Pharm Week 1 Chapter 1 Outline

Hazards of OTC drugs:

-Delay treatment of serious and/or life-threatening disorders -Relieve symptoms without necessarily addressing the cause of the disorder

Pharmokinetics

the study of drugs within the body, absorption , distribution, metabolism, excretion

simplifying the regimen

ultiple studies have been done relating adherence to the number of times a drug must be taken each day and the total number of drugs being taken daily. One study of diabetics (Morris, Brennan, MacDonald, & Donnan, 2000) found that for each increase in daily dosing frequency, there was a 22% decrease in adherence. Likewise, liver transplant patients were more adherent to once-daily dosing of the immunosuppressant tacrolimus than twice-daily dosing (Eberlin, 2013). A systematic review of 38 hypertension drug adherence trials involving 15,519 patients (Schroeder, Fahey, & Ebrahim, 2004) found that simplification of dosing regimens improved adherence between 8% and 19.6%. A literature review of 76 publications by Claxton, Cramer, and Pierce (2001) showed that adherence to once-daily dosing was 79%, twice a day was 69%, three times a day was 65%, and four times a day was 51%. The data on short-term use of antibiotics for respiratory infections are even more impressive, with nearly 100% adherence for once-daily dosing. When given an antibiotic dosing schedule of twice daily, at least one-third of patients missed one or more doses. As the number of doses increased, so did the nonadherence (Carlson, Stool, & Stutman, 2005). The ideal drug, it appears, would be taken once daily. The combination of several medications into one tablet, a poly pill, helps adherence even in the population that is not mentally challenged (Thom, 2013). A meta-analysis of studies regarding the use of fixed-dose combination medications available for hypertension, tuberculosis, and HIV found a 24% to 26% decrease in noncompliance when combination medications are prescribed (Bangalore, Kamalakkannan, Parker, & Messerli, 2007). Consideration of whether the increased cost of fixed-dose combination medication is offset by better disease management due to increased adherence is part of the decision-making process when prescribing.

Controlled substance misuse, Prescriber education, behavior red flags, pressures to prescribe, enabling

(Misuse) 1.Acquisition and wide use of chemical dependence screening skills. 2.Early and firm limit setting regarding indications for controlled drug prescribing. 3.Careful documentation of a confirmed diagnosis and the ruling out of chemical dependence before initiating a controlled prescription or drug subject to misuse. 4.Practice in "just saying no" and feeling comfortable in being firm without escalating the discussion into an argument with the patient. (Red Flags)Once a scam has worked in a given practice, that scam will continue to surface periodically in that office practice until the provider ceases to reinforce the scam. Drug enforcement investigators and patients who abuse prescription drugs commonly observe that the greater the ease of practicing scams and drug-seeking behavior in a provider's practice, the higher the prevalence of drug-abusing patients there will be in that practice. Dealing with scams consists of the following steps: 1.Learning to recognize the common scams. 2.Refusing to give in to scammers. 3.Practicing the skill of turning the tables on the scammer. Scams are generally conducted to obtain more medications, more potent or higher-dosage formulations, higher street-value brands of drugs, a controlled drug without a chart or visit note, or to avoid noncontrolled alternatives. Most scams produce discomfort in providers, and patients using scams are often willing to push the practitioner if they encounter resistance to the scam. Patient-generated pressure to prescribe in the face of clinician hesitancy is one classic sign of a scam. Patients rarely argue pharmacology with providers unless the issue of prescribing controlled drugs is being contested. The clinical phenomenon of an initial no (refusal to prescribe by the practitioner) becoming a yes (eventual willingness to prescribe) if the patient brings the right pressure to bear on the practitioner is pathognomonic of prescription drug misuse. Pressure to Prescribe Another factor that increases the demand for controlled substances is the pressure to prescribe at every visit and the expectation that patients deserve a prescription for something at each visit or for each symptom offered. This process results in two well-known adverse situations: (1) overprescribing of antibiotics and resulting antibiotic resistance and (2) polypharmacy, especially of the elderly. It also may result in a tendency on the part of practitioners to prescribe higher-potency noncontrolled substances and then ultimately controlled drugs when patients persist with vague somatic complaints. Enabling Enabling refers to the powerful instinct in practitioners to do anything medically possible to enable patients with present or potential disability to live at a higher level of function. Unfortunately, the disease of chemical dependence has a bottomless appetite for enabling, also defined as behaviors on the part of a friend, family member, or health-care provider that shelter the chemically dependent individual from the adverse consequences of the disease. When the practitioners' enabling instincts interact with chemically dependent patients, the patients are often able to manipulate the practitioners to avoid the consequences of their disease process, thus permitting that disease to progress to further, more pathological levels. This is especially true when controlled drug prescribing is involved. A common statement from practitioners who have been manipulated into enabling and overprescribing to patients is "I was only trying to help." Chemical dependence is one disease process in which practitioners must strive against enabling tendencies, especially when prescribing controlled drugs.

Drug, patient and provider factors that influence drug selection

1. Pharmacodynamics - The pharmacodynamics of a drug must be specific and selective to the target tissues affected by the disease to have the greatest therapeutic effect with the least adverse effects. 2. Pharmacokinetic - metabolism, renal function, half life 3. therapeutic factors - reviewed in the literature and observed in the patient. 4. Safety - safety profile of a drug taken into consideration and weighed against other factors. 5. Cost - Cost to patient and healthcare system 6. patient factors - adverse effects, health beliefs, values and current drug therapy that may interfere with new drug, patients age, pregnancy 7. provider - ease of prescription monitoring and formularies

Clinical Judgement in prescribing

1. using clinical judgement based on a thorough assessment of the patient and the patients environment. 2. determining the medical and nursing diagnosis. 3. review of potential alternative therapies. 4. specific knowledge about the drug chosen and the disease process it is designed to treat. **least invasive, least adverse reactions, least likely to cause an adverse reaction***

writing and transmitting prescriptions

A number of directions need to be communicated in writing or verbally to the dispensing pharmacist to complete a prescription properly. Tools such as the Institute for Safe Medication Practice's (ISMP) List of Error-Prone Abbreviations, Symbols and Dose Designations (2012) can help prescribers decrease transmission errors. The following are suggestions to provide a complete, safe prescription: 1.Use preprinted prescription pads/electronic templates that contain the name, address, and telephone number and NPI number of the prescriber. This will allow the pharmacist to contact the prescriber if there are any questions about the prescription. 2.Designate the complete drug name, strength, dosage, and form. 3.Indicate the date of the prescription. 4.Use metric units of measure, such as milligrams and milliliters; avoid apothecary units of measure. 5.Avoid abbreviations. 6.Avoid the use of "as directed" or "as needed." 7.Include the general indication, such as "for infection." 8.Indicate "Dispense as Written" if generic substitution is not desired. 9.Include the patient weight, especially if pediatric or elderly. 10.Indicate if a safety cap is not required, as medications will be dispensed with them by default.

antibiotics

ANTIBIOTICS: BETA-LACTAMS The discovery of penicillins initiated the antibiotic era. The active moiety of penicillins is a four-member ring known as the beta-lactam ring. Other antibiotics that contain the beta-lactam ring, mainly cephalosporins, carbapenems, and monobactams, have a similar mechanism of action and share clinical effects. Beta-lactam antibiotics are bactericidal when concentrations exceed the minimum inhibitory concentration (MIC) of the pathogen for approximately 50% of the dosing interval. Efficacy is affected by the organism's susceptibility, dose, tissue concentration, and rate of organism multiplication. They are most effective against rapidly growing organisms forming cell walls. Cephalosporins are discussed in the next section. Monobactams and carbapenems are used to treat serious infections in the hospital, which is outside the scope of this textbook. Beta-lactamase inhibitors are described with the penicillins because they are usually used together as combination products. PENICILLINS Penicillins are characterized chemically by the 6-aminopenicillanic acid joined to the beta-lactam ring. Attachment of different substitutes to 6-aminopenicillanic acid results in different pharmacological and antibacterial characteristics, which are the basis for four penicillin subclasses: (1) penicillinase-sensitive or natural penicillins, (2) aminopenicillins, (3) penicillinase-resistant or antistaphylococcal penicillins, and (4) anti-pseudomonal or extended-spectrum penicillins. Pharmacodynamics Penicillins hinder bacterial growth by inhibiting the biosynthesis of bacterial cell wall mucopeptide (also called murein or peptidoglycan). This action is dependent on the drug reaching the penicillin-binding proteins (PBPs), which include transpeptidase, carboxypeptidase, and endopeptidase enzymes involved in the terminal stages of forming the cell wall. When penicillins bind to the PBPs, the wall is weakened and lysis of the bacterial cell wall occurs. Because human cells lack a cell wall, there is virtually no action against host cells. Penicillins are bactericidal against sensitive organisms and are most effective during active cellular multiplication. Lower drug concentrations may result in bacteriostatic effects only. Penicillin The only natural penicillin commercially available is penicillin. Penicillin can be administered orally (Penicillin V, or oral Penicillin G which is no longer available in the United States), intramuscularly (procaine and benzathine penicillin), and intravenously (Penicillin G). This group is active against aerobic, gram-positive organisms, including Streptococcus species such as S. pneumoniae and group A beta-hemolytic Streptococcus (GABHS), some Enterococcus strains, and some non-penicillinase-producing staphylococci. Only about 5% to 15% of community-acquired Staphylococcus aureus remains susceptible to natural penicillins, principally because the majority of strains produce penicillinase. The concern with penicillin-resistant S. pneumoniae has been somewhat decreased with less indiscriminate use of antibiotics and vaccination against pneumococcus. Resistant strains dropped from a high of 40% in 2000 to 20% by 2003 with the universal use of the PCV-7 vaccine (Thomas, 2005). Penicillin-resistant strains are also commonly resistant to cephalosporins, macrolides, and sulfonamides and, to a lesser extent, to clindamycin; they are commonly called drug-resistant S. pneumoniae (DRSP) (Thomas, 2005). In addition to its bactericidal activity against most strep-tococcocal and community-acquired enterococcal species, penicillin has reliable activity against Pasteurella multocido, Actinomyces, Clostridium, Peptostreptococcus, and Treponema pallidum. The American Academy of Pediatrics (AAP) Red Book recommends penicillin for Group A beta streptococci and for Group B beta streptococci due to low resistance (AAP, 2012a, 2012b). Penicillin G is reliable for treating Listeria monocytogenes but is no longer listed as active against Neisseria gonorrhoeae due to resistance that was first documented in 1976 (CDC, 2013b; see Chap. 44, Sexually Transmitted Infections) or against Staphylococcus species. Penicillinase-producing organisms have reduced the breadth of organisms that this group is used to treat. Aminopenicillins Like penicillin, aminopenicillins have reliable activity against gram-positive organisms, including Streptococcus and Enterococcus species. However, they have greater activity against gram-negative bacteria because of their enhanced ability to penetrate the outer membrane of these organisms. Ampicillin and amoxicillin are the only two available aminopenicillins. Because of the increasing beta-lactamase production among gram-negative pathogens and anaerobes, amoxicillin and ampicillin are often combined with beta-lactamase inhibitors, clavulanic acid, and sulbactam, respectively, for enhanced gram-negative and anaerobic activity. Beta-lactamase inhibitors prevent the destruction of beta-lactam antibiotics by serving as a competitive inhibitor of beta-lactamase. Although beta-lactamase inhibitors also contain a beta-lactam ring, they have poor antimicrobial activity alone. As combination products, ampicillin/sulbactam and amoxicillin/clavulanate have excellent activity against methicillin-susceptible Staphylococcus aureus (MSSA), Streptococcus and Enterococcus species, Moraxella catarrhalis, Haemophilus influenzae, Neisseria meningitidis, Escherichia coli, Klebsiella, Proteus mirabilis, Salmonella, some Shigella species, Pasteurella multocido, Actinomyces, Clostridium, Peptostreptococcus, and Bacteroides fragilis. Penicillinase-Resistant Penicillins Nafcillin, oxacillin, cloxacillin, and dicloxacillin, also called the anti-staphylococcal penicillins, have a unique spectrum of activity. Chemical modifications of penicillin produced this class of antibiotics that is stable in the presence of penicillinase produced by staphylococci; however, activity was eliminated for Enterococcus species, Listeria, gram-negative bacteria, and most anaerobes. They are active against Streptococcus species, MSSA, some coagulase-negative staphylococci, and Peptostreptococcus. Resistance by staphylococci is mediated via the mecA gene, which encodes the low-affinity PBP 2a. This will manifest as methicillin-resistant S. aureus (MRSA) and Staphylococcus epidermidis (MRSE). With the exception of ceftaroline, methicillin-resistant strains are resistant to all penicillins, cephalosporins, and carbapenems. Anti-Pseudomonal Penicillins The anti-pseudomonal penicillin group is comprised of piperacillin, ticarcillin, mezlocillin (discontinued in the United States), and carbenicillin (discontinued in the United States). Piperacillin and ticarcillin have enhanced activity against gram-negative bacilli, particularly Pseudomonas aeruginosa, Enterobacter, Morganella, and Providencia species. They retain activity against aminopenicillin-susceptible organisms, yet have less potency against streptococci and enterococci. Piperacillin and ticarcillin are available as combination products with beta-lactamase inhibitors. Piperacillin/tazobactam and ticarcillin/clavulanate have a wider spectrum of activity that includes MSSA and anaerobes, including Bacteroides species. None of these agents is available for oral use in the United States. Many texts and references, including the Sanford Guide to Antimicrobial Therapy (2012), have tables that list the organisms generally susceptible to various penicillins.

