Addressing Drug and Device Recalls in Hspitals Develped by participants at the meetings f the Califrnia State Bard f Pharmacy s Subcmmittee t Evaluate Drug Distributin in Hspitals January 2010
BOARD MEMBERS Kenneth H. Schell, Pharm.D. President Randy B. Kajika, Pharm.D. Vice President Stanley C. Weisser, R.Ph. Treasurer Ryan L. Brks, Public Member Ramón Castellblanch, Public Member Rsalyn Hackwrth, Public Member Gregry N. Lippe, Public Member Rbert E. Swart, Pharm.D. Debrah Veale, R.Ph. Shirley Wheat, Public Member Tappan Zee, Esq., Public Member Virginia Herld Executive Officer January 2010 1625 N. Market Blvd., Suite N-219, Sacrament, CA 95834 ph 916.574.7900 fx 916.574.8618 www.pharmacy.ca.gv
Nte: This is a guidance dcument (nt law, statute r regulatin) fr recalls in hspitals, and represents a list f pssible actins t take t remve recalled drugs frm all patient care areas in hspitals. These practices can be summarized as: 1. Pre-psitin the facility t receive ntice f recalls frm multiple surces, 2. Identify if the facility has the prduct, 3. If s, quickly remve the prduct frm all patient care areas, 4. Identify, assess, ntify and treat patients wh may have received the prduct, 5. Identify alternative prducts t maintain therapy, 6. Return the quarantined prduct, 7. Dcument and evaluate the prcess.
Actins fr Recalls A prduct recall includes any ntice frm a drug manufacturer, whlesaler and/r FDA t return a drug prduct r medical device due t suspected cntaminatin r defect. Fr ease f discussin thrughut this discussin, drug prduct als includes medical device. Pre-Recall Planning The pharmacy department has direct authrity and ultimate respnsibility fr implementatin f the facility s recall plicy and prcedures. T achieve this, the hspital s administratin needs t prvide full supprt t the pharmacy department in executing the duties described belw. The pharmacy department shuld develp and implement written plicies and prcedures fr the effective and efficient remval f recalled prducts frm all patient care areas (inpatient and utpatient) and strage areas. Hwever, plicy and prcedure develpment must be multidisciplinary in apprach. At a minimum, representatives frm nursing, medicine, pharmacy services and administratin shuld be invlved. The fcus shuld encmpass all patient care areas, including utpatient services. 1. Cmpnents f Written Prcedures fr Recalls: Develp a duties r detail list with all steps needed t be taken during a recall s that any staff member can effectively carry ut the steps. The prcedures shuld identify the specific rles and respnsibilities f all persnnel invlved in the recall prcess in sufficient detail t ensure maximum cmpliance. Fr many hspitals, a dedicated and trained recall team that knws all the plicies, prcedures and pertinent regulatins will prvide best supprt t the hspital in respnding cnsistently in handling recalls. In ther hspitals, fewer staff may be invlved. Ensure knwledge f drug recall prcedures by develping facility-wide systems and prviding peridic training at least annually. Ensure that: Staff understand federal and state regulatins gverning drug prduct r medical device recalls. Cmmunicatin ccurs abut all pertinent recall infrmatin and a ntice f the recall is distributed t all impacted areas and apprpriate staff in a timely manner. Varius cmmunicatin avenues thrughut the rganizatin are used t spread ntices f recalls (email, fax inter-campus, interffice mail, hspital newsletter sme f these methds are t slw but can serve as reminders). Flyers are psted abut recalls; fr example, pst flyers saying bad heparin with the lt numbers recalled. There is a centrally lcated repsitry f recall ntices that is readily retrievable. 2. Knw All Drug Strage Areas in Hspitals: Maintain cntrl ver drug strage everywhere in the hspital. Identify all lcatins where drugs are kept thrughut the hspital: prhibit strage utside these areas.
