Pharmaceutical Pollution Prevention (Pharm P2) Wisconsin Healthcare for a Healthy Environment meeting April 9, 2009 Presented by Barb Bickford, Wisconsin Department of Natural Resources Why minimize pharmaceutical waste? Prevent pollution (air, water, land) Save money (purchasing, disposing) Save staff time (purchasing, disposing, recordkeeping, reporting, training) Comply with regulations and accreditation organizations Examples from Minnesota case studies: (see PGH 10 step Blueprint, Appendix C for details) Example 1: A large urban hospital examined the pharmaceuticals being wasted, and simply by adjusting their inventories on the top 10 drugs, saved at least $80,000 per year and eliminates 100’s of lbs of drug waste. Example 2: A small rural hospital reduced inventory and reducing packaging. The monthly overhead in the pharmacy was reduced from $210,000/mo to $87,000/mo. These two changes dramatically reduced the amount of waste from expiring medications and excess stock. How can we minimize it? These ideas are from Step 5 of Practice GreenHealth’s 10 Step Blueprint for Managing Pharmaceutical Waste in the United States. Change purchasing practices – order the dosage forms used most often and multiples of those to achieve strengths for esoteric doses, purchase for least packaging Change prescribing practices – prescribe lifestyle changes instead of drugs when possible, prescribe less toxic drugs (e.g., single doses that don’t have Thimerosal preservative), create and use therapeutic substitution lists Change systems – dispense unit doses, dispense only what is needed, dispense automatically to get records of amounts wasted, change dispensing devices, order drugs more often to avoid outdating, reduce inventory Change usage – flush chemo lines with saline before and after delivering the chemo drug, administer prescribed dose in oral syringes instead of unit dose cups Change labeling -- pre-label for home use so items can be sent home with patients Monitor dating -- especially on crash carts and in areas where drugs tend to outdate before being used, rotate stock nearing outdates to ER 1 How to start? Gather data o Review reverse distribution manifests o Review hazardous waste disposal manifests o Keep or review records of drugs being wasted by flushing o Review any automatic drug dispensing device records o Examine contents of crash carts o Review pharmaceutical purchase orders and formularies Identify the top few drugs being wasted Find out why each drug is wasted o Compare common prescribed dosages with dosage sizes of pharmaceuticals being purchased o Interview everyone involved with the drug: prescribing doctors, pharmacists, purchasing, GPOs, nurses, waste disposers, waste vendors, even patients if necessary o Ask about motivation AND ability. Why they do things that way? What are they able to do or not do? o Sort out whether the reason is individual, related to groups, or to systems or environment Address each reason if possible. Make it difficult to waste drugs. Make it easy to avoid waste. What resources are available? Documents o Practice GreenHealth 10 Step Blueprint for Managing Pharmaceutical Waste in the United States -- regulations, waste minimization (see step 5 of document) and pharm P2 case studies (see appendices) http://www.practicegreenhealth.org/page_attachments/0000/0102/Pharm WasteBlueprint.pdf Websites o Minnesota Technical Assistance program, MnTAP - Case studies http://mntap.umn.edu/health/pharm.htm o WI Department of Natural Resources, WDNR – regulations, pharm P2 http://www.dnr.wi.gov/org/aw/wm/pharm/nonhousehold.htm o UW Extension, Solid and Hazardous Waste Education Center, SHWEC – links, webcasts, web pages, interns http://www4.uwm.edu/shwec/ http://www4.uwm.edu/shwec/wh2e/pharmp2.cfm o Practice Greenhealth – webinars, links to documents http://www.practicegreenhealth.org http://cms.h2e-online.org/ee/hazmat/hazmatconcern/pharma/ o Teleosis Institute (Green Pharmacy) http://www.teleosis.org/gpp-program.php Experts -- internal and external – see next slide Groups (meetings, listservs, discussion fora, newsletters), e.g., WH2E 2 Who can/should help? --- Everyone involved! Waste handlers (housekeeping, environmental services) Pharmacy staff Nurses and doctors Purchasing and GPOs Administration Waste vendors and consultants Technical assistance providers Interns Pharm P2 Exercise Split into groups with a variety of people in each group. Pick a recorder and a presenter. Review “data” (below) for your group’s situation. Imagine every possible reason why it might be easy to waste this drug or type of drug, and record the reasons on the “Pharm wasting” page. Use complete sentences if possible. Do this quickly, round robin style, i.e., go around the circle, either state an idea or pass until no more ideas surface. Don’t judge or discuss the ideas, just list them. Brainstorm ways to avoid wasting the drug and record the ideas on the “Pharm P2” page. Again, state an idea or pass until no more ideas surface, without discussion. If your group has time, pick a preferred Pharm P2 approach for this situation. Leave the charts here –composite results will be sent out to