I have no relationships withcommercial interests related to thecontent of my presentation.
Objectives Define and apply recent statutory changes affecting the practice of pharmacy. Describe and apply recent rules-based changes affecting the practice of pharmacy. List and apply commonly confused legal precepts to the practice of pharmacy.
State Bills Introduced Concerning Pharmacy S.112, introduced by Senator Purcell To “disapprove” Board rule 21 NCAC 46.1418, Supervision of Unit Dose Medication Systems No co-sponsors Presently sitting in the Senate Health Care Committee No action has been taken on the bill
Pharmacy Technician Opportunities in the Inpatient Hospital Setting Board has adopted a rule that would pharmacy technicians with advanced training in the hospital practice setting to shoulder more responsibilities in various unit dose activities. Requires the technician to obtain an associate’s level degree in pharmacy technology (programs underway in several NC community colleges) Is voluntary for hospitals. A technician does not have to obtain advanced training to be a technician at a hospital – only to take on the additional responsibilities specified in the rule.
Pharmacy Technician Opportunities in the Inpatient Hospital Setting The rule cleared Rules Review Commission and has been published. A small handful of pharmacists and others, however, demanded legislative review of the rule. Rule would have gone into effect in late March 2011 if S.112 had not been introduced Fate of the rule now depends on S.112 If passed, the rule is killed If affirmatively voted down, rule goes into effect If S.112 dies without a vote, rule would go into effect when the General Assembly adjourns
Rule Process This rule was passed after 17 public actions at Board meetings over a five-year period. The rule was passed after two pilot studies at North Carolina hospitals (spanning three and two years, respectively) demonstrated safety. The rule was passed after notice, comment, and public hearing. Many comments were provided to, and considered by, the Board.
What the Rule Is Not A great deal of misinformation has circulated regarding the rule in recent months. It does NOT permit “technician dispensing.” It is strictly limited to inpatient hospitals. It is voluntary for hospital implementation. It does not apply to any other pharmacy practice setting. There is no pilot project, proposed rule, or even discussion occurring at the Board to extend the rule beyond in the inpatient hospital setting.
Pharmacist Vaccination S.246, introduced by Senator Hartsell, co- sponsored by Senators Atwater and Mansfield Referred to Senate Health Care Committee Expand vaccination authority by pharmacists
Backdrop: Flu Vaccine Administration Emergency Rule Pharmacists were always able to administer H1N1 vaccine under the existing vaccination Per a request from Dr. Jeffrey Engel, State Health Director, the Pharmacy and Medical Boards passed an emergency amendment to the pharmacist vaccination rule in November 2009 authorizing pharmacists to administer seasonal and H1N1 influenza vaccine to patients age 14 and older. This authority, however, expired in July 2010. Only a permanent rulemaking proceeding could have extended the authority. The Medical Board again proved difficult to deal with on this issue, and firmly opposed any permanent change. North Carolina lags significantly behind many states on this issue.
S.246 Adds vaccination authority to the Pharmacy Practice Act Would eliminate the need to get rulemaking agreement from the Medical Board on this issue. Reorganizes the definition of “practice of pharmacy” – no deletions, simply reorganization (which, candidly, makes the definition much easier to read).
S.246 Vaccinating Pharmacist qualifications: provider level CPR training certificate program in vaccine administration three hours of vaccine-related CE every two years training in use of the Division of Public Health’s vaccine registry.
S.246 Vaccination Authority Minors, age 7 to 14, pursuant to prescription order and with parental consent. Minors, age 14 to 18, no prescription order necessary, with parental consent Adults 18 or over at patient’s request.
S.246 Recordkeeping/Reporting Maintenance of all vaccines administered in patient profile Notify primary care provider (if identified by patient) within 24 hours Appropriate reports to vaccine registry with 24 hours
Drug Donation S.L. 2009-423 creates N.C.G.S. § 90-85.44, authorizing donation and redispensing of certain drugs, supplies, and devices Who can donate? Patient or patient’s family member, manufacturer, wholesaler, pharmacy Who can participate? Any licensed pharmacy. Who can receive? Uninsured or underinsured patient meeting criteria to be established by the Board.
