Coeliac Disease Overview

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Questions and Answers

Which of the following statements about coeliac disease is NOT true?

The only effective treatment is a strict, gluten-free diet supplemented with over-the-counter vitamins and mineral supplements.

Which of the following is NOT a risk associated with coeliac disease?

Increased risk of developing type 2 diabetes.

What is the recommended treatment for refractory cases of coeliac disease?

Referral to a specialist center, with prednisolone.

Which of the following statements about the treatment of coeliac disease is correct?

<p>The treatment aims to eliminate symptoms and reduce the risk of complications through a strict, lifelong, gluten-free diet.</p> Signup and view all the answers

Which of the following statements about the gluten-free products for coeliac disease is correct?

<p>They are available for prescription by healthcare professionals.</p> Signup and view all the answers

What is the advised action if tuberculosis is diagnosed during vedolizumab treatment?

<p>Discontinue vedolizumab until infection is resolved</p> Signup and view all the answers

What is a common side effect of Vedolizumab?

<p>Night sweats</p> Signup and view all the answers

What is the advised period for effective contraception during and after Vedolizumab treatment?

<p>At least 18 weeks after treatment</p> Signup and view all the answers

When should patients be brought up to date with their immunisation schedule?

<p>Before initiating Vedolizumab treatment</p> Signup and view all the answers

Which organization has recommended Vedolizumab for treating moderately to severely active Crohn's disease after prior therapy?

<p>National Institute for Health and Care Excellence (NICE)</p> Signup and view all the answers

What should be done after each administration of Vedolizumab according to the text?

<p>Record the brand name and batch number</p> Signup and view all the answers

How should intravenous infusion of Entyvio® be given?

<p>Reconstitute in water for injection and gently swirl</p> Signup and view all the answers

What monitoring requirements are recommended during Vedolizumab treatment?

<p>Monitoring infection before, during, and after treatment</p> Signup and view all the answers

What is the advisory regarding pregnancy during Vedolizumab treatment?

<p>Pregnancy is advised only if potential benefit outweighs risk</p> Signup and view all the answers

What action is advised in relation to breastfeeding while taking Vedolizumab?

<p>Breastfeeding is indicated with caution</p> Signup and view all the answers

Which of the following is NOT considered a psychological factor contributing to constipation?

<p>Anxiety</p> Signup and view all the answers

Which of the following is the LEAST common symptom of constipation described in the Rome I criteria?

<p>Incomplete evacuation</p> Signup and view all the answers

Which of the following best explains why the prevalence of constipation is difficult to determine?

<p>Changes in health-seeking behavior can affect the reported prevalence</p> Signup and view all the answers

Which of the following is the MOST significant risk factor for constipation according to the text?

<p>Older age</p> Signup and view all the answers

What is the primary therapeutic strategy for constipation mentioned in the text?

<p>Physical activity and dietary intervention</p> Signup and view all the answers

Which of the following is a key diagnostic criteria for functional constipation?

<p>Presence of symptoms for at least 6 months with onset at least 6 months prior</p> Signup and view all the answers

What is the primary factor contributing to slow transit constipation?

<p>Decreased propulsive motor activity in the colon</p> Signup and view all the answers

Which of the following is NOT a factor contributing to constipation?

<p>High fiber diet</p> Signup and view all the answers

What is the primary characteristic of functional constipation?

<p>No underlying cause</p> Signup and view all the answers

What is a significant minority of patients with chronic constipation likely to become reliant on?

<p>Stimulant laxatives in high doses</p> Signup and view all the answers

What is the primary advantage of polyethylene glycol (PEG) as a laxative?

<p>All of the above</p> Signup and view all the answers

Which of the following statements about osmotic laxatives is NOT true?

<p>They target the underlying cause of constipation</p> Signup and view all the answers

For functional constipation without a known cause, what is the recommended therapy?

<p>Fiber supplementation</p> Signup and view all the answers

Which of the following fiber supplements is considered the most effective for treating chronic constipation?

<p>Psyllium or ispaghula husk</p> Signup and view all the answers

What is the primary limitation of fiber supplementation in treating chronic constipation?

<p>It is unlikely to directly benefit abdominal pain associated with constipation</p> Signup and view all the answers

What is a major source of demand for laxative drugs from a public health perspective?

<p>Chronic constipation</p> Signup and view all the answers

What is the primary goal of the AED tool featuring structured open-ended questions?