Dose-Related ADRs classification

Adverse drug reactions may also be dose-related. This could be from administering an excessive dose or failing to adjust doses properly for age and organ function (i.e., renal insufficiency or liver failure). For example, a person with diabetes may become hypoglycemic after administering an excessive dose of insulin. An individual patient could experience lithium toxicity upon development of acute renal failure with no adjustment of the lithium dose.

Age pregnancy and genetic factors

Age is important when using penicillins because most are renally eliminated. Neonates and elderly patients often have poor renal function and are more prone to drug toxicity. Highly protein-bound drugs such as sulfonamides and the penicillinase-resistant penicillins should be avoided in late pregnancy and neonates because these agents may displace bilirubin from plasma proteins of the newborn, causing kernicterus, a central nervous system (CNS) disorder. Pregnancy contraindicates several classes of antibiotics, such as tetracyclines and fluoroquinolones, so aminopenicillins may be used for gravid women, even though another agent is the drug of choice.

adverse effects of OTC self medication

All medications, whether prescription or OTC, have predictable and unpredictable adverse effects. When a prescriber is choosing a medication, this understanding of adverse effects is integral to the decision making and patient education regarding the medication. Likewise, when pharmacists fill a prescription, they will often discuss significant adverse effects with the patient. These safeguards are lost when a patient self-medicates with an OTC product. Adverse effects of OTC medications may be mild, such as gastrointestinal upset, or severe, as in the case of gastrointestinal bleeding associated with NSAID or aspirin use. Exceeding treatment duration or taking the wrong dose increases the likelihood of adverse reactions (Schmeidl et al, 2014). The elderly are the most likely to be hospitalized due to adverse effects associated with OTC medication use (Villany, Fok, & Wong, 2011; Schmeidl et al, 2014). Patients need to be educated regarding the adverse effects of OTC medications. Education includes reading the label carefully and asking questions of a pharmacist or the provider. Patients should be advised that some OTC medications may impair driving; most state laws do not differentiate between alcohol or prescription or OTC drugs in regard to impaired driving (American Automobile Association, 2011). Table 13-2 discusses OTC medications that may impair driving.

Skin and Tissue Infections

Amoxicillin/clavulanate is indicated as first-line therapy for prophylaxis of infection following animal bites, including cats, dogs, and humans (AAP, 2012d). It may also be used for infected post-operative or post-traumatic wounds. Oral penicillinase-resistant penicillins (dicloxacillin) are indicated for bullous impetigo caused by S. aureus and erysipelas of the extremities (Stevens et al, 2014). Penicillin V and penicillin G benzathine are used in the treatment of impetigo caused by group A streptococci. Wounds accompanied by sepsis and severe tissue involvement require hospitalization and IV treatment.

Receptors: Antagonists and Agonists

Antagonists are drugs that occupy receptors without stimulating them. Antagonists occupy a receptor site and prevent other molecules, such as agonists, from occupying the same site and producing a response. Antagonists produce no direct response. The response we see following administration of antagonists results from their inhibiting receptor stimulation by agonists. For example, beta blockers such as propranolol and atenolol act as antagonists at the beta-adrenoceptor. Adrenergic nerve activity can raise heart rate, and patients with high heart rates experience a significant drop in heart rate following administration of beta blockers. The same administration may have little effect on patients who lack adrenergic nerve activity and already have a lower heart rate. The effect of antagonists is dependent on the background receptor activity that it can block. Antagonists produce a shift in the concentration-effect relationship for agonists acting at that same specific receptor as the antagonist; they make agonists for the same receptor appear less potent. The effect of an antagonist is dependent on its blood levels and its affinity for the receptor. Most antagonists in clinical use are competitive reversible antagonists, and it is possible to overcome the antagonist effects with higher concentrations of the competing agonist. A very small number of antagonist drugs (e.g., echothiophate, phenoxybenzamine) act by irreversibly binding to the receptor; their antagonism remains until new receptors can be produced by the cell. Partial agonists are drugs that have properties in between those of full agonists and antagonists. Partial agonists bind to receptors but when they occupy the receptor sites, they stimulate only some of the receptors. This is sometimes called intrinsic activity. So they can act as part agonist and part antagonist. Partial agonists would require all of the available receptors to produce their full response, and the maximum response for a partial agonist is less than that for a full agonist. The beta blockers acebutolol, penbutolol, and pindolol are partial agonists. Administration can block the effects of adrenergic nerves on heart rate, but partial agonist activity keeps heart rate from falling too low, as might occur following administration of a pure beta-adrenoceptor antagonist. So beta blockers with intrinsic sympathomimetic activity control heart rate within a range that is higher than the response to an antagonist and lower than the response to an agonist.

Antimycobacterial antibiotics

Antituberculosis or antimycobacterial agents represent a diverse group of compounds, which are used either alone or in combination to treat Mycobacterium infections, including tuberculosis and leprosy. These drugs include rifampin, isoniazid, ethambutol, streptomycin, and kanamycin.

Macrolides patients with renal and hepatic impairment

Azithromycin is principally excreted via the liver. Patients with impaired hepatic function require cautious use of this drug. There are no data about use with renal impairment, so cautious use is also recommended in decreased renal function. Clarithromycin is excreted via the liver and the kidney. Dosage adjustments are not required for hepatic impairment in the presence of normal renal function. Renal impairment with CCr less than 30 mL/min with or without hepatic impairment requires that dosages be halved or the dosing interval doubled. Erythromycin is contraindicated for patients with preexisting liver disease. Erythromycin estolate has been associated with the infrequent (1 case per 1,000 patients) occurrence of cholestatis hepatitis. This has also occurred with other erythromycin salts but is rarer in children. Laboratory findings include abnormal liver function tests, peripheral eosinophilia, and leukocytosis. Symptoms include malaise, nausea, vomiting, abdominal cramps, and fever. Jaundice may or may not be present. These symptoms tend to occur after 1 to 2 weeks of continuous therapy, disappear if the drug is discontinued, and reappear within 48 hours if the drug is readministered. Telithromycin has not shown altered AUC for patients with hepatic impairment. In severe renal impairment (CCr less than 30 mL/min), AUC was increased. To date, no dosage adjustments are recommended.

when prescribing recommendations change due to antibiotic resistance and overpricing of antibiotics for URI's

Changes due to resistance stemming from over prescribing antibiotics in the 90's. Increase in pricing to patient also a viable factor

Macrolides drug reactions

Clarithromycin, erythromycin, and telithromycin have more drug interactions than the other two drugs in this class because they are strong inhibitors of the CYP450 enzymes, particularly CYP 3A4. Object drugs in these interactions include such common drugs as cyclosporine, most statins, rivaroxaban, theophylline, carbamazepine, and select benzodiazepines. Other drug effects that will be increased with concomitant use of macrolides include colchicine, digoxin, and warfarin. The combination of most macrolides with pimozide (Orap), a drug used to treat Tourette syndrome, can result in serious dysrhythmia; the inhibited metabolism causes prolonged QT interval of the cardiac cycle, predisposing to potentially fatal cardiac dysrhythmias. Table 24-15 lists the various drug interactions by specific drug. Although azithromycin has fewer drug interactions, confirmed interactions with drugs with narrow therapeutic margins have been observed in clinical practice. Drugs inducing CYP 3A4, such as efavirenz, rifampin, rifapentine, and rifabutin, may significantly increase the metabolism of clarithromycin and decrease effectiveness. Alternative therapy should be considered. Caution should be used when administering any additional medications that may prolong the cardiac QT interval. These may include, but are not limited to, Class 1a and Class 3 antiarrhythmic agents, fluconazole, and promethazine. In addition, antacids containing aluminum or magnesium slow absorption of macrolides and azalides, so they should be taken 1 hour before or 2 hours after the antimicrobial drug, particularly with azithromycin. Drug interaction testing with telithromycin indicated that no significant interactions exist with antacids, grapefruit juice, digoxin, warfarin, or the anti-ovulatory effects of oral contraceptives

