854 Exam One

Compounding

"combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient" Pharmacist-patient-prescriber relationship ("triad") Pursuant to a valid prescription Prior to receiving RX on the basis of history Do not require FDA approval (don't have to send to FDA to test for efficacy Do not need to adhere to CGMP requirements (no stability testing, use beyond use dating)

Section 503A

"traditional" compounding by pharmacist or physician (do if a pharmacy)

Cisgender

- people whose gender identify is the same as the sex they were assigned at birth • Being cisgender does not imply any specific sexual orientation Cisgender people may identify as any sexuality including the sexual minorities

Resources for LGBT

-world professional association for transgender health (WPATH) -the endocrine society guidelines -fenway national LGBTQ health education center -UCSF center of excellence for transgender health

Refractory symptoms

1. Aggressive palliative treatments have failed or have produced intolerable side effects. 2. Additional treatments are unlikely to provide adequate relief without intolerable side effects. 3. Patient is likely to die before conventional treatment could work.

Basic functions of FDA Drug Regulation

1. Approval of drugs on the basis of purity, safety and effectiveness. 2. Regulation of all labeling for prescription and nonprescription drugs. 3. Regulation of advertising for prescription drugs (The Federal Trade Commission [FTC] regulates nonprescription advertising). 4. Regulation of manufacturing processes of drugs and institution of recalls. 5. Regulation of bioequivalence for generics and biosimilars. 6. Monitoring of drugs post-approval to detect any problems with the use of drugs, such as unanticipated adverse reactions (a.k.a.- postmarketing surveillance) 7. Monitoring of the safety of the nation's blood supply. Once the FDA has determined a drug is safe and effective to be sold in the US, it has little direct control over how the drug is used or prescribed

Advanced directives

2 types 1. Living will · Provides directions to physicians concerning the types of treatments/interventions to be employed or not if the patient becomes incompetent 2. Decision-maker/surrogate

CPR perceptions

287 elderly surveyed 41% opted for CPR prior to learning survival statistics After learning survival statistics, 22% wanted CPR, only 6% of >86yo 11% wanted CPR if life expectancy <1 year vs 5% after learning stats Cant do anything about cancer, think of thoracic damage 524 healthy adults Significantly more patients chose DNR when included "Allow Natural Death" included and comprehensive information given

CPR on tv

60 arrests in 97 episodes -28% primary cardiac -65% children, teenagers, young adults -75% immediate survival, 67% to discharge The procedure of CPR was never intended for use in patients dying an expected death from a chronic, fatal, medical illness.

Statues

A statute is a written law passed by a legislature on the state or federal level. Statutes set forth general propositions of law that courts apply to specific situations. A statute may forbid a certain act, direct a certain act, make a declaration, or set forth governmental mechanisms to aid society. Changes to statute require amendment by the legislative body.

Pharmacist role

ASHP Statement on Pharmacist Participation in Medical Aid in Dying Inclusion in the care team Medication dispensing and counseling

Food, Drug, and Cosmetic Act of 1938

All marketed drugs must be proven safe and approved by the FDA Labels on marketed drugs must contain "adequate directions for use" and habit-forming warnings if applicable Cosmetics and Devices were now included as part of act Drugs that were marketed before 1938 excluded from law This act was created to attempt to correct some of the pitfalls of the Pure Food and Drug Act of 1906. The passing of this act established that the FDA must approve all new medications that are to be sold in the U.S., and that drugs will not be approved until they have been determined to be safe to use. It also moved cosmetics under the jurisdiction of the FDA. It established greater authority for the FDA to oversee the safety of drugs, food, and cosmetics, in an effort to improve medication safety and prevent further disasters like the sulfanilamide tragedy. This act allowed medications marketed before 1938 to be exempt from the requirement to prove their safety. The Food, Drug, and Cosmetic Act also established clear definitions for adulteration and misbranding, and established that these actions are illegal. It required medication labels to state adequate directions for using the product as well as warnings if the medication is habit forming to avoid misbranding. In addition, it established that labeling must include the quantities of active ingredients, alcohol content, and name and location of the manufacturer. Products were considered adulterated if they contained any dirty or decayed substances, were manufactured in an unsanitary environment, contained any dangerous coloring additives, were prepared in containers created of unsafe materials, or if they did not have consistent purity. This legislation brought vast improvements to the safety of medications sold in the United States.

Role of surrogate decision maker

Also known as healthcare proxy Has either been named by the patient at a time when he/she had capacity or is a family member or close acquaintance designated by law or statute NM Uniform Healthcare Decisions Act, identify surrogate in descending order: -spouse, unless legally separated or unless there is a pending petition for annulment, divorce, dissolution of marriage or legal separation -an individual in a long-term relationship of indefinite duration with the patient in which the individual has demonstrated an actual commitment to the patient similar to the commitment of a spouse and in which the individual and the patient consider themselves to be responsible for each other's well-being · loosely defined -adult child -parent -adult brother or sister -grandparent

Drug Price Competition and Patent Term Restoration Act of 1984

Also known as the Hatch-Waxman Amendment, this legislation amended the Food, Drug, and Cosmetic Act to help streamline the generic drug approval process to encourage the development of new generic products. It allowed for drug companies to file an abbreviated new drug application (ANDA) when applying for FDA approval of generic drugs, to allow generic medications to be approved without the generic manufacturers conducting their own clinical trials to prove the medication's efficacy. This decreased the amount of time necessary for the FDA to approve generic drugs, as well as decreasing costs for manufacturers of generic products, allowing for increased competition among generic drug manufacturers and inevitably decreasing costs to consumers. It also allows the first company to file an ANDA for the right to exclusively market their generic product for 180 days before other companies may market their generic versions. Lastly, it encouraged the d

destroying controlled substances

Any pharmacy that wants to destroy controlled substances that are damaged or outdated must first apply for permission to destroy these items by completing and submitting DEA form 41. This form should include the date of intended destruction, the name, concentration, and quantity of any controlled substances to be destroyed, the method to be used for destruction, and the names of the witnesses who will be present for the destruction, and must be sent to the DEA at least two weeks before drug destruction. Hospitals may apply for a "blanket authorization" to destroy damaged products and unused portions of injectable controlled substances.

How long should a futile intervention be continued

Appropriate to continue temporarily in order to assist patient or family in coming to terms with gravity of the situation Allow for time for closure/goodbyes Should NOT be used for the benefit of family members if likely to cause substantial suffering to the patient or if family's interests are clearly at odds with those of the patients For example, rather than stating, "It is futile to continue to treat this patient," one would state, "CPR would be medically futile for this patient."

