Pharmaceutical Concepts and Definitions

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Questions and Answers

What is the primary requirement for marketing approval of a generic drug compared to a patented drug?

It must be produced by the original manufacturer.

It must undergo extensive clinical trials.

It should have new therapeutic indications.

It needs to be biologically equivalent. (correct)

Who founded the first school of pharmacy in modern Egypt?

Mohammed Ali Pasha (correct)

Assiut University

Cairo University

Klute Bey

When was the Faculty of Pharmacy at Cairo University declared a separate entity?

1908

1955 (correct)

1929

1965

What distinguishes bioequivalent drug products from one another?

They have the same rate and extent of absorption. Signup and view all the answers

Which college was established first among the governmental faculties of pharmacy in Egypt?

Alexandria University Signup and view all the answers

In what year did the first private pharmacy programs begin in Egypt?

1996 Signup and view all the answers

What is a characteristic feature of the apprenticeship system in pharmacy education before the 19th century?

Pharmacy knowledge was gained through on-the-job training. Signup and view all the answers

Which year marked the graduation of the first pharmacists from Cairo University?

1929 Signup and view all the answers

What is one key characteristic of a good name for a pharmaceutical substance?

It should indicate the therapeutic class. Signup and view all the answers

Which of the following is NOT one of the aims of quality health care?

Cost-effective Signup and view all the answers

Which aim of health care quality indicates that patients' needs should be respected and considered?

Patient-centered Signup and view all the answers

What does the aim of equity in health care ensure?

All individuals have access to quality health care regardless of their background. Signup and view all the answers

What is meant by 'effective' in terms of quality health care?

Patients are accurately diagnosed and treated. Signup and view all the answers

Which aspect of quality health care ensures that patients do not suffer harm during treatment?

Safe Signup and view all the answers

In a system focused on integrated health care, what is prioritized for patients with multiple chronic diseases?

Coordination of care among specialists. Signup and view all the answers

What role do pharmacists play beyond dispensing medication?

They provide drug information and therapy recommendations. Signup and view all the answers

What does the expiration date of a pharmaceutical product represent?

The date when 90% of the material remains within specifications Signup and view all the answers

Which of the following storage conditions is classified as 'cold place'?

Less than 8°C Signup and view all the answers

What is the primary purpose of drug nomenclature?

To ensure drugs are easily recognized and prescribed Signup and view all the answers

Which of the following statements about brand and generic names is true?

Brand names must be unique to avoid prescription errors Signup and view all the answers

Which of the following storage temperature ranges is classified as 'warm place'?

Between 30°C & 40°C Signup and view all the answers

What defines the stability of a pharmaceutical product?

The ability to remain within defined specifications until the expiration date Signup and view all the answers

Which of the following best describes a similarity between brand and generic drugs?

Both must comply with the same manufacturing regulations Signup and view all the answers

What is the correct definition of a 'refrigerator' storage condition?

Between 2°C & 8°C Signup and view all the answers

What distinguishes a drug from a medicine?

A medicine contains excipients and is packaged for sale. Signup and view all the answers

What is an excipient?

A substance used in drug manufacturing that has no pharmacological effect. Signup and view all the answers

How is dose regimen defined?

The frequency of drug administration. Signup and view all the answers

What is the primary purpose of a placebo in clinical trials?

To serve as a psychological benefit for participants. Signup and view all the answers

Why would using a placebo be considered unethical today?

It involves deceiving the patient about their treatment. Signup and view all the answers

What does the term 'drug product' refer to?

A dosage form containing active ingredients and other substances. Signup and view all the answers

What is the function of quality control in pharmaceutical manufacturing?

To verify that products meet specified standards. Signup and view all the answers

Which of the following statements is true about the strength of a drug?

It represents the concentration of the active drug in a dosage form. Signup and view all the answers

What does consumerism in healthcare imply about patient rights?

Patients have the right to make informed choices about their treatment. Signup and view all the answers

Which of the following best describes paternalism in healthcare?

The assumption that healthcare professionals understand patients' needs better than they do. Signup and view all the answers

What is the significance of the abbreviation 'Rx' in pharmacy?

It stands for 'recipe' in Latin, meaning 'take thou'. Signup and view all the answers

What happens to the price of a drug once its patent expires?

The price tends to decrease because of competition from generics. Signup and view all the answers

Which statement regarding patients' rights is accurate?

Patients should give their consent before any treatment plan is initiated. Signup and view all the answers

Which symbol is commonly associated with pharmacy and healing?

The caduceus, often mistaken for the rod of Hermes. Signup and view all the answers

What is one of the roles of pharmacists in regards to patient care?

Pharmacists will utilize their expertise to respect patient preferences. Signup and view all the answers

How do pharmaceutical patents affect drug pricing?

They allow exclusive marketing, enabling higher prices. Signup and view all the answers

Study Notes

Drug versus Medicine

A drug is the active material with pharmacological or therapeutic activity.
A medicine is a drug mixed with excipients, formulated, packed, and labeled.
Pharmaceutical products are drugs processed on a large scale.
Medicines are the pharmaceutical products dispensed to patients.