<p>To help patients express the impact of ED on their daily lives in their own words</p> Signup and view all the answers

What is the primary focus of the studies on erectile dysfunction across six Asian countries?

<p>Examining the common causes and effects of ED in elderly men</p> Signup and view all the answers

What is the primary interpersonal effect on male sexual function mentioned in the text?

<p>Sexual problems with a man's partner</p> Signup and view all the answers

What is the primary psychological problem associated with ED mentioned in the text?

<p>Depressive symptoms</p> Signup and view all the answers

What is the primary advantage of patient-centered and self-directed care for patients with ED?

<p>Improved patient-doctor communication</p> Signup and view all the answers

What is the primary reason education and counseling are important clinical strategies for patients with ED?

<p>To enhance patient self-management</p> Signup and view all the answers

What percentage of men reported ED onset while using medications for hypertension?

<p>7%</p> Signup and view all the answers

What is the success rate of suppositories in treating ED?

<p>20-40%</p> Signup and view all the answers

What is the primary advantage of oral drug therapy in treating ED?

<p>It delivers an erection that can be lasting and sufficient for coitus</p> Signup and view all the answers

What is the success rate of injection therapy in treating various forms of ED?

<p>35-75%</p> Signup and view all the answers

What is the purpose of the constriction ring in Vacuum Suction Devices (VSD)?

<p>To maintain the erection</p> Signup and view all the answers

What is the number of patients reported to undergo procedures for penile prosthesis implantation between July 1993 and November 2009?

<p>2000</p> Signup and view all the answers

What is a crucial primary and adjunctive therapy in various disease states?

<p>Parenteral nutrition</p> Signup and view all the answers

What is a lifeline for patients with permanent loss of the GI tract?

<p>Parenteral nutrition</p> Signup and view all the answers

What can result from improperly prepared and administered PN formulations?

<p>Serious harm and death</p> Signup and view all the answers

What led to a FDA Safety Alert?

<p>Two deaths due to errors in PN compounding</p> Signup and view all the answers

What was misinterpreted on the label of a PN formulation used in homecare?

<p>Dextrose content</p> Signup and view all the answers

What was the consequence of the misinterpretation in homecare?

<p>A pediatric patient's death</p> Signup and view all the answers

What was the consequence of pharmacy-compounding operations for pediatric dextrose solutions?

<p>Two fatal incidents</p> Signup and view all the answers

What is a characteristic of PN formulations?

<p>Complex admixtures containing 40 or more components</p> Signup and view all the answers

What is a common error related to the preparation of Parenteral Nutrition (PN) admixtures?

<p>All of the above</p> Signup and view all the answers

What is the primary benefit of standardized PN order forms?

<p>Reduce prescribing errors</p> Signup and view all the answers

What is the most common PN component associated with errors?

<p>Electrolytes</p> Signup and view all the answers

What is a potential consequence of misinterpretation of a PN label?

<p>Iron overload and liver toxicity</p> Signup and view all the answers

What is a common source of contamination in PN admixtures?

<p>Disposable tubing</p> Signup and view all the answers

What is a benefit of standardized PN order forms in terms of cost?

<p>Decrease in cost</p> Signup and view all the answers

What is a common error related to the administration of PN?

<p>All of the above</p> Signup and view all the answers

What is the primary goal of the 'Safe Practices for Parenteral Nutrition' document?

<p>To reduce the risk of PN-associated errors</p> Signup and view all the answers

What is a common consequence of PN-associated errors?

<p>Patient harm</p> Signup and view all the answers

What is the primary benefit of physician education related to PN therapy?

<p>Reduce prescribing errors</p> Signup and view all the answers

What is the primary purpose of standardizing PN solutions?

<p>To improve patient safety by minimizing errors</p> Signup and view all the answers

What is a common factor associated with the majority of PN prescribing errors?

<p>Inadequate knowledge regarding PN therapy</p> Signup and view all the answers

What is the recommended frequency for reviewing and updating PN order forms?

<p>Daily</p> Signup and view all the answers

What is the primary benefit of using a standardized PN order form?

<p>Improving patient safety by minimizing errors</p> Signup and view all the answers

What is the recommended time frame for submitting PN orders for pharmacy processing?

<p>At least 24 hours in advance</p> Signup and view all the answers

What is the recommended maximum preparation and hang time for PN solutions that are not refrigerated?