Gender

Assigned based on an internal sense of self and how one fits into society

Sex

Assigned based on external genitalia

Withdrawing care

Assuming all other life-sustaining treatments have been stopped, including artificial hydration and nutrition, there are several potential outcomes: -rapid death within minutes -death within hours to days -stable cardiopulmonary function leading to a different set of care plans, including potential hospital discharge Families should be informed about the steps involved and counseled about oxygen and medications for symptom support

FDA Modernization Act of 1997

Because of the high burden of the drug approval process, the FDA Modernization Act was created to streamline the FDA's regulatory process to allow for more rapid approval of new drugs. This act created a mission statement for the FDA to publicly define its responsibilities and required the creation of a compliance plan to reduce the backlog of medications in the approval process. It also created a fast-track approval process for medications for life-threatening conditions, a database of clinical trial information, and gave drug manufacturers expanded rights in distributing information on unlabeled uses of drugs. The FDA Modernization Act increased the FDA's oversight of overthe-counter medications and required inactive ingredients to be listed on labels. This act also changed the requirement for the statement "Federal law prohibits the dispensing of this medication without a prescription" to be replaced by the abbreviation "Rx" on the packaging of prescription products

Harrison Narcotic Act of 1914

Because of the increasing abuse and trafficking of opium, the International Opium Convention met in 1912 to discuss potential international limitations on its use and transport. In 1914, the U.S. passed its own regulations to regulate opium and narcotic use. The Harrison Narcotics Tax Act gave authority to the Internal Revenue Service (IRS) to collect tax on opiates, and anyone that produced, dispensed, or sold opiates had to be registered with the IRS. This act also required a prescription for opium to be given to patients as well as requiring providers to be registered to prescribe opium. Prescriptions for and the dispensing of opium had to be documented, and restrictions on the sale, importation, and distribution of opium and narcotic derivatives were implemented. While the Comprehensive Drug Abuse, Prevention, and Control Act of 1970 largely replaced this act, it was the first of its kind to attempt to

Ethical Principles

Beneficence Nonmaleficence Autonomy Justice Confidentiality Veracity Promise-keeping

USP

Chapters below <1000 are legally enforceable 999 Above are "guidance" USP creates but does not enforce standards Standards enforced by FDA Compliance required by NM state regulations; enforced by BOP

Adverse effects of testosterone

Clitoral enlargement Vaginal atrophy Increased skin oiliness/acne Scalp hair loss

Feminizing hormone therapy

Combine estrogen with anti-androgen

Comprehensive Drug Abuse Prevention and Control Act of 1970

Commonly known as the Controlled Substance Act, this act was the first to establish regulations on the prescription and dispensing of controlled substances as well as their importation, possession, and use. It was created to prevent drug abuse and dependence as well as to strengthen the authority of law enforcement on drug abuse. It led to the creation of the Drug Enforcement Agency (DEA), which is supervised by the Department of Justice

Utilitarian Theory

Consequentialist (ends oriented) Achievement of goals are the primary source of happiness Only the final outcome matters, you can use any means necessary to get there. The correct ethical choice is the one that leads to the greatest amount of good for the greatest number of people.

contraindications to estradiol

Contraindications to estrogen therapy VTE related to underlying hypercoagulable state Estrogen sensitive neoplasm Estrogen therapy in transgender patients shown not to increase risk of developing breast cancers End-stage liver disease Informed consent process for shared decision making should be used in patients with risk factors

Ethical issues unique to long term care

Control and choice (autonomy) -Loss of functional impairment and increasing dependency -Loss of decision making capacity -Limited access to services and specialists Psychosocial -Social and spiritual isolation -Limited availability of family -Depression (major 12%-25%, minor 18%-30%) -Loss of privacy End of life -High rates of untreated pain and other symptoms -Current quality standards and reimbursement incentivize restorative care and technologically intensive treatments rather than laborintensive palliative care -Only 13% of hospice pt. in LTC

Problems with DNR orders

DNR discussions occur too infrequently and patients' preferences regarding resuscitation are neglected. DNR discussions are delayed until it is too late for the patients to participate in decisions regarding resuscitation. Physicians do not provide adequate information to allow patients to make informed decisions. (hesitant to give prognostic factors) Physicians inappropriately extrapolate DNR orders to limit other treatments

male secondary sex characteristics

Decreased spontaneous erections Decreased muscle mass/strength Decreased testicular volume/spermatogenesis Thinning and slowed growth of body hair

Individualizing treatment

Degree of transition -Binary female, androgynous, feminine spectrum Erections -Eliminate or maintain Surgery -Some patients may take hormones to prepare for surgery while other patients may not wish to have surgery

Beneficence

Do anything you can to help the patient Requires action that has a positive effect -Prevent bad outcome -Remove something bad -Promote good Acts of omission violates the principle

Nonmaleficence

Do no harm No problem with not acting (Omission) Acting could cause a problem Deliberate harmful acts Unintentional acts

Kefauver-Harris Amendment of 1962

Drug Efficacy Amendment Thalidomide marketed in 1950's as a popular drug used to treat morning sickness Drug was distributed to the US in 1960s but the approval was withheld by FDA due to lack safety information. Functions to strengthen the new drug approval process, requiring the medication to be SAFE and EFFECTIVE. Another medication tragedy that occurred in the late 1950s prompted the establishment of the Kefauver-Harris Amendment in 1962. The medication thalidomide (Thalomid), a popular sedative, was marketed in Europe, and the manufacturers sought approval for sale in the United States as well. The FDA withheld approval pending further information on the safety of the drug, which turned out to be a great decision when safety information showed it was linked to birth defects. Pregnant women who had taken thalidomide gave birth to children with short or missing limbs, known as phocomelia, and thousands of children around the world were born with this condition. Because the FDA did not grant approval, the number of children born with phocomelia in the U.S. was low, but this worldwide disaster prompted the government to reconsider the regulations in place to prevent similar tragedies. The Kefauver-Harris Amendment established that drugs must be proven to be effective, in addition to being pure and safe, to receive approval from the FDA for sale in the U.S. This was groundbreaking legislation; no laws prior to this had required proof that medications are effective. This act was also retroactively applied to medications approved by the FDA between 1938 and 1962. In addition, this amendment gave the FDA the authority to oversee prescription medication advertising, transferring this responsibility from the Federal Trade Commission. It also established good manufacturing practices (GMP) for the manufacture of medications to place the responsibility of creating quality drug products on the drug manufacturers. Lastly, it established more control over clinical trials, requiring informed consent of participants in drug trials and adverse event reporting.

DEA

Drug Enforcement Administration (DEA) is a US federal law enforcement agency under the US Department of Justice. Responsible for the enforcement of the provisions of the Controlled Substances Act as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances.

