February 2008 COLLEGE OF NOVA SCOTIA the Bulletin …€¦ · · 2016-06-15The NSCP Council is of...

2. Conduct an environmentalscan to identify which require-ments are already available orunder development provincially,nationally or internationally.

3. Establish a plan to develop anyoutstanding requirements

4. Recommend the final modelfor the regulation of pharmacytechnicians in Nova Scotia bythe NSCP

5. Address viability and sustain-ability

6. Develop a communicationsplanCouncil has asked the Task Force to present the plan by 2010.

The Task Force, upon direction from Council, also agreed upon the criteria for the selection of a Pharmacy Technician observer on the Council of the Nova Sco-tia College of Pharmacists and recommended that Cathy Comeau be appointed to this position.

As the health care system evolves to meet the demands of Nova Scotians, the call for phar-macists to make full use of their unique knowledge and skills is growing louder. The NSCP Council is of the position that, in order to optimally serve the public, pharmacists need to relin-quish technical dispensing func-tions where appropriate and engage more fully in cognitive practice. A significant barrier to this full engagement and the delegation of technical activities is the lack of legal accountability of phar-macy technicians and the lack of an established qualification proc-ess to ensure pharmacy techni-cian competency. The regulation of pharmacy technicians will help to address these barriers. There-fore, the NSCP Council sup-ports, in principle, the regulation of pharmacy technicians by the NSCP. Based upon this position, the NSCP has provided support for the following initiatives: ∗ the development of national

entry-to-practice competen-cies for pharmacy technicians (NAPRA)

∗ the development of a process and standards for the accredi-tation of community college pharmacy technicians programs (CCCAP—Canadian Council for the Accreditation of Phar-macy Programs)

∗ the development of educa-tional outcomes for pharmacy technician education programs (CPTEA– Canadian Pharmacy Technician Educators Associa-tion)

∗ the development of a national certification (evaluation) exam for pharmacy technicians (PEBC)

∗ the development of a national strategy to determine the role of pharmacy technicians to support pharmacy practice (CPhA Blueprint for Pharmacy Practice)

The NSCP also established a Pharmacy Technician Task Force (PTTF) to develop a plan to achieve the regulation of pharmacy technicians in Nova Scotia. Chaired by Deb Barnhill, the Task Force includes phar-macy technicians, pharmacy technician educators and phar-macists. During its first meeting, the PTTF reviewed and ac-cepted its mandate and agreed to provide the following deliver-ables to Council:

1. Identify the necessary re-quirements/tools to regulate pharmacy technicians including:

- definition of the roles, respon-sibilities and competencies

- a registration process includ-ing requirements for licensure

- a quality assurance (continuingcompetence) program

- a complaints and disciplineprogram

- a governance structure includ-ing representation on Coun-cil/committees

- standards of practice and acode of ethics

- enabling legislation and regula-tions

NSCP Pharmacy Technician Task Force

NOVA SCOTIA COLLEGE OF

PHARMACISTS

February 2008

Governing the practice of pharmacy in Nova Scotia in the interest of the health and well being of the public

the Bulletin ATTENTION!

This Bulletin is forwarded to every licensed pharma-cist and certified dispenser in Nova Scotia.

Decisions of the Nova Sco-tia College of Pharmacists regarding matters such as regulations, drug schedules, pharmacy practice, etc., are published in this Bulletin.

The Nova Scotia College of Pharmacists therefore as-sumes that all pharmacists/certified dispensers are aware of these matters.

This Issue:

Pharmacy Technician Task Force

1

Competition Bureau 2

NS e-Health Record 2

e-Prescribing 3

Optometrists:TopicalSteroid Prescribers

3

Pharmacists: Compliance 4

Revised Compliance Package Guidelines

4

DDAVP Melt Interchange 5

Drug Schedule Update 6

Safety Advisories 8-10

Council Report 11

Cont. Care Prescriptions 11

Prof Accountability 12

Ethics in Spotlight 13

Buprenorphine 14-19

Pharm Manager Interviews 20

Change in Staff Reporting 20

Prescriptions by Fax 5

Techs:Rx Transfers by Fax 5

Products without NPNs 6

Fentanyl Recall 7

Cathy Comeau makes history by

being the first Pharmacy Technician

on Council

The Nova Scotia College of Pharmacists is currently working with the NS Department of Health on the initial data gather-ing phase of the Provider Regis-try component of the Electronic Health Record project. The NS Department of Health is committed to the implemen-tation of province-wide clinical and administrative systems to improve patient care, health


Guidelines for Point of Care Testing Services

point of care testing (POCT) services (including blood glu-cose levels, INR etc.) when it occurs without the direct oversight of an accredited medical laboratory.

The Standards of Practice Committee has begun work-ing on NSCP guidelines for pharmacies based on the NSCMLT guidelines, adapting them into a relevant, worka-ble document for pharmacies.

The NSCP is a member of an interprofessional working group, led by the Nova Scotia College of Medical Labora-tory Technologists (NSCMLT), that has been developing guidelines and standards for the provision of

The NSCP will

consider the

Competition Bureau’s

report and take steps

to ensure that the

regulation of the

profession in the

public interest is

balanced with

supporting healthy

competition in the

marketplace

Competition Bureau Study on Self Regulated Professions

The Competition Bureau of Canada recently released its study of self regulated profes-sions. The report assessed the link between regulation and competition and raised con-cerns about restrictions in the pharmacy profession, particu-larly in the areas of entry to practice requirements, inter-provincial mobility and profes-sional advertising.

The report recommended that pharmacy regulatory authori-ties review their advertising rules with a view to removing restrictions unless they can show a clear link to a meaning-

ful reduction in consumer harm by such restrictions.

The report also commented on the range of entry- to- practice requirements across the coun-try. Unfortunately, it was re-ported that the practice ex-perience requirements for international applicants enter-ing practice in Nova Scotia may take up to 12 months, when, in fact, the practice experience program is 20 weeks in length.

It further suggested that the duration of practice experience for applicants entering practice for the first time is 36 weeks in Nova Scotia and compared that

number to much shorter peri-ods of time in some other provinces across the country. The report failed to clarify that the 36 weeks includes the 20 weeks of structured practice experience that are obtained during the degree program.

The NSCP will consider the Bureau’s report and take steps to ensure that the regulation of the profession in the public interest is balanced with sup-porting healthy competition in the marketplace. We are also working with the Bureau to correct any mistakes and mis-leading facts in the report.

NS Electronic Health Record The Nova Scotia College of Pharmacists is currently work-ing with the NS Department of Health on the initial data gather-ing phase of the Provider Regis-try component of the province’s electronic health record system called SHARE (Secure Health Access Record).

The NS Department of Health is committed to the implemen-tation of province-wide clinical and administrative systems to improve patient care, health system planning and account-ability. SHARE will create an electronic health record for all Nova Scotians. The record will contain patients' up-to-date health information to support

decision-making and case man-agement by health care provid-ers.

The electronic health record solution will deliver a secure single view of patient informa-tion to authorized users re-gardless of the application source. The SHARE project includes the development of a Client Registry and a Provider Registry. These Registries will link medical records from mul-tiple systems and include a secure health record storage and viewing system for patient information that health care professionals (providers) can access when and where they need.

The Department of Health has engaged three Provider organi-zations for the Provider Regis-try component of the project:

∗ the College of Physicians and Surgeons of NS

∗ the College of Registered

Nurses of NS ∗ the Nova Scotia College of

Pharmacists.

As previously reported, Health Canada has revised its position on e-prescribing (e-Rx). The revised “Policy Statement on e-Prescribing” states that there are currently no regulatory impedi-ments to moving ahead with electronically generated and transmitted prescriptions and that these are permissible to the extent that they achieve the same objectives for privacy, security and authenticity as written prescriptions.

Health Canada will facilitate cooperation among the stake-holders regarding development and implementation. Provincial regulators are looking to Can-ada Health Infoway for technical standards – currently there are

development projects under-way in Alberta and Newfound-land and Labrador.

In addition to the development and approval of technical stan-dards for e-Rx, much work needs to be done to address the fundamental changes that must occur to the way in which information flows between pharmacists and physicians. For example, will the prescription data entry become the respon-sibility of the physicians? How will modifications to an e-Rx be made by the pharmacist? An-swers to these questions will be more easily addressed when the electronic health record (EHR) becomes a reality (see previous article).

