Hospital Pharmacy Regulation Report

Transcription

1 Vol. 2 No. 2 February 2004 Hospital Pharmacy Regulation Report INSIDE Medication use tips Fifty-five percent of fatal hospital medication errors in 2002 involved elderly patients. Check out these error-prevention tips on p. 4. Personal medication organizer See a sample of U.S. Pharmacopeia s personal medication organizer on p. 5. Emergency preparedness The first of a two-part series on emergency preparedness examines the National Pharmacist Response Team. Read more on p. 7. Standard of the month Educate your staff now about drug recalls to reduce stress at survey time. Read the facts on p. 8 and check out the sample policy on p. 10. Notify your patients Your outpatient pharmacy might have to give patients a notice of privacy practices. Read more on p. 11. Don t overlook the enclosed HPRR special report, with tips on how to comply with the HIPAA privacy rule. FOR PERMISSION TO REPRODUCE PART OR ALL OF THIS NEWSLETTER FOR EXTERNAL DISTRIBUTION OR USE IN EDUCATIONAL PACKETS, PLEASE CONTACT THE COPYRIGHT CLEARANCE CENTER AT OR 978/ Medicare update Medicare reimbursement changes to help hospital pharmacies Pharmacies can expect to receive more money in 2004 and beyond with the outpatient prospective payment system (OPPS) revisions included in the Medicare Prescription Drug Improvement and Modernization Act of Hospitals will receive 88% of the average wholesale price (AWP) for certain single-source drugs (drugs with one therapy use) and no more than 68% for multiple-source drugs (drugs with more than one therapy use) in 2004, compared to the 50% 60% pharmacies received in the past. Go to gov for an updated list of 2004 payment rates. The new rates more accurately The pressure is on to clamp down on how you handle highalert medications. In fact, in 2004 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will score how you fare in this area. Four of the JCAHO s seven National Patient Safety Goals cover reflect drug-acquisition costs, says Ernest Anderson Jr., MS, pharmacy director at Lahey Clinic in Burlington, MA. Anderson estimates that his pharmacy received $2 million less in reimbursement than the drug-acquisition costs for This will hopefully get us back to a break-even point, Anderson says. That s going to be a dramatic improvement and will hopefully get us back to a situation where we won t be losing money on drugs. Reimbursements will drop to at least 83% of AWP for single-source drugs in To issue reimbursement rates for 2006, the General Accounting Office (GAO) and the Medicare Payment > p. 6 Medication error report focuses on JCAHO Patient Safety Goals Tips for pharmacists to reduce errors, improve safety medication administration, says Rod Hicks, RN, MSN, MPA, research coordinator for the U.S. Pharmacopeia s (USP) Center for the Advancement of Patient Safety (CAPS) and co-author of the Summary of Information Submitted to MEDMARX in the Year 2002: The Quest for Quality, released November 18, The goals > p. 2

2 Medication error < p. 1 that focus on medication include the following: Improve high-alert medication safety Improve the accuracy of patient identification Improve communication among caregivers Improve the safety of infusion pumps According to the report, USP researchers found that high-alert medications such as insulin, morphine, heparin, and potassium chloride represented 35.1% of cases that resulted in patient harm in Researchers also focused on errors in the geriatric population, finding that miscommunication and misidentification were harmful to elderly patients and 55% of all fatal hospital medication errors involving seniors. (See p. 4 for tips on how to help prevent medication errors with elderly patients.) USP oversees MEDMARX, an anonymous Internet medication error-reporting database. Researchers noticed that reporting of errors increased to 192,477 in 2002, up from 105,603 in According to the report, 3,213 errors (1.7%) resulted in patient harm in 2002, compared to 2.4% in Hicks attributes these numbers to more hospitals subscribing to MEDMARX 482 in 2002 compared to 368 in 2001 and better internal error reporting procedures. USP charges hospitals a fee based on their number of beds to join MEDMARX, Hicks says. USP uses the money to fund the MEDMARX program. There s more awareness to report errors, Hicks says. We want all errors reported, whether they involve harm or not. Pay attention to high-alert meds Eight of the top 10 products that harmed patients in 2002 were high-alert medications drugs more likely to cause an adverse reaction if given improperly. These medications include insulin, morphine, heparin, potassium chloride, warfarin, hydromorphone, fentanyl, and meperidine. resulted in patient harm 8.1% of the time. Hicks says one reason for this is that one larger teaching hospital had as many as 27 different scales for insulin dosing, Hicks says. In fact, he adds, each unit may have a different dosing scale. TIP: Standardize insulin dosing at your hospital. There are more than 20 different formulations of insulin, according to Hicks. For example, intermediate formulations last for up to 24 hours in the patient, whereas short duration could last a few hours, he says. TIP: Look at the vial s label instead of relying on the box label. When the pharmacy sends insulin vials to the floor, staff sometimes place vials in boxes labeled regular or intermediate, depending on the dose of the vials in the box, Hicks says. The problem, Hicks explains, is that sometimes vials get placed in the wrong box. Staff do not look at the vials before administering them to patients, and thus give the wrong dose in the process. So pay attention to the vial s label. It s not a high-tech solution, Hicks says. Just throw the outer container away. Double-check for safety Hicks suggests that pharmacists be wary when Top five error causes in Performance deficit (63,954 errors) 2. Procedure not followed (28,857 errors) 3. Transcription inaccurate/omitted (17,998 errors) 4. Computer entry (17,998 errors) 5. Documentation (17,198 errors) Source: Summary of Information Submitted to MEDMARX in the Year 2002: The Quest for Quality. U.S. Pharmacopeia. Of all the high-alert medications, insulin errors For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Page HCPro, Inc. Hospital Pharmacy Regulation Report February 2004

