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Drug Information Bulletin Drug Information Centre (DIC) Indian Pharmaceutical Association Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org

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Ireland passes reference pricing,pro-generics lawLegislation to enable the introduction of reference pricing and pro-genericinitiatives has now been passed by bothhouses of Ireland's parliament(Oireachtas) and is expected to takeeffect next month.Welcoming the passage of the Health(Pricing and Supply of Medical Goods) Bill2012, Health Minister Dr James Reilly saidthe legislation gives effect to thegovernment's commitment that referencepricing and greater use of generics will beintroduced "to reduce the state's large

drug bill and the cost to individuals of their medicines. It will promote pricecompetition and deliver lower medicineprices for both the state and patients," hesaid.Currently in Ireland, if a specific brand of medicine is prescribed for a patient, thepharmacist must supply that brand - theycannot supply cheaper generic versions.However, under the Bill, they will now bepermitted to substitute medicines whichhave been designated by the IrishMedicines Board (IMB) asinterchangeable.

Content Editorial Ireland passes reference pricing, pro-generics law USPNF Compendial updates FDA approves RFID-Enabled Blood Bag tracker Study reveals Physicians insufficiently informed of Drug Side Effects

E d i t o r i a l

Use of generic medicines is gradually getting popularity. Several countries havealready passed suitable legislation to reduce Govt. health expenditure and thecost to individuals of their medicines. Recently Ireland Govt. has passedlegislation for introduction of reference pricing and pro-generic initiative.It may be noted that several state Governments and the Govt. of India hasdirected the doctors working under the Government health care system toprescribe in generic name. The Medical Council of India has also directed allprescriber to prescribe in generic name as far as possible. These developments

will give a fillip in promotion of the concept of Rational Use of Medicines (RUM)and will help to improve access to essential medicines.

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"It is only where the IMB is satisfied thata medicinal product satisfies all theconditions set out in the Bill that it can doso," noted Alex White, the Minister of State with responsibility for primary careat the Department of Health."To further enhance patient safety, thebill allows a prescriber to indicate on aprescription that a brandedinterchangeable medicinal productshould, for clinical reasons, not besubstituted," he added.The Bill also introduces a referencepricing system which will establish theprices that the Health Service Executive(HSE) will pay for products supplied topatients under the General Medical

Services (GMS) and community drugschemes. If patients wish to receive abrand that costs more than the referenceprice, they will have to pay the additionalcost out-of-pocket, but in cases wheresubstitution is prohibited for clinicalreasons, patients will not pay anyadditional costs if the prescribed productcosts more than the reference price.Currently, usage of generics in Ireland isvery low - patients in the UK are fourtimes more likely to use them - and athird of medical cardholders in Ireland,who now account for more than half thepopulation, are not using generics.However, Teva Pharmaceuticals Irelandhas this month launched a campaign tohelp raise awareness of genericmedicines and provide assurances ontheir safety, quality and affordability.The campaign, Understandgenerics.ie, is

supported by 400 pharmacies nation-wideand fronted by veteran televisionpresenter Gay Byrne. It includes a videoat http://bit.ly/hlgenerics .

"Through Understandgenerics.ie, Ilearned that generics are approved inexactly the same way as all othermedicines, guaranteeing that generics

meet the required safety and qualitystandards," says Mr Byrne. "Withgenerics, the name, packet or colour of your medication may change, but what'sinside is essentially the same, only moreaffordable."

However, a group representing peoplewith epilepsy has been campaigningstrongly to have anti-epilepsy drugs(AEDs) excluded from substitution, andhas expressed strong concern that thisexemption was not included in the finalBill.The risks associated with switching frombranded AEDs to generic AEDS, or moreparticularly from one generic version to

another, have been highlighted "onnumerous occasions," says the group,Epilepsy Ireland."It has been extremely frustrating to seea series of amendments voted downwhich would have offered safety andreassurance to people with epilepsy. Agolden opportunity to enshrine the rightsof people with epilepsy has been missed, says the group's chief executive, MikeGlynn.The challenge now for Epilepsy Ireland isto ensure that the IMB does notdesignate AEDs as interchangeable, hesaid. The group will also launch aneducation campaign to educate peoplewith epilepsy about staying safe, toinform prescribers of the need to write"do not substitute' on AED prescriptionsand to ensure that pharmacists do notswitch AEDs, said Mr Glynn.

However, he added, Epilepsy Ireland hasreceived reports that AED switching hasbeen taking place even before the Billwas passed.- The new legislation also sets outstatutory procedures governing thesupply, reimbursement and pricing of medicines and other items to patientsunder the GMS and community drugs

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schemes. It will allow the HSE to attachconditions to the supply of certain items,provided that any restrictions areevidence-based and in the interests of patients and ensuring value for money,the government adds.