Meanwhile, there is no system of e-Rx (i.e. via email etc.) ap-proved for implementation in Canada. For further clarifica-tion on approved forms of generating and transmitting prescriptions, pharmacists and physicians are referred to the NSCP’s Clarification of the Cur-rent Signature Criteria for a Valid Prescription .

e-Prescribing: An Update


To move forward

towards

e-prescribing, much

work needs to be

done to address the

fundamental

changes that must

occur to the way in

which information

flows between

pharmacists and

physicians

NSCP Patient Safety Program: SafetyNet

The NSCP is in the final process of securing financial support for its Continuous Quality Improve-ment Initiative, SafetyNet.

The initiative will pilot a Con-tinuous Quality Improvement process that pharmacies can adopt, assisting them in meeting their legislated requirement for

the establishment and mainte-nance of policies to: ∗ monitor the performance of the

pharmacy and its adherence to standards of practice.

∗ document and report known, alleged and suspected medica-tion errors and discrepancies, and the steps taken to resolve the problem.

When funding is in place, the NSCP will be inviting fourteen pharmacies to pilot and refine the process. By actively work-ing on this project, the NSCP and participating pharmacies demonstrate to the public and other health professionals that community pharmacy cares about patient safety.

Optometrists: Topical Steroid Prescribers

Further to “What Can Optome-trists Prescribe” published in the June 2005 President’s Bulletin, recent amendments to the Regulations Respecting Optome-trists authorize an optometrist who holds a therapeutic drug license to use the following drugs for the treatment of ocu-lar anterior segment disorders:

• mydriatics

• cycloplegics

• non-steroidal anti-allergymedications

• non-steroidal anti-inflammatory medications

• anti-infective medications

• topical ocular steroids andsteroid anti-infective combina-tion drugs, but only in thefollowing manner:

- to treat specific condi-tions of the ocular surface

and adnexa (i.e. eyelids, eyelashes, conjunctiva and related tissue) when there is no corneal ulceration present.

- for short term therapyonly, meaning less thanfour weeks duration inmost cases, and the op-tometrist may prescribeonly a single, non-refillablecourse of these drugs.

information to the NSCP for future issues of the Bulletin:

∗ clinical experiences

∗ medication incidents

∗ enhancements to practice

∗ tips for enhanced patient compliance/ concordance

∗ other topics relevant to patient safety

In the previous publication of the Bulletin, colleagues shared their learning from medication incidents in practice. This is a valuable means of serv-ing the profession and the public, facilitating optimal patient care and enhanced patient safety.

The NSCP encourages pharma-cists to communicate with col-leagues by submitting the following

Patient Safety: Learning from the Experiences of Colleagues


Pharmacists’ Responsibility in Patient Compliance/Concordance

Non-compliance can significantly impact patient health outcomes. Pharmacists possess the knowl-edge & skills, and are ideally situ-ated, to assist patients in this area.

Accordingly, the Model Standards of Practice for Canadian Pharmacists clearly indicates that identifying and actively addressing non-compliance is a minimum stan-dard of practice expected of all pharmacists.

However, there are many factors that can impact the extent of a patient’s compliance / concor-dance with their prescribed treat-ment, some of which are compli-cated and not easily overcome.

The independent study program “Compliance Management” de-veloped by PANS in 2003 is a useful resource for pharmacists wanting to improve their effec-tiveness in this area.

Pharmacists can contact PANS at (902) 422-9583 to request a copy.

In addition, the Bulletin will regu-larly include tips from pharmacists to their colleagues on ways to optimize their practice in enhanc-ing patient compliance.

Please submit your suggestions to the NSCP to assist your fellow pharmacists in improving health outcomes.

“Actively

identifying and

addressing

non-compliance

is a minimum

standard

expected of all

pharmacists”

Revised Guidelines for Compliance Packaging

As part of the Standards of Prac-tice Committee’s mandate for continuous quality improvement, the guidelines for pharmacies providing compliance packaging were recently reviewed. The revised guidelines are in-cluded with this Bulletin, and are posted on the NSCP website as Compliance Packaging under Poli-cies, Positions and Guidelines

Note: While guidelines are not regulations, they do have legal weight in that they describe recommended and expected practice. Practice that is non-compliant with established guidelines must be justified by demonstrating that the alternative process pro-vides better patient care, effec-tively addresses all of the rele-vant issues, achieves the same or better quality outcomes, and has adequate measures to ensure patient safety.

Pharmacy Technicians and Transfer of Prescriptions by Fax

prohibiting technicians from being involved in and perform-ing the transfer process as long as there are pharmacists on either end overseeing the proc-ess and taking responsibility for the accuracy of the process.

The Standards of Practice Committee reviewed the Council policy on Fax Transmis-sion of Prescriptions, as well as the legislation specific to pre-scription transfers, and deter-mined that there is nothing


The College has received que-ries from pharmacists con-cerning whether pharmacy technicians can send and / or receive faxed transfers of pre-scriptions.

Pharmacists are reminded that DDAVP Melt (desmopressin sublingual) is not interchange-able with regular-release des-mopressin tablets by Apo, Novo or Ferring.

The Pharmacy Act permits substitution of products if they are listed as interchangeable in

DDAVP Melt Interchangeability

a formulary of interchangeable drugs approved or issued by the Province or a department or agency of the Province.

A product must be within an “Interchangeable Product Group Box” (see page iii of the NS Formulary) in the NS

Formulary for it to be an ap-proved interchangeable drug.

The NS Formulary is provided by the NS Department of Health to pharmacies, and is accessible on the NS Phar-macare website http://www.gov.ns.ca/health/Pharmacare/formulary.pdf

Requirements for Accepting Prescriptions by Fax

Pharmacists are reminded that, before a faxed prescription can be honored, the requirements listed in the “Council Policy: Facsimile Transmission of Pre-scriptions” must be fulfilled. This policy includes the requirement that the faxed prescription needs to contain the following certifica-tion signed by the prescriber at the time of prescribing:

-the prescription represents theoriginal of the prescription drugorder

-the addressee (the pharmacy) isthe only intended recipient andthere are no others

-the original prescription will beinvalidated by marking it in such away that it cannot be reissued

In addition to being posted on the NSCP website (under Poli-cies, Position Statements and Guidelines), this policy, along with a model prescription form, has been provided to the Col-lege of Physicians and Surgeons of Nova Scotia to ensure col-laboration between pharmacists and physicians.

It has come to the attention of the NSCP that some pharmacies have been accepting faxed pre-scriptions that do not include the certification noted above.

Not only does this practice con-travene the requirements set out by the NSCP and the federal government, it creates difficulties

for those pharmacies that are following the requirements be-cause it encourages prescribers to adopt a practice that is incon-sistent with the rules.

The responsibility to ensure the requirements of the policy are met lies with the pharmacist filling the prescription and also the pharmacy manager, who is ultimately responsible for the maintenance and enforcement of professional policies and proce-dures.

It has come to the

attention of the

NSCP that

some pharmacies

have been

accepting faxed

prescriptions that

do not meet

requirements.

Drug Schedule Update

Drug Schedules. Because only meningococcal conjugate Group C is recom-mended for routine immuni-zation schedules, Menactra is not recommended for routine immunization and therefore is in Schedule I and requires a prescription.

• Ibuprofen and its salts instrengths not to exceed 400mg per oral dosage unit hasmoved from Schedule III toUnscheduled status.

• Pharmacists are remindedthat clobetasone butyrate,when sold in concentrationsof 0.05% in cream prepara-tions for topical use on theskin is in Schedule II.

• 50% Isopropyl myristatefor use in the treatment ofhead lice is in Schedule III.

The complete up to date list of scheduled drugs can be searched on the NSCP website (www.nspharmacists.ca) under “Drug Schedules”.

Pharmacists are reminded that drug schedule changes are posted on the NSCP website under “Drug Schedules” / ”Notice Board”.

• Menactra vaccine is a com-bination of meningococcal(Groups A, C, Y and W-135)polysaccharide and diphtheriatoxoid conjugate vaccine.Vaccines that are not part ofprovincial routine immuniza-tion programs are placed inSchedule I of the National


New NDSAC Member NAPRA’s National Drug Sched-uling Advisory Committee re-cently appointed Dr Peter Zed as a member. Dr Zed is currently the Clinical Coordinator - Emergency Medi-cine at the Queen Elizabeth II

Health Sciences Centre in Hali-fax, and an Associate Professor at both the College of Pharmacy and at the Department of Emer-gency Medicine at Dalhousie University.