3 dealing with patients weights. Conversions between pounds and kilograms often trouble physicians, pharmacists, and nurses, he says. Heparin doses, for example, depend on the patient s weight. If a physician writes the order in kilograms and the weight must be converted from pounds, the potential for error exists because someone may not do the math correctly. TIP: Give staff laminated cards that convert kilograms to pounds. Double-check the conversion before filling the order. Identify the correct patient Computer systems may also cause patient identification problems. Computer entry was the fourth overall cause of errors in 2002, with 17,998 errors recorded. It was seventh overall in 2000 and fifth in 2001, Hicks says. System design is one reason for errors, Hicks says. For example, a prescriber may confuse James Brown Sr. with James Brown Jr. because there is no distinction between each row on the computer screen. TIP: Design computer entry systems that highlight every other line or prohibit physicians from prescribing medications for patients other than their own. What s happening visually is the prescriber is seeing one name on the screen, but the eye doesn t follow to that suffix, Hicks says. You need to make each line discernable by highlighting every other one. Keep track of seniors meds Communication is a major issue when dealing with senior citizens, Hicks says. Seniors often see multiple specialists or visit more than one department while in a hospital. For example, an elderly patient could move from the emergency room (ER) to internal medicine to the cardiac unit, with physicians prescribing medications in each department. They could prescribe contradictory therapies or staff could misplace medication orders when a patient moves from one unit to another, Hicks says. TIP: Give patients a medication organization list to carry wherever they go. This will help hospital staff avoid giving a drug that could interact with medication the patient already takes. (Check out a sample medication organizer on p. 5.) Beware of infusion pumps The JCAHO wants facilities to use infusion pumps that avoid free, or uncontrolled, flow of solutions, Hicks says. Facilities should also program the pumps correctly to ensure that patients receive proper doses. USP researchers found 1,846 errors involving an infusion pump, 161 of which caused patient harm. Staff often programmed the pumps incorrectly, giving the patient too much or too little of a medication. For example, a 60-year-old patient had an order for an initial meperidine dose of 20 mg followed by 10 mg every 12 minutes, not to exceed 180 mg in four hours. The patient became unresponsive after receiving an initial 170-mg dose because a staff member programmed the pump incorrectly, according to the report. TIP: Clearly label IV bags with the patient name, medication, dosage, and infusion rate. Hospitals should consider smart IV pumps, which allow hospitals to program minimum and maximum dosage ranges for medications, Hicks says. Staff would receive a warning if they entered a dose outside of the accepted range. Editor s note: Next month s HPRR will detail the steps your facility should take to improve IV pump safety. For more information on the MEDMARX survey, go to For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Hospital Pharmacy Regulation Report February HCPro, Inc. Page 3

4 Prevent medication errors in elderly patients Use these twelve tips to keep seniors safe Fifty-five percent of fatal hospital medication errors in 2002 involved elderly patients, according to the U.S. Pharmacopeia s (USP) 2002 MEDMARX medication error reporting data. Geriatric patients often take different medications or see several specialists, which can lead to confusion, says Rod Hicks, RN, MSN, MPA, research coordinator for USP s Center for the Advancement of Patient Safety. USP created a list of tips to help the elderly and their caregivers manage their medications and reduce errors. Offer the following suggestions to patients and staff to prevent medication errors: 1. Check prescription labels to verify that you ve received the proper medication. If possible, read back the prescription to your pharmacist or health care provider. 2. Try to keep all medications in original containers. 3. Talk to your pharmacist or health care provider about what to do if you miss a dosage. 4. Try to fill all prescriptions at the same pharmacy. 5. Read the patient information sheet that accompanies your medication. If you do not receive one, ask your pharmacist for the printed information about your prescription. 6. Should there be a change in the color, size, shape, or smell of your medication, notify your pharmacist immediately. 7. Never share or take another person s medications. 8. If you have any questions or concerns about a medication, always consult your pharmacist or health care provider. Ask about any possible side effects. 9. When in the hospital, state your name before taking any medications and always offer your wrist bracelet for identification. Ask the nurse to identify each medication by name before you take it. If you do not receive your medication at its regular time during your hospital stay, ask the nurse. Remind health care providers about any allergies to medications or food and any health conditions that could affect the use of certain medications. 10. Tell your health care providers about any dietary supplements or over-the-counter (OTC) medications that you take. 11. Create a list of all your medications. The list should include the following information: Your full name and date of birth Drug names (both generic and brand names) Strength (dosage) Medication instructions, such as how many times a day and when you should take the medication The types of liquids or foods you use or should use with the medication Allergies to certain medicines and foods Pharmacy and health care provider names, addresses, and telephone numbers Family emergency contact information 12. Update the medication list every month. Keep copies at your home and tell family members and friends where you keep your personal medication list. Bring the list to doctor s appointments, hospital stays, or emergency room visits, and show it to all your health care providers so they are aware of all your medications. Source: Adapted from U.S. Pharmacopeia. Reprinted with permission. For more information, go to www. usp.org. For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Page HCPro, Inc. Hospital Pharmacy Regulation Report February 2004

