Wyeth sold it to Monarch. Large retailers are out, smaller suppliers still have "some" available.

No new supply due from manufacturer for awhile, classified as "long term back order".

Some pharms were charging $550 for three shots, when 10 are $400ish.

Products affected--description

Penicillin G benzathine/Penicillin G procaine suspension (Bicillin C-R), 300,000 unit/mL / 300,000 unit/mL, King Pharmaceuticals
1 mL syringes, 10/package, 61570-0139-10
2 mL syringes, 10/package, 61570-0141-10
2 mL syringes, 10/package (21 guage), 61570-0140-10
4 mL syringes, 10/package, 61570-0142-10

Penicillin G benzathine / Penicillin G procaine suspension (Bicillin C-R 900/300 Pediatric), 900 unit/mL / 300 unit/mL, King Pharmaceuticals
2 mL syringes, 10/package (1 1/4 inch needle), 61570-0143-10
2 mL syringes, 10/package (1 inch needle), 61570-0144-10

Penicillin G benzathine suspension (Bicillin L-A), 600,000 unit/mL, King Pharmaceuticals
1 mL syringes, 10/package, 61570-0146-10
2 mL syringes, 10/package, 61570-0147-10
4 mL syringes, 10/package, 61570-0148-10

Reasons for the shortages

Pfizer was unable to supply penicillin G injection due to manufacturing difficulties.1
Sandoz now has adequate supplies of penicillin G injection.2 The company was previously allocating product.2
Penicillin G benzathine and penicillin G procaine products are available in limited quantities.3
Estimated resupply dates

Pfizer expects to have product available by mid-April 2005.1
Sandoz has both penicillin G potassium and penicillin G sodium available. However, pharmacies are encouraged to contact their specific wholesaler or distributor to determine whether product is currently in stock.2
Baxter has frozen bags of penicillin G available in 1 million unit, 2 million unit, and 3 million unit sizes.4
King states that all Bicillin C-R and Bicillin L-A products are on intermittent back order. The company is shipping product to major wholesalers and distributors approximately every 3 weeks.3
Implications for patient care

Penicillin G injection is labeled for the treatment of severe infections caused by penicillin-susceptible microorganisms when rapid and high penicillin levels are required.5 Penicillin G is used in streptococcal infections, pneumococcal infections, anthrax, actinomycosis, clostridial infections including tetanus and botulism, diphtheria, erysipeloid endocarditis, fusospirochetal infections, gram-negative bacillary infections, listeria infections, pasteurella infections, rat-bite fever, disseminated gonococcal infections, syphilis including congenital and neurosyphilis, and meningococcal meningitis.5,6 Penicillin G injection may also be used to treat Lyme disease.6-8
During this shortage, use alternative antimicrobial agents when appropriate.5-7

Safety

Clinicians must take extra care to ensure patients receive accurate doses during this shortage. For example, if a patient requires a 5 million unit dose, and the institution only has 2 and 3 million unit pre-mixed doses available, ensure the patient receives the entire dose.

Alternative Agents and Management

Intravenous penicillin G is considered the treatment of choice for congenital syphilis, neurosyphilis, and for prevention of perinatal Group B streptococcal disease.9 Institutions should consider reserving penicillin G injection for use in these cases.
Intramuscular penicillin therapy may be an option for some patients.9
In 1999, the Centers for Disease Control and Prevention (CDC) provided guidelines for a nationwide penicillin shortage.9 Table 1 incorporates these CDC recommendations and provides alternatives for selected situations.
Table 1. Alternatives to Penicillin G Injection in Selected Situations8

Situation
Recommendation
Comments

Infants with clinical or laboratory evidence of congenital syphilis
Procaine penicillin G 50,000 units /kg/dose IM once daily for 10 days.9,10

Ampicillin 50 mg/kg/dose IV every 6 hours for 10-14 days.9

Ceftriaxone:9
For infants < 30 days old: 75 mg/kg/day IV or IM in a single dose for 10-14 days.
For infants > 30 days old: 100 mg/kg/day IV or IM in a single dose for 10-14 days.
There is not strong evidence to support the use of ampicillin or ceftriaxone. Careful clinical and serologic follow-up is needed. The CDC recommends consultation with an expert in the treatment of infants with congenital syphilis. Management may include a repeat CSF exam at 6 months of age if the initial exam was abnormal. Use ceftriaxone with caution in infants with jaundice.

