MIMS Pharmacy June 2015 RG

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  • MAY/JUNE 2015NEWS & INSIGHTS

    87 percent of ICU patients at SGH experience drug-drug interactions

    CLINICAL PHARMACY

    Imatinib may be a novel treatment option for colon cancer

    NEWS

    Attenuated sunitinib regimen better for Asians with late-stage kidney cancer

    DRUG PROFILE

    Sofosbuvir for hepatitis C virus infection

    BUSINESS

    New headquarters to help Sigma-Aldrich support AsiaPac clients

  • 87 percent of ICU patients at SGH experience drug-drug interactionsRADHA CHITALE

    Eighty-seven percent of patients in the inten-sive care unit (ICU) of Singapore General Hospital (SGH) experienced drug-drug interac-

    tions (DDI); about a third were major or contra-

    indicated drug interactions with significant ad-

    verse effects such as major bleeding.

    In our study, with every increase in the num-

    ber of drug interactions, the risk of adverse drug

    reactions [ADR] for our patients increased by

    1.2 percent, said Ms. Jasmine Ong, a pharma-

    cist at SGH, speaking at the SGH 21st Annual

    Scientific Meeting, held recently in Singapore.

    For an average ICU patient with a mean of

    eight drug interactions per patient, this will be at

    least a 10 percent risk.

    The prospective observational cohort study

    included 91 adults admitted to the SGH ICU

    (mean age 62 years, 59 percent male) in May

    2014 who were followed up for their entire ICU

    stay or until the end of the 1-month study pe-

    riod. The median length of ICU stay was 6 days

    and the median length of hospital stay was 21

    days. Twenty-five percent of the cohort died

    during the study.

    The researchers reported a total of 794 DDIs.

    Eighty-seven percent of patients had at least one

    DDI, for a mean 8.6 DDIs per patient or 147 DDIs

    per 100 patient days. The majority of these were

    a result of pharmacodynamic drug interactions,

    as opposed to pharmacokinetic or other types of

    interactions. One-third were major or contraindi-

    cated DDIs.

    Polypharmacy is common in ICUs, Ong noted,

    but the clinical consequences are poorly under-

    stood, and they can vary between institutions de-

    pending on prescribing practices.

    During the follow-up period, there were 14

    cases of ADR due to DDIs, the most common of

    which were major bleeding. Bleeding was likely

    due to concurrent use of antiplatelet combina-

    tions of aspirin, clopidogrel, ticagrelor, enoxapa-

    rin, warfarin, or amiodarone.

    Strategies need to be developed to reduce

    this risk of bleeding, Ong said. For example...

    determine the baseline bleeding risk of ICU pa-

    tients and if it is high, consider using alternative

    medications or totally avoiding the drug interac-

    tion.

    Nephrotoxicity, peripheral necrosis, hepato-

    toxicity, QTc prolongation and hypotension also

    occurred.

    ADRs warranted drug discontinuation in 10

    MAY-JUNE 2015 NEWS 2

  • patients along with some additional measures

    such as dialysis for nephrotoxicity.

    Patients with more DDIs had a higher risk of

    ADRs. Patients with ADRs had an average of 10

    DDIs per patient compared with 6.5 DDIs in pa-

    tients without ADRs.

    Patients with ADRs also stayed longer in the

    ICU, an average of 15 days compared with 5

    days for patients without ADRs.

    Other factors associated with longer hospital

    stays ICU mortality, 28-day mortality were

    not associated with ADR.

    The longer ICU stay and additional moni-

    toring and management required by patients

    who develop ADR also led to a sharp increase

    in costs, Ong said. If they experience an ADR,

    patients can pay an additional S$9,000 on top

    of the average cost of S$910/day which ex-

    cludes consultation, laboratory test, and proce-

    dure fees at SGH.

    Ong said the reported incidence of DDIs and

    corresponding high rate of ADRs in the SGH

    ICU population was higher than those reported

    in other studies, likely because their study in-

    cluded patient data from two databases as well

    as a literature search.

    The study was limited by the follow-up period,

    which may not have captured patients who expe-

    rienced an ADR after discharge, and by the tool

    for evaluating how likely an adverse reaction is the

    result of a drug, which is meant to address reac-

    tions to single drugs only.

    This highlights the role of the pharmacist in

    the active surveillance for DDI and the streamlin-

    ing of medication regimens and monitoring for

    potential ADRs, Ong said.

    MAY-JUNE 2015 NEWS 3

  • MIMS rolls out new identity, purpose

    Leading medical and drug information provider MIMS has rolled out a major re-brand initiative to better engage healthcare

    communities and provide healthcare profes-

    sionals with unified multichannel information

    they can put into practice.

    All MIMS publications Medical Tribune,

    Oncology Tribune, Pharmacy Today, and JPOG

    were renamed MIMS Doctor, MIMS Oncol-

    ogy, MIMS Pharmacy and MIMS JPOG, re-

    spectively. The publication titles now carry the

    new red logo to mirror the companys renewed

    commitment to connect and engage people.

    Mr Ben Yeo, managing director of MIMS

    Asia Pacific, recognized the importance of

    communicating the companys new identity

    and purpose across a global platform.

    We see MIMS as the link that brings to-

    gether healthcare communities, helping

    them to obtain and exchange knowledge

    to improve patient outcomes through better

    care, he said.

    To further support clinicians treatment

    decisions, MIMS introduced 12 disease

    specialty channels (Multispecialty, Phar-

    macy, Oncology, Cardiology, Respirology,

    Endocrinology, Hepatology, Gastroenterol-

    ogy, Neurology, Psychiatry and Obstetrics &

    Gynaecology and Paediatrics) on its website

    www.mims.com and MIMS mobile app.

    Were going beyond just providing infor-

    mation, said Ms Diana Edwards, managing

    director, MIMS Hong Kong and Singapore.

    To build and sustain thriving communities,

    we need to engage and connect people. We

    hope our news and insights, eLearning pro-

    grams, congress coverage and other servic-

    es will facilitate knowledge-sharing and build

    such communities.

    MIMS, a subsidiary of AXIO Data Group,

    with presence across 13 countries, has been

    the source of clinical news and drug infor-

    mation for health care professionals in Asia.

    With MIMS integrated multichannel content,

    information becomes even more accessible

    on print, online and mobile, said Ms Sher-

    lynn Tan, deputy director, MIMS Marketing.

    This allows MIMS to grow its registered user

    base to over 2 million and to generate an av-

    erage of 30,000 new users each month.

    MAY-JUNE 2015 NEWS 4

  • MAY-JUNE 2015 FORUM 5

    NCDs and the need for policy solutions, effective interventionsExcerpted from a speech by Dr Margaret Chan, WHO director general, during a

    dialogue on non-communicable diseases held recently in Geneva, Switzerland.

    Noncommunicable diseases (NCDs) have overtaken infectious diseases as the lead-ing cause of mortality worldwide. WHO esti-

    mates that 80 percent of the burden from NCDs

    now falls on low- and middle-income countries,

    where people develop these diseases earlier,

    fall sicker, and unfortunately die sooner than

    their counterparts in wealthy nations. WHO es-

    timates that NCDs are responsible for 14 million

    premature deaths in the developing world each

    year.

    In some developing countries in Asia, the

    number of deaths from cardiovascular disease

    before the age of 55 is twice that in wealthy

    countries. The reference to type 2 diabetes as

    adult onset diabetes is no longer apt as so

    many children are now being diagnosed with

    this disease.

    The responsibility for the rise in NCDs does

    not fall on individuals who choose to eat,

    smoke, and drink too much or opt for a sed-

    entary lifestyle. The responsibility falls on the

    environments in which these choices are made.

    Can children be blamed for an addiction to

    nicotine when single cigarettes are sold at the

    gates of their schoolhouse? Can parents be

    blamed for their overweight children when cit-

    ies have no green spaces or the crime rate is

    so high that children are not safe playing out-

    doors? For the millions of people living in so-

    called urban food deserts, healthy eating is

    simply not an option.

    This is the first big challenge. The evidence,

    statistics, and arguments you put forward for

    international cooperation must stress the need

    for policy solutions that shape social environ-

    ments. These solutions must be supported at

    the highest level of government, and they need

    to be put in place through a whole-of-govern-

    ment approach.

    A second big challenge is competition. With

    17 goals and 169 targets currently proposed

    for the post-2015 development agenda, this is

    competition for a sliver or some crumbs from

    the pie, not a piece.

