Although pharmacies can order drugs & ingredients directly from each manufacturer, they typically contract a primary wholesaler to supply them with these products instead. Pharmacies can have multiple wholesalers, such as for special orders, but they may order 80-90% of their pharmaceuticals from a prime vendor. Because of the large warehouse facilities that wholesalers have, they are capable of buying in bulk & in turn offering pharmacies lower prices than they'd normally be able to get. Best of all, a pharmacy's entire order can be conveniently placed on one invoice called a PO, or purchase order. The PIC, or pharmacist in charge, is ultimately responsible for managing the inventory but the pharmacy technician generally does the ordering & receiving. Since it would be too costly to order every single drug, ingredient & medical device, pharmacies rotate a stock of drugs from an approved dispensing list, or formulary. In a hospital setting this list is created by a pharmacy & therapeutics committee, or P&T. There is often a designated pharmacy buyer who makes these purchases but in a retail setting the head pharmacist may do so, & in an independent retail setting the owner usually does.
In between orders, the pharmacy technician maintains adequate stock levels, monitors for expiration dates, brings the drugs expiring the soonest to the front of the stock, & sees to the proper storage of all medical components & drugs to maximize their safety & effectiveness. The systems used for inventory control & management vary. Some pharmacies will use a point of sale, or POS, system while others will do it manually, or even a combination of both. Large retail & hospital pharmacies tend to use specialized computer systems that automatically record all inventory transactions.
POS systems track drugs & medical components from the time they're ordered to the time they're dispensed, saving the pharmacy technician from having to keep track of stock levels manually. Some POS systems can even create medication re-orders automatically, based on how quickly an item is depleted from the pharmacy's inventory. In this way, the pharmacy technician only needs to review the computer generated orders for accuracy before they're sent. The minimum amount of product left before a re-order is triggered is called the minimum order point & the maximum quantity of product that should be stocked at any given time is called the maximum order level. These levels can fluctuate for any particular item. A good POS-based ordering system will balance cost & savings by keeping enough stock between orders without over ordering. A "want book" can be used to aide in the re-ordering process. Technicians & pharmacists use the want book to write down drugs that are low or out of stock. Maintaining a keen eye on product usage is the key to inventory management success.
Inventory orders can be made over the phone, on pre-printed forms (with several copies for each order), & electronically. A purchase order, at the least, should contain the following information for each drug:
- Drug name
- Dosage form
- Package size
- Concentration / strength
- Package quantity
- NDC number
Wholesale pharmacy suppliers deliver at least twice a day & most orders are delivered within 24 hours of being placed. Some even deliver on the weekends for 24 hour pharmacies. This further saves cost on inventory & ensures adequate stock. However, orders placed directly from the manufacturer can take much longer. Controlled substances are listed on a separate invoice & packed in separate containers from the other drugs. They must be verified by a pharmacist. Chemotherapy drugs & refrigerated/frozen items will arrive in another separate container.
The medications are delivered in totes and/or sealed boxes with corresponding packing slips & invoices. The wholesaler uses the packing slips to pull & pack the pharmacy's order while the invoice is used to bill the pharmacy for the medications that have been ordered & delivered. It's important to verify that what was delivered is what was ordered as there can be mistakes such as missing shipments or even shipments ordered erroneously by the POS system. You do not want to enter a product into the inventory that didn't actually arrive because it won't actually be available when its needed for a patient & consequentially, may be very costly mistake for the pharmacy.
Along with the invoices, you may often receive stickers as well. They are there to make reordering easier as they have specific information for each drug such as the wholesaler's item #, date of receipt, net cost, average wholesale price (AWP), & invoice #. As you go down the invoice line by line, affix the stickers to the particular product. Make sure not to cover any information like the drug name, strength, lot #, expiration #, etc. when affixing stickers.
Here's a receiving inventory checklist:
- Is the name & address on the boxes correct? Especially with chain stores, deliveries can end up at the wrong store
- Does the shipping manifest of the carrier match the actual # of boxes delivered? All boxes should be accounted for & free of leaks & external damage before signing the delivery order.
- As you go down the manufacturer/warehouse invoice and/or packing slip, immediately put away any items marked for refrigeration or the freezer to avoid product damage. Likewise, any chemotherapy & investigational drugs should be handled according to facility protocol.
