Law Final

THE PHARMACIST IN CHARGE SHALL:

- Develop and implement written error prevention procedures as part of the Policy and Procedures Manual. - Report incidents, including relevant status updates, to the Board on Board approved forms within fifteen (15) days of discovery.

The Board Shall:

- Maintain confidentiality of information relating to the reporter and the patient identifiers. - Compile and publish in the newsletter and on the Board web site, report information and prevention recommendations. - Assure reports are used in a constructive and non-punitive manner.

Notify the DEA Field Division Office and local police of theft or significant loss within ___ business day of discovery, in writing

1 Use DEA Form 106

DEA Form ___ (Registrants inventory of drugs surrendered) - reverse distributor submits to DEA when drugs get destroyed

41

Define what is an adverse drug event

An unfavorable and unintended response to a drug, whether or not it is considered related to the product (may or may not be causal) ADE includes medical errors, adverse drug reactions, allergic reactions and overdoses

Which of the follow are/is true regarding Title 16 Chapter 19 Part 25 of the New Mexico administrative code regarding Pharmacist and adverse events? A. The Pharmacist in Charge is required to report incidents, including relevant status updates, to the Pharmacy Board using the approved forms within 72 hours of discovery. B. The Board of Pharmacy will maintain confidentiality of the information relating to both the reporter and the patient. C. The objective of this section of the NM administrative code is monitor the incident rates of drug related adverse events and errors in dispensing. D. All of the above are true

B. The Board of Pharmacy will maintain confidentiality of the information relating to both the reporter and the patient.

The total number of dosage units of all controlled substances distributed by a pharmacy may not exceed ____ percent of all controlled substances dispensed by the pharmacy during a calendar year - if it exceeds this percent, the pharmacy is required to register as a distributor. A. 1% B. 3% C. 5% D. 7% E. 10%

C. 5%

An adverse event following immunization (AEFI) consists of all of the following except: A. An unfavorable or unintended sign, abnormal laboratory finding, symptom or disease. B. Vaccination errors C. An untoward medical occurrence which follows immunization where a causal relationship must exist D. Product quality defects and inherent properties of the vaccine and anxiety- related reactions.

C. An untoward medical occurrence which follows immunization where a causal relationship must exist

Who are required to report adverse events to MedWatch? A. Physicians B. Pharmacists, Nurses and other practitioners C. Drug Manufacturers D. Consumers E. All of the above

C. Drug Manufacturers

This law became effective April 13, 2009 and as of that date, it is illegal under federal law to deliver, distribute or dispense a controlled substance by means of the internet unless the online pharmacy holds a modification of DEA registration authorizing it to operate as an online pharmacy. A. ControlledSubstancesAct B. DEA Online Pharmacy Registration Act of 2008 C. Ryan Haight Online Pharmacy Consumer Protection Act of 2008 D. OnlinePharmacyActof2009 E. Combat Methamphetamine Epidemic Act

C. Ryan Haight Online Pharmacy Consumer Protection Act of 2008

What elements need to be on the prescription to abide by federal regulations?

Date and signed on the date when issued Patient's full name and address and practitioner's full name, address and DEA registration number Drug name Strength Dosage form Quantity prescribed Directions Directions for use Number of refills authorized (if any)

What patient characteristics are important to include in ADE reporting?

Demographic info Medical condition prior to therapy Comorbidities Concomitant therapies Relevant family hx Any possible risk factors assoc with ADE

A complete MedWatch adverse event form should include the following information except: A. Description of the adverse event B. Product NDC or Name and strength C. When the adverse event started D. The outcome of the adverse event and who reported it. E. All of the above should be included

E. All of the above should be included

T/F. Refills are permitted for schedule II medications/prescriptions

False. They are prohibited

Know who can submit a MedWatch adverse drug event report

Health professionals and consumers/patients can voluntarily report on Form 3500/B Mandatory Form 3500A - User facilities (medical devices) - Manufacturers • Drugs, biologics • Human cell and tissue products • OTC products/medical devices

Combat Methamphetamine Epidemic Act of 2005

Placed Pseudoephedrine, ephedrine, and phenylpropanolamine to the category "schedule listed chemical products" product must be sold behind RX counter Maintain log for 2 years Requires Picture ID/ must be 18 yoa/ provide information Patients allowed only 3.6 g per Day & 9g in a 30 day period max