    You are being asked to sharpen the evidence

    showing the two-way links between NCDs and

    poverty. You are being asked to make a stron-

    ger case for viewing the prevention and control

  • MAY-JUNE 2015 FORUM 6

    of NCDs as an explicit poverty-reduction strat-

    egy.

    You are being asked to provide an inventory

    of international agencies that have integrated

    NCDs into their development policies and ex-

    tract the lessons learned. We want to hear your

    proposals about how official development as-

    sistance can be used to strengthen prevention

    and control, yet without compromising funding

    for other health priorities.

    We ask you to do all of these things because

    of your expertise, knowledge, and experience.

    A third big challenge is the opposition. This

    is opposition from powerful economic opera-

    tors who strongly oppose any regulatory con-

    trol or restrictions on their marketing of health-

    harming products.

    This is a formidable obstacle to prevention.

    Economic power readily translates into politi-

    cal power. We rely on civil society for support

    in many areas, but most especially in this one.

    The public health community has some

    tools in hand to respond to these challenges.

    The 2011 UN Political Declaration on NCDs

    sets out some compelling arguments. It posi-

    tions these diseases as one of the major chal-

    lenges for development in the 21st century. It

    points out their threat to economies and their

    contribution to inequalities. It gives the primary

    role and responsibility of responding to these

    challenges to governments. And it underscores

    how strongly prevention and control depend on

    the engagement of multiple non-health sectors.

    To guide work, we have an action plan

    through 2020, a monitoring framework with

    nine global targets, and a set of effective and

    affordable interventions, known as best buys,

    that can make a difference in any resource set-

    ting.

    As the root causes of NCDs lie beyond the

    direct purview and responsibility of the health

    sector, combatting these diseases is a com-

    plex task involving multiple sectors. Here, too,

    we have support from the Global Coordination

    Mechanism and a UN Interagency Task Force.

    There are two points made in the discus-

    sion paper prepared for this meeting. First, the

    UN General Assemblys 2014 progress review

    found no lack of high-level government commit-

    ment to NCDs. But it witnessed, in far too many

    countries, a lack of capacity to act, largely be-

    cause of insufficient national expertise in low-

    and middle-income countries. International co-

    operation can provide this expertise. Second,

    efforts to prevent and control NCDs depend on

    a well-functioning health system, ideally one

    that aims to reach universal health coverage.

    Any look at the interactions between NCDs

    and poverty must also look at ways to increase

    access to care and reduce the catastrophic

    medical bills that push so many millions of fam-

    ilies below the poverty line each year.

  • Attenuated sunitinib regimen better for Asians with late-stage kidney cancerRADHA CHITALE

    An attenuated regimen of the first-line meta-static renal cell carcinoma (mRCC) treat-ment sunitinib had similar efficacy to the con-

    ventional regimen but significantly reduced

    toxic side effects among Asian patients, said

    researchers from the National Cancer Centre

    Singapore (NCCS).

    Compared with the standard 50 mg/day

    in a 4-weeks on, 2-weeks off treatment cycle,

    a 37.5 mg/day dose of sunitinib for the same

    6-week treatment cycle resulted in fewer se-

    vere toxicities (59 percent attenuated vs 85

    percent conventional, p=0.0088), dose delays

    (24 percent attenuated vs 58 percent conven-

    tional, p=0.0004), and dose reductions (35

    percent attenuated vs 70 percent conven-

    tional, p=0.0005). [Clin Genitourin Cancer

    2014;pii:S1558-7673(14)00255-9. doi:10.1016/j.

    clgc.2014.11.004]

    Just 3 years into the 7-year study, which be-

    gan in 2007, oncologists around Singapore ad-

    opted the attenuated regimen for their mRCC

    patients and it has now become the standard

    of care, said lead researcher Dr. Tan Min Han,

    a member of the genitourinary oncology team

    and visiting consultant in the Division of Medical

    Oncology at NCCS.

    Many of the patients were experiencing se-

    vere side effects of grade 3 or higher with the

    conventional dosing, Tan said. Our immediate

    response was to refine the treatment protocol to

    improve patients quality of life.

    The attenuated regimen also lowers the cost

    of treatment with sunitinib by about S$1,350 per

    month from the average cost of conventional

    treatment, which is about S$5,400 per month,

    Tan said.

    Sunitinib is a targeted therapy for use in

    mRCC and the 50 mg/day 6-week cycle regi-

    men is the US Food and Drug Administration-

    (FDA) approved dosing, determined safe and

    efficacious, with acceptable toxicity, through a

    number of studies in Western populations.

    However, studies in Asian populations

    showed that many had to stop treatment or

    lower their dose due to grade 3-4 toxicities in-

    cluding neutropaenia, thrombocytopaenia, and

    MAY-JUNE 2015 NEWS 7

  • hand-foot syndrome.

    One alternative was to lower the dose to 37.5

    mg/day for continuous once-daily dosing (CDD)

    but a retrospective analysis in Asian vs non-Asian

    patients showed Asian patients continued to have

    a higher frequency of grade 3-4 toxicities, al-

    though the antitumour effect remained. [Ann On-

    col. 2010;21(Suppl. 8):913P]

    Other than the CDD regimen, there is lim-

    ited data on alternative sunitinib regimens, the

    researchers said.

    In the current study, 127 mRCC patients at

    the NCCS were treated with the attenuated

    regimen and compared to mRCC patients

    around Singapore who were treated with the

    conventional sunitinib regimen.

    Overall survival (OS) from treatment initiation

    (18.3 vs 16.5 months; p=0.54), total OS (27.4

    vs 21.8 months, p=0.45), and progression-free

    survival (6.7 vs 7.9 months, p=0.64), were simi-

    lar between the conventionally and attenuated

    dosed groups, respectively. There was a lower

    rate of adverse outcomes in the attenuated

    group during treatment real world results that

    the researchers said is evidence for such a regi-

    men in the absence of a randomized trial.

    Light-based assay could swiftly identify treatment for XDR bacteriaRADHA CHITALE

    A light-based assay could help identify the best antibiotic combinations for combating extremely drug resistant (XDR) bacteria.

    Combination therapy is highly strain-spe-

    cific, which means that one combination may

    be effective against one strain but not another,

    said Ms. Jocelyn Teo, a pharmacist at Singa-

    pore General Hospital, during a presentation

    at the SGH 21st Annual Scientific Meeting, held

    recently in Singapore.

    But which antibiotic combina-tions to use?

    There is no assay for this.

    XDR bacterial infections are an increasingly

    common clinical scenario, Teo said, with weekly

    cases occurring at SGH. Such infections can re-

    quire strong antibiotic treatments used in com-

    bination, which can be toxic to patients.

    While there are a number of treatment op-

    tions available, swiftly determining optimal

    treatment can be challenging.

    Traditional efficacy testing using the viable

    plate count method is sensitive and specific but

    requires a lot of manpower to plate cells and

    compare the effects of various drug combina-

    tions, Teo said, and can take over 2 days.

    Teo and colleagues capitalized on the pres-

    ence of the intracellular energy molecule ade-

    nosine triphosphate (ATP), present in all living

    cells, as a surrogate marker for viable bacteria

    count.

    MAY-JUNE 2015 NEWS 8

  • Applying the light-emitting compound lucif-

    erin to ATP allowed Teo to measure the amount

    of ATP as a function of bioluminescence.

    Teo and her team used 100 randomly select-

    ed XDR isolates with a variety of bacteria cov-

    ering many different resistance mechanisms.

    Each isolate was tested against single and

    two-drug combinations of the most appropriate

    set of antibiotics. For example, Klebsiella pneu-

    moniae was tested against tigecycline, rifampi-

    cin, polymyxin B, levofloxacin, and meropenem.

    Results were available within 24 hours.

    The researchers then analysed for sensitivity

    and specificity, determining the cut-off point be-

    low which the drug combination was no longer

    inhibiting bacterial growth. Prospective valida-

    tion using additional strains showed the meth-

    od to be robust.

    We identified individual cut offs for each

    species combination, Teo said.

    The bioluminescence assay proved sensitive

    and specific at determining optimal drug com-

    binations effective against XDR bacterial infec-

    tions, reduced the testing time to 24 hours, and

    was easy to perform.

