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2ND MOD STUDY GUIDE
2ND MOD STUDY GUIDE- JERI GORDON
| Question | Answer |
|---|---|
| WHAT ARE THE 2 ORANGE AUXILLARY LABELS THAT YOU WILL FIND ON A SCHEDULE II DRUG? | CAUTION: FEDERAL LAW PROHIBITS THE TRANSFER OF THE DRUG TO ANY OTHER PERSON THAN THE PATIENT IT WAS PRESCRIBED.CAUTION: CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED. |
| WHAT IS AN AUXILLARY LABEL? | ADDITIONAL DIRECTIONS |
| WHAT IS THE CONTROL SUBSTANCE ACT? | CLASSIFIES DRUGS INTO SCHEDULES BASED ON THEIR ABUSE POTENTIAL. |
| WHAT IS FEDERAL LEGEND? | CAUTION FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. |
| WHAT IS THE DURHAM-HUMPHREY AMENDMENT ALSO REFERRED TO AS? | THE PRESCRIPTION DRUG AMENDMENT |
| WHAT IS THE DEFINITION OF THE DURHAM-HUMPHREY AMENDMENT? | IT ESTABLISES TWO CLASSES OF DRUGS, OVER THE COUNTER AND PRESCRIPTION, AND MANDATED THAT LABELS OF PRESCRIPTION DRUGS INCLUDE THE LEGEND "CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCIPTION." |
| WHAT IS THE DEFINITION OF ORPHAN DRUGS? | DRUGS USED FOR DISEASES AND CONDITIONS CONSIDERED RARE IN THE UNITED STATES, FOR WHICH ADEQUATE DRUGS HAVE NOT YET BEEN DEVELOPED AND DO NOT GENERATE INCENTIVES FOR DRUG MANUFACTURERS TO RESEARCH AND DEVELOP TREATMENTS. |
| WHAT DOES HIPAA MEAN? | HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT- IT IS AN IMPORTANT LAW THAT REQUIRES THE ADOPTION OF SECURITY AND PRIVACY STANDARDS IN ORDER TO PROTECT PERSONAL HEALTH CARE INFORMATION. |
| WHAT DOES NDC STAND FOR? HOW MANY DIGITS ARE IN IT? WHAT ARE THEY USED FOR? | NATIONAL DRUG CODE; 11 DIGITS; THE FIRST 5- IDENTIFY THE MANUFACTURER OR DISTRIBUTOR; AND THE LAST 6- IDENTIFY THE DRUG NAME, PACKAGE SIZE, AND TYPE OF DRUG. |
| WHEN IS A CLASS I DRUG RECALL USED? | WHEN THERE IS A REASONABLE PROBABILITY THAT THE USE OR EXPOSURE TO A PRODUCT WILL CAUSE SEVERE ADVERSE HEALTH CONSEQUENCES OR DEATH. |
| WHEN IS A CLASS II DRUG RECALL USED? | WHEN THE USE OF OR EXPOSURE TO A PRODUCT MAY CAUSE TEMPORARY OR MEDICALLY REVERSIBLE ADVERSE HEALTH CONSEQUENCES. |
| WHEN IS A CLASS III DRUG RECALL USED? | WHEN THE USE OR EXPOSURE TO A PRODUCT IS NOT LIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCES. |
| PHARMACY PRACTICE STANDARDS, GUIDELINES, AND STATEMENTS: | IMPROVE THE DELIVERY OF PHARMACEUTICAL CARE. |
| WHAT DOES FDA STAND FOR? WHAT IS THE DEFINITION? | FOOD AND DRUG ADMINISTRATION; PROMULGATES RULES, REGULATIONS, AND STANDARDS; INSPECTS DRUG AND FOOD FACILITIES TO ENSURE PUBLIC SAFETY REGARDING DRUG PRODUCTS. |
