UHSP Pharmacy Technician Training Modules 1 & 2

Main roles of a pharmacy technician

Inventory management - organization, ordering, and receiving of medications

Medication dispensing

Customer service

Main roles of a pharmacist

Medication review and counseling, clinical decision-making

Supervision and training of technicians and other supporting healthcare professionals

How often must pharmacy technicians in Missouri renew their registration?

Annually. CE credits are not required, but staying up to date with the field is highly recommended

Controlled Substances Act

The Controlled Substances Act, enforced by the Drug Enforcement Administration (DEA) and enacted by congress in 1970, regulates the manufacturing, distribution, and dispensing of controlled substances at the federal level. It classifies drugs into different schedules based on their potential for abuse and accepted medical use. Compliance with this act is essential to prevent diversion and misuse of controlled substance, safeguarding public health

Food, Drug, and Cosmetic Act

Administered by the FDA, this act ensures the safety, efficacy, and proper labeling of drugs, including prescription and over-the-counter medications. Adherence to this act is crucial to prevent the distribution of unsafe or ineffective medications, protecting patients from harm and promoting public confidence in the pharmaceutical industry

Missouri Pharmacy Practice Act

Governs the practice of pharmacy within the state, covering areas such as licensure requirements, pharmacist and pharmacy technician responsibilities, and pharmacy operations. Compliance with this act is essential to maintain the integrity of the profession and ensure that pharmacy professionals adhere to established standards of practice

Non-compliance

Violations of the CSA - can result in civil penalties, criminal charges, and loss of licensure

Non-compliance with the FDCA - product recalls, fines, damage to reputations of pharmacies and pharmaceutical companies

HIPAA (Health Insurance Portability and Accountability Act)

Protects patients’ privacy and confidentiality of their medical information

Applies to pharmacies in safeguarding patient health information

Pharmacy Board Rules and Regulations

Issued by the Missouri Board of Pharmacy to provide specific guidelines for pharmacy practice

Cover areas such as compounding, dispensing, record-keeping, and medication storage

Drug Product Selection Laws

Dictate the substitution of generic drugs for brand-name drugs and require pharmacist communication with patients

Drug diversion

The illegal distribution or abuse of prescription drugs or their use for purposes not intended by the prescriber

CSA Schedules

Schedule I: High potential for abuse, no accepted medical use (e.g. heroin, LSD)

Schedule II-V: Decreasing potential for abuse and increasing accepted medical use (e.g. opiods, benzodiazepines)

DEA Regulations

In order to comply with DEA regulations, pharmacists must be registered and have a DEA number

• DEA registration: anyone involved in the manufacture, distribution, or dispensing of controlled substances must register with the DEA

• Different registration categories exist for practitioners, pharmacies, hospitals, manufacturers, & researchers

DEA number

• Practitioners and pharmacies are issues a DEA number, which allows them to handle controlled substances

• DEA numbers must be renewed periodically and include specific formats to verify authenticity

• DEA numbers serve as unique identifiers for authorized prescribers and dispensers of controlled substances

Patient Trust - HIPAA

One of the most notable impacts of HIPAA Security and Privacy Rule on pharmacy practice is the enhancement of patient trust. By safeguarding the confidentiality of patients’ medical records and personal health information (PHI), HIPAA assures individuals that their sensitive data will be protected from unauthorized access or disclosure. Thus patients are more likely to confide in health professionals about relevant health information

Patient Confidentiality - HIPAA

Pharmacists have an ethical obligation to respect patient autonomy and safeguard sensitive health information. HIPAA provides a framework for pharmacists to fulfill this obligation by outlining specific requirements for the protection of electronic protected health information (ePHI)

Purpose and Scope of HIPAA

• HIPAA was enacted in 1996 with the primary goal of protecting patients’ health information while allowing for seamless exchange of electronic health records (EHRs)

• It applies to covered entities, including healthcare providers, health plans, and healthcare clearinghouses, that transmit health information electronically

HIPAA Privacy Rule

• Establishes national standards for protecting individuals’ medical records and other PHI

• It grants patients certain rights, such as the right to access their medical records and request amendments to inaccuracies

HIPAA Security Rule

• The Security Rule sets forth standards for safeguarding electronic protected health information (ePHI) held bu covered entities

• It requires the implementation of administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of ePHI

Risk Assessment and Management- HIPAA

Covered entities must conduct regular risk assessments to identify vulnerabilities in their systems and implement appropriate safeguards to mitigate risks

• Risk management strategies may include encryption, access controls, and employee training on data security protocols

QD

Quaque die = once daily

BID

Bis in die = twice daily

PO

Per os = by mouth

Controlled Substance Prescription Requirements

Controlled substance prescriptions must include the patient’s name, drug name, strength, dosage form, quantity prescribed, and directions for use

• Prescriptions for Schedule II controlled substances general require a handwritten or electronic signature from the prescriber and cannot be refilled

Receiving Controlled Substance Prescriptions

• Pharmacies must verify the authenticity of controlled substance prescriptions and ensure that they meet regulatory requirements before dispensing

• Pharmacists may need to contact prescribers for clarification or verification of prescriptions as needed

Refilling Controlled Substance Prescriptions

• Refilling of controlled substance prescriptions is subject to specific limitations based on drug schedules and state regulations

• Schedule III-V controlled substances may be refilled within certain timeframes and quantity limits, while II prescriptions generally cannot be refilled

• In Missouri, Schedule III-V prescriptions can be refilled for up to 6 months after the original date written on the prescription

• In Missouri, Schedule II prescriptions cannot be refilled

Transferring Controlled Substance Prescriptions

• Controlled substance prescriptions may be transferred between pharmacies under certain conditions, such as between pharmacies under common ownership or between pharmacies with shared electronic prescription systems

• Transfer of Schedule III-V controlled substance prescriptions must be communicated directly between pharmacists, while transfers of Schedule II prescriptions are generally prohibited