Midterm Study Guide PDF

Midterm Breakdown: Pharmacy Law: Interpreting Prescription Orders: Outpatient prescription: an order from a prescriber for a medication or device to be dispensed from a pharmacy for use outside of a hospital, extended care facility, or other institutional practice setting. By what...

Midterm Breakdown: Pharmacy Law: Interpreting Prescription Orders: Outpatient prescription: an order from a prescriber for a medication or device to be dispensed from a pharmacy for use outside of a hospital, extended care facility, or other institutional practice setting. By what means can prescriptions be transmitted to the pharmacy? Written, faxed, electronically or phoned in How many prescriptions can be written on a prescription? Handwritten: up to 4 Computer-generated: up to 6 True or False: Controlled and non-controlled prescriptions can be written on the same prescription document ➔ TRUE! True or False: A prescriber needs to indicate the total number of drugs on each paper prescription ➔ TRUE! The required components of a written prescription are: ○ Date and signature of the prescriber ○ Full name of patient ○ Prescriber’s printed name and address ○ Drug name and strength ○ Quantity prescribed ○ Directions for use ○ Number of refills authorized Required components for a controlled substance prescription: ○ DEA number and professional designation ○ Quantity in both written and numerical terms ○ ALWAYS ZERO REFILLS FOR CIIs! ○ Patient’s address Required components for a controlled substance for an animal:  ○ Species of animal ○ Full name and address of the owner True or False: When a patient’s address is missing on a script for a controlled substance, a pharmacist is allowed to enter it based on Michigan Law. ➔ TRUE! How long are each of these prescriptions valid for: CII: must be filled within 90 days of the date written CIII: maximum of 6 months from the date written CIV: maximum of 6 months from the date written CV: valid for up to a year from the date written Non-controlled legend drugs: valid for up to a year from the date written The quantities for controlled substances should be listed in: Both alpha and numeric format ○ Ex. #30 (thirty) Identifying the drug schedule: Legend drugs have “Caution: Federal Law prohibits dispensing without a prescription” or “RX Only” on its original container Controlled substances may be identified by the CII, CIII, CIV, and CV designating their schedule and is found on the front of the drug container, on the package insert and in current references such as Facts and Comparisons If refill status is not listed on a prescription, how many times can it be refilled? ○ ZERO How many times can a CIII or CIV prescription be refilled? ○ No more than 5 times If a prescription has PRN refills, how many times can it be refilled for: ○ CII: none ○ CIII: 5 times or 6 months ○ CIV: 5 times or 6 months ○ CV or non-controlled: may be filled at appropriate intervals for one year as authorized by the prescriber DEA policy regarding information that can be changed on a CII prescription after the pharmacist contacts the prescribing practitioner: Patients address Drug strength Drug quantity Directions for use Dosage form DEA policy regarding information that CANNOT be changed on a CII prescription: Patient’s name Controlled substance prescribed (except for generic substitutions permitted by state law) Prescriber’s signature Who has a DEA number? All practitioners who prescribe controlled substances The first letter of a DEA number is: A/B/F/M- Hospital/clinic/practitioner/teaching institution/pharmacy M- Mid-level practitioner (NP/PA/OD/ ET, etc) The second letter of a DEA number is: The first letter of the registrant’s last name What product names must be on a prescription label when a generic is substituted for a brand name product? Brand name prescribed and the generic name of the product dispensed When is a pharmacist not permitted to substitute a generic drug for a brand name product? When prescriber writes in their own handwriting “DAW” and/or brand medically necessary When prescriber tells you verbally that the prescription is to be dispensed as communicated Labeling Prescriptions: Legend Label Requirements based on Federal Law are:  ○ Name and address of the pharmacy ★ Best practice would suggest the pharmacy include phone number with area code ○ Serial number of the prescription (RX #) ○ Date a prescription was filled or refilled ○ The name of the prescriber ○ The name of the patient ○ The directions for use along with any precautions indicated in the prescription as given by the prescriber Additional legend label requirements for the state of michigan: ○ Prescription labels contain the name of the med and strength, unless the prescriber indicates “do not label” ○ Quantity dispensed, if applicable ○ Patient notification and labeling when generic substitution occurs (include both the name of the brand prescribed followed by the generic name of the drug dispensed) ○ The brand name or the name of the manufacturer or supplier of the drug dispensed must be noted on the prescription ○ Must include, “discard this medication one year after the date it is dispensed” or the actual expiration date of the medication Medication expiration date can be found on the medication stock bottle ○ If medication expires in less than one year, use the actual expiration date What information should be placed on a prescription receipt if a drug that has no brand name is dispensed? ○ The name of the manufacturer or