<p>30 hours</p> Signup and view all the answers

What is the primary purpose of including contact information for the person writing the PN order on the PN order form?

<p>To clarify unclear or inappropriate orders</p> Signup and view all the answers

What is the recommended approach to reducing errors in PN prescribing?

<p>All of the above</p> Signup and view all the answers

What is the primary benefit of using a standardized PN order form as an educational tool for prescribers?

<p>Improving patient safety by minimizing errors</p> Signup and view all the answers

What is the recommended approach to minimizing errors in PN prescribing?

<p>All of the above</p> Signup and view all the answers

What is the primary reason for including the location of the venous access device on the PN order form?

<p>To assure appropriate venous access for the osmolarity of the PN formulation</p> Signup and view all the answers

What is the estimated osmolarity of a PN formulation containing 170g of dextrose, 60g of amino acids, 20g of fat emulsion, and 243mEq of electrolytes?

<p>1707 mOsm/L</p> Signup and view all the answers

Why is it essential to specifically address calcium and phosphorus compatibility on the PN order form?

<p>To prevent patient harm or death from calcium phosphate precipitates</p> Signup and view all the answers

What is the purpose of including a general statement warning of the potential for PN formulation incompatibilities on the PN order form?

<p>To alert prescribers to potential formulation incompatibilities</p> Signup and view all the answers

What is the primary benefit of including institutional policy for maximum or minimum nutrient hang times on the PN order form?

<p>To prevent patient harm from nutrient dosing errors</p> Signup and view all the answers

Why is knowledge of patient dosing weight vital in assessing nutrient needs?

<p>To identify nutrient dosing errors, especially in the pediatric population</p> Signup and view all the answers

What is the primary purpose of including guidelines for stopping or tapering of PN on the order form?

<p>To prevent rebound hypoglycemia and ensure patient safety</p> Signup and view all the answers

What is the primary benefit of including example calculations to guide prescribers in determining patient-specific total calories, protein, fluid, and electrolyte requirements?

<p>To simplify the ordering process for prescribers</p> Signup and view all the answers

What is the primary purpose of including specific guidelines for the use of insulin on the PN order form?

<p>To address insulin requirements in patient-specific PN formulations</p> Signup and view all the answers

What is the primary benefit of including institutional policy for maximum dextrose infusion rate or IVFE infusion rate on the PN order form?

<p>To prevent patient harm from excessive dextrose or IVFE infusion rates</p> Signup and view all the answers

What is the primary purpose of identifying persons involved in reviewing the order, other than the prescriber and the pharmacist?

<p>To ensure ease of contact and continuity</p> Signup and view all the answers

What is the recommended duration of PN therapy in acute care institutions?

<p>10-14 days</p> Signup and view all the answers

What is the purpose of including guidelines for nutrient restriction or supplementation in various disease states?

<p>To follow published clinical guidelines</p> Signup and view all the answers

What is the primary advantage of using grams of base components per liter in PN labeling?

<p>It simplifies the conversion of nutrients to calorie and gram doses</p> Signup and view all the answers

What is the consequence of misinterpretation of a PN label?

<p>Patient death</p> Signup and view all the answers

What is the primary reason for standardizing PN labeling?

<p>To avoid misinterpretation of PN labels</p> Signup and view all the answers

What is the primary benefit of guidelines for long-term PN administration?

<p>They provide recommendations for monitoring or supplementation</p> Signup and view all the answers

What is the purpose of providing guidelines for the use of specialty amino acids?

<p>To ensure the utility of specialty amino acids</p> Signup and view all the answers

What is the primary advantage of pharmacist-to-pharmacist interaction when patients are transferred between healthcare environments?

<p>It resolves potential problems with transfer of the prescription</p> Signup and view all the answers

What is the primary benefit of using the percent of final concentration of dextrose, amino acids, or IVFE in PN labeling?

<p>It is consistent with the label of original commercial products</p> Signup and view all the answers

What is the unit of measurement for phosphorus content in PN formulations?

<p>mmol</p> Signup and view all the answers

What is the recommended range for daily protein intake in catabolic patients?

<p>1.2-2 g/kg</p> Signup and view all the answers

What is the purpose of the auxiliary label in PN formulations?

<p>All of the above</p> Signup and view all the answers

What is the recommended range for daily energy intake in adult patients?