    Teo said further testing on more bacterial

    strains and drug combinations to assess the

    clinical utility of the test would be necessary.

    Solution-focused conversations help motivate patients to changeRADHA CHITALE

    A solution-focused approach is more likely to help clinicians engage with their patients and motivate them to change their behaviours

    than a problem-solving approach, said Ms.

    Cheryl Ng, a senior Speech-Language therapist

    in the Department of Speech Therapy at Sin-

    gapore General Hospital (SGH).Rather than

    focusing on whats wrong, [a solution-focused

    approach] focuses on what works, said Ng,

    during a presentation at the SGH 21st Annual

    Scientific Meeting, held recently in Singapore.

    Clinicians often adopt a problem-solving ap-

    proach to patients, Ng said, which is appropri-

    ate in situations such as diagnosis, prescribing

    treatment and information counselling. Howev-

    er, this approach can be flawed.

    We work in hospitals, we are very accus-

    tomed to the medical model, and there is a ten-

    dency to perceive our clients in terms of their

    deficits and as problems to be solved, Ng said.

    For example, an overweight patient who

    wants to lose weight might be told what they

    should and should not do as far as diet and ex-

    ercise.

    But this reinforces the clinicians as experts,

    clients are disempowered, and they dont have

    ownership of the solution. We shouldnt be sur-

    prised when the client comes back not having

    MAY-JUNE 2015 NEWS 9

  • lost any weight.

    In addition, the pressure to constantly solve

    patient problems can increase the rate of clini-

    cian burnout.

    Solution-focused brief therapy (SFBT) was

    developed in the 1970s as a therapeutic ap-

    proach that favours how change happens over

    how problems develop, focusing on patient

    knowledge and resources. It is used most often

    in the context of palliative care, cancer care, de-

    pression, fatigue, and pain management.

    The overarching principles guiding the pa-

    tient-clinician interaction are that they should

    be patient-led, future-oriented, and strength-

    focused. Conversations should re-frame nega-

    tive feelings and transition to asking for stories

    where patients created solutions. Positive feed-

    back is also critical.

    For example, asking a patient who forgets

    to take medicine to recall times when they did

    remember to take it and identify helpful behav-

    iours such as putting it in a convenient place

    like the kitchen counter is more helpful than

    asking why they forget to take the medicine, tell-

    ing them the risks of not taking medicine, or ad-

    vising them to buy a pill box or create reminders

    in their calendar.

    Since the solutions come from the patients

    frame of reference and not ours, they have a

    much higher chance of fitting naturally in their

    lives and a much higher chance to be effective

    and complied with, Ng said.

    A review of 43 controlled-outcome SFBT

    studies showed that 74 percent reported sig-

    nificant positive benefit from the approach and

    23 percent reported positive trends. Other re-

    views generally support SFBT for non-severe

    presenting problems, although they have not-

    ed problems with SFBT study methodology

    such as concurrent therapies and a wide vari-

    ety of subjects included. [Research on Social

    Work Practice 2013,23:266-283; J Child Psy-

    chol Psychiatry 2013,54:707-723; Fam Process

    2000,39:477-498]

    Clinicians themselves may balk at engag-

    ing with patients this way because they lack the

    confidence or skills for such interactions.

    However, they should remember that the

    knowledge and experience of patients is a valu-

    able resource, Ng said

    MAY-JUNE 2015 NEWS 10

  • Tabalumab no better than placebo for RAELVIRA MANZANO

    An investigational anti-B-cell activating fac-tor (BAFF) monoclonal antibody is no bet-ter than placebo in achieving clinical response

    in patients with rheumatoid arthritis (RA) who

    had not responded to methotrexate (MTX), a

    phase III study has shown.

    There was no difference in ACR20 (American

    College of Cardiology 20 percent) response

    score at week 24 the primary endpoint of

    the study or change in mTSS (modified To-

    tal Sharp Score) from baseline at week 52 be-

    tween patients treated with tabalumab and

    placebo. Nearly 30 percent of patients treated

    with tabalumab 120 mg every 4 weeks and 32.8

    percent of those assigned to tabalumab 90 mg

    every 2 weeks achieved ACR20 compared with

    25.1 percent for placebo. There were also no

    significant differences between the tabalumab

    and placebo groups in the percentage of pa-

    tients achieving ACR50 and ACR70 responses

    at the end of treatment. [Ann Rheum Dis 2015;

    doi:10.1136/annrheumdis-2014-207090]

    Despite changes in CD20+ B cells, RF

    rheumatoid factor, and immunoglobulins follow-

    ing tabalumab treatment, BAFF inhibition with

    tabalumab was not clinically, functionally, or

    structurally efficacious in patients with moder-

    ate-to-severe RA taking MTX, said lead inves-

    tigator Professor Josef Smolen of the Medical

    University of Vienna in Vienna, Austria.

    The study included 1,041 patients with mod-

    erate-to-severe RA (6 months duration) who

    had inadequate responses to MTX therapy, ran-

    domized to tabalumab 120 mg every 4 weeks

    or 90 mg every 2 weeks or placebo. Median

    CD20+ B-cell counts increased at week 1 in the

    tabalumab groups, but decreased from week

    4 to 52. The differences in absolute and rela-

    tive CD20+ B-cell-level changes from baseline

    to week 52 were significant in both tabalum-

    ab groups compared with the placebo group

    (p

  • First WHO guidelines on hep B take public health approachSARAS RAMIYA

    The first-ever WHO guidelines on hepatitis B take a public health approach. This will simplify and standardize approaches, to ensure

    every person has access to treatment, says

    Dr. Gottfried Hirnschall, director, department of

    HIV/AIDS, WHO, Geneva, Switzerland, at the of-

    ficial launch of the guidelines.

    The evidence-based guidelines, which target

    national programme managers, are intended for

    low- and middle-income countries (LMICs) that

    have poor access to liver biopsy and HBV DNA

    testing. [2015 WHO Guidelines for the preven-

    tion, care and treatment of persons with chronic

    hepatitis B infection. Available at: www.who.int/

    hiv/pub/hepatitis/hepatitis-b-guidelines/en/ Ac-

    cessed on 16 March]

    The guidelines aim to strike a balance be-

    tween implementing the best-proven standard

    of care and what is feasible on a large scale in

    resource-limited settings, said Dr. Philippa East-

    erbrook, department of HIV/AIDS, WHO.

    Priority for treatment is given to those most

    in need, and treatment is provided in an envi-

    ronment free of stigma and discrimination, she

    added.

    Key recommendations include:

    the use of a few simple non-invasive tests

    to assess the stage of liver disease to help

    identify who needs treatment;

    prioritizing treatment for those with cirrhosis

    the most advanced stage of liver disease;

    the use of two safe and highly effective medi-

    cines, tenofovir (TDF) or entecavir (ETV), for

    the treatment of chronic hepatitis B; and

    regular monitoring using simple tests for ear-

    ly detection of liver cancer, to assess wheth-

    er treatment is working, and if treatment can

    be stopped.

    Source: WHO. Available at: www.who.int/

    mediacentre/news/releases/2015/hepatitis-b-

    guideline/en/

    The WHO guidelines offer opportunities to

    Asia through massive price reductions for TDF

    and ETV. These reductions have been achieved

    through negotiation among governments, the

    pharmaceutical industry and NGOs, said Pro-

    fessor Ji-Dong Jia, Liver Research Center, Bei-

    jing Friendship Hospital, China. He noted that

    there are both voluntary and compulsory licens-

    es, and tiered pricing eg, US$0.50 per day for

    TDF in Thailand.

    Furthermore, there is a need for Asian coun-

    tries to establish long-term follow up systems

    MAY-JUNE 2015 NEWS 12

  • to monitor and evaluate patients in relation to

    efficacy and safety of treatment, treatment com-

    pliance and disease progression, he added.

    Documenting disease burden of hepatitis B

    is a challenge in sub-Saharan Africa, said Pro-

    fessor Olufunmilayo Lesi, Gastroenterology and

    Hepatology Unit, department of medicine, Col-

    lege of Medicine, University of Lagos, Nigeria.

    Although hepatitis B screening is done rou-

    tinely in blood transfusion services, antenatal

    care (in some hospitals) and health screening,

    there are no clear guidelines for population

    screening. Assessment of liver disease is most-

    ly done in specialist and referral and private

    hospital settings. Most chronically infected per-

    sons are unaware and undiagnosed, she said.

