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	#Pharmacy Times, ''A Review of Federal Legislation Affecting Pharmacy Practice'', Virgil Van Dusen , RPh, JD and Alan R. Spies , RPh, MBA, JD, PhD, https://secure.pharmacytimes.com/lessons/200612-01.asp		#Pharmacy Times, ''A Review of Federal Legislation Affecting Pharmacy Practice'', Virgil Van Dusen , RPh, JD and Alan R. Spies , RPh, MBA, JD, PhD, https://secure.pharmacytimes.com/lessons/200612-01.asp
	#''Strauss's Federal Drug Laws and Examination Review, Fifth Edition'' (revised), Steven Strauss, CRC Press, 2000		#''Strauss's Federal Drug Laws and Examination Review, Fifth Edition'' (revised), Steven Strauss, CRC Press, 2000
		+	#''Pharmacy Technician Practice and Procedures'', Gail G. Orum Alexander and James J. Mizner, Jr., McGraw Hill, 2011

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Revision as of 08:06, 10 February 2015

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.

Comprehensive Drug Abuse Prevention and Control Act of 1970 (with updates)

The Controlled Substances Act (CSA) was passed by Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. And signed into law by President Richard Nixon on October 27, 1970.

Since the passage of the Harrison Narcotics Tax Act in 1914 many attempts had been made to strengthen government control and regulation of illicit substances with varying degrees of success. The Comprehensive Drug Abuse Prevention and Control Act is our countries most ambitious attempt to date and replaces similar legislation from the past including the Harrison Narcotics Tax Act.

The Comprehensive Drug Abuse Prevention and Control Act provides for the classification, acquisition, distribution, registration/verification of prescribers, and appropriate record keeping requirements of controlled substances. This act also provided the legal framework for the creation of the Drug Enforcement Administration (DEA), which is the organization primarily tasked with the enforcement responsibilities of the CSA.

To ensure an appropriate understanding of this law various updates will be included with discussion of this act.

Classification of controlled substances

Besides over the counter medications (OTC) such as aspirin and ibuprofen, behind the counter medications (BTC) such as Allegra-D (fexofenadine with pseudoephedrine), and prescription medications (Rx legend) such as amoxicillin and digoxin, there is another group of medications to be concerned with called controlled substances.

Controlled substances are medications with further 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. The DEA is provided with this authority by the Controlled Substances Act. Below is a brief explanation of the schedules along with example medications.

Schedule I (CI)

• Characteristics:
  • Unaccepted medical use.
  • Highest potential for abuse.
  • Not available by a prescription.
• Examples:
  • LSD
  • heroin
  • Quaaludes (methaqualone)

Schedule II (CII)

• Characteristics:
  • High potential for abuse or misuse.
  • Sufficient medicinal use to justify availability as a prescription.
• Examples:
  • oxycodone
  • morphine
  • amphetamines
  • Vicodin (hydrocodone bitartrate and acetaminophen)

Schedule III (CIII)

• Characteristics:
  • Potential risk for abuse, misuse, and dependence.
• Examples:
  • Suboxone (buprenorphine and naloxone)
  • AndroGel (testosterone)
  • Codeine when combined with acetaminophen or a cough suppressant in a solid dosage form (tablet, capsule, etc.).

Schedule IV (CIV)

• Characteristics:
  • Low potential for abuse and limited risk of dependence.
• Examples:
  • phenobarbital
  • benzodiazepines
  • other sedatives and hypnotics

Schedule V (CV)

• Characteristics:
  • Low potential for abuse or misuse.
• Examples:
  • Cough medicines that contain a limited amount of codeine.
  • Antidiarrheal medications that contain a limited amount of an opiate such as Lomotil (diphenoxylate and atropine).

Many problems associated with drug abuse are the result of legitimately-manufactured controlled substances being diverted from their lawful purpose into the illicit drug traffic. Many of the narcotics, depressants and stimulants manufactured for legitimate medical use are subject to abuse, and have therefore been brought under legal control. The goal of controls is to ensure that these "controlled substances" are readily available for medical use, while preventing their distribution for illicit sale and abuse.

Purchasing

Controlled substances require special consideration when it comes to purchasing.

