Dilaudid 1mg/ml Pf Inj, 0.5ml

Manufacturer FRESENIUS KABI USA Active Ingredient Hydromorphone Injection(hye droe MOR fone) Pronunciation hye droe MOR fone
WARNING: This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life-threatening if not treated.Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor. @ COMMON USES: It is used to manage pain when non- opioid pain drugs do not treat your pain well enough or you cannot take them.
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Drug Class
Opioid Analgesic
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Pharmacologic Class
Opioid Agonist
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Pregnancy Category
Not available
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FDA Approved
Jan 1942
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Hydromorphone is a strong pain medicine (an opioid) used to treat moderate to severe pain. It works in your brain and nervous system to change how your body feels and responds to pain. It is given by injection (shot) into a vein, muscle, or under the skin.
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How to Use This Medicine

Taking Your Medication Correctly
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions precisely. This medication is administered via injection into a muscle, vein, or subcutaneously into the fatty tissue beneath the skin.

Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

Missing a Dose
If you miss a dose, contact your doctor immediately to receive guidance on the best course of action.
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Lifestyle & Tips

  • Avoid alcohol and other sedatives while taking this medication, as they can increase the risk of serious side effects like severe drowsiness and breathing problems.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider using a stool softener or laxative as directed by your doctor.
  • Store this medication securely to prevent accidental ingestion by children or pets, which can be fatal.

Dosing & Administration

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Adult Dosing

Standard Dose: IV: 0.2-1 mg every 2-3 hours as needed. IM/SC: 1-2 mg every 4-6 hours as needed.
Dose Range: 0.2 - 4 mg

Condition-Specific Dosing:

opioid_naive_iv: Initial 0.2-0.6 mg every 2-3 hours.
chronic_pain_iv: Titrate dose based on patient response and tolerability, starting with lowest effective dose.
post_operative_pain_iv: 0.2-1 mg every 2-3 hours, titrate to effect.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: IV: 0.015 mg/kg/dose every 4-6 hours as needed (max 0.08 mg/kg/dose or 2 mg/dose).
Adolescent: IV: 0.2-1 mg every 2-3 hours as needed (same as adult initial dosing).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75% and extend dosing interval significantly. Avoid if possible. Monitor for accumulation of active metabolites (e.g., hydromorphone-3-glucuronide).
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Dose adjustment needed; monitor for prolonged effects.

Hepatic Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75% and extend dosing interval. Avoid if possible. Monitor for prolonged effects.

Pharmacology

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Mechanism of Action

Hydromorphone is a full opioid agonist, primarily acting at the mu-opioid receptors in the central nervous system (CNS). It produces analgesia by mimicking the actions of endogenous opioid peptides, leading to inhibition of pain transmission, alteration of pain perception, and induction of euphoria.
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Pharmacokinetics

Absorption:

Bioavailability: IV: 100%
Tmax: IV: 5-10 minutes; IM: 30-60 minutes; SC: 30-90 minutes
FoodEffect: Not applicable for parenteral administration.

Distribution:

Vd: Approximately 4 L/kg
ProteinBinding: Low (8-19%)
CnssPenetration: Yes, readily crosses the blood-brain barrier.

Elimination:

HalfLife: Approximately 2-3 hours (terminal half-life)
Clearance: Approximately 1.9 L/min
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10% (in urine)
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Pharmacodynamics

OnsetOfAction: IV: Within 5 minutes; IM/SC: 15-30 minutes
PeakEffect: IV: 10-20 minutes; IM/SC: 30-90 minutes
DurationOfAction: IV: 2-4 hours; IM/SC: 4-5 hours

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; ACCIDENTAL INGESTION.
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Side Effects

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Abnormal heartbeat, including fast, slow, or irregular rhythms
Breathing difficulties, including:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Shakiness
Trouble passing urine
Inability to control eye movements
Trouble controlling body movements
Changes in eyesight
Chest pain or pressure
Changes in balance
Memory problems or loss
Thoughts of hurting yourself or suicide
Swelling in the arms or legs