Collaboration with other providers

Collaboration is critical for quality patient care. 1. improves safety and quality of care.

complexity of drug regime and polypharmacy

Collaborative management is an important method of encouraging adherence to a complex health-care regimen. Collaborative management is care that "strengthens and supports self-care in chronic illness while assuring that effective medical, preventive, and health maintenance interventions can take place" (von Korff, 1997, p 1097). The process of collaborative management is both dynamic and continuous. Collaborative management: 1.Begins with dialogue and mutual respect between the patient and the health-care team. 2.Is a starting point for care in chronic illness that includes choosing desirable and obtainable goals that provide direction for care management. 3.Is flexible in nature to enhance care and communication. 4.Does not end with regimen selection but progresses through stages in the direction of improving adherence, optimal health, and survival (Jani Stewart, Nolen, & Tavel, 2002, p 84). Moreover, von Korff (1997, p 1098) further outlines the essential elements of health care central to such collaborative management. These essential elements are the following: 1.Collaborative definition of problems. 2.Targeting, goal setting, and planning. 3.Creating a continuum of self-management training and support services. 4.Active and sustained follow-up. These four elements provide a unique manner for addressing not only medication adherence issues but also chronic illness care in general. For example, patients and providers may define problems differently. Patients may focus on functionality, subjective complaints, and lifestyle choices; providers may focus on disease prevention, medication therapy, nonadherence to recommendations, and risk factors related to prognosis. It is imperative that patients and providers have a mutual understanding of problems and understand one another's points of view

When you suspect a patient is misusing medication: Communication, systemic solutions, prescribing tips, medication agreement, prescription drug monitoring programs.

Communication - Curricula in training programs over the past two decades have come to emphasize the clinical interview and practitioner-patient relationship-building skills. Skill building involves active learning strategies in the areas of verbal and nonverbal communication, empathy, and rapport building. ractitioners must be able to identify common scams and defuse them efficiently and effectively. One strategy is to just say no and mean it. Chemically dependent patients have learned that the practitioners' enabling instincts and confrontation discomfort are so great that when NPs initially say no, it usually ultimately can be turned into a yes if enough pressure is applied. Thus, it is important to be able to mean no and to stick with it. A higher-level clinical skill is initially to say no and then to turn the tables on a patient who demands the prescription. This strategy is based on the clinical fact that patients who demand controlled drugs generally have a pathological relationship with that prescription because of underlying chemical dependence. By making the statement "I am feeling pressured by you to write a prescription today that is not clinically indicated. Because of this I am really concerned about you, and we need to talk about your use of alcohol or other substances," the NP can often effectively turn the tables and shift the discomfort to the patient while still refusing to prescribe. Systemic solutions - Law enforcement and legislative efforts have produced few solutions to the problem of imbalance in controlled drug prescribing. Until recently, these approaches have targeted diversion of drugs and overprescribing. Results of duplicate and triplicate prescription policies, as well as stricter investigation and enforcement, led to decreased prescribing of controlled drugs across the board, even to patients in need of them for legitimate medical reasons. The development of more permissive policies and pain management guidelines by state legislatures and health regulatory boards increased prescribing for pain management; however, a concurrent 65% increase in hospitalizations in the United States for poisonings from prescription drugs Prescribing tips - few prescribing tips can help the practitioner reduce environmental facilitation of prescription misuse. First, collect and document a complete history and examination before prescribing controlled substances. Do not rely on patient-supplied history, x-rays, or medical records to confirm your assessment—obtain this information directly from the primary source. Passik and Weinreb (2000) advise use of the four "A's" to guide initial and ongoing assessment of medication efficacy: (1) analgesia measurement by use of pain scales or other assessment tools, (2) activities of daily living (ADLs) as measured by levels of physical and psychological functioning, (3) adverse effects, and (4) abuse issues. Prescribe limited quantities without refills on a first visit, allowing additional time for patient assessment and confirmatory documentation. Educate medical and assistive staff in reinforcement of consistent clinic policies and procedures related to scheduling, forms, urine drug screening, records review and release, and refills. It is not uncommon for patients who do misuse substances to quickly identify the "weak link" among the treatment team and focus their energies on this person or process. Standardize expectations regarding after-hours calls, use of multiple providers, and weekend or early refills and post them where they are readily available. Patients covered by insurance plans, including Medicaid and Medicare, can be limited to one pharmacy or one prescriber through their payment plan. Case managers can often be utilized to help review and manage medication use and advocate for access to additional options for pain management and control. Other tips include prescribing generic, longer-acting formulations of drugs that have less street value and writing out the quantity prescribed rather than using only numerals, which can be altered. Medication agreement - One tool for defining and implementing treatment objectives is the medication agreement. This written tool can be incorporated into treatment of chronic pain, particularly if long-term management with opioids is indicated. The agreement is not limited to opioid prescribing practice, however. A medication agreement can be used for treatment of pain or other conditions with medications that are not opioids but still have potential for patient misuse, such as benzodiazepines, tramadol, or other adjunctive medications. drug monitoring programs - As of 2012, all but one state (Missouri) have an active or legislatively enabled Prescription Drug Monitoring Program (PDMP). A PDMP enables practitioners to query a confidential database of controlled substances statewide to evaluate whether a patient is currently receiving a prescription elsewhere. Some states also have regulations that permit cross-state sharing of this information, which has reduced the ability of patients who misuse controlled substances to obtain multiple prescriptions from multiple providers. For more information regarding these programs and how to access them, contact the local DEA office or state board of pharmacy or the Alliance of States with Prescription Drug Monitoring Programs

Combat Methamphetamine Epidemic Act of 2005

• Enacted to regulate the OTC sales of pseudoephedrine. • Identity and address of each purchaser to be kept for two years. • Daily sales of regulated products not to exceed 3.6 grams. • 30 day purchase limit not to exceed 9 grams • 30 day purchase via mail order not to exceed 7.5 grams

Drug interactions with antacids

DRUG INTERACTIONS When patients receive a prescription from a provider or fill a prescription in the pharmacy, a review of current medications occurs and potential drug interactions are identified. When a patient self-medicates with an OTC medication, often no professional knowledgeable about drug interactions is involved. Patients may not be aware that OTC medications may interact with prescription or other OTC medications or alcohol. Antacids Antacids consist of a metallic cation and basic ion (calcium carbonate, magnesium hydroxide, etc.), which neutralize acidity in the stomach by raising the pH. The basic property of these drugs causes them to interact with most medications, by either binding with the drug molecule or altering pH and thus the absorption of drugs that need an acidic environment for optimal absorption. Most interactions can be avoided by separating the dosing of antacids by at least 2 hours from the dosing of the other oral medications. Intraluminal interactions occur in the stomach when an antacid chelates another drug or adsorbs another drug onto its surface. The best-known antacid interaction is with tetracycline. Aluminum hydroxide and magnesium hydroxide have a strong affinity for tetracycline and form an insoluble and inactive chelate. This interaction can reduce the bioavailability of tetracycline by 90% and result in clinical failures. This chelation occurs with all other forms of tetracycline, including doxycycline and minocycline. Patients should not take any antacid until at least 2 hours after tetracycline administration. A similar interaction exists with the quinolone antibiotics, such as ciprofloxacin and ofloxacin.

Nutritional management

Deficiencies of vitamin B12, folic acid, and iron; impaired calcium metabolism; and reduced absorption of calcium and vitamin D develop as a result of partial removal of the stomach. These problems are caused by a shortage of intrinsic factor. Monitor CBC for signs of megaloblastic anemia and leukopenia.

Process of rational drug prescribing 6 steps WHO

Define the patient's problem Specify the therapeutic objective Collaborate with the patient Choose the treatment Educate the patient Monitor effectiveness

Impact of generic drugs on drug therapy

Drug pricing in today's health-care system is complex. The goal is to reduce drug acquisition costs to the lowest possible amount without affecting quality of care. Most pharmacies can control acquisition costs by purchasing generic drugs. However, in some situations, brand-name drugs are less expensive than generic-drug products owing to internal bidding, group purchasing, and negotiations with vendors. The cost of generic drugs and single-source, brand-name drugs to pharmacies and patients differs and is driven by market-force competition for the limited pool of dollars. Although most drugs are sold for 15% to 20% less than the average wholesale price (AWP) and prices vary widely, AWP is routinely used for comparing different agents. A common method for determining reimbursement and controlling health-care system costs used by the Federal Health Care Financing Administration (HCFA) and private payers is the maximum allowable cost (MAC). Although drug pricing is complex, most pharmacy benefits groups are still businesses that seek profits. According to the MAC list prices, most pharmacy benefits groups select a drug with the lowest acquisition cost regardless of generic or brand-name status to reduce the cost of drug therapy. In most cases, pharmacy benefits groups pass this cost savings on to the patients by means of substantially lower co-payments for generic drugs. Many benefit plans have a two- or three-tiered benefit, in which the patient pays a greater co-payment for brand-name drugs than for generic equivalent prescriptions. Most pharmacy benefits groups have maximum annual benefits for brand-name drugs ranging from $1,500 to $2,000 per year. The generic-drug benefit is unlimited and the purchase of generic drugs will not count against the $2,000 annual ceiling. For many generic drugs, the AWP is at least 50% that of the brand-name drug. Therefore, in general, co-payments are usually 50% of the wholesale price for single-source brand-name drugs. Patients may also take advantage of the numerous prescription programs offered by many large retail pharmacies where they can get a month's supply of a generic drug for $4 and not have to be concerned about their prescription coverage. Generic medications are available to treat the most common diseases seen in primary care, including diabetes, hypertension, asthma, and common infections; therefore, patients benefit from the prescription of generic equivalents (IMS Health, 2012). Lipitor, the number-one-selling drug in 2011, with sales of $7,668,425,000, went off patent in November 2011, which has provided savings to consumers (Bartholow, 2012). The availability of less costly generic-drug products for expensive agents would ease financial burdens for most patients, enabling them to comply with their treatments. Increased compliance may decrease health-care utilization in these patients, allowing greater access to health care for other patients. In addition, most patients can easily be stabilized on a generic-drug product with a narrow therapeutic index as well as on an innovator brand.