the WH2E listserv. DISCLAIMER: I am not a pharmacist. I have never worked in a healthcare facility. If these examples don’t make sense, are too broad or too narrow, change them. If necessary, make up some “facts” and go on with the exercise. Record any changes you make so your answers make sense to future readers. To generate ideas, consider the following factors and questions: The individual’s motivation -- what makes them want to do the wrong thing or not want to do the right thing? The individual’s ability – why can’t they prevent wasting? What about them personally makes it easy to waste drugs? Social issues – what do people around this individual do that enables wasting or disables pollution prevention? Consider both motivation and ability here too, for coworkers and superiors. Environmental – what is it in the physical surroundings that enables wasting or disables pollution prevention? Systems -- What systems, policies, contracts, union rules, regulations, etc., enable wasting? What prevent or disable waste minimization? 3 Group 1: Sample medications. (Source: case study on MnTAP website.) A small clinic generates pharmaceutical waste from expired, unused, or contaminated medications, products, drugs, and vaccines. The most prominent source of pharmaceutical waste at this clinic is from expired sample medications supplied by pharmaceutical representatives. Physicians then offer the samples to patients as a free trial. The clinic staff members attempt to maintain log books to document sample inventory, usage, expiration, and recalls. However, the logs are not always accurate; some representatives are unaware of the log book and physicians rarely have time to record each sample they distribute. The samples supplied to the clinic by pharmaceutical companies often go unused and expire. Once a month, a member of the clinic staff sorts each of the roughly 100 different types of samples to find those that expired. All of the expired samples must then be documented and properly disposed of. When samples become waste, regulations may require they be disposed of as hazardous waste. Why are these sample medications becoming waste? No inventory control They are outdated Physicians don’t use them because they don’t know what they have. No policy being followed They are accepting too many samples. The samples are not being used for the intended purpose. Doctors may want samples for their personal use. Vendors won’t take them back. (in fact, they can’t take them back.) What might this clinic do to minimize or eliminate sample waste? Limit the volume/number of samples accepted. Have a sorting system. Give out vouchers instead of samples. Rotate stock. Make it a policy for the Reps to leave less. implement and follow an inventory policy. Make a list of certain sampls available. Educate (who?) on each medication and quantity. Review stocks of the same kind of medicine for certain diseases. Have a coordinator of medication control. create guidelines for doctors on the use of medicine. Donate to another organization, e.g., a free clinic for helping others. Return to the manufacturer. Make the reps responsible for disposal. While they cannot take drugs back, they could bring envelopes for mailing the drugs back to the manufacturer. To see how the clinic decided to deal with sample medications, see this case study on the MnTAP website: http://mntap.umn.edu/health/CAHS.html 4 Group 2: Crash boxes. (source: MnTAP case study, Appendix C, PGH 10 step guide) A large urban hospital examined the pharmaceuticals being wasted. Last year, the hospital returned over 900 different outdated pharmaceuticals for credit, most in multiple quantities, through the reverse distribution process. The total cost to purchase was $150,000. Only 202 items were credited for a total of $75,000. Crash boxes, similar to crash carts, were found to be a significant source of pharmaceutical waste. These boxes contain emergency medicine needed to revive someone under cardiac arrest. Drugs that are not used by their expiration date are wasted. When this occurred in the past, the pharmacy exchanged the box and updated all the drugs so they are good for about one year. Nearly outdated drugs were sent for reverse distribution. Many of the drugs found in the boxes are regularly used in other locations in the hospital. Here are some examples of drugs wasted from the crash boxes: A specialty Epinephrine Intracardiac Syringe that was rarely used. It expired or was returned 98% of the time. Glutose Gel in a 45 gram dosage type, much of which was wasted. In most cases, a 30 gram dose of glucose is used. Name brand nitroglycerin bottle of 100-count size. Why are the pharmaceuticals in the crash boxes being wasted? Need to maintain an emergency supply Doses are too high Too many bottles are located in one crash cart Supplies are not being rotated Due to rules and regulations What can this hospital do to eliminate or minimize pharmaceutical waste from its crash boxes? Better inventory control is needed (ie- check inventory levels more often) and order supplies in smaller dosages Use of reverse distribution Pull items off of the shelf right before