< PreviousHEALTH & SAFETY20Pharma Business International www.pbiforum.netPHOTO: SHUTTERSTOCK.COM/RGTIMELINEPHOTO: SANTIBHAVANK P / SHUTTERSTOCK.COM18-21_Layout 1 10/04/2017 12:24 Page 3Pharma Business International 21www.pbiforum.netHEALTH & SAFETYguidelines only, and cannot be enforcedin hospitals. The WHO have also updated their ownguidelines on the use of PPE, includingmandatory training in how to use theequipment in a no-risk environment, priorto being allowed to approach patients.Although all of this is currently limited tothe Ebola crisis, experts believe that theguidelines issued here could bestandardised to dealing with allpotentially dangerous viral epidemics inthe future. However, the Assistant Director-General for Health Systems andInnovation at the WHO, Marie-PauleKieny, says “Although PPE is the mostvisible control used to preventtransmission; it is effective only if appliedtogether with other controls includingfacilities for barrier nursing and workorganisation, water and sanitation, handhygiene and waste management.”The bottom line for pharmaceuticalcompanies is that PPE, and the way thatstaff use it, has come into the spotlightheavily over the recent months. Whilethere have yet to be any large cases inthe pharmaceutical research ormanufacturing industry, it will only take asingle case of contamination to open thefloodgates to negative attention for theseindustries as well. Companies are beingadvised to look at their investment intoPPE, and consider the potentialramifications of failing to update theirequipment and systems to handle thehigh danger of such threats as Ebola,HIV or any other dangerous virus. 18-21_Layout 1 10/04/2017 12:24 Page 4BIRTH CONTROL22Pharma Business International www.pbiforum.netThe saying goes that if you canremember the sixties, you weren’t reallythere. But the decade is bestremembered as being a time ofchange; countercultural, societal andsexual. Second wave feminism sawwomen kicking against thepatriarchy, and putting a crack inthe glass ceiling. It was also theflower power generation that werethe first to receive therevolutionary new birth control pill.Suddenly, women were able toenjoy the same sexual freedoms ofmen, without having to worry aboutunwanted pregnancies or resorting toabortive measures. Though the pill was apharmaceutical cornerstone and a majorturning point in the history of women’sliberation, the contraceptive is stillassociated with blood clots anddepression. A number of high profile cases acrossthe UK in which young women died fromthromboembolism (blood clots) believedto be symptomatic of their specificcombined contraceptive have sparked amoral panic. The tabloids fanned theflames with fear-baiting headlines statingmillions of women were at risk. The pillitself doesn’t directly lead to blood clots,but rather puts the user at higher risk byup to three or four times. The NHSestimate the figure at around 12 womenper 10,000 thought to be at risk in anygiven year. A recent review found that thebenefits of using this form of combinedcontraception outweighed the negative. Another pervasive notion surroundingthe pill is that it causes depression andanxiety. The most recent data comesfrom Denmark, where researchesidentified a link between the pill anddepression, particularly in young andadolescent women. The nationwide studyincorporated more than 1 million Danishwomen between 15 and 34 over a 13year period. The aim was to determine aconnection between first diagnoses ofdepression among users of differenttypes of hormonal contraception: the pill,patch, IUS and vaginal rings. Thelimitations of this study, though, need tobe addressed. It wasn’t a controlledtrial, with numerous environmental,societal and even economic factorsto consider. The study was alsoannexed from information fromDanish health care professionals,meaning the subsequent datawas skewed. While we have yet to determinethe severity, it’s clear from thesefindings, other studies and first-hand accounts from users, that thepill can wreak havoc with women’shormones, exacerbate underlying issuesor contribute towards disorders thatmight have otherwise lain dormant.Further in-depth and controlled study isrequired to provide comparative resultsand determine the extent of the effect. The world’s longest-running study intooral conceptive use, however, recentlymade a surprising discovery. Newresearch from the University of Aberdeenin Scotland