Schedule III – V drugs may be ordered by a pharmacy or other appropriate dispensary on a general order from a wholesaler and you should check the delivery in against the original order.

Schedule II drugs have much more stringent requirements. A pharmacy must register with the Drug Enforcement Administration (DEA) to purchase Schedule II medications. The purchase of such controlled substances must be authorized by a pharmacist and executed on either a triplicate DEA 222 order form or an electronic 222 form through a controlled substances ordering system (CSOS)

The DEA form 222 is a triplicate form. The pharmacy retains the third sheet while sending the first and second pages to the wholesaler. The wholesaler is responsible for sending the second page to the DEA while retaining the first page for its own records. When the Schedule II medications arrive in the pharmacy they should be checked in against the DEA form.

Below is an image explaining how ordering schedule II medications work with a controlled substances ordering system (CSOS)

1. An individual enrolls with the DEA and, once approved, is issued a personal CSOS Certificate.
2. The purchaser creates an electronic 222 order using an approved ordering software. The order is digitally signed using the purchaser's personal CSOS Certificate and then transmitted to the suppliers. The paper 222 is not required for electronic ordering.
3. The supplier receives the purchase order and verifies that the purchaser's certificate is valid with the DEA. Additionally, the supplier validates the electronic order information just like it would a paper order.
4. The supplier completes the order and ships to the purchaser. Any communications regarding the order are sent electronically.
5. The order is reported by the supplier to the DEA within two business days.

Receiving

When the pharmacy receives controlled substances they should be carefully checked in against the purchase order including product name, quantity, strength, and package size. Controlled substances are shipped in separate containers from the rest of the pharmacy order and should be checked in by a pharmacist, although pharmacy technicians may assist with this process under the direct supervision of a pharmacist. Schedule II medications need to be checked in against your DEA 222 form (whether the paper triplicate form, or the electronic form on your CSOS enabled software).

Schedule II medications may be stocked separately in a secure place or disbursed throughout the stock. Their stock must be continually monitored and documented.

You may store CIII – CV medications in one of two ways:

• In a secured vault or,
• Dispersed throughout the pharmacy stock. By dispersing the stock through out, you effectively prevent someone from being able to obtain all your controlled substances since they can not do easy "One stop shopping."

Controlled substances prescriptions

Controlled substances have some additional things to keep in mind when reviewing prescription orders. All controlled substance prescriptions require the prescriber to include their DEA number on the prescription. While traditional prescriptions are good for one year from the date they are written and (at the prescriber's discretion) may have a sufficient number of refills to cover an entire one year supply; controlled substances have some differences based on which schedule they are. Schedule V medications may be refilled for up to a one year supply like prescriptions for non-controlled substances. Schedule III-IV medications may be written for up to a six month supply of medications including any refills on the original prescription. Schedule II medications may be written for up to a 90 day supply but may not include any refills. If a patient has a 30 day limit from their insurance the physician would need to write three separate prescriptions for thirty days to cover the full 90 days. Prescribers are not allowed to exceed a 90 day supply of a schedule II medications with out seeing the patient again.

Telephone orders and facsimiles

Pharmacies may accept telephone orders and faxes for schedule III-V medications. The pharmacist must immediatley reduce telephone order prescriptions to writing. Schedule II medications may not be ordered over the phone or via a fax machine under ordinary circumstances.

DEA has granted three exceptions to the facsimile prescription requirements for Schedule II controlled substances. The facsimile of a Schedule II prescription may serve as the original prescription as follows:

1. A practitioner prescribing Schedule II narcotic controlled substances to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may transmit the prescription by facsimile. The pharmacy will consider the facsimile prescription a "written prescription" andno further prescription verification is required.All normal requirements of a legal prescription must be followed.
2. Practitioners prescribing Schedule II controlled substances for residents of Long Term Care Facilities (LTCF) may transmit a prescription by facsimile to the dispensing pharmacy. The practitioner’s agent may also transmit the prescription to the pharmacy. The facsimile prescription serves as the original written prescription for the pharmacy.
3. A practitioner prescribing a Schedule II narcotic controlled substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may transmit a prescription to the dispensing pharmacy by facsimile. The practitioner or the practitioner’s agent may transmit the prescription to the pharmacy. The practitioner or agent will note on the prescription that it is for a hospice patient. The facsimile serves as the original written prescription.