Nutrient-Drug Interactions

Drugs may alter food intake by either increasing or decreasing appetite or the ability to eat. •They may also affect the absorption, metabolism, and excretion of certain nutrients. •Food intake and vitamin/mineral supplementation may affect the absorption, distribution, metabolism, and action of some medications.

fluoroquinolone precautions and contradictions

Elevated BUN, AST, ALT, Serum Creatinine, Alkaline phosphatase, decreased WBC and hematocrit. The fluoroquinolones are synthetic, broad-spectrum antibiotics chemically related to the quinolone nalidixic acid (NegGram), a narrow-spectrum antibiotic used to treat UTIs. Fluoroquinolones are a newer class of antibiotics introduced in the 1980s. The fluoroquinolones are divided into the older group (ciprofloxacin [Cipro], norfloxacin [Noroxin], ofloxacin [Floxin]) and the newer group (gemifloxacin [Factive], levofloxacin [Levaquin], and moxifloxacin [Avelox]). The newer fluoroquinolones are often referred to as the respiratory fluoroquinolones, which is a reference to their activity against S. pneumoniae, not to drug distribution or limited treatment indications. Two newer fluoroquinolones have been withdrawn from the market because of adverse effects: trovafloxacin (Trovan) because of liver toxicity and gatifloxacin (Tequin) because of hypoglycemia and hyperglycemia. Sparfloxacin is no longer available in the United States. An ophthalmic solution of gatifloxacin (Zymar) is still available.

cultural influence on care

Equally important to understanding health disparities is having knowledge of cultural factors that may impact the well-being of patients. Knowing who makes the decisions in the family about health care and if this person supports the use of the prescribed drug and the plan of care, how the patient and family members view health and illness and their views on the management plan, and cultural factors that may create challenges in adhering to the treatment plan are all important to helping clients improve and/or maintain their health. Although each person with a specific cultural heritage is unique and may not subscribe to all or even most of the health beliefs and health practices of that cultural group, it is important to know what is common to members of the group and in particular what risk factors the group shares. Cultural heritage plays an important role in helping to explain values, attitudes, beliefs, customs, language preferences, and behaviors that influence health practices (Giger, 2013). Socioeconomic factors also influence prescription choices and they may supersede cultural and racial differences. For this reason, we discuss the cultural factors to be taken into account, including background socioeconomic data, such as current demographics, median income, education, and employment (since many patients obtain health insurance through their employment) as well as LEP status, percent foreign-born (if applicable), and health-care utilization. This chapter focuses on both cultural and ethnopharmaco-logical factors that influence the practioner's choice of drugs. Pharmacogenetics, described in Chapter 8, also influences prescription choice. The data provided here are based on evidence derived from drug research and on the pharmacokinetics of those drugs most likely to exhibit differences. In using this information, it is important to keep in mind that most Americans are not of any "pure" cultural or racial background and that patients must be treated as unique individuals. The United States is a constantly changing and evolving cultural mosaic made up of individuals who represent a variety of ethnic and racial backgrounds, each having its own culture and beliefs that influence health. How much of the material presented in this chapter on the cultural values, beliefs, and practices of different ethnic and racial minority groups continues to be valid in the 21st century is unknown. There is little empirical research to support the information on cultural beliefs and practices presented here, although every effort has been made to locate current evidence-based research. The reader should understand that the majority of our sources are found in cultural and anthropological texts that do not clearly state where the information originated or if it is still relevant to today's health-care consumer. Thus, we caution readers that our descriptions may be outdated and may not apply to all members of that particular group. Further research is needed to discover whether the long-reported cultural values, beliefs, and practices continue to represent the majority of the ethnic and minority populations discussed. The reader should acknowledge that culture is a living concept that is evolving and changing and that patients may represent a kaleidoscope of these ever-changing cultural beliefs and practices (Purnell, 2013).

Clinical judgment in prescribing includes: 1. Factoring in the cost to the patient of the medication prescribed 2. Always prescribing the newest medication available for the disease process 3. Handing out drug samples to poor patients 4. Prescribing all generic medications to cut costs

Factoring in the cost to the patient of the medication prescribed

State Law

Federal law establishes whether a drug requires a prescription but does not dictate who may prescribe. The authority to prescribe is a function of state law. Unlike the uniform nature of federal law, prescriptive authority varies from state to state. The states have the authority to license health-care professionals. Although a state may sign a compact agreement permitting cross-state practice, as is the case with the Nurse Licensure Compact, there are no currently implemented cross-state agreements that cover NP practice.

communication difficulties

Finding common terminology is not the only communication difficulty. There are also speech, hearing, and language barriers. Communication barriers can create safety concerns, as well as frustration for the provider and patient.

prescribing generic vs. brand name medications

Generic drugs that are considered therapeutic equivalents may be exchanged for brand-name drugs with confidence. Pharmacists may substitute a generic equivalent for a brand name unless the prescriber specifies "Dispense as Written" on the prescription. Shrank and colleagues (2011) studied 5.6 million prescriptions written for 2 million patients and found there was a greater chance that the prescription was not filled if "Dispense as Written" was on the prescription or requested by the patient. It is critical to discuss pharmacy benefit coverage with the patient before prescribing a drug as "Dispense as Written." Many retail stores offer prescription programs in which a select list of generic drugs are offered for $4 for a 30-day supply and $10 for a 90-day supply. This may be a substantial savings for patients, especially those without prescription drug coverage or with a high co-payment for their medications. For example, generic metformin 500 mg tablets are $4 for a 30-day supply, whereas the retail price for the brand-name Glucophage is $70 for the same 30-day supply. The caveat is that the patient must live near or have transportation to one of the retail pharmacies that have retail drug programs, such as Walmart, Target, Kroger, and Sam's Club stores.

patient education regarding OTC Medications

Given the concerns over OTC self-medication, providers are required to educate their patients about safe OTC use. Reading the label and following the label instructions are critical, but if patients do not understand the label, they should ask for assistance from a pharmacist or the provider. In a study of OTC medication consultation by pharmacy students in a community pharmacy, McConaha, Finole, Heasley, and Lunney (2012) found that only 37.6% of consumer participants initiated a consultation with the pharmacist, and that consultation resulted in significant cost savings by switching to a generic product and nonsignificant but clinically relevant prevention of OTC medication-related adverse outcomes. Educating patients that even though a medication is available over-the-counter, it still has the same concerns for adverse effect, drug interactions, and toxicity as prescription medication may increase safety when self-medicating

G6PD deficiency

Low NADPH leads to hemolytic anemia (free radicals) with bite cells and heinz bodies Fava beans, sulfonamides, primiquine, dapsone X-linked recessive

Drug responses

Homeostasis is the tendency of a cell, tissue, or the body not to respond to drugs but instead to maintain the internal environment by adjusting physiological processes. Before a medication can produce a response, it often must overcome homeostatic mechanisms. Drug effects depend on the amount of drug that is administered. If the dose is below that needed to produce a measurable biological effect, then no response is observed; any effects of the drug are not sufficient to overcome homeostatic capabilities. If an adequate dose is administered, there will be a measurable biological response. With an even higher dose, we may see a greater response. At some point, however, we will be unwilling to increase the dosage further, either because we have already achieved a desired or maximum response or because we are concerned about producing additional responses that might harm the patient.

Sulfamides & trimethoprim: Adverse effects

Hypersensitivity (Steven Johnson Syndrome), blood dyscrasias (imbalance of blood components), crystalluria within kidneys, ureters, bladder), acute kidney injury, kernicterus (accumulation of bilirubin in brain tissue) hyperkalemia

Generic Substitution

In cases in which the patent on a specific pharmaceutical product expires and drug manufacturers produce generic versions of the original branded product, the generic version of the drug (which is theorized to be identical to the product manufactured by a different firm) is dispensed, even though the original product is prescribed. Some managed care organizations and Medicaid programs mandate generic substitution because of the generally lower cost of generic products. There are state and federal regulations regarding generic substitutions.

Fosfomycin

Inhibits enolpyruvate transferase in early cell wall synthesis Oral treatment of uncomplicated lower UTI's caused by G+ or G- organisms

Common causes of ARDs including common drugs involved and which cause skin reactions

It is important for practitioners to realize that many ADRs are preventable. Approximately one-third result from medication errors and up to one-third from allergic reactions (Budnitz et al, 2006). Practitioners can reduce ADRs by being aware of specific drugs and drug classes that have a high incidence of ADRs. Budnitz and others evaluated ADRs that led to an emergency department visit. One single drug or drug class was the suspected cause in 94% of those cases. The top five drug classes responsible included insulins, opioid-containing analgesics, anticoagulants, amoxicillin-containing medications, and antihistamines or cold remedies. Additionally, the top five drug classes implicated in precipitating hospitalizations following admission to the emergency department included anticoagulants, insulins, opioid-containing analgesics, oral hypoglycemic medications, and antineoplastic agents. In the elderly population, one-third of all ADRs requiring treatment in the emergency department were due to only three medications: warfarin, insulin, and digoxin (Budnitz et al, 2006). In addition to the above medications, practitioners should be aware that antibiotics, sedatives, antipsychotics, and chemotherapeutic agents are also drug classes that have a high rate of ADRs (Bates et al, 1995; Evans, Lloyd, Stoddard, Nebeker, & Samore, 2005; Gurwitz et al, 2005; Woolcott et al, 2009). One of the most common manifestations of ADRs is in the form of cutaneous skin reactions, ranging from mild skin rashes to life-threatening Stevens-Johnson syndrome. Out of the top 10 drugs linked to skin reactions, the majority are antibiotics. Specifically, the top 10 drugs linked to skin reactions are, in order, amoxicillin, trimethoprim-sulfamethoxazole, ampicillin, iopodate, blood products, cephalosporins, erythromycin, dihydralazine hydrochloride, penicillin G, and cyanocobalamin (vitamin B12) (Roujeau & Stern, 1994).

Systemic Azoles and other antifungals

Ketoconazole, Flucanazole, Itraconazole, Voriconazole, e systemic antifungal agents used in the treatment of fungal infections of the skin include griseofulvin; the azoles ketoconazole, itraconazole, and fluconazole; and the oral allylamine terbinafine. Griseofulvin is an antifungal antibiotic produced by certain species of Penicillium. Griseofulvin exerts its fungistatic activity by disrupting the mitotic spindle structure of the fungal cell. This arrests metaphase cell division. Griseofulvin may also produce defective DNA. Griseofulvin, which has a greater affinity for diseased tissue than for healthy tissue, has an affinity for keratin precursor cells. These are gradually exfoliated and replaced by uninfected tissue. It is tightly bound to the new keratin, which becomes highly resistant to fungal infections. Fluconazole is a synthetic, broad-spectrum triazole antifungal agent of the imidazole class. Fluconazole has a broader spectrum than the other imidazole antifungals. It exerts its effect by altering the fungal cell membrane and is a highly selective inhibitor of fungal CYP450 and sterol 14-alpha-demethylase. This inhibition results in increased cellular permeability, causing leakage of cellular contents. Ketoconazole alters the permeability of the cell membrane and inhibits fungal synthesis of phospholipids. Itraconazole is a synthetic triazole antifungal medication that is closely related to ketoconazole. Similar to ketoconazole, it exerts its effect by altering the fungal cell membrane. Itraconazole inhibits the CYP450-dependent synthesis of ergosterol, which increases cellular permeability and causes leakage of cellular contents. Terbinafine is an allylamine antifungal that exerts its antifungal effect through interfering with fungal sterol biosynthesis by inhibiting the enzyme squalene monooxygenase. This causes accumulation of squalene, which weakens the cell membrane in sensitive fungi. The accumulation of squalene within the fungal cell causes fungal cell death. Terbinafine has fungicidal activity against dermatophytes; it is less active against Candida. Naftifine's mechanism of action is not known, but it is thought to work similarly to terbinafine.