5 Sample personal medication organizer Patient information Patient s name: Patient s birth date: Address: Telephone number: ( ) Emergency contact (Name/phone number): Drug/food allergies: Health care provider s information Primary physician: Telephone number: ( ) Address: Specialist(s): Telephone number: ( ) Address: Pharmacy: Telephone number: ( ) Address: Drug information Drug (trade and generic name) and over-the-counter product name Prescriber Strength (dosage) How many times a day and at what time during the day do you take this prescription? What liquid/food shouldn t you take with this Medication? Other special instructions? Source: U.S. Pharmacopeia. Reprinted with permission. For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Hospital Pharmacy Regulation Report February HCPro, Inc. Page 5

6 Hospital pharmacies < p. 1 Advisory Commission (MedPAC) will collect data on hospital drug acquisition costs. Recouping losses The Balanced Budget Act of 1997 held reimbursement rates to between 50% and 60% of the AWP in previous years, says Kathleen Cantwell, director of federal legislative affairs and government affairs counsel for the American Society of Health-System Pharmacists. The Balanced Budget Act gave the Centers for Medicare & Medicaid Services (CMS) the authority to create a prospective payment system for outpatient drug services, Cantwell says. CMS has repeatedly adjusted the rates during the last few years, causing drastic cuts in reimbursement rates. It wasn t sufficient to cover the cost of the product and the administration of the drug, Cantwell says. CMS will use the May 1, 2003, Red Book values to calculate AWP, Anderson says. The Red Book, a compendium of AWPs as reported by pharmaceutical companies, is published by Medical Economics Co. Anderson multiplies the new AWP-based reimbursement rate by the amount of billing volume in 2003 for each particular drug the pharmacy purchases to determine how much money the pharmacy will recover, he says. Bundling threshold reduced to $50 In 2003, drugs that cost less than $150 were bundled into ambulatory payment classifications (APCs), meaning that the cost of the drug was included in the overall cost for that therapy or treatment, says Anderson. The APC usually did not cover the acquisition and administration cost of the drug because it included other treatment costs as well, he says. We were losing money on most drugs, Anderson says. The Medicare reform law reduces that threshold to $50. Drugs less than $50 will be bundled into APCs, but drugs costing more than $50 will be removed from APCs and reimbursed at the outpatient prospective rates. For example, some anti-nausea drugs will be removed from APCs and reimbursed at OPPS rates, Anderson says. Drugs used to treat chemotherapyinduced nausea that cost more than $50 will be unbundled, but drugs used to treat post-operative nausea and vomiting remain bundled into an APC because they are less expensive, he says. This will allow hospitals to purchase certain drugs to treat chemotherapy-induced nausea and receive more money to cover acquisition costs, Anderson says. HPRR Subscriber Services Coupon Start my subscription to HPRR immediately. Options: No. of issues Cost Shipping Total Print 12 issues $299 (HPRRP)* $18.00 Electronic 12 issues $299 (HPRRE) N/A Print & electronic 12 issues of each $374 (HPRRPE)* $18.00 Order online at and save 10% Sales tax* MA residents please add 5.0% Grand total Mail to: HCPro, P.O. Box 1168, Marblehead, MA Tel: 800/ Fax: 800/ customerservice@hcpro.com Web: Your source code: N0001 Name Title Organization Address City State ZIP Phone Fax address (Required for electronic subscriptions) Payment enclosed. Please bill me. Please bill my organization using PO # Charge my: AmEx MasterCard VISA Signature (Required for authorization) Card # (Your credit card bill will reflect a charge to HCPro, the publisher of HPRR.) Expires For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Page HCPro, Inc. Hospital Pharmacy Regulation Report February 2004