An accomplished clinician, teacher, and researcher, with many publications and awards to his credit who has served on many committees, he is licensed with the Nova Scotia College of Pharmacists.

Natural Health Products without NPNs

Health Canada has provided the NSCP with the following reminder for pharmacists:

In Canada, drugs, natural health products and cosmetics are regu-lated via different regulations un-der the Food and Drugs Act. A product is classified as a drug, a natural health product (NHP) or cosmetic depending on the claims and the medicinal ingredients in the product. Cosmetics are re-quired to obtain a registration number which can be verified with Health Canada. Drugs and NHPs will display either an eight-digit Drug Identification Number (DIN) or Natural Products Number (NPN) on the label.

It is crucial that purchasers of

drugs, NHPs and cosmetics for pharmacies are aware of the requirements of the Food and Drugs Act and Regulations. The sale of a product not in compliance with the legislation is illegal and may place consum-ers at risk. Recently, for exam-ple, several unapproved Chi-nese toothpastes made their way to the Canadian market and exposed Canadians to diethylene glycol, a poisonous chemical in antifreeze.

At the same time Health Can-ada is asking that pharmacists be vigilant in checking for DINs and NPNs, it is also in the process of reclassifying many nonprescription products from

DIN (drug) to NPN (natural product) status. Because of a significant back-log in this re-classification process, Health Canada is allowing manufactur-ers to market certain natural health products without an NPN, as long as Health Canada has an application on file.

Therefore, it is possible that pharmacists may come upon natural products without an NPN on the label. Should this occur, you are encouraged to contact the Atlantic Regional Office of Health Canada at (902) 426-2160 or email [email protected] forverification.

Pharmacists

that come upon

products

without an NPN

on the label

are encouraged

to contact

the Atlantic Regional

Office of

Health Canada

to determine if they

have permission to

be on the market.


Recall: Fentanyl Transdermal Pain Patches

OTTAWA - Health Canada is advising Cana-dians not to use 25 mcg/hr Dur-agesic (Janssen-Ortho Inc). and 25 mcg/hr Ran Fentanyl Trans-dermal System ( Ranbaxy). These patches are being volun-tarily recalled by the manufac-turer because they may have a cut along one side of the patch which could result in leaking of the fentanyl gel from the patch.

Exposure to fentanyl gel that has leaked from the patch may lead to increased skin absorp-tion and could result in serious, potentially life-threatening ad-verse events, including respira-tory depression (slowed breath-ing) and possible overdose, which may be fatal.

The products should be re-turned to their pharmacy for safe disposal. Patches should not be handled directly.

Anyone who comes into con-tact with fentanyl gel that has leaked from a patch should thoroughly rinse exposed skin with large amounts of water only; do not use soap or al-cohol. Signs of fentanyl overdose in-clude difficult or shallow breath-ing, tiredness, extreme sleepi-ness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused.

Patients and their caregivers should be aware of the signs and symptoms of fentanyl over-dose, and should seek medical

attention immediately if any of these side effects are noted. Patches with a cut edge that have leaked gel may not provide effective pain relief.

To report a suspected adverse reaction to this product, please contact the Canada Vigilance Program of Health Canada by one of the following methods: Telephone: 1-866-234-2345 Facsimile: 1-866-678-6789 Canada Vigilance Program Marketed Health Products Di-rectorate Ottawa, Ontario, AL 0701C K1A 0K9

E-mail: [email protected]

Recruitment Notice – National Drug Scheduling Advisory Committee

The National Drug Scheduling Advisory Committee (NDSAC) was established by the National Association of Pharmacy Regula-tory Authorities (NAPRA) in 1995. It was formed to advise provincial pharmacy regulatory bodies as well as governments at the provincial and federal levels, on matters related to the condi-tions for sale of drugs in Canada.

NDSAC’s eight expert members are chosen for their knowledge and experience in such disciplines as pharmacotherapy, drug utiliza-tion, drug interactions and toxicol-ogy, pharmacy practise, academic research, the drug industry and pharmaceutical regulatory affairs at provincial and federal levels. This knowledge and experience must be relevant to the Canadian health care system.

In addition, candidates for appoint-ment to NDSAC must possess: • An appreciation for thehealth, pharmaceutical and mar-

ketplace contexts on which the committee’s recommendations will impact, • Objective analytical skills,

• No personal stake in thecommittee’s scheduling recom-mendations, • A high degree of integrityand respect for the confidentialnature of the proprietary infor-mation under study, • Effective interpersonalskills relevant to committeedynamics, • An ability to serve in thebest interests of the Canadianpublic, and Canadian residency.

Appointments of expert mem-bers are not representational in nature, and NDSAC expert members may not promote the views of any business, organiza-tion or association. Commit-tee members must declare any real or perceived conflicts of interest, and adhere to strict

confidentiality codes.

There are currently two specific vacancies on the committee: 1. An individual with expertisein drug policy and safetyissues from the perspective ofpharmaceutical regulatory af-fairs at the provincial or federalgovernment levels

2. An individual with expertisein the area of toxicology re-lated to pharmaceuticals.

The NAPRA website (www.napra.org) has detailed information about the commit-tee and the drug scheduling process. For further informa-tion, contact Barbara Wells, NDSAC Secretariat by e-mail at [email protected]; telephone at 613-233-0348, or fax at 613-233-0343.

Nominations with resumes must be received (by email or fax) no later than Fri-day, April 4th, 2008.

Anyone who

comes into

contact with

fentanyl gel that

has leaked from

a patch should

thoroughly rinse

exposed skin with

large amounts

of water only;

do not use

soap or alcohol.

Pharmacists, especially Pharmacy Managers, are reminded that critical health/drug advisories, warnings and drug recalls are posted on the NSCP website homepage under “Safety Advisories”, as well as on the Health Canada website.

It is the responsibility of every licensed pharmacist and certified dispenser to keep abreast of these safety advi-sories and to advise their patients where appropriate.

The following is a list of the titles of Safety Advisories distributed by Health Canada since August 2007:

Important Safety Advisories


February: February 13, 2008: Important Safety Information on Stryker Trident Hip Implants - Notice to Hospitals

February 6, 2008: 9 Foreign Product Alerts

January: January 28, 2008: 3 Foreign Product Alerts

January 24, 2008: Unauthorized health product contains heavy metals - Consumer Information

January 3, 2008: Foreign Product Alerts: Baby’s Bliss Gripe Water and Zhong Ti Xiao Er Jian Pi San - Consumer Information

January 2, 2008: Unauthorized health products manufactured by Wild Vineyard may pose health risks - Consumer Information

January 2, 2008: Use of Unlicensed Pap-Ion Magnetic Inductor May Pose Health Risk - Consumer Information

December: December 28 , 2007: Recall of ULTIVA (remifentanil hydrochloride) 1 mg vials dueto potential for overdose - Health Professional Communication- Abbott Laboratories Limited

December 21 , 2007: New warnings regarding ALERTEC (modafinil) and serious rash, allergic reactions, and mental problems - Health Professional Communication- Public Communication- Shire Canada Inc.

December 21 , 2007: Important Information on Viracept (PDF)

December 12 , 2007: Three Lots of Measles, Mumps and Rubella Vaccine Suspended from Use - Consumer Information

December 10 , 2007: It's Your Health - Breast Implants - Consumer Information

December 5 , 2007: Health Canada reminds Canadians of precautions during cold and flu season - Consumer Information

November: November 29 , 2007: Foreign Product Alert: Axcil and Desirin - Consumer Information

November 27 , 2007: Important Safety Information and availability of Trasylol (aprotinin) - Notice to Hospitals- Bayer Inc.

November 15 , 2007: Foreign Product Alerts: Royal Medic No.1 Chinese Caterpillar Fungus, and Steripaste Medicated Paste Bandages - Consumer Information

November 7 , 2007: New restrictions on the use of rosiglitazone prod-ucts due to cardiac safety concerns (Avandia, Avandamet, Avandaryl) - Health Professional Communication- Public Communication- GlaxoSmithKline Inc.

