History of Antibiotics, Drug Industry Regulation, and Pharmacy Practice

Vocabulary flashcards covering the history of antibiotics, drug development, patent regulations, roles within pharmacy practice, and the legal framework governed by the Pharmacy Council of Jamaica.

Penicillin

An antibiotic discovered in 1928 that was difficult to produce until 1942, when the Pfizer pharmaceutical company developed a mass production method that supplied the Allied military by D-Day during World War II.

Food and Drug Administration (FDA)

The federal agency responsible for drug regulation in the United States, requiring testing to prove safety and efficacy before market approval and holding the authority to recall drugs with significant adverse effects.

Standards and Regulation Unit

The unit of the Ministry of Health in Jamaica responsible for drug regulation, distribution standards, and the removal of any marketed drug that poses a threat to public health.

Pharmaceutical Research and Development (R&D) Allocation

The financial commitment by the pharmaceutical industry in which approximately one-sixth of its income is devoted to the research and development of new drugs.

Drug Patent

A legal protection lasting a total of $20\text{ years}$ that prevents illegal copying of a discovered drug, giving a company market exclusivity (typically leaving about $10\text{ years}$ post-FDA approval) to recover its initial investment.

Prescription Drug

A medication that has been ordered or prescribed by an authorized prescriber to treat a patient.

Omnibus Budget Reconciliation Act (OBRA) of 1990

A United States congressional act that mandated pharmacists to provide counselling services to Medicaid patients, establishing a standard of care later adopted by multiple states for all patients.

US Prescription and Pharmacist Growth (1997–2007)

A ten-year period during which the number of prescriptions filled in the United States increased by $72\text{\%}$, while the number of practicing pharmacists grew by approximately $15\text{\%}$.

Pharmacy Technician

A pharmacy support role responsible for routine, day-to-day functions not requiring a pharmacist's professional judgment, including receiving and processing prescriptions, repackaging medications, and maintaining inventory.

Pharmacist

A licensed professional responsible for overseeing pharmacy technician performance, providing patient drug education, suggesting medication alternatives to prescribers, and performing duties requiring clinical judgment.

Pharmacy Practice Settings

The operational environments where pharmacy is practiced, categorized into Community Pharmacy, Hospital Pharmacy, Mail-Order Pharmacy, and Distribution Pharmacy.

Pharmacy Council of Jamaica

A regulatory body established in August 1975 under The Pharmacy Act (1966) by the Ministry of Health to regulate pharmacists, students, pharmacy owners, and authorized poison sellers, as well as set educational and practice standards.

Composition of the Pharmacy Council of Jamaica

A governing body composed of ten members: six elected by the Pharmaceutical Society of Jamaica and four (including the chairman) appointed by the Minister of Health.

Registrar of the Pharmacy Council of Jamaica

An official appointed and employed by the Pharmacy Council of Jamaica who serves as Secretary to the Council and oversees inspectors executing the provisions of The Pharmacy Act.

Pharmacist Registration Requirements (Jamaica)

The criteria for new licensure requiring a candidate to be $21\text{ years}$ of age or older, complete an accredited Bachelor's degree in pharmacy, complete vocational training, pass the licensing exam, apply, and pay the requisite fee.

Annual Registration Renewal (Jamaica)

A requirement implemented in April 2003 mandating that all pharmacist registrations expire annually on March 31st and require $12$ continuing education (CE) credits, an official application, and fee payment for renewal.

Prescription Retention Period

The legal requirement under Jamaican regulations mandating that a pharmacist verify prescriber authenticity, sign, date, document, and retain a dispensed prescription for a prescribed period of two ($2$) years.

List #1 and List #2 Dispensing Restrictions

A statutory requirement dictating that pharmacy owners must never permit the sale or dispensing of List #1 or List #2 drugs in the absence of a registered pharmacist.