7 Spotlight: The pharmacist s role in emergency preparedness and response Teams help immunize and educate public Editor s note: This is the first of a two-part series on the pharmacist s role in emergency preparedness. This issue focuses on the National Pharmacist Response Team. Next month we will cover what you can do in your community. For more information on the NPRT, go to Mitchel Rothholz, RPh, realized after the September 11 terrorist attacks and the subsequent anthrax attacks that pharmacists played vital roles in emergency assistance. They could distribute medication, educate victims about disease and treatments, and staff clinics. But many pharmacists wouldn t be able to help out in a crisis unless they received privileges to practice in another state. Rothholz, the vice president of professional practice for the American Pharmacists Association (APhA) and a licensed pharmacist in Virginia, learned this first hand when he contacted the District of Columbia Board of Pharmacy to help health officials handle the anthrax attacks. Because he had a Virginia pharmacy license, Rothholz needed special permission from the District s pharmacy board. Working with officials at the U.S. Public Health Service, Rotholz developed the idea of a national pharmacist network under the federal government s supervision. The federal government would be able to move pharmacists to disaster areas to help out with medication distribution and immunization. Those discussions led to the creation of National Pharmacist Response Teams (NPRT). The U.S. Department of Homeland Security oversees 10 NPRTs throughout the United States. Pharmacists may join the teams to help staff immunization clinics or medication distribution centers after a terrorist attack or major natural disaster. The goal is to have nearly pharmacists for each region, says Lt. Cmdr. Scott Giberson, PhC, PharmD, NPRT coordinator with the U.S. Public Health Service. Thus far, between 20 and 30 people have signed up in each region. Educating the public Pharmacists are just as valuable in emergencies as paramedics and physicians, Rothholz says, because mass-immunization clinics or medication dispensing areas need pharmacists active participation, he says. Pharmacists were looking to be recognized [in disaster aid], Rothholz says. We have a valuable role to play. FEBRUARY > p. 8 Upcoming events Audioconferences: 2/11/2004 JCAHO environment of care standards for /18/2004 Preparing for communicable disease outbreaks 2/24/2004 Get full reimbursement under Medicare Part B 2/25/2004 Innovative performance improvement strategies Call customer service at 800/ to register. For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Hospital Pharmacy Regulation Report February HCPro, Inc. Page 7

8 Emergency response < p. 7 For example, if an anthrax attack occurred in Boston, the federal government could activate the Region I NPRT to hand out ciprofloxacin and educate patients about anthrax and how to use the medication, Giberson says. A mass smallpox immunization would also require pharmacists help, Rothholz says. Pharmacists would check patients arms several days after they receive the vaccine to see whether the treatment worked. Any member of the NPRT assisting in giving out the smallpox vaccine would initially receive training and immunization because it contains a strain of live virus, Giberson says. Voluntary duty NPRT members would receive payment and coverage under federal workman s compensation insurance as well as food and travel stipends, Rothholz says. Pharmacists would serve in two-week rotations if their teams were activated. Most states currently have a Disaster Medical Assistance Team (DMAT), which consists of doctors, pharmacists, and nurses that can be activated during a natural disaster. A DMAT and members of the U.S. Public Health Service s Commissioned Corps Readiness Force would most likely respond first, and then the federal government could activate the NPRT to provide additional support, Giberson says. Most NPRTs would not travel outside their region, Giberson says, although the possibility does exist in the case of major disasters. Pharmacists can decline to travel to a disaster site if their NPRT is activated, he says. It s not the military, Giberson says. It s a totally voluntary civilian force. JCAHO standard of the month MM.4.70 Educate staff about drug recalls for survey prep Drug recalls may be a topic of conversation during your next Joint Commission on Accreditation of Healthcare Organizations (JCAHO) survey. Make sure your staff are on the same page now to reduce survey day stress. The JCAHO s medication standard MM.4.70 requires pharmacies to retrieve recalled drugs. Knowing your hospital s procedure will help you during your survey. Under Shared Visions New Pathways, the new JCAHO survey process, surveyors will select a patient and trace his or her stay in the hospital from admission to discharge. Surveyors may ask pharmacists what they would do if a manufacturer recalled any of the patient s medications, says Joseph Deffenbaugh, MPH, RPh, director of public health quality for the American Society of Health-System Pharmacists (ASHP). Hopefully the pharmacist would know the policies and say, This is what I would do, Deffenbaugh says. Look for the lot number Drug manufacturers assign lot numbers to groups of medications as they are manufactured and shipped. Therefore, pharmacists should look for a lot number when the recall notice arrives. Check your pharmacy s stock record for the recalled lot number. Depending on your hospital s system, you may be able to record it in an electronic database or automated cabinets such as Omnicell or Pyxis. If not, keep it in a written log. Your record should tell you where the medication is located in the hospital. Pharmacy technicians at St. Michael s Hospital in Stevens Point, WI, manually search their stock records for lot numbers, says For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Page HCPro, Inc. Hospital Pharmacy Regulation Report February 2004

