Final Policy and Procedure SubmissionIt is time to synthesize the elements of your Policy and Procedure into a document. Your document should be a 3-4-page paper, written in APA format, which draws up

To dispense controlled substances, a pharmacist must know the requirements for a valid prescription which are described in this section. A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an order for medication which is dispensed for immediate administration to the ultimate user (i.e., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription).

A prescription for a controlled substance must be dated and signed on the date when issued. The prescription must include the patient’s full name and address, and the practitioner’s full name, address, and DEA registration number.

The prescription must also include:

1. Drug name

2. Strength

3. Dosage form

4. Quantity prescribed

5. Directions for use

6. Number of refills authorized (if any)

A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner on the date when issued. An individual (i.e., secretary or nurse) may be designated by the practitioner to prepare prescriptions for the practitioner’s signature. The practitioner is responsible for ensuring the prescription conforms to all requirements of the law and regulations, both federal and state.

Who May Issue

A prescription for a controlled substance may only be issued by a physician, dentist, podiatrist, veterinarian, mid-level practitioner, or other registered practitioner who is:

1. Authorized to prescribe controlled substances by the jurisdiction in which the practitioner is licensed to practice, and

2. Registered with DEA or exempted from registration (e.g., Public Health Service, Federal Bureau of Prisons, military practitioners), or

3. An agent or employee of a hospital or other institution acting in the normal course of business or employment under the registration of the hospital or other institution which is registered in lieu of the individual practitioner being registered, provided that additional requirements as set forth in the C.F.R. are met.

Purpose of Issue

To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances.

A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. Pharmacies receive payments from a variety of sources. Payments will vary based on the pharmacy setting and the type of patients served and prescriptions filled. Let's take a look at the variety of payment types by setting:

Community (Retail) Pharmacy

Community pharmacies receive payments for prescriptions drugs and durable medical supplies by billing the patient's insurance plan, or charging the patient cash if they do not have any insurance coverage. Insurance types range from employer-sponsored plans and private insurance (HMOs and PPOs) to state and federal programs such as Medicaid and Medicare. For Medicare patients, most drugs are covered under Medicare Part D. Medical supplies such as diabetic testing strips and certain drugs (some nebulizer medications, anti-rejection or chemotherapy drugs) are paid for by Medicare Part B. Every insurance plan has a formulary and patients either pay a copay or coinsurance. Many patients also have a deductible to meet every year, and will pay for the cost of drugs out of pocket until the deductible is met.

Nearly every health insurance plan contracts out the pharmacy benefits portion to a Pharmacy Benefits Manager (PBM). These PBMs manage the prescription billing and are to whom the pharmacy actually submits prescription claims. Examples of PBM companies include, MedImpact, Prime Therapeutics and Express Scripts.

It is important to note that the pharmacy does not set the patient's copay or coinsurance; that is set up in the specifics of the patient's individual health plan. Pharmacies bill prescriptions electronically to insurance companies; the claim is adjudicated instantly and the patient's copay prints out on the prescription label. This can sometimes be confusing to patients as they may not understand the process. Pharmacy staff can help patients by explaining the adjudication process and directing them to contact their insurance company directly for an explanation of plan benefits. Most insurance cards have help desk phone numbers on the back of the card.

Hospital Pharmacy

Billing for hospital pharmacy services is done quite differently than other settings. Drugs used during a patient's hospital stay are not billed the same way as outpatient prescriptions. The billing is combined with the rest of the charges the patient incurs while in the hospital and is taken care of by the hospital's billing department. Pharmacy staff have very little interaction with the patient's specific insurance plans and therefore do not have to handle insurance rejections.

Long-term Care Pharmacy

Long-term care pharmacies frequently bill insurance companies and Medicare and Medicaid just as community pharmacies do. However, since nursing home stays are sometimes billed to Medicare Part A, the pharmacy will dispense and bill prescriptions for those patients a little differently. Most Part A patients will only receive a short amount of medications at a time, such as a weeks' supply.

The Process from Start to Finish

Pharmacy Technicians are involved in the prescription order process from start to finish.

• In a community pharmacy, this starts with the intake of the prescription or refill request from the patient and ends with ringing up the sale of the prescription.

