OMIC and Maryland Society of Eye Physicians and Surgeons (MSEPS) Jointly Sponsor Webinar
OMIC and MSEPS are pleased to offer a risk management webinar for Maryland ophthalmologists titled “Telephone Screening: Liability Issues and Guidelines” on May 9 at 6:00 PM (EDT). This webinar will qualify OMIC insureds for a 10% premium discount (must be an active MSEPS member).
To register a physician contact Linda Nakamura at OMIC at 800-562-6642 ext. 652 lnakamura@omic.com.
JCAHPO will also offer this risk management webinar to your ophthalmic medical personnel (OMP) for continuing education credit. JCAHPO will contact OMP in a separate mailing regarding event registration and payment process. For more information, you or your staff may contact JCAHPO Administrative Services Department at (800) 284-3937 ext. 223 or 239, or e-mail registrations@jcahpo.org
| Webinar registration: | The registration deadline for the live webinar is Thursday, May 2, 2013. To register for the live webinar simply respond to this email and include your first and last name. We will send you login instructions after you register.
This webinar is being recorded for future participation and credit. If you want to register for the recorded webinar simply respond to this email and include your first and last name and state that you want to view the recorded webinar. We will send you login instructions after you register. |
QUESTIONS?
- Registration issues, amount of discount, and other ways to get your risk management premium discount: call Linda Nakamura, Risk Management Coordinator, 1-800-562-6642, ext. 652.
Medical personnel can register by contacting JCAHPO at 800-284-3937 ext.223 registrations@jcahpo.org.
Compounded Drugs and Off-Label Use
Welcome to OMIC’s Compounded Drugs and Off-Label Use risk management resource library. We are committed to providing you with the resources and templates necessary to adequately inform your patients about the risks, benefits, and alternatives of this procedure.
Compounded Products: Use, Regulation, and Risk
Liability and Coverage for Contaminated-Product Claims
Reduce the Risks of Compounded Drugs
Read the Label Carefully: How Ads for Off-Label Drugs and Devices Could Harm Your Practice
Hotline Q&A: Standing Order Medications
Medical Implications of Using Off-Label Drugs and Devices
Case Study: Lack of Informed Consent for Use of a Research Drug
Informed Consent for Off-Label Use of a Drug or Device
When FDA Leaves Doctors to Their Own Devices
Responding to “Dear Healthcare Provider” Letters
2013 Update: New Regulations For Compounding Drugs Coming Into Focus…
Visit OMIC’s Drugs and Devices library to view other resources for Compounded Drugs and Off-Label Use including risk management articles, closed claim studies, and recommendation and procedure guides.
See also: Advertising resources.
Reduce the Risk of Compounded Drugs
Anne Menke, RN, PhD, OMIC Risk Manager
Digest, Fall 2012
State and federal legislatures are reviewing changes in law to increase the safety of compounded drugs. Even before new laws and regulations go into effect, ophthalmologists can take action to reduce the risk of administering compounded drugs.
Q Am I required to use FDA-approved drugs instead of compounded ones?
A No. OMIC is not aware of any law that prevents physicians from choosing the drug or device they feel is in the best interest of their patient. Physicians should certainly be aware of whether there are FDA-approved medications available to treat the condition, and document the decision-making process that led to choosing one drug over another. Bear in mind that compounded drugs do not undergo the same premarket review for safety and efficacy as FDA-approved manufactured drugs.
Q What do I need to do to credential a compounding pharmacy?
A You need to perform due diligence by evaluating the compounding pharmacy’s licensure, accreditation, and compliance with laws and regulations. First, check with the board of pharmacy in your state. Ask the pharmacy board to send you your state laws governing compounding pharmacies; this will help you determine if state law requires the pharmacy to be licensed in your state, and whether a patient-specific prescription is needed before ordering drugs. Ask the pharmacy board if it is aware of any concerns about the particular company. Second, determine whether the pharmacy has achieved voluntary accreditation by the Pharmacy Compounding Accreditation Board (PCAB), an organization composed of eight of the nation’s leading pharmacy organizations. Third, gather information about the compounding process. The IACP has created The Compounding Pharmacy Assessment Questionnaire (“CPAQ”), a comprehensive tool to help the medical community assess and select a compounding pharmacy. It is available online at www.iacprx.org. Ask the pharmacy if it complies with the United States Pharmacopeia Convention (a scientific nonprofit standard setting organization) 797 standards for the compounding, transportation, and storage of compounded sterile products.[1] Go in and actually meet the pharmacists and inspect the facility. Determine where the compounding pharmacy’s raw products are obtained, if they are pharmaceutical grade for humans, and how batches are sorted and tested.[2] Ask what sample size the pharmacists use and whether they have sterility tests performed independently at an unaffiliated lab. Although price shopping is tempting, do not base your choice of pharmacy on cost alone.
Q What steps can my practice take?
A When ordering products, ask the compounding pharmacy to prepare the medication specifically for ophthalmic use, confirm the dose and sterility, identify the syringe suitable for the medication, provide storage and beyond-use instructions, and include a copy of the sterility tests with each order. Follow the storage and beyond-use instructions provided by the compounding pharmacy. Keep a log of medications that were compounded, and document the lot number in the patient’s medical record so that you can easily contact affected patients in the event of a recall. Follow current clinical guidelines on the proper aseptic technique during the preparation and administration of injections. Report any suspected adverse events following use of compounded products to the FDA’s MedWatch program at www.fda.gov/medwatch. For help with adverse events, recalls, and patient communications OMIC insureds are encouraged to contact OMIC’s confidential Risk Management Hotline by calling (800) 562-6642, option 4.
Q Am I required to obtain informed consent to administer or use compounded drugs?
A Informed consent is generally required for procedures or treatments whose risks exceed those that a lay person with average knowledge of medical issues would understand. The standard is not what a physician feels a patient should know, but what a prudent layperson would want to know. Informed consent is thus not required for a simple x-ray, but would be for fluorescein angiogram since the dye can cause fatal, allergic reactions. In the case of medications, physicians are expected to obtain informed consent from patients by explaining the condition, the expected benefit from the medication, known complications, and available alternatives. If the drug is being used off-label, that information should be part of the consent process. Prior to the highly publicized meningitis cases discussed in the lead article, it is unlikely that ophthalmologists explained to patients where they obtained their drugs. In the current environment, some patients may ask, and most patients would probably want to know. While it is not necessary to obtain the patient’s informed consent to use compounded drugs, be prepared to answer any questions patients may have about the issue. Practices and ambulatory surgery centers who use many compounded drugs may want to prepare an information sheet that explains what compounding is, and the steps the practice has taken to credential the compounding pharmacy.
1. Welcome to USP797.org, http://usp797.org.
2. Sellers S, Utian WH. “Pharmacy compounding primer for physicians: prescriber beware.” Drugs 2012 Nov 12;72(16):2043-50.