9 pharmacy director Todd Faulks, RPh. It s fairly easy to track, Faulks says. We start in the pharmacy and work our way out to look for the lot number. Some vendors place the lot number on the invoice pharmacies receive with medication shipments, Deffenbaugh says. That provides pharmacies with a documented lot number record and makes it easier to enter the number in a database. If there is no lot number on the invoice, check the packages for the number, Deffenbaugh says. TIP: Maintain an up-to-date log with medication lot numbers and expiration dates. If you do not have a computerized database, record the lot numbers in a log. The Food and Drug Administration (FDA) is developing standards for manufacturers to place the medication s lot number and expiration date in bar codes, Deffenbaugh says. That would help facilities electronically record where the medication is located in the hospital. Standard MM.4.70 at a glance The pharmacy must retrieve medications recalled or discontinued by the Food and Drug Administration (FDA) or the manufacturer. Requirements for MM Staff retrieve medications according to the organization s policy when the FDA or the manufacturer informs the hospital of a recall. 2. The hospital must notify all staff ordering, dispensing, and giving out medications when the FDA or manufacturer issues a recall order. 3. Staff identify and notify patients who may have received the recalled medication. That s the best part of it, Deffenbaugh says. You have a bar code right down to the unit of use. Electronically, [the medication] is very easy to retrieve. The FDA will publish the final bar-coding rule early this year, FDA spokesperson Crystal Rice says. The rule will apply to all prescription drugs, including biological products and vaccines, as well as over-the-counter drugs commonly used in hospitals. Track down those meds Pharmacy staff at St. Michael s Hospital search the floor stock for the medications when a recall notice arrives, Faulks says. Pharmacy technicians check the inventory and notify clinics that may use the medication. Faulks checks with pharmacy technicians and other staff responsible for stocking the medications to see whether the recalled drug is in the hospital s inventory, he says. Staff check the pharmacy first and then move out to patient care areas, he says. For example, drug manufacturer Pharmacia recalled Lunelle, a monthly birth-control injection, in October 2002 because it was subpotent, Faulks says. His staff immediately located it in several hospital clinics in central Wisconsin and retrieved it, he says. No one wants a subpotent birth control injection out there, Faulks says. We jumped on that one right away. Follow the manufacturer s instructions Once you have collected the recalled medications, follow the manufacturer s instructions on what to do with them, Faulks says. These instructions will be included in the recall notice. For more serious recalls, manufacturers may require you to ship medications back and will provide shipping instructions, Faulks says. Other times, he adds, manufacturers may simply send you new labels to place on the medication if the recall is due to a labeling error. Read the fine print A group purchasing organization (GPO) often noti- For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Hospital Pharmacy Regulation Report February HCPro, Inc. Page 9

10 Drug recalls < p. 9 fies hospitals when a manufacturer issues a drug recall, Deffenbaugh says. Wholesalers such as McKesson or Cardinal will also pass along recall notices, he says. Manufacturers often send recall notices through priority mail and alerts, Faulks says. Manufacturers and GPOs send the notices to any pharmacist with a license and sometimes to the entire pharmacy in general, he says. Sometimes pharmacists don t receive notices because they are unaware of the notification process, Deffenbaugh says. It is important to know how you receive recall notices, either from manufacturers, prime vendors, or industry associations such as ASHP. Sometimes a physician will call the pharmacy saying, We ve received a notice that Product A has been recalled, and the pharmacy doesn t know anything about it yet, Deffenbaugh says. TIP: Make sure you know what your contract with your drug vendor says about recalls, Deffenbaugh says. Network with your peers Having a drug recall policy will be important when JCAHO surveyors arrive at your hospital. Surveyors may want to know what you would do if a manufacturer recalled a drug, and your staff must be able to explain the policy, Deffenbaugh says. Talk with your colleagues if your hospital does not have a defined drug recall policy, Faulks says. Other pharmacy directors may be able to offer guidance and suggestions to help you design a recall policy, he says. Most JCAHO standards require you to have a policy and that s all they say, Faulks says. It s a matter of networking. Sample drug recall policy The Food and Drug Administration (FDA) defines a Class I recall as a situation where there is a reasonable possibility that use or exposure to a violative product will cause serious adverse effects or even death. Pharmacy personnel are responsible for checking all floor stock, patient medication boxes, as well as the stock in the pharmacy. Pharmacy will notify clinics that have purchased the recalled products. The FDA defines a Class II recall as situations where use or exposure to a violative product may cause temporary or medicinally reversible adverse health consequences. Pharmacy personnel are responsible for checking all floor stock and patient medication boxes as well as the stock in the pharmacy. Pharmacy will notify clinics that may have purchased the recalled product. The FDA defines a Class III recall as situations in which use of the product is not likely to cause adverse health consequences. Pharmacy personnel are responsible for checking floor stock as well as stock in the pharmacy. Pharmacy will notify clinics that have purchased the recalled product. Class I and II recalls will be processed within 24 hours upon receipt of recall notice in the pharmacy. Recall records shall be kept on file in the pharmacy for two years. Source: St. Michael s Hospital, Stevens Point, WI. Reprinted with permission. For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Page HCPro, Inc. Hospital Pharmacy Regulation Report February 2004