supplier of the drug What labels should include the statement “Caution: Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”? ○ CII ○ CIII ○ CIV The prescription files that are required in Michigan are: 1) CII 2) CIII, CIV and CV 3) All other prescriptions (noncontrolled)  What information is required on a label when a person dispenses or sells a non-prescription CV medication? ○ The date ○ Their own name ○ The name and address of the place of practice in which the preparation is sold or dispensed How old must a person be to purchase a non-prescription CV medication? ○ At least 18 years of age What is the maximum quantity of a non-prescription CV medication that can be purchased every 48 hours? ○ 4 oz. Where must the sale of a non-prescription CV medication be recorded? ○ In an exempt narcotic book Drug Information Resources What is Evidence-Based Medicine? The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients Individual clinical expertise is integrated with the best available external clinical evidence from systematic research What is done to make the best decision for a given situation? Combine the best evidence from clinically relevant studies Add in your clinical expertise to determine if it applies to the individual patient Incorporate the patient’s values Factors that make looking for information difficult are: Information explosion Too many sources of information Increase in number and sophistication of drugs/medical interventions Traditional resources often inadequate Readily available search tools More knowledgeable patient Daily need for valid information  Too many sources of information: 2018: estimated there are over 30K medical science journals PubMed includes about 5600 journal titles Over 800k new citations added to PubMed each year Information Explosion: Research info doubles every 10 years Explosion of misinformation Traditional Resources Often Inadequate: Textbooks can be outdated Many books take 1-3 years to get to print Readily Available Search Tools: 1986: Medline available via librarians only Today: numerous search tools readily available More Knowledgeable Patient ➔ 30% of adults seeing MD discuss a drug they saw through direct-to-consumer advertising ➔ Almost ½ of these patients received a prescription for the drug they asked about Increase in Number and Sophistication of Drugs/Medical Interventions: 10% of drugs on market between 1975-1999 pulled from market/black box warning added 10% of biologicals approved between 1995-2007 had a black box warning added ½ of all withdrawals occur within 3 years of the drug coming to market (approx. 500 market withdrawals worldwide) Need to develop strategies to identify QUALITY information that is RELEVANT in an EFFICIENT manner Systematic approach ○ Systematic way of searching the literature Why use the systematic approach?  ○ To improve search efficacy ○ To enhance search effectiveness What are the steps of the systematic approach? 1. Classify the issue/request 2. Obtain clarifying information 3. Conduct a systematic search 4. Evaluate the information found 5. Apply the information to the actual question/setting 6. Communicate the response 7. Follow-up 1. Classify the issue: Two components to classifying a request: ○ WHO is requesting the info ○ WHAT TYPE of question is it 2. Obtain clarifying information Is it a general question or patient-specific question? What info is really needed that isn’t being asked 3. Conduct a systematic search Determine most appropriate resources to use Point of care resources for P1 year: textbooks and databases Types of resources: ○ Tertiary resources: drug information handbook ○ Secondary resources: PubMed, OVID, Google Scholar (web sources) ○ Primary sources: Journals or articles 4. Evaluate and apply the information Can you use the information found to manage the patient ○ Factors to consider: whether the information found is for a similar indication, age group, etc. Is the information you found sufficient to answer the question 5. Communicate the response Gather info found Formulate a response Restate the request State response/ provide recommendation Describe data sources used State limitations  Anticipate further questions Ethical considerations and liability What are the pros of a verbal response? ○ Allows you to engage in dialogue ○ Allows you to clarify/explain details What are the cons of a verbal response? ○ Info may not be retained well (easy to forget) ○ Run risk of info being inaccurately transmitted to 3rd party What are the pros of a written response? ○ Allows for a formal record of info shared ○ Clarity improved ○ Good if complex issue or legal implications What are the cons of a written response? ○ Time consuming ○ No dialogue occurs 8. Follow-Up … and follow through Was the recommendation accepted/implemented? What was the patient outcome Does the recommendation need to be re-evaluated or modified based on patient response Pharmacist Patient Care Process MEDICATION PROFILE REVIEW List information that should be included in a patient’s pharmacy profile ○ Name ○ Phone # ○ DOB ○ Address ○ Other info: compliance, abuse, difficulty swallowing, difficulty reading instructions/comprehending, dosage preference  ○ Comprehensive list of meds, relevant devices and OTCS How long must a pharmacy keep records of dispensed medications? ○ 5 years How can a pharmacist use a patient profile when assessing adherence? ○ Compare time that patient comes back for a refill w/ quantity dispensed and instructions for use Why is it important