Delaware Scorecard

Grading Scale:
A – 85-100%, B – 70-84.9%, C – 55-69.9%, D – 40-54.9%, F – 0-39.9%

Grading Categories & Criteria

Delaware Law

I. Laws

2502. Definitions.
The following words, terms, and phrases when used in this chapter have the meanings ascribed to them in this section, except where the context clearly indicates a different meaning.
(1) “Board,” “Board of Pharmacy,” or “State Board of Pharmacy” means the Delaware State Board of Pharmacy.
(2) “Certified pharmacy technician” means a person who is certified by the Pharmacy Technician Certification Board (PTCB) or other entity approved by the Board of Pharmacy.
(3) “Direct supervision” means oversight and control by a licensed pharmacist who remains on the premises and is responsible for the work performed by a subordinate.
(4) “Dispense” means to furnish or deliver a drug to an ultimate user by or pursuant to the lawful prescription of a practitioner. Dispense includes the preparation, packaging, labeling, or compounding necessary to prepare a drug for furnishing or delivery.
(5) “Division” means the Division of Professional Regulation.
(6) “Drug” means:
a. A substance recognized as a drug in the Official United States Pharmacopoeia/National Formulary;
b. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of any illness, condition, or disease in humans or animals;
c. A substance, other than food, intended to affect the structure or any function of the body of a human or an animal; or
d. A substance intended for use as a component of any substance specified in paragraph (6)a., b. or c. of this section. “Drug” does not include devices or their components, parts, or accessories.
(7) “Drug outlet” means a pharmacy, an in-state or out-of-state drug wholesaler, a drug manufacturer, a drug distributor, or a nonpharmacy veterinary drug seller.
(8) “Executive Secretary” means the executive secretary of the Delaware State Board of Pharmacy who shall be a pharmacist.
(9) “Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations” means the publication with that title containing a list of prescription drugs by generic name.
(10) “Intern” means a person who is registered by the Board of Pharmacy and supervised by an approved preceptor and who is completing the practical experience requirement of the Board prior to that person’s licensure as a pharmacist.
(11) “Internship” or “externship” means a period of practical experience established by Board of Pharmacy regulation that must be completed by an applicant for a license to practice pharmacy in this State.
(12) “Manufacturer” means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug, but does not include a person who is engaged in the preparation and dispensing of a drug pursuant to a prescription.
(13) “Monitoring drug therapy” means interpreting and analyzing information needed to evaluate the safety and efficacy of drug therapy.
(14) “Over-the-counter product” or “OTC” means a substance which may be sold without a prescription and which is packaged for use by the consumer and labeled in accordance with the requirements of state and federal statutes and regulations.
(15) “Person” means a natural person or an entity.
(16) “Pharmacist” or “licensee” means an individual licensed by the State pursuant to this chapter to engage in the practice of pharmacy.
(17) “Pharmacy” means a place where drugs are compounded or dispensed.
(18) “Pharmacy technician” means an individual who is not registered as an intern with the Board of Pharmacy or a certified pharmacy technician.
(19) “Practice of pharmacy” means the interpreting, evaluating, and dispensing of a practitioner’s or prescriber’s order. The practice of pharmacy includes, but is not limited to, the proper compounding, labeling, packaging, and dispensing of a drug to a patient or the patient’s agent, and administering a drug to a patient. The practice of pharmacy includes the application of the pharmacist’s knowledge of pharmaceutics, pharmacology, pharmacokinetics, drug and food interactions, drug product selection, and patient counseling. It also includes:
a. Participation in drug utilization and/or drug regimen reviews;
b. Participation in therapeutic drug selection, substitution of therapeutically equivalent drug products;
c. Advising practitioners and other health care professionals, as well as patients, regarding the total scope of drug therapy, so as to deliver the best care possible;
d. Monitoring drug therapy;
e. Performing and interpreting capillary blood tests to screen and monitor disease risk factors or facilitate patient education, the results of which must be reported to the patient’s health care practitioner; screening results to be reported only if outside normal limits;
f. Conducting or managing a pharmacy or other business establishment where drugs are compounded or dispensed; and
g. Administration of injectable medications, biologicals and adult immunizations pursuant to a valid prescription or physician-approved protocol approved by a physician duly licensed in the State under subchapter III of Chapter 17 of this title. Pharmacists shall request which physician or physicians and notify the physician or physicians as designated by the patient of such administration within 24 hours. The notice shall include the patient’s name, the name of the immunizations, inoculations or vaccinations administered, and the date of administration and may be submitted by phone, fax, post or electronically. Upon request a copy of the protocol will be made available to the designated physician or physicians without costs.
(20) “Practitioner” or “prescriber” means an individual who is authorized by law to prescribe drugs in the course of professional practice or research in any state.
(21) “Preceptor” means a licensed pharmacist who is approved by the Board to supervise an intern.
(22) “Prescription drug” or “legend drug” means a drug required by federal or state law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients, subject to § 503(b) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 353(b)).
(23) “Prescription drug order” or “prescription” means the lawful written or verbal order of a practitioner for a drug.
(24) “State” means the State of Delaware.
(25) “Substantially related” means the nature of the criminal conduct, for which the person was convicted, has a direct bearing on the fitness or ability to perform 1 or more of the duties or responsibilities necessarily related to the practice of pharmacy.
(26) “Substitution” means pharmacists selection of prescriber authorized generic or therapeutically equivalent prescription medications. Generic substitution means a drug that is the same active ingredient. equivalent in strength to the strength written on the prescription and which is classified as being therapeutically equivalent to another drug in the latest edition or supplement of the Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as the “Orange Book.”
(27) “Therapeutically equivalent drug” means a drug which contains the same active ingredient or ingredients and is identical in strength or concentration, dosage form, and route of administration and which is classified as being therapeutically equivalent to another drug in the latest edition or supplement of the Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, Evaluations, sometimes referred to as the Orange Book.
(28) “Use or abuse of drugs” means:
a. The use of illegal drugs;
b. The use of prescription drugs without a prescription; or
c. The excessive use or abuse of alcoholic beverage or drugs to the extent that it impairs a pharmacist’s ability to perform the work of a pharmacist.
(29) “Wholesale distribution” means the distribution of drugs to a person other than a consumer or patient. Wholesale distribution does not include:
a. The distribution of drugs within a healthcare group-purchasing organization;
b. The transfer of prescription drugs by a pharmacy to another pharmacy to alleviate a temporary shortage;
c. The dispensing of a drug pursuant to a prescription; or
d. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug:
1. By a charitable organization described in § 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. § 501(c)(3)) to a nonprofit affiliate of the charitable organization to the extent permitted by law;
2. Among hospitals or other health care entities which are under common control;
3. For emergency medical reasons.
(30) “Wholesale distributor” means a person engaged in the wholesale distribution of drugs, including, but not limited to, a manufacturer’s or distributor’s warehouse, a chain drug warehouse or wholesale drug warehouse, an independent wholesale drug trader, and a pharmacy that engages in the wholesale distribution of drugs.
68 Del. Laws, c. 206, § 1; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 412, § 1; 74 Del. Laws, c. 262, § 42; 76 Del. Laws, c. 167, § 1.;

