Basics 5

Advantages of Automation

- reduction in medication errors - increased speed in medication processing - manage and track inventory

Electronic Prescribing

-eliminates illegible prescriptions -uses clinical decision support to reduce error -improves communication between patient and clinician -improves communication thru prescribing chain -increase access to info -improve efficiency

PATIENT COUNSELING

A pharmacy technician may ask patients if they have any questions about their medications, but it is the pharmacist's responsibility, not a pharmacy technician's, to counsel a patient. The following information can be given to either the patient or the patient's representative. This information is not considered to be counseling. • Name of medication • Dosage form • Dosage • Route of administration However, providing the information below is considered counseling because these decisions require professional judgment and they must be made by the pharmacist. • Duration of therapy • Action to be taken if a dose is missed • Common or severe side effects • Interactions and contraindications of the medication (to include food) • Self-monitoring of medication • Proper storage of medication • Special directions for use

IV Radiocontrast agents

A small percentage of patients will have a severe allergic reaction to radiocontrast agents, including: difficulty breathing, cardiac arrest, swelling of the throat or other parts of the body, convulsions, and profound low blood pressure.

CONFUSED DRUG NAMES: There have been many drug names that either look alike or sound alike that have resulted in medication errors and have been identified by reporting them through the ISMP- MERP. Examples of confused drug names are below:

Accupril-Aciphex Clozaril-Cozaril NexIUM- NexAVAR SINEquan-Singulair Actonel-Actos Cozzar-Zocor NovoLIN- HumuLIN sotalol-Sudafed Adderall-Inderal Denavir-indinavir NovoLOG- NovoLIN SUMAtriptan- ZOLMitriptan Advair-Advicor Depakote- Depakote ER Paxil-Plavix Tegretol XR- Tegretol Allegra-Viagra Diabeta-Zebeta Precose-Precare Tobrex-Tobradex ALPRAZolam- LORazepam Dilacor XR-Pilocar PriLOSEC-PROzac traZODone- traMADol Axert-Antivert metroNIDAZOLE- metFORMIN Provera-Proscar tretinoin- ISOtretinoin buPROPion- busPIRone Miralax-Mirapex RisperDAL-Restoril carvedilol-captopril Myleran-Alkeran SEROquel- SEROquel XR CeleBREX-CeleXA Myleran-Leukeran SINEquan-SEROquel

Liposomal forms of drugs - (e.g., liposomal amphotericin B)

Amphotericin b liposome is an antifungal antibiotic. It works by killing the fungus and preventing its reproduction. Liposomal forms of drugs are not chemically stable in aqueous solutions for long-term storage.

Tegretol (carbamazepine)

An overdose can cause seizures, respiratory depression, and respiratory arrest.

Propylthiouracil

Antithyroid drug prototype: reduces iodination of tyrosine and coupling of MIT and DIT in the thyroid; orally active. Tox: rash, agranulocytosis (rare)

ADVERSE DRUG EVENTS

Any injury caused by a drug (at normal dosage or caused by an overdose) and any harm associated with the use of drug (e.g., discontinuation of drug therapy) may result in an adverse drug event. If a patient informs the pharmacy technician of an adverse drug event he or she experienced, the pharmacist should be informed immediately. The pharmacist will collect information regarding the adverse drug event, notify the prescriber to determine if the current therapy should be continued, and if necessary file an FDA Adverse Event Reporting System (FAERS, formally known as AERS) report to the FDA.

Insulin, subcutaneous and IV

Can result in hypoglycemia.

Tips for Recall Compliance

Develop a checklist with all steps needed to conduct a recall so that any staff member can perform the recall procedures and steps are not forgotten. Identify all areas where medications are stored and used. Be sure to include outpatient areas, as well as any off-site locations such as clinics and hospital-owned physician practices. Maintain current lists of medication stocks in each area including medications in automated dispensing cabinets (ADCs). Implement a standard process for delivering floor stock medications that ensures the pharmacy has knowledge of all medication locations and quantities in the event of a recall. Maintain dispensing logs for medication samples that include recording the lot numbers. Include checks for recalled medications in the medication area inspections. Check with state laws, the applicable accreditation agency standards, and organizational policies that may include the notification of patients currently using a recalled medication.