Autonomy and prescriptive power

More states are broadening and expanding the legal, reimbursement, and prescriptive authority to practice for all APRNs, including NPs. By January 2004, all states had recognized the NP title, scope of practice, and prescriptive authority in legislation. Momentum to full autonomy is gaining, with 26 states allowing independent practice for NPs and 21 states allowing independent full prescribing as of January 2015 (National Council of State Boards of Nursing [NCSBN], 2015). APRNs in other states have also gained recognition, although the scope of practice and prescriptive authority is often more restricted. (Woo 8)

Nitrofurantoin (Macrodantin)

Multigenerational antibiotic. Use: UTI. Precautions: broad-spectrum, contraindicated in renal dysfunction, urine will have brown discoloration.

Risk factors of ARDs

Multiple patient characteristics can increase an individual's risk of experiencing an adverse drug reaction (Aronson & Ferner, 2003). Risk factors for ADRs include genetic abnormalities, age, sex, polypharmacy (increasing the risk for drug-drug interactions), and concomitant medical conditions (increasing the chance for drug-disease interactions). Not all drug classes are susceptible to these risks, but an assessment should be made for all patients when starting or stopping medications to determine the relevance.

drug interactions of NSAIDS

NSAIDs prolong bleeding time and potentiate the effect of warfarin, thrombolytic agents, some cephalosporins, antiplatelet agents, and valproates. Prolonged use with aspirin may result in increased GI side effects and decreased effectiveness. NSAIDs may also decrease response to diuretics or antihypertensive therapy. COX-2 inhibitors do not negate the cardioprotective effect of low-dose aspirin.

Nucleosides analogs

Nucleoside analogues are nucleosides which contain a nucleic acid analogue and a sugar. Nucleotide analogs are nucleotides which contain a nucleic acid analogue, a sugar, and one to three phosphate groups. Nucleoside and nucleotide analogues can be used in therapeutic drugs, include a range of antiviral products used to prevent viral replication in infected cells. The most commonly used is acyclovir, although its inclusion in this category is uncertain, because it acts as a nucleoside but contains no actual sugar, as the sugar ring is replaced by an open-chain structure. These agents can be used against hepatitis B virus, hepatitis C virus, herpes simplex, and HIV. Once they are phosphorylated, they work as antimetabolites by being similar enough to nucleotides to be incorporated into growing DNA strands; but they act as chain terminators and stop viral DNA polymerase. They are not specific to viral DNA and also affect mitochondrial DNA. Because of this they have side effects such as bone marrow suppression. There is a large family of nucleoside analogue reverse transcriptase inhibitors, because DNA production by reverse transcriptase is very different from normal human DNA replication, so it is possible to design nucleoside analogues that are preferentially incorporated by the former. Some nucleoside analogues, however, can function both as NRTIs and polymerase inhibitors for other viruses (e.g., hepatitis B). Less selective nucleoside analogues are used as chemotherapy agents to treat cancer, e.g. gemcitabine. They are also used as antiplatelet drugs to prevent the formation of blood clots, ticagrelor and cangrelor.

OTC characteristics and regulations

OVER-THE-COUNTER MEDICATIONS An over-the-counter (OTC) drug has the following characteristics: (1) it must be safe (the benefit must outweigh the risks), (2) it has low potential for misuse or abuse, (3) it can be labeled, (4) the patient must be able to self-diagnose the condition for which the drug is being taken, and (5) it must be for a condition that the patient can manage without supervision by a licensed health professional (U.S. Food and Drug Administration Center for Drug Evaluation and Research [FDA CDER], 2012). The FDA CDER is responsible for ensuring that OTC drugs are properly labeled and that their benefits outweigh their risks. New OTC drug ingredients must undergo the New Drug Application process, just as prescription drugs do (FDA CDER, 2012). There are more than 80 therapeutic categories of OTC drugs and over 100,000 OTC drug products (FDA CDER, 2012). In addition, there has been a dramatic increase in the number of prescription medications that have moved to OTC status, for a variety of reasons. Cohen, Paquette, and Cairns (2005) propose three motives for this: "pharmaceutical firms' desire to extend the viability of brand names, attempts by healthcare funders to contain costs, and the self-care movement" (p 39). A blockbuster drug such as the proton pump inhibitor Prilosec or the antihistamine Zyrtec can continue to reap large profits by moving to OTC status. Insurers often drop drugs from coverage when they become OTC and so have pushed for drugs to become OTC, as in the case of Well-Point's petitioning the FDA to designate three antihistamines (loratadine, cetirizine, and fexofenadine) as OTC (Cohen et al, 2005; Sullivan, Nair, & Patel, 2005). Clearly, when drugs are close to reaching the end of their patent, pharmaceutical firms and insurers are motivated to move the drug to OTC status. Because patients are likely to treat many symptoms and conditions first with nonprescription drugs, the practitioner should assume that some therapy has been started when patients present for care and therefore should ask about OTC medication use. Patients are more likely to self-treat themselves or their children when they feel their illnesses are not serious enough to require medical care.

time related classification of ADRs including drug associated with withdraw symptoms

One distinguishing feature of drug reactions is the correlation between administration and tissue exposure to onset of the reaction. The World Allergy Organization classifies immunological reactions as immediate or delayed. Symptom presentation that occurs within 1 hour following exposure is classified as an immediate reaction, whereas a delayed reaction occurs more than an hour following exposure (Johansson et al, 2004). Time-related reactions can be further categorized as rapid, first dose, early, intermediate, late, and delayed. Rapid reactions occur during or immediately following the administration of a medication. These unintended adverse reactions generally occur when medications are administered improperly and are not necessarily related to being the first dose. For example, vancomycin can cause an adverse reaction known as red man syndrome when administered too rapidly (Aronson & Ferner, 2003). Phenytoin can cause can adverse reaction known as purple glove syndrome (blood vessel irritation and inflammation) when administered peripherally (Earnest, Marx, & Drury, 1983). Skin or tissue necrosis secondary to extravasation may occur with administration of chemotherapeutic agents. For example, hand-foot syndrome may occur when extravasation of chemotherapy occurs and damages the surrounding tissues in the hands and feet, causing redness, swelling, burning, blisters, ulcers, peeling skin, and difficulty when walking (Yokomichi et al, 2013). For these reasons, it is important for practitioners to be familiar with the proper administration technique of medications to avoid precipitation of these adverse reactions. First-dose reactions occur following the first dose of a medication. For example, orthostatic hypotension is a common reaction that occurs following the first dose of doxazosin, which generally does not occur with repeated doses. Cytokine release syndrome can occur following the first dose of orthoclone OKT3. Patient education and monitoring are essential when administering medications that are known to have a first-dose reaction, especially to ensure continued adherence, as the reaction is unlikely to persist. Early reactions occur early in treatment and generally resolve with continued treatment as the patient develops tolerance. These reactions typically do not require discontinuation of the drug but may simply require patients to adapt to the medications. It is often useful to initiate drugs likely to cause early reactions with low starting doses and sequentially titrate the dose upward to mitigate the severity and duration of side effects. Examples include gastrointestinal upset following the initiation of metformin or selective serotonin reuptake inhibitors. Immune hypersensitivities may occur following the first or subsequent dose. These reactions, however, often do require immediate discontinuation of the drug and possibly further medical attention, such as in the case of anaphylaxis resulting from administration of penicillin or its derivatives. Intermediate reactions occur following repeated exposure to a medication. Examples include hyperuricemia from furosemide, hemolytic anemia from ceftriaxone, interstitial nephritis from penicillin G, and contact dermatitis from neomycin. Intermediate reactions are difficult to predict but should be monitored. Patients with predisposing factors or increased susceptibility for adverse reactions should be followed vigilantly while on therapy for occurrence of these reactions. Late reactions occur after prolonged exposure to an offending agent. Examples include osteoporosis or thinning of the skin due to prolonged corticosteroid use or hypogonadism following prolonged use of opioids (Brennan, 2013). It may be possible to symptomatically treat late adverse drug reactions, but most are predictable and occur following repeated exposures. Thus, it is often recommended to remove the offending agent before the reaction is predicted to occur in order to manage this type of adverse effect. Late reactions also include reactions that occur when a dose of a chronic medication is reduced or withdrawn. For example, rapid discontinuation of oxycodone can cause the patient to experience symptoms of withdrawal (i.e., anxiety, insomnia, rhinorrhea, diaphoresis, tremor, vomiting, diarrhea, and/or tachycardia). A patient who takes clonidine or propranolol may experience rebound hypertension following withdrawal of the medication. These types of adverse drug reactions are relatively common and can often be avoided by thoughtful tapering of the drug, as they are a predictable extension of the drug's therapeutic effect. Delayed reactions occur at variable time points following drug exposure and can even occur after the discontinuation of a drug. For example, drug-induced tardive dyskinesia may occur following prolonged exposure to antipsychotics or metoclopramide, with symptoms persisting for months to years following discontinuation of the precipitating drug (Tarsy & Baldessarini, 1984). Polyalkylimide implant injection (cosmetic filler) can cause swelling and tender nodules near the injection site as well as other symptoms (fever, arthritis, xerostomia) up to 12 months following the injection.

Pregnancy use with sulfas

One exception to this is the use of sulfa antibiotics, commonly used for urinary or other infections in combination with another antibiotic, trimethoprim, in the drug Septra or Bactrim. While Septra does not cause congenital abnormalities and is safe for use early in pregnancy, it can cause jaundice in newborns.