November 6 , 2007: Urgent Medical Device Information on Medtronic Sprint Fidelis Lead Recall and Patient Management Recommendations



- Health Professional Communication (2007-10-25)- Public Communication- Medtronic of Canada Ltd.

November 5 , 2007 : Manufacturer temporarily suspends marketing of Trasylol in Canada - Consumer Information

October:

October 30, 2007 : Important Safety Information on Abbott Diabetes Care Precision Xtra - Health Professional Communication- Public Communication- Abbott Diabetes Care

October 26, 2007 : Foreign Product Alerts: Red Yeast Rice, Red Yeast Rice/Policosonal Complex and Cholestrix, and Xie Gan Wan - Consumer Information

October 26, 2007 : Urgent Medical Device Information on Medtronic Sprint Fidelis Lead Recall and Patient Management Recommendations - Health Professional Communication- Medtronic of Canada Ltd.

October 24, 2007 : Important Safety Information Regarding Colleague Volumetric Infusion Pumps - Health Professional Communication- Baxter Corporation

October 19, 2007 : Important safety information on Definity (Perflutren Injectable Suspension) - Health Professional Communication- Bristol-Myers Squibb Canada

October 12, 2007 : Recommendations for the Appropriate Use of Cough and Cold Products in Children - Consumer Information

October 11, 2007 : Important Safety Information on Iressa (gefitinib) - Health Professional Communication- AstraZeneca Canada Inc.

October 9, 2007 : Update on recall of COMPLETE All-in-One Contact Lens Care Solution - Consumer Information

October 9, 2007 : Withdrawal of Market Authorization for Prexige (lumiracoxib) - Health Professional Communication- Public Communication- Novartis Pharmaceuticals Canada Inc.

October 4, 2007 : Withdrawal of Market Authorization for Prexige - Consumer Information

October 2, 2007 : Calabash Chalk May Pose Health Risk for Pregnant and Breastfeeding Women - Consumer Information

October 2, 2007 : Foreign Product Alerts: Gu Ci Dan and Xu Log Bou / Zhen Feng Da Brand Xi Tong Wan and Wellring Brand Yin Qiao Jie Du - Consumer Information

October 1, 2007 : Foreign Product Alerts: Khun-Phra and Asam Urat Flu Tulang, PJ Dewandaru - Consumer Information

September: September 25, 2007 : Information Update - Vitamin D and Health - Consumer Information

September 25, 2007 : Foreign Product Alerts: Top Gun for Men Herbal Extracts / Oyster Plus / Deguozhanjiang / Chongcaoliubian Jiaonang and Santi Scalper Penis Erection Capsule - Consumer Information

September 19, 2007 : Safety Alert Notification for IV Administration Sets - Health Professional Communication- Cardinal Health

September 18, 2007 : Foreign Product Alerts: Jacaranda, Queenmer Fat Loss, Li Da Dai Dai Hua Jiao Nang, J-minus and Jelimel Slimming

Capsules / Junyu Jiaonanyihao / Satis 60 Hours Ever

Lasting Formula / Qiangli Zhuanggutongbiling / Heng Tong

Jiangtangning Jiaonang / Endopile Capsules / BuXie PaiDu XiaoDou Su /True Man and Energy Max - Consumer Information



September 11, 2007 : Important safety information on VIRACEPT (nelfinavir mesylate) - Health Professional Communication- Public Communication- Pfizer Canada Inc.

September 10, 2007 : Unauthorized Colloidal Silver Water Product May Pose Health Risk - Consumer Information

September 6, 2007 : Important Safety Information on KETEK (telithromycin) - Health Professional Communication- Public Communication- sanofi-aventis Canada Inc.

August: August 27, 2007: Foreign Product Alerts: Excite for women and Ulti-mates for men - Consumer Information

August 27, 2007: Health Canada reminds consumers about the risks of buying drugs online - Consumer Information

August 27, 2007: New safety information regarding Prexige (Lumiracoxib) - Consumer Information

August 27, 2007: Cease Sale of Permax (pergolide mesylate) in Can-ada as of August 30, 2007 - Health Professional Communication- Public Communication- Eli Lilly Canada Inc.

August 27, 2007: Recall of Metaboslim capsules due to potential health risks - Consumer Information

August 27, 2007: Important Safety Information on THELIN (sitaxsentan sodium) - Health Professional Communication- Encysive Canada Inc.

August 27, 2007: Neem Active Toothpaste with Calcium found to pose additional health risks - Consumer Information

August 14, 2007: Important Safety Information on Medtronic MiniMed Paradigm Insulin Infusion Pump - Health Professional Communication- Public Communication- Medtronic of Canada Ltd.

August 14, 2007: Important Safety Information on RITUXAN (rituximab) - Health Professional Communication- Public Communication- Hoffmann-La Roche Limited

August 13, 2007: Important Product information on the Colleague Volumetric Infusion Pumps - Health Professional Communication- Baxter Corporation

August 9, 2007: Health Canada is advising consumers that it is cur-rently reviewing new preliminary safety information regarding serious cardiac events in patients using Losec (omeprazole) and Nexium (esomeprazole), two prescription drugs used to treat acid-related stomach disorders.

August 8, 2007: Important Safety Information on Xylocaine (Lidocaine HCI) Jelly 2% Single Use Plastic Syringe (10 mL):

August 7, 2007: Reminder to use lancing devices for blood sampling as directed

Council Report


♦ welcomed Craig Connolly as the new representative fromZone 1

♦ agreed to hold a strategic planning session in November2008

♦ recommended that pharmacists be reminded, via the Bulletin,of their authority to extend existing prescriptions, whereappropriate, as enabled by the Continued Care PrescriptionAgreement

♦ provided support, in principle, for working with NAPRA andCCEEP on the accreditation of pharmacy certificate pro-grams

♦ agreed that the Standards of Practice Committee shoulddevelop guidelines for point of care testing (POCT), once themulti-stakeholder committee led by the College of MedicalLaboratory Technologists finalizes Standards of Practice forPOCT

♦ Identified the Compliance Management Module developed byPANS as a helpful resource for pharmacists seeking to en-hance their practice in the area of patient compliance, andasked that PANS consider a re-launch

♦ agreed that sampling is still a patient safety issue that needsto be addressed and, further agreed that Council shouldconsider establishing a formal policy on drug sampling

♦ clarified the role of pharmacy technicians in transferringprescriptions by fax

♦ received a report from the Prescription Monitoring Boardthat all NS pharmacies are now on-line with the program

♦ agreed to work with Doctors NS and the provincial gov-ernment to move e-prescribing forward

♦ approved the report/direction of the Pharmacy TechnicianTask Force

♦ discussed the issue of posting the names of licensed phar-macists/pharmacies on the NSCP website, similar to otherregulatory authorities

♦ considered appeals regarding fines for late submission ofannual license renewals/CE- PDRs

At it’s January 2008 meeting, Council:

• The pharmacist shall be reasonably satisfied that the physi-cian, if available, would in all likelihood provide the authori-zation.

• The medication to be continued shall be for a chronic orlong-term condition.

• The patient shall have an established stable history (no re-cent changes to dosages or drug therapy) with that medica-tion.

• The original prescription shall be with that particular phar-macy, and the patient shall be under the current care of thepharmacy.

• Narcotics or controlled substances shall not be provided bya continued care prescription.

• The pharmacist shall “continue” an existing prescriptiononce only. Further requests for extensions must be handledby the patient’s physician or an on-call physician.

• The amount of medication provided shall be determined bythe pharmacist based upon the circumstances of the particu-lar patient, but must not exceed the previous amount filledor one month, whichever is the lesser. (*NOTE: the NSCP iscurrently in discussions with the College of Physicians and

Surgeons and the Department of Health to remove the one month limit)

• The pharmacist shall assign a new prescription number to theContinued Care Prescription (CCP) and shall record, on theCCP, the prescription number of the original prescription.The pharmacist’s name shall replace the physician’s name asthe prescriber.

• The CCP shall be documented on the patient record in sucha manner as to ensure the prescription will not be“extended” a second time.

• The CCP shall be reported as soon as reasonably possible tothe original prescribing physician (or to the primary carephysician if different from the prescribingphysician).