For Schedule II controlled substances, an oral order is only permitted in an emergency situation. An emergency situation is defined as a situation in which:

• Immediate administration of the controlled substance is necessary for the proper treatment of the patient.
• No appropriate alternative treatment is available.
• Provision of a written prescription to the pharmacist prior to dispensing is not reasonably possible for the prescribing physician.

In an emergency, a practitioner may call-in a prescription for a Schedule II controlled substance by telephone to the pharmacy, and the pharmacist may dispense the prescription provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. The prescribing practitioner must provide a written and signed prescription to the pharmacist within seven days. Further, the pharmacist must notify DEA if the prescription is not received.

E-prescribing

The regulations concerning electronic transmission of controlled substances via e-prescribing recently changed. As of June 1, 2010 physicians and pharmacies are now allowed to transmit prescriptions for Schedule II, III, IV, and V medications as long as they are using properly certified software (i.e., SureScripts). While this is a recent shift in federal law, some states may still prohibit e-prescribing for controlled substances.

Partial fill of prescriptions

Pharmacists often question the DEA rule regarding the partial refilling of Schedule III, IV, or V prescriptions. Confusion lies in whether or not a partial fill or refill is considered one fill or refill, or if the prescription can be dispensed any number of times until the total quantity prescribed is met or 6 months has passed. According to the DEA's interpretation, as long as the total quantity dispensed meets with the total quantity prescribed with the refills, and they are dispensed within the 6-month period, the number of refills is irrelevant.

The Code of Federal Regulations states that the partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that:

• Each partial filling is recorded in the same manner as a refilling.
• The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
• No dispensing occurs 6 months after the date on which the prescription was issued for schedule III and IV medications or 12 months after the date on which the prescription was issued for schedule V medications.

For a Schedule II drug, the pharmacist may partially dispense a prescription if he or she is unable to supply the full quantity in a written or emergency oral prescription, provided the pharmacist notes the quantity supplied on the front of the prescription. The remaining portion must be supplied within 72 hours of the first partial dispensing. Otherwise, the pharmacist is obligated to notify the prescribing physician of the shortage.

Transferring prescriptions

The DEA allows the transfer of original prescription information for Schedule III, IV, and V controlled substances for the purpose of refill dispensing between pharmacies on a one-time basis. Pharmacies which electronically share a real-time, online database may transfer up to the maximum number of refills permitted by the law and authorized by the prescriber. In either type of transfer, specific information must be recorded by both the transferring and the receiving pharmacist.

The DEA does not allow for the transfer of Schedule II controlled substances, as they do not allow refills on these medications and partial fills, as discussed above, have strict limitations.

DEA number verification

Many problems associated with drug abuse are the result of legitimately-manufactured controlled substances being diverted from their lawful purpose into the illicit drug traffic. Many of the narcotics, depressants and stimulants manufactured for legitimate medical use are subject to abuse, and have therefore been brought under legal control. The goal of controls is to ensure that these "controlled substances" are readily available for medical use, while preventing their distribution for illicit sale and abuse.

Under federal law, all businesses which manufacture or distribute controlled drugs, all health professionals entitled to dispense, administer or prescribe them, and all pharmacies entitled to fill prescriptions must register with the DEA. Authorized registrants receive a "DEA number". Registrants must comply with a series of regulatory requirements relating to drug security, records accountability, and adherence to standards.

A DEA number is a series of numbers assigned to a health care provider (such as a dentist, physician, nurse practitioner, or physician assistant) allowing them to write prescriptions for controlled substances. Legally the DEA number is solely to be used for tracking controlled substances. The DEA number, however, is often used by the industry as a general "prescriber" number that is a unique identifier for anyone who can prescribe medication.