<p>20-30 kcal/kg</p> Signup and view all the answers

Why is pharmacist-to-pharmacist communication important during patient transfer?

<p>To ensure accurate transfer of the PN prescription</p> Signup and view all the answers

What is the primary goal of providing standard nutrient ranges in PN formulations?

<p>To serve as a reference point for safe practice</p> Signup and view all the answers

What is the recommended range for daily fluid intake in adult patients?

<p>30-40 mL/kg</p> Signup and view all the answers

What information is required on the label of PN formulations?

<p>The amount per day and the dosing weight</p> Signup and view all the answers

What is the primary advantage of using grams per total volume in a 24-hour nutrient infusion system?

<p>It requires the least number of calculations to determine the calorie or gram dose per day.</p> Signup and view all the answers

Why is it important to determine individual nutrient requirements for each patient?

<p>To adjust for factors such as organ function, disease state, and medication usage</p> Signup and view all the answers

What is the primary consideration for implementing practice guidelines in alternative healthcare settings?

<p>The cost of implementing a once-per-day nutrient infusion system</p> Signup and view all the answers

Why is it useful to express additives as quantity per liter on the PN label?

<p>It helps the pharmacist in determining electrolyte compatibility.</p> Signup and view all the answers

What is the purpose of the 'amount per day' column on the PN label?

<p>To facilitate review of the order for appropriate nutrient doses.</p> Signup and view all the answers

Why is it important to include the administration date and time on the PN label?

<p>To ensure the PN is administered correctly.</p> Signup and view all the answers

What is the primary benefit of using automated compounding devices in PN compounding?

<p>They are more accurate and faster than gravity-fill PN admixture systems.</p> Signup and view all the answers

Why is it important to include the dosing weight on the PN label?

<p>To determine if the doses of nutrients are appropriate.</p> Signup and view all the answers

What is the purpose of the supplemental label template for IVFE?

<p>To provide a format for standardizing labels for IVFE when administered separate from the PN admixture.</p> Signup and view all the answers

Why is it important to include the route of administration on the PN label?

<p>To ensure the PN is administered correctly.</p> Signup and view all the answers

What is the primary benefit of using the 24-hour nutrient infusion system in PN compounding?

<p>It decreases PN wastage and reduces personnel time in compounding and administering PN.</p> Signup and view all the answers

What is the recommended fat content of the PN formulation per kilogram of body weight in adult patients?

<p>2.5 g/kg/day</p> Signup and view all the answers

What is the primary purpose of the PN label template?

<p>To provide a format for standardizing labels for all patients, including adults, pediatric, and neonatal patients.</p> Signup and view all the answers

What is the minimum percentage of total caloric intake as linoleic acid required to prevent essential fatty acid deficiency?

<p>2%</p> Signup and view all the answers

What is the primary reason for adjusting the standard distribution of nonprotein calories in obese patients?

<p>Tolerance issues</p> Signup and view all the answers

What is the primary benefit of hypocaloric feeding in patients receiving fat-free PN?

<p>Liberalization of essential fatty acids from endogenous fat stores</p> Signup and view all the answers

What is the primary factor influencing the need for continued provision of IVFE in patients receiving home PN?

<p>Amount of fat taken by mouth and efficiency of absorption</p> Signup and view all the answers

What is the primary characteristic of essential fatty acid deficiency syndrome?

<p>Poor wound healing and hair loss</p> Signup and view all the answers

What is the recommended carbohydrate content of the PN formulation per kilogram of body weight in adult patients?

<p>7 g/kg/day</p> Signup and view all the answers

What is the primary application of topical EFA in preventing essential fatty acid deficiency?

<p>Preventing EFA deficiency in patients receiving fat-free PN</p> Signup and view all the answers

What is the primary limitation of protein restriction in patients with liver disease?

<p>Limited efficacy in acute hepatic encephalopathy</p> Signup and view all the answers

What is the primary difference between commercial IVFE available in the US and structured lipid products available in Europe?

<p>EFA content</p> Signup and view all the answers

What is the primary reason for restricting potassium, phosphate, or magnesium in patients with renal disease?

<p>Impaired excretion</p> Signup and view all the answers

What is the recommended approach to maintain acid-base balance in PN formulation?

<p>Using equal amounts of chloride and acetate</p> Signup and view all the answers

Why is it necessary to state the specific amino acid product name used in compounding on the PN label?