Pharmacists are encouraged to familiarize themselves with the Agreement and to use their authority to extend prescriptions where appropriate for the continuity of patient care.

The NSCP is pleased to report that the Continued Care Prescription (CCP) initiative has been deemed successful by the NSCP, the College of Physicians and Surgeons of Nova Scotia and the provincial Department of Health.

Although almost 100% of CCPs were filled in accordance with the conditions set out in the CCP Agreement, there were sev-eral instances where prescriptions were extended more than once or where prescriptions for benzodiazepines were extended. Pharmacists are reminded that continued care prescriptions may be provided only where the following conditions are met:

Continued Care Prescriptions


Professional Accountability: Resolution of a Disciplinary Matter

In response to a complaint received from the public in Novem-ber 2006, the NSCP conducted an investigation of the metha-done maintenance service provided by pharmacists David Fergu-son and Donald Ferguson at Ferguson’s Pharmacy in Glace Bay, NS. The complaint was precipitated by the death of a metha-done patient.. It is important to note that the Investigation and Hearing Committees are bound by the laws of natural justice and can only assess sanctions for allegations that can be sup-ported by evidence. While the investigation by the College did identify breaches to the Pharmacy Act and its Regulations, it found insufficient evidence to link the standards of practice at Ferguson’s Pharmacy to the death of that patient.

As per an order of the Hearing Committee on January 24th 2008, the following is information relating to the details and resolution of the matter.

Allegations were set out in Notices of Hearing dated May 7, 2007 and December 20, 2007, alleging that Mr. David Ferguson and Mr Donald Ferguson breached provisions of the Pharmacy Act and Regulations made thereunder, and conducted themselves in a way in which a Hearing Com-mittee properly constituted under the Pharmacy Act could conclude that their conduct amounted to professional mis-conduct.

The College and the pharmacists of complaint, Mr. David Ferguson and Mr Donald Ferguson, believed that a Settle-ment Agreement was the proper method of disposing of the matter, and agreed to the following statement of facts and disposition:

Statement of Facts:

1. On July 21, 2005, Mr. Donald Ferguson, a pharmacistemployed at Ferguson’s Pharmacy Limited at 35 SterlingRoad, Glace Bay, Nova Scotia (the “Pharmacy”), underthe management of Mr. David Ferguson, learned thatthree patients who had received the same dose ofmethadone and/or solution in which the methadonewas suspended, became sick, ill, suffered from nausea,vomited and complained that the dose tasted bad. As aresult, Donald Ferguson compounded a new metha-done solution. While Mr. Donald Ferguson was onduty, a technician destroyed the first methadone solu-tion, thereby failing to comply with the federal require-ments for the destruction of narcotics .

2. Two days subsequent to the above, on July 23, 2005, amethadone patient at Ferguson’s Pharmacy was founddead. The Nova Scotia Medical Examiner Servicesdetermined that the cause of death was methadoneintoxication. The patient had received a prescriptionof 50mg methadone in Tang filled at the Pharmacy by

Donald Ferguson on July 21st 2005. Subsequent to receipt of a complaint from the patient’s father about Ferguson’s Pharmacy, the Nova Scotia College of Pharmacists con-ducted an inspection at the Pharmacy.

3. Upon inspection by the Nova Scotia College of Pharma-cists, it was revealed that Ferguson’s Pharmacy failed tocomply with the “Methadone, Information for a PharmacistProviding Methadone Maintenance Therapy”, a practiceresource established by the Nova Scotia College of Phar-macists. Mr. Donald Ferguson failed to properly supervisethe compounding of the methadone solution, the dispens-ing of the methadone and administration of the methadonein that he:

a. Would allow a process for compounding that in-cluded non-pharmacists compounding and checkingthe methadone solution;

b. Would allow a technician to administer methadonewhile in his view but outside his ability to verify thedose of the bottle and confirm the quantity of thesolution;

c. Would allow patients to receive their dosage with-out their signing it.

In so doing, Mr. Donald Ferguson failed to properly ensure that the methadone preparation and administration proc-ess had adequate measures to ensure patient safety.

4. Upon inspection by the Nova Scotia College of Pharma-cists, it was further revealed that an administration logbook in which all patients receiving methadone at thepharmacy and their current daily dose were listed suchthat the technician could record the administration of adose with a check mark in the appropriate column. Thislist could be viewed by other patients, thereby failing toproperly and adequately protect patient confidentiality.

5. Upon inspection by the Nova Scotia College of Pharma-cists, it was further revealed that Mr. Donald Fergusonfailed to maintain proper records in that:

a. All bottles of methadone were not separately labeled(the information was kept in a book only and not onbottles);

b. The compounding record did not include the lotnumber or manufacturer of the methadone used.

c. The Pharmacist had not been checking every bottlecompounded by a technician.

6. The pharmacy manager at Ferguson’s Pharmacy, Mr. DavidFerguson, failed to develop, maintain and enforce policies


Professional Accountability: Resolution of a Disciplinary Matter

(continued from previous page)

and procedures to comply with the Pharmacy Act of Nova Scotia and Nova Scotia College of Pharmacists practice resources, as detailed above, and failed to en-sure optimal patient care, all of which amount to pro-fessional misconduct.

The conduct described above amounts to professional misconduct.

Disposition:

1. That there shall be a publication in the President’s Bul-letin, with reference to name, of an article or informa-tion relating to the details and resolution of the matter;

2. Mr. David Ferguson and Mr. Donald Ferguson shallattend, for one business day, at a pharmacy arranged bythe Nova Scotia College of Pharmacists, with a metha-done program, for the purpose of mentorship and edu-cation on the proper administration and the properconduct of a methadone program;

3. Mr. David Ferguson and Mr. Donald Ferguson shall doa written assessment to the Registrar of the Nova Sco-tia College of Pharmacists of what each learned fromClause (2), and what changes each intends to make tohis pharmacy practice as a result of his experience;

4. A letter of reprimand shall be placed in the files of Mr.David Ferguson and Mr. Donald Ferguson

5. Mr. David Ferguson and Mr. Donald Ferguson shalleach pay half the costs of this proceeding in the amountof $4852.90 each;

6. The licenses of Mr. David Ferguson and Mr. DonaldFerguson to practice pharmacy in Nova Scotia shall besuspended for a period of one week, which shall be inplace for seven consecutive days.

Ethics under the Spotlight

The Code of Ethics provides guidance to pharmacists making ethical decisions. It educates pharmacists about their ethical duties and obligations.

As the practice of pharmacy evolves, factors such as economic restraints and increased technology chal-lenge the ability of pharmacists to practice ethically.

The Code provides pharmacists with direction for ensuring ethical decision making.

To increase the awareness by Nova Scotia pharmacists of their Code of Ethics, which the legislation requires them to observe, the Bulletin will regularly highlight specific ethical requirements in each issue.

This issue’s Ethic under the Spotlight:

Value I

Pharmacists hold the health and safety of each patient to be of primary consideration.

• Pharmacists have specialized knowledge about medicines, health related products, and medicinal andnonmedicinal therapies and are expected to use this knowledge to benefit their patients.

• Pharmacists are aware of the limitations of their knowledge and skills and refer patients to appropriatehealth care professionals when they are unable to meet the needs of their patients.

• Pharmacists supply only prescription and nonprescription medicines and health related products that aresafe, effective and of good quality.


The following article on buprenorphine (Suboxone® by Schering Plough) was developed by the Centre for Addiction and Mental Health (CAMH) in Ontario. It was originally published in Pharmacy Connection, a publication of the Ontario College of Pharmacists, and has been reprinted in this Bulletin with permission from the authors.

Int r oduct ionAfter much anticipation by health care providers provid-ing addiction services in Canada, buprenorphine is nowavailable for the treatment of opioid dependence. I t ismarketed as Suboxone® by Schering-Plough, Canada, incombination with naloxone in a sublingual tablet. Thismedication has been available for several years in manyparts of the world, including the United States. Pharma-cists in Ontario now have an opportunity play an impor-tant role in the management of Suboxone® treatment withother members of the treatment team.

