Pharmaceutical industry Flashcards
ACTIVITIES IN A PHARMACEUTICAL MANUFACTURING LABORATORY
Research
Production
Quality Control
Distribution or Marketing
Pharmacist play a role in the formulation of the most suitable dosage forms
Research
They determine whether the medication should be given orally, injected, inhaled or rubbed on.
research
Stability, packing, mode of action and released at the intended site are some of the problems solved by the research team.
Research
Research activities directed to the ______
creation of new drugs for new products
New drugs may be intentionally or accidentally produced from ____
Natural sources or by chemical synthesis
Identifying a promising compound
Lead Compound Selection
(Compound design and testing)
Discovery Testing
(Safety testing in lab animals)
Pre-Clinical Research
(Technical development)
Manufacture Research
(Assessing safety of testing in humans)
Investigational New Drug (IND) Application
(Safety and efficacy testing)
Clinical Trials: Phase I, Phase II, Phase III
(Assessing safety and efficacy for marketing)
New Drug Application (NDA)
(Safety and efficacy in general population)
Post-Marketing Surveillance
Exploratory, to establish if agent will work as desired
Phase 0
Determine basic pharmacological and toxicological information in humans especially on safety
Phase I
Conducted on a larger number of patients to further evaluate the safety of the treatment and to determine how well it works
Phase II
Involves a large number of patients to asses risks and
benefits
Phase III
Post marketing study to determine if drug works over time and if it works for purposes other than what it was intended for
Phase IV
How many years is the development process of a drug
15 years in total
Products sold under a brand name by the owner of the patent.
Patented drug or products
Embraces all those activities, which are involved in the conversion of “raw materials” into “finished products”
Production
Production embraces all those activities, which are involved in the conversion of ____
“raw material” into “finished products”
The pharmacist supervises the operation.
Production
Pilot Plant provides a link between the research and production.
Production
The raw materials, the intermediate and the finished products including packaging components are subjected to qualitative and quantitative check for control purposes.
Quality control
Detailmen
DISTRIBUTION or MARKETING
Detailmen responsibility
Responsible primarily for personally contacting potential prescribers and pharmacists regarding their company’s products.
Is the maintenance or improvement of health via the prevention, diagnosis, and treatment of disease, illness, injury, and other physical and mental impairments in human beings
Healthcare
A state of complete physical, mental and social well-being and not merely the absence of disease of infirmity
Health
Is a person’s perception of how he or she feels
illness
Is a judgement of one’s state of health by medical professional
disease
Proportion of illness in a population
Morbidity
Incidence of deaths in a population
Mortality
Is a very dynamic, complex, and challenging, characterized by an abundance of business opportunities there for the picking by everyone, despite of the fact that multinational drug companies dominated the industry for many decades up to the present
Philippine pharmaceutical market
True or False: Women tend to live longer than men for four years
False, five
Average life expectancy is ____
72 years
The most important development within the national scene which has direct bearing on the Pharmaceutical Industry was the formulation of _________ and the signing into law of the Generic Drug Act of 1988 now known as RA 6675.
Philippine National Drug Policy (PNDP)
The most important development within the national scene which has direct bearing on the Pharmaceutical Industry was the formulation of the Philippine National Drug Policy (PNDP) and the signing into law of the _____ now known as RA 6675.
Generic Drug Act of 1988
The most important development within the national scene which has direct bearing on the Pharmaceutical Industry was the formulation of the Philippine National Drug Policy (PNDP) and the signing into law of the Generic Drug Act of 1988 now known as _____
RA 6675.
It came about because of the confluence of favorable factors and circumstances:
New Government ff. the EDSA revolution.
The strong-felt need to provide essential drugs of high quality, safety, and efficacy to the people.
The ongoing Cooperation Project in Pharmaceuticals among ASEAN
The worldwide concern about the problem of inadequate access to essential drugs and irrational use of drugs.
The goal of the PNDP is ________
make essential drugs available, accessible, and affordable to the people
Four pillars anchoring the PNDP
Quality assurance
Rational drug use
Self-reliance
Tailored procurement
When was the GENERICs ACT OF 1988 established
September 13, 1988
An act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names
RA 6675
To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for free to indigent patients;
RA 6675
To encourage the extensive use of drugs with generic names through a rational system of procurement and distribution;
RA 6675
To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant of their therapeutic effectiveness; and
RA 6675
The full implementation of the Generics Act of 1988 was covered by Administrative Orders only on
Generic Labeling
Generic Advertising
Generic Prescribing
Generic Dispensing for single active ingredient products and subsequently also for multiple active ingredient
This law as pointed out by _____, improved equity or access to essential drugs, by simple expedient of requiring use of generic names and giving the patient or buyer informed choice and the option to buy cheaper alternatives.
DOH
True or False: Under the Generic Prescribing Guidelines of RA 6675, the doctor still retains the responsibility of determining the AI of the drug his patient and he directs how it will be used.
True
True or False: retains the right to indicate his preferred brand although the patient/ consumer is not obligated to choose that particular brand, especially if he cannot afford it
True
Inevitably, the ____, until now has major apprehensions on the possible adverse effects of the Generics Law particularly on the marketing of their branded drug products whose market shares are gradually being eroded by the purely Generic Drug preparations which are fast gaining a strong foothold in the market.
Philippine Drug Industry
But most certainly, RA 6675 never did and never will toll the death knell for branded drug products. At worst, the Generics Law created _____ wherein branded products co- exist with the generic drug lines.
a two-tier marketing system
” is a list of drugs prepared and periodically updated by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria. It shall consist of a core list and a complementary list.
Essential Drugs List” or “National Drug Formulary
is a list of drugs that meets the health care needs of the majority of the population.
“Core List”
is a list of alternative drugs used when there is no response to the core essential drug or when there is hypersensitivity reaction to the core essential drug or when for one reason or another, the core essential drug cannot be given.
Complementary List”
________ is an integral component of the Philippine National Drug Policy, aimed at making available and accessible, essential medicines of proven efficacy, safety and quality at affordable cost.
The Philippine National Drug Formulary (PNDF)
The PNDF Volume I, ______, is a major step towards rational use of medicines in the country. The medicines are selected with due regard to public health relevance, evidence of efficacy and safety and comparative cost‐effectiveness. The national list of essential medicines is a subset of registered medicines divided according to different levels of care.
the Essential Medicines List
provided by physicians and dentists, also by pharmacists in hospitals, industrial, and medicinal clinics.
MEDICAL CARE
patients caring for themselves
SELF-CARE
precludes guidance by a licensed pharmacist or physician. The trend toward self- medication places an increased professional responsibility on pharmacists, one which requires pharmacists to analyze each patients’ condition and make a decision on minor illness referred to, for appropriate medication
Self Medication
