Microsoft word - june 2008.doc

June 2008

PRINCE EDWARD ISLAND
matters such as regulations, drug related
PHARMACY BOARD
incidents, etc. are published in it. The PEI
Pharmacy Board therefore assumes that all
pharmacists are aware of these matters
ARE YOU USING YOUR
NAPRA/PEIPB EMAIL?
system? If not, you are left out of receiving Administrative Assistant: Rachel Lowther- The Board sends information to registrants Office Hours: Monday thru Friday 9am-5pm using only electronic means. You could lose out on safety or other information important to your practice if you aren’t part of the e- If you haven’t signed on, please do so soon. forward the Boards e-mail to another e-mail Nadine Pettipas (The Drugstore Pharmacy) Every P.E.I. Pharmacist has been given a username and password for the system. If you’ve forgotten yours, please contact the REGISTRATIONS
www.healthregistrations.ca
Pharmacists are reminded that the renewal Permits: 41 + 7 hospitals + Provincial Phcy and file updating process is now done on- line. If you require assistance, contact the This newsletter is distributed to all licensed
adding permits, and students to the process. pharmacies in PEI, emailed and posted on
our website. Decisions regarding all
ONTARIO & QUEBEC TO REJOIN
NATIONAL PHARMACY
TECHNICIANS COMPETENCIES
DOCUMENT ADOPTED
representatives from NAPRA, the National process to establish national competencies practice. NAPRA recognized the need for a Pharmacists (OCP) as well as the Ordre des pharmaciens du Quebec about both Colleges rejoining NAPRA. Presentations were made educational, accreditation and examination discuss the proposed changes to the vision; Recognizing the considerable work already Quebec to rejoin. In November, President Gdyczynski and Registrar Williams, as well pharmaciens du Quebec attended a visioning representatives from provincial regulatory reviewed. Size of the board, committee to Society of Hospital Pharmacists, Canadian board relationship, voting structure and funding issues were discussed. The result of Association, Association of Faculties of both Ontario and Quebec, similar to the one Pharmacy Programs. The Board adopted the NAPRA Professional Competencies for Canadian Pharmacy Technicians at Entry to was satisfied that this model will focus on similarities rather than the differences, and will ensure that all NAPRA activities move The PEI Pharmacy Board is participating in Society studying for a process to formalize structure which requires Alberta, British technicians. Norma Vass (Pharmacist) and annual fees of $75,000, a significant drop from the previous per capita levy of $26.57 BRUSH UP ON TEETH/HEART
CONNECTION
Can oral hygiene regimen make or break a endeavor has ensured that Quebec rejoins If you are looking for a topic to discuss with patients at an upcoming information session, that suggests a like between tooth decay and heart disease? A recent study in the journal Heart has than one when it comes to controlling blood added more information to this theory. The sugar levels in Type 2 diabetes patients. journal study followed 12,000 people in the The two drugs in the study were sitagliptin diabetes patients received either one of the The researchers examined the participants’ drugs, both of the drugs, or placebo. At school-entry medical and dental records, and baseline, the average A1C level was 8.8 per cent. All study patients who received drug Health System records. The scientists were treatment benefited over those in the placebo experienced teeth loss due to cavities and registering the greatest improvement. After gum disease early on in the study were at six months, 66 per cent, and 44 per cent of risk of developing heart disease later in life. the same group had A1C levels of less than Other academic studies have reached similar conclusions, although no study, including this most recent one, has based its findings on a comparative clinical investigation. In the Heart study, researchers found that PRACTICE NOTES
subjects missing nine or more teeth in young adulthood were one-third more likely to die teeth. Overall, those with the most severe seeking cancer-related treatment information tooth loss as students were 35 per cent more likely to have died than those missing fewer launched a website with access to scientific The tooth decay-heart disease scenario is bacteria based. Scientists believe the same (URL below) provides access to a number of germs that cause cavities and gum disease academic publications, including Lancet Oncology, The Breast, Cancer Letters and The American Journal of Medicine, and inflammation response in the body that lays links to other resources. Users must register the groundwork for future heart disease. with the site, but the company has waived University of Leeds, told Reuters Health that unlike similar studies this one looked at oral health early in life rather than in old age. WHAT WENT WRONG?