II. Regulations
19.0 Technicians: Qualifications, Training, and Duties
19.0 Technicians: Qualifications, Training, and Duties
19.1 Qualifications and Training
19.1.1 Pharmacy Technicians shall successfully complete a training program. Training shall begin immediately upon initiation of employment and be completed within 90 days. Once training is commenced the technician in training may work in the pharmacy under the direct supervision of a pharmacist or a trained technician.
19.1.1.1 The pharmacist-in-charge is responsible for ensuring proper training of all pharmacy technicians. The actual training may be delegated to a pharmacist or other trained pharmacy technicians.
19.1.1.2 The areas of training required are to be determined by the pharmacist-in-charge and will be appropriate to the practice site and responsibilities assigned to the technicians. Training should be a minimum of 10 hours of didactic training in the following areas:
19.1.1.2.1 general drug and dosage form knowledge
19.1.1.2.2 medical terminology
19.1.1.2.3 pharmaceutical calculations
19.1.1.2.4 prescription labeling requirements
19.1.1.2.5 general filling/dispensing responsibilities
19.1.1.2.6 patient profile record system requirements
19.1.1.2.7 requirements for patient counseling
19.1.1.2.8 confidentiality
19.1.1.2.9 safety practices
19.1.1.2.10 inventory functions
19.1.1.2.11 knowledge of applicable State and Federal Statutes and Regulations
19.1.1.2.12 other site-specific parameters
19.1.1.3 The general content of the training program must be maintained in the policy and procedure manual.
19.1.1.4 Documentation of successful training in specific areas by oral or written evaluation will be maintained and will be available for inspection by the Board of Pharmacy.
19.1.1.5 Supervision. Pharmacy technicians must be supervised by a registered pharmacist who will be responsible for the activities of the pharmacy technicians.
19.1.2 Certified pharmacy technicians must be at least 18 years of age, and successfully pass the PTCB Exam or other national technician certification exam approved by the Board of Pharmacy. Only certified pharmacy technicians or those individuals approved pursuant to Regulations 19.1.2.1 may assist the pharmacist by reconstituting oral solutions and contacting the prescriber or their agent to obtain refill authorization or other patient or prescription information of a non-clinical nature, or assisting the pharmacist with compounding.
19.1.2.1 A pharmacy technician completing a training program approved by the Board in lieu of passing the PTCB exam or passing a national certification program may perform the functions of a certified technician. However, approval to perform the functions of the certified technician is limited to the approved setting and is not transferrable to any other facility.
19.2 Allowed Activities
19.2.1 Except in emergency situations for short periods where staff is unavailable only pharmacy technicians and certified pharmacy technicians may assist the pharmacist or deliver prescriptions in the pharmacy to a patient or the patient’s agent.
19.2.2 Pharmacy technicians and certified pharmacy technicians may carry out any pharmacy-related duty assigned to them by their supervising pharmacist except for those activities specifically excluded by 24 Del.C. §§2507(b) and 2502(19).
13 DE Reg. 506 (10/01/09)
13 DE Reg. 1581 (06/01/10)