Palliative/terminal sedation

Estimated to be used in 15-30% of dying patients Provided to both cancer and non-cancer patients Incidence varies from 5-52%, depending on setting, patient population, cultural, ethnic, religious factors, and on how it is defined - LOTS of variance in definitions

AAHPM statement

Ethical concerns -Decreased ability to interact with others, inability to change mind, inability to eat/drink Ethically defensible when: -Used after careful interdisciplinary evaluation and treatment -Palliative treatments not intended to affect consciousness have failed or are very likely to fail -Its use is not expected to shorten the patient's time to death -Only for the actually or expected duration of symptoms · Use lowest effective dose, not sedating deeply Hastening Death -Palliative sedation does not alter timing or mechanism of patient's death as refractory symptoms are often associated with advanced terminal illness -Clear intent to palliate, not shorten survival -Artificial hydration/nutrition generally not expected to benefit the patient

Intern

Everything a pharmacist can do EXCEPT: -final check on all aspects of the completed prescription · dose, accuracy of drug, strength, labeling, verification of ingredients and proper container -evaluation of pharmaceuticals for formulary selection within the facility · Can research, present materials, but cannot vote supervision of ALL supportive personnel activities · preparation, mixing, assembling, packaging, labeling and storage of medications ensure that supportive personnel have been properly trained any verbal communication with a patient or patient's representative regarding a change in drug therapy or performing therapeutic interchanges (Ex. Cannot recommend changing from Lisinopril to HCTZ)- this does not apply to substitution of generic equivalents any other duty required of a pharmacist by any federal or state law.

Psychedelics

Evidence links higher levels of existential/spiritual well being with improved QOL and decreased depression, hopelessness and suicidality; now considered an integral component of care Hallucinogens studied in the 1940s-50s for treatment of alcoholism, and in the 1960s-early 70s for management of cancer-related distress; Controlled Substances Act of 1970 changed scheduling of serotonergic hallucinogens to Schedule I which stopped additional research, despite that fact that psilocybin was not known to be addictive and that it may have anti-addictive properties -LSD -Psilocybin - tryptamine serotonergic psychedelic that alters consciousness via agonism at 5HT2A; ingredient in 'magic mushrooms' · Can produce spiritual/mystical states of consciousness associated with enduring (i.e. months-years) positive impact upon cognition, affect, behavior and spirituality

male secondary sex characteristics from testosterone

Facial/body hair growth Increased muscle mass/strength Deepened voice Body fat redistribution

Justice

Fairness and equity Equals are treated equally Pharmacy services should be available to all and equally provided to all Do pharmacy services meet the ethical standard of justice? Patients without insurance? Patients with socially-unacceptable diseases? The homeless, health disparities

determining futility

Futility does not apply to treatments globally, to a patient, or to a general medical situation. Instead, it refers to a particular intervention at a particular time, for a specific patient For example, rather than stating, "It is futile to continue to treat this patient," one would state, "CPR would be medically futile for this patient."

Gender nonbinary

Gender which does not fit as male or female Spectrum

Federal vs. State Law

General rule: state has authority to set statute that does not conflict with federal statute. States may be more restrictive, but never less. The 10th amendment grants the state government the authority to regulate pharmacy practice not granted to the federal government by the constitution. Statutes are passed by the state legislature and enforced by state agencies. Laws relating to the health, safety and welfare of its people belong (mostly) to the state. The Interstate Commerce Law gives federal authority to regulate drug distribution.

Masculinizing HT

Goals To develop male secondary sex characteristics To suppress/minimize female secondary sex characteristics • General approach Testosterone monotherapy

euthanasia

Greek meaning of "good death" Legal practice in the Netherlands, Belgium, Luxembourg, Columbia and Canada In US <20% of physicians have reported receiving a patient request for such with <5% reporting compliance with the request In Netherlands and Belgium, ~50% have reported a request Estimated that 0.3-4.6% of deaths occur by means of euthanasia or physician aid-indying in areas where legalized Switzerland has EXIT right to die laws in which 2006 Swiss Federal Court ruled all people of sound judgement, even if suffering from mental illness, have the right to decide their manner of death No Swiss law against suicide since 1937; law interpreted as anyone can assist suicide on a physically sick person if done for altruistic reasons EXIT has now voted to add "suicide due to old age" in its statutes - i.e. elderly who are not terminally ill

Health disparities in LGBT

Higher rates of depression and anxiety Higher rates of suicide attempts and homelessness Higher rates of violence victimization Lower rates of mammography and Pap smear screening Higher rates of smoking and substance abuse Higher rates of HIV and other sexually transmitted diseases Higher rates of unhealthy weight control/perception

Monitoring female HT

Hormone levels often maintained at the level of premenopausal cis-gender females Estradiol: 100-200 pg/ml Testosterone: <55 ng/dl Patient preferences and satisfaction guide treatment

Hospital pharmacies

Hospital pharmacy facilities Have a process for access to medications when pharmacist is not on duty or is when pharmacy is closed Pharmacist must acknowledge and verify medications withdrawn from pharmacy within 72 hours. Accurate records must be maintained in patient record, including drug, dose, location of patient in hospital, qty used and qty returned to stock Sch II CS--Perpetual inventory required; locked storage

Side effects of estrogen

Hot flashes Mood swings Migraines Weight gain Venous Thromboembolism (VTE) Oral ethinyl estradiol 2-6% incidence of VTE in transgender women, no increased risk with other formulations. Transdermal estrogen administration showed no increased risk in observational studies of menopausal cis-gender women Hypertriglyceridemia

controlled substance theft

If a pharmacy discovers controlled substances have been stolen from the pharmacy, the pharmacy must inform the closest DEA diversion office as well as the local police, and complete DEA form 106. This form should include the pharmacy's DEA registration information, the purchase value of the products, and the name, dose, and quantity of all controlled substances that were stolen. The original copy of this form should be sent to the DEA and a copy should be maintained at the pharmacy along with its controlled substance records.

Experience in washington

In 2018, medication was dispensed to 267 individuals Prescriptions were written by 158 different physicians Medications were dispensed by 61 different pharmacists Of the 267 participants in 2018: -251 are known to have died · 203 died after ingesting the medication · 29 died without having ingested the medication. · For the remaining 19 people who died, ingestion status is unknown For the 16 participants not included among those known to have died, the department has received no documentation (death certificate or after death form) that indicates death has occurred

Testosterone

Injectable Cypionate, Enathate, Propionate esters Intramuscular or Subcutaneous Administered Q 1-2 weeks Dose: 20-100mg/week Transdermal Patch (Androderm), dose: 2-8mg applied QHS Gel (Androgel), dose: 12.5-100mg applied QAM Compounded creams/ointments Subcutaneous implant Testopel

Problems with invoking futility

Judgments are often mistaken or problematic Futility applies to few patients Unilateral decisions polarize parties Value judgments may be masked as scientific expertise Physicians don't understand they are not obligated to offer/recommend all interventions

Use of medical cannabis

Lack of efficacy from RCTs regarding efficacy and safety Unstandardized dosing, no FDA approval Lack of knowledge of risks/benefits Lack of data on long term effects Most commonly used route of administration is smoked (autonomy/harm to others?) Palliation of many symptoms experienced in terminal illness Variation in THC contents

