Viagra – Case Focus Blocks

Viagra (Sildenafil Citrate) – Case Review – Focus Blocks

Viagra was approved in 1998 and used to treat erectile dysfunction (impotence) in men.

Viagra (Sildenafil) relaxes muscles and increases blood flow to particular areas of the body.

MANUFACTURER: Pfizer

Men who suffered heart attacks, strokes, vision problems and hearing troubles filed lawsuits against the drug maker. In 2005, the U.S. Food and Drug Administration ordered that warnings about vision loss be added to the drug’s label.

Now, Pfizer may soon have to face a new barrage of lawsuits. A 2014 study found that Viagra (Sildenafil) nearly doubles men’s risk of the deadly skin cancer melanoma. The drug’s label fails to warn about this potential side effect.

LAWSUIT FOCUS: Failure to warn patients of the risk for melanoma

According to allegations raised in cases being investigated nationwide, if warnings and information about the risk of skin cancer from Viagra were provided, men may have avoided a melanoma diagnosis by choosing not to use the drug or may have prevented the skin cancer from reaching an advanced stage if they were informed about the importance of looking for unusual moles or growths on the skin.

Early detection of melanoma is critical for treatment and long-term survival. Users of Viagra could have been warned about ABCDE system of checking the skin for signs of cancer, looking for:

  • Asymmetrical moles or growths, where one half is different from the other
  • Borders that are irregular in shape
  • Color changes over time and more than one color on one growth
  • Diameter of growths and moles that exceed 6 mm; larger than a pencil eraser
  • Evolution of the mole or growth, meaning that it changes appearance over time

DOSAGE FORMS AND STRENGTHS

Viagra is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with PFIZER on one side and VGR25, VGR50 or VGR100 on the other to indicate the dosage strengths.

ADMINISTRATION

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, Viagra may be taken anywhere from 30 minutes to 4 hours before sexual activity.

Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.

INDICATIONS: Viagra (Sildenafil) is used to treat erectile dysfunction or impotence in men

CONTRAINDICATIONS:

  • Administration of VIAGRA to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. VIAGRA was shown to potentiate the hypotensive effect of nitrates
  • Known hypersensitivity to sildenafil or any component of tablet

WARNINGS AND PRECAUTIONS

  • Patients should not use VIAGRA if sexual activity is inadvisable due to cardiovascular status
  • Patients should seek emergency treatment if an erection lasts >4 hours. Use VIAGRA with caution in patients predisposed to priapism
  • Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Anterior Ischemic Optic Neuropathy (NAION). VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a ”crowded” optic disc may also be at an increased risk of NAION.
  • Patients should stop VIAGRA and seek prompt medical attention in the event of sudden decrease or loss of hearing
  • Caution is advised when VIAGRA is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension
  • Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in VIAGRA dosage is recommended

VIAGRA SIDE EFFECTS

Common adverse reactions: Headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash

CASE REVIEW FOCUS AREAS:

  • Whether the patient was prescribed Viagra?
  • Reason for Viagra Prescription?
  • Dosage and Intake details

Critical Review of

  • Physician Drug Prescription Details
  • Pharmacy Dispensing Details
  • Pharmacy Refill Details
  • Details of Pharmacy Dispensing Details are taken as Confirmatory
  1. Did the patient have any pre-existing conditions, allergies or contraindications for Viagra?
  1. What was the injury due to Viagra?
  1. When and where was the injury diagnosed? Whether hospitalized? Dates of hospitalization?
  • Treatment/management. Any complications
  • Follow-up visits for treatment/management of injury.
  • Outcome/prognosis. Resolution of injury?

SPECIFIC FOCUS

Identify and report cases with the following scenarios:-

  1. No Injuries: Patient took Viagra but did not develop any injuries
  2. No Viagra intake: Patient was given a different drug and not Viagra. Hold case and communicate to client
  3. Viagra contraindicated in patient but still prescribed
  4. Any medical/surgical history, social history that could have had an effect on the injury

MISSING RECORD COMMUNICATION:

Identify and report on missing medical records

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable. This will also help in following up and retrieving the records.

Missing Records are presented in the following format

What Records/Medical Bills are NeededHospital/

Medical Provider

Date/Time PeriodWhy we need the Records/BillsIs Record Missing Confirmatory or Probable?Hint/Clue that records are missing
      

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