References

Delaware Code Title 24, Chapter 25
http://delcode.delaware.gov/title24/c025/sc01/index.shtml

Delaware Administrative Code Title 24, Division of Professional Regulation
http://regulations.delaware.gov/AdminCode/title24/2500.shtml

The data contained in this 2012 Annual Scorecard are accurate as of December 2012 .  Because statutes and regulations are continually revised, the data are subject to change.  These data have been verified with the state board of pharmacy.  This scorecard is updated on an annual basis in order to incorporate statutory and regulatory changes.  A new scorecard will be issued in July 2013.

Scoring rationale for Education and Training:
In order to protect the public and help ensure patient safety, it is important that pharmacy technicians are properly educated and trained.  The most rigorous training is accredited training.  The sole entity empowered to accredit pharmacy-technician training programs is the American Society of Health-System Pharmacists (ASHP).  Please note that this is “programmatic accreditation” – not “institutional accreditation.”  It is the content of the training program – as measured against established standards – that is being evaluated and accredited.  Accredited training is vital to protecting patient safety because it means that a pharmacy-technician training program has met established quality standards to provide assurance and confidence to the public.  For more information, please see http://www.ashp.org/menu/Accreditation/TechnicianAccreditation.aspx.

Scoring rationale for Certification:
Certification is the process by which a nongovernmental agency or association grants recognition to an individual who has met certain predetermined qualifications specified by that agency or association.  This is often determined by an examination process.  Numerous organizations have recommended that the certification exam conducted by the Pharmacy Technician Certification Board (PTCB) should be recognized as the sole, nationally-accredited certification exam for pharmacy technician certification – including the National Association of Boards of Pharmacy (NABP), the Texas State Board of Pharmacy (TSBP), and the U.S. Department of Veterans Affairs (VA). In a recent report, NABP recommended that states be encouraged to “recognize certification by the Pharmacy Technician Certification Board (PTCB).” Moreover, NABP performed a psychometric audit of the PTCB’s pharmacy technician certification examination (PTCE) in 2001 and determined that the PTCE is psychometrically sound, defensible, and valid. In May 2010, the TSBP awarded the PTCB with the Pharmacy Technician Certification Provider contract in Texas. PTCB was selected for the contract after a rigorous bidding and evaluation process that included formal reviews and evaluations from three independent psychometricians. TSBP confidently recognizes PTCB as the single provider of certification examinations for pharmacy technicians. In addition, in June 2010, the VA began requiring PTCB certification for VA pharmacy technicians employed at grade GS-6 and above.

Scoring rationale for Registration/Licensure:
Registration/licensure is the process by which the state maintains a list of all pharmacy technicians in the state and grants permission for an individual to work as a pharmacy technician in the state based on the applicant’s completion of all pre-requisites to registration/licensure – such as required training and certification.

Scoring rationale for Continuing Education:
Continuing education enables pharmacy technicians to fulfill their professional responsibility to maintain competence and up-to-date knowledge and skills in an environment of technological advances and increasingly complex, new medications and therapies.