GnRH analog

MOA: Blocks GnRH receptor, thus blocking the release of follicle stimulating hormone and luteinizing hormone at the level of the pituitary Monthly injection ~$3,000-$8,000 per month

NM Pharmacy Act

Major purpose: Establish BOP, regulate pharmacy profession and distribution of drugs in NM Establishes BOP, districts (currently 5 districts), membership Delegates powers and duties to BOP Record keeping requirements RPh licensing by examination: requirements RPh licensing by reciprocity Intern licensing requirements Pharmacy technician registration requirements and duties Pharmacy licensure, classes of license, application requirements, inspections Nonresident pharmacy licensure Empowers BOP to require by regulation minimum pharmacy equipment and references Requires licenses to be displayed Grounds for disciplinary actions —withholding, suspending, revoking licenses • Prohibits (with exceptions): -any person except RPh from selling, compounding any dangerous drug -Possession of any dangerous drug without Rx -Conducting pharmacy business w/o license

controlled substances

Major purpose: control and monitor access to CS to prevent diversion and to designate drugs for scheduling Sch II-IV: A pharmacy employee must verify the identity of the patient or the patient's representative before a new Rx is delivered. "Acceptable identification": driver's license or other government issued photo ID. The identification number and name must be recorded in a manner to be determined by a written policy developed by the pharmacist-in-charge. Exceptions: a patient known to the pharmacist or pharmacist intern, whose identification has already been documented; prescription filled for home delivery; or a prescription filled for and delivered to a licensed facility. (Effective 01/15/08)

Impaired pharmacists act

Major purpose: to create a program to rehabilitate pharmacists unable to practice safely because of the substance abuse, mental illness, aging, loss of motor skills Empowers BOP to appoint committee to administer program Establishes functions of committee Referral of impaired pharmacist by the BOP Voluntary participation by impaired pharmacist (confidential unless noncompliant)

Adverse effects of feminizing HT

Male pattern baldness Decreased libido/sexual dysfunction

Morphine and hastened death

Many inaccurately believe that morphine has an unacceptably high risk of causing death, particularly in frail elderly and near EOL - equate its use to heavy sedation and being left to die Double effect principle Safe when used with appropriate titrations and monitoring Drowsiness -> confusion -> loss of consciousness -> respiratory depression Meta-analysis of 30,000 post-op pts receiving opioids found incidence of respiratory depression (RR < 10) of 1.1% (10g-15g)

Palliative sedation medications

Midazolam, lorazepam, phenobarbital, propfol NOTE: Continue opioid therapy as appropriate. If patient is taking oral/transmucosal opioids, consider switching to parenteral opioid therapy. Monitoring 1. Daily documentation of the treatment effectiveness: · a. Any evidence of distress (respiratory or pain) · b. Signs of unrelieved symptoms of suffering (i.e. facial grimacing, body movements, moaning) · c. Eyelash reflex will be used to assess the level of sedation (soft tactile stroke over a closed eyelid should elicit a flicker or reflex). A lack of response may suggest deep sedation and need for decrease in medication doses should be discussed. 2. Deterioration in respiration is expected in terminally ill patients and should not serve as the sole reason to decrease sedation

Palliative sedation hesitancies

Moral experiences -Evolving terminology doesn't remove all ethical concerns -25% of families experienced high levels of distress over decision to use PS (Claessens et al, 2008) -A survey of nurses in Flanders showed that 77% thought that continuous deep sedation (CDS) was partly or explicitly intended to hasten death (Inghelbrecht et al, 2011) -Almost 50% of the medical specialists in Quebec surveyed in 2011 reported that palliative sedation can be likened to a form of euthanasia (Vogel L, 2011) Practice variation -Intent (aim is symptom relief, not unconsciousness) -Advanced knowledge of symptom management and palliative care -Variance by provider and country -Difficulty with prognostication (especially non-cancer) -Need for improved communication, education, guidelines -Loss of a holistic approach to human suffering?

Pharmacies

Must have a "pharmacist-in-charge" record with the BOP; Responsible for: P&P-all storage, records, movement of drug in and out of the pharmacy Supervision of all personnel-both professional and non professional Notify the Bop within 10 days of the termination of pharmacy tech If terminated owner must notify BoP immediately and name a successor Defines Minimum equipment, standards -Square footage, space etc Conspicuous Display of: -Pharmacy license and Controlled Substance License -Licenses and Certifications of all applicable employees -Sign for the "Prohibition of Return of Drugs" -Current BoP inspection report -Patient's Bill of Rights Pharmacies permanently closing must notify the BoP at least 30 days prior to closing Must Submit a "Request for Inspection" and new facility must be inspected before business is moved. Computerized Rx information requirements- § Must be capable of producing all specified prescription information within 72 hours (Original date, prescriber, patient information etc) § Hard copy for non-controlled-maintained on premises for 120 days from initial date of dispensing § Hard copy for a controlled -maintained on premises for 2 years § Paper Hardcopy must be stored and retrievable for minimum of 3 years § Electronic Prescription image must be retrievable for minimum of 10 years Prescriptions § name and address of the prescriber, the name and address of the patient, the name and strength of the drug, the quantity prescribed, directions for use, the date of issue, and preferably the diagnosis or indication, refills if any § a prescription may be communicated to the pharmacist by an employee or agent of the registered practitioner § Label-name and address or name and pharmacy license number of the pharmacy dispensing the prescription and the name and address of the pharmacy which receives the dispensed prescription o Nonresident pharmacy licensure § NM pharmacy statutes and regs apply § Toll-free number & RPh for patient questions

Pharmacist

Must: -graduate from an accredited college of pharmacy -pass the NAPLEX -Pass the NABP Multistate Pharmacy Jurisprudence Examination (MPJE) Renew license every 2 years and have obtained 30 contact hours CE (3.0 CEU) -10 hours must be live -2 hours must be in area of patient safety -2 pharmacy law offered by the NM BOP -2 in the area of appropriate use of opioids Additional CE is required for · prescribing and administering vaccinations · Smoking cessation · Prescribing Naloxone-DOH currently has a standing order · Emergency Contraception-now available OTC · TB testing · Notify BOP of change of employment within 10 business days

Pharmacy regulations

New Mexico Board of Pharmacy is the state executive agency for pharmacy granted authority to establish and amend pharmacy regulations. New or amended regulations follow a process -Committees including pharmacists and other health care providers) develop proposed or amended regulation(s). -Proposed regulation is presented to NM BOP for review -The proposal is published for public comment. -Revisions are made and the BOP approves/disapproves the new regulation. -Regulation goes into effect. NM houses all state regulations in the New Mexico Administrative Code. The Chapter specific to the practice of pharmacy in New Mexico is 19-Pharmacists

DNR orders

No code or allow natural death (AND) Typically employed in patients who have failed multiple therapeutic interventions Main goal to avoid life-sustaining measures that would be futile or could cause harm in the patient's final days or hours Does not mean "do not treat" May include DNI (separate decision) Written documentation by a physician giving permission to medical personnel to not attempt resuscitation in the event of cardiac arrest.