Antivirals for Influenza

Oseltamivir (Tamiflu), Peramivir (Rapivab), Zanamivir (Relenza) used to treat influenza. Preg C, safe in lactation. Zanamivir may cause bronchitis and SOB, Oseltamivir may cause N/V. The recommended treatment course for uncomplicated influenza is two doses per day of oral oseltamivir or inhaled zanamivir for 5 days, or one dose of intravenous peramivir or oral baloxavir for 1 day

health and cultural beliefs

Other influences regarding a patient's knowledge deficit include culturally based health beliefs (see Chapter 7) and the relationship between the patient and the provider (Castro & Ruiz, 2009). Some patients do not want to share in the decision-making process. Their beliefs about health or their cultural beliefs may influence how they perceive their role in their care, and they may believe they need to do what the health-care provider tells them to do. To some others, the idea of having to share the control of taking care of themselves is foreign. Those patients who expect the provider to tell them what to do may perceive that the decision-sharing provider does not know what she or he is doing and may not return to that provider. Conversely, a mismatch can also occur between the patient who wants to be in control and a provider who presents information in an authoritarian manner.

acute bronchitis and URI: Sinusitis

Over the past 15 to 20 years, concern has been growing that overuse and misuse of antibiotics for URIs contribute to antibiotic resistance (AAP, 2012c; Bucher et al, 2003; Schumann & Nollette, 2000). In 1998, "Common Cold: Principles of Judicious Use of Antimicrobial Agents" was published in Pediatrics to begin a dialogue and recommendation for avoiding antibiotic prescriptions for the common cold (Rosenstein et al, 1998). In spite of recommendations not to prescribe antibiotics for the common cold, the CDC reported that up to 50% of patients treated for colds, bronchitis, and URIs received antibiotics inappropriately and launched a nationwide campaign called "Get Smart: Know When Antibiotics Work" (http://www.cdc.gov/getsmart) to educate providers and patients regarding the inappropriate use of antibiotics. In spite of almost 15 years of focusing on appropriate use of antibiotics, approximately 75% of antibiotic prescriptions written in pediatric practice are for otitis media, sinusitis, cough illness/bronchitis, pharyngitis, and the common cold (AAP, 2009). Because the common cold, URI, and acute bronchitis are seasonal, self-limiting illnesses usually caused by viruses, antibiotics have no role in management of uncomplicated cases (CDC, 2012c). Symptomatic treatment, rest, and proper nutrition should be mainstays of treatment; these are discussed in Chapter 46, Upper Respiratory Infections. Cough of less than 3-weeks duration seldom requires treatment in adults or generally well-appearing children (CDC, 2012c). The American College of Chest Physicians produced an extensive guideline regarding the management of acute and chronic cough with clear guidelines recommending antibiotic avoidance coupled with patient education (Irwin et al, 2006). Bronchitis requires antimicrobial therapy only if there is prolonged cough with a diagnosed etiology of a specific infection, such as Bordetella pertussis or Mycoplasma pneumoniae (Irwin et al, 2006). Penicillins are generally not appropriate for the infecting organisms in these complicated cases of bronchitis. During the common cold, mucopurulent rhinitis (thick, opaque, or discolored nasal discharge) is not an indication for antimicrobials unless it persists without improvement for more than 10 days, at which point the symptoms meet the criteria for acute bacterial sinusitis, discussed in depth in Chapter 47 (Chow et al, 2012; Wald et al, 2013). Chronic Bronchitis It is important to distinguish acute bronchitis from an acute bacterial exacerbation of chronic bronchitis (ABECB). Chronic bronchitis, a condition largely confined to smokers, is defined as a recurrent daily cough with sputum production that persists for at least 3 months in at least 2 consecutive years (Irwin et al, 2006). Patients with underlying chronic bronchitis may periodically become infected with a wide variety of organisms. The common organisms found in the sputum of patients with chronic bronchitis are most commonly viruses, as well as H. influenzae, S. pneumoniae, M. pneumoniae, and M. catarrhalis (Rabe et al, 2007). Throat swab with Gram's stain and culture are unreliable in these patients because the respiratory tract is normally colonized below the vocal cords. The decision to use antimicrobial drugs may be based on the presence of at least two of the three cardinal symptoms: increased sputum volume, increased sputum purulence, and increased dyspnea. A radiograph of the chest may be required to rule out bronchopneumonia. Recovery usually begins 3 to 4 days after antibiotics are initiated. Amoxicillin/clavulanic acid, macrolides, and double-strength sulfamethoxazole/trimethoprim are all appropriate first-line choices (Rabe et al, 2007). Resistant organisms require selection of an antibiotic agent based on susceptibilities. Patients who don't respond to first-line therapy should be treated with a respiratory fluoroquinolone (levofloxacin, moxifloxacin, gemifloxacin). The length of treatment is 7 to 14 days.

monitor effectiveness of drugs

Passive monitoring occurs when the patient is educated on the expected outcome of the drug therapy and is instructed to contact the provider if the treatment is not effective or if adverse drug effects occur. This is common when short-term treatment, such as an antibiotic, is prescribed, and no test of cure is required. Active monitoring occurs when the provider schedules a follow-up examination to determine the effectiveness of the drug therapy (de Vries et al, 1994). Active monitoring may include evaluating therapeutic blood levels and making dosage adjustments, as is necessary in anticoagulant therapy or patients taking an antiseizure medication. Active monitoring may also include adding or subtracting medications from the treatment regimen based on the effectiveness of the treatment.

drug interactions with CNS depressants

Patients may be aware that their prescription medication may cause sedation, but they may not be aware of the additive central nervous system (CNS) sedating effects of OTC medication taken with their prescribed medication. Over-the-counter medications that contain alcohol, antihistamines, antitussives, or antidiarrheals may all cause additive sedation when taken with CNS-sedating medications.

Beta-lactams

Penicillins Cephalosporins Carbapenems Monobactams

Influences on Rational Prescribing

Pharmaceutical promotion May influence prescribing When Prescribing Recommendations Change When guidelines change, providers may need to be coached or reeducated regarding appropriate prescribing

pharyngitis: recommended for GABHS alternative for PCN allergic

Pharyngitis is usually caused by a virus, and concurrent rhinorrhea, cough, hoarseness, conjunctivitis, and diarrhea strongly suggest this etiology. Most bacterial pharyngitis is self-limiting and will subside without sequelae (AAP, 2012a; Shulman et al, 2012). The exception is that caused by group A beta-hemolytic streptococci (GABHS; Streptococcus pyogenes), which is associated with rheumatic fever if not treated (Shulman et al, 2012). The risk of rheumatic fever is now so rare in the United States that 3,000 to 4,000 patients with GABHS would need to be treated to prevent a single case (Thomas, 2005). An antigen detection ("rapid strep") test should be used to confirm the diagnosis, with negative results confirmed by throat culture. Antibiotics have no effect on the clinical course of patients with negative cultures. Antibiotic therapy started within 9 days of onset will prevent rheumatic fever (AAP, 2012a; Shulman et al, 2012). Treatment for GABHS pharyngitis is best managed with narrow-spectrum agents. Due to consistent susceptibility, penidcillin remains the first choice in both adults and children (AAP, 2012a; Shulman et al, 2012). Penicillin V 250 mg 2 to 3 times a day for children weighing less than 27 kg (60 lb) and 500 mg 2 to 3 times a day for patients weighing more than 27 kg, including adolescents and adults, is recommended (AAP, 2012a; Shulman et al, 2012). To prevent acute rheumatic fever, penicillin should be given for 10 days, even if the patient is afebrile and asymptomatic (AAP, 2012a). Treatment failure is more likely with oral penicillin than IM penicillin G benzathine (AAP, 2012a). Due to the poor taste of the oral penicillin V solution, amoxicillin 50 mg/kg/d in one dose (maximum 1,000 mg/d) for 10 days may be used in children. If nonadherence is anticipated, penicillin G benzathine as a single IM dose of 1.2 million U for patients weighing greater than 27 kg, or 600,000 U for those under 27 kg, is recommended (AAP, 2012a; Shulman et al, 2012). For patients who are allergic to penicillin, first-generation cephalosporins (cephalexin) or a macrolide (clarithromycin, azithromycin) may be substituted.

How drugs are developed

Phase 1 - first use of a new drug or a new drug indication in humans; tests for safety and side effects and establishes dosing for future trials; Phase 2 - therapy tested in larger number of patients to determine how well it works and other less common side effects. Phase 3 - treatments compared to common or standard therapies; patients randomized to receive trial drug or standard therapy; determines whether experimental therapy is more beneficial Phase 4 - performed after a drug has been shown to work and been granted a license so these involve drugs already available for doctors to prescribe! main purpose is to find out more about the side effects and safety of the drugs and more wide-spread use

New Drug Approval Process including clinical phase

Requires safety and efficacy of drugs brought to market. Phase 1 - first use of a new drug or a new drug indication in humans; tests for safety and side effects and establishes dosing for future trials; Phase 2 - therapy tested in larger number of patients to determine how well it works and other less common side effects. Phase 3 - treatments compared to common or standard therapies; patients randomized to receive trial drug or standard therapy; determines whether experimental therapy is more beneficial Phase 4 - performed after a drug has been shown to work and been granted a license so these involve drugs already available for doctors to prescribe! main purpose is to find out more about the side effects and safety of the drugs and more wide-spread use

H. Pylori Eradication therapy

Resistance: Develops quickly to Flagyl and Biaxin Does not develop quickly to amoxicillin or tetracycline Combo options: 2 antibiotics+ PPI or bismuth Antral gastritis and peptic ulcer of the stomach or duodenum are associated with colonization of H. pylori; 95% to 100% of duodenal ulcers are colonized by this organism. Once colonized, it remains in the body for life unless eradicated by antibiotics. Eradication of the organism decreases recurrence of ulcer and promotes resolution of gastritis. Although there are many treatment regimens for H. pylori eradication, treatment with amoxicillin 1 g given twice daily for 10 to 14 days in combination with two other drugs is standard therapy (Lew, 2009). Because there is greater than 90% eradication with 7-day therapy with these combinations, selective pressure for resistance and adverse effects are reduced by limiting therapy to 1 week. Other antimicrobials used in H. pylori eradication include clarithromycin, metronidazole, tetracycline, and bismuth subsalicylate. Some experts recommend H. pylori eradication prior to initiation of NSAIDs to prevent NSAID-induced peptic ulcers, but further research is needed to confirm the efficacy of this strategy. Further discussion of H. pylori eradication is found in Chapter 34, and four treatment protocols are found in Table 34-6.