The Institute for Safe Medication Practices DIABETES DRUG COMBO
alert earlier this year, following up on a Blood sugar levels better controlled comprehensive safety bulletin published in 2003, to help health care providers avoid A recent study published in Diabetes Care, Association, found that two drugs are better and the U.S. of medication errors resulting bulletin illustrate some of the potential Case Study #1
have standardized policies and procedures concentration of 1mg/mL. The patient was The following risk-reduction actions should hospitalized, and a telephone order for 12 ml be incorporated into practice if they are not methadone po daily was received by a nurse hospital’s stock solution was the same ¾ All methadone orders must be written in ¾ Prescribers should write the methadone A technician using 10 mg/mL stock solution ¾ Dates and times for administration should pharmacist checked it against the pharmacy be specified (avoiding the use of the word copy of the original order and the patient’s ¾ Concomitant use of methadone with other methadone stock bottle was verified, and the narcotics, benzodiazepines and sedatives measure the volume pulled back to 12 mL. The patient received 120 mg methadone, but ¾ If more than one concentration is required fortunately, vomited much of the dose. The Case Study #2
formula, maintain a manufacturing log and PRACTICE NOTES
reported that she felt unwell (pale, sweaty, Providing bone density testing results clammy, shaky) two days after receiving her prescription for 8 mL of a 5 mg/mL stock offering bone density screening clinics in prescribed dose for the patient was 14 mL public awareness about the importance of (total dose 70mg). The significant under dose resulted in withdrawal symptoms, in Performing the technical functions of the bone density test is not a reserved action of Keeping patients safe
any designated health profession. Because Methadone’s dosing complexities and other practice limitations, the council of the Board contributing factors, such as dosing errors agrees that pharmacists can provide this and errors associated with nomenclature, have resulted in multiple reports in Canada However, it is incumbent on each individual products has accepted responsibility for the required knowledge, skills and abilities to do safe and effective drug treatment of that It is also very important that test results not Pharmacists can provide the numerical test call from a patient who was denied access to a Schedule II injectable local anaesthetic questionable results should be referred to product. After a brief conversation with the their family physicians for follow-up and individual, it soon became apparent that the pharmacist had intervened and it had been the pharmacist’s professional judgment that DRUG UPDATES
self-treatment with this drug product would have been unsafe for the individual. While “prescribing” by the pharmacist, it also suggests that some individuals are under the • Side-effects of Baby’s Bliss Gripe Water misconception that the pharmacist cannot • Unauthorized health products by Wild provided the appropriate care by refusing to provide the product and referred the patient • Precautions during cold and flu season. It is possible that some pharmacists may have facilitated this public misconception. • Availability of Trasylol® (aprotinin). pharmacist can only sell a Schedule II drug, including exempted codeine products, after discussing with the purchaser (patient) the gesture to the pharmacy technician to supply a Schedule II product, does not comply with Precision Xtra™ blood glucose monitor profession is involved in developing new prescriptive authority, it is important to ARE PHARMACISTS ALREADY
review the regulations and the Standards of “PRESCRIBING”?