Existential suffering

No concise definition Lack of meaning or purpose, loss of connectedness to others, thoughts about the dying process, struggles around the state of being, difficulty in finding a sense of self, loss of hope, loss of autonomy, and loss of temporality Concerns about separating the physical symptoms from spiritual and psychological distress, moving away from a holistic perspective

Orphan Drug Act of 1983

Orphan drugs are those used to treat conditions that affect fewer than 200,000 people worldwide. Because many drug manufacturers create products based on potential profitability, products for these conditions were not being developed at the same speed as products for more prevalent conditions. The Orphan Drug Act created the allowance for tax incentives for companies that produce orphan drug products, as well as allowing them exclusive licensing rights to their products for seven years after approval by the FDA. Research assistance and grants were also made available to drug manufacturers under this act. Companies that produce drug products for diseases that affect more than 200,000 people could also qualify for assistance if they can prove that the development cos

Chemotherapy at EOL

Palliative considerations vs. curative intent Elderly significantly underrepresented in clinical trials but fastest growing patient population Bone marrow reserve diminishes with aging May be a sign of a lack of adequate/ongoing conversation between patient and physician (be clear with diagnosis curative vs. pallative) Can decrease the quality of remaining life or even shorten survival time Not thought to be hastening death, unlike terminal sedation Violates nonmaleficence - refrain from harming patients; ethical principal employed to argue against treatments likely to inflict pain & suffering and unlikely to result in benefit

Testosterone side effects

Polycythemia -Transdermal administration may have less effect Weight gain -Increase in visceral fat -Fluid retention -Increased appetite Mood lability Increase sex drive Infertility Lower HDL cholesterol & elevated triglycerides

Contraindications to testosterone

Pregnancy Informed consent process for shared decision making should be used in patients with risk factors

Durham-Humphrey Amendment of 1951

Prescription Drug Amendment Legalization of the verbal transmission of drug orders Allowing pharmacists to recognize refills if authorized on initial prescription • Established two distinct classes of drugs -Prescription -Non-prescription-Over the Counter (OTC) "Caution-Federal law prohibits dispensing without a prescription" Without this amendment pharmacists would be required to label prescriptions with same content as manufacturers. Many medications were unable to establish appropriate directions for use under the Food, Drug, and Cosmetic Act of 1938, because use under the direction of a prescriber was not considered adequate. The Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act was passed in 1951 to resolve this issue. It established two classes of medications, prescription (legend) drugs that require a prescriber's order to dispense, and over-the-counter (non-legend) drugs that can be purchased without a prescription. After passing this act into law, prescription medications were allowed to have the prescriber's directions for use on the label if they had the wording "Caution: Federal law prohibits dispensing without a prescription" on the label. The Durham-Humphrey Amendment allowed for prescriptions to be called in to the pharmacy over the telephone for ease of receipt at the pharmacy. It also established

Lethal medication

Prescription shall not be filled until 48 hours after it was written Indicate the date and time the prescription was written and the first allowable date and time when it may be filled Secobarbital is commonly prescribed, phenobarbital and morphine also used 9 grams of secobarbital capsules mixed in juice and administered on an empty stomach (cost ~$3500) Antiemetics recommended 1 hour prior to ingestion

Manufacturing

Production, preparation, propagation, conversion, processing, packaging, repackaging, or labeling of a prescription drug (stability, particles of dust, specific and strict) Commercially available products from bulk for resale by pharmacies, practitioners, or other persons Must follow Current Good Manufacturing Practice (CGMP) regulations

Confidentiality

Protecting the privacy of a patient's medical condition and health information is the definition of confidentiality. It is crucial to achieving the best outcomes for a patient, because patients may be less likely to share personal information if they feel their confidentiality will be violated, which could prevent the pharmacy team from acting in the best interest of the patient. Private health information is protected by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and pharmacists and technicians must both take an active role in preventing unauthorized disclosures of protected information. Daily duties must be conducted in a way that prevents health information from reaching unauthorized sources, and the pharmacy's policies and procedures should reflect the importance of maintaining confidentiality. To maintain a patient's trust, pharmacy personnel should respect the wishes of the patient on who they want their patient information to be disclosed.

Decisional capacity

Provider makes determination based on clinical examination that a patient is able to make decisions for him/herself Differs from competency Assessment -Patient can do the following: · Receive information · Evaluate and analyze information · Communicate a treatment preference -Provider should look for: · Understanding · Logic · Consistency (difficult) Provider identifies that patient can easily communicate treatment preference

Informed consent

Purpose is to promote autonomy of the individual in medical decision making May be viewed as counter productive to physician ideals of patient's well-being PROCESS whereby a provider discloses information to help a patient make healthcare choices (not a quick beside consult) Requires 3 conditions -Patient is able to make a voluntary decision -Patient is informed -Patient has capacity to make medical decisions

Physician Aid in Dying

Recognized in Oregon, Washington, Montana, Vermont, Colorado, California, District of Columbia, Hawaii, Maine, New Jersey Bernalillo county - in 2014, district judge Nash ruled as a right under NM state constitution but later overturned after appeal to the Supreme Court 2021 Legislative session: · HB 47 - The Elizabeth Whitefield End-Of-Life Options Act Terminally ill patient determined to have capacity and ability to self-administer oral medication

Estrogen formulations

Recommended agent: 17 beta-estradiol Referred to as "bioidentical" in guidelines Avoid: Conjugated equine estrogens (Premarin®) Not recommended Inability to accurately measure blood levels Potential of increased thrombotic and cardiovascular risk Ethical concerns about methods of production Ethinyl estradiol Synthetic estrogen, commonly used in oral contraceptives Associated with increased thrombotic risk

Autonomy

Respect for person/patient Treat patients who are competent as independent decisionmakers Person/Patient should make own decisions if it affects them - Freedom to choose, respect their choices Each person has their own unique view and should be able to act on their views Even if action is foolish or unwise Decisions that infringe upon the rights of others do not need to be respected