Documentation of Recall Activities

Documentation of recall activities is important for demonstrating compliance with recall notices. Federal regulations require manufacturers to report not only the quantity of recalled product returned, but also the number of receivers of the product that respond and those that do not. The FDA can request the identity of non-responding organizations, which may lead to an inspection. Various government agencies conduct inspections to monitor compliance, including the FDA, boards of pharmacy, and state departments of health. Fines may be levied if noncompliance is found. In addition, surveyors from the Centers for Medicare and Medicaid Services (CMS) and accrediting organizations (i.e., The Joint Commission) may ask for this documentation during surveys. To demonstrate compliance, maintain appropriate records including copies of the recall notice and documents submitted to the supplier as well as documentation of recall activities. The following information should be documented for each recall: Date notified Date(s) action taken Action(s) taken including areas inspected; quantities removed; notification of shipment to wholesaler/manufacturer; notifications to prescribers and staff and other actions required by the recall notice, law or regulation, and organizational policy.

FOOD AND DRUG ADMINISTRATION AND INSTITUTE OF SAFE MEDICATION PRACTICES LIST OF DRUG NAMES WITH "TALL MAN" LETTERS: The look-alike drug names in the tables that follow have been modified using "tall man" (mixed case) letters to help draw attention to the dissimilarities in their names. Several studies have shown that highlighting sections of drug names using tall man letters can help distinguish similar drug names, making them less prone to mix-ups. The ISMP, the Food and Drug Administration (FDA), TJC, and other safety-conscious organizations have promoted the use of tall man letters as one means of reducing confusion between similar drug names.

Drug Names with Tall Man Letters Confused with buPROPion busPIRone clomiPHENE clomiPRAMINE cyctoSERINE cycloSPORINE DAUNOrubicin DOXOrubicin glyBURIDE glipiZIDE hydrALAZINE hydrOXYzine medroxyPROGESTERone methylPREDNISolone, methylTESTERone methylTESTOSTERone medroxyPROGESTerone, methylPREDNISolone NIFEdipine niCARdipine prednisoLONE prednisone SulfaDIAZINE SulfiSOXAZOLE

PHARMACIST INTERVENTION

Drug Utilization Evaluation (Formerly Known as Drug Utilization Review) Drug utilization evaluation is mandated by the Omnibus Budget Reconciliation Act of 1990 (OBRA-90). Every patient who has filled a prescription in a particular pharmacy has a patient profile. During the prescription filling process, a new prescription is checked against all of the medications in the patient's profile to determine if a possible interaction may occur, the drug is contraindicated, or the patient may be allergic to the medication. If the computer system detects a possible interaction, a warning (e.g., changing the color of the computer screen) will appear on the screen to alert the pharmacist or pharmacy technician. The pharmacy technician must stop the filling process and alert the pharmacist. The pharmacist will examine the patient's profile and make a decision whether to continue with the filling process. Some factors that may affect the pharmacist's decision include: • The date the prescription was filled • Whether the medication is still being taken by the patient • Whether the physician was aware of the other medication being prescribed • The severity of the interaction, such as filling a prescription for amoxicillin and patient is taking an oral contraceptive

INSTITUTE OF SAFE MEDICATION PRACTICES LIST OF ADDITIONAL DRUG NAMES WITH RECOMMENDED "TALL MAN" LETTERS Although this list is not sanctioned by the FDA, the ISMP has recommended that the medications listed below also be incorporated using tall man letters.

Drug name with Tall Man Letters Confused with ALPRAZolam LORazepam carBAMazepine OXcarbamazepine ceFAZolin cefoTEtan, cefOXitin, cefTAZidime, cefTRIAXone CeleBREX CeleXA ePHEDrine EPINEPHrine FLUoxetine DULoxetine, PARoxetine HumaLOG HumuLIN ISOtretinoin tretinoin KlonoPIN cloNIDine metFORMIN metroNIDAZOLE NexAVAR NexIUM NovoLIN NovoLOG OxyCONTIN oxyCODONE PriLOSEC PROzac QuiNIDine quinine RisperDAL rOPINIRole SandIMMUNE SandoSTATIN TEGretol TRENtal traMADOL traZODone

ISMP list of high-alert medications

High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.

ISMP

ISMP operates three national reporting programs: The National Medication Errors Reporting Program (ISMP MERP) The National Vaccine Errors Reporting Program (ISMP VERP) The National Consumer Medication Errors Reporting Program (ISMP C-MERP) ISMP encourages healthcare practitioners and consumers to report medication errors, vaccine errors, preventable adverse drug reactions, close calls, and hazards to ISMP. Examples of reportable instances include, but are not limited to: *Errors when prescribing, transcribing, dispensing, and administering medications or vaccines *Errors related to patient monitoring of the effects of medications or vaccines *Errors with medications or vaccines that are captured before they reach the patient *Potential or actual confusion regarding look- and sound-alike drug or vaccine names, packaging similarities, or label ambiguity *Misuse, nonuse, or malfunction of medication-related tools (e.g., syringes, needles), equipment (e.g., tubing, infusion pumps), and technology (e.g., computerized order entry systems, barcode scanning) Note: ISMP asks that you please do NOT submit any provider- or patient-identifiable information.

