This space is reserved for an article that will be posted here shortly. In the mean time please check out the article on Federal pharmacy law.

The pharmaceutical industry is a highly regulated industry with laws impacting it dating back as far as the Pure Food and Drug Act of 1906 to the Kefauver-Harris Amendment of 1962 to various impacts from the Patient Protection and Affordable Care Act of 2010, and many laws in between. Despite being a highly regulated industry already, according a recent (2010) Harris Poll, 10% of Americans would like to see an increase in regulation on pharma and drug companies. With that in mind, there are sure to be additional regulations placed on the industry in the future.

This article will focus on the following knowledge areas to provide an overview of pharmacy laws and regulations:

• Storage, handling, and disposal of hazardous substances and wastes (e.g., MSDS)
• Hazardous substances exposure, prevention and treatment (e.g., eye wash, spill kit, MSDS)
• Controlled substance transfer regulations (DEA)
• Controlled substance documentation requirements for receiving, ordering, returning, loss/theft, destruction (DEA)
• Formula to verify the validity of a prescriber’s DEA number (DEA)
• Record keeping, documentation, and record retention (e.g., length of time prescriptions are maintained on file)
• Restricted drug programs and related prescription-processing requirements (e.g., thalidomide, isotretinoin, clozapine)
• Professional standards related to data integrity, security, and confidentiality (e.g., HIPAA, backing up and archiving)
• Requirement for consultation (e.g., OBRA-90)
• FDA’s recall classification
• Infection control standards (e.g., laminar air flow, clean room, hand washing, cleaning counting trays, countertop, and equipment) (OSHA, USP 795 and 797)
• Record keeping for repackaged and recalled products and supplies (TJC, BOP)
• Professional standards regarding the roles and responsibilities of pharmacists, pharmacy technicians, and other pharmacy employees (TJC, BOP)
• Reconciliation between state and federal laws and regulations
• Facility, equipment, and supply requirements (e.g., space requirements, prescription file storage, cleanliness, reference materials) (TJC, USP, BOP)

Terminology

To get started with, there is some terminology that should be defined.

National Institute for Occupational Safety and Health (NIOSH) - NIOSH is part of the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS). NIOSH is responsible for conducting research and making recommendations for the prevention of work-related injury and illness. Of particular interest to pharmacy is their role in establishing a list of Hazardous Drugs (HDs).

hazardous drugs (HDs) - Hazardous drugs are identified as hazardous or potentially hazardous based on the following six criteria:

• carcinogenicity, which is the ability to cause cancer in animal models, humans or both;
• teratogenicity, which is the ability to cause defects on fetal development or fetal malformation;
• drugs are known to have the potential to cause fertility impairment;
• organ toxicity at low doses in humans or animals;
• genotoxicity, which is the ability to cause a change or mutation in genetic material; and
• new drugs that mimic existing HDs in structure or toxicity.

These drugs are often classified as antineoplastics, cytotoxic agents, biologic agents, antiviral agents, and/or immunosuppressive agents. As of writing this text the 2014 NIOSH list of HDs is the current standard and may be found at http://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf

Occupational Safety and Health Administration (OSHA) - OSHA is a government agency within the United States Department of Labor responsible for maintaining safe and healthy work environments.

Material Safety Data Sheet (MSDS) - OSHA-required notices on hazardous substances which provide information on potential hazards associated with a particular material or product, safe handling procedures, proper clean-up, and first aid information.

personal protective equipment (PPE) - Personal protective equipment is worn by an individual to provide both protection to the wearer from the environment or specific items they are manipulating, and to prevent exposing the environment or the items being manipulated directly to the wearer of the PPE.

Drug Enforcement Administration (DEA) - The Drug Enforcement Administration (DEA) is a United States Department of Justice law enforcement agency, a federal police service tasked with enforcing the Controlled Substances Act of 1970.

controlled substances - Controlled substances are medications with restrictions due to abuse potential. There are 5 schedules of controlled substances with various prescribing guidelines based on abuse potential, counter balanced by potential medicinal benefit as determined by the Drug Enforcement Administration and individual state legislative branches.

Risk Evaluation and Mitigation Strategy (REMS) - The Food and Drug Administration may require risk evaluation and mitigation strategies (REMS) on medications, if necessary, to minimize the risks associated with some drugs. REMS may require a medication guide, a communications plan, elements to assure safe use, an implementation plan, and a timetable for submission of assessments.

United States Pharmacopeia (USP) - The United States Pharmacopeia (USP) is the official pharmacopeia of the United States, and is published dually with the National Formulary as the USP-NF. Prescriptions and over-the-counter medicines, and other healthcare products sold in the United States, are required to follow the standards in the USP-NF. The USP also sets standards for food ingredients and dietary supplements. Chapters in the USP that are listed as below 1000 are considered enforceable, while chapters enumerated as 1000 or greater are considered guidelines. Therefore, USP 797 and USP 795 are considered enforceable, while USP 1160 and USP 1176 are simply considered guidelines for best practices.

compounded sterile preparations (CSP) - Compounded sterile preparations are admixtures that need to be assembled under aseptic conditions to prevent contamination.