Psilocybin

Ross et al conducted a double-blind, active placebo (niacin 250 mg) crossover RCT of psilocybin (single dose of 0.3 mg/kg) in 29 patients with cancer-related anxiety/depression; employed in conjunction with psychotherapy psilocybin provided rapid and sustained (i.e. 6 mo. follow-up) anxiolytic and antidepressant effects in 60-80% of subjects, as well as sustained benefits in existential distress and QOL, and improved attitudes re: death · psilocybin experiences were reported as highly meaningful and spiritual, and associated with positive cognitive, affective and behavioral effects lasting weeks-months no serious ADRs occurred, and there was no secondary abuse behavior noted; minor medical (H/A, nausea and non-significant BP and HR elevations) and psychiatric AEs (transient anxiety and near-psychotic symptoms) known to occur with psilocybin were considered transient and tolerable A separate study by Griffiths et al noted the same findings in a group of 51 cancer patients with life-threatening diagnoses and symptoms

In hospital cardiac arrest

Several clinical factors have been identified that predict a greater likelihood of survival to hospital discharge -Witnessed arrest -VT or VF as initial rhythm -Pulse regained during first 10 minutes of CPR 209, 000 treated for in-hospital cardiac arrest in 2016 Survival to discharge -24.2% of patients of any age -23.9% adults -40.2% children (excluding neonates who experienced in-hospital cardiac arrest with any first recorded rhythm)

Experience in oregon

Since the law passed in 1997, a total of 2,217 patients have had prescriptions written under the DWDA and 1,459 (65.8%) have died from ingesting the medications Majority of patients white males citing loss of autonomy, loss of dignity and decreased ability to engage in activities that make life enjoyable Average age 74, 63% cancer diagnoses, 15% neurologic, 9% cardiac

POLST Paradigm program

Started in Oregon in 1991 Developed as a standardized, advance care planning document to be completed by health care professionals, together with a patient or surrogate decision-maker Active medical order that is transferred with the patient throughout the healthcare system Physicians' Orders for Life Sustaining Treatment. Decreases unwanted treatment and enhances symptom management at end of life.

Regulations

State law gives authority to executive agencies to develop, enact and enforce regulations that support the statutes. Regulations are designed to increase flexibility and efficiency in the operation of laws. Many of the actual working provisions of statutes are embodied in regulations. Regulations are indirectly enforceable laws. Most regulations are developed and enacted through a rule-making process, which includes public input.

Duties of a pharmacist

Technical role -Filling the prescription correctly with drugs that are of appropriate quality -Guardian of nation's drug supply Professional status -Societal right and duty = rational and efficient drug therapy -Individualized rather than mass-produced -Altruism - benefit to others at self-expense

Monitoring Testosterone

Testosterone: 400-700 ng/dl midway between injections Patient preferences and satisfaction guide treatment

Transferring of Controlled Substance Prescriptions

The Controlled Substance Act allows prescriptions for Schedule III to V controlled substances to be transferred between pharmacies one time, unless the pharmacies share a real-time online database. If a database is shared between pharmacies, prescriptions may be transferred up to the maximum number of refills given by the prescriber. The transfer must occur between two licensed pharmacists. The pharmacy transferring the prescription out must write the word VOID on the face of the prescription to invalidate it, and must record on the back of the prescription the name, address, and DEA number of the receiving pharmacy as well as the transfer date and the name of the pharmacist transferring the prescription. The receiving pharmacy must write the word "Transfer" on the face of the prescription, as well as the original date of the prescription, the original number of refills, the original date of dispensing, the number of refills remaining and the dates of previous refills, the prescription number given at the transferring pharmacy, the name, address, and DEA number of the pharmacy sending the prescription, and the name of the pharmacist responsible for transferring the prescription. Both pharmacies involved in the transfer must keep their copy of the prescription for at least two years from the last refill date.

OBRA 87

The Omnibus Budget Reconciliation Act of 1987 was an extensive piece of legislation affecting many different government programs. Because of increasing concerns about substandard care for patients in nursing homes, legislation was incorporated into this act to address the quality of health care available for the elderly under Medicare. The enactment of OBRA required many changes to the Medicare and Medicaid conditions of participation for pharmacies and long-term care institutions that service Medicare and Medicaid patients, reforming nursing home care. Standards of care for Medicare and Medicaid patients living in nursing homes were established by OBRA-87. It prevents the use of medications that are not necessary to treat a patient's medical condition and establishes requirements for the use of anti-psychotic agents. It requires that psychiatric medications can only be used to treat patients with a specific documented psychiatric condition. Doses of antipsychotics must be gradually tapered to ensure the correct dosage is used, and drug holidays and behavioral modifications should be used regularly to assess appropriateness of medication discontinuation. OBRA-87 also established that residents of long-term care facilities should be free of significant medication errors, and must be provided routine and emergency medications as needed. Medications must be labeled as required by law, and stored in a locked storage area under recommended storage conditions. Lastly, it established that long-term care facilities must be serviced by a consultant pharmacist to ensure patients are receiving proper medication therapy.

OSHA 1970

The enactment of this law created the Occupational Safety and Health Administration to ensure employees have the right to a safe and healthy workplace. It allowed for the development of employee health and safety standards and a reporting system for injuries that occur on the job. It also was created to aid in the reduction of hazardous working environments and allows the Occupational Safety and Health Administration to audit workplaces to ensure they remain in compliance with the law. In the pharmacy environment, this act requires the use of material safety data sheets to inform employees of the risks associated with chemicals they come in contact with. It establishes standards for communicating hazardous issues, and addresses contaminants in the air as well as combustible and flammable materials. It requires eye and skin protection when working with hazardous materials, such as when compounding sterile products. The Occupational Safety and Health Administration also publishes the Guidelines for Cytotoxic (Anti-neoplastic) Drugs. This publication discusses the potential hazards of working with cytotoxic products and provides recommendations to decrease the risk of hazards.

FDA

The government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States. In the case of food supplements , the F.D.A. does almost nothing to ensure that dietary supplements work as advertised. It is only when supplements are proved to be unsafe or to contain regulated substances can the agency take action.

DSHEA 1994

This act allowed the creation of regulations for herbal products. It requires the labeling of herbal products to list the ingredients and quantities of each ingredient, as well as the plant and part of the plant used to create the product, and a statement that the product is a dietary supplement. Herbal products must meet standards for purity, quality, and composition, and production of these products must comply with standards set by any official compendium. Guidelines were created to require manufacturers of herbal products to follow good manufacturing practices and prevent adulteration of these products.

Drug Listing Act of 1972

This act created the requirement of a distinct 11-digit number to identify each medication, known as the National Drug Code (NDC) number. The first five digits of this number comprise the labeler code, used to identify the drug manufacturer. The next four digits are for the product code, used to represent the specific drug product. The last two digits represent the package code, used to identify the package size and type. The product and package codes are developed by the drug company to differentiate their products.

Poison Prevention Packaging Act of 1970

This act was created to decrease the risk of accidental poisoning in children and prevents hundreds of deaths that were occurring annually from children accidentally ingesting medications and household chemicals. It requires that most prescription and over-the-counter products be packaged in materials that are resistant to opening by children. Containers are considered by this act to be child-resistant if they cannot be opened by 80 percent of children under 5 but can be opened by 90 percent of adults.