Practice for Schedule II and III Products to The answer should probably be “Yes”, responsibilities with respect to providing especially when we consider drug products safe and effective care for patients. The Supplemental Standards of Practice for Schedule II and III Products (June 2005) strictly regulated than Schedule F, controlled or narcotic drugs, access to Schedule II drug (mapra.ca) by selecting Pharmacy Practice. products requires professional intervention prescription is not required under the current HOUSE GIVES ROYAL ASSENT TO
pharmacist’s license. Rather it will be a PHARMACISTS PRESCRIBING
“certification” – or recognition of an “advanced practice”. “Specialist” would “Continued Care Prescriptions” and met
professions with broader education – eg: How a physician becomes a specialist in a particular field of medicine. Highlights of pharmacists prescribing. We were successful in having a Bill tabled in the legislature this • Once certified, there would be a time include pharmacists under the definition of • If you have been practicing in that area, “prescription”: a direction for the preparation and dispensing of a drug that is than if you haven’t been practicing the (i) a person authorized by the laws of any • The “certification” will not be done by province or territory to practice as a physician, dentist or veterinarian (ii) a person authorized to do so by the Minister under section 14.1 (eg: nurse • The programs cannot just be knowledge- based programs – they must be practice • There is a need to develop standards for It also includes under the definition of the “practice of pharmacy” “giving a knowledge and practice standards for the Under the “functions of the Board” is added • A pharmacist could be liable if they “prescribe conditions and restrictions on the advertise a certification without ensuring • There is a need to get on with a new can start work on the specific regulations. rigorous framework for recognizing these Our proposal is to initially have “continued care prescriptive authority” – that will, over time expand the role of the pharmacist in prescribing and ordering certain lab tests. If anyone would like to have a copy of the proposal – please contact the Board office pharmacist would receive a “certificate of completion” being certified. For vendor type SPECIALTY CERTIFICATION –
ADVANCED PRACTICE IN
possibly assess the program based on set PHARMACY
representative that should be keeping their Director in April to discuss their initiative in “Post Entry to Practice Certification
process – as there are regulatory issues that Programs in Pharmacy”. This is not
need to be monitored and addressed as this intended to be “specialization” – it is not intended to add a designation to a all unfolds. Nationally, the NAPRA ED will whose medication error claimed the life of a maintain a close link with the CCCEP ED. result, an Ohio grand jury indicted him on Pharmacists are reminded again:
manslaughter and reckless homicide. Both Section 29 defines professional misconduct charges carry penalties of up to five years in prison. The technician, Katie Dudash, was (k) “purporting to have a qualification or special expertise which he does not in fact The medication error occurred at Rainbow possess and which has not been recognized (o) “advertising that is, in the judgment of undergoing chemotherapy. The intravenous the Board with reference to such written medication that Emily received should have guidelines as may be developed, improper been mixed in a standard bag of 0.9% saline. Instead, Dudash reportedly mixed the drug Such advertising guidelines go further to say (2)(c) “use of the term “Specialist” or any similar designation suggesting a recognized nonetheless, the mistake was overlooked, special status or accreditation as a and the lethal dose was administered. The pharmacist or pharmacy on any letterhead or business card or in any marketing activity, unless the person to whom the Dudash was fired after the incident. The Ohio Board of Pharmacy revoked Cropp’s specialization granted pursuant to a license in April 2007 for this mistake and 14 program approved by the PEI Pharmacy other errors he committed since Emily’s jurisdiction over technicians, Dudash did not (See “Child’s Death Prompts State and Report to the PEI Pharmacists Association. Until such time as the CCCEP accreditation Regulations for Pharmacy Technicians” in process is complete, pharmacists may not claim a specialty or advanced practice in any COMPETITION BUREAU SELF-
Again, I do have a copy of the initial draft REGULATED PROFESSIONS STUDY
The Competition Bureau released its study of Self-regulated Professions on December PRACTICE ELSEWHERE
Ohio Pharmacist Indicted for
pharmacists and real estate agents. Some of Manslaughter after Lethal Error
Ohio pharmacist Eric Cropp was responsible for reviewing the work of the technician Graduates) and advertising. The Executive physician are not authentic, secure or
Summary is a disappointing read from the private and do not meet Health Canada’s
policy. The graphic picture of a signature
