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VOLUME 18 N0.1 JANUARY 2003
PHARMACY, THERAPEUTICS AND NUTRITION COMMITTEE ACTION
FOR 2002
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Request Evaluated |
Not approved |
Added to formulary |
Deleted from formulary |
Comments |
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ACCUZYME ointment |
x |
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Panafil ointment |
x |
|||
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Nitric Oxide (INOMAX) Gas |
x |
Restricted |
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Drotrecogin (XIGRIS) Injection |
x |
Restricted |
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Poractant (CUROSURF) Inratracheal |
x |
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Polyethylene Glycol 3350 (MIRALAX) Powder |
x |
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INFUVITE Adult Injection |
x |
|||
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INFUVITE Ped Injection |
x |
|||
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Iron Sucrose (VENOFER) Injection |
x |
|||
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INFASURF |
x |
|||
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MVI-12 Injection |
x |
|||
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MVI Ped Injection |
x |
|||
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Ertapenem (INVANZ) Injection |
x |
Restricted |
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Cefdinir (OMNICEF) oral |
x |
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Ranitidine (ZANTAC) oral |
x |
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Nizatidine (AXID) oral |
x |
|||
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Fondaparinux (ARIXTRA) injection |
x |
Restricted |
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LORTAB 7.5/500mg tablet |
x |
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Tolterodine (DETROL, DETROL-LA) tabs |
x |
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Ziprasidone (GEODON) Injection |
x |
Restricted |
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Escitalopram (LEXAPRO) tablet |
x |
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Paroxetine (PAXIL-CR) tablet |
x |
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Epinephrine (EPI-PEN, EPI-PEN JR) Injection |
x |
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Cascara Sagrada |
x |
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Casanthranol agents |
x |
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TOTAL 25 (100%) |
2 (8%) |
17 (68%) |
6 (24%) |
FORMULARY EVALUATION SUMMARY (1991-2002)
The Pharmacy, Therapeutics and Nutrition Committee added 165 drugs to the formulary and deleted 148 drugs from the formulary during this time period. In addition, the FDA approved 699 agents during this time period. The FDA approvals included new molecular entities, biologicals and new dosage forms of existing agents.
RATE OF FORMULARY ADDITIONS/REQUESTS (1995-2002)
The Pharmacy, Therapeutics and Nutrition Committee evaluated 173 requests for formulary inclusion during this time period. The Pharmacy, Therapeutics and Nutrition Committee approved the addition of 113 drugs and rejected 60 for formulary inclusion. The rate of formulary addition is 65%.
SUMMARY OF ADVERSE REACTIONS REPORTED FOR 2002
Monitoring ADRs is an important process to prevent or minimize the occurrence of ADRs to reduce the severity of ADRs, and to prescribe appropriate care when ADRs occur. Since the frequency of ADRs may not be evident during premarketing trials, the FDA relies on post-marketing reports to increase its database on ADRs. The Pharmacy, Therapeutics and Nutrition Committee reviews and evaluates all ADRs reported at the institution. The following is a summary of ADRs reported in 2002:
A total of three hundred (300) ADRs were reported.
Two hundred and fifty-three (253) were reported by the Pharmacist
Thirty-four (34) were reported by the Physician
Twelve (12) were reported by the Nurse
One (1) was reported by the Nurse Practitioner
Approximately 1200 potential ADRs were reviewed by the pharmacy staff.
Adverse Drug Reaction Rate (Total number of ADRs/Total hospital discharges)
There were three hundred (300) ADRs per 24,539 hospital discharges for an annual ADR rate of 1.2%
Severity of Reported ADRs (Significance)
There were no significant ADRs reported to the Pharmacy, Therapeutics and Nutrition Committee.
Summary by Drug Class:
Cardiovascular Agents 59 (19.7%)
Antidiabetic Agents 53 (17.7%)
Analgesics 52 (17.3%)
Antibiotics 51 (17.0%)
Anticoagulants 35 (11.7%)
Psychotherapeutic agents 13 ( 4.3%)
Anti-epileptic agents 10 ( 3.3%)
Miscellaneous 27 ( 9.0%)
TOTAL 300 100%
Medications Most Frequently Implicated in ADRs:
Analgesics:
Acetaminophen (Tylenol)
Aspirin
Cardiovascular Agents:
Digoxin
Enalapril
Furosemide
Antibiotics:
Augmentin - oral
Ciprofloxacin (Cipro) - parenteral
Ceftriaxone (Rocephin) - parenteral
Gatifloxacin (TEQUIN) - parenteral
Antidiabetic Agents:
Insulin
Glyburide
Glucophage
Anticoagulants:
Warfarin (Coumadin)
Anti-epileptics:
Phenytoin (Dilantin)
ADRs Reported by Patient Age and Gender:
Age (years) Males Females Total
0 - 10 8 2 10
11 - 20 2 8 10
21 - 40 15 17 32
41 - 60 27 46 73
61 - 80 45 65 110
80+ 15 50 65
Total 111 (37%) 189 (63%) 300
Common Causative Agents:
Age 0-10 (M/F) Accidental ingestion
11-20 (F) Intentional ingestion (Acetaminophen)
21-40 (M/F) Intentional ingestion (Analgesics) 41-60 (M/F) Cardiovascular agents, Analgesics, Antibiotics
61-80 (M/F) Cardiovascular agents, Anticoagulants, Antidiabetics
80+ (M/F) Cardiovascular, Antidiabetics, Analgesics, Anticoagulants
Place of Occurrence of ADRs:
