Study: Pregnant women with diabetes at higher risk of delivering baby with birth defect
NEWCASTLE UPON TYNE, England — Pregnant women with diabetes are almost four times more likely to have a baby with a birth defect than women without the condition, and the likelihood is linked to the mother’s glucose level, according to a new study released by Newcastle University Monday.
The study, led by researchers at Newcastle University and the Regional Maternity Survey Office and funded by Diabetes UK, suggests that as many as 1-in-13 deliveries to women with Type 1 or Type 2 diabetes involves a major congenital anomaly, also known as a birth defect.
The analysis showed that the risk of a birth defect in the pregnancies of women with Type 1 or Type 2 diabetes was 7%, compared to an average of around 2% in pregnancies in which the mother did not have diabetes. The chance of a birth defect was reduced significantly in women with diabetes who had blood-glucose levels within the recommended ranges — which, according to Diabetes UK, has highlighted the importance of healthcare teams encouraging women who are thinking of becoming pregnant to get their blood-glucose level as low as is safely possible.
But the researchers and Diabetes UK have emphasised that, while concerning, this still means that the vast majority of pregnancies in women with diabetes do not involve a birth defect. The study also showed that blood-glucose levels around the time of conception were the most important factor predicting risk of congenital anomaly.
The findings have prompted Diabetes UK to urge women with diabetes who are considering becoming pregnant to make sure they understand the importance of careful planning. The group has also called for England’s National Health Service to provide better care for women with diabetes who may be planning to have a baby and for women who are thinking of becoming pregnant to attend a pre-conception clinic if one exists in their area or to ask their general practitioner to put them in contact with a diabetes specialist if not.
"The risk of problems can be reduced by taking extra care to have optimum glucose control before becoming pregnant," stated Ruth Bell, the study’s lead researcher. "Any reduction in high glucose levels is likely to improve the chances of a healthy baby. " Previous research has established that having diabetes increases the chance of birth defects, but this is one of the first studies to quantify the effect of glucose levels on risk."
Published in the journal Diabetologia, the study involved an investigation of the recorded outcomes of 401,149 pregnancies, including 1,677 pregnancies in women with diabetes, between 1996 and 2008 in the north of England.
Diabetes UK has an online video about pre-conception care and diabetes available here.
NACDS chairman Loeffler, CEO Anderson urge pharmacy to be ‘disruptive innovator’
NAPLES, Fla. — Leaders of the National Association of Chain Drug Stores on Monday urged Regional Chain Conference attendees to participate in NACDS RxImpact Day on Capitol Hill, a key initiative designed to shape the public policy arena.
“If you can envision the possibility of your company being pushed off the edge of a cliff, as a result of policies that aren’t right and that jeopardize patient care, then you need to be with us in Washington, D.C., on March 21 and 22,” said NACDS chairman Robert Loeffler of H-E-B, referring to NACDS RxImpact Day on Capitol Hill, which will be held in Washington, D.C., on those dates.
“This is the event when pharmacy advocates — people just like you and me — meet with their members of Congress and help advance pro-pharmacy, pro-patient public policy,” Loeffler explained. “And we have no shortage of topics to discuss: Medicaid average manufacturer price and federal upper limits, medication therapy management and pharmacy benefit manager issues — in other words, policies that relate to the value and viability of community pharmacy, and everything that it means for patient care.”
NACDS president and CEO Steve Anderson said that NACDS is more focused than ever before on showcasing and empowering the “wonderful things that community pharmacy does every day,” and helping to make possible community pharmacy’s role as a “disruptive innovator” — a term advanced by Harvard Business Professor and author Clayton Christensen, which also was an inspiration to the late Steve Jobs in his work at Apple.
Anderson described “disruptive innovation” as an innovation that creates new markets and value networks. Pharmacy is providing innovations that are creating new methods of healthcare delivery and that are lowering healthcare costs, according to Anderson.
“If we position community pharmacy effectively as the face of neighborhood health care, this industry will emerge as a disruptive innovator and will create a positive long-term impact on healthcare delivery and for the good of patients. But we cannot just sit back and let that happen; we have to get out and fight for it,” Anderson said.
Anderson also noted Christensen’s and Jobs’ emphasis on the importance of focusing on core priorities and products, and on Jobs’ demand that people working for a company have to be in love with the product. “We at NACDS love that we represent a product — community pharmacy — that is adding so much value to healthcare delivery and to the American people, in terms of savings lives and improving lives."
Loeffler and Anderson highlighted NACDS’ engagement on pharmacy benefit manager issues as an example of the high-stakes environment facing pharmacy patient care in the policy and political realms. They noted NACDS’ work to highlight the potential anti-competitive and anti-consumer ramifications of the proposed Express Scripts and Medco merger, as well as NACDS’ advocacy for legislation to regulate PBMs.
Loeffler said, “Increased rancor on the part of the PBMs is accompanied by a damaging array of PBM practices, all of which you personally know too well. Let me throw out just a few and see if they sound familiar to you: lack of transparency; the frequency, or should I say infrequency, of updating [maximum allowable cost] pricing; more margin compression each year; restricted networks; unreasonable and capricious audit rules; use of our patients’ data; [and] blatant conflicts of interest, including converting your patients to mandatory mail order — in short, topics that threaten the sustainability of many in this room, and that threaten the access and cost of care to the patients we serve.”
Summarizing NACDS’ effort to battle the proposed Express Scripts and Medco merger given the deep concern of NACDS member companies, Loeffler summarized, “Well, we’ve heard what you had to say about it … and now we’re hearing what consumer groups, antitrust watchdogs, federal and state legislators, and others have to say about it.”
Anderson concluded by giving credit to the passion for patient care that is demonstrated every day by community pharmacy and that guides the work of NACDS. He said, “Looking back over the past five years or so, I see an NACDS that better resembles your spirit” and compared NACDS to the persona of Winston Churchill, who said: “It was the nation … dwelling all round the globe that had the lion’s heart. I had the luck to be called upon to give the roar.”
“I propose today that it is all of you in community pharmacy who possess and portray the lion’s heart — and it is the responsibility and privilege of NACDS to reflect your passion, and to sound the roar,” Anderson said.
Mylan acquires rights to two Valeant drugs
PITTSBURGH — Mylan has completed its acquisition of two skin drugs from Valeant Pharmaceuticals, the generic drug maker said Monday.
Mylan announced that it had acquired the regulatory approval applications for generic clindamycin phosphate and benzoyl peroxide gel, a generic version of Valeant’s BenzaClin, and a license to manufacture and market fluorouracil cream in the 5% strength, a version of Valeant’s Efudex.
The first drug, which according to IMS Health had sales of about $205 million in 2011, is used to treat acne. The second drug, which had sales of $79 million, is used to treat basal cell carcinomas and actinic or solar keratoses, a skin condition that can be a precursor to skin cancer.