A valid DEA number consists of:

• 2 letters and 7 digits
• The first letter is always an A (deprecated), B (most common), or F (new) for a dispenser. (Also M is available for mid-level practitioners in some states and either P or R is used for a wholesaler)
• The second letter is typically the initial of the registrant's last name
• The seventh digit is a "checksum" that is calculated as:
  • Add together the first, third and fifth digits
  • Add together the second, fourth and sixth digits and multiply the sum by 2
  • Add the above 2 numbers
  • The last digit (the ones value) of this last sum is used as the seventh digit in the DEA number

Record keeping requirements

Every pharmacy must maintain complete and accurate records on a current basis for each controlled substance purchased, received, distributed, dispensed, or otherwise disposed of. These records must be maintained for 2 years. It is also required that records and inventories of Schedule II and Schedule III, IV, and V drugs must be maintained separately from all other records or be in a form that is readily retrievable from other records. The "readily retrievable" requirement means that records kept by automatic data processing systems or other electronic means must be capable of being separated out from all other records in a reasonable time. In addition, some notation, such as a 'C' stamp, an asterisk, red line, or other visually identifiable mark must distinguish controlled substances from other items.

Inventory requirements

A pharmacy is required by the DEA to take an inventory of controlled substances every 2 years (biennially). This inventory must be done on any date that is within 2 years of the previous inventory date. The inventory record must be maintained at the registered location in a readily retrievable manner for at least 2 years for copying and inspection by the Drug Enforcement Administration. An inventory record of all Schedule II controlled substances must be kept separate from those of other controlled substances. Submission of a copy of any inventory record to the DEA is not required unless requested.

When taking the inventory of Schedule II controlled substances, an actual physical count must be made. For the inventory of Schedule III, IV, and V controlled substances, an estimate count may be made. If the commercial container holds more than 1000 dosage units and has been opened, however, an actual physical count must be made.

Theft or loss of controlled substances

In the event that controlled substances are stolen, or are found to be missing a pharmacy should:

1. contact the local police and the DEA,
2. fill out and file DEA form 106.

The DEA form 106 is available as both a printed form, or may be filed electronically. To obtain the printed form click here and printout the PDF. To file elctronically proceed to https://www.deadiversion.usdoj.gov/webforms/dtlLogin.jsp .

The DEA requires that theft of controlled substances must be reported within 24 hours.

State regulations

Many states have additional regulations for controlled substances. It is a necessary to know the differences that exist in your state. Some examples include:

• Some states have made additional drugs scheduled medications such as Arkansas and Kentucky have made tramadol a controlled substance.
• Many states, such as Pennsylvania, treat schedule V prescriptions the same as schedule III and IV prescriptions with regards to refill limits and totally quantity that may be prescribed at a time.
• Various states, such as New York, limit schedule II prescriptions to a 30 day supply.
• Some states, such as Hawaii and Montanna, currently do not allow e-prescribing of controlled substances.

Be aware of the differences with regards to controlled substances in the states you practice in and remember that the expectation when state and federal law appear to be in conflict is that you will follow the stricter regulation.

Restricted drug programs

There are a number of medications with restrictions due to patient safety concerns. The FDA primarily manages these medications through their Risk Evaluation and Mitigation Strategy (REMS) initiative. The FDA may require manufacturers of drugs with safety concerns to submit a REMS program at the time a new drug is approved. These programs may contain any combination of 5 criteria (Medication Guide, Communication Plan, Elements to Assure Safe Use, Implementation System, and Timetable for Submission of Assessments). Restricted access programs are considered Elements to Assure Safe Use. A current list of medications with REMS programs can be found at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

Some of the medications with the most significant restrictions include thalidomide, clozapine, buprenorphine, and isotretinoin. These programs are intended to make sure that the patients are using the medications appropriately and to monitor them for undesirable side effects.

Thalidomide

Thalidomide was first developed in Germany as a sleep aid and shortly after entering the European market, the manufacturer decided it was also good for treating morning sickness. Unfortunately, the drug caused severe and life-threatening birth defects in 40% of infants. In 1998 thalidomide was approved for limited distribution in the United States for treating multiple myeloma. It is also used to treat erythema nodosum leprosum.

Thalidomide is only available through the THALOMID REMS program. Prescribers must be certified with program, patients must comply with the strict guidelines of the program, and pharmacies must be certified with the program. Pharmacies must only dispense to patients that are authorized to receive the drug and comply with the requirements.