Drug Donation What can be donated? Drugs, supplies, or a medical device: That is in the original, unopened, sealed, and tamper- evident packaging or, if packaged in single-unit doses, the single-unit dose packaging is unopened. The pharmacist has determined that the drug, supplies, or medical device is safe for redistribution. The drug bears an expiration date that is later than six months after the date that the drug was donated. The drug, supplies, or medical device is not adulterated or misbranded, as determined by a pharmacist. The drug, supplies, or medical device is prescribed by a practitioner for use by an eligible patient and is dispensed by a pharmacist.
Drug Donation Rulemaking The Board has completed rulemaking (effective June 1, 2010) Topics addressed by the rule: Requirements for free clinics and pharmacies to accept and dispense donated drugs, supplies, and medical devices pursuant to the Program, including eligibility criteria, confidentiality of donors, and standards and procedures for a free clinic or pharmacy to accept and safely store and dispense donated drugs, supplies, and medical devices. The amount of the maximum handling fee that a free clinic or pharmacy may charge for distributing or dispensing donated drugs, supplies, or medical devices. (Note: resale of a donated product is specifically prohibited) Small categories of drugs whose donation is prohibited (e.g., controlled substances due to federal law) or restricted (e.g., certain injectables and biologicals can only be donated by pharmacies, wholesalers, or manufacturers).
Drug Donation Liability Protection – As long as drug is donated, received, and dispensed in compliance with the statute and rules, participating donors, pharmacies, pharmacists, and practitioners are “immune from civil liability for an act or omission that causes injury to or the death of an individual to whom the drug, supplies, or medical device is dispensed under the Program, and no disciplinary action may be taken against a pharmacist or practitioner.”
Other Rulemaking Topics Floating Around Amendments to the patient counseling rules. At the April 2010 meeting, Board members asked that Board staff prepare a discussion draft of a “targeted” mandatory counseling rule. The Board has now indicated that it wants to see the results of an ISMP study on this issue (due in Spring 2011) before taking any further action. Remote order entry rule changes or additions. No proposal on the table, but the issue keeps arising. Clarity in delivery or “concierge” services. New models of delivery service being proposed by various pharmacies.
Board Election for Northern and Western Districts
Board Election The Northern and Western District seats are up for election this spring. Betty Dennis (Northern) and Rebecca Chater (Western) will complete their second consecutive five-year terms on May 1, 2012 and are therefore ineligible for re-election. Every pharmacist residing in North Carolina as of March 15, 2010 is eligible to vote.
Candidates Northern District Beth Williams, Kernersville Keith Waege, King Carol Day, Carrboro Western District Bill Mixon, Hickory Troy McNeill, Candler Stephanie Kiser, Candler Al Berg, Hendersonville
Procedure Voting will again be electronic and will open in mid-April. Pharmacists may access candidate biographies, photos, and an electronic ballot by logging in to the Board’s website using license number and PIN. Paper ballots are available by request only. All requests must be received at the Board office by April 20, 2011. Watch your email accounts and the Board’s website for more information.
Effective Dates Rulemaking began in June 2008. Comment period closed September 2008. DEA published the “interim final rule” on March 24, 2010 Rule effective June 1, 2010
Pharmacy Conditions for Use Pharmacies must use a system for receiving CSERx that has been certified by a DEA-approved auditor. Contact your hardware/software vendors. More information available here: http://www.ncbop.org/faqs/Pharmacist/Co ntrolledSubstanceE-RXFAQsApr2010.pdf
Bottom Line at this Point Board staff has received many calls and e-mails from pharmacies inquiring whether they may accept electronic prescriptions for controlled substances under the DEA’s new rule on the subject. Unfortunately, the answer at this point remains “no.” DEA’s rule requires that systems for sending and receiving CSERx must be “certified” by a “third-party auditor” as meeting the security requirements specified in the rule. DEA has stated that no such systems are certified yet; moreover, DEA has not even designated any third-party entities that it will allow to conduct audits and issue certification.