has found that women whohave taken the oral contraceptive pill areprotected from some types of cancer foras long as thirty years.The results – published in theAmerican Journal of Obstetrics andGynaecology – showed that having everWe need to talkabout birth controlIt’s been over fifty years since the introduction of the birth control pill, acontraception still mired in controversy. © Shutterstock / Barbara J. Johnson24 Á22-25_Layout 1 10/04/2017 11:13 Page 1© Shutterstock / areeya_ann22-25_Layout 1 10/04/2017 11:13 Page 2BIRTH CONTROL24Pharma Business International www.pbiforum.netused the pill, women are less likely tohave colorectal cancer, endometrialcancer or ovarian cancer than womenwho had never used the pill. It alsolooked at the risk of all types of cancer inwomen who have taken the pill. Resultsshowed that using the pill during theirreproductive years does not producenew cancer risks later in life – the timewhen more cancers typically occur.Established by the Royal College ofGeneral Practitioners’ in 1968, the OralContraception Study has the primary aimof investigating the long-term healtheffects of oral contraceptives. Theselatest findings – led by Dr Lisa Iversen –relate to 46,000 women, followed for upto 44 years, creating more than 1.2million woman-years of observation.Dr Iversen, Research Fellow in theInstitute of Applied Health Sciences atthe University, says: “Because the studyhas been going for such a long time, weare able to look at the very long termeffects, if there are any, associated withthe pill.“What we found from looking at up to44 years’ worth of data, was that havingever used the pill, women are less likelyto get colorectal, endometrial andovarian cancer.“So the protective benefits from usingthe pill during their reproductive years arelasting for at least 30 years after womenhave stopped using the pill.“We were also interested in what theoverall balance of all-types of cancer isamongst women who have used the pillas they enter the later stages of their life.We did not find any evidence of newcancer risks appearing later in life aswomen get older.”Male contraception has largely beenrelegated to condoms, fertility awarenessbased methods (such as withdrawal and‘outercourse’) or a vasectomy for a morepermanent solution. Over the last fewyears, though, calls for an effective andreversible method of male contraceptionhave grown louder. In 2016, the results of a clinical trialdetermining the effectiveness of a malecontraceptive were released. The maintakeaway was that the trial (a Phase IItrial in a three step process to securingUS Food and Drug Administrationapproval) posted a 96 per cent successrate. The findings, however, weredominated by the fact the trial was cutshort after a number of side effects –including mood changes and increasedacne – were shown to occur amongparticipants. The irony wasn’t lost onwomen. It immediately sparked a viralreaction on social media platforms and aslew of opinion pieces in mainstreammedia outlets. Yet the purpose of clinicaltrials is to identify these issues so theycan be resolved, later tested and, aboveall, preserve the safety of users. It’s easy to become jaded after almost60 years with oral contraception, but theinnocuous little pill remains a cornerstonein the pharmaceutical industry and thenarrative of women’s liberation. Thoughthere is indeed a likely link between thecontraception, blood clots anddepression, further in-depth studies andanalysis are needed so that a solution oralternative can evolve. For the millions ofwomen currently taking the pill, thebenefits outweigh the risks, at least untilan alternative is introduced. © Shutterstock / Image Point Fr22-25_Layout 1 10/04/2017 11:13 Page 3© Shutterstock / racorn22-25_Layout 1 10/04/2017 11:13 Page 4PACKAGING26Pharma Business International www.pbiforum.netThe point of packaging is loosely dividedin to two distinct categories, with the firstbeing functional. With nothing between aproduct and its environment, it falls onpackaging to protect its integrity. Thesecond category is aesthetic, giving aproduct on-shelf appeal and engaging withconsumers. A buyer’s first interaction withany given item is typically through its shelfappeal or advertising. For the pharmaceutical industry, it’s morecomplex, as while branded over-the-counter(OTT) products possess appealing graphicaldesigns, drug and medical products usuallycome packaged in