    So, these guidelines provide an opportunity

    for a paradigm shift in hepatitis management

    [It] certainly simplifies treatment and resources

    to prioritize those in greatest need of treatment,

    which will reduce the health cost disparity and

    contribute to the regional control of hepatitis B

    infection, said Lesi.

    These guidelines are an important step to-

    wards making sure that governments have

    treatment programs for hepatitis B, and get re-

    imbursement for the best drugs, said Charles

    Gore, president, World Hepatitis Alliance, Lon-

    don, UK.

    At the same time, we need help from the

    governments to outlaw stigma. Too many coun-

    tries have allowed testing and then exclusion of

    people with hepatitis B from education or em-

    ployment. And that again is not acceptable. We

    have to make sure the guidelines are put into

    practice by all countries, he said.

    Fish oil consumption may induce chemoresistanceJENNY NG

    Consuming fish oil has been shown to in-duce chemo-resistance in mice, leading experts to advise avoiding fish and fish oil sup-

    plements when undergoing chemotherapy.

    Patients with cancer often adopt lifestyle

    changes such as taking dietary supplements

    with the intention to influence and improve their

    health. However, mice studies showed that add-

    ing the fatty acid fish oil component 16:4(n-3) to

    cisplatin chemotherapy substantially reduced

    the drugs effect on tumour suppression.

    MAY-JUNE 2015 NEWS 13

  • A 95.5 mm3 difference in tumour volume was

    seen in mice treated with 16:4(n-3) plus cispla-

    tin vs cisplatin alone (p=0.04), while cisplatin

    alone effectively reduced tumour volume by

    142.4 mm3. [JAMA 2015, doi:10.1001/jamaon-

    col.2015.0388]

    Similar chemoresistant effects of 16:4(n-

    3) were seen with irinotecan and oxaliplatin

    (p

  • FDA to assist pharma in developing abuse-deterrent opioidsCHRISTINA LAU

    The US FDA is to assist the pharmaceuti-cal industry in developing abuse-deterrent opioids and in making these safer formulations

    available sooner, according to a final guidance

    document issued on 1 April 2015.

    These safer opioids are to be formulated in

    ways that make it more difficult to inhale or in-

    ject the medications.

    The document, titled Abuse-Deterrent Opi-

    oids Evaluation and Labelling Guidance for

    Industry, is part of the FDAs efforts to curb

    the escalating misuse or abuse of prescrip-

    tion opioids in the US, which has become a

    public health concern. [http://www.fda.gov/

    downloads/Drugs/GuidanceComplianceReg-

    ulatoryInformation/Guidances/UCM334743.

    pdf; Addiction 2014;109:177-181; Addiction

    2014;109:185-186]

    The science of abuse-deterrent medication is

    still relatively new and rapidly evolving. The FDA

    is eager to engage with manufacturers to sup-

    port advancements in this area and make these

    medications available as quickly as possible,

    said FDA Commissioner, Dr. Margaret Hamburg.

    In the Asia-Pacific region, Australia takes the

    lead in the opioid epidemic and the develop-

    ment of measures against abuse.

    The prescription of oxycodone and tramad-

    ol in Australia saw dramatic increases between

    1992 and 2007, said William Chui, President

    of the Society of Hospital Pharmacists of Hong

    Kong. In Victoria, a 21-fold increase was seen

    in the detection of oxycodone in deaths reported

    to the Coroner between 2000 and 2009. Almost

    54 percent of the cases of death were the result

    of drug toxicity. [Inj Prev 2011;17:254-259]

    Diversion of prescription opioids to drug

    abusers or dealers is very common in Austra-

    lia. To curb the opioid epidemic, a formulation

    of hydromorphone is enteric-coated with a hard

    substance to prevent abuse through injection,

    he told MIMS. Furthermore, community phar-

    macists actively provide counselling and moni-

    toring for patients on opioid therapy through a

    government-run programme.

    In the rest of Asia Pacific, little data is pub-

    lished on the prevalence of opioid diversion,

    he continued. In Hong Kong, opioid diversion

    is uncommon because these analgesics are

    generally underused except in oncology set-

    tings. Also, our choice of opioid analgesics is

    limited, and no abuse-deterrent opioids are cur-

    rently available on the Hong Kong market.

    Although the development of abuse-de-

    MAY-JUNE 2015 NEWS 15

  • terrent opioids can help reduce diversion and

    abuse, Chui said pharmacists also play impor-

    tant roles in ensuring appropriate use of these

    medications. Their roles include opioid pre-

    scription monitoring, identification and referral

    of patients at risk of opioid abuse, and collab-

    orative care with physicians in cases of misuse,

    abuse or diversion, he suggested.

    In Hong Kong, opioid registries should be

    implemented and made mandatory for all pre-

    scribers, including those in the private sector,

    he added.

    Tenofovir safe, effective in pregnant women with hep B refractory to lamivudine or telbivudineLIANNE COWIE

    Tenofovir monotherapy appears to be both safe and effective for treating pregnant women with chronic hepatitis B refractory to lamivudine or

    telbivudine, according to a recent study in China.

    In the retrospective study, clinical data were

    evaluated from 17 pregnant women (median age

    30.6 [range 2345] years) with chronic hepatitis B

    resistant to lamivudine or telbivudine therapy who

    were subsequently treated with tenofovir mono-

    therapy. [World J Gastroenterol 2015;21:2504-

    2509]

    The median level of hepatitis B virus (HBV) DNA

    among the women was 5.9 (range 4.27.2) log10

    copies/mL at baseline. Ten women also had ab-

    normal levels of alanine aminotransferase (ALT).

    All of the women were treated with tenofovir 300

    mg/day initiated at a median gestational age of 15

    (range 028) weeks and continued for a median

    of 24.4 (range 1240) weeks. The researchers de-

    termined the effects of tenofovir on maternal and

    perinatal outcomes, foetal growth and develop-

    ment, and neonatal prognosis.

    At the time of delivery, HBV levels were signifi-

    cantly reduced to

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  • Hepatitis C virus (HCV) infection is a major global public health issue and chronic

    infections can lead to cirrhosis and end-stage liver disease or hepatocellular carcinoma.

    Existing drug regimens have been limited by poor response in some patient subgroups

    as well as a lack of efficacy across the range of HCV genotypes. Sofosbuvir (Sovaldi,

    Gilead), a nucleotide polymerase inhibitor, terminates HCV RNA synthesis and leads

    to sustained virological response across a number of HCV genotypes.

    Sofosbuvir for hepatitis C virus infection

    NAOMI ADAM

    MSc (Med), Category 1

    Accredited Education Provider

    (Royal Australian College of General Practitioners)

    Introduction

    Hepatitis C virus (HCV) infection is emerging

    as a major public health issue worldwide. Acute

    infection is the cause of over 54,000 deaths an-

    nually. However the major burden of disease is

    due to the adverse consequences of chronic in-

    fection. About 20 percent of patients with HCV

    eventually develop cirrhosis and die due to end-

    stage liver disease or hepatocellular carcinoma.

    It is estimated that there are 3-4 million new HCV

    infections each year and 170 million people with

    chronic infection. [Hepatology 2013;57:1333-42]

    The prevalence of HCV is relatively high in

    some parts of Asia: in East Asia (China, Hong

    Kong, Macau, North Korea, Taiwan) 3.7 percent

    and South Asia (Afghanistan, Bangladesh, Bhu-

    tan, India, Nepal, Pakistan) 3.8 percent. Preva-

    lence is lower in Southeast Asia (including Ma-

    laysia, Philippines, Thailand, Vietnam) at 2.0

    percent and high-income Asia-Pacific nations

    (Brunei, Japan, South Korea, Singapore) 1.4 per-

    cent. [Hepatology 2013;57:1333-42]

    With the rising prevalence and serious con-

    sequences of HCV infection, there is an urgent

    need for effective and safe therapies. The first

    treatment used was interferon alfa-2b introduced

    in the early 1990s, followed a few years later by

    interferon alfa-2a. Combination therapy with the

    antiviral ribavirin was introduced in 1998.

    More recently, the protease inhibitors telapre-

    vir and bocepravir have become a third compo-

    nent of standard care for HCV. With this approach,

    a subgroup of patients are able to achieve a sus-

    tained virological response (defined as complete

    eradication of the virus) and enjoy an excellent

    benefit in terms of reversal of liver fibrosis and re-

    duction in long-term adverse hepatic outcomes.