USP

MEDMARX is an Internet-accessible, anonymous medication error reporting program designed for hospitals and health systems to systematically collect, analyze, and report medication errors. The USP has developed an Internet-accessible method for hospitals to anonymously report and track medication errors in a standard format. The software program, MedMARx®, permits users to track errors within their organization as well as learn from the anonymous experiences of others by searching an aggregate database. MedMARx is designed to augment, not replace, the ISMP MERP and FDA MedWatch programs. While these programs complement each other well, each serves a different purpose. MedMARx lets hospitals internally monitor the progress of their error prevention strategies and share their successes with other hospitals while maintaining awareness of problems and solutions reported by other institutions. Total anonymity of the program overcomes one of the major obstacles to reporting and sharing incident report information and experiences among facilities. This will help national efforts at error reduction and provide useful numerical information about errors. USP is exploring ways for both FDA and ISMP to access the MedMARx database

Epidural/intrathecal medications

Medications such as narcotics, corticosteroids, and antineoplastics often are administered into the central nervous system (CNS). However, such delivery methods (eg, epidural or intrathecal) can leave the patient vulnerable to spinal leaking, bleeding, infection, and toxicity due to exogenous compounds. Drugs that contain preservatives have been linked to adverse effects when administered via the CNS, and as a result, hospitals advise using only preservative-free agents. Still, inadvertent administration of drugs that contain preservatives does occur, making neurotoxicity a real concern.

Over the Counter Recommendations

Only a pharmacist may recommend an over-the-counter (OTC) medication to a patient after evaluating the patient's symptoms and the other medications a patient may be taking. When a pharmacist recommends an OTC medication to a patient, he or she is making a professional judgment that is in the scope of practice of the pharmacist. Pharmacy technicians are not permitted to make professional judgments.

Transdermal Medications

Patients may inadvertently place more than one patch on the skin, forget to rotate sites, and patients may absorb medications at different rates transdermally.

Oral immediate release medications

Patients may not understand the speed with which these medications act on the body, leading to dangerous situations (such as attempting to drive home after administration).

Oral sustained-release formulations

Patients may split or crush these tablets leading to an overdose of medication.

missed dose

Patients should ask the pharmacist what to do if they forget a dose. Situations vary depending on the medication and frequency of dosing. Providing this information is part of counseling and can be done only by a pharmacist.

Recall Notification

Pharmacies are notified of recalled medications from a variety of sources including drug manufacturers, compounding pharmacies, outsourcing facilities, drug wholesalers and other vendors, and government agencies such as the FDA, state departments of health, and boards of pharmacy. When a notification is received, the pharmacy staff needs to communicate the recall information to prescribers and medical staff who dispense or administer medications. Common methods include e-mail notices, memos, staff meetings and posters/flyers in medication rooms. The pharmacy must review dispensing records and medication sample logs to identify patients taking the recalled product. When required by law and regulation or organizational policy, patients must be notified of medication recalls.

Hypoglycemics, oral - [e.g., Glucophage (metformin)]

Sometimes people are seriously injured in accidents related to hypoglycemia, such as falling down stairs. It is equally important to avoid unconsciousness and seizures caused by hypoglycemia, not only because of the increased risk for accidents, but because of the potential for brain damage related to repeated severe hypoglycemia.

FDA

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse drug events and medication error reports submitted to the FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products (MedWatch). FAERS is a useful tool for FDA for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance to reporting regulations and responding to outside requests for information. If a potential safety concern is identified in FAERS, further evaluation is performed. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market. Reporting of adverse events and medication errors by healthcare professionals and consumers is voluntary in the United States. FDA receives some adverse event and medication error reports directly from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report adverse events and/or medication errors to the products' manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations. The reports received directly and the reports from manufacturers are entered into the FAERS database.

STANDARD CONCENTRATIONS OF NEONATAL DRUG INFUSIONS

The ISMP and the Vermont Oxford Network (VON) are working to standardize the concentrations for typical neonatal infusions. The goals of this standardization are to: • Reduce medication error risk when critically ill neonates are transferred from one facility to another • Stimulate development of standardized infusion device drug libraries • Provide the demand necessary for all manufacturers to offer commercially prepared standard solutions

ISMP High Alert Medication Classifications

The ISMP has identified specific categories of medications and specific medications that may cause patients significant harm if they are used in error. The pharmacy should make every attempt to separate or identify these medications from other medications to prevent medication errors.