| WHAT DOES DEA STAND FOR? WHAT IS THE DEFINITION? | DRUG ENFORCEMENT ADMINISTRATION; A FEDERAL AGENCY ESTABLISHED TO IMPLEMENT THE RULES AND REGULATIONS TO ENFORCE THE CONTROLLED SUBSTANCE ACT (CSA) TO COMBAT CONTROLLED SUBSTANCE ABUSE. |
| WHY WAS THE KEFAUVER-HARRIS AMENDMENT ADOPTED? | IT WAS ADOPTED AS A RESULT OF A POPULAR SEDATIVE, THAT WAS BEING MARKETED IN EUROPE BUT WAS NOT APPROVED BY THE FDA FOR THE U.S MARKET. IN 1961 IT WAS CONFIRMED THAT THALIDOMIDE HAD CAUSED SERIOUS BIRTH DEFECTS IN THOUSANDS OF INFANTS IN EUROPE. |
| WHAT IS THE KEFAUVER-HARRIS AMENDMENT ALSO KNOWN AS? | THE DRUG EFFICACY AMENDMENT |
| WHAT IS THE DEFINITION OF THE KEFAUVER-HARRIS AMENDMENT? | AN AMENDMENT TO THE FEDERAL FOOD AND COSMETIC ACT THAT REQUIRED ALL NEW DRUGS MARKETED IN THE UNITED STATES TO BE SHOWN NOT ONLY SAFE, BUT ALSO EFFECTIVE. |
| WHAT DOES OSHA STAND FOR? WHAT LAW ESTABLISHED IT? | OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION;THE OCCUPATIONAL AND SAFETY ACT OF 1970 |
| WHAT IS THE DEFINITION OF THE OCCUPATIONAL AND SAFETY ACT OF 1970? | FEDERAL LAW THAT ASSURES EVERY WORKING MAN AND WOMAN IN THE NATION SAFE AND HEALTHY WORKING CONDITIONS. |
| WHAT IS THE DEFINITION OF THE POISON PREVENTION ACT? | FEDERAL LAW MANDATING SPECIAL PACKAGING REQUIREMENTS THAT MAKE IT DIFFICULT FOR CHILDREN UNDER THE AGE OF 5 TO OPEN THE PACKAGE OR CONTAINER. |
| WHAT IS A SCHEDULE I DRUG? | A CONTROLLED SUBSTANCE WITH CURRENTLY NO APPROVED MEDICAL USE IN THE UNITED STATES. |
| WHAT IS A SCHEDULE II DRUG? | DRUGS WITH A HIGH POTENTIAL FOR ABUSE, WITH SEVERE PSYCHOLOGICAL AND/OR PHYSICAL DEPENDENCE. |
| WHAT IS A SCHEDULE III DRUG? | A CONTROLLED SUBSTANCE WHO ABUSE POTENTIAL MAY LEAD TO LOW PHYSICAL DEPENDENCE OR HIGH PSYCHOLOGICAL DEPENDENCE. |
| WHAT IS A SCHEDULE IV DRUG? | A CONTROLLED SUBSTANCE WITH LESS ABUSE POTENTIAL AND LIMITED RISK OF PHYSICAL AND PSYCHOLOGICAL DEPENDENCE. |
| WHAT IS A SCHEDULE V DRUG? | CONTAINS PREPARATIONS WITH LIMITED QUANTITIES OF CERTAIN NARCOTIC DRUGS. |
| THE EVIDENCE TO GRANT PRIOR APPROVAL OF NONFORMULARY DRUGS USUALLY MUST INDICATE: | 1.) PATIENT INTOLERANCE OF EXISTING DRUGS. 2.) TREATMENT FAILURES3.) DIAGNOSIS WITHOUT ANY LISTED TREATMENTS ON THE FORMULARY.4.) NEW DRUG MODALITIES. |
| WHAT IS AWP? WHAT DOES IT MEAN? | AVERAGE WHOLESALE PRICE; THE COST OF DRUGS AND PHARMACEUTICALS PURCHASED FROM A DRUG WHOLESALER. |
| WHAT IS MAC? WHAT DOES IT MEAN? | MAXIMUM ALLOWABLE COST; BASED ON WHOLESALE ACQUISITION COSTS. |
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jeri_gordon
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