11 Notify patients of their HIPAA privacy rights Give patients your hospital s notice of privacy practices if your pharmacy offers retail services in its outpatient setting. A notice of privacy practices describes how a hospital will use a patient s protected health information (PHI). It also explains patients rights according to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy rule and how to file HIPAA-related complaints about privacy violations. Hospitals must give patients a notice of privacy practices upon admission. However, the admissions department may not process all of the patients who simply pick up prescriptions at the pharmacy, so pharmacies must be prepared to provide patients with notices, says Bill Sarraille, JD, a partner with the Washington, DC based law firm Sidley Austin Brown & Wood, LLP. Even when a hospital pharmacy is not marketing a retail business, it is likely that the pharmacy would have [clients] who have not been through the hospital system [from admission to discharge] and thus have not received a notice of privacy practices, Sarraille says. In those circumstances, the pharmacy is obligated to provide the patient with a notice of privacy practices. Check your compliance St. John Medical Center in Tulsa, OK, fills prescriptions for its employees in the outpatient pharmacy, says pharmacy Director Robert Cather, DPh. The pharmacy began providing a notice of privacy practices to employees when they first filled prescriptions after the April 14, 2003, privacy rule compliance deadline. We just decided this is what we needed to do to be in compliance, Cather says. The hospital administration asked the pharmacy whether dispensing prescriptions in the outpatient setting would require a notice of privacy practices, Cather said. If patients never received a notice of privacy practices elsewhere in the hospital, the pharmacy would have to give them one the first time they filled a prescription, Sarraille says. The pharmacy gives the patient the hospital s standard notice of privacy practices, Cather says. Every employee and family member who fills a prescription at the outpatient pharmacy receives a copy of the notice, he says. Make it visible Your pharmacy must use three different methods to notify patients of your hospital s privacy practices. These methods include the following: Give the patient a copy of the notice of privacy practices when they first receive treatment or fill a prescription. Post a copy of the notice in a location visible to the patient. An appropriate place would be the back wall of the pharmacy area, facing the counter, Sarraille says. Post the notice of privacy practices in a downloadable version on the hospital s Web site, if the hospital maintains such a site. Get a receipt The pharmacy needs to document that each patient received the notice of privacy practices. Having the patient sign a form will serve as proof, Sarraille says. Outpatient pharmacy customers at St. John Medical Center sign a logbook as proof of receipt, Cather says. Staff also place a signed copy of the form in the patient file, he says. TIP: Record the patient s inability or refusal to sign for a notice of privacy practices in a file. If the patient is physically unable to sign the form or refuses to sign it for any reason, note in your records that the patient received the hospital s notice of privacy practices but did not sign for it, Sarraille says. An appropriate entry might say, Mr. Sarraille refused to sign the acknowledgement, but received a copy of the notice of the hospital s privacy practices, Sarraille says. For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Hospital Pharmacy Regulation Report February HCPro, Inc. Page 11

12 Quick tip: Find freezer space to properly store your nasal flu vaccines Scarcity of the influenza vaccine early this winter led many health care facilities to purchase FluMist, the nasal spray brand. The nasal flu vaccine, also called the live attenuated influenza vaccine because it contains a weakened live flu strain, must be frozen at 15 degrees below zero Celsius, according to the Centers for Disease Control and Prevention (CDC). So where do you store it? Todd Faulks, RPh, pharmacy director at St. Michael s Hospital in Stevens Point, WI, needed to find freezer space for 2,500 doses of the spray vaccine. His pharmacy supplies eight clinics in central Wisconsin with FluMist. Finding freezer space is the toughest part, Faulks says. Any freezer will have a vaccine in it. TIP: Do not store the nasal flu vaccine in a frostfree freezer because the temperature cycles may sometimes reach more than 15 degrees below zero Celsius, according to the CDC s influenza Web site, If you must store the vaccine in a frost-free freezer, use a storage box from the manufacturer. You may store it in a refrigerator between 2 degrees and 8 degrees Celsius for 24 hours once it is thawed. It should not be refrozen, the CDC says. St. Michael s Hospital and its clinics reached the end of their flu injection stock near Christmas, Faulks says. Fortunately, flu cases were not widespread early in the winter in Wisconsin. In addition, Faulks accidentally ordered 2,000 extra doses of the flu shot before the season, which reduced the strain on the facility s supply. It was the best mistake I ve made in long time, Faulks says. Hospital Pharmacy Regulation Report Editorial Advisory Board Michael Hoying, RPh, MS Pharmacy Director Fairview and Lutheran Hospitals Cleveland, OH Donna Soflin, PharmD Director of Pharmacy Tri-County Hospital Lexington, NE We want to hear from you... For news and story ideas: Contact Editorial Assistant Matt Bashalany Phone: 781/ , Ext Mail: 200 Hoods Lane, Marblehead, MA mbashalany@hcpro.com Fax: 781/ Publisher/Vice President: Suzanne Perney Executive Editor: Julia Fairclough Robert Marder, MD Director Quality and Patient Safety The Greeley Company Marblehead, MA William Sarraille, Esq. Sidley Austin Brown & Wood LLP Washington, DC Douglas Wong, PharmD Pharmacy Healthcare Solutions AmerisourceBergen Corporation Fort Washington, PA Online resources: Web site: Access to past issues: Subscriber services and back issues: New subscriptions, renewals, changes of address, back issues, billing questions, or permission to reproduce any part of Hospital Pharmacy Regulation Report, please call customer service at 800/ Hospital Pharmacy Regulation Report is published monthly by HCPro, Inc., 200 Hoods Lane, P.O. Box 1168, Marblehead, MA Subscription rate: $299/year or $538/two years Copyright 2004 HCPro, Inc. All rights reserved. Printed in the USA. Except where specifically encouraged, no part of this publication may be reproduced, in any form or by any means, without prior written consent of HCPro, Inc. or the Copyright Clearance Center at 978/ Please notify us immediately if you have received an unauthorized copy. For editorial comments or questions, call 781/ or fax 781/ For renewal or subscription information, call customer service at 800/ , fax 800/ , or customerservice@hcpro.com. Occasionally, we make our subscriber list available to selected companies/vendors. If you do not wish to be included on this mailing list, please write to the Marketing Department at the address above. Opinions expressed are not necessarily those of HPRR. Mention of products and services does not constitute endorsement. Advice given is general, and readers should consult professional counsel for specific legal, ethical, or clinical questions. For permission to reproduce part or all of this newsletter for external distribution or use in educational packets, please contact the Copyright Clearance Center at or 978/ Page HCPro, Inc. Hospital Pharmacy Regulation Report February 2004