- Verify for each drug:
- Drug name (brand and/or generic)
- NDC number
- Dosage form
- Expiration date (drugs with substantially short dating should be returned)
- Finally, attach inventory labels to the drugs & place them in their correct storage areas. Rotate the stock by bringing shorter expiration drugs to the front
A code cart, also known as a crash cart, is a wheeled cart containing medication, equipment, & supplies to resuscitate patient who goes into cardiac arrest, stops breathing, or otherwise "crashes". Medical facilities have code carts in all patient care areas. When a patient crashes a "Code Blue" is called and medical personnel wheel the cart to the patient and try to resuscitate them. Since the code cart has medication in it, the pharmacy is responsible for ensuring that it's stocked with the proper medications and IV solutions, unexpired and of high integrity. The medications are typically stored inside of the cart's drawers or on tackle boxes sitting on top of the cart and the pharmacy technician is responsible for the cart's inventory. All other equipment and supplies for the carts are the responsibility of the respective departments. After a crash cart is opened or used, the medication trays are typically brought to the pharmacy and exchanged for new sealed trays. All medications replaced or exchanged must be checked by the pharmacist. Most injectable drugs in the carts come in PFS, or prefilled syringes, as they need to be administered quickly. PFS are easy to open and draw up medications from.
It's important to audit & remove stock that no longer belongs in the pharmacy's inventory immediately. In a hospital setting for example, routine nursing station inspections are performed on a monthly or quarterly basis for recalled, expired, soon to expire & improperly stored drugs in the central pharmacy, satellite pharmacies, nursing units, patient care areas, & any other locations where drugs are stored since the pharmacy is responsible for medication control of the entire facility.
In accordance with Article 20 of the FDA's Pharmaceutical GMP, or Good Manufacturing Practices, recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. Once a product is in widespread use, unforeseen problems can sometimes lead to a recall. Contaminated spinach, for example, led to a recall of spinach products under multiple brand names. Contaminated peanut butter led to the recall of thousands of jars of two popular brands. In both cases, the FDA responded immediately to minimize harm to the public. When an FDA-regulated product is either defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public. Recalls are almost always voluntary. Sometimes a company discovers a problem & recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA's role is to oversee a company's strategy & assess the adequacy of the recall.
These guidelines categorize all recalls into one of three classes, according to the level of hazard involved:
Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.
Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.
Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect & lack of English labeling in a retail food.
There are also market withdrawals & medical device safety alerts.
Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
Schedule I drugs are considered the most dangerous class of drugs with a high potential for abuse & potentially severe psychological and/or physical dependence. As the drug schedule changes-- Schedule II, Schedule III, etc., so does the abuse potential-- Schedule V drugs represents the least potential for abuse. The following lists are intended as general references & are not comprehensive listings of all controlled substances.
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use & a high potential for abuse. Schedule I drugs are the most dangerous drugs of all the drug schedules with potentially severe psychological or physical dependence. Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, & peyote
Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, less abuse potential than Schedule I drugs, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of Schedule II drugs are: Combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, & Ritalin
Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical & psychological dependence. Schedule III drugs abuse potential is less than Schedule I & Schedule II drugs but more than Schedule IV. Some examples of Schedule III drugs are: Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone
Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse & low risk of dependence. Some examples of Schedule IV drugs are: Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, Tramadol
Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV & consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, & analgesic purposes. Some examples of Schedule V drugs are: cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin
Schedule II, or C-II, drugs can only be ordered from a supplier using DEA Form 222. A DEA number is needed to order & dispense schedule II drugs. The DEA Form 222 is a paper form with ten lines on three copies (the brown original, green 2nd copy & blue 3rd copy). In most cases, the pharmacist has the authority to sign the DEA Form 222. The brown & green copies are sent to the supplier & the blue copy is kept by the pharmacy. Upon filling the order, the supplier sends the green copy to the DEA & keeps the brown copy. This is all done to facilitate tracking of C-II drugs by the DEA from its manufacturing site to the supplier, to the pharmacy, & finally to the patient.
There can be no changes, cross outs, erasures, etc. to the DEA Form 222. If there is a mistake, the form must be marked VOID & kept with the other DEA Form 222's. Only pen or typewriter can be used on a DEA Form 222 & only one drug can be ordered per line. The 3rd copy must be kept for 2 years & kept separate from all other records and/or forms. State laws may require longer holding periods When schedule II drugs are delivered, the receiver must be at least 18 years old & the date received must be written on the pharmacy's copy.