    MAY-JUNE 2015 DRUG PROFILE 17

  • A significant proportion of patients, however, do

    not respond. Furthermore, many patients experi-

    ence intolerable side effects from interferon. In

    others, interferon cannot be commenced due to

    contraindications or an unwillingness to take the

    therapy.

    Another limitation of available therapies arises

    from the fact that HCV exists in at least six distinct

    genotypes. The protease inhibitors are effective

    in patients infected with HCV genotype 1 (the

    more commonly occurring genotype) and 2, but

    have no or limited efficacy in other genotypes.

    This has stimulated interest in alternative thera-

    peutic strategies and interferon-free regimens.

    [Digestive Liver Dis 2014;46:S174-S178; Ther

    Adv Chronic Dis 2015;6:414] The emerging class

    of nucleotide polymerase inhibitors has been the

    subject of intense research in recent years, with

    15 candidate drugs investigated. To date, only

    one of these sofosbuvir has been approved

    for clinical use. [Phamacogenom Personal Med

    2014;7:387-98]

    Pharmacology and pharmacokinetics

    Sofosbuvir is a prodrug that undergoes in-

    tracellular metabolism in the liver to form GS-

    461203 a triphosphate analogue of uridine

    nucleotides, modified by the addition of methyl

    and fluoro groups. During replication of HCV,

    GS-461203 competes with naturally occurring

    uridine and is incorporated into the growing RNA

    strand in a process mediated by NS5B protein

    an RNA-dependent RNA polymerase. The struc-

    tural modifications introduced into the strand

    limit elongation and lead to premature termina-

    tion of RNA synthesis, thereby stopping viral rep-

    lication. GS-461203 is highly specific to its viral

    target and has no affinity for human RNA or DNA

    polymerases. [Pharmacogenom Personal Med

    2014;7:387-398; Product Monograph, SOVAL-

    DI (sofosbuvir). Gilead Sciences Inc.]

    Sofosbuvir is rapidly absorbed orally, with

    plasma levels peaking within 0.5-2 hours. Ab-

    sorption is slowed by the presence of food,

    however overall exposure remains the same. It

    is readily taken up by hepatocytes from the plas-

    ma, where a number of activation steps occur.

    The triphosphate metabolite has a long intracel-

    lular half-life of 17.8 hours. Eventually dephos-

    phorylation produces inactive metabolites that

    are mainly cleared by the kidney.

    Clinical efficacy

    The phase II ELECTRON study of sofosbu-

    vir (with and without ribavirin) provided prom-

    ising proof of concept that the oral nucleoside

    polymerase inhibitor could produce a sustained

    virological response in HCV, without the need

    for interferon. This prompted phase III investi-

    gations. Five trials (FISSION, POSITRON, FU-

    SION, NEUTRINO and VALENCE, n = 1724)

    studied the effects of sofosbuvir in combination

    with ribavirin or pegylated interferon plus ribavi-

    rin, mostly in treatment-nave but also in previ-

    ously treated patients with chronic HCV. Many of

    the subjects (16-34 percent) had cirrhosis. The

    PHOTON-1 study enrolled subjects that were

    co-infected with HCV and HIV-1, while a further

    study was conducted in patients awaiting liver

    transplantation. The clinical trials program pro-

    vided sufficient data for product registration and

    clearly demonstrated that sofosbuvir represents

    MAY-JUNE 2015 DRUG PROFILE 18

  • a major advance in the treatment of HCV. Sus-

    tained virological response rates were 89-90 per-

    cent among patients with genotypes 1, 4, 5 and

    6 treated with pegylated interferon, ribavirin and

    sofosbuvir for 12 weeks.

    Sofosbuvir targets the highly conserved active

    site of the HCV polymerase and this results in an-

    tiviral activity across the spectrum of HCV geno-

    types albeit with some variations in potency.

    The drug also has a high barrier to the develop-

    ment of acquired resistance. Some intrinsic re-

    sistance to sofosbuvir exists in the NS5B S282T

    mutation, however this mutant has reduced re-

    productive fitness compared to wild-type virus

    and is also susceptible to ribavirin.

    Safety and tolerability

    Pooled analysis of phase III trials found that

    permanent treatment discontinuations due to

    adverse events occurred in 4 percent of patients

    receiving placebo, 1 percent for subjects receiv-

    ing sofosbuvir plus ribavirin for 12 weeks,

  • MAY-JUNE 2015 BUSINESS 20

    New headquarters to help Sigma-Aldrich support AsiaPac clientsRADHA CHITALE

    Life science and biotechnology firm Sigma-Aldrich opened a new regional business headquarters at Singapores Biopolis Research

    Park in April, consolidating existing laboratories

    and offices to become a supply hub for phar-

    maceutical manufacturers in the Asia Pacific

    region.

    The new facility also houses the companys

    Cell Culture Technical Center, the first such cen-

    ter in the region, which will focus on developing

    and optimizing cell culture media for clients.

    Mr. Jason Apter, vice president at Sigma-

    Aldrich and the Asia Pacific managing director,

    noted the ease of reaching out to regional clients

    in Tokyo, Shanghai, Bangalore, and elsewhere,

    from Singapore, as well as the significant front

    and back ecosystems here of talent that can com-

    municate across the region.

    [This headquarters] is the only place from

    which we can technically support customers in

    Asia, Apter said.

    The company also plans on completing a re-

    gional distribution center in Tuas by the end of the

    year.

    Sigma-Aldrich is one of several biomedical

    sciences companies, including Amgen, Novar-

    tis, and GlaxoSmithKline, that are capitalizing

    on Singapores strategic location and business

    infrastructure to grow their Asia operations.

    Today, the fact that nine of the top 10

    Mr. Kevin Lai (center) with executives from Sigma-Aldrich at the launch of the Cell Culture Technical Center at Biopolis Research Park. Photo courtesy of Sigma-Aldrich.

    global pharmaceutical companies have a

    presence in Singapore across manufacturing,

    headquarters and R&D operations is testimo-

    ny to the continued growth of our pharmaceu-

    tical industry, said Mr. Kevin Lai, executive

    director of Biomedical Sciences and Con-

    sumer Businesses of the Singapore Econom-

    ic Development Board. We welcome Sigma-

    Aldrichs new investment and are confident

    that this will further strengthen our supporting

    ecosystem for biopharmaceutical manufac-

    turing and R&D.

    The overall goals of consolidating and ex-

    panding operations are to improve efficiency

    and profits, reduce risk, and accelerate speed-

    to-market for products from the many biotech

    companies in the region, from those well es-

    tablished companies in Korea, for example, to

    smaller start-ups in China. Apter said the rate of

    growth in the biotech sector will be twice what it

    has been in the US.

  • MAY-JUNE 2015 BUSINESS 21

    Novel radiation-free test to aid diagnosis of gastroparesis

    KAVITHA G. SHEKAR

    The US Food and Drug Administration (FDA) has approved gastric emptying breath test (GEBT) to aid the diagnosis of gastroparesis.

    GEBT measures carbon-13, a naturally exist-

    ing non-radioactive form of carbon-12, in a pa-

    tients breath. Gastric scintingraphy, the standard

    diagnostic test for gastroparesis, uses radioactive

    material and requires specialist training.

    [GEBT] can be performed in any clinical set-

    ting since it does not require the health care pro-

    fessionals administering the test to undergo spe-

    cial training or to take special precautions related

    to radiation emitting compounds, as no radioac-

    tive materials are used said Dr. Alberto Gutierrez,

    director of the Office of In Vitro Diagnostics and

    Radiological Health in the FDAs Center for De-

    vices and Radiological Health.

    The approval is based on a study of 115 par-

    ticipants who underwent both GEBT and gastric

    scintigraphy. Performed over a 4-hour period fol-

    lowing an overnight fast, GEBT measured the ra-

    tio of carbon-13 to carbon-12 in breath samples

    at multiple points, which is then compared to

    the baseline measure. Participants consumed a

    carbon-13 enriched meal containing scrambled

    egg-mix and Spirulina platensis. GEBT and scin-

    tigraphy results agreed 73-97 percent of the time.

    Gastroparesis interferes with normal diges-

    tion causing severe nausea and vomiting, dehy-

    dration, and malnutrition. Diabetes is the most

    common cause of gastroparesis. Other causes

    include infections, internal surgery, neurological

    disease like Parkinsons disease, and endocrine

    disorders like hypothyroidism.