13 HIPAA compliance for pharmacy: How to protect patient privacy. A supplement to HCPro, Inc. publications A supplement to HCPro, Inc. publications

14 Dear reader, Almost one year has passed since health care organizations had to comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy rule. Is your pharmacy any more compliant now than it was April 14, 2003? HIPAA was created to ease the transfer of electronic health care data and insurance information among providers. However, exchanging electronic information created privacy and security concerns. Without proper safeguards, people would be able to log on to a health care organization s computer system and access patient information. The HIPAA privacy rule addresses those concerns. Although pharmacies are usually located outside care areas and inpatient pharmacy staff do not often have contact with patients or visitors, you still need to comply with the HIPAA privacy rule. From protecting patient information on medication labels to taking patients into private rooms to have conversations, the privacy rule affects the way you do your job. This special report shows you how to comply with the HIPAA privacy rule. Experts explain what information you need to protect in the pharmacy and how you need to do it. We show you proven methods to educate your staff and provide examples to keep training interesting and make the lessons stick. Sample policies and checklists also explain what you should look for when auditing your pharmacy s HIPAA compliance. Read on to see how HIPAA affects your pharmacy and what you need to do to be in compliance, and stay tuned to future issues of Hospital Pharmacy Regulation Report for more HIPAA updates. Sincerely, Matthew E. Bashalany Editor Hospital Pharmacy Regulation Report Table of contents Five ways to keep patient information private Protect a patient s information during investigations Sample verification of PHI recipients policy Interaction key to successful staff education Reality TV: An example to educate your staff Work with privacy officers to audit HIPAA compliance Sample privacy and security walk-through training checklist HIPAA compliance for pharmacy: How to protect patient privacy

15 Five ways to keep protected patient information private Picture yourself as the patient when dealing with HIPAA compliance. What would you want to keep private? HIPAA to me is very common sense, says Christopher Forst, RPh, MPA, pharmacy director at HealthSouth Medical Center in Dallas. I always look at it as, What do you not want me to know about you? That s how you should be thinking. Although the pharmacy is usually in a separate area of the hospital away from the public, protecting patient information is still important. From medication labels to patient records to computers screens, the pharmacy must safeguard protected health information (PHI). Check out your colleagues simple ways to protect patient information: Look for the minimum necessary 1. Do not access more information than you need, says Laura Krogman, RHIT, director of medical records and privacy officer at Jackson County Public Hospital in Maquoketa, IA. Look at only the minimum information necessary to do your job. For example, if you only need information from the patient s history and physical, do not look at the nursing notes in the medical record. Also, be aware that you can t look up information about a friend or relative in the hospital unless you have that person s permission, says Michael Hoying, RPh, MS, pharmacy director at Fairview Hospital in Cleveland. Those requests for information must go through the medical records department at his hospital, he says. Hoying relates one experience a pharmacy had at another hospital. A pharmacist s wife had complications delivering a baby, so he called his colleagues at the pharmacy to look up her information, a violation of HIPAA. Even if you want to do that, this information is protected and you re not the person in charge of the patient s care, Hoying says. The medical records department would need to handle the request because the reason for the information does not involve patient care, billing, or normal hospital processes, in this case drug use evaluation, Hoying says. Be aware of your surroundings 2. Talking with patients or physicians in public areas about treatment could allow other people to overhear sensitive PHI. Although HIPAA allows this incidental disclosure, staff need to be aware of patients privacy rights, Krogman says. We have to be a lot more cautious than we have been, Krogman says. That s the key thing. Be careful about talking about patients cases in the hallways. For example, you may go from room to room to educate patients about their medications, how to use them, and any possible side effects, Krogman says. If the patient shares a room, consider how you consult with him or her, she says. The roommate doesn t need to know that the patient is taking an antidepressant, Krogman says. TIP: Take the patient into a private room or find a quiet setting to discuss medications or treatments. Destroy patient information 3. Medication labels on drug packages and intravenous (IV) bags often contain the patient name, room number, drug name, and dosage information. That makes the labels protected information, and they need to be destroyed after continued on p. 4 HIPAA compliance for pharmacy: How to protect patient privacy 3