Serotonin Syndrome: A Rare but Serious Condition

If you take this medication with certain other drugs, you may be at risk for a severe and potentially deadly condition called serotonin syndrome. Seek medical attention immediately if you experience any of the following symptoms:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Sweating a lot
Severe diarrhea, upset stomach, or vomiting
Severe headache

Long-term Use and Hormonal Changes

Long-term use of opioid medications like this one may lead to lower sex hormone levels. If you experience any of the following symptoms, contact your doctor:
Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following possible side effects:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Sleepiness
Tiredness
Weakness
Dry mouth
Flushing
Sweating
Headache
Itching
* Trouble sleeping

If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Slow or shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Confusion or disorientation
  • Bluish lips or fingernails
  • Severe constipation or inability to have a bowel movement
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to severely high blood pressure.
If you are currently taking any of the following medications:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including:

Prescription and over-the-counter medications
Natural products
* Vitamins

Your doctor needs to be aware of all your medications and health conditions to determine if it is safe for you to take this medication. Do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.

Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer period, may increase the risk of severe side effects.

Interactions with Other Medications
Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor. If you experience worsening pain, increased sensitivity to pain, or new pain, contact your doctor immediately. Do not take more than the prescribed dose.

Monitoring and Maintenance
If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.

Allergies and Sensitivities
If you are allergic to sulfites, discuss this with your doctor, as some products may contain sulfites.

Alcohol Interactions
Do not consume alcohol or products containing alcohol while taking this medication, as this may lead to unsafe and potentially life-threatening effects.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of opioid medications like this one may cause dependence. If you need to reduce the dose or stop taking the medication, consult your doctor to avoid withdrawal or other severe problems.

Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.

Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Seek medical attention immediately if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.

Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Breastfeeding
If you are breastfeeding, inform your doctor, as this medication passes into breast milk and may harm your baby. Seek medical help immediately if your baby appears overly sleepy, limp, or has trouble breathing.
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Overdose Information

Overdose Symptoms:

  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness, unresponsiveness, or coma
  • Pinpoint pupils
  • Cold, clammy skin
  • Limp muscles
  • Slowed heart rate
  • Low blood pressure

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. If naloxone (Narcan) is available and you are trained to use it, administer it as directed. Stay with the person until emergency help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to risk of serotonin syndrome or severe respiratory depression.
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol) - increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) - risk of serotonin syndrome.
  • Mixed agonist/antagonist and partial agonist opioids (e.g., buprenorphine, nalbuphine, pentazocine) - may precipitate withdrawal symptoms or reduce analgesic effect.
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Moderate Interactions

  • Anticholinergic drugs (e.g., atropine, scopolamine) - increased risk of urinary retention and/or severe constipation.
  • Diuretics - opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • Antihypertensives - increased hypotensive effects.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain assessment (intensity, character, location)

Rationale: To establish baseline pain level and guide initial dosing.

Timing: Prior to first dose

Respiratory rate and depth

Rationale: To assess baseline respiratory function and identify risk for respiratory depression.

Timing: Prior to first dose

Level of consciousness/sedation score

Rationale: To assess baseline neurological status and identify risk for excessive sedation.

Timing: Prior to first dose

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status.

Timing: Prior to first dose

Renal and hepatic function tests (e.g., BUN, creatinine, LFTs)

Rationale: To identify potential need for dose adjustment in patients with organ impairment.

Timing: Prior to initiation, especially in at-risk patients

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Routine Monitoring

Pain assessment

Frequency: Every 1-2 hours initially after parenteral dose, then as clinically indicated (e.g., every 2-4 hours) to assess efficacy.

Target: Patient-specific pain goal (e.g., reduction by 2 points on 0-10 scale)

Action Threshold: Inadequate pain control: consider dose increase or alternative; excessive pain relief/sedation: consider dose decrease.

Respiratory rate and depth

Frequency: Every 15-30 minutes for first hour after parenteral dose, then every 1-2 hours or as clinically indicated.

Target: Typically >10-12 breaths/min, regular rhythm

Action Threshold: <10 breaths/min, shallow breathing, or signs of respiratory distress: administer naloxone, provide respiratory support, notify physician.