    GEBT is not advisable for patients with an al-

    lergy to Spirulina, egg, milk, wheat, or certain

    lung diseases or conditions that cause small

    bowel malabsorption.

  • MAY-JUNE 2015 BUSINESS 22

    First home-use EEG device for autism launched in SingaporeELVIRA MANZANO

    A novel neurofeedback device designed to reduce overactive brain waves in children with autism has been rolled out in Singapore.

    MenteTM, touted as the first portable home-

    use electroencephalogram (EEG) device for au-

    tism, uses neurofeedback to help mentally relax

    patients with autism, allowing them to focus bet-

    ter and engage positively with the environment.

    Children with autism spectrum disorder

    [ASD] process sensory information sights and

    sounds in particular differently from children

    without autism, said Dr. Adrian Attard Trev-

    isan, founder and managing director of AAT Re-

    search, which makes Mente. They have higher

    levels of delta waves in the brain even during

    daytime and low levels of alpha [] and beta []

    waves. This causes many of the symptoms and

    distractions patients experience.

    The device comprises an EEG headband

    and a software application that creates tailor-

    made binaural beats to level the brainwaves ac-

    cording to a patients mental state. All it takes is

    40 minutes of use every morning and the effects

    last the rest of the day until the child goes back

    to sleep, Trevisan said. With sleep, the delta

    waves naturally increase so the process must

    be repeated daily. Depending on the childs

    symptoms, this treatment must be used for 4 to

    8 weeks to start seeing positive results.

    In one study, the use of Mente significantly

    reduced delta wave peaks and increased and

    wave peaks in children (age 6-18) with ASD,

    allowing them to be more relaxed over time.

    Parents reported that their children had fewer

    tantrums and were able to concentrate more. [J

    Neural Discord 2013;1:4]

    These led to longer attention spans, en-

    hanced relaxation and improved communi-

    cation skills for most patients, said Trevisan.

    The device was originally developed to help a

    friends son who had Aspergers syndrome, a

    form of autism that affects language and behav-

    ioral development in children.

    I spent time observing him, watching him

    carefully, trying to figure out how I could help.

    Through this neurofeedback technology, chil-

    dren like him with autism can focus and better

    engage with the world.

    Mente is FDA-registered and has been given

    the CE Medical mark of approval as a medical

    device in April. It is easy to set up and doesnt

    require specialist supervision, making it ideal

    for home use, said Trevisan.

  • MAY-JUNE 2015 CLINICAL PHARMACY 23

    Imatinib may be a novel treatment option for colon cancerRADHA CHITALE

    Imatinib halves colon tumour growth and may be a novel method for preventing or control-ling colon cancer, according to Singaporean

    and Swedish researchers.

    In mice with human colon cancer, imatinib

    was shown to prolong survival, said Dr. Parag

    Kundu, senior research fellow at Nanyang Tech-

    nological Universitys (NTU) Lee Kong Chian

    School of Medicine, Singapore. The drug was

    also effective in increasing the survival of mice

    with late-stage tumours and rectal bleeding.

    [Sci Transl Med 2015;7:281ra44]

    Imatinib targeted and blocked cell recep-

    tors of EphB proteins, which control growth and

    movement of intestinal stem cells and progeni-

    tor cells.

    Importantly, while imatinib blocked EphB re-

    ceptors, it did not affect EphB itself, which acts

    to prevent progression to invasive carcinoma.

    When administered in vitro to cancerous cells

    taken from humans with colon cancer, imatinib

    performed similarly to the mouse model.

    Although there are side effects associated

    with long-term imatinib use cardiotoxicity and

    oedema are the most serious these could be

    attenuated by administering treatment in short,

    intermittent bursts, the researchers said.

    Our work has important clinical implica-

    tions, since imatinib is a potentially novel drug

    for the prevention and treatment of colorectal

    cancer, said senior principal investigator Pro-

    fessor Sven Pettersson of the Lee Kong Chian

    School of Medicine, Singapore and Karolinska

    Institute in Solna, Sweden.

  • MAY-JUNE 2015 CLINICAL PHARMACY 24

    Paracetamol study highlights risks of long-term use

    A new study shows paracetamol, the worlds most commonly used and recommended painkiller, is not as benign as once thought.

    Until recently, paracetamol was perceived

    as relatively safe, but new research shows pa-

    tients with chronic pain on long-term, highdose

    paracetamol are increasing their risk of kidney,

    intestinal and heart problems, and also death.

    In a systematic review of paracetamol safety

    studies, UK researchers selected eight obser-

    vational studies to analyse. [Ann Rheum Dis; 2

    March early online publication]

    Two studies showed an increase in mortality

    of up to 63 percent for longterm paracetamol

    users, compared with those not prescribed

    it. Four showed a higher risk of kidney dam-

    age and another four reported cardiovascular

    events increasing by between 19 to 68 per-

    cent.

    Gastrointestinal problems also increased in

    one study. Generally, the higher the dose, the

    higher the risk, researchers found.

    The researchers acknowledged their results

    may be affected by the study populations often

    being on other drugs to treat multiple comor-

    bidities, and also that paracetamols benefits

    may still outweigh its risks for many people.

    However, given that recent studies have

    called into question the efficacy of paracetamol

    for treating osteoarthritis joint pain and acute

    low back pain, they wanted health profession-

    als to think carefully before recommending or

    prescribing paracetamol for long-term use.

    Based upon the data presented above, we

    believe the true risk of paracetamol prescription

    to be higher than that currently perceived in the

    clinical community. Given its high usage and

    availability as an over-the-counter analgesic,

    a systematic review of paracetamols efficacy

    and tolerability in individual conditions is war-

    ranted, the researchers say.

    However, the industry body for over-the-

    counter medicines is pointing to the long his-

    tory of use and well-established safety profile of

    paracetamol.

    The study only looked at people on prescrip-

    tions for paracetamol, but, in a press release,

    Self Medication Industry executive director Tim

    Roper says the maximum recommended dose

    for people over 12 years is 4000mg in a 24-hour

    period, and people should consult a medical

    professional if they want more.

    Arthritis New Zealand chief executive Sandra

    Kirby says the study is a timely reminder that all

    medications have side effects, but urged peo-

    ple not to be alarmed.

    This latest study is another of the ongoing

    challenges chronic pain sufferers face of bal-

    ancing pain relief with potential adverse effects.

    The internet is full of information about

    adverse effects from painkillers, including

    paracetamol, but often pain relief will allow

    people to participate in everyday activities, in-

    cluding exercise, which in turn helps with ar-

  • MAY-JUNE 2015 CLINICAL PHARMACY 25

    thritis, Kirby says.

    Pharmacists should reassure people that

    as long as they take their paracetamol as pre-

    scribed and have regular check-ups, the ben-

    efits usually outweigh the risks.

    Pharmacists can also talk to people about

    other ways of managing their pain, such as

    through exercise, joint support, relaxation

    techniques, and hot and cold packs. There

    is also good evidence for acupuncture, mas-

    sage, capsaicin cream and transcutaneous

    electrical nerve stimulation (TENS), which

    uses electricity to stimulate the nerves, Kirby

    says.

    Directing people to the Arthritis New Zealand

    helpline is another good option, she says.

    Pharmacists can really add value by looking

    at the patients whole picture, finding out what

    other pain management they are using, includ-

    ing complementary medicine, and looking for

    drug interactions.

    Pharmaceutical Society clinical advisor Bob

    Buckham says the standard advice following

    studies such as this, is people shouldnt just

    stop taking their medication without discussing

    it with their doctor first. Unichem Hillpark Phar-

    macy owner Kathy Maxwell says she has not

    had any customer queries following the release

    of the study, but says patients would

    have to consider what the alternatives to

    paracetamol are and how their safety profiles

    compare. PTNZ

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  • Pharmacists can help to ease chronic pain patients off opioids

    Pharmacists have a vital role to play in iden-tifying and referring patients with chronic pain, according to pain specialists.

    About 17 percent of the population has

    chronic pain, which lasts for longer than three

    to six months, New Zealand Pain Society presi-

    dent-elect and chronic pain clinical psychologist

    Frances James says.

    Thats one person in five, and certainly not

    all of them are making it to a specialist, James

    says.