PDMA of 1987

This act was created to solidify the supply chain of prescription medications and reinforce the standard route that drug products follow from drug manufacturers to wholesalers to pharmacies. It was developed to prevent counterfeit products from entering the supply chain and to decrease the diversion of prescription products. It prevents hospitals and medical facilities from reselling medications to outside businesses, and prevents the reimportation of drug products that have been exported unless the original manufacturer reimports them. This act also bans the distribution of medication samp

Reducing VTE risk

Use 17 beta estradiol - patches are preferred Avoid first pass metabolism Avoid tobacco use Avoid combination of progesterone with estrogen Do not exceed estrogen levels above physiologic range of cisfemales Low dose aspirin?

Outsourcing facilities

a middle ground Compounders may apply to become an outsourcing facility - "503B facility" Drug Quality and Security Act (DQSA), a response to the 2012 fungal meningitis outbreak caused by poor compounding Updated parts of the Federal Food, Drug and Cosmetic Act (FD&C Act) regarding compounding Section 503B of this act added a new category of compounders: outsourcing facilities (not required to be a licensed pharmacy) - May distribute to other facilities (create bulk and send to hospital or providers office) - Must follow CGMP - Must submit to FDA inspection - Must report adverse events to FDA Blends concept of manufacturing and compounding

Bisexual

a person emotionally, romantically or sexually attracted to more than one sex, gender or gender identity though not necessarily simultaneously, in the same way or to the same degree.

Gay

a person who emotionally, romantically, or sexually attracted to members of the same gender. This term often refers to homosexual men but is not limited to this use.

gender identity

a person's deeply felt identification as a man, women or some other gender, may or may not correspond to their sex assigned at birth

sexual orientation

a person's romantic and emotional attraction to another person

Queer

a term people often use to express fluid identities and orientations. Often used interchangeably with 'LGBT.' Academic, political, and cultural adoption of this term and its addition to the LGBTQ acronym has been recent, and its historical use may hold a negative connotation for some LGBT people.

Lesbian

a woman who is emotionally, romantically, or sexually attracted to other women

Privelege

advantages granted to a particular person or group

Implicit

an individual feeling that we are unaware of and/or mistaken about their nature Our own personal preference Our own personal aversions

Transgender

an umbrella term for people whose gender identity and/or expression is different from cultural expectations based on the sex they were assigned at birth Being transgender does not imply any specific sexual orientation Transgender people may identify as any sexuality including the sexual minorities

Spironolactone

anti-androgen MOA: Directly inhibits testosterone synthesis and androgen binding to the androgen receptor (testicles and adrenal glands) Dose is usually higher than cardiovascular disease (100-400mg/day) Oral tablet Inexpensive

Female secondary sex characteristics (Desired)

body fat redistribution breast growth softening of skin/decrease oiliness

Justice

can be applied to pharmacy practice, and refers to the practice of allocating products and services to patients fairly, regardless of race, gender, religion, or any other external factors. A common example of the principle of justice applies to patients who are waiting for an organ transplant. These patients are added to a waiting list of patients and are served as fairly as possible based on their condition and organ needs. Patients are ranked based on their need, and those ranked at the top of the list are matched with donors as they become available. While not always perfect, this system allows patients to receive life-saving transplants fairly. All patients have the right to be treated fairly by their medical providers, so in the pharmacy environment, medications should be allocated in a first-come, first-served fashion, unless another fair system has been developed. This will ensure all patients have the same ability to access important medications

Returning controlled substances

can only occur between two entities registered with the DEA. A completed DEA 222 form must accompany any transfer of Schedule II controlled substances with records maintained at both the receiving and transferring pharmacy, and the green copy of the 222 form should be sent to the DEA field office within 60 days of transfer.

Nonmaleficence

describes the concept of "doing no harm." Avoiding harm for patients has been a central idea of health care for millennia, and continues to play an essential role today. Health care providers must constantly keep this concept in mind when providing care to patients to ensure the actions they are taking to help the patient do not end up causing harm. There are many ways pharmacy professionals can apply the principle of nonmaleficence when assisting patients. Pharmacists can prevent harm in many ways, such as preventing medication errors by checking for the presence of drug interactions, adverse events, and duplicate therapies. Pharmacy technicians can also take an active role in preventing harm to patients by focusing on medication safety and ensuring prescriptions are filled correctly and accurately, as well as by learning from mistakes and preventing their repetition. Nonmaleficence and beneficence often go hand in hand, because not harming a patient can also be considered to be acting in the best interest of the patient. However, "doing no harm" does not always mean the pharmacy professional is "doing good." For example, a patient with high blood pressure comes to the pharmacy counter asking about the side effects of pseudoephedrine. The pharmacist tells the person it can increase the blood pressure but does not recommend an alternate product. In this scenario, the pharmacist prevented harm by letting the patient know it can further increase their blood pressure, which can be dangerous, but did not act in the best interest of the patient by recommending a safer alternative. These concepts are applicable to both pharmacists and technicians alike.

Beneficence

describes the ethical principle of acting in the best interest of the patient, or "doing good." This principle encourages health care providers to help patients achieve the best possible outcomes of their medical treatment, through advocating for them and providing them with information to make informed decisions. Providing patients with an opportunity to consult with a pharmacist to ensure they are informed on the use of their new medication is an example of beneficence. Pharmacy professionals play an important role in encouraging positive outcomes for the patient, and should bear this principle in mind on a daily basis

Deontology

duty AKA "Idealist" (means and ends oriented) Both the outcome of the action and how you get there matters Certain acts may be wrong, therefore unethical, regardless of outcome Acts that violate our duties to others should not be undertaken, no matter what the outcome.

Fidelity

fidelity refers to the duty to do what a person has promised to another. It requires health care professionals to be faithful to their patients and to always keep the patient's best interest in mind. Keeping promises to patients helps to maintain and build the patient-pharmacy relationship, allowing a pharmacy staff to better serve its patients.

USP 800

hazardous drugs

Veracity

is the principle of being honest with patients and always telling the truth. Both pharmacists and technicians can take an active role in promoting veracity by conveying honest and truthful information to patients. Building trust with patients is essential to creating a solid relationship between the pharmacy and the patient, and this trust comes with continuously being honest with patients. Building trust also allows the pharmacy to obtain thorough information from patients on their health care, and helps pharmacists act in the best interest of their patients. Being completely honest with patients is important, and this principle can be violated in several ways. When critical information is left out of a conversation with a patient, it is considered an omission. Commission occurs when a lie is intentionally told. While pharmacists may need to use professional judgment when assessing what and how much information to disclose to patients, the principle of veracity should be kept in mind at all times. Technicians should refer any confusing situations to the pharmacist to ensure veracity is maintained.