USPNF Compendial updates

Recently the US-NF updated the followingmonographs:Seven New Revision Bulletins:

* Anagrelide Hydrochloride (posted 31-May-2013; official 01-Jun-2013)* Atorvastatin Calcium (posted 31-May-2013; official 01-Jun-2013)

* Cefdinir for Oral Suspension (posted31-May-2013; official 01-Jun-2013)* Griseofulvin Tablets (posted 31-May-2013; official 01-Jun-2013)* Saw Palmetto Extract (posted 31-May-2013; official 01-Jun-2013)* Temozolomide (posted 31-May-2013;official 01-Jun-2013)* Verapamil Hydrochloride Extended-Release Capsules (posted 31-May-2013;official 01-Jun-2013)Three New Interim Revision

Announcements:

* Escitalopram Oxalate (posted 31-May-2013; official 01-Jul-2013)* High Fructose Corn Syrup (posted 31-May-2013; official 01-Jul-2013)* Tamsulosin Hydrochloride Capsules (posted 31-May-2013; official 01-Jul-2013)

FDA approves RFID-Enabled BloodBag trackerMedPage Today (5/30, Gever) reportsthat the US Food and Drug Administrationon Tuesday announced it has approvedBrookfield, Wisconsin-based SysLogicsiTrace, a radio frequency identificationtagging system that uses small memory

chips placed on blood component bagsand readers to download data and storeinformation on the contents in the bagsand their expiration dates as well as other

collection and processing details. TheiTrace system would be used alongsideexisting labels and barcode IDs, theagency said in the announcement. FDACenter for Biologics Evaluation andResearch Director Dr. Karen Midthunexplained that the iTrace for BloodCenters will be used in bloodestablishments by trained personnel as atool in streamlining blood collection andprocessing and aiding in product trackingand reconciliation.

Study reveals Physiciansinsufficiently informed of Drug SideEffects

An international study involving 255physicians practising in Vancouver,Montreal, Sacramento and Toulousefound that physicians are not givenenough information about the adverseeffects of drugs during presentationsmade by medical sales representativesfrom pharmaceutical companies. And yet,these same physicians are willing toprescribe at least some of the presented

drugs. Dr. Genevive Durrieu (from thePharmaco-epidemiology team assessingthe use of medication and the risksinvolved, Unit 1027 Epidemiology andpublic health analyses: risks, chronicdiseases and handicaps Inserm /Universit Toulouse III Paul Sabatier)led the French part of this study, theresults of which are published in the

Lecture on

Clinical Trial -What and Why"

By Dr Srirupa Pal8th June Saturday at 6pm

in IPA Auditorium

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Journal of General Internal Medicine.Within the framework of this internationalstudy, is France proving to be a modelstudent?Prescription-only drugs play a major partin the therapeutic care of the patient.However, they can also have adverseeffects on the patients health. Severalstudies have shown that the informationprovided by the medical sales repsstrongly influence the decision to add adrug to a prescription, often without thephysician being fully aware of the sideeffects. In order to find out more,international researchers carried out anaccurate study on the quality of theinformation given by medical sales reps

when promoting drugs to physicians.4 sites were selected: Vancouver,Montreal, Sacramento and Toulouse. Thephysicians were selected by a draw. Of the 704 physicians contacted, 36%agreed to participate. Then informationwas gathered about 1692 drugspromoted by medical sales reps betweenMay 2009 and June 2010.

After each visit from the sales rep, thephysicians were asked to fill in aquestionnaire about how the drugs werepromoted by the sales rep: they gaveinformation (benefits and risks) abouteach promoted product, handed out freesamples and gave invitations to events.

An overall lack of informationIn this study, the researchers reportedthat the information given by the medicalsales reps concentrated on the benefits of the drugs presented more often than

their potential risks. And the same situation was reported forall sites in the study (Montreal,Sacramento, Toulouse and Vancouver).During more than half of the visits madeto promote drugs (59%), the sales repdid not mention any adverse effects atall. This figure rose to 66% for Vancouverand Montreal. Even more worrying: the

results showed that serious side effectsof drugs were only mentioned in 6% of the sales promotions.France may be a model student, but..France differs from other countries by thefact that that the risks are mentionedmore often by the sales reps: in 61% of cases to be exact.But the overall figure taking into accountall the countries involved in the studygave an average of only 41%.However, this figure must be consideredwith caution, because the informationgiven mainly concentrated on frequentand benign side effects (such as nausea,diarrhoea), whereas, in the other sites,94% of presentations mentioned no

serious side effect whatsoever.On the other hand, the therapeuticbenefits are highlighted in 80% of cases.Physicians are willing to prescribepromoted drugsIn this study and whatever the country,2/3rds of physicians declared that thepresentation would encourage them toprescribe a promoted product, or would

probably or very probably incite themto prescribe this product more often.What are the rules applicable to medicalsales reps?In France and in the USA, governmentauthorities in charge of medicationregulations are in charge of the rules andsupervision of medical sales reppresentations at physicians surgeries. InFrance an additional approach wasintroduced in 2005. It is known as theCharter of Ethics for Pharmaceutical Sales

Visits. This charter sets out theauthorized and the prohibited practicesand the information that must be given tothe physician.In Canada, the medical sales rep visitsare regulated by Canadas research-basedpharmaceutical companies (Rx& D), whoset out criteria concerning the informationto be given to the physician.