    In acute cases, pain is useful because it alerts

    the patient to an injury and encourages them to

    look after the injured area, she says.

    But chronic pain is like an alarm that sounds

    and then cant be turned off, James explains.

    Pain doesnt always mean that somethings

    wrong, but were programmed to believe it is,

    and thats what people are often very frightened

    of.

    Pain clinics help patients with chronic pain

    live with that pain and maximise quality of life.

    In most cases, it is important to keep moving,

    and the likes of physiotherapy or acupuncture

    can help, James says.

    Patients who are coming into the pharmacy

    to buy a lot of overthe-counter (OTC) pain medi-

    cation should be referred to a doctor, and should

    be checked to see if they are taking the recom-

    mended doses, she says.

    We commonly find people who are really sore

    will take a handful of Panadol [paracetamol], as

    opposed to whats recommended, James says.

    The more that pharmacists can ask sensible

    questions and give quality advice, the better, be-

    cause there are a lot of people living with chron-

    ic pain, she says.

    New Zealand Pain Society president and pain

    medicine specialist Brigitte Gertoberens agrees

    many patients self-medicate and take pain med-

    ications incorrectly.

    There are heaps of patients, especially head-

    ache patients, who self-medicate and it would

    be helpful if pharmacists help them, because

    you see them before we do, Gertoberens says.

    Medication over-use headaches, or rebound

    headaches, are caused by taking too much pain

    medication. They are the third most common

    type of headache, after migraine and tension-

    type headaches, according to the Healthcare

    Handbook 2014 (pp8889).

    Patients can become addicted to pain medi-

    cations and can suffer from adverse effects, and

    pharmacists need to educate them about this,

    Gertoberens says.

    Pharmacists should advise patients with on-

    going pain to consult their GP, and ask for a re-

    ferral to a pain service, if necessary. It is impor-

    tant to rule out anything sinister that could be

    causing the pain.

    Medications play a minor role

    In a pain clinic, medications play a minor role

    in the management of chronic pain, Gertobe-

    MAY-JUNE 2015 PHARMACY PRACTICE 26

  • rens says.

    They can be useful, but are never curative,

    and patients often show adverse reactions.

    Tricyclic antidepressants are one treatment

    option, and can be useful if the patient is also

    suffering a mental health condition, she says.

    Other options for long-term use include epi-

    lepsy medication gabapentin.

    Opioids are not considered useful for non-

    cancer chronic pain, Gertoberens says. Pa-

    tients who have been taking opioids should be

    weaned off them, but this needs to be done as

    part of a team, she says.

    The movement against opioids

    An Auckland GP who specialises in addic-

    tion, Graham Gulbransen, agrees doctors and

    pain services are very much against the use of

    opioids. People build up a tolerance and need

    bigger and bigger doses. On the other hand,

    people like me, and a lot of GPs, see people

    who arent getting adequate pain relief unless

    they do take adequate doses of opioids.

    Controlled dispensing is one way to control

    opioid use, reducing the risk of overdose or di-

    version, Gulbransen says.

    Referring patients to a pain service is another

    option, but the waiting lists can be as long as

    nine months, he says.

    Other medications like tricyclic antidepres-

    sant amitriptyline and anticonvulsant gabapen-

    tin should be considered, Gulbransen says.

    They are less likely to be diverted to other

    people, [patients are] less likely to build up a tol-

    erance, and they are most likely to be safer, but

    some people will have intolerable side effects,

    he says.

    Gulbransen encourages pharmacists to ring

    the doctor with any queries, especially for opioid

    prescriptions. Pharmacists should also look out

    for drug-seeker red flags, including frequent ap-

    pearances, scripts in different names or scripts

    that have been changed.

    Pharmacies have a role to play

    Pharmacists can play a big role in the man-

    agement of chronic pain, according to Welling-

    tons Miramar pharmacist Ann Privett.

    Customers who are frequently buying strong

    OTC pain relievers, such as codeine-containing

    medicines or diclofenac, are queried, Privett

    says.

    Its very easy for us to see, on our LOTS com-

    puter system, their history of OTC purchases, all

    we have to do is put their name in, she says.

    That often opens the door for us to say we

    notice that youre buying quite a lot of these, do

    you want to talk to us about it?

    Pharmacies can help patients manage their

    pain, such as by suggesting glucosamine and

    chondroitin if the person has arthritic pain, or re-

    ferring the patient to physiotherapy or acupunc-

    ture, Privett says.

    Its important to find out exactly what the pain

    is, so you can have a chat with them about it.

    If we notice that their usage rate is not ap-

    propriate, we will not sell [an OTC product] to

    them, and will refer them to a doctor.

    Long-term help needed

    Privett also works with her local general prac-

    tice to assist patients suffering from chronic pain

    MAY-JUNE 2015 PHARMACY PRACTICE 27

  • who have been taking opioid pain medications

    for years.

    At the request of GPs, and in consultation

    with them, she helps these patients manage

    their medications, in a service similar to a medi-

    cines therapy assessment.

    Privett initially meets with patients weekly to

    discuss their medications, then monthly.

    Some are on horrendous doses, she says.

    Usually we look at ways of reducing the co-

    deine and tramadol, and anti-inflammatories, in

    a very, very slow and structured regimen, and

    increasing other medication, like amitriptyline

    and gabapentin.

    If a patient is being taken off opioids, it is im-

    portant they are not left in pain and have some

    sort of other pain relief, Privett says.

    Once the process starts, we usually find

    weve got good acceptance because the patient

    doesnt want to be on these drugs.

    KEY POINTS: About 17% of people suffer from chronic pain.

    Pharmacies play a key role in identifying and refer-

    ring patients who use too many OTC pain reliev-

    ers.

    Pharmacists can help patients come off opioids

    with intense one-on-one care.

    Privett also refers patients to pain clinics,

    when available, and encourages patients to dis-

    tract themselves from the pain, with a number

    taking up crochet.

    While the patients are registered with the

    Long Term Conditions service, Privett admits

    this is not enough funding to cover the cost of

    the service.

    Its what the doctors want, and, ethically, you

    cant turn these patients away. Plus it is really

    rewarding, she says. PTNZ

    MAY-JUNE 2015 PHARMACY PRACTICE 28

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    2015-MIMSmobileapp156x216_NewLogo.indd 1 27/4/15 9:50 am

  • MAY-JUNE 2015 IN FOCUS 29

    Irritable bowel syndrome patients need guidance, supportWith as many as 20 percent of people having irritable bowel syndrome, many customers

    are looking for help to manage their symptoms.

    Irritable bowel syndrome (IBS) is a common gastrointestinal disease.Symptoms typically include abdominal bloat-

    ing and pain, diarrhoea with occasional periods

    of constipation, and mucus in the stools, accord-

    ing to the Healthcare Handbook 2014.

    Symptoms can range from minor and occa-

    sional, to severe and disabling.

    When it comes to health, IBS patients have

    similar quality of life to those with diabetes and

    end-stage renal patients (Pharmacy Today, Sep-

    tember 2013).

    There are not a lot of New Zealand data indi-

    cating how frequent IBS is, aside from a Dunedin

    population-based study which estimated 20 per-

    cent of the population has the syndrome, Christ-

    church gastroenterologist Richard Gearry says.

    I usually say about one in six women and

    one in nine men have irritable bowel syndrome,

    and most of my colleagues would agree, Gearry

    says.

    There are a number of theories as to why the

    syndrome is more common in women, including

    a possibility of it being related to endometriosis

    or hormones, or more reporting by women, he

    says.

    The causes of IBS are currently unknown and

    are not defined anatomically or biochemically. Di-

    agnosis is based on chronic and relapsing symp-

    toms.

    Irritable bowel syndrome does not do any

    long-term damage even if untreated, Gearry

    says.

    However, it is important for patients to get a

    proper diagnosis to rule out anything else in-

    cluding cancer, inflammatory bowel disease like

    Crohns and ulcerative colitis, or coeliac disease.

    Pains that are not specific require clinical

    tests, and they may require faecal tests or blood

    tests to be sure, Gearry says.

    And then, if a diagnosis has been made, it

    comes down to what symptoms annoy people

    the most if its constipation, look at agents for

    that, if its diarrhoea there are agents for that.