<p>To account for its electrolyte content</p> Signup and view all the answers

What is the recommended daily dose of vitamin K in parenteral vitamin preparations for adults?

<p>150 mcg/day</p> Signup and view all the answers

Why should patients who are to receive the anticoagulant warfarin be monitored more closely when receiving vitamin K?

<p>To ensure the appropriate level of anticoagulation is maintained</p> Signup and view all the answers

What is the recommended supplementation of thiamin in PN patients who have a history of alcohol abuse?

<p>25-50 mg/d</p> Signup and view all the answers

What was the consequence of the parenteral vitamin shortages in the 1990s in the US?

<p>Vitamin deficiencies in patients receiving PN</p> Signup and view all the answers

What is the purpose of using commercially available amino acid injection products in PN formulation?

<p>To provide phosphorus to the patient</p> Signup and view all the answers

Why is it not recommended to list the electrolyte components of the amino acid solution on the PN label?

<p>It may lead to confusion</p> Signup and view all the answers

What is the recommended daily dose of ascorbic acid (vitamin C) in parenteral vitamin preparations for adults?

<p>200 mg/day</p> Signup and view all the answers

What is the recommended approach to providing vitamins during a parenteral vitamin shortage?

<p>Restrict the use of vitamin products during periods of short supply and use oral vitamins when possible</p> Signup and view all the answers

What is the primary concern when providing long-term PN therapy?

<p>Trace element toxicity</p> Signup and view all the answers

What is the recommended approach to providing iron supplementation during PN therapy?

<p>Provide iron supplementation only in patients with iron deficiency anemia</p> Signup and view all the answers

What is the recommended maintenance iron dose for patients receiving PN therapy?

<p>25-50 mg once monthly</p> Signup and view all the answers

Why should iron dextran not be added to TNA?

<p>It can destabilize the IVFE and result in the formation of large oil droplets</p> Signup and view all the answers

What is the recommended approach to providing trace elements during PN therapy?

<p>Provide individualized doses of trace elements based on patient needs</p> Signup and view all the answers

What is the primary concern when providing PN therapy to pediatric patients?

<p>Providing inadequate energy</p> Signup and view all the answers

What is the primary goal of monitoring serum ferritin concentrations during PN therapy?

<p>To monitor for iron overload</p> Signup and view all the answers

What is the primary concern when adding iron sucrose or sodium ferric gluconate to PN formulations?

<p>Incompatibility with PN formulations</p> Signup and view all the answers

What is the primary advantage of using individualized trace element preparations during PN therapy?

<p>Reduced risk of trace element toxicity</p> Signup and view all the answers

What is the recommended dose of L-cysteine hydrochloride per gram of amino acids in neonatal/infant amino acid formulations?

<p>40 mg</p> Signup and view all the answers

What percentage of nonprotein calories from fat is typically derived in the enteral diet of neonates or infants?

<p>50%</p> Signup and view all the answers

What is the recommended limit for IVFE administration in small for gestational age neonates and preterm neonates less than 32 weeks gestational age?

<p>3 g/kg/day</p> Signup and view all the answers

How early can neonates develop biochemical signs of EFAD after fat-free PN?

<p>As early as the second day of life</p> Signup and view all the answers

What is the primary difference in calcium and phosphorus requirements between neonates and infants compared to older children and adults?

<p>Neonates and infants require more calcium and phosphorus</p> Signup and view all the answers

What is the recommended age for using adult multivitamins in pediatric PN formulations?

<p>Above 11 years</p> Signup and view all the answers

What is the concern with the long-term use of multiple trace element products at recommended doses?

<p>Excessive serum concentrations of chromium</p> Signup and view all the answers

What is the primary advantage of using 20% IVFE compared to 10% product in neonates and infants?

<p>It has a higher caloric content per unit volume</p> Signup and view all the answers

What is the primary reason for the difference in time in which EFAD syndrome may occur in neonates and infants compared to adults?

<p>Limited endogenous store of fatty acids</p> Signup and view all the answers

What is the recommended weight for using adult electrolyte dosage guidelines in pediatric PN formulations?

<p>Above 50 kg</p> Signup and view all the answers

What is the primary responsibility of a pharmacist when reviewing a PN prescription?

<p>To review each prescription for appropriate indication, dose, and route of administration</p> Signup and view all the answers

What is essential to assess when reviewing a PN prescription?