USP 795

non-sterile compounding

Nursing Home Drug Control

nursing homes, SNF, long-term care and custodial facilities All drugs administered to patients pursuant to a direct order from a licensed practitioner- Must have current orders in place Must maintain medication administration record (MAR) documenting medications administered to residents, including over-the-counter medications. Must have a pharmacist, either part time or on a consulting basis All drugs shall be stored in locked cabinets, locked drug rooms, or state of the art locked medication carts. Separate sheets shall be maintained for controlled substances records indicating the following information for each type and strength of controlled substances: date, time administered, name of patient, dose, physician's name, signature of person administering dose, and balance of controlled substance in the container Licensed Custodial care with a 24-hour/365 day per year on-site nurse may use an emergency drug tray containing controlled substances-otherwise the emergency drug tray may not contain controlled substances Detailed Drug Destruction records

Gender expression

one's pattern of outward behavior in relation to common standards of a gender category

Implicit bias

our attitude towards people and associated stereotypes with them without conscious knowledge

Section 503B

outsourcing facilities

Futility

pointlessness or uselessness Medical Futility Merriam Webster - as " serving no useful purpose; completely ineffective" -Confusing, inconsistent, and controversial. Strict definitions -Intervention has no pathophysiological rationale (e.g. ineffective antibiotic) -Cardiac arrest despite maximal treatment (e.g. septic shock with pressors, on dialysis) -Intervention has already failed (e.g. CPR ineffective for asystole after 30 minutes) Loose definitions -No worthwhile goals of care can be achieved (e.g. cardiopulmonary bypass for failed CPR) -The likelihood of success is very small (e.g. less than 1% success - Schneiderman LJ, Jecker NS, Jonsen AR, 1990.) -Quality of life is unacceptable (e.g. PVS and renal dialysis - Renal Physicians Association and American Society of Nephrology Clinical Guideline 2, 1999)

Pure Food and Drug Act of 1906

prohibited the adulteration and misbranding in interstate commerce...but it failed. -It lacked protection against false efficacy claims -It didn't regulate cosmetics or devices This act was enacted in 1906 to address public concerns about improperly labeled and unsanitary food and medications. It prohibited food and medications from being misbranded or adulterated if they are bought and sold across state lines. This was the first act to address the safety risks associated with contaminated and inappropriately labeled food and drug products, but it was not found to be comprehensive enough. Drug safety issues continued, because false or incorrect claims of efficacy were not prohibited, labeling was not regulated, safety was not required to be proven, and the FDA did not have the right to ban unsafe products. This resulted in the sulfanilamide tragedy of 1937, when the toxic solvent diethylene glycol was used to make sulfanilamide elixir, resulting in 107 deaths. This tragedy, as well as other safety issues, prompted a more comprehensive act to be passed in 1938.

USP 825

radiopharmaceuticals

Pure Food and Drug act 1912

revised the Pure food and Drug act of 1906 to state that a drug was misbranded if it contained a false and fraudulent statement regarding curative or therapeutic effect prohibited the use of false efficacy claims- proved to be difficult to enforce. Difficult to prove fraudulent claims or intent

HIPPA

set out to acknowledge the basic privacy rights of all patients, and to require health care professionals to explain those rights to patients. It ensures the confidentiality of protected health information (PHI), requires the use of only the minimum amount of PHI necessary, and gives patients the right to see who has accessed their PHI. It also requires that all pharmacy staff and any other facility employees who have access to PHI must receive formal training on HIPAA.

USP 797

sterile compounding

Heteronormative

the cultural belief which assumes that heterosexuality is the norm

Autonomy

the ethical term used to describe the right for patients to make decisions for themselves. It allows patients to choose what medical treatments are best for them and allows them to take ownership of their own health care. After receiving all of the information necessary to make an informed decision, health care choices must be made by patients themselves without coercion. When patients are unable to make an informed decision on their own, such as infants, children, and those with dementia, their responsible family member or caregiver can make decisions for them. While it can be difficult at times for health care professionals to respect a patient's decision, especially if they disagree, it is ultimately the patient's right to decide whether he or she wants to take a medication or have a procedure done. For example, if a patient who has been given all of the information about the side effects of Celebrex decides he or she does not want to take it, the health care professional must respect the person's decision. Health care professionals do have the responsibility to provide patients with all of the information they need to make an informed decision, through counseling or other means, but the decision is ultimately up to patients.

Imminent-demise futility

the likelihood that the patient will die in the very near future EX: Taking an actively dying patient to the cath lab · Procedure wont reverse death

Coming out

the ongoing process in which one acknowledges, accepts and appreciates one's sexual orientation or gender identity and shares it with others

Lethal-condition futility

the patient has a terminal illness that will result in death in the not-too-distant future that the intervention does not affect EX: Full code for a patient with widely metastatic cancer and no treatment options

Physiological/quantitative futility

the proposed intervention cannot achieve the desired effect EX: Whether hemodialysis can adequately replace renal function

OBRA 90

was a large bill concerned with many aspects of government funding. Only a small portion affected the practice of pharmacy, but that small portion had a significant impact on pharmacy practice. This bill was the first to recognize that the duties of pharmacists include identifying and resolving drug therapy issues, expanding the standards of practice for pharmacy professionals. This act states that prospective drug utilization evaluations must be conducted before a prescription is filled to ensure safety for every patient, and must include a review of appropriateness of medication, contraindications, potential drug interactions, and accuracy of dosage and treatment duration. It established that drug utilization reviews (DUR) should be completed by pharmacists and are composed of three steps: verification and screening of prescriptions before they are dispensed, patient counseling, and documentation of relevant information. DURs are also required to include computer programs that can create alerts to notify the pharmacist of potential interactions, adverse events, and pertinent safety issues that may affect the patient. The act also established a DUR board to retrospectively review whether ideal drug therapies are actually used. The DUR board can also recommend educational programs based on problems that it has identified in its retrospective reviews.

Qualitative futility

where the quality of benefit an intervention will produce is exceedingly poor EX: PEG tube for advanced dementia · Not going to prolong life and may not give better QOL

Medical induced sedation

without intending to cause death, utilizing a non-opioid drug to control intolerable symptoms that are refractory in patients with advanced and incurable disease whose death is imminent Most commonly used for pain, dyspnea, delirium, N/V, agitation/restlessness, seizure, myoclonus One survey revealed >50% of patients receiving PS have more than one qualifying symptom; 34% received for nonphysical symptoms

FDA and covid

· The FDA has relaxed some compounding requirements during COVID-related drug shortages · Medications on the FDA's drug shortage list are considered "not commercially available" (could compound) · FDA will not take action against facilities that compound drugs that are "essentially a copy" of approved drugs that are discontinued or unavailable during the pandemic · Enforcement flexibilities for 503B facilities to provide compounded drugs for hospitalized patients with COVID-19 (bulk products or patient in the hospital)