Drug Product Terms

A drug product is the dosage form containing one or more active ingredients and excipients.
Excipients are inactive materials in a dosage form.
Strength is the concentration of the drug in a dosage form.
Dose is the amount of drug taken each time.
Dose regimen is the frequency of use of a drug.

Placebo

A placebo is a fake treatment that can have a real response.
It's a substance with no known medical effects, like sterile water or a sugar pill.
Placebos are prescribed for psychological benefits rather than physiological effects.
Their use in clinical studies helps eliminate bias.

### Quality Control

Physical or chemical tests ensure the required specifications of raw materials or dosage forms.
Specifications are defined by pharmacopoeia or factory guidelines.

Stability of a Pharmaceutical Product

It's the ability of a formulation in a specific container to remain within defined physical, chemical, microbiological, therapeutic, and toxicological specifications until the expiration date.

Expiration Date

The date on the container indicates when the product is expected to remain within specifications under appropriate storage conditions.
Typically, 90% of the material remains until the expiration date.

Storage

Safekeeping of starting materials, packaging materials, and drug products.

Storage Conditions

Specified conditions for storing products, including temperature, humidity, container, and light.

Temperature for Storing Products

Cold place: Less than 8°C
Refrigerator: Between 2°C & 8°C
Deep freezer: Less than -10°C
Cool place: Between 8°C & 15°C
Warm place: Between 30°C & 40°C
Room temperature: Between 15°C & 30°C

Drug Nomenclature

Empirical formula: Examples such as C15H12N2O2C_{15}H_{12}N_2O_2C15H12N2O2 for phenytoin.
Chemical name: A lengthy name following IUPAC rules, like sodium 5,5-diphenyl-2, 4-imidazolidinedione.
Code numbers before the assignment of a non-proprietary name.
Generic name: The official, non-proprietary name used in the Pharmacopoeia, such as Phenytoin.
Brand name: The proprietary or trademark name, like Dilantin.

Brand and Generic Names

During patent protection, a drug is marketed under its brand name.
Other companies must use the generic name but create their own brand name.
The same generic drug can be sold under the generic name or multiple brand names.
Generic drugs are often less expensive but typically as effective and of the same quality as brand-name drugs.

Name Choice

Brand names should be short, distinctive, and not easily confused with existing names.
They should indicate the general pharmacologic or therapeutic class, like Lopressor for lowering blood pressure, Glucotrol for controlling high blood sugar, and Disflatyl for relieving flatulence.

General Mission For Healthcare

Continually reduce the burden of illness, injury, and disability, and improve the health and functioning of the public.

Aims of Healthcare System Quality

Effective: Accurate diagnosis and treatment.
Safe: Care received does not harm the patient.
Patient-centered: Decisions tailored to patient needs and preferences.
Timely: Timely access to care.
Equitable: Equal access to good quality healthcare for all.
Integrated: Coordinated care across multiple specialists for patients with chronic diseases.
Efficient: Avoiding unnecessary tests and procedures.

Pharmacist Role in Society

Pharmacists provide drug information and therapy recommendations.
The role is evolving, with a growing bond between pharmacists and society.

Consumerism versus Paternalism

Paternalism is the belief that the healthcare professional knows best.
It was standard practice, but now patients are true consumers with the right to be informed and give consent.
Healthcare professionals must meet patients' demands.

Patient's Rights

Pharmacists will employ their knowledge and experience in caring for them.
Pharmacists will respond to patients' wishes about their treatment.
Patients can choose their own physician, pharmacy, and hospital.
Patients can give their informed consent prior to care.
Patients can choose from multiple treatment options when available.
Treatment should be safe and effective within defined parameters.

Pharmaceutical Symbols

The serpent of Epidaurus on the staff of Aesculapius.
The bowl of Hygeia with the serpent of Epidaurus.
The Caduceus (staff of Hermes).

Rx

Universally accepted as an abbreviation of "recipe" (Latin for "take thou").
It may have originated from the astronomical sign of Jupiter or evolved from the Eye of Horus.

Drug Patents

Patents grant companies the exclusive right to market a drug in a particular country.
This leads to higher prices for the product, but also incentivizes drug development.
When patents expire, generic versions become available, increasing competition and lowering prices.

Pharmacy Education

Apprenticeship system: Until the 19th century, there were no formal educational requirements.
First school of pharmacy in Egypt: Founded in 1824 by Mohammed Ali Pasha.
First Faculty of Pharmacy in Egypt: Established in 1908 as part of Cairo University, with the first graduates in 1929.
Governmental Faculties of pharmacy: Alexandria (1948), Assiut (1961), El-Azhar (males, 1965), Mansoura (1970), Tanta (1973), Zagazig (1975), Suez Canal (1993), Beni-Suef (1994), Helwan (1995), Ain Shams (1996), ElAzhar (females) and El-Minya (late 1990s).
Private Faculties of pharmacy: Four private universities started pharmacy programs in 1996.

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Description

This quiz explores key concepts related to drugs, medicines, and pharmaceutical products. It covers definitions, terminology, and the role of placebos, as well as the importance of quality control in drug manufacturing. Test your understanding of these fundamental principles in the field of pharmacology.