<p>Serum electrolyte and glucose values</p> Signup and view all the answers

What is defined as the presence of the proper proportion of calories, protein, fluid, electrolytes, vitamins, and trace elements?

<p>Balanced nutrient formulation</p> Signup and view all the answers

What should be optimized and validated as a safe and efficacious method when compounding PN?

<p>Additive sequence</p> Signup and view all the answers

What should be reviewed with the manufacturer when using automated compounding devices?

<p>Additive sequence</p> Signup and view all the answers

What type of analysis can be readily applied in the pharmacy practice setting to assess the accuracy of PN compounding?

<p>Gravimetric analysis</p> Signup and view all the answers

What is an alternative method to assess the final concentration of PN additives?

<p>Refractometric analysis</p> Signup and view all the answers

Why is in-process or end-product testing of PN formulations recommended?

<p>To ensure patient safety</p> Signup and view all the answers

What should be visually inspected for signs of gross particulate contamination, particulate formation, and/or phase separation?

<p>PN formulations</p> Signup and view all the answers

What is the primary goal of quality assurance in PN compounding?

<p>To ensure patient safety</p> Signup and view all the answers

What is the recommended daily fluid requirement for a pediatric patient weighing 1500g?

<p>130-150 mL/kg</p> Signup and view all the answers

What is the daily protein requirement for a preterm neonate?

<p>3-4 g/kg</p> Signup and view all the answers

What is the recommended daily energy requirement for a pediatric patient aged 1-7 years?

<p>75-90 kcal/kg</p> Signup and view all the answers

What is the primary concern when using parenteral iron preparations in pediatric patients?

<p>Risk of iron overdose</p> Signup and view all the answers

Why is it important to monitor patients receiving PN therapy for iron deficiency?

<p>To prevent iron deficiency</p> Signup and view all the answers

What is the primary goal of screening the PN order?

<p>To prevent nutrient deficiencies</p> Signup and view all the answers

What is the consequence of omitting parenteral vitamins from PN formulations?

<p>Risk of vitamin deficiency</p> Signup and view all the answers

Why is it important to choose PN components with the lowest aluminum content?

<p>To prevent aluminum toxicity</p> Signup and view all the answers

What is the primary concern when using individual trace element products in PN therapy?

<p>Risk of trace element toxicity</p> Signup and view all the answers

What is the recommended frequency of administering a parenteral vitamin preparation to patients receiving PN therapy?

<p>Daily</p> Signup and view all the answers

Study Notes

Causes and Effects of Erectile Dysfunction (ED)

  • Organic factors like vascular disease and diabetes can lead to ED, causing patients to lose confidence in their ability to achieve an erection.
  • Psychological problems associated with ED include depressive symptoms, with overt depression often seen in older patients.

Interpersonal Effects on Male Sexual Function

  • Interpersonal effects on male sexual function include sexual problems with a partner, perceived lack of support from the partner, sexual abuse in childhood, and problems with sexual orientation.

Study Findings and Tools

  • The International Index of Erectile Function (IIEF) was used to obtain findings across six countries, marking the first in-depth qualitative work on ED in diverse Asian populations.
  • The AED tool features a qualitative component with structured open-ended questions, allowing patients to express how ED affects them in their own words.

Treatment and Management of ED

  • Education and counseling are important clinical strategies towards improving self-management of ED.
  • Effective clinical practice must consider factors in the wider environment, including life stresses and psychosocial losses.
  • Oral drug therapy is a treatment option that could significantly improve a patient's quality of life.
  • Penile prosthesis is known as a highly effective means of erectile re-establishment.
  • Injection therapy has been shown to be effective in treating various forms of erectile dysfunction, with success rates between 35 and 75%.
  • Vacuum Suction Devices (VSD) are a mechanical way of producing an erection for men who do not want or cannot use drug treatments.

Prevalence and Drug Non-Responsiveness

  • The prevalence of drug non-responsive ED is unknown, but a survey found that 7% of men reported ED onset while using medications for hypertension.
  • Up to 2000 patients underwent procedures for penile prosthesis implantation between July 1993 and November 2009.