Home 183 3N 4
5S 20 PEDS 4
4S 16 ASU 3
3S 13 CPC 2
ED 12 CCU 2
NH 11 CARDIAC CATH 1
4N 10 TBI 1 5N 10 MEDICAL CLINIC 1
MICU 6 OR 1
Preventability of ADRs:
None of the reported ADRs were classified as being preventable
Type of ADR:
Dose related (intentional ingestion) 33
Dose related (accidental ingestion) 4
Non-dose related 263
Total 300
ADVERSE DRUG REACTIONS (1997 - 2002)
|
2000 |
2001 |
2002 |
|
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Total number of ADRs reported |
324 |
300 |
300 |
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ADR rate (total number of ADRs/total hospital discharges |
1.4% |
1.3% |
1.2% |
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SUMMARY BY DRUG CLASS |
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Drug Class |
2000 |
Rank |
2001 |
Rank |
2002 |
Rank |
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Cardiovascular |
33.5% |
1 |
44.6% |
1 |
37.4% |
1 |
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Analgesics |
21.9% |
2 |
17.7% |
2 |
17.3% |
2 |
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Antibiotics |
12.7% |
3 |
11.6% |
3 |
17.0% |
3 |
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Psychotherapeutic agents |
4.9% |
5 |
3.0% |
5 |
4.3% |
5 |
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Anticoagulants |
11.4% |
4 |
11% |
4 |
11.7% |
4 |
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Antiepileptic agents |
4.3% |
6 |
2% |
6 |
3.3% |
6 |
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Miscellaneous |
12.2% |
7 |
9.7% |
7 |
9.0% |
7 |
JCAHO NATIONAL PATIENT SAFETY GOALS - 2003
The six Joint Commission on Accreditation of Healthcare Organization national patient safety goals require organizations to improve the following:
¨ The accuracy of patient identification
Use at least two patient identifier (excluding the patient's room number) when taking blood samples or administering medications or blood products. Before a surgical or invasive procedure, verify for the last time, through a "time out", the correct patient procedure, and surgical site.
¨ The effectiveness of communication among caregivers
Whoever takes verbal or telephone orders must verify them by reading back the complete order. Standardize the abbreviations, acronyms, and symbols used throughout the organization, including those not to use.
¨ The safety of using high-alert medications
Remove concentrated electrolytes (including, but not limited to, potassium chloride, potassium phosphate, and sodium chloride) from patient units and standardize and limit the number of drug concentrations.
¨ Eliminate wrong-site, wrong-patient, and wrong-procedure surgery
Create a preoperative verification process, such as a checklist, to confirm that staff have all the appropriate documents (i.e. medical records and imaging studies). Mark the surgical site and involve the patient in the marking process.
¨ The safety of using infusion pumps
Ensure free-flow protection on all general use and patient-controlled analgesia infusion pumps.
¨ The effectiveness of clinical alarm systems
Guarantee regular preventive maintenance and testing of alarm systems and make sure staff properly activate alarms and can hear them, especially against competing noise within the unit.
JCAHO National Patient Safety Goals - High-Alert Medications:
The first six JCAHO National Safety Goals became effective January 1, 2003. Goal #3: Improve the safety of using high-alert medications is a priority for the Pharmacy, Therapeutics and Nutrition Committee. Specifically the removal of concentrated electrolytes from patient care units and standardizing and limiting the number of drug concentration available in the institution. This goal has been addressed for the top five high-alert medications identified by JCAHO.
1) Insulin
Humulin (R, L and N) are available as floor stock, and all other insulins are dispensed per patient medication order.
2) Opiates and Narcotics
Par levels and daily controlled drug distribution system
3) Injectable Potassium Chloride (or Phosphate) Concentrate
Pharmacy controlled, pre-mixed I.V. bags
4) I.V. Anticoagulant (Heparin)
Pharmacy controlled, pre-mixed I.V. bags
5) Sodium Chloride Solution above 0.9%
Pharmacy controlled.
CRITERIA FOR EVALUATING FORMULARY DRUGS
The Pharmacy, Therapeutics and Nutrition Committee develops the hospital's formulary. The formulary includes and excludes drugs available for routine prescribing/ordering. The Pharmacy, Therapeutics and Nutrition Committee members (Physicians, Pharmacists, Nurses and Administrators) are involved in the development of the formulary.
The formulary is maintained based on the following criteria:
a) The hospital's need for the medication
b) The effectiveness of the medication based on an evaluation of efficacy, toxicity, pharmacokinetic properties, bioequivalence, pharmaceutical equivalence, and therapeutic equivalence
c) The risk of the medication based on known adverse drug reactions, the possibility to cause medication errors and other adverse drug events.
d) The cost and financial impact on the institution.
CRITERIA FOR DRUGS TO BE DELETED FROM THE FORMULARY
The pharmacy monitors drug use on an ongoing basis and makes recommendations to the Pharmacy, Therapeutics and Nutrition Committee to delete medications from the formulary. The recommendations are based on:
a) The hospital's continued need for the medication (a low usage pattern is a factor)
b) A comparison of efficacy to currently available therapeutic alternatives
c) Adverse drug reaction and medication error reports (both local and national reports)
d) Economic impact due to the above mentioned criteria
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