    Greenhithe pharmacist Samit Patel, who spe-

    cialises in natural treatments to manage bowel

    conditions, agrees a proper diagnosis is essen-

    tial. Youre looking for all the red flags, including

    how long they have had symptoms, if there is a

  • MAY-JUNE 2015 IN FOCUS 30

    lot of mucus in the stools. Blood in the stools al-

    ways needs to be checked out.

    People who have been diagnosed with IBS

    will know all about it, but some patients know

    nothing about the condition, Patel says.

    People frequently coming into the pharmacy

    for products for diarrhoea or constipation should

    be encouraged to see their doctor.

    For some patients, diagnosis is a process, as

    it can take years to eliminate everything.

    These patients still need support, and can be

    treated as if they have some sort of inflammatory

    bowel condition, Patel says.

    Manage flare-ups first

    Managing primary symptoms is one of the

    first steps in managing IBS, particularly if they are

    suffering from bad diarrhoea, Patel says.

    Over-the-counter medicines can help with

    symptoms.

    Peppermint in oil or tea form can help get

    rid of bloating, and aloe vera can help soothe the

    stomach. A good probiotic is also worth recom-

    mending, he says.

    An Auckland dietitian recommended by gas-

    troenterologists, Nikki Talacek, agrees probiotics

    are good for people with unhappy guts.

    But it is important they do not contain

    fructo-oligosaccharides (FOS) as they are

    usually not tolerated by people with IBS,

    Talacek says.

    Other products, including turmeric, Boswellia

    and essential amino acid glutamine, can also

    help with inflammation, Patel says. It is important

    to encourage the patient to come back and give

    feedback about whether the products work, he

    adds.

    I always emphasis a bit more care, rather

    than just giving a product thats pharmacys

    point of difference.

    Diet is key to managing IBS

    Managing diet is important in managing IBS,

    as different foods can often trigger symptoms,

    Gearry says.

    There are a million different diets recommend-

    ed for IBS but the only one clinically proven to

    help is the low-Fodmap (fermentable oligosac-

    charides, disaccharides, monosaccharides and

    polyols) diet.

    Studies replicated in Australia, New Zealand

    and the UK show 75 percent of patients will get a

    significant improvement in abdominal pain, diar-

    rhoea and bloating with a low-Fodmap diet, he

    says.

    Gearry outlines Fodmaps in a Pharmacy To-

    day How to Manage feature (September 2013).

    Oligosaccharides are shortchain carbohy-

    drates found in large amounts in wheat, barley,

    rye and some vegetables like onions and cab-

    bage.

    Disaccharides include lactose, with high-lac-

    tose foods including cows milk yoghurt and ice-

    cream.

    Monosaccharides include fruits with high fruc-

    tose-to-glucose ratio, such as pears, apples and

    watermelon.

    Polyols are sugar alcohols found in stone fruit,

    some vegetables and some sugar-free products.

    As the low-Fodmap diet is so exclusionary,

    patients need to consult a Fodmap-trained dieti-

    tian, to make sure they do not become deficient

  • MAY-JUNE 2015 IN FOCUS 31

    in nutrients, Talacek says.

    Information is power

    Patel agrees a proper low-Fodmap diet

    which involves reducing all Fodmap foods then

    slowly reintroducing them is very involved and

    requires someone to offer the patient guidance.

    He offers one-hour clinical sessions, which his

    patients pay for, or a dietitian is another option.

    But pharmacies can always better inform their

    patients, including talking about the low-Fodmap

    diet, Patel says.

    There are information sheets available to hand

    out to patients and even a Fodmap app, he says.

    As people are told fruit and vegetables are

    healthy to eat, they may not realise they could be

    causing them problems, he adds.

    Start simple in pharmacy

    Rather than telling patients what they should

    be eliminating, Patel prefers to suggest things

    that they can eat.

    Rice with fish or chicken is a simple dish that

    is easily digestible. Vegetables like carrots are

    good, and cooked foods are easier to digest

    than raw foods, he says.

    Its about keeping the food a little bit bland

    and allowing the bowel to heal up, he says.

    Another option is a soup or bone broth, with

    vegetables added then strained out, giving good

    nutrition, but not too much fibre.

    Stress also needs addressing

    Stress is another trigger that also needs to be

    reduced, Gearry says.

    Ms Talacek agrees, saying food alone isnt the

    answer. The gut has got more nerves than ev-

    erywhere else in the body. Everything around us

    has an effect on the gut.

    Reducing caffeine and alcohol is also impor-

    tant, as is getting adequate sleep, and drinking

    water.

    Antidepressants an option

    Antidepressants are another treatment for IBS,

    with both tricyclic antidepressants and selective

    serotonin reuptake inhibitors (SSRIs) shown to

    be effective, Gearry says.

    Antispasmodics, such as meberverine, have

    also been shown to be effective for the manage-

    ment of abdominal pain due to spasm.

    However, not all patients want to be on these

    medications, and lifestyle changes should be

    tried first, he says.

    IBS is a lifestyle disorder so, if you can man-

    age it with lifestyle, thats a much better approach

    than putting someone on a drug long term. While

    there are data that they work, many patients

    wouldnt want to go on an antidepressant.

    The gut is hypersensitive, so any stimulus

    will cause symptoms at a much lower threshold

    than people without IBS. You can reduce sensi-

    tivity with drugs or you can reduce the triggers

    [through diet]. PTNZ

    KEY POINTS: Patients with IBS symptoms need a GP

    assessment to rule out anything more

    sinister.

    OTC products can help manage symptoms as a

    first step.

    A low-irritant diet and stress reduction are key for

    longterm management of IBS.

  • ISSN 2382-6487

    EDITORIAL ADVISORY BOARD S INGAPORE

    Associate Professor Chui Wai KeungHead of Department of Pharmacy, Faculty of Science National University of Singapore (NUS)

    Assistant Professor Lita ChewChief Pharmacist, Ministry of Health, Singapore Registrar, Singapore Pharmacy Council Head, Pharmacy Department, National Cancer Center Singapore Assistant Professor, Department of Pharmacy, NUS

    Associate Professor Alexandre Chan Department of Pharmacy, NUS Associate Consultant Clinical Pharmacist, Department of Pharmacy National Cancer Center Singapore

    Dr. Joyce Yu-Chia LeeAssistant Professor of Clinical Pharmacy Department of Pharmacy, NUS Principal Clinical Pharmacist, National Healthcare Group Polyclinics

    P U B L I S H E R

    Ben Yeo

    M A N A F I N G E D I T O R

    Elvira Manzano

    D E P U T Y M A N A F I N G E D I T O R

    Radha Chitale

    C O N T R I B U T I N G E D I T O R S

    Saras Ramiya, Pank Jit Sin, Dr Joslyn Ngu (Malaysia)

    B U S I N E S S M A N A G E R

    Carrie Ong, Josephine Cheong, Melanie Nyam

    D E S I G N E R S

    Razli Rahman, Anson Suen, Joseph Nacpil, Agnes Chieng, Cindy Ang, Ryan R.A. Baranda,

    P R O D U C T I O N

    Jasmine Chay

    C I R C U L A T I O N E X E C U T I V E

    Christine Chok

    A C C O U N T I N G M A N A G E R

    Minty Kwan

    A D V E R T I S I N G C O O R D I N A T O R

    Angeline Chua

    P U B L I S H E D B Y

    MIMS Pte Ltd 6 Shenton Way, #15-08 OUE Downtown 2, Singapore 068809 Tel: (65) 6290 7400 Fax: (65) 6290 7401 Email: [email protected]

    MIMS Pharmacy is published 6 times a year by MIMS Pte Ltd. MIMS Pharmacy is on controlled circulation publication to pharmacists in Singapore. It is also available on subscription to members of allied professions. The price per annum is US$48 (surface mail) and US$60 (overseas airmail); back issues at US$5 per copy. Editorial matter published herein has been prepared by professional editorial staff. Articles ending with PTNZ have been adapted from Pharmacy Today New Zealand. Views expressed are not necessarily those of MIMS Pte Ltd. Although great effort has been made in compiling and checking the information given in this publication to ensure that it is accurate, the authors, the publisher and their agents shall not be responsible or in any way liable for the continued currency of the information or for any errors, omissions or inaccuracies in this publication whether arising from negligence or otherwise howsoever, or for any consequences arising therefrom. The inclusion or exclusion of any product does not mean that the publisher advocates or rejects its use either generally or in any particular field or fields. The information contained within should not be relied upon solely for final treatment decisions.

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