Infants at risk for congenital syphilis without any clinical or laboratory evidence of infection
Procaine penicillin G 50,000 units/kg/dose IM once daily for 10 days.9,10

Benzathine penicillin G 50,000 units/kg IM as a single dose.9
For premature infants who may not tolerate IM injections because of decreased muscle mass, IV ampicillin or ceftriaxone may be considered with careful clinical and serologic follow-up. Adjust doses of ampicillin and ceftriaxone according to the level of prematurity.

Neurosyphilis
Procaine penicillin G 2.4 million units IM daily for 10 to 14 days plus probenecid 500 mg four times per day for 10 to 14 days.8,9
For patients who cannot tolerate IM procaine penicillin, IV ampicillin 3 to 4 grams per dose every 6 hours for 10 to 14 days or ceftriaxone 2 grams IV per day for 10 to 14 days may be considered with careful clinical and serologic follow-up and with the consultation of an expert in treating neurosyphilis.

Perinatal Group B streptococcal disease prophylaxis
Ampicillin 2 g IV initially, then 1 g IV every 4 hours until delivery.8,9
Patients with penicillin allergy but a low risk of anaphylaxis may receive cefazolin
2 g IV initially, then 1 g IV every 8 hours until delivery.8
Patients with cultures susceptible to clindamycin my alternatively receive clindamycin 900 mg IV every 8 hours until delivery.8

Infants with meningitis secondary to Group B streptococcal infection
Age < 7 days: ampicillin 200 to 300 mg/kg/day IV in 3 divided doses.8
Age > 7 days: ampicillin 300 mg/kg/day IV in 4 to 6 divided doses.8
Clinicians may wish to consult with a pediatric infectious disease clinician.

References

Pfizer (personal communications). March 30, May 5, June 8, July 20, August 17, September 20, and October 22, 2004; and January 3, and February 2, March 28, and April 6, 2005.
Sandoz (personal communications). March 30, April 6, May 5, June 8 and 14, July 20, August 17, September 20, and October 22, 2004; and January 3, and February 2, 2005.
King Pharmaceuticals (personal communications). April 1, 2004; and April 7, 2005.
Baxter Healthcare (personal communications). March 30, May 5, June 8, July 20, August 17, September 20, and October 22, 2004; and January 3, and February 2, 2005.
Penicillin G potassium for injection [Pfizerpen product information]. New York, NY: Pfizer; September 2003.
Gilbert DN, Moellering RC, Sande MA, eds. The Sanford Guide to Antimicrobial Therapy. 33rd ed. Hyde Park, VT: Antimicrobial Therapy, Inc; 2003.
Antimicrobial Drugs of Choice. In: Drug Information Handbook. 12th ed. Hudson, OH: Lexi-Comp Inc; 2004: 1693-99.
In: Pickering LK, ed. 2003 Red Book: Report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2003.
Alternatives to intravenous penicillin G for specific infections. MMWR Weekly October 29, 1999. Available at http://www.cdc.gov/nchstp/dstd/pencillinG.htm. Accessed March 31, 2004.
Young TE, Mangum B, eds. Neofax 2000. Raleigh, NC: Acorn Publishing; 2000.
Updated April 7, 2005, by Erin R. Fox, Pharm.D., Drug Information Specialist. Created April 1, 2004 by Jane Chandramouli, Pharm.D., and Erin R. Fox, Pharm.D., Drug Information Specialists. Copyright 2005, Drug Information Service, University of Utah, Salt Lake City, UT.

CVS announced recently that they will not longer order product from secondary wholesalers. Cardinal Health, the drug wholeslaer for CVS also announced thta they are closing their secondary distribution biz.

I would suspect that benzanine is not an on-the-shelf/in-stock product for CVS-it is too expensive, and not enouigh people use it. This would mean that CVS would order the drug from their drug wholesaler Cardinal Health. You might want to ask CVS to call the pharmaceutical company directly. They might not want to do this. If they protest, call your state board of pharmacy.

Although pharmacy regs vary from state to state, typically a pharmacy is required to contact the physician if they are not able to fill a script as written. I seem to recall that CVS also has company 'rules' that require notification-I am not sure if they only notify the patient or if they are also required to notify the prescriber.

Another thing that you can do is have your LLMD write a new script specific to a brand of PenG that is currently being manufactured.
For example: DAW: Pfizer brand (or another brand) medically necessary. Always keep a copy of the prescription.

This was on the FDA shortage website, dated 5-20-05: http://www.fda.gov/cder/drug/shortages/default.htm#Current

Resolved Drug Shortages