surprisingly, the report leans towards an analogous to a rubber stamp and therefore not acceptable. Prescriptions issued in this advertising restrictions will better serve the manner are not legal and do not meet the particularly for privacy protection, security applicable to the self-regulation of a health care profession. The report can be view at: www.competitionbureau.gc.ca/epic/site/cb- The future of the e-Rx initiative will be best realized within an integrated electronic health record system. There is much work ELECTRONIC PRESCRIPTIONS
to be done to deal with such a fundamental pharmacists and practitioners. For example: Contrary to the previous advice given to Canada’s provincial and territorial pharmacy • Prescription data entry will become the and medical regulatory authorities by Health responsibility of the prescriber, not the Canada we are now in receipt of a Policy Statement on E-prescribing stating “there are currently no regulatory impediments to modifications to the prescription made by moving ahead with electronically generated and transmitted prescriptions and that these • How will the system handle dispenser are permissible to the extent they achieve the same objectives concludes by advising • How will the system handle transfers of Health Canada has initiated discussions with regulatory authorities in order to determine how it can be of assistance in facilitating • There needs to be freedom of choice of The full potential of e-Rx will also require responsible to Health Canada to ensure the appropriate standards are in place regarding SALE OF PSEUDOEPHEDRINE IN
authenticity, security, privacy-protection and PRINCE EDWARD ISLAND
authorities are looking to Canada Health Pharmacy Only Sale: In Prince Edward
there are development projects underway in directly covered by regulations to The PEI Pharmacy Act. The regulations and the Act restrict the retail sale to pharmacies only. To date there is no system of e-Rx approved Single ingredient pseudoephedrine must be for implementation in Prince Edward Island sold as a NAPRA Schedule II product from Prescriptions faxed to pharmacies from a
physician’s office software system,
without being actually signed or
“immediately adjacent” to the dispensary. providing a “unique identifier” by the
Non Pharmacy Sale: The regulations and
Schedule A to the FDA is a list of diseases, the Act restrict the retail sale in pharmacies (hereafter referred to as diseases) for which strong or as direct a regulatory link to preventative, treatment, and cure claims are prohibited by subsections 3(1) and 3(2) of pseudoephedrine from outlets that are not the FDA (hereafter referred to as section 3) in the labeling and advertising to the general court challenges to over rule the “Pharmacy Only” sale may have been successful in other provinces, these decisions do not apply Island pharmacists, noticing the sale of “treatment” that are used in the FDA have pseudoephedrine in a Prince Edward Island always been interpreted by Health Canada to include “risk reduction” and “symptomatic governing the sale. The retailer can return preventative, risk reduction, treatment, the product to their wholesale, as it should symptomatic, and cure claims are prohibited not have been sold to someone who cannot in the labeling and advertising to the general sell the product by retail. Should the retailer public for diseases listed in Schedule A. choose not to discontinue the sale, the matter can be referred to the Registrar, Neila Auld cancer, appendicitis, gout, and heart disease. NHPs and drugs that are subject to these CHANGES TO THE DRUG
new regulations will be permitted to carry ADVERTISING RESTRICTIONS
UNDER THE FEDERAL FOOD AND
advertising to the general public for diseases DRUGS ACT AND THE
that remain in Schedule A. For these NHPs CORRESPONDING REGULATIONS
practitioner intervention, but treatment or more restrictive than in United States. The restrictions are contained in the federal Food and Drugs Act (FDA) and its regulations. subject to all other provisions in the FDA, Advertising any drug to the general public the Controlled Drugs and Substance Act as a treatment, prevention or cure of any of (CDSA), and their regulations, therefore, any the diseases listed in schedule A to the FDA is not permitted. This will change June 1st
advertising of claims or any conditions for the market authorization of these products Changes will occur to the Food and Drug Regulations (FDR), the Natural Health diseases would not be permitted for drugs Products Regulations (NHPR), and the Medical Devices Regulations (MDR) that In 2008, the health care environment has (1) Revise the list of Schedule A diseases; changed substantially from when Schedule (2) Exempt natural health products (NHPs) Medical science has advanced, pre-market and certain drugs from the prohibition of preventative claims for the diseases listed in prescription drug regime exists, and publicly funded health care is available. Information about diseases where self-help is appropriate http://canadagazette.gc.ca/partII/2007/20071 is increasingly available to the Canadian make more informed decisions about their health. The public’s desire for this approach QUESTIONS AND ANSWERS
is reflected in an increasing emphasis on I own a small community pharmacy. I do
involvement of patients in their choice of not have the room or expertise to do
specialty compounding. If I get a
prescription for a specialty compound, can
The new list of Schedule A diseases coming I fill the prescription using product
into effect on June 1, 2008 is as follows: compounded by another pharmacy?
