individual of the reason for the delay. STUDY TIP: TSBP Rule 291.28 requires pharmacies to reply to a request from a patient for a copy of his or her confidential information within 15 days, which is stricter than HIPAA. Patients have a right to amend their PHI records and request an accounting of disclosures of their PHI made by a pharmacy under certain circumstances. Pharmacies must comply with a request to amend or request for an accounting of disclosures within 60 days but may extend by no more than 30 additional days if they notify the individual of the reason for the delay. Pharmacies must establish policies and procedures to protect from accidental or intentional uses and disclosures of PHI through the use of appropriate administrative, technical, and physical safeguards to protect the privacy of PHI. —— — —-—64 Copyright B 2023 Gary Cacciatore Pharmacies must train all employees on privacy policies and impose sanctions on employees for any violations of privacy policies. Pharmacies must designate a Privacy OSicial who is responsible for the development and implementation of HIPAA-related policies and procedures and compliance. Pharmacies must also designate a contact person to receive complaints. This person may also be the Privacy Official. Minimum Necessary Standard. When using and disclosing PHI, a pharmacy must make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose. The minimum necessary standard does not apply to disclosures to healthcare providers for treatment purposes. These disclosures would include prescription transfers or providing prescription information to physicians. The minimum necessary standard does not apply to disclosures for which the patient has signed an authorization. The minimum necessary standard does apply to disclosures for payment. Incidental Disclosures. Unintended “incidental” disclosures are not a violation of the Privacy Rule as long as reasonable safeguards are in place. Examples: Sales representatives or janitorial service members accidentally see PHI during the normal course of their jobs; a customer overhears counseling that is performed discreetly in a private area. Note: PHI must be properly disposed of by pharmacies. Pharmacies have been fined for improperly disposing of PHI (such as labeled pharmacy vials and paper records) into dumpsters accessible to the public and unauthorized individuals. HITECH Act—The HITECH Act amended HIPAA to strengthen many of its provisions. Among other things, the HITECH Act added a breach notification requirement that requires: Covered entities, including pharmacies, to notify individuals of a breach of their “unsecured” PHI within 60 calendar days after the breach is discovered. 65 Copyright 0 2023 Gary Cacciatore B.A.s to report any breaches of unsecured PHI to the covered entity and provide the identities of each affected individual. z. A “breach” is defined as the unauthorized acquisition, access, use, or disclosure of PHI that compromises its security or privacy. It does not include instances in which there has been an inadvertent disclosure from an authorized individual to another person authorized to access PHI within the same organization. A breach also does not include instances in which the covered entity or B.A. has a good faith belief that the PHI is not further acquired, accessed, retained, used, or disclosed. For breaches affecting fewer than 500 individuals, covered entities must maintain a log of these breaches and notify HHS of these breaches annually. If more than 500 individuals are affected, the Secretary of HHS and prominent local media must be notified in addition to the affected individuals within 60 days after the breach is discovered. Texas “HIPAA”—Texas privacy laws, among other requirements, have a broader definition of a covered entity and more stringent training requirements. See the TEPDL pages A.41-45. The Texas State Board of Pharmacy also has specific rules on “Confidentiality” and “Patient Access to Confidential Records” that are generally consistent with HIPAA. One difference, however, is that TSBP rules require a pharmacy to respond to a request for confidential records by a patient within 15 days, which is stricter than HIPAA's 30-day timeline. See TSBP Rules 291.27 and 291.28 or TFPDL pages E.18-20. 66 Copyright O 2023 Gary Cacciatore