for a pharmacist to conduct drug interaction screenings? ○ Automated programs are not updated regularly enough ○ Computers are unable to cross check items that are not entered into the computer (ex. If patient uses more than one pharmacy) ○ Too many clinical checks end up getting overlooked by pharmacists; techs learn ways to bypass warning screens PHARMACISTS’ PATIENT CARE PROCESS Why was this process created? ○ To have a consistent process of care in the delivery of patient care services What is the first step of the pharmacists’ patient care process? ○ Establish a patient-pharmacist relationship What components are at the core of the process? ○ Pharmacists continually collaborate, document, and communicate with physicians, other pharmacists and other healthcare professionals in the provision of safe, effective, and coordinated care Provide examples for each of the following principles of evidence-based practice: ○ Collect:  Current medication list and medication use history Relevant health data Patient lifestyle habits, preferences and beliefs, health and functional goals, and socioeconomic factors that affect access to medications and other aspects of care ○ Assess Appropriateness, effectiveness, safety, and patient adherence for each medication Health and functional status, risk factors, health data, cultural factors, health literacy and access to medications or other aspects of care Immunization status and need for preventive care and other health care services, where appropriate ○ Plan Address medication-related problems and optimize medication therapy Set goals of therapy for achieving clinical outcomes in the context of the patient’s overall health care goals and access to care Engage patient through education, empowerment, and self-management Support care continuity, including follow-up and transitions of care as appropriate ○ Implement Address medication and health-related problems and engages in preventative care strategies Initiates, modifies, discontinues or administers medication therapy as authorized Provides education and self-management training to patient or caregiver Contributes to coordination of care, including referral or transition of patient to another health care professional Schedules follow up care as needed to achieve goals of therapy ○ Follow-up: Monitor and evaluate Medication appropriateness, effectiveness, and safety and patient adherence  Clinical endpoints that contribute to patient’s overall health Outcomes of care, including progress toward or the achievement of goals therapy Drug therapy problems: Introduction Why should drug therapy problems be identified? ○ To help patients achieve their goals of therapy and realize the best possible outcomes from drug therapy Drug therapy problems: Terminology Define drug therapy problem: Any undesirable event experienced by a patient that involves, or is suspected to involve, drug therapy, and that interferes with achieving the desired goals of therapy and requires professional judgment to resolve. Components of a drug therapy problem List the three components of a drug therapy problem ○ An undesirable event or risk of an event experienced by the patient ○ The drug therapy (products and/or dosage regimen) associated with the problem ○ The relationship that exists (or is suspected to exist) between the undesirable patient event and drug therapy List the seven types of drug therapy problems and link them to the words indication, effectiveness, safety, and adherence The drug therapy is unnecessary because the patient does not have a clinical indication at this time— INDICATION Additional drug therapy is required to treat or prevent a medical condition in the patient— EFFECTIVENESS The drug product is not being effective at producing the desired response in the patient— EFFECTIVENESS The dosage is too low to produce the desired response in the patient— EFFECTIVENESS The drug is causing an adverse reaction in the patient— SAFETY The dosage is too high, resulting in undesirable effects experienced by the patient— SAFETY  The patient is not able or willing to take the drug therapy as intended— ADHERENCE Drug therapy problem 1: Unnecessary drug therapy Describe common causes of unnecessary drug therapy ○ Duplicate therapy: multiple drug products being used for a condition that requires only a single drug therapy ○ No medical indication at the time ○ Nondrug therapy more appropriate ○ Addiction/recreational drug use ○ Treating avoidable adverse reaction Drug therapy problem 2: Needs additional drug therapy Describe common causes leading to the need for additional drug therapy ○ Preventative therapy required to reduce risk of developing a new condition ○ Untreated condition: medical condition requires initiation of drug therapy ○ Synergistic therapy: medical condition requires additional pharmacotherapy to attain synergistic or additive effects Drug therapy problem 3: Ineffective drug Describe common causes leading patients to take medications at are not effective ○ More effective drug available ○ Condition refractory to drug ○ Dosage form inappropriate ○ Contraindication present ○ Drug not indicated for condition Drug therapy problem 4: Dosage too low Describe common causes leading to dosage regimens that are insufficient ○ Dosage too low ○ Ineffective dose ○ Needs additional monitoring ○ Frequency inappropriate ○ Incorrect administration  ○ Drug interaction ○ Incorrect storage ○ Duration inappropriate Drug therapy problem 5: Adverse drug reaction Describe