OTC Medication sales

Sales of OTC medications reported by the Consumer Healthcare Products Association were $33.1 billion in 2013 (Consumer Healthcare Products Association [CHPA], 2014a). CHPA data can be used to determine the common physical complaints patients self-treat with OTC medications. Over $4 billion was spent on cough and cold medications in 2008, representing the highest sales category (CHPA, 2014b.) Internal analgesics represented $3.99 billion in 2013 sales, indicating acute and chronic pain were common self-treated conditions. Self-treatment of heartburn led to $2.28 billion in sales of heartburn remedies in 2013, doubling in 5 years as multiple proton pump inhibitors became OTC. Other conditions commonly treated by OTC medications include constipation ($1.3 billion), acne ($617 million), and diarrhea ($225 million). Nicotine replacement products used for tobacco cessation represented $855 million in sales in 2013 (CHPA). The CHPA proposes that every dollar spent on OTC medications by consumers saves the U.S. health-care system $6 to $7, based on cost savings in clinical visits and drugs

Controlled drug DEA schedules (Table 4-1)

Schedule Controls Required Drug Examples I No accepted medical use No legal use permitted For registered research facilities only Heroin, LSD, mescaline, peyote, marijuana* II No refills permitted No telephone orders unless true emergency and followed up by written prescription within 7 days Electronic prescribing permitted as of 2011 with specific software and secure identification processes Narcotics (morphine, codeine, meperidine, opium, hydromorphone, oxycodone, oxymorphone, methadone, fentanyl) Stimulants (cocaine, amphetamine, methylphenidate) Depressants (pentobarbital, secobarbital) III Prescription must be rewritten after 6 mo or 5 refills Telephone or fax prescription okay Narcotics (codeine in combination with non-narcotic ingredients not to exceed 90 mg/tab; hydrocodone not to exceed 15 mg/tab) Stimulants (benzphetamine, chlorpheniramine, diethylpropion) Depressants (butabarbital) Anabolic steroids, testosterone IV Same as Schedule III Penalties for illegal possession are different Pentazocine, phentermine, benzodiazepines, meprobamate V Same as all prescription drugs May be dispensed without a prescription unless regulated by the state Loperamide, diphenoxylate Cough medications with less than 200 mg/100 mL Pregabalin *Marijuana may be classified under individual state law as a Schedule II drug and used for medical purposes. It may not be "prescribed," however.

Teracyclines

Tetracyclines are an old class of antibiotics. They got their name for their chemical structure which contains four hexagonal rings. Tetracyclines are derived from a species of Streptomyces bacteria. Tetracycline antibiotics are bacteriostatic agents and work by inhibiting the bacterial protein synthesis via interaction with the 30S subunit of the bacterial ribosome. Tetracyclines are effective against a wide variety of microorganisms, including spirochetes, atypical bacteria, rickettsia, and amebic parasites. Current applications of tetracyclines include treatment of peptic ulcer disease as part of a multi-drug regimen, infections of the respiratory tract, cholera, Rocky Mountain spotted fever, Lyme disease, typhus, prophylaxis of traveler's diarrhea, malaria prophylaxis. Their most common current use is in the treatment of acne vulgaris and rosacea. Tetracycline antibiotics are: doxycycline minocycline oxytetracycline tetracycline Tetracyclines side effects Common side effects associated with tetracyclines include stomach cramps, diarrhea, nausea, vomiting, esophageal ulceration, sore mouth or tongue. Tetracyclines can cause skin photosensitivity, which increases the risk of sunburn under exposure to UV light. This may be of particular importance for those intending to take on holidays long-term doxycycline as a malaria prophylaxis. Rarely, tetracyclines may cause allergic reactions. Very rarely severe headache and vision problems may be signs of dangerous secondary intracranial hypertension. Tetracycline antibiotics should not be used in children under the age of 8, and specifically during periods of tooth development. Tetracyclines are classed as pregnancy category D. Tetracyclines may cause the gray to yellow discoloration of actively forming teeth and deposition in growing bones.

US FDA Regulatory Jurisdiction

The FDA regulatory jurisdiction over drugs encompasses the standardization of nomenclature, the approval process for new drugs and new indications, official labeling, surveillance of adverse drug events, and methods of manufacture and distribution (FDA, 2012). The classification of a drug as a prescription or nonprescription medication is a matter of federal law. Products labeled with the legend "Caution: Federal law prohibits dispensing without a prescription" are regulated by the FDA and are referred to as legend drugs. The FDA also regulates medical and electronic devices that meet criteria under the 1976 Medical Devices Amendment of the Food, Drug, and Cosmetic Act (FDA, 2012). Examples of medical and electronic devices include ultrasound imaging equipment, artificial joints, and HIV testing kits.

Nurse practitioner prescriptive authority is regulated by: 1. The National Council of State Boards of Nursing 2. The U.S. Drug Enforcement Administration 3. The State Board of Nursing for each state 4. The State Board of Pharmacy

The State Board of Nursing for each state

Overview of non adherence

Those at highest risk include patients who have asymptomatic conditions, chronic conditions, cognitive impairment, psychiatric illness, or disorders requiring significant lifestyle changes (e.g., smoking cessation) and those who are on complex regimens with multiple daily dosing and significant adverse reactions. When patients' interactions with the provider include poor communication the risk of nonadherence is even higher. Nonadherence to pharmacological regimens can lead to failure to reach the desired treatment goal, which may be very costly. Patients who stop using their drugs have more complications from their disease, which results in total increased cost for themselves and the health-care system.

drug interactions of ASA

The cyclooxygenase inhibitors, including aspirin and the NSAIDS ibuprofen and naproxen, have a well-documented risk of gastrointestinal bleeding. When combined with antiplatelet or anticoagulant medications, the risk is significantly increased and may be life-threatening. Patients who are taking antiplatelet or anticoagulant medications should be educated to not take any OTC medication without consulting with a pharmacist or their provider.

Controlled Substances Act

The federal law giving authority to the Drug Enforcement Administration to regulate the sale and use of drugs.

Cytochrome P450

The general name for a large class of enzymes that play a significant role in drug metabolism and drug interactions.

first pass effect

The initial metabolism in the liver of a drug absorbed from the gastrointestinal tract before the drug reaches systemic circulation through the bloodstream.

macrolides precautions and contradictions

The macrolides are another early antibiotic group. The prototype drug in this group, erythromycin, was discovered in 1952. The drugs in the class (erythromycin, clarithromycin [Biaxin], dirithromycin [Dynabac]) are compounds characterized by a macrocyclic lactone ring with deoxy sugars attached. A closely related drug, azithromycin (Zithromax), is chemically an azalide derived from erythromycin by the addition of a methylated nitrogen to the lactone ring. The latest addition to this group is telithromycin (Ketek), which is chemically a ketolide derived from erythromycin by the lack of alpha-L-cladinose at position 3 on the erythronolide A ring. They are generally included with the macrolide group and are discussed in the same section here. In addition to their antibiotic activity, macrolides exhibit immunomodulating properties, which increase their usefulness in infectious diseases and cystic fibrosis

Macrolides adverse drug reactions

The most common adverse reactions to macrolides are dose-related GI symptoms, including nausea, vomiting, abdominal pain, cramping, and diarrhea. Taste disturbances have been reported with clarithromycin. In general, these reactions are transient, mild to moderate in severity, and reversible when the drug is discontinued. Erythromycin is most likely to cause GI symptoms whether given orally or parenterally because it stimulates the motilin receptor in the GI tract. An off-label use of erythromycin for the treatment of gastroparesis derives from this receptor activity. Diarrhea may also be secondary to CDI. Azithromycin, erythromycin, and telithromycin have been associated with liver abnormalities, including hepatitis, cholestatic jaundice, and hepatic failure. Erythromycin has been associated with urticaria, bullous eruptions, eczema, and Stevens-Johnson syndrome. Allergic reactions have been reported with all available macrolides. Isolated cases of reversible hearing loss have also been reported with erythromycin, clarithromycin, and azithromycin, particularly with parenteral administration or high doses. Hyperkinesia, dizziness, and agitation have occurred in fewer than 1% of children taking azithromycin. Stomatitis, dry mouth, and dysphagia have occurred in a small number of adults for all macrolides. Laboratory abnormalities include elevated liver function studies (azithromycin), increased platelet counts (dirithromycin and erythromycin) and elevated potassium levels (dirithromycin). In each case, less than 6% of patients were affected.

Influence of diet on pharmacokinetics

The most frequent type of drug-food interaction is the effect that food has on the gastrointestinal (GI) absorption of drugs. Drug absorption can be decreased, delayed, accelerated, or increased by food. The rate of drug metabolism in both the GI tract and the liver is affected by nutrient intake. A low-carbohydrate, high-protein diet may increase drug-metabolizing enzymes. Increasing intake of antioxidant cruciferous vegetables may increase the activity of these enzymes. Clinically, we see examples of the effect of foods on metabolism daily, as unexplained variability in drug response or therapeutic drug levels. The cytochrome P450 (CYP450) system is the major enzyme group responsible for the metabolism of foreign chemicals that come into the body. Information is expanding about the clinically significant interactions between nutrients and drugs utilizing the CYP450 enzyme system. In addition, the CYP450 system has a significant amount of polymorphism associated with it; that is, there are between-individuals differences in the presence and/or function of a particular enzyme group. This difference reinforces the need to understand the nutrient effect on metabolizing enzymes. Grapefruit juice influences the metabolism of many drugs because it contains components that inhibit CYP3A4, leading to alterations in the metabolism of drugs. Studies have determined that it is the furanocoumarins in the grapefruit juice that have been identified as CYP3A4 inhibitors, decreasing the first-pass metabolism of drugs. Other foods or beverages that influence drug oxidation or conjugation reactions include indolic compounds in vegetables (cruciferous), methylxanthine-containing beverages (caffeine), and charcoal broiling. Cruciferous vegetables induce CYP1A2, an enzyme responsible for the metabolism of many drugs including theophylline. Patients who consume large amounts of cruciferous vegetables may have therapeutic failure if they are being treated with drugs that are metabolized by CYP1A2 (Peterson et al, 2009). Apiaceous vegetables (carrots, parsnips, celery or parsley family) inhibit CYP1A2 activity (Peterson, Lampe, Bammler, Gross-Steinmeyer, & Eaton, 2006). Tobacco smoking and charcoal-broiled meat induce CYP1A2 due to their high concentrations of olycyclic aromatic hydrocarbons (Larsen & Brosen, 2005). Patients will need to be educated regarding intake of foods that induce CYP1A2 if they are on a medication with a narrow therapeutic index, such as theophylline.