Level of consciousness/sedation score (e.g., Pasero Opioid-Induced Sedation Scale)

Frequency: Every 15-30 minutes for first hour after parenteral dose, then every 1-2 hours or as clinically indicated.

Target: Awake and alert or mildly drowsy, easily aroused.

Action Threshold: Difficult to arouse or unarousable: administer naloxone, provide respiratory support, notify physician.

Blood pressure and heart rate

Frequency: Every 1-2 hours initially, then as clinically indicated.

Target: Within patient's normal range

Action Threshold: Significant hypotension or bradycardia: notify physician, consider dose adjustment.

Bowel function

Frequency: Daily

Target: Regular bowel movements

Action Threshold: Constipation: initiate bowel regimen.

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Symptom Monitoring

  • Excessive sedation
  • Respiratory depression (slow, shallow breathing)
  • Dizziness
  • Nausea/vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Confusion or disorientation
  • Pinpoint pupils

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not recognized and treated.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations, though data are limited and inconsistent for opioids.
Second Trimester: Risk of neonatal opioid withdrawal syndrome with prolonged use.
Third Trimester: High risk of neonatal opioid withdrawal syndrome with prolonged use. Risk of respiratory depression in the neonate if administered close to delivery.
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Lactation

Hydromorphone is excreted into breast milk. While levels are generally low, infants should be monitored for signs of sedation, respiratory depression, and poor feeding. A safer alternative may be preferred, especially for prolonged use or in preterm/neonatal infants.

Infant Risk: Moderate to high risk (L3-L4). Potential for infant sedation, respiratory depression, and withdrawal symptoms if maternal hydromorphone is discontinued abruptly.
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Pediatric Use

Use with caution. Dosing must be carefully calculated based on weight. Infants and young children may be more susceptible to respiratory depression. Not recommended for use in neonates due to lack of established safety and efficacy.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of hydromorphone, particularly respiratory depression and sedation, due to decreased renal and hepatic function, reduced lean body mass, and concomitant medications. Start with lower doses and titrate slowly, monitoring closely.

Clinical Information

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Clinical Pearls

  • Hydromorphone is significantly more potent than morphine (approximately 5-7 times). Always verify dose and concentration carefully to avoid overdose.
  • Rapid IV administration can lead to severe respiratory depression, hypotension, and circulatory collapse. Administer slowly over at least 2-3 minutes.
  • Patients with renal impairment are at increased risk of accumulation of hydromorphone and its neurotoxic metabolite (H3G), leading to prolonged sedation, respiratory depression, and neuroexcitatory effects. Dose reduction and extended intervals are crucial.
  • Tolerance and physical dependence can develop with prolonged use. Do not discontinue abruptly in physically dependent patients to avoid withdrawal symptoms.
  • Naloxone should be readily available when administering hydromorphone, especially in opioid-naΓ―ve patients or those at high risk for respiratory depression.
  • Assess for underlying causes of pain and consider multimodal analgesia to reduce opioid requirements.
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Alternative Therapies

  • Morphine
  • Fentanyl
  • Oxycodone
  • Hydrocodone
  • Tramadol
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
  • Regional anesthesia
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 1mg/ml, 0.5ml vial
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often requires prior authorization for chronic use)
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General Drug Facts

It is essential to monitor your symptoms and health problems while taking this medication. If you notice no improvement or a worsening of your condition, contact your doctor promptly.

To ensure safe use, keep your medication to yourself and never share it with others. Similarly, do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the best disposal method, consult your pharmacist. You may also want to inquire about drug take-back programs available in your area.

This medication is accompanied by a Medication Guide, which provides important information about its use. Read this guide carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be used as part of the treatment. Talk to your doctor or pharmacist about obtaining and using naloxone. If you suspect an overdose has occurred, seek medical attention immediately, even if naloxone has been administered. Be prepared to provide information about the medication taken, the amount, and the time it happened.

In case of a suspected overdose, contact your local poison control center or seek medical care right away. Have the necessary information readily available, including the type of medication, dosage, and time of ingestion, to facilitate prompt and effective treatment.