Buprenorphine treatment provides an alternative tomethadone maintenance treatment in Canada. Opioidmaintenance therapy, whether with buprenorphine ormethadone, has been shown to be far more effective thandetoxification in improving health outcomes in those withsevere dependence or long standing opioid abuse.1

Research on opioid substitution therapy has been con-ducted primarily in heroin dependent individuals. Stud-ies are current ly underway in the US to determinebuprenorphine's role in the treatment of prescription opi-oid abuse, which has become an issue of increasing con-cern relative to heroin use in Ontario. 2

Over the last 5 years, some patients seeking treatmentat the Centre for Addiction and M ental H ealth for opioiddependence have been treated with buprenorphinethrough the special access program. This article reflectsthe current evidence regarding buprenorphine treatment,as well as the authors' experience in working with thesepatients.

As with methadone treatment, pat ients prescribedbuprenorphine should be carefully monitored within a

framework of medical, social, and psychosocial support aspart of a comprehensive opioid dependence treatmentprogram.3 Pharmacist involvement in buprenorphinetreatment can include the supervision of drug adminis-trat ion, monitoring patients, communicat ing with thetreatment team, providing encouragement and support,and dispensing take-home doses ( c̀arries'). Involvementin the treatment of opioid dependent pat ients withbuprenorphine has the potential for pharmacists toexpand their scope of practice and provide a satisfyingprofessional opportunity to participate in the recovery ofindividuals dependent on opioids. This area of practicemay be of particular interest to those pharmacists cur-rent ly involved in the provision of methadone mainte-nance treatment. Opioid dependence is a complex disor-der; therefore pharmacists who take training specific tobuprenorphine therapy and other treatment options willbe well positioned to provide pharmacy services to thesepatients. With buprenorphine maintenance treatment, aswith methadone maintenance treatment, patients bene-f it from physicians and pharmacists working togethereffectively to provide optimal treatment.

Key Messages f o r Bupr eno r phine• Suboxone® is an opioid prescription medication con-

taining buprenorphine 2 mg and 8 mg (in subl ingualtablets) in fixed combination with naloxone 0.5 and 2mg respectively (to deter injection drug use).

• Buprenorphine:- is efficacious as substitution therapy in the treat-

ment of opioid dependence.4-6

B U P R E N O R P H I N E :

A New Treatment ForOpioid Dependence

Pearl Isaac, RPh, BScPhmEva Janecek, RPh, BScPhmAnne Kalvik, RPh, BScPhmBeth Sproule, RPh, BScPhm, PharmD

Centre for Addiction and Mental Health33 Russell Street,Toronto, ONM5S 2S1

Pearl [email protected] [email protected] [email protected] [email protected]


- is an alternative to, but not a substitute for,methadone maintenance treatment.7

- acts primarily as a partial agonist at mu-opioidreceptors.3

- is considered safer in overdose than methadone,although if combined with other CNS depressantdrugs (e.g., benzodiazepines) respiratory depressioncan occur.8 I f clinical symptoms of overdose occurit may require higher doses of naloxone or othermeasures for treatment.9

- may have a lower potential for abuse and depend-ence than pure agonists such as morphine9-11,although abuse does occur.10;12 The addition ofnaloxone to the Suboxone® product formulation isintended to deter injection.

- can be titrated to an effective dose within days, incontrast to methadone which typically may takeweeks to achieve.

- prescribed at maximal doses may not be sufficientfor all patients. When the maximum daily dosedoes not stabil ize a patient, consideration shouldbe given to using methadone.

- may induce withdrawal in patients dependent onopioids if administered too soon after last use offull opioid agonists.

- may be easier to taper from than methadone- may be associated with less stigma than

methadone

• dissolution of Suboxone® sublingual tablets usuallytakes 2 to 10 minutes. A suitable, confidential area inthe pharmacy is needed where patients can waitwhile the dose is dissolving under the observation ofthe pharmacist.

• a possible barrier to treatment may be the cost ofSuboxone® (approximately $90 - 460 per month drugcost, plus fees) and it is not yet available on ODB.

How Bupr eno r phine Wor ksBuprenorphine is a synthetic opioid with a unique profile:it is a part ial mu-opioid receptor agonist .3 Buprenor-phine has a lower intr insic act i vi ty at the mu-opioidreceptor than a full agonist (e.g., methadone or oxy-codone). This means that there is a "ceiling effect" to itsopioid agonist effects at higher doses13 making it safer inoverdose and reducing its potential for abuse. 3 For exam-ple, above doses of 16-32mg daily, there is no increased

effect from increasing the dose further.13 Although it is apartial agonist, buprenorphine has a very high aff ini tyfor (i.e., binds tight ly to) the mu receptor . This tightbinding means that buprenorphine can block the effectsof other opioid agonists (e.g., methadone or oxycodone),and it may even precipitate withdrawal in those physi-cally dependent on opioids by displacing agonists fromopioid receptors.3 The tight binding is also associated witha slow dissociat ion from the mu receptor resulting in along duration of action.3 This is why buprenorphine isassociated with a milder withdrawal syndrome and hasbeen used to assist in detoxification (unapproved indica-tion in Canada) from other opioids. 8;14

Buprenorphine's partial mu-opioid agonist activity isbeneficial in the treatment of opioid dependence because:- I t reduces craving for opioids.- I t may block the effects of other opioids (e.g., mor-

phine, oxycodone, heroin).3

- I t can attenuate opioid withdrawal. 3

Phar macokinet ic Char act er ist icsSpecif ic t o Bupr eno r phine15

Buprenorphine's pharmacokinetic propert ies al low i tto be uti l i zed as a feasible subst i tut ion treatment foropioid dependence. I ts slow onset of act i on andextended duration of act ion are both desi red featuresin a treatment for opioid dependence. Buprenorphinehas poor oral bioavailability due to extensive metabolismby intestine and liver. Sublingual administration allowsabsorption through the oral mucosa and thus preventsbreakdown via first-pass metabolism. Suboxone® tabletsare formulated to be dissolved under the tongue. Theonset of action is slow with peak effects from sublingualadministrat ion occurring 3 - 4 hours after dosing.Buprenorphine is converted in the l iver primari ly bycytochrome P450 (CYP) 3A4 to an active metabolite (nor-buprenorphine) with weak intrinsic activity. Both nor-buprenorphine and buprenorphine are subject to hepaticglucuronidation. The mean elimination half-life is indi-cated as 37 hours in the product monograph 3, with evi-dence in the literature of large inter-individual variation(24 to 69 hours) following sublingual administration. 15

M ost of dose is el iminated in the feces, with approxi-mately 10 - 30 % excreted in urine.

Not es about nal oxone:Naloxone, a pure opioid antagonist, is contained in Sub-oxone tablets in combination with buprenorphine, with

B U P R E N O R P H I N E


the intention of deterring patients from dissolving andinjecting the tablet. When Suboxone® is used sublingually,naloxone is largely unabsorbed and does not exert phar-macological activity.15 When injected, naloxone may atten-uate the effects of buprenorphine or cause opioid with-drawal effects in opioid-dependent individuals.

Tr eat ment Pr ogr amI nit ial ly, Suboxone® must be dosed under supervisionof a health professional (e.g., a pharmacist) for a min-imum of 2 months.3 The exception to this is in circum-stances in which the pharmacy is not open on weekends;in that case, suitable patients may receive take-homedoses for Saturday and/or Sunday. 3

I nduct ionTherapy is initiated when the patient is experiencing opi-oid wi thdrawal symptoms:• at least 4 hours after use of short-acting opioid (e.g.,

heroin, oxycodone)3

or• at least 24 hours or longer after the use of a long-act-

ing opioid (e.g., methadone).- Note: For methadone maintenance patients wanting

to switch to Suboxone®, it is recommended that themethadone dose be tapered down to 30 mg or lessbefore buprenorphine treatment is initiated to mini-mize the possible precipitation of intense withdrawalsymptoms.

Initially a single dose of 2 to 4mg is given under super-vision. An additional 4 mg may be administered later onin the same day depending on the individual patient'srequirement.

M aintenanceThe dose should be increased progressively according tothe individual patient's needs and should not exceed amaximum daily dose of 24 mg according to the productmonograph.3 The dose is titrated according to reassess-ment of the physical and psychological status of thepatient.3 Once a patient has been stabilized on a mainte-nance daily dose, there is the option to reduce the fre-quency of administration to less than daily dosing (e.g.,double the dose given every second day. See productmonograph for details.)

