Little Known Laws and Regulations the Community Pharmacist Should Know
Often-missed requirements for the community pharmacy manager
The following are laws, guidelines, and regulations that I either see missed quite often or rarely discussed in either practice or in pharmacy school. With each of these I am not intending to provide a comprehensive guide, but rather introduce each one and provide you the references to read more on them and hopefully confirm compliance or bring your pharmacy into compliance.
Resource Conservation Recovery Act
The Resource Conservation and Recovery Act (RCRA) was passed in 1976 and gives the Environmental Protection Agency the authority to regulate hazardous waste ‘from cradle to grave.’1 Under RCRA, pharmacies are considered hazardous waste generators, and it is up to the generator to determine if a drug is hazardous or not. The EPA does provide some guidance on characteristics of hazardous waste as well as a ‘U’ and ‘P’ lists of medications that are specifically identified as hazardous waste. The most common medications that fall in one of these categories are nicotine and warfarin, along with most chemotherapy agents.2
Regulations vary widely depending on how much waste you generate. The majority of community pharmacies can follow the regulations required for a Conditionally Exempt Small Quantity Generator (CESQG). The EPA has created a set of rules to provide guidance specifically to pharmacies and healthcare facilities on hazardous waste management.2
USP <800> and Handling Hazardous Drugs Guidelines
While there has been a lot of talk surrounding USP <800> and its effects on the compounding of sterile, hazardous medications, there has been significantly less about the proposals to protect community pharmacy staff from exposure to hazardous drugs. Other organizations such as the National Institute for Occupational Safety and Health (NIOSH) have guidelines as well.4,5 Some best practices include:3,4,5,6
1. Dedicated equipment and chemical deactivation: You should have a separate counting tray and spatula specifically for dispensing hazardous pharmaceuticals. Note that rubbing alcohol, while we often use it to clean trays, does not deactivate the majority of chemotherapy agents. To clean these trays it is best to use a deactivating system, which is widely available through various healthcare distributors.
2. Separate storage area: Storing hazardous drugs separately allows staff to immediately identify them and prevents those medications from contaminating non-hazardous medications. The shelf should be labeled and should be at or below eye level.
3. PPE requirements: NIOSH’s ‘List of antineoplastic and other hazardous drugs in healthcare settings’ has an excellent table at the bottom that lists appropriate PPE by activity. Community pharmacy activity would generally involve single-gloving. Note that gloves must meet standards set by the American Society for Testing and Materials (ASTM). This is crucial because some glove materials do not prevent penetration of the hazardous drug and could lead to hazardous drug exposure.
CDC Vaccine Storage and Handling Toolkit
In a previous Pharmacy Times article, I discussed some best practices regarding vaccine storage7; however, I would encourage anyone who stores not only vaccines but any refrigerated medications to download the full CDC toolkit and read it in its entirety carefully.8 Here are some common misses:
1. Storing vaccines in a dorm refrigerator — a dorm refrigerator’s freezer compartment is inside the refrigerator, and because of this the freezer will blow cold air into the refrigerator and destabilize the temperatures. Dorm refrigerators should NEVER be used to store vaccines or refrigerated medications.
2. Using the wrong type of thermometer: Food thermometers and mercury thermometers are among the many types of thermometers that are either too inaccurate or measure ambient air temperature rather than estimating internal vial temperature. Thermometers recommended by the CDC are accurate to 1oF and also have a digital data logger that records the temperature at least every 30 minutes, providing you more data in the event of an excursion. The probe is also suspended in a buffering agent to more accurately reflect vaccine temperature.
3. Checking temperatures once daily: In addition to a digital data logger, temperatures should be manually checked twice daily, including min/max. After checking, the min/max should be reset.
4. Having an excursion and not doing anything: If there has been an out of range temperature you cannot be confident the vaccine is still effective without consulting either the manufacturer or, in the case of VFC vaccine, the local health department. The CDC’s reference has a full guide to handling temperature excursions properly.
Another incredible resource is www.immunize.org, which provides temperature logs, signage, frequently asked questions, and numerous other resources to assist you in both storing and administering your vaccines safely.
Controlled Substance Act
While every pharmacist is familiar with the Controlled Substance Act, there are portions of this legislation I have seen missed often by both pharmacists and providers. The DEA has written an excellent outline of the Controlled Substance Act that is titled “Pharmacist’s Manual: An Informational Outline of the Controlled Substance Act.”9 It is available as a free download, and I would encourage anyone who has not seen it to download and review it. Some commonly missed areas include:
1. Controlled substance prescriptions cannot be stamped — On page 29 of this guide, the DEA states that a prescription “must be written in ink or indelible pencil and must be manually signed by the practitioner.” This means that the provider cannot use a stamp for the drug name, dose, directions, or quantity. I have had physicians get very upset with me and tell me that they have ‘been doing it for years and never had any problems.’ I remember one surgeon in particular who had a habit of stamping Lortab Elixir for all of his surgery patients. After several months of me sending prescriptions back, I think (or hope) he has thrown that stamp away. Physician information, however, can be stamped.