expiration date to use where it’s needed. Rotate the supplies to higher volume areas (a better rotation system is needed). Get rid of outer packaging Need smaller containers or doses for gel and nitroglycerin Is there a less specialty type of syringe? The specialty syringe is currently wasteful and is rarely used. To see what the hospital actually did, see Appendix C of the 10 step guide http://www.practicegreenhealth.org/page_attachments/0000/0102/PharmWasteBl ueprint.pdf 5 Group 3: Pharmacy (source: MnTAP case study, Appendix C, PGH 10 step guide.) In a small rural hospital, a staff pharmacist noticed many drugs on site were outdated and the facility was stocking too many extra medications. This hospital was checking for outdated drugs every other month, stock was not rotated regularly and par usage reports were not available. Looking closely into quantities ordered and costs, the pharmacist realized that chemotherapy drugs were the largest expense for the facility. They were being ordered monthly and in one month, the facility spent over $90,000. Because of the long holding time for some of the chemotherapeutics, they were outdating on the shelf. Some chemotherapy drugs were very high cost and came in multiple strengths. Why are so many chemotherapy drugs in this hospital being wasted? Those prescrbing are not the same as those ordering No stock rotation Patients have bad reactions to certain chemo drugs and are not able to finish their therapy and the remaining drug is wasted. Not administering full doeses, throwing out the remainder Uncooperative physicians Chemotherapy drugs need to be used quickly to avoid waste, and sometimes they are not used as soon as they are mixed up. Prescriptions via phone can mismatch the paper prescription Over ordering each strength What can this hospital do to minimize wasted chemotherapy drugs? Inventory controls Partial vas chemo order on demand target high use drugs look into strengths vs. volumes prescribed dosages correlate with purchased dosages work w/physicians to go to a standard dose rotate stock check for outdates monthly check automated machines min/max inventories drug spend trending order drugs based on patient's schedule don't order drugs until labs are confirmed and it is nearly time to use them management of drug preparation have patients getting the same treatment come in on the same day require a written prescription To see what the hospital actually did, see Appendix C of the 10 step guide http://www.practicegreenhealth.org/page_attachments/0000/0102/PharmWasteBl ueprint.pdf 6 Group 4: Bedside wasting. (Source: Russell Mankes, Albany Medical Center, Albany New York. Personal communication. Percentages were altered for the sake of the exercise) An urban hospital looked into the amounts of controlled substances that are being wasted after being dispensed. The environmental safety director reviewed weekly print-outs of all drugs dispensed, wasted, returned from the facility’s drug dispensing machines and compared that to the drugs found in the pharmaceutical waste containers from that area for the same time period. An average of 5% of controlled substances dispensed were being wasted at the patient’s bedside. Acetaminophen and codeine (30% of what is dispensed). hydromorphone (27%) midazolam (21%) morphine (2%) hydrocodone and acetaminophen (1%) An additional 7% of dispensed controlled substances were found in the facility’s pharmaceutical waste containers. Testosterone (35% of what is dispensed) ketamine (6%) fentanyl patches(2%) morphine (0.4%) midazolam (0.3%) Why are dispensed controlled substances being wasted in this facility? New regulations on sterility require them to be used withing 24 hours. The drug only comes in certain sizes. e.g., testosterone comes only in 2 sizes, a multidose vial and a pre-set dosage, and ketamin comes in 10 and 20 ml sizes only. There is no other alternative for disposal of fentanyl patches. More variety in packaging would be better but it increases error. Pharmacy companies charge less for larger sizes. OR or the pharmacy sends up standard doses. What can this hospital do to prevent or minimize wasting controlled substances? Make up doses for each patient as needed. Don’t take CS out of the package until just before ready to use. Go to a bar code system. If used properly, this will reduce waste. Direct staff and nurses to start with the small sizes first. Reduce the number of products based on similar applications. Ask the pharm companies to charge the same cost per dose or per milligram. Change the DEA accountability standards. What the hospital did: “We have developed educational information for the patient care staff and conducted follow ups to determine if re-education is 7 needed. We currently do the sorts in house but are looking to out source this to one of the many commercial pharmaceutical disposal programs. We have had excellent by in by our pharmacists as well as our nursing staff. Major stumbling blocks to any program is commingling of sharps and controlled substances in the pharmaceutical waste. This requires re-education and constant quality improvement. Each time we sort the containers, a