Inventory Maintenance

The ISMP has identified specific high-alert drug classifications and medications that may cause potential harm to patients if taken inappropriately. These drug classifications and medications should be either identified in some manner or stored away from the other medications to eliminate possible errors. The pharmacy should have a method in place to identify short-dated medications. In addition, the pharmacy should allocate a specific area of the pharmacy for outdated, damaged, and returned medications to be stored. These medications should not be left in their original home in the pharmacy because of the possibility of being dispensed accidentally to the patient. Finally, the pharmacy should identify a place to store recalled medications until they are returned to the drug manufacturer.

Medication Error and Adverse Drug Event Reporting Programs

The ISMP, USP, and the FDA are the three main organizations involved with the reporting of medication errors and/or adverse drug events (ADEs). With practitioners reporting incidents through each national reporting program, the experiences of others can be used to its fullest capacity to help prevent future medication errors and adverse drug reactions.

FDA & CDC

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). The purpose of VAERS is to detect possible signals of adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events (possible side effects) that occur after the administration of US licensed vaccines. Reports are welcome from all concerned individuals: patients, parents, health care providers, pharmacists and vaccine manufacturers.

IV Medications

There is more opportunity for dosing errors, infections, and wrong route of administration when administering IV medications. Reversing an overdose can be extremely difficult.

Parenteral Nutrition

These are complex admixtures and an error in the quantities of ingredients can lead to the creation of a hypertonic or hypotonic solution with dangerous results for the patient.

Antiretrovirals (HIV drugs) [e.g, Sustiva (efavirenz), Epivir (lamivudine)]

These drugs can cause bone marrow suppression, leading to anemia (lack of red blood cells), neutorpenia (low neutrophil count), and thrombocytopenia (low platelet count). Antiretrovirals can also cause: hepatic toxicity & pancreatitis.

Immunosuppressant Agents [Gengraf (cyclosporine), Azasan (azathioprine), Prograf (tacrolimus)]

These drugs increase the risk of infection.

Inotropic agents, IV - [e.g., Lanoxin (digoxin), Primacor (milrinone)]

These medications affect the contraction of the heart muscle.

Moderate sedation agents, IV - [e.g., Precedex (dexmedetomidine), Versed (midazolam)

These medications have been associated with respiratory depression and/or cardiac arrest.

THERAPEUTIC SUBSTITUTION

This is the substitution of a drug product with another that differs in composition but is considered to have the same or very similar pharmacologic and therapeutic activity. State regulations and institutional policies will determine if therapeutic substitution is permissible.

Moderate sedation agents, oral for children - (e.g., chloral hydrate)

Toxic doses (overdoses) can cause a marked drop in blood pressure and severely compromised respiration (breathing).

Flolan (epoprostenol)

Treats high blood pressure in the blood vessels of the lungs (pulmonary arterial hypertension [PAH]). Hypoxemia, hypotension, and respiratory arrest leading to death have been reported in clinical practice following overdosage of Flolan.

epinephrine

Treats severe allergic reactions (including anaphylaxis) in an emergency situation. Overdose may lead to: cerebrovascular hemorrhage from extremely elevated arterial pressure, dyspnea, & fatal cardiac arrhythmia.

Storage and Disposition of Recalled Medications

Upon removal from storage areas, quarantine recalled medications in a designated area in the pharmacy while awaiting disposition. Post a sign or label in the area such as "Recalls - Do Not Use." Recalled products must be disposed of according to instructions outlined in the recall notice. In most cases, recalled medications are returned to the wholesaler or manufacturer.

Identification and Removal of Recalled Medications

When a recall notice is received, the pharmacy must determine if any of the affected product or preparation is present in the organization. All areas where medications are stored and used must be inspected, even areas that obtain medications from sources other than the pharmacy department. All recalled medications must be promptly removed and returned to the pharmacy or other departments, as directed by the manufacturer, for proper disposition (to transfer to another's care). Recall notices should contain specific instructions. Continue to monitor incoming shipments of medications from vendors to ensure that no recalled product is received.

Chemotherapeutic agents, both parenteral and oral [e.g., Doxil (liposomal doxorubicin)]

are designed to damage/destroy human cells.

Adrenergic antagonists, IV (e.g., propranolol, metoprolol, labetolol)

are drugs which act on the nervous system, blocking alpha and beta receptors, resulting in a relaxing effect on muscle cells. Massive adrenergic antagonist overdose typically presents with coma, seizures, bradycardia and cardiogenic shock (a condition in which the heart suddenly can't pump enough blood to meet the body's needs).

Dialysis solutions

are made of a mixture of dextrose, salt, and other minerals dissolved in water. Patients receiving dialysis are at greater risk for cardiovascular events.

Sodium chloride for injection, hypertonic, (greater than 0.9% concentration)

can be fatal if given in a hypertonic state.