• In hospital pharmacy it starts with receiving the medication order for the patient from the physician and ends with delivery of the product to the nursing unit for eventual administration to the patient.

• In long-term care pharmacy, the process is similar to hospital pharmacy with respect to the initial medication order intake and delivery process.

There are several critical steps where Pharmacy Technicians play important roles. Those steps, while varying slightly based upon the setting, have some commonalities:

Data Entry

At this step, technicians are creating or updating the patient profile and entering the prescription order. The data entry step also involves calculations of drug doses, quantities and days' supply, proper selection of the correct medication, and input of all other required prescription order elements, including correct directions.

• In a community pharmacy and often in a long-term care pharmacy this will involve billing the patient's insurance plan and handling any insurance rejections.

Prescription Order Filling

This will vary considerably depending on the order to be prepared and the pharmacy setting. In any setting, it will require accurate selection of the drug to be dispensed, the correct quantity, selection of proper container for dispensing, and application of proper labels.

• In a long-term care setting, this often involves filling tablets and capsules into unit-of use blister packs (sometimes called punchpaks). These are intended to allow for safe and accurate administration to the patient by avoiding nursing staff having to take pills from a prescription bottle.

• In a community pharmacy setting, this involves preparing the prescription for the patient to administer it themselves. Proper directions, auxiliary warning labels and patient information leaflets are a part of this dispensing process.

• In a hospital pharmacy setting, this may involve filling unit-dose medications into a cart for delivery to a nursing unit. It will also involve sterile parenteral compounding. Labeling requirements for medications are different for hospital inpatients since the drugs are administered by nursing staff.

Compounding

An exciting part of the Pharmacy Technician's job is compounding. Most pharmacies, regardless of the setting, do some type of compounding. Years ago when the pharmacy industry had just begun, all medications were individually compounded by the pharmacist. If you recall from your study of the history of pharmacy, mass production of pharmaceuticals developed as a result of increasing demand from injuries sustained during the major World Wars. Today, pharmaceutical manufacturers produce most of the medications pharmacies dispense. There is still a need for compounding, however, especially in hospital pharmacies.

Reasons for Compounding

There are many reasons why a patient would need a compounded medication:

• The most obvious is that the product does not come in a dosage form that the patient can take.

• Another would be a patient that cannot swallow capsules may need to have that medication compounded into an oral suspension.

• Perhaps the physician may want to order a cream in a strength that isn't available. For example, the physician may want 2% strength instead of the commercially available 1% strength.

• Sometimes pharmacies compound medications to save the patient money. Compounding generic omeprazole suspension instead of dispensing Prevacid solu-tabs could be a cost-saving example here.

• Hospital pharmacies need to compound sterile parenteral medications to meet the needs of acutely ill inpatients.

• Total parenteral nutrition must be made to exact specifications depending on the patient's nutritional needs. Chemotherapy follows similar preparation requirements.

It is important to remember that patient safety is paramount when performing compounding procedures. Strict sterility guidelines must be followed each and every time in order to avoid contamination. While this is important in any setting, in the hospital environment it is particularly critical. Contamination of sterile IV products could result in patient harm, including infection and death.

Important Aspects of Compounding

How well do you remember these important aspects of compounding?

Personal Protective Equipment

Personal Protective Equipment (PPE) must be put on in proper order prior to compounding. The purpose of PPE is to protect you from coming in to contact with any hazardous substances and also to maintain a sterile environment to prevent compounded products from becoming contaminated.

As a reminder, the proper order for putting on PPE is:

1. Shoe covers

2. Hair cover

3. Face mask

4. Aseptic hand washing

5. Gown

Shelf-life and Beyond-use Dates

No pharmaceutical product has an indefinite shelf-life. All compounded products, both sterile and non-sterile, have beyond-use dates. Once a product has reached its beyond-use date, it must be discarded. The stability of a compounded product starts to diminish after the expiration date, and may result in a loss of effectiveness or degradation of the ingredients, both of which have the potential to cause patient harm.

Remember that sterile compounding is regulated by USP 795 and non-sterile by USP 797. Specific guidelines are included in those resources. Pharmacies will maintain a compounding formula for each pharmaceutical product they compound, whether sterile or non-sterile. Think of this as the "recipe" for making the product. Sterile compounded products have beyond -use dates that are based upon risk categories.