Ethical aspects of prescribing

The notion of informed consent is shorthand for the doctrine of informed decision making, which proposes that patients have the right to make informed decisions about those things that will affect them. Although some question whether consent to medical procedures can ever be truly informed, the doctrine has been assimilated into American society's concept of what clinical practice should include. Informed consent should be obtained from a patient before all medical interventions, diagnostic as well as therapeutic. A patient may either agree to or refuse a proposed intervention; in both situations, the patient is making her or his own informed decision

outcomes of nutrition drug interactions

The physiological and cellular basis for nutrient-drug interactions is strong. However, it is the outcome of the interaction that takes the spotlight. Does the interaction cause a change in the expected outcome of drug therapy or a nutrient deficiency that enhances the potential for adverse reactions or disease progression? Clinically, practitioners often overlook this area. If the expected outcome of drug therapy is not occurring or the adverse reaction profile is enhanced, the practitioner must know the key questions to ask to determine what is happening. It should be clear that a piece of the data needed is related to food and nutrient intake. Could the patient who became pregnant on the low-estrogen birth control pill have a reduction in drug bioavailability owing to food intake? Is the antidepressant not working secondary to high caffeine intake? Is the digoxin (Lanoxin) serum level low because of an aggressive bowel care program with high-fiber intake? And even more important, did the change in dietary fiber intake contribute to the digoxin toxicity the patient is experiencing? An example of a food-drug interaction is one that occurs between warfarin and vitamin K-containing foods. Patients who are taking warfarin should not ingest foods high in vitamin K, as the combination may lead to therapeutic failure. Patients taking warfarin need to be educated regarding the vitamin K content of foods (Table 9-1). Warfarin and vitamin K interactions are further discussed in Chapter 18. A high intake of food containing tyramine can result in enhanced norepinephrine synthesis—which can be problematic if the same patient is taking drugs that increase norepinephrine availability at the neurological synapse. For example, the adverse effect of acute hypertension associated with the use of monoamine oxidase inhibitors (MAOIs) is enhanced by intake of foods high in tyramine. The inhibition of aldehyde dehydrogenase by metronidazole results in a disulfiram-like reaction—flushing, headache, nausea, and abdominal or chest pain—when it is taken with alcohol or alcohol-containing products because of alteration in the alcohol metabolism. Food contains many highly interactive ingredients that can have an impact on drug therapy. For example, the use of caffeine with known central nervous system (CNS) effects is problematic for patients utilizing psychotropic medications. The ability to manage the mental health problem becomes a challenge when high or variable levels of caffeine are consumed. Sorbitol, a common ingredient in sugar-free foods, has a significant effect on GI transit time and thus can influence the absorption of both drugs and nutrients. Alcohol consumption is also associated with significant drug interaction problems. Alcohol can either induce or inhibit the CYP450 system enzymes, depending on the ingestion pattern. Chronic low levels cause enzymatic induction, whereas high binge intake or high chronic use, resulting in hepatic failure, inhibits the metabolizing enzymes. Therefore, the provider needs to know the patient's specific level of alcohol consumption to better understand the potential for interaction with drugs.

drug interactions with anticholinergics

The primary adverse effects of diphenhydramine and doxylamine are anticholinergic, such as dry mouth, constipation, blurred vision, and tinnitus. Older male patients may have difficulty in urinating. These effects may be additive with the anticholinergic effects of other drugs that are being taken. Older patients may develop delirium from modest doses of diphenhydramine.

Severity of ARDS

The severity of an adverse drug reaction varies based on the clinical effect and the outcome. The FDA defines serious ADRs as those that result in death, are life-threatening, result in hospitalization (new or prolonged), are disabling or incapacitating, produce congenital abnormality or birth defect, or require an intervention to prevent one of these outcomes. Any ADR that meets FDA criteria should be reported to the FDA MedWatch program (FDA, 2013). In this chapter, the severity of ADRs will be further categorized as mild, moderate, and severe. Mild adverse events can typically be managed by dose reduction, discontinuation of the drug, or with no intervention if the reaction subsides following development of tolerance by the patient (Aronson & Ferner, 2003; FDA, 2013;). Moderate adverse events often require discontinuation of the drug and minimal medical intervention but typically do not cause permanent harm. An example of a moderate adverse reaction is drug-induced sunburn requiring an analgesic to treat the pain. Severe ADRs may be life-threatening and result in hospitalization, disability, birth defects, or even death and will require intensive medical intervention (FDA, 2013)..

Mechanistic classification of ADRs including types of immune mediated ADRs and Type A-F

There are two basic types of ADRs: pharmacological and idiosyncratic 1. Pharmacological ADRs are more common and comprise approximately 85% to 90% of reported ADRs (Pirmohamed et al, 1998). These reactions are often an exaggerated physiological response related to the pharmacology of the drug, for example, hypotension from the beta blocker metoprolol, diarrhea from the fat-blocking drug orlistat, and insomnia from the stimulant methylphenidate. These adverse reactions are often managed by withdrawing the medication or reducing the dose. 2. idiosyncratic reactions are concerning because they are unpredictable, often serious, and may result in death. Idiosyncratic reactions are mediated by the immune system, receptor abnormalities, drug-drug interactions, abnormalities in drug metabolism, pharmaceutical variations, or unmasking of an abnormal biological system. Most commonly, idiosyncratic reactions are mediated by the immune system when a drug molecule is recognized as a foreign substance Type I IgE-mediated, immediate-type hypersensitivity Example: angioedema and anaphylaxis Type II Antibody-dependent cytotoxicity Example: heparin-induced thrombocytopenia Type III Immune complex hypersensitivity Example: Arthus reaction to tetanus vaccine Type IV Cell-mediated or delayed hypersensivity Example: Drug Rash, Eosinophilia and Systemic Syndrome ADRs have also been categorized as Types A-F. Type A reactions are equivalent to pharmacological reactions, account for 85% to 90% of ADRs, are dose-dependent, and are predictable, whereas Type B reactions are idiosyncratic, account for 10% to 15% of ADRs, are not dose-dependent, and are not predictable (Rawlins, 1981). Adverse reactions have been further stratified by letters C through F. Type C reactions result from chronic medication use, Type D reactions are delayed, Type E reactions are from drug-drug interactions, and Type F reactions result from treatment failures.

Keys to effect patient education

To be effective, patient education must: •Be simple and focus on the critical points. What does the patient need to know to take this drug safely? •Use language that is clear and understandable to the patient. This does not just mean "English versus Spanish," for example; it means reduced "medicaleze." It is important not to talk down to people who do understand the medical terms; however, never assume patients do or do not understand terms used. Likewise do not assume that a fellow health-care worker does not have knowledge deficits. •Be in a form the patient can refer to as needed after the contact with the provider, such as an after-visit summary. Zagaria (2008) found many prepackaged materials are written at the 12th-grade reading level at least. Most patients read medical information at or below the 6th-grade reading level, and some do not read at all and are too embarrassed to tell the provider. •Be in the order of use or preparation if steps therapy is used. •Be inclusive of the family and caregivers. Health behaviors are learned and reinforced with the family, so a family-centered approach (Mahat et al, 2007; Tyler & Horner, 2008) that engages and supports parents and children has a better chance of improving adherence.

Nutraceuticals ****(need to add more)

a food containing health-giving additives and having medicinal benefit. As noted previously, nutraceuticals are foods that claim to have a medicinal effect on health. Nutraceuticals may also be referred to as functional foods, but the terms are not interchangeable; functional foods are foods that have health benefits, whereas neutraceuticals include dietary supplements (Crowe & Francis, 2013). There are five major categories of nutraceuticals used routinely in primary care: dietary fiber; vitamins and minerals; bioactive substances; fatty acids; and pre-, pro-, and symbiotics. The list of nutraceuticals reviewed here is not exhaustive and is limited to those for which there are adequate safety and efficacy data to recommend their use.

UTIs

Urinary tract infections (UTIs) are responsible for 8.27 million (1.41 million men; 6.86 million women) office visits per year (Litwin & Saigal, 2007). E. coli is responsible for 85% of community-acquired UTIs and 50% of hospital-acquired UTIs. Empirical treatment with trimethoprim/sulfamethoxazole (TMP/SMX, Septra, Bactrim) or nitrofurantoin are the first-line choice when no complicating factors are present (Gupta et al, 2011). Amoxicillin-clavulanate for 3 to 7 days can be prescribed as therapy to patients who are allergic to first-line drugs (Gupta et al, 2011). Because of its safety profile, amoxicillin/clavulanate 500 mg twice daily for 3 to 5 days is an acceptable therapy for treating asymptomatic bacteriuria or UTI during pregnancy (Hooton & Stamm, 2010). Up to 25% to 70% of E. coli is resistant to amoxicillin; therefore, it should not be used as first-line therapy unless patient factors warrant its use.

Sulfamides & trimethoprim: Interactions

Use cautiously in patients with impaired kidney function, older adults taking ACE inhibitors or angiotension II receptor blockers, do not give if patient has folate deficiency, increased effects with anticoagulants, oral hypoglycemics, phenytoin.

health literacy

a person's capacity to learn about and understand basic health information and services, and to use these resources to promote one's health and wellness

Patient Education

a process of assisting people to learn health-related behaviors so that they can incorporate these behaviors into everyday life. Patient education regarding the purpose of the medication, instructions for administration, and potential adverse drug effects will improve adherence to the medication regimen. Patient education should be tailored to the patient and presented in plain language (fifth- or sixth-grade-reading level), with an understanding that nine out of 10 adults have difficulty reading health information

blood dyscrasia

any pathologic condition of the cellular elements of the blood

Excretion of drugs

drugs and their metablosim are excreted through sweat, saliva, and secretions primarily through kidneys

Ethnopharmacology

study of the effect of ethnicity on responses to prescribed medication, especially drug absorption, metabolism, distribution, and excretion

State the three (3) most important characteristics of any drug

effectiveness, safety and selectivity

Macrolides

erythromycin, clarithromycin, azithromycin

Abuse of OTC Drugs

generally have a greater margin of safety than their prescription counterparts, but issues of abuse need to be considered. Physical dependence. Psychological dependency Nonprescription products that can be quite habit-forming: decongestants, laxatives, antihistamines, sleep aids, and antacids.

antimicrobial resistance

occurs when pathogens undergo changes that allow them to resist antimicrobials - become resistant to common medicine. Factors that contribute to this phenomenon include increasing populations of immunocompromised patients, increases in the number and complexity of invasive medical procedures, and increased survival of patients with chronic diseases. Spread of resistant organisms in the community has been associated with day care for young children, overcrowding, travel, and the use of antibiotics in agriculture

labeling vs. off label use of drugs

off labeling - involves prescribing currently available and marketed meds for an indication that has never received FDA approval labeling - A drug label refers to all the printed information included with any dietary supplement, over-the-counter medicine, or prescription drug. They're strictly regulated by the Food and Drug Administration and provide plenty of useful information savvy healthcare investors use to evaluate a company's products

Roles and Responsibilities of APRN Prescribers

responsibility of the final decision on which drug to use and how to use it is in the hands of the APRN prescriber. Summary of role: prevent, diagnosis, prescription, treatment.