2. Doctor’s first and last name must be on the prescription — Page 29 of this guide also states that “a prescription for a controlled substance must include the patient’s full name and address, and the practitioner’s full name, address and DEA registration number.” The times I have seen providers run into problems with this is when they are writing on a hospital blank, they do not have a stamp for their information, and they write something like ‘Smith’ under MD name and then sign it. ‘Smith’ is not their full name and thus it does not meet all the requirements of a prescription. Just as with the stamp, I have been told by providers that they have been doing that for years without problems, leading me to believe this often gets filled.
3. Patient address must be on the front of the prescription: The DEA does not consider the trailer on the back of the prescription to be in compliance with the required patient address portion of the regulation. However, the good news is that pharmacists are allowed to write in the address after confirming it with the patient. Be sure you have the entire address on there, including the ZIP code. I also have my staff check each one and sign the book before filing it away.
4. Controlled substances must be filled once before they can be transferred — According to page 37, you may “transfer original prescription information for schedules III, IV, and V controlled substances to another DEA registered pharmacy for the purpose of refill dispensing between pharmacies, on a one-time basis only.” Notice the words refill dispensing. This means if you have profiled a schedule III-V medication and have not filled it then you are not allowed to transfer it.
DEA ‘Know Your Customer’ Program
Although this program applies to wholesalers it does affect community pharmacy. In addition, if you are a community pharmacy that also has a permit in your state to act as a wholesaler, you must comply with this program. Some highlights include.9,10,11,12,13
1. Due diligence and a system to detect suspicious orders: A wholesaler must “take reasonable measures to identify their customers, understand the normal and expected transactions typically conducted by those customers, and, consequently, identify those transactions conducted by those customers that are suspicious in nature.” Because of this, as many pharmacists know, wholesalers now often set monthly limits on classes of schedule II medications and require a formal application process to increase those limits. In addition, some wholesalers will inspect your pharmacy, so don’t be alarmed if this happens.
2. Reporting to ARCOS: ARCOS is the manufacturer and wholesaler’s system to report controlled substance transactions, similar to a pharmacy reporting controlled substance transactions to a PDMP. Manufacturers and distributors are required to report all schedule II medications and select schedule III and IV medications. While this will not affect most pharmacies, if you are wholesaling more than 5% of your inventory then according to federal law you would be required to register as a distributor and thus report those transactions to ARCOS. In addition some states have their own reporting systems that are stricter than the federal reporting system. For example, in Florida all wholesale transactions for schedule II-V must be reported to their state reporting system on a monthly basis.
1. Summary of the resource conservation and recovery act. EPA website. https://www.epa.gov/laws-regulations/summary-resource-conservation-and-recovery-act. Accessed November 19, 2016.
2. Management standards for hazardous waste pharmaceuticals. EPA website. https://www.regulations.gov/document?D=EPA-HQ-RCRA-2007-0932-0150. Accessed November 19, 2016.
3. Hazardous drugs — handling in healthcare settings (general information chapter 800). In: United States Pharmacopeia, 39 rev., and the National Formulary, 34 ed. Rockville, MD: the United States Pharmacopeial Convention; Official. 2016; 83-102.
4. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings. NIOSH website. http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Accessed November 21, 2016.
5. NIOSH alert: preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. CDC website. https://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf. Accessed November 20, 2016.
6. Landeck L, Gonzalez E, Koch OM. Handling chemotherapy drugs — do gloves really protect? Int. J Cancer 2015;138(8):1800-1805.
7. Evans A. 6 best practices for refrigerated vaccine storage and handling. Pharmacy Times website. http://www.pharmacytimes.com/contributor/alex-evans-pharmd-cgp/2016/06/6-best-practices-for-refrigerated-vaccine-storage-and-handling. Accessed November 21, 2016.
8. CDC Vaccine storage and handling toolkit (June 2016). Centers for Disease Control website. http://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. Accessed November 21, 2016.
9. Pharmacists manual: an informational outline of the Controlled Substance Act. Drug Enforcement Administration website. https://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf. Accessed November 21, 2016.
10. Knowing your customer/suspicious orders reporting. Drug Enforcement Administration website. https://www.deadiversion.usdoj.gov/chem_prog/susp.htm. Accessed November 21, 2016.
11. Automation of reports and consolidated orders system (ARCOS). Drug Enforcement Administration website. https://www.deadiversion.usdoj.gov/arcos.
12. Customer questionnaire. ANDA website. Accessed online November 21, 2016 at https://image.andanet.com/docs/andanet/customerQuestionnaire_Anda.pdf. Accessed November 21, 2016.
13. Division of drugs, devices, and cosmetics: controlled substances reporting. Florida department of business and professional regulation website. http://www.myfloridalicense.com/dbpr/ddc/CSR.html. Accessed November 21, 2016.