Take-home dosesAfter the initial time period of two months of superviseddosing, take home dosing can be considered based on theassessment of clinical stabil ity, length of time in treat-ment and the patient's abil ity to safely store the drug.Patients with take home doses should be assessed andreviewed on a regular basis.

Take home doses should be kept in the original strippackaging. Use of childproof closures are recommended.Take home doses need to be securely stored.

M anagement of M issed D osesCompliance with buprenorphine treatment needs to betracked by the pharmacist. Any missed doses should becommunicated to the prescriber. The pharmacist shouldconsult the prescriber to develop a plan on how to con-tinue with buprenorphine treatment after several (e.g., 3or more) missed consecutive doses.

M anagement of I ntoxicated Pat ientsPatients should be assessed for intoxication prior to dos-ing. An intoxicated patient should not be given a dose ofSuboxone®. The prescriber should be consulted regardinga management strategy (e.g., delaying the dose), keepingpatient safety paramount.

Transi tions of CareW hen a pat ient is swi tching pharmacies, communica-tion must occur among pharmacists and other health careproviders (as with methadone maintenance treatment) toensure that there are no omissions or overlaps inbuprenorphine dosing. This is also important when thepatient is admitted or discharged from institutions suchas hospitals or jails.

Adver se Ef f ect sI t is important to distinguish adverse effects from with-drawal symptoms that can be precipitated by buprenor-phine.

After the f irst dose of buprenorphine there may besome precipitated opioid withdrawal symptoms, such asheadache, gastrointestinal upset, nausea, diarrhea, runnynose, sweating.

Adverse effects during buprenorphine treatment aredose related and similar to other opioids. M ost commonare constipation, headache, CNS depression (e.g, seda-tion) euphoria, sweat ing, nausea, insomnia and ortho-static hypotension.



Toxic effects can be caused by buprenorphine alone orin combinat i on wi th other CN S depressants. Sincebuprenorphine is a partial agonist, there is a ceiling effecton respiratory depression; however, very high doses ofbuprenophine in some individuals have been associatedwith severe symptoms. Respiratory depression, when itoccurs, may be delayed in onset and more prolonged thanwith opioids such as morphine, and reversal with nalox-one is more difficult due to buprenorphine's very tightbinding to opioid receptors. Other treatment approachesmay be necessary (e.g., assisted ventilation).

Dr ug Int er act ionsSerious respiratory depression has occurred whenbuprenorphine has been combined with CNS depressantsincluding other opioids, alcohol, benzodiazepines, certainantidepressants, sedating H 1-receptor antagonists, bar-biturates.3 Special caution is recommended with the useof benzodiazepines and buprenorphine as this combina-t ion has resulted in respiratory depression, coma anddeath.3 M edications with CNS effects should be avoidedand pat ients counselled regarding the risks associatedwith alcohol and benzodiazepine use. 3

Buprenorphine is primarily metabolized by CYP3A4.Inducers (e.g., phenytoin, carbamazepine, rifampin) orinhibitors (e.g., ketoconazole, fluvoxamine, erythromycin,indinavir, saquinavir ) of this enzyme would be expectedto interact with buprenorphine. Ketoconazole, a power-ful inhibitor of CYP3A4, has received particular atten-tion and it has been reported to significant ly increasepeak plasma concentrations of buprenorphine. 16 Carefulpatient monitoring and adjustment of buprenorphine dosewhen necessary, is recommended.

Special Pat ient Popul at ions:Pregnant Pat ientsThe role of buprenorphine in pregnancy has not beenclearly elucidated and Suboxone® is not approved for usein this populat ion.3 I ni t ial studies have shown thatbuprenorphine is efficacious, well tolerated and safe inpregnancy,17-19 however, use of the combination productwith naloxone is not appropriate at this time. Buprenor-phine crosses the placenta.15 Neonatal withdrawal canoccur, although some sources indicate that symptoms aremild or absent in many cases.9;20 The current standard forcare for opioid dependency in pregnancy is methadonetreatment.

Patients wi th Renal or H epat ic Fai lureThe dose of buprenorphine does not have to be signifi-cantly adjusted in renal impairment. 15 I t is possible thatthe dose may need to be modified in chronic liver dis-ease.15

Abuse o f Bupr eno r phineBuprenorphine is considered to have a lower potentialfor abuse due to i ts pharmacological propert ies (i .e.,par t ial opioid agonist act ivi ty) compared to opioidswhich are ful l agonists, for example, oxycodone ormorphine. H owever, abuse has been reported in coun-tr ies where both buprenorphine alone and in combi-nat ion wi th naloxone are avai lable. 10-12 Buprenorphinehas been abused by crushing and then administration bysnorting or by the intravenous route.

Supervised daily dosing in the f irst 2 months ofbuprenorphine treatment is intended to reduce the risk ofdiversion. Pharmacists may minimize diversion throughcareful dispensing and dose monitoring, watching for"double doctoring" and communicating possible diver-sion (e.g., lost or stolen carries) to the physician.

Diversion to other people can result in overdose, par-ticularly when combined with alcohol, benzodiazepinesor other CNS depressants. Diversion for use in a persondependent on methadone or other opioids can cause themto experience precipitated withdrawal.

Pr act ical Tips f o r Phar macist s• Patients need to be positively identified, for example,

with photo ID.• Pharmacists should assess patients for intoxication

and compliance prior to dosing.• Tablets should not be handled, but should be tipped

into the mouth from a medication cup.• I f the dose consists of more than one tablet, tablets

should be put under the tongue at the same time.• Suboxone® tablets require some time to dissolve

under the tongue (up to 10 minutes). Dosing is bestdone in a quiet area of the pharmacy where thepatient can sit undisturbed by other patients, yet beobserved by pharmacist. From time to time, checkunder the tongue to assess dissolution (discreetly andrespectfully). The first few minutes are the mostimportant for avoidance of dose diversion - i.e.,once the tablet dissolves into a pulpy mass it wouldbe more difficult to divert.

• Drinking water/fluids prior to medicating may facil i-



tate dissolution of tablets and speed up the process ofmedicating.

• Patients should be instructed not to swallow theirsaliva while tablets are dissolving.

• I f the patient vomits after the dose, there is noimpact on buprenorphine absorption once the tablethas dissolved.

• Patients should refrain from drinking for about 5minutes after tablets have dissolved in order to makesure that all medication has been absorbed.

• I f more than one pharmacy is used, communicationamong pharmacists must occur in order to ensure

that no double dosing or dosing after tolerance is lostoccurs

• Pharmacists should consider using a treatment agree-ment with the patient (similar to methadonepatients).

Reference L ist1. Stein M D, Friedmann PD. Optimizing opioid detoxification: Rear-

ranging the deck chairs on the Titanic. Journal of Addictive Diseases2007;26: 1-2

2. Brands B, Blake J, Sproule BA, et al. Prescription opioid abuse inpatients presenting for methadone maintenance treatment. Drug andAlcohol Dependence 2004;73: 199-207

3. Schering-Plough Canada I. SuboxoneTM Product M onograph. 2007:4. Johnson RE, Jaffe JH, Fudala PJ. A controlled trial of buprenorphine

treatment for opioid dependence. JAM A 1992;267: 2750-2755

FormulationEffective treatment for opioid dependence?Physician exemption required to prescribe?Pharmacology at opioid receptorsOnset of actionDuration of actionTitration time to stable doseSupervised dosesTake-home doses possible?Need for extemporaneous preparationby pharmacistTime to ingest dose

Alternate day dosing possible?Ceiling dose for opioid substitution effects?

Ceiling dose for respiratory depressant effects?SedationWithdrawalAbused ?