Parenteral Nutrition (PN)

  • PN has become a crucial therapy in various disease states over the past four decades
  • PN formulations benefit patients with significant disruption in gastrointestinal function and are a lifeline for those with permanent loss of the GI tract

Importance of Proper Preparation and Administration

  • Improperly prepared and administered PN formulations have resulted in serious harm and death
  • Early PN programs focused on minimizing complications, and an interdisciplinary approach was found to improve efficacy, reduce complications, and facilitate efficient, cost-effective PN therapy

Errors in PN Preparations

  • Two deaths occurred due to errors in PN compounding, leading to a FDA Safety Alert
  • Errors led to infusion of incorrect formulas, leading to patient deaths and harm
  • Errors were related to pharmacy practices, misinterpretation of labels, and improper preparation of PN formulations

Ordering PN

  • Life-threatening errors continue to occur in the preparation and delivery of PN admixtures to patients
  • Errors are related to the ordering process, including lack of uniformity, incorrect units of measure, and errors of omission
  • Standardized PN order forms can reduce prescribing errors by 9% to 82%

Benefits of Standardized PN Order Forms

  • Provide more precise guidelines for PN prescribing
  • Educate physicians on PN therapy
  • Reduce prescribing errors
  • Improve efficiency and productivity of nutrition support
  • Allow comprehensive nursing and dietary care of the patient
  • Reduce pharmacy inventory and costs

Common Factors Associated with PN Prescribing Errors

  • Inadequate knowledge regarding PN therapy
  • Certain patient characteristics related to PN therapy
  • Calculation of PN dosages
  • Specialized PN dosage formulation characteristics and prescribing nomenclature

Principles for Creating a PN Order Form

  • Mandatory components: data to be collected on the form, information to be communicated to the clinician, and contact information
  • Strongly recommended components: basic PN education tools, example calculations, guidelines for ordering laboratory tests, and guidelines for stopping or tapering PN
  • Worthy of consideration components: additional guidelines for nutrient restriction, specialty amino acids, and long-term PN administration

Labeling PN Formulations

  • Lack of standardization in labeling PN ingredients causes confusion
  • Standardized labels are essential for patient safety and to avoid misinterpretation
  • Labels should express clearly and accurately what the patient is receiving
  • Methods of labeling: percent of original concentration, percent of final concentration, grams per liter, and grams per total volume### PN Label Requirements
  • The PN label should express components as amount/kg/day, in addition to amount/day, for neonatal and pediatric patients.
  • The label may include an additional column expressing components as amount/liter or amount/100 ml in parenthesis.
  • The label should specify the route of administration, administration date and time, and beyond-use date and time.
  • The dosing weight should be provided so that anyone evaluating the contents of the label may determine if the doses of nutrients are appropriate.
  • The inorganic phosphorus content should be provided as both the mmol quantity of phosphorus and the mEq quantity of the additive salt's cation (potassium or sodium).
  • If the PN formulation includes overfill, it should be clearly stated on the label.
  • Rate should be expressed in mL/hour over 24 hours, and if the PN formulation is cycled, the infusion duration and rates should be expressed on the label.

Auxillary Labels

  • Auxillary labels may be used to list individual electrolytes as mEq and phosphorus content as mmol provided per day.
  • The auxillary label could also express the total calories provided per day, as well as the percent of total calories provided by carbohydrate and fat.

Practice Guidelines

  • The labels for PN formulations should be standardized and include the amount per day as the only column required on the label for the base formula, electrolyte additives, micronutrients, and medications.
  • Auxillary labels or information may be used.
  • Patient transfer between healthcare environments requires pharmacist-to-pharmacist communication and documentation to ensure the accurate transfer of the PN prescription.
  • The PN label should be compared with the PN order and for beyond-use date before administration.

Nutrient Requirements

Adults

  • Protein requirements:
    • Maintenance: 0.8-1 g/kg
    • Catabolic patients: 1.2-2 g/kg
    • Chronic renal failure (renal replacement therapy): 1.2-1.5 g/kg
    • Acute renal failure + catabolic: 1.5-1.8 g/kg
  • Energy requirements: 20-30 kcal/kg
  • Fluid requirements: 30-40 mL/kg
  • Fat content of the PN formulation should not exceed 2.5 g/kg/day and carbohydrate content should not exceed 7 g/kg/day.
  • Essential fatty acid deficiency (EFAD) may occur if fat content is less than 2% to 4% of total caloric intake as linoleic acid and 0.25% to 0.5% of total caloric intake as alpha linolenic acid.