report is generated to the nurse manager of any maldisposals. This has resulted in a marked increase in compliance where maldisposals of controlled substances are a rarity and few sharps are found in the containers. You must get a buy in from your DEA or State Bureau of Narcotic Enforcement to alternatives to sink or toilet bedside wasting. Generally if the process results in the drug being rendered unrecognizable and unrecoverable you have met the requirements but you need to communicate with your regulators to make sure they agree with your approach. “ Russell F. Mankes, PhD Associate Professor, Neuropharmacology and Neuroscience, Immunology and Microbial Disease Albany Medical Center / Albany Medical College Albany, New York Tel: 518-262-5490 mankesr@mail.amc.edu Group 5 OR cases (for the conference callers) (Source: Russell Mankes, Albany Medical Center, Albany New York. Personal communication.) The director in Group 4’s facility also found that propofol was commonly wasted in large amounts in the operating rooms. Surgeons often ordered the 50 and 10 ml sizes to be “picked” before surgery. The 10 ml size was often unused and the 50 ml size was usually partially used. A 20 ml size of propofol is available. Why is this drug being wasted? The dosage is nto known for each patien and can vary. The surgeons have a standard “pick” list, i.e. they order it for every surgery. The pharmacy purchases only those sizes to streamline ordering. Sequencing of patient order. When the OR schedule changes, drugs ordered for one person get used on someone else. They open the larger size so they don’t have to open multiples of the 10 ml size. They are using a prefilled syringe instead of a multidose vial. The wholesaler contract pricing may favor a certain size. Procedure coding. How the facility charges the patient may dictate the sizes used. What can be done to minimize or avoid wasting this drug? Determine what is the appropriate drug and amount for each patient. Determine if the drug is even needed at all. Open the 10 ml size first during surgery. Determine how much is most often used and order that size. 8 Investigate substitute drugs that would come in different doses. Have stock of this drug in the OR and pull it only if needed. Stop offering the 50 ml size, only order 10s and 20s. Educate the physicians – maybe they don’t know other dose sizes are available. Update the pick cards with the most likely doses to be used. Talk to the Group Purchasing Organization (GPO) about offering other sizes. Make it physically easier to access and use multiple 10 ml vials. Charge the department or surgeon for the disposal cost. Change how they charge the patient. What the hospital did: “We found propofol to be commonly wasted in large amounts. By eliminating the 50 and 10 ml size and only providing the 20 ml size of propofol to the operating rooms, we markedly reduced waste and expect to see over $100,000 in savings from reduced propofol waste. “ Russell F. Mankes, PhD Associate Professor, Neuropharmacology and Neuroscience, Immunology and Microbial Disease Albany Medical Center / Albany Medical College Albany, New York Tel: 518-262-5490 mankesr@mail.amc.edu See also the MnTAP website for another example of waste minimization of OR supplies picked before surgeries. http://mntap.umn.edu/health/hospitals.htm http://mntap.umn.edu/health/pharm.htm 9 “WASTING” IDEAS Group number _____ Who is your recorder? _______________ Recorder: please record all ideas using complete sentences, such as “the nurse is too busy” or “there is no other container” or “it takes too long to order from our supplier” so we can compile your group’s ideas later without inadvertently distorting them. Who is your presenter? ________________ (in case there is time to present) Starting with your recorder, go around the circle, as quickly as possible, stating possible reasons why this drug or type of drug is being wasted or would be easy to waste. Try to state your idea in one complete sentence. Each person should either state a reason or pass, and keep going around the circle until everyone passes in a row. Don’t judge or discuss the ideas at this point. The idea is to think of as many reasons as possible. Did your group change the “facts” of this situation, or change the question in any way? If so, write down those changes here so your answers make sense to people in the future. Why is this drug being wasted? What enables wasting or disables waste minimization? See the factors/questions at the bottom of page 3 to help generate ideas. 10 PHARM P2 IDEAS Group number _____ Recorder _______________ Presenter ________________ Brainstorm ways to minimize wasting this drug or type of drug. Again, each person will state an idea or pass until no more ideas surface, without discussion. Refer to the questions at the bottom of page 3. Write down all ideas. While it may seem silly or unworkable in this situation, you may help generate a solution for someone else who reads the list in the future. What can people do in this situation to minimize or prevent pharmaceutical waste? If you have time, star the solutions your group would actually implement. 11