Concern of added toxicity when combined withCNS depressants?CYP3A4 interactionsStigmaDoes counseling improve treatment outcomes?Ontario Drug Benefit CoverageReimbursement for services

Buprenorphine

Sublingual tabletYesNo (but training recommended)Partial mu-agonistSlow sublinguallyVery longDays (to weeks)YesYes

NoMinutes (need to dissolveunder tongue)YesYes

Yes (may be safer in overdose)May be lessMay be less/ milderYes (naloxone included to IVabuse)

YesYesMay be lessYesNot at this timeNot yet determined

Methadone

Oral liquidYesYesFull mu agonistSlow orallyLongWeeksYesYes

YesSeconds (swallowed)

NoNo (can titrate dose higher forpatients who require it)NoMay be more pronouncedMay be more difficultYes (juice added to IV abuse)

YesYesPossibly moreYesYesEstablished structure

Compar ison o f Bupr eno r phine t o Met hadone



5. Johnson RE, Chutuape M A, Strain EC, et al. A comparison of lev-omethadyl acetate, buprenorphine, and methadone for opioiddependence. New England Journal of M edicine 2000;343: 1290-1297

6. M attick RP, Kimber J, Breen C, et al. Buprenorphine maintenanceversus placebo or methadone maintenance for opioid dependence.Cochrane Database of Systematic Reviews 2003;2003:

7. Srivastava A, Kahan M . Buprenorphine: a potential new treatmentoption for opioid dependence. Can M ed Assoc J 2006;174: 1835-1836

8. Robinson SE. Buprenorphine-containing treatments. Place in themanagement of opioid addiction. CNS Drugs 2006;29: 697-712

9. M artindale The Complete Drug Reference. Buprenorphine. Pharma-ceutical Press; 2007:

10. Cicero TJ, Inciardi JA. Potential for abuse of buprenorphine inoffice-based treatment of opioid dependence. New England Journalof M edicine 2005;353: 1863-1865

11. Smith M Y, Bailey JE, Woody GE, et al. Abuse of buprenorphine inthe United States: 2003-2005. Journal of Addictive Diseases2007;26: 107-111

12. Robinson GM , Dukes PD, Robinson BJ, et al. The misuse ofbuprenorphine and a buprenorphine-naloxone combination inWellington, New Zealand. Drug and Alcohol Dependence 1993;33:81-86

13. Walsh SL, Preston KL, Stitzer M L, et al. Clinical pharmacology ofbuprenorphine: Ceiling effects at high doses. Clin Pharmacol Ther1994;55: 569-580

14. Blondell RD, Smith SJ, Servoss TJ, et al. Buprenorphine andmethadone: A comparison of patient completion rates during inpa-tient detoxification. Journal of Addictive Diseases 2007;26: 3-11

15. Elkader A, Sproule BA. Buprenorphine. Clinical pharmacokineticsin the treatment of opioid dependence. Clin Pharmacokinet2005;44: 661-680

16. AHFS Drug Information. Buprenorphine Hydrochloride.2007:2164-2171

17. Fischer G, Ortner R, Rohrmeister K, et al. M ethadone versusbuprenorphine in pregnant addicts: a double-blind, double-dummycomparison study. Addiction 2006;101: 275-281

18. Lacroix I, Berrebi A, Chaumerliac C, et al. Buprenorphine in preg-nant opioid-dependent women: first results of a prospective study.Addiction 2004;99: 209-214

19. Fischer G, Johnson RE, Eder H, et al. Treatment of opioid-depen-dent pregnant women with buprenorphine. Addiction 2000;95: 239-244

20. Loustauneau A, Auriacombe M , Franques P, et al. A report of 18pregnancies among buprenorphine-treated women. Drug and Alco-hol Dependence 2000;60: S132


Q What is the regulatory status of buprenorphine?

A Buprenorphine is a narcotic (listed in the Controlled Drugs and Substances Act) and requires a triplicate pre-scription.

Q What buprenorphine products are available in Canada?

A Subutex® and Subutone® by Schering Plough have been approved by Health Canada for the treatment of opioiddependence. However, only Suboxone® (buprenorphine and naloxone combination) has been introduced to the Canadian market.

Q Can buprenorphine be prescribed for pain?

A No, buprenorphine is indicated for the treatment of opioid dependence only.

Q Physicians need a special exemption to prescribe methadone. Will the same rule apply to buprenorphine?

A Unlike methadone, physicians do not need special authorization from Health Canada to prescribe buprenor-phine. It is recommended, however, that physicians have training in the area of opioid dependence/addiction medicine and/or have familiarized themselves with the Suboxone Education Program for physicians before initiat-ing therapy.

Q Are there special requirements for Nova Scotia pharmacists?

A Pharmacists are expected to become familiar with buprenorphine by taking the Suboxone Education Program forphysicians and pharmacists, available online at www.suboxonecme.ca. The module directly relating to pharma-cists is Module 6.

Buprenorphine: Questions from Pharmacists

1464 Dresden Row Halifax, NS

B3J 3T5

Phone: 902-422-8528 Fax: 902-422-0885

E-mail: [email protected]

NOVA SCOTIA COLLEGE OF

PHARMACISTS

The NSCP Council welcomes Craig Connolly as the newest Zone 1 Councillor. Craig attended his first meeting of Council on January 23, 2008, where Council welcomed him and expressed appreciation for his commitment to the public of Nova Scotia and the affairs of the Nova Scotia College of Phar-macists.

Born and raised in Halifax, Craig obtained a BSc from St Mary’s in 1996, after which he worked as a Lawtons front store manager until entering the College of Pharmacy at Dal.

He is a class of 2006 graduate from Dalhousie, where he was an active student, including being the president of the Dalhousie Student Pharmacy Soci-ety 2005-2006, and recipient of the 2005 CPhA

Centennial Award. While a student, he sat as a student member on the PANS Pharmacy Practice Committee from 2004 – 2006.

After graduating from Dal, Craig worked as a relief pharmacist for Sobeys and Lawtons until he ac-cepted his current position as Pharmacy Manager at Sobeys in Clayton Park in October 2006.

In addition to his practice at Sobeys, he also is a skills lab demonstrator at the Dalhousie College of Pharmacy, sits on the Dalhousie College of Phar-macy curriculum committee, is a member at large for the Dalhousie University College of Pharmacy Alumni Division, and is an active preceptor for the Practical Experience Program.

New Councilor for Zone 1


Stay Current Bookmark the NSCP website:

www.nspharmacists.ca

President, Zone 1 Sujay Khiroya

Past President, Zone 1 Carol-Ann Chaddock

Vice President, Zone 1 Anne Marentette

Secretary/Treasurer Public Representative Dr Thomas Mahaffey

Councillor, Zone 1 Craig Connolly

Councillor, Zone 2 Ruth Shea

Councillor, Zone 3 Deb Barnhill

Councillor, Zone 4 Janelle Gray

Councillor Zone 5 Trevor Simmons

College of Pharmacy Rita Caldwell

Public Representatives Jean MacDougall Frank Burgoyne

Pharmacy Technician Ob-server Cathy Comeau

Registrar Susan Wedlake

Deputy Registrar Bev Zwicker

Inspector Interviews with Pharmacy Managers

The Council of the Nova Scotia College of Pharma-cists is of the position that the public is best served when pharmacy managers are fully aware of their role and responsibilities as described in the legisla-tion.

Therefore, effective January 1st 2008, the NSCP will interview a pharmacist prior to their commencement in the role of pharmacy manager in a pharmacy.

The NSCP will contact the pharmacist to schedule the telephone interview upon receipt of a completed Change in Manager form by the NSCP. A copy of the new Change in Manager: NSCP Interview Form has been included with this Bulletin.

The Pharmacy Self-Audit has also been updated to include this formal review of the pharmacy manager’s role.

Pharmacy managers are encour-aged to carefully consider and respond when completing this new component of the self-audit, and to use it as a tool to assist them and their pharmacy in com-plying fully with the legislation and in providing optimal patient care.

Change in Pharmacy Staff Reporting

The Practice Regulations [s 2.1(e)] clearly state that pharmacy managers are required

to notify the NSCP in writing of any changes in the pharmacy staff when they occur.

To assist you in this process, the NSCP has pre-pared a Change in Pharmacy Staff form for you to complete and submit. A copy of this form is in-cluded with this Bulletin. This form is also accessible on the NSCP website at www.nspharmacists.ca/registration/

Email from NSCP The NSCP has begun to use its email system to notify pharmacies of important information including safety advisories.

Pharmacy Managers are reminded of their obligation to disseminate this information to all pharmacy staff in a timely manner. As such, the pharmacy manager must establish a process to ensure that the phar-macy’s email address provided to the NSCP is cur-

rent, and that it is checked and acted upon appro-priately regardless of vacations or other absences.

The NSCP will be conducting tests over the next several months to ensure compliance.

Email from NSCP will be from: “NSCP”

February 2008 COLLEGE OF NOVA SCOTIA the Bulletin …€¦ · · 2016-06-15The NSCP Council is of...

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