Safety requirements

There is a vast array of information to be aware of with safety requirements posed by various organizations. Of particular concern is the safe storage, handling, managing accidental exposure, and disposal of hazardous materials. Hazardous drugs are drugs that are known to cause genotoxicity, which is the ability to cause a change or mutation in genetic material; carcinogenicity, which is the ability to cause cancer in animal models, humans or both; teratogenicity, which is the ability to cause defects on fetal development or fetal malformation; and lastly, hazardous drugs are known to have the potential to cause fertility impairment, which is a major concern for most clinicians. These drugs can be classified as antineoplastics, cytotoxic agents, biologic agents, antiviral agents, and immunosuppressive agents. This is why safe handling of hazardous drugs is crucial.

Product storage

The safety requirements include everything from the proper inventory rotation to avoid dispensing expired products, to material safety data sheets to provide the necessary information for safe clean up after accidental spills, to appropriate handling of oncology materials, and proper storage of chemicals and flammable items.

Proper rotation of inventory and periodic checking of expirations help to reduce the potential for dispensing expired medications. It also maximizes the utilization of inventory before medications become outdated. When looking at expirations on medication vials, it is important to note that if a medication only mentions the month and year, but not the day, then you are to treat it as expiring at the end of the month. As an example, if a medication is marked as expiring on 02/2020, then you would treat it as expiring on February 29, 2020.

The Occupational Safety and Health Administration (OSHA) requires all workplaces, including pharmacies, to carry material safety data sheets (MSDS) for all hazardous substances that are stored on the premises. This includes oncology drugs and volatile chemicals along with other hazardous chemicals. The MSDS provide handling, clean-up, and first-aid information.

Segregating inventory by drug categories helps to prevent potentially harmful errors. The Joint Commission (TJC), formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), requires that internal and external medications must be stored separately. This reduces the potential that someone will dispense or administer an external product for internal use. The Joint Commission also has requirements for separate storage of oncology drugs and volatile or flammable substances.

Hazardous drugs (e.g., oncology drugs) shall have a separate space on the shelves at or below eye level and should be labeled in such a way that it will alert staff of the hazardous potential of these medications. HDs in their final dosage form or unit of use may be interspersed with other medications on the shelves but still need to be adequately labeled. Oncology drugs are often cytotoxic themselves and must be handled with extreme care. They should be received in a sealed protective outer bag that restricts dissemination of the drug if the container leaks or is broken. Staff should wear personal protective equipment (PPE) when receiving and storing HDs. When an increased potential exists for exposure to hazardous drugs, all personnel involved must wear additional PPE while following a hazardous materials cleanup procedure. All exposed materials must be properly disposed of in hazardous waste containers.

Volatile or flammable substances (including tax free alcohol) require careful storage. They must have a cool location that is properly ventilated. Their storage area must be designed to reduce fire and explosion potential.

Product handling

Whenever receiving and/or handling hazardous materials, individuals are recommended to use personal protective equipment (PPE). PPE typically consists of booties, hair covers, a respirator (typically a HEPA mask), face shield, coated gowns capable of providing at least 4 hours of protection if accidentally exposed, powder free impermeable gloves (either double gloved and/or chemotherapy gloves). The American Society of Healthsystem Pharmacists (ASHP) and the National Institute of Occupational Safety and Health (NIOSH) both recommend changing gowns every three hours during extended work with hazardous substances. It is also recommended that gloves be changed every 30 minutes. For more specific guidelines associated with the proper selection of PPE for use with HDs, consult the following table (table has been adopted from material in the USP):

Insert ppe for hds table here from info in usp 800

Accidental exposure

Workers may be exposed to a hazardous drug at any point during its manufacture, transport, distribution, receipt, storage, preparation, and administration, as well as during waste handling, and equipment maintenance and repair. All workers involved in these activities have the potential for contact with uncontained drug.

In case of accidental exposure, you should consult the Material Safety Data Sheet (MSDS) which provide information on potential hazards associated with a particular material or product, safe handling procedures, proper clean-up, and first aid information. An eyewash is an appropriate device to utilize if hazardous or other unwanted materials come in contact with the eye. The individual exposed will probably be required to file an initial incident report (IIR) with their facility.

Facilities that utilize hazardous drugs are required to have spill kits, which may be useful in the containment and cleanup of hazardous materials. Spill kits typically contain PPE, waste containers, warning signs to help minimize traffic through the contaminated area, powders for solidifying liquids, disposable scoops and brushes, absorbent gauze or pads, and a common deactivating agent such as sodium hypochlorite.

Proper waste disposal

Properly labeled, leak-proof, and spill-proof containers of non reactive plastic are required for areas where hazardous waste is generated, and can be further broken down into either yellow or black containers. Fully used vials, syringes, tubing, and bags of hazardous drug waste, along with PPE used while working with hazardous drugs, may be disposed in yellow, properly labeled containers. Also, any partially used or expired hazardous drugs that are not also considered to be RCRA (Resource Conservation and Recovery Act) regulated hazardous drugs should be placed in these yellow buckets. Trace contaminated items such as booties, gowns, and masks, even if they were not involved in spills, MUST be treated as hazardous waste (the yellow buckets are sufficient for this).

Partially used bags, vials, syringes, etc. of RCRA listed hazardous pharmaceutical waste MUST be placed in black RCRA approved containers. Hazardous waste must be properly manifested and transported by a federally permitted hazardous waste transporter to a federally permitted hazardous waste storage, treatment, or disposal facility.

A licensed contractor may be hired to manage the hazardous waste program.

1. The Harris Poll, Americans Less Likely to Say 18 of 19 Industries are Honest and Trustworthy This Year, December 12, 2013, http://www.harrisinteractive.com/vault/Harris%20Poll%2096%20-%202013%20Industry%20Regulation_12.12.2013.pdf