Pharmacists who do not provide specialty • Acute infectious respiratory syndromes 1. Refer the patient to a pharmacy that can • Acute, inflammatory and debilitating • Addiction, except nicotine addiction provides the service. A contract between the two pharmacies must be signed and retained by both pharmacy managers if the service is WHOLESALING & ESTABLISHMENT
LICENSING
regarding the requirement for Establishment selling/transferring prescription drugs not
pursuant to a prescription, is considered
“wholesaling” and specific federal laws Re: Wholesaling & Establishment
Licenses – Drugs
As a follow up to a previous Health Canada Associations across Canada on the issue of regulatory responsibilities with respect to wholesaling by pharmacies, this letter serves • Ulcer of the gastro-intestinal tract to provide further guidance to your members obtained through the Health Canada website “.to sell any of the following drugs, other than at retail sale, where the seller’s name Guidance on Good Manufacturing Practices, does not appear on the label of the drugs: Establishment Licensing requirements and (a) a drug listed in Schedule C, D, or G to the application forms can be found on the Regulations or a controlled drug as defined (b) a narcotic as defined in the Narcotic Further information on this matter; feel free subsection (2), no person shall, except in accordance with an establishment license, Krista Ricketts, Senior Compliance Officer An Establishment License holder is subject to the Good Manufacturing Practices section An update from Health Canada – June
(Division 2) of the Food and Drug 2008
Regulations as it applies to wholesalers. Requirements include, but are not limited to: A patient just presented an electronically-
generated prescription with an
¾ Maintain adequate distribution records to electronically-generated prescriber’s
signature. The signature is legible, but is
¾ Store drugs under acceptable conditions this an acceptable form of prescriber
authorization?
An electronic prescriber’s signature is only acceptable if the signature is unique. Health signature to be equivalent to a paper-and – signature written on the prescription with an mutual benefit where one pharmacy engages electronic pen pad, similar to signing a pen and paper prescription. It is an illegal electronic signature if it is cut and pasted members, these activities are considered to be wholesaling and would be subject to the Similarly, if a pharmacy routinely purchases signatures should be slightly different if they distributes them to one or more pharmacies, are unique, as is an original signature each it is also considered wholesaling and subject If you don’t have an old signature with please call the prescriber to determine if a activities need to apply for a Health Canada an Establishment License would constitute a violation of the Food and Drugs Act. A computer-generated prescription that is given to the patient or faxed to the pharmacy Health Canada is now determined that the must have an original prescriber’s signature automated many recordkeeping functions. It Is it legal to complete a prescription
transfer by fax?
when second and subsequent part-fills are A prescription transfer must involve direct program allows tracking between the part- pharmacist must enter on the patient record number) and the original prescription. A “paper trail” copy of the prescription must continue to be filed in the daily prescription • Identification of the pharmacist from pharmacists may continue to document each part-fill on the reverse side of the original prescription. A “paper trail” copy filed on • Identification of the pharmacist to who RECORDING OF CEUs
pharmacist must transfer all remaining refill Beginning with re-licensing for 2009/2010 year there will no longer be “carry-overs” of The prescription transfer may be completed development log, available on-line or by request must be emailed to the Board
contain all of the required information cited office or mailed through Canada Post. We
will no longer accept faxed forms. They
are often illegible and when there is trouble What is the proper way of documenting
with either the sending fax machine or the part-fills for controlled drugs and
substances (including narcotics)?