Pitressin (vasopressin) IV or intraosseous (into the marrow of a bone)

can be used during cardiopulmonary resuscitation (CPR) to aid in the return of spontaneous circulation. Vasopressin has been shown to increase the risk of death in children with septic shock and it should not be used except on the advice of a Paediatric Intensivist (specializes in the care of critically ill infants, children, & teenagers).

Anesthetic agents, inhaled and IV [e.g., Diprivan (propofol), Ketalar (ketamine)]

can dramatically lower patients' blood pressure, and everyone reacts differently. Determining how much anesthetic should be given to overweight patients can be especially difficult. If improperly dosed, the patient is at risk for serious injury or even death. It is crucial for medical staff to consider the patient's age, weight, state of health, and other medications in the patient's system.

Potassium chloride for injection concentrate

for Injection Concentrate is indicated in the treatment of potassium deficiency when oral replacement is not feasible. This is a highly concentrated (hypertonic) solution which is intended for use in a pharmacy admixture service and is restricted to the preparation of admixtures for intravenous infusion. Potassium Chloride for Injection Concentrate is administered only after dilution in a larger volume of fluid. Direct patient injection of potassium chloride at hypertonic concentrations may be instantaneously fatal.

Opioids (all formulations)

in severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

Trexall (methotrexate)

interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells. Methotrexate is used to treat certain types of cancer of the breast, skin, head and neck, or lung. It is also used to treat severe psoriasis and rheumatoid arthritis. Overdose symptoms may include pale skin, easy bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood or vomit that looks like coffee grounds, and urinating less than usual or not at all. Methotrexate overdose can be fatal.

Antiarrhythmics, IV [e.g., Xylocaine (lidocaine), Cordarone IV (amiodarone)

intravenous antiarrhythmics, whether used to stop arrhythmias or to control or treat pain, affect the central nervous system. Symptoms include numbness of the mouth and throat and can cause problems with swallowing and breathing. The National Institutes of Health, or NIH, warns that patients receiving IV antiarrhythmics require close observation; health care personnel administering antiarrhythmics should do so only when emergency resuscitative equipment is readily available. Trouble breathing can deteriorate into respiratory arrest.

Phenergan (promethazine) IV

is a commonly used product that possesses antihistamine, sedative, anti-motion sickness, and antiemetic effects. Although deep intramuscular injection into a large muscle is the preferred parenteral route of administration, product labeling states that the drug may be given by slow IV push, which is how it is typically given in most hospitals. However, there has been a frequency of severe, tragic, local injuries after infiltration or inadvertent intra-arterial injection, leading to gangrene and amputations.

Pitocin (oxytocin)

is a hormone used to help start or continue labor. Oxytocin causes contractions of the uterus. In women who are unusually sensitive to its effects, these contractions may become too strong. In rare cases, this may lead to tearing of the uterus. Also, if contractions are too strong, the supply of blood and oxygen to the fetus may be decreased.

Nitropress (nitroprusside sodium for injection)

is a hypotensive agent. The principal pharmacological action of sodium nitroprusside is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins. Nitropress can cause a dangerous decreases in blood pressure. In patients not properly monitored, these decreases can lead to irreversible ischemic injuries or death. Sodium nitroprusside should be used only when available equipment and personnel allow blood pressure to be continuously monitored.

Magnesium Sulfate Injection

is a sterile solution of Magnesium Sulfate heptahydrate in Water for Injection, administered by the intravenous or intramuscular routes as an electrolyte replenisher or anticonvulsant. It must be diluted before I.V. use. Magnesium intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. In the event of overdosage, artificial ventilation must be provided.

Drug Recalls

is an action taken when a product is found to be in violation of laws and regulations administered by the FDA. Medications may be recalled for a variety of reasons including safety, mislabeling, contamination and deviations in strength or potency. Recalls may be conducted by a voluntary action by the manufacturer/supplier, by request from the FDA, or by a legally mandated order from the FDA. There are three recall classifications:

Neuromuscular blocking agents - [e.g., Anectine (succinylcholine)]

is an intravenous medication used as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Severe anaphylactic reactions to neuromuscular blocking agents have been reported. These reactions have in some cases been life-threatening and fatal. There is also a risk of bradycardia, which may progress to asystole (a lack of electrical signals to the heart).

U-500 insulin

is five times more potent than standard U-100 and is utilized in patients requiring high doses of insulin. An overdose of insulin may lead to anxiety, confusion, extreme hunger, fatigue, irritability, sweating or clammy hands, trembling hands, rapid heartbeat, seizures, passing out, death. *Please note that all forms of insulin are considered a class of high-alert medications. U-500 insulin has been singled out for special emphasis to bring attention to the need for distinct strategies to prevent the types of errors that occur with concentrated forms of insulin.