simple, functionalpackaging. This design aims to protect theproduct as well as displaying and house allthe relevant information. Incorrect or missinginformation can spell disaster for apharmaceutical company who could be leftwith an expensive recall on their hands, aThe rise in counterfeit medicine hasforced pharmaceutical companies torethink their packaging. Counteringthecounterfeiters26-29_Layout 1 10/04/2017 11:14 Page 1PACKAGINGPharma Business International 27www.pbiforum.netlawsuit or, worse still, a hospitalised user.A case in point is with Nurofen, ReckittBenckiser’s targeted OTC pain relief. Themultinational consumer goods companywas recently slapped with a $6 millionfine, following a lengthy legal battle lastyear. Put simply, the company had anumber of medicines purporting to targetdifferent parts of the body, from migraineto period pain. All were found to containthe same active ingredient and did thesame thing, they were just packaged andpresented to suggest otherwise. The market is saturated withcounterfeit medicines, especially withmore and more consumers turningtowards online channels as a means ofprocuring drug products, illicit orotherwise. In many instances, theseproducts will closely resemble their realmarket counterparts, leading someconsumers to be fooled into thinkingwhat they’re purchasing is the same. Asthese medicines and their sellers remainunregulated, there’s no way of knowing ifwhat is being purchased is safe or fit forpurpose, leaving consumers vulnerable toharmful medicines. It is also creating aparallel economy alongside the globalpharmaceutical market, one which isdamaging stakeholders and eroding theoverall integrity of the industry. Combatting counterfeit medicines is abattle fought as much through regulationand surveillance as through packaging.The growing demand for safe packaginghas grown out of this dark marketsubsection, and to ensure that legitimatemedicines are kept safe from harmful28 ÁSHUTTERSTOCK.COM/PAVELGR26-29_Layout 1 10/04/2017 11:14 Page 2PACKAGING28Pharma Business International www.pbiforum.netenvironmental factors. This market is predicted torise at a CAGR of 12.1 per cent until 2026, accordingto the latest report from Future Market Insights. Innovation in the packaging segment is heraldingsome robust results. Some of the most commonexamples of anti-counterfeit measures are advancedholograms, as well as watermarks and barcodes. Aswell as presenting a challenge to counterfeiters,these measures also prove costly to recreate, oftencutting into whatever profits these manufacturers aremaking on the black market. Track and tracetechnology is common across a variety of industries,from food to pharmaceuticals. It helps manufacturersfollow a shipment from end-to-end, ensuring thatwhat leaves the production line is exactly whatarrives in a pharmacy, hospital or supplier. In theevent that counterfeit products flood the market, acompany can reassure consumers that their ownproducts are safe and secure. But counterfeiters are cunning, and will explorenew ways of recreating existing methods, no matterhow robust. To that end, the World HealthOrganisation (WHO) and the US Food and DrugAdministration actively encourage thepharmaceutical industry to integrate advanced anti-counterfeiting packaging technology, and to explorenew possibilities. In turn, it creates ever more robustsolutions, and creates value for makers and suppliersof anti-counterfeit packaging technology. Pharmaceutical packaging ranges from theubiquitous blister pack to complex delivery systemssuch as epinephrine autoinjector for diabetics. All arevulnerable to adulteration and counterfeiting in amarket place that has become a breeding ground fora dark economy. As consumers turn to cheaperalternatives, the risk of taking unregulated medicinesthat can lead to severe side effects and even deathrises. To tackle the issue, manufacturers andregulators are incorporating increasingly innovativeanti-counterfeit measures as standard for packages.As the market is forecast for impressive growth overthe coming years, it shows the severity of the issue,but also how the solution is going from strength tostrength. 26-29_Layout 1 10/04/2017 11:14 Page 3Pharma Business International 23www.pbiforum.netPACKAGINGBut counterfeiters arecunning, and will explorenew ways of recreatingexisting methods, nomatter how robust.26-29_Layout 1 10/04/2017 11:14 Page 4Next >