Editorial: Compounding with Hazardous Drugs

I remember, as a young pharmacist, popping open fluorouracil injection and pouring it into vials for oral administration�all done on the countertop of the pharmacy. Chemo agents were prepared with minimal protection. Compounding with hazardous powders was done in the open. That was then�this is now. An article recently appeared in the Seattle Times with the headline: "Lifesaving drugs may be killing health workers". This is nothing new, as we have been aware of the potential problems for years. We tend to think of oncology drugs when thinking about hazardous drugs but many, many other drugs can be considered hazardous, especially when compounding using bulk ingredients, etc. Although today's compounders are making great strides in this area, there are still those that are not addressing the problem. We will see more standards and regulations on this in the future.

The newspaper article mentioned above provides stories from healthcare workers who developed cancer after being involved in handling oncology drugs. It also reports a 2005 survey of 7,500 nurses (Oncology Nursing Society) where there were significant associations with infertility and miscarriage in nurses who handled these drugs before the age of 25.

There are more than 5.5 million workers in nursing, pharmacy, the transportation industry and cleanup of chemo wastes with potential exposure. Of these, about 2 million are estimated to actually mix or dispense these oncology drugs. Those exposed also include veterinarians.

This story can be accessed at the following website and should be read by pharmacists involved in compounding with hazardous drugs.

http://seattletimes.nwsource.com/html/localnews/2012327665_chemo11.html

Three resources immediately come to mind to help come "up to speed" on this topic, as follows:

1. The International Journal of Pharmaceutical Compounding has published a number of articles on compounding with hazardous drugs:

See the four-part series in IJPC as follows:

Part I : An Introduction; IJPC 10(5): 377-379.
Part II: Regulation and Sources of Contamination; IJPC 10(6):446-448
Part III: Safe Handling and Personal Protection; IJPC 11(1): 50-51.
Part IV: Developing the Hazardous Drugs List and Containment Workstations; IJPC 11(2): 149-151.

2. There is a free article that can be downloaded from: www.paddocklabs.com
See Secundum Artem, Vol 15(2).

3. The PCAB Guidance to Pharmacies Regarding Hazardous and Potent Substances and Primary Engineering Controls can be downloaded at: www.ijpc.com/PCAB_Guidance

We will definitely see more on this topic in the near future.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

21 More Lots of Nonprescription Products Recalled by McNeil
Continuing review by McNeil Consumer Healthcare has resulted in the company announcing the recall of 21 more lots of nonprescription products that were produced before the earlier recall. The packaging material in these earlier lots had been shipped and stored on the same type of chemically-tainted wooden pallet (treated with 2,4,6-tribromoanisole) which has a musty smell and is responsible for previous recalls.

This recall includes Benadryl Allergy Ultratab tablets, Children's Tylenol Meltaways, Motrin tablets and caplets, Tylenol Extra Strength tablets, caplets, and gel caps, and Tylenol PM caplets, gel caps, and gel tablets.

Any person having product from the lots in this recall is being told to stop using the product and follow the company's instructions (call 1-888-222-6036 or go to www.mcneilproductrecall.com) to obtain a refund or replacement.
http://mcneilproductrecall.com/page.jhtml?id=/include/news_july.inc

Pay-for-Delay Ban Passed by House
The War supplemental bill included a provision that would restrict drug makers' ability to pay their generic competitors for delaying the introduction of cheaper generics. The so-called "Pay for Delay" provision would strengthen the FTC ability to restrict the practice. The Congressional Budget Office estimates this would save the federal government more than $2.4 billion over 10 years in lower drug costs for Medicare, Medicaid, military, and veterans' health programs; a 2009 study found that such a ban would save American consumers $35 billion over 10 years.

The House bill would require higher rebates from drug makers who participate in Medicaid, supposedly saving the federal government $2.1 billion over 10 years. This provision affects inhalation, infusion, and injectable drugs dispensed outside pharmacies.
http://thehill.com/blogs/healthwatch/prescription-drug-policy/108193-house-war-supplemental-includes-pay-for-delay-restrictions-other-healthcare-measures

Pfizer Board Liable for Marketing Violations, Suit Says
Pfizer directors should be held liable for the drug maker's repeated violations of federal laws governing drug-marketing practices that resulted in the company having to pay a $2.3 billion settlement, a union pension fund said in a lawsuit.

Pfizer's board disregarded criminal guilty pleas the company entered over marketing practices for medicines such as its Bextra and Neurontin, the Bricklayers Local 8 & Plasters Local 233 Pension Fund, a Pfizer shareholder, said in the suit. The inaction by the Directors has hurt the value of investors' stakes in the company, the fund's lawyers contend.

The attorneys state that "The board and senior management made a calculated bet that the negative consequences of getting caught would never become significant." However, the defendants lost that bet.
www.businessweek.com/news/2010-07-13/pfizer-board-liable-for-marketing-miscues-suit-says.html

�that you can always get the status of drug shortages at: www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm and that you can be notified by e-mail by the FDA as drug shortages occur and are resolved by going to: www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm?

Hazardous Planning

Start planning now for the steps needed to protect yourself and your employees when handling hazardous drugs.