Potassium phosphates injection

is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. Potassium Phosphates Injection is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. To avoid potassium or phosphorus intoxication, infuse solutions containing potassium phosphate slowly. In patients with severe renal or adrenal insufficiency, administration of potassium phosphate may cause potassium intoxication. Infusing high concentrations of phosphorus may cause hypocalcemia, which can be fatal.

MedWatch

is the FDA Safety Information and Adverse Event Reporting Program. Health professionals and the general public can use the MedWatch program to report medication errors and medical product injuries. This information will be entered into the FAERS database. MedWatch was created to increase the discovery of adverse events in the general population. This service is freely available on the Internet and serves both health care professionals and the medical product-using public. Making MedWatch open and available on the Internet is crucial, considering most Americans are exposed to the potential risks of medical products. MedWatch focuses on drug and medical device reporting. It offers a choice between a voluntary reporting form, designed primarily for health care professionals and the general public, and a mandatory reporting form, available to manufacturers, importers, and medical product user facilities that manage and store medical products. The latter group is required by law to submit the mandatory form immediately upon discovery of a product malfunction. Printable mail-in forms are available as an alternative to the online submission. The MedWatch adverse event and reporting system allows anyone to report to the FDA injuries and/or deaths caused by medical products. Submitting a report is easy for the average user and only an Internet connection is required. Additionally, the MedWatch information service provides comprehensive, current information on drug alerts, recalls, and labeling changes and offers a variety of delivery methods including RSS, email, and a Current News section on the Website, which is updated regularly.

Sterile water for injection, inhalation, and irrigation

may be used in error (bacteriostatic, or distilled water), and may be given in a hypotonic state.

Pregnancy X Category Drugs - [e.g., Accutane (isotretinoin), Tracleer (bosentan)]

must be avoided in pregnant woman or women who could become pregnant.

Antithrombotic/Anticoagulants (e.g., warfarin, heparin)

patients may experience excessive bleeding.

Recall Class III

products that are unlikely to cause any adverse health problems but violate FDA manufacturing or labeling laws.

Recall Class I

products that could cause serious health problems or death.

Recall Class II

products that may cause a temporary or reversible adverse health problem or where the probability of a serious health problem is remote.

Adrenergic agonists, intravenous (IV) (e.g., epinephrine, adrenaline, phenylephrine, norepinephrine)

sometimes referred to as a sympathomimetic agent, is a drug which acts on what is known as the sympathetic nervous system, preparing the body to act in an emergency. Medically, an adrenergic agonist may be used in the treatment of conditions such as asthma, allergy, cardiac arrest or shock. An overdose of adrenergic agonists can cause breathing trouble, chest pain, uneven heartbeats and dangerously high blood pressure.

Pediatric liquid medications that require measurement

these are dangerous due to the potential for dosing/measuring errors and because they are given you babies/young children.

Cardioplegic solutions

these solutions are used to induce asystole (an absence of electrical signals to the heart) during open heart surgery. An example of a cardioplegic solution would be a mixture of Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Potassium Chloride and Sodium Chloride.

Hypertonic dextrose (20% or greater)

used to provide a maximum source of calories in a minimal fluid volume.

Examples of Pharmacy Automation

• Accusource monitoring system (Baxter, Deerfield, IL): Automated total parenteral nutrition compounder with total nutrient admixture • Baker cells (McKesson Corp., San Francisco, CA): An example of an automated counting and filling device. Each cell contains a particular medication. The desired quantity is entered, and the Baker cell counts the desired quantity for the pharmacist. • Bar code scanners: The FDA requires that bar codes be placed on all human drugs and biological agents, which will result in an improvement in both patient and medication safety. The potential for errors will be greatly reduced because the right patient will be receiving the right drug and dose at the right time through the right route. • A physician order entry system results in a reduction of medical errors by having complete and accurate information, accurate dose calculation, and appropriate clinical decision support. • Mobile robots that travel through a hospital to the various nursing units deliver medication. • Pyxis (Cardinal Health) is an automated point-of-use storage system supporting decentralized medication management. The Pyxis Med Station System makes floor stock items available to nursing staff. Servers are connected to a Pyxis server and link hospital billing and information systems together. Bar code scanning ensures accurate medication dispensing, features to prevent loading of the wrong medication, and active alerts to provide an added safety precaution for high-risk medications.