common causes leadings to patients taking drug products that are not safe ○ Adverse drug reaction ○ Undesirable effect ○ Unsafe drug for patient ○ Drug interaction causing undesirable effect ○ Incorrect administration ○ Allergic reaction ○ Dosage increase/decrease too fast Drug therapy problem 6: Dosage too high Describe common causes of dosage regimens that are too high ○ Dosage too high resulting in toxicity ○ Needs additional monitoring ○ Frequency too short ○ Duration too long ○ Drug interaction Drug therapy problem 7: Adherence (noncompliance) Describe common reasons that patients may not take their medication as prescribed ○ Dose not understand instructions ○ Cannot afford drug ○ Patient prefers not to take ○ Patient forgets to take ○ Drug product unavailable ○ Cannot swallow/ administer drug Vaccines List the three roles of pharmacists related to immunizations 1. Educator 2. Facilitator  3. Immunizer How many states allow pharmacists to administer immunizations? ○ All 50 states How can a pharmacist serve as an educator related to immunizations? ○ Through increasing awareness of personal and public health benefits of immunization Define “gaps in coverage” and how it relates to immunizations? ○ Refers to period during which a patient lacks health insurance coverage of drugs and healthcare services ○ A pharmacist should routinely monitor a patient’s immunization status and identify any gaps in coverage How can a pharmacist serve as a facilitator related to immunizations? ○ By hosting others who immunize in their pharmacy or facility. This can be done by hosting a nurse-run immunization clinic, referring patients to other health care providers, or collaborating with local health departments to refer patients to community immunization programs. What kind of protocols or agreements might be required (depending on the state) before a pharmacist immunizes a patient? ○ A pharmacist may provide immunizations under a protocol, collaborative-practice agreement, standing order, or individual prescription. The liability aspects of these approaches are dependent on state-based scope of practice laws and regulations Quality Standards for Pharmacy-Based Immunization 1. According to Standard 1, what must be given? ○ Info about risks and benefits associated with immunization ○ Vaccine information statement (VIS) developed by the CDC ○ Discuss questions and concerns patients may have about the vaccine ○ Patients should be informed about the importance of receiving other preventive medical services and the benefits of having a medical home ○ Pharmacist must provide culturally and linguistically appropriate info, at a reading level easily understood 2. Standards 3 and 4 reinforce what action to occur prior to a pharmacist giving an immunization?  ○ Pharmacists MUST screen patients before immunization to check for preexisting health conditions, allergies, prior adverse events, and whether the patient received the vaccine previously ○ During screening, the pharmacist must probe for the presence of potential contraindication If contraindication exists, the pharmacist must inform the primary-care provider or local health department and the vaccinee. 3. According to Standard 5, outside of the pharmacy profile, what other three places should patient immunization information be sent? ○ Primary-care provider ○ Local health department ○ Regional immunization registry 4. According to Standard 7, what actions must a pharmacist be ready to do in the event of an emergency? ○ Call for emergency medical services ○ Administer epinephrine ○ Provide cardiopulmonary resuscitation What are the four pharmacist roles in emergency preparedness and response? 1. Prepare 2. Participate 3. Develop Partnerships 4. Response Manual Blood Pressure Assessment Stage 1 hypertension is categorized as a blood pressure reading of: ○ 130-139 mm Hg systolic ○ 80-89 mm Hg diastolic Stage 2 hypertension is categorized as a blood pressure reading of: ○ 140 or higher systolic ○ 90 or higher diastolic BEFORE taking a blood pressure measurement, what is the minimum number of minutes a patient should rest quietly? ○ 5 minutes  Sam is a new patient and has arrived for his FIRST visit. You do not see any previous blood pressure readings in Sam's record. Which arm should you use to measure Sam's blood pressure? ○ Measure blood pressure in both arms Sam has returned for their next visit. According to Sam's chart, their left arm had a higher reading on their first visit. How should you measure Sam's blood pressure for this and the next visit? ○ Measure twice or more on their left arm (1-2 minutes apart), then average those readings. What patient actions increases the chances of inaccuracies during blood pressure measurement? ○ Talking on cell phone ○ Standing ○ Crossing their legs What actions should a patient AVOID doing for 30 minutes prior to their blood pressure measurement at a doctor’s office? ○ Exercising ○ Using tobacco products ○ Drinking caffeine What is regarded as proper patient positioning for blood pressure measurement? ○ The patient should have their arm supported with palm facing up and muscles relaxed When using the auscultatory technique with a manual blood pressure device to measure blood pressure, which Korotkoff sounds correspond to the DIASTOLIC blood pressure? ○ When the Korotkoff sound disappears Following a blood pressure measurement, how should the results of the measurement be provided to the patient? ○ In writing immediately afterwards ○ Verbally immediately afterwards