Felony Controlled Substance Convictions and Federal Law Some pharmacists are unaware that the federal controlled substances rules prohibit a registrant (i.e., a pharmacy) from employing “any person who has been convicted of a felony offense relating to controlled substances” if that person will have access to controlled substances. 21 CFR § 1301.76(a). The would-be employing pharmacy must submit a request to DEA to have this requirement waived (and such waivers are rarely granted). Pharmacist-managers need to exercise due diligence in hiring to avoid violating this regulation.
Technician Diversion Continues to be a disproportionately heavy component of Board investigations. Pharmacist-managers are responsible for the security of the pharmacy. Appropriate oversight of technicians is critical. One source of diversion opportunity commonly seen: complete delegation of controlled substance ordering and stocking to technicians.
Prescription Drug Shortages Drug shortages continue to plague patients and pharmacists. Information about known drug shortages, their cause, and anticipated resolution is compiled by FDA: http://www.fda.gov/Drugs/DrugSaf ety/DrugShortages/ucm050792.htm
Background The FD&C Act defines a “cosmetic” as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.” The FD&C Act defines a “drug” as, among other things, “articles intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
Who Regulates the Manufacturing of Cosmetics? The Food and Drug Administration. No North Carolina agency directly regulates the manufacturing of cosmetics. If, however, the “cosmetics” were really “drugs” (discussed shortly), both the Board of Pharmacy and the Department of Agriculture would have direct regulatory authority.
Is Cosmetic “Compounding” Specifically Authorized by the FD&C Act? Section 510(g) of the FD&C Act states that pharmacies do not have to register as manufacturers if they “do not manufacture, prepare, propagate, compound or process drugs or devices for sale other than in the regular course of their business . . . .” Accordingly, any “making” of cosmetics is manufacturing as that term is used in the FD&C Act.
What Is Required of a Cosmetic Manufacturer by FDA? Cosmetics are not subject to pre-market approval by the FDA (as are drugs). Certain color additives used in cosmetics are, however, subject to pre-market approval. The manufacturing of cosmetics does not require compliance with any specifically stated Good Manufacturing Practices (GMPs). Drugs are. Manufacturers of cosmetics are not required to register with FDA, though the FDA maintains a Voluntary Cosmetic Registration Program.
What Is Required of a Cosmetic Manufacturer by FDA? Cosmetic products are subject to labeling requirements under the FD&C Act and its regulations. Failure to comply in all respects would be a misbranding violation of the Act. Labeling requirements are numerous and are summarized in the FDA’s Cosmetic Labeling Guide: http://www.fda.gov/Cosmetics/CosmeticLabelingLabelCla ims/CosmeticLabelingManual/ucm126444.htm Note that a cosmetic whose safety has not been substantiated by studies must state on its labeling: “Warning—The safety of this product has not been determined.” Failure to include this warning is a misbranding violation of the Act.
What Is Required of a Cosmetic Manufacturer by FDA? Because there are no cosmetic GMPs, failure to comply with such does not lead to an adulteration violation of the FD&C Act. Nonetheless, a cosmetic can be deemed adulterated under the FD&C Act on other grounds. E.g., contains an injurious substance, prepared under unsanitary conditions, contains an unsafe color additive
When Does a Cosmetic Become a Drug? If the manufacturer of a cosmetic makes a “disease” or “structure/function” claim about its product, it is a “drug” under the FD&C Act. Claims of this sort may be evidenced by: Product labeling Typical consumer use of the product, especially if that use is based on an expectation created by the manufacturer Inclusion of a substance in the cosmetic that is regulated as a drug United States v. Article . . . Consisting of 216 Cartoned Bottles . . . “Sudden Change”, 409 F.2d 734 (2d Cir. 1969). A lotion derived from bovine serum albumin and distilled water deemed a “drug” because of the manufacturer’s claims that it would “lift out puffs” and give a “facelift without surgery”
Consequences of a Cosmetic Being Deemed a Drug Absent pre-market approval of the product as safe and effective for the labeled indication, the product is adulterated and misbranded. Pharmacy would face severe civil liability and likely criminal liability.
Other Considerations General product liability laws will govern the sale of cosmetics. Will a pharmacy’s malpractice insurance policy cover cosmetic manufacturing? “Cozy” relationships with prescribers or others who are making disease or structure/function claims about the cosmetic could lead to liability.
“The Safety of the People shall be the Highest Law” ~~~Cicero