Examples of Medications That Should Not Be Crushed

• Accutane (isotretinoin) • Actonel (risedronate) • Adalat CC (nifedipine) • Allegra D (fexofenadine/pseudoephedrine) • Ambien CR (zolpidem) • Augmentin XR (amoxicillin/clavulanate) • Avodart (dutasteride) • Calan SR (verapamil) • Cardizem (CD, LA, XL) (diltiazem) • Cymbalta (duloxetine) • Depakote (divalproex sodium) • Detrol LA (tolterodine) • Ecotrin (aspirin) • EES 400 (erythromycin ethylsuccinate) • Effexor XR (venlafaxine) • Evista (raloxifene) • Flomax (tamsulosin) • Glucophage XR (metformin) • Indera LA (propranolol) • Janumet XR (sitagliptin/metformin) • K-Dur (potassium chloride) • Lithobid (lithium) • MS Contin (morphine sulfate) • Nexium (esomeprazole) • Nitrostat (nitroglycerin) • Paxil CR (paroxetine) • Prilosec (omeprazole) • Ritalin (LA, SR) (methylphenidate) • Seroquel XR (quetiapine) • Tessalon Perles (benzonatate) • Wellbutrin (SR, XL) (bupropion)

ERROR REDUCTION: WAYS PHARMACY TECHNICIANS CAN REDUCE ERRORS

• Always question illegible handwriting. • Question ambiguous orders. • Question the prescription order that uses abbreviations you are not familiar with or that are uncommon. • Do a mental check on dosage appropriateness. • Keep your work area free of clutter. • Always keep the prescription and the label together during the filling process. • A new prescription should be viewed at least three times during the filling process. • Check the drug three times: when removing the medication bottle from the shelf, after placing the medication in the bottle, and before returning medication bottle to the shelf. • Make sure the label is always compared with the original prescription by at least two people. If an error occurs at this stage, the refills may be filled incorrectly as well. • Observe and report pertinent OTC purchases. • Triple check your work. • Verify your own data entry before processing.

POTENTIAL INAPPROPRIATE MEDICATION USAGE IN ELDERLY PATIENTS There are many drug classifications and medications elderly patients should use cautiously because of their adverse drug effects. These include:

• Anticholinergic Drugs: First-generation antihistamines such as Chlor- Trimeton (chlorpheniramine), Atarax (hydroxyzine), Benadryl (diphenhydramine) and Periactin (cyproheptadine) should be avoided because they may cause confusion, constipation, and dry mouth. • Benzodiazepines such as lorazepam cause drowsiness. • Nonbenzodiazepine sedatives such as zolpidem cause drowsiness. • Androgens such as methyltestosterone may cause cardiac problems. • Estrogens with or without progestins may cause carcinogenic effects. • Insulin: the risk of hypoglycemia is greater. • Sulfonylureas such as glyburide may cause hypoglycemia. • Nonsteroidal antiinflammatory drugs (NSAIDS) such as ibuprofen and naproxen increase the possibility of gastrointestinal (GI) bleeding. • Aspirin may increase the risk of GI bleeding. • Skeletal muscle relaxants such as Soma (carisoprodol) and Flexeril (cyclobenzaprine) have anticholinergic effects. • Oral decongestants such as pseudoephedrine lead to central nervous system stimulation. The pharmacist should be notified when warnings appear for elderly patients who may be prescribed these medications. The pharmacist will contact the prescriber to determine whether an alternative treatment might be more appropriate for the patient.

WAYS PHARMACISTS CAN DECREASE ERRORS

• Avoid using abbreviations that have more than one meaning and verify the meaning of these abbreviations with the prescriber. • Check prescriptions in a timely manner. • Document all clarifications on orders. • Encourage OTC and herbal remedy documentation. • Initial checked prescriptions. • Use the ISMP Medication Error Reporting Form to inform manufacturers of errors caused by commercial packaging and labeling. • Visually check the product in the bottle. • Educate patients to always verify their insulin purchases.

Drug Adherence

• Calculate how many days the prescriptions should last (i.e., day's supply = quantity dispensed/quantity taken each day). • If the patient is seeking a refill early or the prescription is lasting longer than it should, the pharmacy technician should bring this to the attention of the pharmacist. If the directions have changed, a new prescription should be issued from the physician. • The pharmacist should empathetically determine the reason for noncompliance.

MEDICATION ERROR REPORTING AND PREVENTION RECOMMENDATIONS FOR VERBAL ORDERS Initiate institutional policies that:

• Describe limitations or prohibitions on use of verbal orders. • Provide a mechanism to ensure validity/authenticity of the prescribers • List the elements required for inclusion in a complete verbal order. • Describe situations in which verbal orders may be used. • List and define the individuals who may send and receive verbal orders.

MEDICATION ERROR REPORTING AND PREVENTION RECOMMENDATIONS

• Develop written policies and procedures for persons who administer medications. • Provide training to personnel who are responsible for medication management. • Ensure that controlled medications are stored properly to prevent theft and diversion. • Encourage personnel to report medication errors to appropriate drug error reporting programs. • When a medication error occurs, evaluate possible causes to improve the facility's system for drug management and to prevent future errors.