Allw n drugs in the hspital that were nt purchased thrugh the pharmacy. There shuld be n allwance fr drugs t be brught in fr patient use withut the express knwledge and apprval f the pharmacy department. Medical devices shuld be inventried and cntrlled in a manner that facilitates their rapid lcatin by the manufacturer, mdel prduct r serial number. Minimize the number f and maximize the quality and authrity f the individuals carrying ut mnthly inspectins. Ensure that smene is authrized t d what is necessary t secure the drug supply thrughut the facility. During mnthly inspectins, check fr recently recalled drugs t duble check they have been remved frm the hspital s supplies. 3. Once a Recall Has Been Initiated: Establish a centralized methd t receive, interpret and disseminate infrmatin abut recalls, especially Class 1 recalls. Assess the actual r ptential clinical significance f the recall n patient care, and identify alternative drug therapy fr recalled drugs r devices. Specify wh is respnsible fr checking specified drug strage areas and btain a signff by the individual cnducting the check. Establish timelines fr cmpletin f each task. Establish a methd t ensure all drug strage areas are checked, and then perfrm an audit. Fr example, after recall ntices are faxed t all pharmacies, require all respnses cnfirming that all recalled drugs have been remved be returned within 72 hurs. After the faxes are received, cnsider duble checking via audit f the drug strage lcatins. Ensure that recalled drugs and devices are stred by the pharmacy in an area clearly designated as a quarantine area until dispsed f as directed in the recall ntice. 4. Additinal Steps: Mnitr subsequent prduct shipments t ensure recalled prducts are nt shipped int the facility. Establish a system by which patients wh may have been affected by the recalled prduct are identified and the patients primary physician is ntified and prvided with recall infrmatin. Establish a system t mnitr implementatin n a regular basis t prvide insight int pprtunities fr prcess imprvement. 5. Quality Assurance and Prcess Imprvement: Implement mnthly reprting f recall activities. Such reprts shuld include: The number f recalls received by the rganizatin. The number f recalls requiring actin by the rganizatin. The length f time frm receipt f the recall ntice until clsure is attained. The number f patients affected r ptentially affected, including any adverse utcmes. The lcatin and quantity f recalled prduct returned.
Identificatin f any prblems encuntered with the recall prcess. Share these reprts with staff t review and identify pprtunities fr prcess imprvement. 6. Activities with Drug Whlesalers t Imprve Recalls: Have a whlesaler representative dedicated t the hspital r hspital grup. Alternatively, designate ne persn as the hspital s liaisn with the whlesaler. This persn can run reprts and identify recalled drugs purchased by the hspital. Cllabrate and cmmunicate with the whlesaler n drug shipments and recalls, including shipments after a recall is annunced. 7. Technlgy-Based Slutins: Stck drugs in autmated dispensing cabinets (Pyxis, Omnicell) t easily and quickly d an electrnic lckut fr recalls. Implement an adverse drug reactin system that allws better tracking f what ccurred in relatin t a recalled drug was administered t patients. Outcme: better cmmunicatin with patients. Obtain an electrnic receipt f recall ntices frm multiple surces. IMPROVEMENTS FOR THE RECALL SYSTEM: 1. Ntificatin System fr Recalls Needs Imprvement: Have a mre effective recall ntificatin system that riginates in ne place, listing what the issue is, what shuld be dne, what steps shuld be taken, etc. Having ne ntice frm ne surce with all the relevant infrmatin wuld minimize cnfusin. Encurage the FDA t develp a standardized frmat fr recalls, including listing the reasn fr the recall, s adherence is easier t achieve. Recall ntices shuld state whether the recall is a Class I, II r III recall. Als, ntices shuld have clear instructins abut what actins t take. Encurage whlesalers t cmmunicate recalled lt numbers t purchasers f their prducts. Recalled prducts repackaged under anther name r brand by a different distributr shuld be recalled by all names, and a separate recall ntice shuld be listed fr the distributr. 2. Establish Tracking f Drugs Thrughut the Hspital: Institute bar cding t better track drugs thrughut the facility. Hspitals need t priritize bar cding technlgy. Electrnic tracing r ntificatin (e.g., secure email) f recalls wuld be helpful. Institute RFID r bar cdes and advcate t have standardized methdlgy in the way the infrmatin is sequenced. This shuld apply t the entire lifecycle f the prduct, s a recalled prduct can be identified in the hspital. E-pedigree requirements wuld enable better executin f a recall within a hspital.
3. Methds f Obtaining Recall Infrmatin: Redundant ntificatin systems shuld be established t ensure the facility receives recall ntices. Facilities are encuraged t subscribe t mre than ne methd available fr prduct recalls. Sle reliance n recall ntificatin via the US Pstal Service is nt acceptable. Recall ntices can arrive at hspitals via fax, certified letter, standard mail, emails frm manufacturers, whlesalers, r ntices with invices fr ther drugs. Listserves f the FDA (http://www.fda.gv/safety/medwatch/default.htm, the Califrnia Bard f Pharmacy and ther entities can prvide recall infrmatin. Clsely wrking with the hspital s drug whlesalers will imprve ntice and distributin f recall infrmatin. 4. Administrative Plicies Require that drugs be stred in specific lcatins and institute cnsequences when drugs are stred ut f these areas. Increase the authrity f the pharmacist-in-charge t better cntrl where and hw drugs are stred. Expand plicies t increase respnsibility f ther department heads during a recall. All health care prviders that are tuching the drug are accuntable. Bring tgether management, Califrnia Hspital Assciatin, Medical Bard, Nursing Bard and Bard f Pharmacy. Other health care prviders shuld be cited and fined fr their failure t fllw the facility s recall prcedures. 5. Gegraphic Cncerns: Ensure there is a system t identify all utpatient clinics and ther departments that are n the facility s license. This will help clarify what a pharmacist-in-charge is respnsible fr. Establish guidelines fr an authrized medicatin strage area. Outside medicatins frm vendrs r cntractrs shuld nt be allwed in the hspital.