16 Patient information continued from p. 3 the medication is finished to prevent others from reading them. The Hospital of the University of Pennsylvania places all medication labels and IV bags in trash containers, says assistant hospital director and pharmacy services director Richard Demers, MS, RPh, FASHP. Staff send the trash to incinerators to be destroyed. Hospital administrators first considered shredding the labels, but they feared some staff members would become so preoccupied with destroying labels that it would take away from their patient care duties, Demers says. Also consider peeling the labels off medication bottles or blacking out patient names before throwing the bottles in the trash, Forst recommends. The Hospital of the University of Pennsylvania outpatient pharmacy does shred some information, according to Demers. Patient information is pretty private. Just remind people that they aren t supposed to lay things down with patient names on them. Christopher Forst, RPh, MPA cart in a hallway if they need to deliver medications to more than one unit on a floor instead of pushing the cart back and forth, Hoying says. People walking past the unattended cart would be able to see medication labels and other patient information. Fairview Hospital prohibits pharmacy technicians from leaving carts unattended, Hoying says. They must push the cart to each unit when making deliveries. If technicians do not hand the medication to someone, they place it in a drop-off bin in view of the unit secretary. The drop-off bin is under the unit secretary s constant supervision or is in a locked room that is only accessible to authorized staff, Hoying says. Technicians must also be careful to make sure labels are not in plain view of the general public. The pharmacy prints a backup copy of the daily dispensing log, which staff shred within a week. That s more of a larger compendium of patient names, Demers says. If it were to get accidentally disclosed, you have a lot of patient names and their drug information on it. TIP: Store backup information on disk instead of printing a hard copy. Pharmacy staff now save daily work lists to disks, which are password-protected, Demers says. Instead of printing out a second copy of the document and worrying about losing it or having to shred it later, staff can simply access it electronically. 4. Watch your carts Pharmacy technicians may sometimes leave a Staff at the Hospital of the University of Pennsylvania use service elevators to distribute medications to the floors, keeping them out of public view for as long as possible, Demers says. Keep records private 5. Staff should always keep patient records and other patient information with them if they leave their work station, Forst advises. Do not leave papers with patient information unattended. The easiest solution is to keep medical records and other patient information in dispensing areas, including the pharmacy and nursing stations, according to Forst. That s already been pretty routine, Forst says. Patient information is pretty private. Just remind people that they aren t supposed to lay things down with patient names on them. 4 HIPAA compliance for pharmacy: How to protect patient privacy

17 Protect a patient s information during investigations You receive a call from your state board of pharmacy. It needs your help in an investigation. A patient never received the narcotics his or her physician prescribed. The patient s nurse is accused of stealing narcotics from the hospital. The state board of pharmacy needs to determine whether the nurse is pilfering drugs and wants to see the patient s medical records and any orders the pharmacy may have received. What do you do? Can you provide that patient s information to authorities without violating his or her privacy rights? The HIPAA privacy rule considers a state board of pharmacy a health oversight agency, and therefore you can disclose patient information without first obtaining patient approval, says Susan Bishop, MA, senior manager of regulatory affairs and political action for the American Pharmacists Association. You would still have to document the release to inform the patient if he or she asks for a record of protected health information (PHI) disclosures, she says. The provider would have the protection of HIPAA to provide this information, Bishop explains. To be cautious, the provider should take reasonable efforts to limit the disclosure to information that s relevant to the investigation. Protect the patient s identity Take steps to protect patient information during an investigation, says Michael Hoying, RPh, MS, pharmacy director at Fairview Hospital in Cleveland. If it s an initial investigation, the patient identifier could be coded so you can t identify the patient, Hoying says. For [the state board of pharmacy] to know I was in the hospital on certain narcotics is a little much. They need to know how the nurse was using the narcotics, was it documented, was it pulled out of the automated system. TIP: Black out the patient s name, Hoying says. This will protect the patient s identity and still provide authorities with enough information for the investigation. Get legal advice Evaluate each situation separately. Bishop suggests that you determine what information authorities want before turning over patient records. Unfortunately, the regulation does not specify exactly what information should be given, Bishop says. The privacy regulation is very complex. There are some areas where it says, You can do this, but then may list exceptions based on the situation. TIP: Check with your hospital s legal counsel to determine what information you can withhold from authorities and what information you must release. If you receive a subpoena or court order to turn over patient information, you must provide the information or possibly face legal penalties. The subpoena or court order should specify exactly what information you must provide, says Bishop. Check on documentation Law enforcement officials or a health oversight agency may ask facilities not to document the PHI disclosure if they believe it could hinder the investigation, Bishop says. For example, perhaps the patient in the narcotics theft case wants a record of PHI disclosures for reasons other than treatment. If police requested the hospital suspend disclosure, the patient would not know for a certain time period that police had his or her medical information. If law enforcement officials make a verbal request, the facility cannot document the disclosure for 30 days, Bishop says. If officials submit a written request, they may specify the time period they wish to suspend patient access to disclosure information. See p. 6 for a sample policy on verifying the identity of people requesting PHI. HIPAA compliance for pharmacy: How to protect patient privacy 5