What is meant by "serious" and a "non-serious but unexpected adverse event

Serious ADE fatal, life threatening, permanently disabling. Requires prolong hospitalization Causes a birth defect Requires intervention to prevent permanent impairment or damage Potential for harm/close calls (drugs or devices) Non-Serious but unexpected Previously unidentified adverse effect of drugs (not in the pkg insert)

T/F. When receiving a controlled substance prescription, the RPH must verify practitioner and valid DEA number each time

True

T/F. When transferring controlled substances to another pharmacy or to original suppliers/manufacturer, they also need to issue DEA form 222

True

Significant ADE

a drug related incident that results in harm to the patient

Incident

a drug that is dispensed in error, that is administered and results in harm, injury or death

Dispensing error

a prescription that was dispensed from the pharmacy differently from what was prescribed

1938: The Food Drug and Cosmetic Act

as a result of Sulfanilamide poisoning, manufacturers required to submit application to receive approval for a drug and prove safety but not efficacy. The FDA also gained authority to regulate devices to ensure that they are not adulterated or misbranded.

1962: The Kefauver-Harris Drug Amendment

as a result of Thalidomide tragedy, required well controlled trials to be conducted to prove efficacy for Rx and OTC drugs. It also defined rules for informed consent of research participants.

Which of the follow is/are true about VAERS? a. The programs only objective is to monitor for new, unusual or rare vaccines adverse events. b. Initiated as a response to the National Childhood Vaccine injury act. c. Focuses primarily on childhood vaccines d. Only healthcare providers who vaccinate or are physicians can submit a VAERS report. e. All of the above

b. Initiated as a response to the National Childhood Vaccine injury act.

Which of the follow are examples of the limitation of the VAERS system a. VAERS is subject to bias. For example, adverse events that are common or mild are underreported b. The quality and completeness of VAERS data are variable c. Causality is never determined by using VAERS data d. All the above are true

c. Causality is never determined by using VAERS data

In the FDA MedWatch video, Dr. Marks describes how MedWatch received multiple reports of pancreatitis associated with the use of Depakote. The take home message from this story is that: a. Patients should let their provider know if they have a history of GI conditions when prescribed Depakote. b. This condition is rare and should not be a concern with most patients taking Depakote. c. The reporting of this adverse event associate with Depakote confirms what was found in clinical trials. d. This added boxed warning is an example of why all medical products need to continually be assess for safety.

d. This added boxed warning is an example of why all medical products need to continually be assess for safety

When counting controlled substances, an _______ (exact/estimate) count if schedule II. For schedule III,IV or V an ______(exact/estimate) count is required. Unless container holds more than _____ tablets or capsules, then an exact count is required

exact estimate 1000

How soon does the DEA need to be reported of stolen or lost DEA forms?

immediately (Must provide serial numbers of each lost/stolen form, or the approx date of issue

1976: The medical device amendment required

manufacturers to register with the FDA and follow quality control standards for devices prior to marketing.

1990: The Safe Medical Device Act required the

post marketing surveillance and adverse event reporting of implanted devices.

1906: The Federal Food and Drug Act

prohibited the interstate commerce of misbranded or adulterated drugs. The 1912 Shirley Amendment prohibited false therapeutic claims.

Harm

temporary or permanent impairment of the physical, emotional or psychological function or structure of the body and/or pain resulting there from requiring intervention

1997: Food and Drug Administration Modernization Act regulated

the advertising of drugs and devices for unapproved indications. Also an accelerated review process for orphan drugs and diseases that had no current available treatment.

1983: The Orphan Drug Act first enacted in the United States

was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed. Rare diseases are classified as those affecting fewer than 200,000 persons in the United States.

Identify and list the essential components related to adverse event reporting

• Description of adverse event-time to onset of signs and symptoms • Suspected and concomitant product therapy(s) details: (lot number, schedule, dates of use and duration) • Include OTC meds, herbals, dietary supp and any recently discontinued drugs • Clinical course of the events and patient outcomes (hospitalization, disability and death) • Relevant therapeutic measures such as laboratory data - at baseline, during therapy, subsequent to adverse event should be noted • info about the response to dechallenge and rechallenge of medication

list barriers to the dissemination of information related to an adverse drug event

• Many ADEs are likely never reported since the association is not recognized as causal • They are not recognized as safety concerns • HCP are unfamiliar with the reporting process and its importance • Takes too much time to submit a report