reminder also that they can be sent in at any point in the year and must be received by controlled drugs and substances (including Attending or participating in continuing education is not “about getting 20 points. It dispensed on a given date on the reverse side of the original prescription, along with the knowledge base for practice. It is for this reason that we also require you to indicate responsible for dispensing the part-fill. In the particular competency element from the addition, a “paper trail” copy of the Standards of Practice achieved. Pharmacists prescription, for information purposes, had should recognize where they are lacking in to be included in the daily prescription file particular element and seek CE training in ISMP MEMBERSHIP
letter of standing, jurisprudence examination and applicable fee. You are a Pharmacist, The Board has purchased annual access to not a student and not an intern. The Board is the newsletters of the Institute for Safe flexible in allowing jurisprudence to be Medication Practices (ISMP) Canada. They written in another province and also works will be forwarded to pharmacists through the available for a sitting at their earliest convenience. In practicing, colleagues and the public would view you as a pharmacist. In the future, the pharmacist-in-charge, the permit holder and the pharmacist will be Medication Safety Self-Assessment (MSSA) held accountable for failure to complete the for Community Pharmacies”. It would be proper licensing process. Other provinces made available/accessible for pharmacists have taken pharmacists to task for failure to across PEI. It meets the needs for a quality assessment of pharmacy systems and acts as an educational tool of what constitutes a safe POOR LITERACY CAN EQUAL POOR
identify opportunities for improvement in a Poor reading skills can make the difference between taking three pills once a day or one immediate results in tabular and graphic Canada spends $2 billion a year on hospital form of one’s own results as well as a admissions as a result of people taking their comparison with aggregated results of other respondents on both a national and regional People with low literacy skills experience basis (if sufficient numbers). ISMP Canada more health problems; prescription labels provides support for questions, provides and written instructions about medications self-assessment booklets/PDF versions, and are useless to patients who can’t understand passwords for on-line access. ISMP is also active in encouraging medication incident And health information on the Internet is informed. The fee for access to this overall often at an even higher level, making it program is $400 for the newsletters (giving the Board authorization to distribute them) and $1600 for pharmacists having access to MSSA. The Board is working on a training A recent Ontario literacy council report session/sponsor for PEI before we purchase access. More information can be found at Canadians hide their low literacy skills and are lies likely to feel confident to ask questions of their health-care providers. The PHARMACISTS TRANSFERRING
study found they may also overestimate their FROM ONE JURISDICTION TO
literacy skills and few health-care workers are aware of how common literacy problems As a licensed pharmacist transferring into PEI from another province or jurisdiction, the complete registration process must be
“Literacy is hidden. It’s a shameful thing. completed prior to commencing
disclose it. They don’t disclose it to the people who really need to know it, who are reviewed the safety and effectiveness of this pharmacists,” said Julie Patterson, a literacy You are reminded that the Standards for Pharmacist Practice state that a pharmacist Standard 7 of the Standards for Pharmacist prescription is appropriate. The Standards Practice (Pharmacist’s duty to provide sufficient information to patients in relation to Schedule 1 drugs and Schedule 2 drugs), take into consideration the possibility of low prescription orders a drug for indication that literacy when counseling patients. Verbal is approved by Health Canada, considered a instructions, having the patient repeat back best practice or accepted clinical practice in and/or paraphrase instructions, and using peer-reviewed clinical literature, or part of With regards to prescribing, the Standards OFF-LABEL USES OF DRUGS –
state that a pharmacist must not prescribe a EXERCISE CAUTION
drug or blood product unless the intended Pharmacists are reminded that it is good practice to critically evaluate and reflect on 2. is considered a best practice or accepted whether the learning activity is accredited or non-accredited. It is through reflection that you can consider the new information – the 3. is part of an approved research protocol. validity of the information, how it fits with MULTIMED BLISTER PACKS
practice. You may want to seek additional blister packs to patients please ensure the information from independent, objective, and peer-reviewed scientific literature. package. This is of particular importance in those packages that have a fold over cover. You may want to be particularly diligent Hospitals have been reporting that they have regarding off-labels uses of approved drugs. It is not illegal to dispense drugs prescribed patient. When presented in outpatients or for unapproved drugs. It is not illegal to admitted, the hospital staff cannot identify dispense drugs prescribed for unapproved the contents, the dose or the directions. On indications, nor is it illegal or contrary to dispensing, the pharmacist should ensure the accreditation guidelines for a continuing patient is appropriately counseled on the use indications. (It is contrary to the Food and enclosed. It may be advantageous to have Drug Act for pharmaceutical manufacturers unapproved conditions.) However, lack of approval means that Health Canada has not

Source: http://pei.in1touch.org/document/385/Capsule_June2008.pdf