MEDICATION ERROR REPORTING: TRACKING MEDICATION ERRORS The following agencies track medication errors:

• FDA MedWatch is a voluntary program that allows the reporting adverse health events and medical problems. • The ISMP oversees the MERP. • The FAERS is a database that contains information regarding both adverse events and medication error reports submitted to the FDA. • Institute of Medicine (IOM) • TJC • National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) • United. States Pharmacopoeia (USP): MedMarx is a national, Internet- accessible database used by hospitals and health care systems to track and trend adverse drug reactions and medication errors. • The FDA and Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System is a postmarketing safety surveillance program that collects information about adverse events that occur after the administration of U.S.-licensed vaccines.

ERROR PREVENTION STRATEGIES TJC assists organizations implement safety standards to reduce medication errors in five distinct areas:

• Leadership process and accountability • Competent and capable workforce • Safe environment for staff and patients • Clinical care of patients • Improving quality and safety

GUIDELINES FOR TIMELY ADMINISTRATION OF MEDICATIONS The ISMP developed guidelines for the administration of medications in an acute care facility where medications are to be administered to the patient up to 1 hour before or 1 hour after the scheduled time. The guidelines apply only to scheduled medications that are all maintenance doses that are administered in a standard, repeated cycle of frequency, such as q4h, QID, TID, BID, daily, and so on. Scheduled medications do not include:

• STAT and NOW doses • First doses and loading doses • One-time doses • Specifically timed doses • On-call medications • Time-sequenced or concomitant medications • Medications administered at specific times to ensure accurate drug levels • PRN (as-needed) medications • Investigational drugs Time-critical scheduled medications are those for which early or delayed administration of maintenance doses of greater than 30 minutes before or after the scheduled time may cause harm or result in sub-optimal therapy or pharmacologic effect. A hospital will determine which medications in its formulary will be placed on this list. Nontime critical scheduled medications are medications where early or delayed administration within a specific range of either 1 or 2 hours should not cause harm or result in suboptimal therapy or pharmacological effect. It is the responsibility of both pharmacists and pharmacy technicians to ensure that a patient's medication is present when it is to be administered to the patient by a member of the nursing staff.

ISMP- DO NOT CRUSH LIST The ISMP has established a list of medications that should never be crushed before administration because of a variety of reasons, which include:

• Slow-release dosage form • Enteric-coated dosage form • May irritate the mucous membrane • Taste • Skin irritant • Liquid filled • Sublingual dosage form • Film-coated dosage form • Effervescent tablet • Teratogenic effect (women who are or may become pregnant should not handle crushed or broken tablets because the medication can be absorbed into the body and produce birth defects to the fetus) • Local anesthesia of the oral mucosa (this may result in choking)

AMERICAN SOCIETY OF HEALTH SYSTEM PHARMACISTS, INSTITUTE OF SAFE MEDICATION PRACTICES, THE JOINT COMMISSION, INFUSION NURSES SOCIETY, AND NATIONAL PATIENT SAFETY FOUNDATION RECOMMENDATIONS FOR PARENTERAL MEDICATION ERROR PREVENTION

• Standardize product concentrations, patient care procedures, and equipment. • Develop toolkits and other resource material to enhance adoption of recommendations. • Improve mechanisms for communicating in a timely manner specific information about medication errors that can reduce the likelihood of the event from occurring again.

ways pharmacies can reduce errors

• Use electronic prescribing. • Automate and bar code all fill procedures. • Encourage physicians to use common terminology and abbreviations. • Maintain a safe work area. • Provide adequate computer applications and hardware. Use the metric system. A leading zero should always be present in decimal values less than 1. Remember that an error of this nature will mean a dosage error of at least 10-fold. • Provide adequate storage areas. • Maintain accurate and up-to date patient profiles to include OTC, nutritional, and herbal supplements. • Make sure prescriptions and orders include the correctly spelled drug name, strength, appropriate dosing, quantity or duration of therapy, dosage form, and route. Missing information should be obtained from the prescriber. • Never used error-prone abbreviations in internal communications, telephone and verbal prescriptions, computer-generated labels, labels for drug storage bins, and medication administration records. • Use both the brand and generic names on a drug label. • Configure computer selection screens to prevent look-alike drug names from appearing consecutively. • Scan the original prescription. • Scan the prescription label and the UPC code found on the bulk medication bottle. Keep dangerous or high-alert medications in a separate storage area of the pharmacy. Know the common look-alike and sound-alike drugs and keep them stored in different areas of the pharmacy so that they will not be easily mistaken