Clozapine

Clozapine is an atypical antipsychotic medication used in the treatment of schizophrenia, and is also sometimes used off-label for the treatment of bipolar disorder. Clozapine carries many warnings, including warnings for agranulocytosis, CNS depression, leukopenia, neutropenia, seizure disorder, bone marrow suppression, dementia, hypotension, myocarditis, orthostatic hypotension (with or without syncope) and seizures.

With these severe side effects in mind each of the manufacturers are required to enroll patients taking their medication into a national registry where they will monitor a patient's white blood cell count (WBC) and their absolute neutrophil count (ANC). If the numbers fall below a particular level their therapy may need to be halted and the national registry has a responsibility to report the information to the nonrechallengeable database, that way if a physician goes to place the patient on the medication again the various manufacturers will know they are not allowed as they always need to check new orders for a patient against the nonrechallengeable database. Once listed in the nonrechallengeable database they may never use clozapine again.

Buprenorphine

The Drug Addiction Treatment Act of 2000 (DATA 2000) permits physicians who meet certain qualifications to treat opioid addiction with Schedule III, IV, and V narcotic medications that have been specifically approved by the Food and Drug Administration for that indication. Such medications may be prescribed and dispensed by waived physicians in treatment settings other than the traditional Opioid Treatment Program (methadone clinic) setting.

Since there is only one narcotic medication approved by the FDA for the treatment of opioid addiction within the Schedules given, DATA 2000 basically refers to the use of buprenorphine for the treatment of opioid addiction. Methadone is a Schedule II narcotic approved for the same purpose within the highly regulated methadone clinic setting.

Under the Act, physicians may apply for a waiver to prescribe buprenorphine for the treatment of opioid addiction or dependence. Requirements include a current State medical license, a valid DEA registration number, specialty or subspecialty certification in addiction from the American Board of Medical Specialties, American Society of Addiction Medicine, or American Osteopathic Association. Exceptions were also created for physicians who participated in the initial studies of buprenorphine and for State certification of addiction specialists. However, the Act is intended to bring the treatment of addiction back to the primary care provider. Thus most waivers are obtained after taking an 8 hour course from one of the five medical organizations designated in the Act and otherwise approved by the Secretary of the Department of Health and Human Services. When a physician qualifies for the waiver, he is given a second DEA number that begins with an 'X'. This new DEA number is only to be used when prescribing buprenorphine for the purpose of treating addictions. Once a physician obtains the waiver, he or she may treat up to 30 patients for narcotic addiction with buprenorphine. Recent changes to DATA 2000 have increased the patient limit to 100 for physicians that have had their waiver for a year or more and request the higher limit in writing.

Isotretinoin

Isotretinoin is indicated for severe nodular acne unresponsive to conventional therapy in patients 12 years of age and older. Isotretinoin is a teratogen and is highly likely to cause birth defects if taken by women during pregnancy or even a short time before conception. A few of the more common birth defects this drug can cause are hearing and visual impairment, missing or malformed earlobes, facial dysmorphism, and mental retardation.

Due to the teratogenicity of this product, isotretinoin is only available through a restricted program under REMS called iPLEDGE. Prescribers, patients, pharmacies, and distributors must enroll in the iPLEDGE program (https://www.ipledgeprogram.com).

Phentermine and topiramate

Phentermine and topiramate (available under the brand name Qsymia) is intended to be used in combination with calorie reduction and increased physical activity to assist in chronic weight management. The combination product of phentermine and topiramate is a teratogen and is highly likely to result in either cleft palate and/or cleft lip.

Due to the teratogenic concerns associated with this product, women of childbearing age should take a pregnancy test prior to starting this therapy and they should consistently use effective contraception while taking this medication. Pharmacies must be certified by VIVUS (the manufacturer for Qsymia) to dispense the medication and as part of the mandatory REMS on this product pharmacies must handout the FDA approved Qsymia brochure that details concerns over the products teratogenicity and offers guidance on effective birth control options.

Omnibus Budget Reconciliation Act of 1990

While most federal laws provide the pharmacist with guidance on handling pharmaceuticals, the Omnibus Budget Reconciliation Act of 1990 (OBRA-90) placed expectations on the pharmacist in how to interact with the patient. While the primary goal of OBRA-90 was to save the federal government money by improving therapeutic outcomes, the method to achieve these savings was implemented by imposing on the pharmacist counseling obligations, prospective drug utilization review (ProDUR) requirements, and record-keeping mandates.

