pharmaceutics

Friedrich Serturner (1783-1841)

Karl Wilhelm Scheele (1742-1786)

• *adopt standards for drugs, pharmaceutical ingredients and dosage froms
• *reflect the best current practices of medicine
• *provides information on tests and assay procedures for demonstrating compliance with these standards
• *for individual components not combinations

• the marshall apothecary shop in 1729
• * a leading retail pharmacy
• * a place for training pharmacist
• * a large scale chemical manufacturer
• * was managed by marshall's grand daughter Elizabeth who became first women pharmacist in US

• *1982 patent medicines were taxed due to financial demands of the civil war
• *In US these stamps were affixed on patient medicine (it torn when the container was open)
• *helped make patent medicines the domain of large manufacturing companies the drug stroe flourised

• *the mission of the pharmacists is to provide pharmacuetical care "a practice in which the practitioner takes responsibility for patient's drug-related needs and is held accountable for this commitment"
• *today pharmacists are striving to practice pharmacy using the principles of pharmaceutical care. this began to rally pharmacist to serve a higher good that was said to prevent related morbidity and drug related mortality

very first federal law in the US

strength purity and quality

Because of the US vs Johnson

• no more false claims
• declared products misbranded

• b/c of the tragedy of Sulfanilamide "wonder drug"
• the drug was manufactured as an elixer and diethylene was used as the solvent 105 people died
• need for safe administration of drug
• *require all new drugs be tested by their manufacturers for safety
• *require the test be submitted to the government for marketing via the NDA
• *Authorized FDA to conduct unannounced inspection

• no new drug could be distributed without the prior filing of a new drug application NDA
• the FDA now dealt with safe use of drug substance but did not require that the drugs to
• be effective in the treatment of disease

• based on
• *product's ingridients
• *methods used to evaluate products
• *standards used to evaluate formulations
• *principle studies(toxicology, phramacology)
• *clinical trial(still, FDA did not require drugs to be efficacious)

• introduced on the market october 1,1957 in west Germany
• prescirbed to pregnant women with morning sickness
• thalidomine babies resulted all around the world
• led Kefauver-Harris Amendments of 1962

• *Thalidomide Tragedy was the main reason behind the development of this Act
• *this amendment required manufactureres to prove a drug to be both safe and efficacious b4 granting FDA approval for marketing
• *Exempted from both safety n efficacy requirements were drugs that happened to enter the market b/t 1906-1938 ~grandfather clause. why? drugs never subjected to NDAs

• *no refills without valid prescription
• *further supported by drug abuse control amendment of 1965
• *comprehensive drug abuse prevention and control Act 1970

• * Drug of abuse were put under a comprehensive regulatory framework
• * The act established 5 schedules for classification and control of drug substances particularly those that were more likely to be abuse

1979 US FDA introduced classification of fetal risks due to pharmaceutical agent use

• category A: studies failed to demonstrate risk(1st trimester-no evidence of risk in later trimester)
• b,c,d,e,
• category X: animal studies or human demonstrated fetal abnormalities. Woman outweigh potential benefit

• FDAs absolute strongest labeling requirements used for highest risk medications
• *it stresses importance of close patient monitoring when using the medication
• *no "reminder ads" for health care professionals allowed
• *local and state law may only strengthen FDA laws, never weaken them

the schedule provide decreasing levels of contrl from schedule I to schedule V

• schedule I & II are highly potential (heroin)
• schedule III is moderate potential (codien)
• schedule IV & V are low potential (diazepam)

• *each firm that manufactures or repackages drugs for the ultimate sale or distribution to patients or consumers must register with the FDA and submit appropriate informaiton for listing
• *national drug code permanent registration code to identify manufacturer or distributor
• 10 digit long

• labeler code : manufacturer/distributor (1st 4digits)
• product code : used to identify drug formulation (3-4)
• package code : used to identify package size & type (3-2)
• NDEC 0081-5412-21
• there are 4-2 configuration and 3-3 configuration

• *a demand to change the speed for approving generic compounds
• *generic drugs must be bioequivalent to brand name drugs
• *new modifications to FDA guidelines to "accelerate the approval of generic drugs and to extend the life of innovative patented tech"
• Ronald Reagen signed law on 9/24/84 to make generic more widely available

the drug price competition and patent terms restoration act of 1984 said that

"any original approved new drug can be filed through and ANDA and by pass animal and human study testing" this reduced the time and money to market the generic version of a drug compound.

• *in order to encourage pioneering research effort the life of patents was extended
• *this time was extended to the amount of time required to review the NDA
• - plus 1/2 the time required to evaluate the drug testing phase
• - no less than 5y and no more than 20y

• this act prohibits reimportation of drugs, prohibits sales trading and purchasing of drugs
• why imp? functioned to protect the supply of prescription agents and prevent repackaged an mislabeled drugs from entering the legitimate market

• *due to growing interests in using dietary supplements, congress expressed the need to regulate all labeling claims
• *manufacturers had to state the following
• -this product is not intended to diagnose,treat, cure or prevent any disease
• *influences on body structure and function were ok

• *streamlined FDA policies
• *codify agency's newer regualtions
• *expanded patient's access to investigational treatment for serious life threatening disease
• *accelerated approval of new drugs
• *pediatric use of investigational drugs was now made possible

• *title 21 consists of eight volumes consisting of all regulations issued under the FDA cosmetic act and other statutes administered by the FDA
• *updated each year
• *most definitive info on federal laws n regulations pertaining to drugs

• class I - exposure will cause serious adverse health consequences or even death
• class II- exposure will cause temporary or medically reversible adverse health consequences
• class III-exposure is not likely to result in adverse health consequences

• *effective Jan 1 1993
• *each state now expected to develop and mandate drug use review(DUR) programs to improve quality of pharmaceutical care provided to patients
• *prescriptions fit needs of patients, are necessary, and should not cuase adverse medical effects
• *state plan should request review of drug therapy prior to patient use

• -conduct work in a prfessional manner-high principles are essential
• -no scientific misconduct tolerated
• -recognize n respect differences in opinion in the interpretation of scientific data
• -disclose sources of external conflicts
• -report results honestly n accurately
• -respect ownership rihts of others n seek prior written approval from owner b4 disclosure
• -do not discriminate on the basis of race,gender,creed or national origin