Examples of how to calculate a beyond-use date for various CSPs:

1. An immediate-use CSP was compounded at 4:00 PM on May 3rd of this year and stored at room temperature. When will it expire?

   1. It will expire at 5:00 PM, 1-hour after being compounded.

2. A high-risk category CSP was compounded at 12:00 PM on May 1st of this year and stored in the refrigerator. When will it expire?

   1. It will expire at 12:00 PM on May 4th of this year (3-days after being compounded).

3. A medium-risk CSP was compounded at 8:00 AM on April 1st of this year and stored in the freezer. When will it expire?

   1. It will expire at 8:00 AM on May 16th of this year (45-days after being compounded).

4. A low-risk CSP was compounded at 2:00 PM on April 2nd of this year and was stored in the refrigerator. When will it expire?

   1. It will expire at 2:00 PM on April 16th of this year (14-days after being compounded).

5. Automated systems are now used in a variety of pharmacy practice settings. Automation types are very diverse and range from simple counter-top tablet counting units, all the way to robotic systems that prepare sterile parenteral admixtures.

6. Examples of Pharmacy Automation

7. Community pharmacies often use automated systems that count, package and label prescription drugs, and prepare them for final pharmacist verification. One example of this is a system made by McKesson called ScriptPro. For more information on how the ScriptPro system works, click here: http://www.scriptpro.com/

8. Hospital pharmacies may employ a few different types of automation. In the hospital pharmacy itself, they may use an automated IV admixture system. One example is RIVA. Here is a video that explains how a RIVA system works: RIVA Robotic IV Automation

9. Hospitals may also use a type of automation called an AMDS (Automated Medication Dispensing System). These systems are placed in nursing units on the hospital floors or in the emergency department. These units often look like cabinets and have drawers of differing sizes. The pharmacy is responsible for stocking the units with drugs. Two examples are Pyxis and Omnicell.

10. Pharmacy Technicians Responsibilities with Automated Systems

11. Pharmacy Technicians have many responsibilities with automated systems. The technician is responsible for stocking the system, cleaning and maintenance. Depending on the type of system, the technician may also scan prescriptions and input patient information. As pharmacist's roles continue to expand, technicians will also take on additional duties in the pharmacy. Using automation to help with the manual aspects of filling prescription will allow technicians and pharmacist to have more time to spend with patients and complete other pharmacy tasks.

12. uch of the focus during your training is on hospital and community pharmacy. These two settings generally account for the majority of Pharmacy Technician jobs. However, there are many other fulfilling settings for you to work. Let's discuss a few:

13. Long-term Care Pharmacy

14. A traditional long-term care pharmacy is generally a closed-door pharmacy, meaning that they are not open to the general public as a community retail pharmacy is. Prescriptions are packaged in unit-dose punch-paks or other unit-dose dispensing systems and are delivered to the nursing facility's pharmacy services. These pharmacies service nursing homes, group homes, assisted living facilities and sometimes even recovery centers and jails.

15. Veteran's Administration

16. VA pharmacies strictly serve Veterans and, depending on the facility, may service both inpatients and outpatients. The setting here is quite diverse. Similar to hospital pharmacies, VA pharmacies have specific formularies and the pharmacy will automatically substitute the formulary alternative when necessary.

17. Mail-order Pharmacy

18. Mail-order pharmacies are becoming more and more popular as insurance company plans change to offer incentives for patients to use mail-order service. These are generally large facilities but otherwise operate much like a community pharmacy. The obvious difference is that patients do not come to the pharmacy to pick up medications. Depending on the type of mail-order pharmacy the prescriptions may be shipped anywhere in the country. Many large PBMs operate mail order pharmacies such as Express Scripts and Medco.

19. Specialty Compounding

20. One unique specialization is a compounding pharmacy. Some specialize in compounding parenteral medications for home IV infusion. Others may specialize in bioidentical hormones. In these settings, the Pharmacy Technician may not dispense many "traditional" prescriptions but will have the opportunity to do a lot of sterile and non-sterile compounding. __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________