The OBRA-90 ProDUR language requires state Medicaid provider pharmacists to review Medicaid recipients' entire drug profile before filling their prescription(s). The ProDUR is intended to detect potential drug therapy problems. Computer programs can be used to assist the pharmacist in identifying potential problems. It is up to the pharmacists' professional judgment, however, as to what action to take, which could include contacting the prescriber. As part of the ProDUR, the following are areas for drug therapy problems that the pharmacist must screen:

• Therapeutic duplication
• Drug–disease contraindications
• Drug–drug interactions
• Incorrect drug dosage
• Incorrect duration of treatment
• Drug–allergy interactions
• Clinical abuse/misuse of medication

OBRA-90 also required states to establish standards governing patient counseling. In particular, pharmacists must offer to discuss the unique drug therapy regimen of each Medicaid recipient when filling prescriptions for them. Such discussions must include matters that are significant in the professional judgment of the pharmacist. The information that a pharmacist may discuss with a patient is found in the enumerated list below.

1. Name and description of the medication.
2. Dosage form, dosage, route of administration, and duration of drug therapy.
3. Special directions and precautions for preparation, administration, and use by the patient.
4. Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered.
5. Techniques for self-monitoring of drug therapy.
6. Proper storage.
7. Refill information.
8. Action to be taken in the event of a missed dose.

Under OBRA-90, Medicaid pharmacy providers also must make reasonable efforts to obtain, record, and maintain certain information on Medicaid patients. This information, including pharmacist comments relevant to patient therapy, would be considered reasonable if an impartial observer could review the documentation and understand what has occurred in the past, including what the pharmacist told the patient, information discovered about the patient, and what the pharmacist thought of the patient's drug therapy. Information that would be included in documented information are listed below.

1. Name, address, and telephone number.
2. Age and gender.
3. Disease state(s) (if significant)
4. Known allergies and/or drug reactions.
5. Comprehensive list of medications and relevant devices.
6. Pharmacist's comments about the individual's drug therapy.

While OBRA-90 was geared to ensure that Medicaid patients receive specific pharmaceutical care, the overall result of the legislation provided that the same type of care be rendered to all patients, not just Medicaid patients. The individual states did not establish 2 standards of pharmaceutical care-one for Medicaid patients and another for non-Medicaid patients. The end result is that all patients are under the same professional care umbrella requiring ProDUR, counseling, and documentation.

References

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
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3. Strauss's Federal Drug Laws and Examination Review, Fifth Edition (revised), Steven Strauss, CRC Press, 2000
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6. Controlled Substance Ordering System, http://www.deaecom.gov/
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11. FDA, Approved Risk Evaluation and Mitigation Strategies (REMS), http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
12. Medscape, Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses, and Pharmacists, Claudia B. Karwoski, PharmD; Marcie A. Bough, PharmD; Todd M. Colonna, MD; Lisa A. Gorski, RN, MS, May 15, 2012, http://www.medscape.org/viewarticle/762673_transcript
13. ParagonRx, Risk Evaluation and Mitigation Strategies (REMS) - A Brief History. September 2009, http://www.paragonrx.com/rems-hub/rems-history/
14. FDA, Postmarket Drug Safety Information for Patients and Providers, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm
15. Wikipedia, Drug Addiction Treatment Act, http://en.wikipedia.org/wiki/Drug_Addiction_Treatment_Act
16. iPledge program, https://www.ipledgeprogram.com
17. Vivus, Risk of Birth Defects with Qsymia, https://qsymia.com/wp-content/wbuploads/pdf/risk-of-birth-defects.pdf
18. Pharmacy Times, A Review of Federal Legislation Affecting Pharmacy Practice, Virgil Van Dusen , RPh, JD and Alan R. Spies , RPh, MBA, JD, PhD, https://secure.pharmacytimes.com/lessons/200612-01.asp
19. Strauss's Federal Drug Laws and Examination Review, Fifth Edition (revised), Steven Strauss, CRC Press, 2000
20. Pharmacy Technician Practice and Procedures, Gail G. Orum Alexander and James J. Mizner, Jr., McGraw Hill, 2011