Pediatrics

  • Standard nutrient ranges for infants and children receiving PN have been established.
  • Requirements for fluids, protein, and energy are substantially higher on a unit-of-weight basis for children than for adults.
  • Careful monitoring of growth is necessary to assess adequacy of nutrient provision.
  • Above 18 years of age, estimated nutritional requirements should be established using nutrient ranges suggested for the adult population.
  • Protein restriction in certain disease states such as hepatic and renal failure should be done with caution and in consideration of the need for adequate protein to support growth in the pediatric population.

Electrolytes, Vitamins, and Trace Elements

  • Standard ranges for electrolytes, vitamins, and trace elements for infants and children with normal organ function are provided.
  • Calcium and phosphorous requirements of the neonate and infant are substantially different from those of the older child and adult.
  • Guidelines for vitamin and trace element additions to PN solutions for pediatric patients up to age 11 have been published.### Pediatric Parenteral Nutrition
  • Long-term use of multiple trace element products at recommended doses can lead to excessive serum concentrations of chromium.
  • The ratio of trace elements in commercially available pediatric multiple trace element products can result in excessive intake of manganese if recommended doses of zinc are given.

Iron Needs in Pediatric Patients

  • Iron needs in pediatric patients can be dramatically lower compared to adults.
  • Vigilance is necessary regarding iron doses administered to pediatric patients.

Fluid Requirements for Pediatric Patients

  • Daily fluid requirements for pediatric patients vary based on body weight:
    • 1500 g: 130-150 mL/kg
    • 1500-2000 g: 110-130 mL/kg
    • 2-10 kg: 100 mL/kg
    • 10-20 kg: 1000 mL for 10 kg + 50 mL/kg for each kg > 10
    • 20 kg: 1500 mL for 20 kg + 20 mL/kg for each kg > 20

Protein Requirements for Pediatric Patients

  • Daily protein requirements for pediatric patients vary based on age and weight:
    • Preterm neonates: 3-4 g/kg
    • Infants (1-12 months): 2-3 g/kg
    • Children (10 kg or 1-10 years): 1-2 g/kg
    • Adolescents (11-17 years): 0.8-1.5 g/kg

Energy Requirements for Pediatric Patients

  • Daily energy requirements for pediatric patients vary based on age:
    • Preterm neonate: 90-120 kcal/kg
    • 6 months: 85-105 kcal/kg
    • 6-12 months: 80-100 kcal/kg
    • 1-7 years: 75-90 kcal/kg
    • 7-12 years: 50-75 kcal/kg
    • 12-18 years: 30-50 kcal/kg

Practice Guidelines

  • Determine protein, calorie, fluid, electrolyte, vitamin, and trace element components of a PN formulation based on standard nutrient requirements.
  • Provide IVFE in a dose sufficient to prevent EFAD in adults and pediatric patients who are NPO.
  • Provide a parenteral vitamin preparation on a daily basis to all patients receiving PN.
  • Choose PN components with the lowest aluminum content when possible.
  • Use individual trace element products when necessary to prevent toxicity or deficiency states.
  • Limit parenteral iron supplementation to conditions of iron deficiency when oral iron supplementation fails.

Sterile Compounding of Parenteral Nutrition Formulations

  • Review each PN prescription for appropriateness of dose and adequacy of nutrient composition.
  • Assess each PN component for appropriateness of dose and potential compatibility or stability problems.
  • Question and clarify any dose of a nutrient outside a normal range not explained by a specific patient condition or history.

PN Compounding Practice Guidelines

  • Optimize and validate the additive sequence in compounding as a safe and efficacious method.
  • Review the compounding method if it has not been recently reviewed or if the contract with a manufacturer is about to change.
  • Ensure the safety and support of the automated compounding device and avoid splitting PN contracts unless combinations have adequate physicochemical data.

Quality Assurance of the Compounding Process

  • Perform gravimetric analyses to assess the accuracy of individual additives delivered or the final contents of the PN.
  • Incorporate chemical analyses to directly measure the final content of individual additives.
  • Use refractometric analysis as an alternative or indirect measure of final additive concentration.
  • Perform in-process or end-product testing of PN formulations daily to assure a safe final formulation is dispensed to the patient.
  • Adhere to the USP (797) Pharmaceutical Compounding-Sterile Preparations Chapter and the ASHP Guideline on Quality Assurance for Pharmacy-Prepared Sterile Products.

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